Prospective , randomized , multicenter , controlled phase 2/3 clinical trial .


The study comprised 43 trial sites in Germany , India , and the United States .


Enrolled patients ( n = 97 ) were randomized to 1 of 3 groups : treatment group A ( n = 36 ) , treatment group B ( n = 40 ) , and the control group ( n = 21 ) .


Patients from each group received either of 2 doses of subconjunctival CsA ( group A , low-dose CsA ; group B , high-dose CsA ) or placebo ( carrier only ) implants at the time of high-risk penetrating keratoplasty .


The incidence and degree of corneal neovascularization occurring after penetrating keratoplasty were evaluated in a substudy ( LX201-01 study : NCT00447187 ) .


A web-based image upload system was developed .


Standardized digital slit-lamp pictures were quantitatively and objectively evaluated using CellF morphometry software .


No statistically significant difference in incidence and degree of corneal neovascularization developing after penetrating keratoplasty was found between treatment groups and placebo group .


Mean corneal neovascularization area at week 52 ( visit 12 ) was 2.321.79 % in treatment group A versus placebo ( 2.792.11 % ; P = 0.45 ) and 2.742.22 % in treatment group B versus placebo ( 2.792.11 % ; P = 0.94 ) .


High-dose subconjunctival CsA implants do not significantly affect corneal neovascularization after high-risk penetrating keratoplasty .


This suggests that local CsA has negligible antiangiogenic effects in the human cornea , at least in the transplant setting .


Cardiovascular diseases ( CVD ) and metabolic alterations are among the majors public health concern that have been reported in people living with HIV infections .


Factors contributing to cardio metabolic syndrome in HIV include body fat distribution , dyslipidemia , insulin resistance , cardiovascular dysfunction and inflammation .


The aim of the study was to determine the effect of Spirulina platensis ( Cyanobacteriaceae ) supplementation versus local diet on lipid profile in HIV-infected antiretroviral-naive patients .


A prospective single-blind , randomized , multicentre study was conducted from February 2010 to December 2012 .


A total of 320 HIV antiretroviral-nave patients were screened and 169 were recruited in this study .


Patients were randomized and received either Spirulina supplementation combined with local diet ( n = 82 ) or local diet only ( n = 87 ) .


Age , weight , body mass index ( BMI ) , lipid profile , CD4 count , and local food intake variables were assessed on three separate occasions ( three , six and twelve months ) .


An average age of the patients was 35.69 years .


The majority of participants were female 67.1 % .


Regarding the lipid profile , there is a significant increase in HDL-cholesterol and a significant decrease in total cholesterol , LDL-cholesterol and triglycerides in the group of patients who consumed Spirulina platensis .


A change in the atherogenic index defined by the ratio CT/HDL-C substitutable by LDL-C/HDL-C and the TC/HDL decreased significantly from 10.83 at baseline to 2.22 after 12 months ( p = 0.21 and p < 0.0001 ) in the patients taking Spirulina .


Nutritional supplementation with Spirulina combined with a quantitative and qualitative balanced diet for at least six months can retard an exposition to lipid abnormalities in HIV-infected antiretroviral-naive patients .


Further studies are recommended on a large group of people not infected with HIV and exposed to cardiovascular risk factors .


In the Strategic Reperfusion Early After Myocardial Infarction ( STREAM ) trial , a pharmaco-invasive ( PI ) strategy was compared with primary percutaneous coronary intervention ( pPCI ) in ST-segment-elevation myocardial infarction patients presenting within 3 hours after symptom onset but unable to undergo pPCI within 1 hour .


At 30 days , the PI approach was associated with a nominally but nonstatistically significant lower incidence of the composite primary end point of death , shock , congestive heart failure , and reinfarction when compared with pPCI .


The aim of the present study was to determine the effect of these strategies on 1-year mortality .


Vital status at 1 year was available in 936 of 944 ( 99.2 % ) and 941 of 948 ( 99.3 % ) patients in the PI and pPCI arm , respectively .


At 1 year , all-cause mortality rates ( 6.7 % versus 5.9 % ) were similar for PI and pPCI-treated patients ( P = 0.49 ; risk ratio , 1.13 ; 95 % confidence interval , 0.79-1 .62 ) .


Cardiac mortality rates were similar as well ( 4.0 % versus 4.1 % , P = 0.93 ; risk ratio , 0.98 ; 95 % confidence interval , 0.62-1 .54 ) .


Overall , only 34 patients died between day 30 and 1 year , 20 in the PI arm and 14 in the pPCI arm , of whom 20 died of noncardiac reasons ( 13 in the PI and 7 in the pPCI arm ) .


There was no significant difference in 1-year all-cause mortality between the 2 groups among the prespecified key subgroups .


At 1 year , mortality rates in the PI and pPCI arms were similar in ST-segment-elevation myocardial infarction patients presenting within 3 hours after symptom onset and unable to undergo pPCI within 1 hour .


http://www.clinicaltrials.gov .


Unique identifier : NCT00623623 .


To use measurement by cycling power meters ( Pmes ) to evaluate the accuracy of commonly used models for estimating uphill cycling power ( Pest ) .


Experiments were designed to explore the influence of wind speed and steepness of climb on accuracy of Pest .


The authors hypothesized that the random error in Pest would be largely influenced by the windy conditions , the bias would be diminished in steeper climbs , and windy conditions would induce larger bias in Pest .


Sixteen well-trained cyclists performed 15 uphill-cycling trials ( range : length 1.3-6 .3 km , slope 4.4-10 .7 % ) in a random order .


Trials included different riding position in a group ( lead or follow ) and different wind speeds .


Pmes was quantified using a power meter , and Pest was calculated with a methodology used by journalists reporting on the Tour de France .


Overall , the difference between Pmes and Pest was -0.95 % ( 95 % CI : -10.4 % , +8.5 % ) for all trials and 0.24 % ( -6.1 % , +6.6 % ) in conditions without wind ( < 2 m/s ) .


The relationship between percent slope and the error between Pest and Pmes were considered trivial .


Aerodynamic drag ( affected by wind velocity and orientation , frontal area , drafting , and speed ) is the most confounding factor .


The mean estimated values are close to the power-output values measured by power meters , but the random error is between 6 % and 10 % .


Moreover , at the power outputs ( > 400 W ) produced by professional riders , this error is likely to be higher .


This observation calls into question the validity of releasing individual values without reporting the range of random errors .


Communication and information in order to reduce anxiety in the intensive care unit ( ICU ) has been described as area needing improvement .


Therefore , the aim of this trial was to evaluate whether a structured information program that intensifies information given in standard care process reduces anxiety in ICU patients .


Multicenter , two-armed , non-blinded , parallel-group randomized controlled trial in hospitals in the cities of Marburg , Halle , and Stuttgart ( Germany ) .


The trial was performed in cardiac surgery , general surgery , and internal medicine ICUs .


Two-hundred and eleven elective and non-elective ICU patients were enrolled in the study ( intervention group , n = 104 ; control group , n = 107 ) .


The experimental intervention comprised a single episode of structured oral information that was given in addition to standard care and covered two main parts : ( 1 ) A more standardized part about predefined ICU specific aspects - mainly procedural , sensory and coping information , and ( 2 ) an individualized part about fears and questions of the patient .


The control group received a non-specific episodic conversation of similar length additional to standard care .


Both conversations took place at the beginning of the ICU stay and lasted 10-15 minutes .


Study nurses administered both interventions .


The primary outcome ICU-related anxiety ( CINT-Score , 0-100 pts. , higher scores indicate higher anxiety ) was assessed after admission to a regular ward .


The primary outcome could be measured in 82 intervention group participants and 90 control group participants resulting in mean values of 20.4 ( SD 14.4 ) compared to 20.8 ( SD 14.7 ) and a mean difference of -0.2 ( CI 95 % -4.5 to 4.1 ) .


A structured information intervention additional to standard care during ICU stay had no demonstrated additional benefit compared to an unspecific communication of similar duration .


Reduction of anxiety in ICU patients will probably require more continuous approaches to information giving and communication .


ClinicalTrials.gov NCT00764933 .


High blood pressure is associated with poor outcome after stroke .


Whether blood pressure should be lowered early after stroke , and whether to continue or temporarily withdraw existing antihypertensive drugs , is not known .


We assessed outcomes after stroke in patients given drugs to lower their blood pressure .


In our multicentre , partial-factorial trial , we randomly assigned patients admitted to hospital with an acute ischaemic or haemorrhagic stroke and raised systolic blood pressure ( systolic 140-220 mm Hg ) to 7 days of transdermal glyceryl trinitrate ( 5 mg per day ) , started within 48 h of stroke onset , or to no glyceryl trinitrate ( control group ) .


A subset of patients who were taking antihypertensive drugs before their stroke were also randomly assigned to continue or stop taking these drugs .


The primary outcome was function , assessed with the modified Rankin Scale at 90 days by observers masked to treatment assignment .


This study is registered , number ISRCTN99414122 .


Between July 20 , 2001 , and Oct 14 , 2013 , we enrolled 4011 patients .


Mean blood pressure was 167 ( SD 19 ) mm Hg/90 ( 13 ) mm Hg at baseline ( median 26 h [ 16-37 ] after stroke onset ) , and was significantly reduced on day 1 in 2000 patients allocated to glyceryl trinitrate compared with 2011 controls ( difference -70 [ 95 % CI -85 to -56 ] mm Hg / -35 [ -44 to -26 ] mm Hg ; both p < 00001 ) , and on day 7 in 1053 patients allocated to continue antihypertensive drugs compared with 1044 patients randomised to stop them ( difference -95 [ 95 % CI -118 to -72 ] mm Hg / -50 [ -64 to -37 ] mm Hg ; both p < 00001 ) .


Functional outcome at day 90 did not differ in either treatment comparison-the adjusted common odds ratio ( OR ) for worse outcome with glyceryl trinitrate versus no glyceryl trinitrate was 101 ( 95 % CI 091-113 ; p = 083 ) , and with continue versus stop antihypertensive drugs OR was 105 ( 090-122 ; p = 055 ) .


In patients with acute stroke and high blood pressure , transdermal glyceryl trinitrate lowered blood pressure and had acceptable safety but did not improve functional outcome .


We show no evidence to support continuing prestroke antihypertensive drugs in patients in the first few days after acute stroke .


UK Medical Research Council .


The mercury sphygmomanometer has been the gold standard used for obtaining blood pressure ( BP ) for the National Health and Nutrition Examination Survey ( NHANES ) from 1960 to the present .


However , due to environmental concerns and an increased use of automated oscillometric BP devices , NHANES has been exploring an alternative to using the standard mercury sphygmomanometer ( mercury ) to measure BP .


The accuracy of Omron HEM-907XL BP readings was compared with that of mercury BP device readings for gender , age group , race and ethnicity , and body mass index categories and cuff-size subgroups .


Each person had three BP measurements per device recorded sequentially .


The order of the devices and readers were randomly assigned .


A total of 6,460 participants had three valid systolic readings , and 6,338 had three valid diastolic readings .


Omron and mercury measurements were correlated ( r = 0.92 , systolic BP ; r = 0.79 , diastolic BP ) .


Overall , the mean between-device differences ( Omron and mercury ) were -1.6 mm Hg for systolic and -0.6 mm Hg for diastolic ( p < 0.05 for both ) .


The mean between-device differences were less than or about 2 mm Hg for each subgroup : gender , age group , race and ethnicity , and body mass index categories , and cuff-size subgroups .


The exceptions were mean systolic between-device differences for those using the extra-large BP cuff ( -3.1 mm Hg ) and obese individuals ( -2.6 mm Hg ) , and the mean diastolic between-device differences for the underweight group ( -3.5 mm Hg ) .


Assuming mercury to be the gold standard , between-device agreements for the frequency of high BP ( 140/90 mm Hg or more ) and stage II high BP ( 160/100 mm Hg or more ) were above chance ( kappa = 0.72 for both ) .


Omron underestimated the high BP frequency by 2.28 % and stage II high BP frequency by 0.77 % .


Lower estimates of high BP by the Omron device may require adjusting future national prevalence estimates accordingly to account for between-device differences .


Challenging behaviors exhibited by individuals with dementia might result from an unmet need that they can not communicate directly due to cognitive restrictions .


A dementia-specific case conference represents a promising means of analyzing and exploring these unmet needs .


The ongoing FallDem study is a stepped-wedged , cluster-randomized trial evaluating the effects of two different types of dementia-specific case conferences on the challenging behaviors of nursing home residents .


This study protocol describes the process evaluation that is conducted , along with the FallDem study.The goal of the process evaluation is to explain potential discrepancies between expected and observed outcomes , and to provide insights into implementation processes and recruitment strategies , as well as the contexts and contextual factors that promote or inhibit the implementation of dementia-specific case conferences .


The process evaluation will use a mixed-method design comprising longitudinal elements , in which quantitative and qualitative data will be gathered .


Qualitative data will be analyzed using content analysis , documentary analysis and a documentary method .


Quantitative data ( standardized questionnaires ) will be analyzed using descriptive statistics .


Both types of data will complement one another and provide a more comprehensive picture of the different objects under investigation .


The process evaluation will allow for a comprehensive understanding of the changing processes and mechanisms underlying the ` black box ' of the complex intervention of the FallDem study .


These findings will provide practical knowledge regarding issues related to the implementation of dementia-specific case conferences in nursing homes .


Current Controlled Trials identifier : ISRCTN20203855 , registered on 10th July 2013 .


The Achilles tendon is a tissue that responds to mechanical loads at a molecular and cellular level .


In vitro and in vivo studies have shown that the expression of anabolic and/or catabolic proteins can change within hours of loading and return to baseline levels within 72h .


These biochemical changes have not been correlated with changes in whole tendon structure on imaging .


We examined the nature and temporal sequence of changes in Achilles tendon structure in response to competitive game loads in elite Australian football players .


Elite male Australian football players with no history of Achilles tendinopathy were recruited .


Achilles tendon structure was quantified using ultrasound tissue characterisation ( UTC ) imaging , a valid and reliable measure of intratendinous structure , the day prior to the match ( day 0 ) , and then reimaged on days 1 , 2 and 4 postgame .


Of the 18 participants eligible for this study , 12 had no history of tendinopathy ( NORM ) and 6 had a history of patellar or hamstring tendinopathy ( TEN ) .


Differences in baseline UTC echopattern were observed between the NORM and TEN groups , with the Achilles of the TEN group exhibiting altered UTC echopattern , consistent with a slightly disorganised tendon structure .


In the NORM group , a significant reduction in echo-type I ( normal tendon structure ) was seen on day 2 ( p = 0.012 ) that returned to baseline on day 4 .


There was a transient change in UTC echopattern in the Achilles tendon as a result of an Australian football game in individuals without a history of lower limb tendinopathy .


To assess the feasibility of conducting a randomized trial comparing two strategies [ physician ( MD ) vs. non-physician ( non-MD ) ] for approaching substitute decision makers ( SDMs ) for research and to evaluate SDMs ' experiences in being approached for consent .


A pilot mixed methods study of first encounters with SDMs .


Of 137 SDMs ( 162 eligibility events ) , 67 and 70 were randomized to MD and non-MD introductions , respectively .


Eighty SDMs ( 98 events ) provided consent and 21 SDMs ( 24 events ) declined consent for studies , including 2 SDMs who provided and declined consent .


We identified few missed introductions [ 4/52 ( 7.7 % ) ] and protocol violations [ 6/117 ( 5.1 % ) ] , high comfort , satisfaction and acceptance scores and similar consent rates in both arms .


SDMs provided consent significantly more often when a patient update was provided in the MD arm .


Most SDMs ( 85.7 % ) felt that physician involvement was inconsequential and preferred physician time to be dedicated to patient care ; however , SDM experiences were closely related to their recall of being approached and recall was poor .


SDMs highlighted 7 themes of importance to them in research surrogate decision-making .


SDMs prioritized the personal attributes of the person approaching them over professional designation and preferred physician time to be dedicated to patient care .


A mixed methods design evaluated intervention fidelity and provided the rationale for not proceeding to a larger trial , despite achieving all feasibility metrics in the pilot trial .


NCT01232621 .


Describe the three-year results of a program designed for the adoption of a healthy life style in primary school students on the body mass index ( BMI ) and the consumption of food .


Community randomized and controlled trial .


Two communities in the State of Mexico with similar socio-demographic characteristics were randomized to implement the intervention ( n = 816 ) or serve as a control ( n = 408 ) .


The intervention was carried out in primary schools and it consisted of education on healthy habits , modification of distributed food and physical activity .


The primary outcome was the change in BMI .


After three years , intervention resulted in a lower increase of BMI ( 1.6 vs. 1.9 Kg/m , p < 0.01 ) and a decreased consumption of total calories , bread , fat and sugar consumption in the schools .


School programs are useful to address childhood obesity , but its benefits are not immediate .


To evaluate the clinical efficacy of electroacupuncture ( EA ) for apoplectic urinary incontinence .


Two hundred and four cases of apoplectic urinary incontinence were randomized into an EA group ( 136 cases ) and an indwelling catheter group ( 68 cases ) .


The EA was applied at Qugu ( CV 2 ) , Zhongji ( CV 3 ) , Shuidao ( ST 28 ) , Qihai ( CV 6 ) and Guanyuan ( CV 4 ) , etc. in the EA group ,5 times a week .


Indwelling catheter was applied in the indwelling catheter group at intervals of 2-4 hours , and periodic bladder irrigation along with bladder rehabilitation training were also given .


The efficacies were evaluated after 4 weeks of treatment .


Before and after treatment , the urination diary ( including the interval of urination , nocturia frequency , urination difficulty , urinary incontinence severity ) , bladder capacity , patients ' satisfaction of the two groups were observed and the efficacy was evaluated .


The total effective rate was 96.2 % ( 125/130 ) in the EA group , which was apparently superior to 87.5 % ( 56/64 ) in the indwelling catheter group ( P < 0.05 ) ; except for nocturia frequency in the indwelling catheter group , the total score and the subitem score in the urination diary were all improved significantly after treatment in both groups ( all P < 0.001 ) , which were more obvious in the EA group ( P < 0.001 , P < 0.05 ) ; the patients ' satisfaction and bladder capacity were all improved significantly after treatment in both groups ( all P < 0.001 ) , which were more obvious in the EA group ( both P < 0.001 ) .


The EA has an obvious effect for apoplectic urinary incontinence in urinary incontinence alleviation and bladder capacity increase , which has better efficacy than indwelling catheter therapy .


To determine changes in Canine Brief Pain Inventory scores for dogs with osteoarthritis after administration of a monoclonal antibody ( mAb ) against nerve growth factor ( NGF ) that was modified by use of a proprietary process for administration to dogs .


11 adult dogs .


Dogs received the anti-NGF mAb ( 0.2 mg/kg , IV ) at various evaluation times during the study period ; at other evaluation times , dogs received an equivalent volume of PBS solution IV .


Owners determined Canine Brief Pain Inventory pain severity ( PS ) and pain interference ( PI ) scores immediately before ( baseline ) and 2 , 4 , and 6 weeks after administration of the anti-NGF mAb ; owners were unaware of the evaluation time at which the mAb had been administered .


Compared with baseline PS scores ( median , 4.75 ; range , 0.75 to 8.5 ) , dogs had significantly lower PS scores 2 weeks ( median , 3 ; range , 1 to 5.5 ) and 4 weeks ( median , 2.25 ; range , 0.25 to 7.25 ) after administration of anti-NGF mAb .


Compared with baseline PI scores ( median , 5.33 ; range , 1.17 to 9.33 ) , dogs had significantly lower PI scores 2 weeks ( median , 3 ; range , 0.67 to 6.83 ) and 4 weeks ( median , 3.33 ; range , 0.67 to 6.67 ) after administration of anti-NGF mAb .


The PS and PI scores 6 weeks after mAb administration were lower than baseline scores , although values were not significantly different .


Results of this study suggested the evaluated anti-NGF mAb decreased PS and PI scores for 4 weeks after administration .


This treatment may be effective for alleviation of signs of pain in dogs with osteoarthritis for up to 4 weeks .


Dilation-assisted stone extraction , also termed small endoscopic sphincterotomy ( EST ) plus endoscopic papillary balloon dilatation , is more efficient than EST alone for removal of large common bile duct ( CBD ) stones .


However , whether this technique can be used for all stones is unclear .


This study was designed to evaluate the efficacy and complications of dilation-assisted stone extraction for CBD stones .


A total of 462 patients with CBD stones were randomized to undergo either dilation-assisted stone extraction ( group A ) or EST ( group B ) .


The efficacy and complications of the two techniques were compared .


Groups A and B showed similar outcomes in terms of stone removal .


The short-term and 1-year complication rates were also similar between the two groups .


However , the first-session stone removal rate in group A was significantly higher than that in group B. Mechanical lithotripsy was required significantly more often in group B than in group A.


The total procedure time and total fluoroscopy time in group A were significantly shorter than those in group B.


Dilation-assisted stone extraction and EST are safe and effective techniques for the treatment of CBD stones .


Dilation-assisted stone extraction has high efficiency .


This technique is an alternative method for removal of CBD stones .


The 5-amino acid ( AA ) signature , including isoleucine , leucine , valine , tyrosine , and phenylalanine , has been associated with incident diabetes mellitus and insulin resistance .


We investigated whether this same AA signature , single-nucleotide polymorphisms in genes in their catabolic pathway , was associated with development of impaired fasting glucose ( IFG ) after atenolol treatment .


Among 234 European American participants enrolled in the Pharmacogenomic Evaluation of Antihypertensive Responses ( PEAR ) study and treated with atenolol for 9 weeks , we prospectively followed a nested cohort that had both metabolomics profiling and genotype data available for the development of IFG .


We assessed the association between baseline circulating levels of isoleucine , leucine , valine , tyrosine , and phenylalanine , as well as single-nucleotide polymorphisms in branched-chain amino-acid transaminase 1 ( BCAT1 ) and phenylalanine hydroxylase ( PAH ) with development of IFG .


All baseline AA levels were strongly associated with IFG development .


Each increment in standard deviation of the 5 AAs was associated with the following odds ratio and 95 % confidence interval for IFG based on a fully adjusted model : isoleucine 2.29 ( 1.31-4 .01 ) , leucine 1.80 ( 1.10-2 .96 ) , valine 1.77 ( 1.07-2 .92 ) , tyrosine 2.13 ( 1.20-3 .78 ) , and phenylalanine 2.04 ( 1.16-3 .59 ) .


The composite P value was 210 ( -5 ) .


Those with PAH ( rs2245360 ) AA genotype had the highest incidence of IFG ( P for trend = 0.0003 ) .


Our data provide important insight into the metabolic and genetic mechanisms underlying atenolol-associated adverse metabolic effects .


Clinical Trial Registration - http://www.clinicaltrials.gov; Unique Identifier : NCT00246519 .


Tobacco use is still the leading preventable cause of death and morbidity in the U.S. Web-assisted tobacco interventions are an effective but underutilized tool in assisting smokers with quitting .


The dental visit is an excellent opportunity to assist smokers in quitting by referring them to these tobacco-cessation online programs .


The study purpose was to test two patient referral methods-paper referrals ( information prescriptions ) versus paper plus e-referrals-to a web-assisted smoking-cessation induction system .


RCT that used implementation research methods .


A total of 100 community-based dental practices were enrolled and 1814 smokers were referred to the web-assisted tobacco induction system .


The study intervention was a proactive e-referral of smokers to a web-assisted tobacco induction system called Decide2Quit.org , and the control group used paper referrals ( information prescriptions ) to refer smokers to the Decide2Quit.org .


The outcome measurements were the referral numbers , Decide2Quit registration numbers , and the smokers ' quit rate .


Data were collected in 2010-2011 and analyses were completed in 2012 .


Although total referrals from intervention practices was lower than control , subsequent proportions of registrations among smokers referred to Decide2Quit.org were nearly fourfold higher ( adjusted mean percentages : 29.5 % vs 7.6 % , p < 0.01 ) in intervention compared with control practices .


Subsequent rates of cessation among referred smokers were threefold higher ( adjusted mean percentages : 3.0 % vs 0.8 % , p = 0.03 ) in intervention practices as compared with control .


Intervention practices using the e-referral system had higher smoker registration numbers and higher quit smoking rates than the control practices .


This study finds that e-referrals are effective in getting smokers to the web-assisted smoking-cessation induction system and in assisting with quitting that more than compensates for any additional effort that e-referrals require on the part of the practitioner .


DPBRN Hygienists Internet Quality Improvement in Tobacco Cessation ( HiQuit ) ; NCT01108432 .


The plasticity of bone marrow stem cells has been confirmed to self-renew and transdifferentiate into hepatocytes .


Thus , we performed autologous stem cell transplantation for rapid liver regeneration with extensive hepatectomy in hepatocellular cancer patients .


With informed consent , patients aged 20 to 75 who needed large extensive hepatectomy due to hepatocellular carcinoma were randomly divided into three groups : control , mononuclear cells ( MNCs ) , and CD34 + cells , based on infused cell type .


After portal vein embolization ( PVE ) , mobilized MNCs or CD34 + cells were returned to the patient via the portal vein on mobilization day without manipulation .


Liver volume , liver function , clinical score and Indocyanine green R15 ( ICG-R15 ) were compared before and after PVE .


Total bilirubin , albumin , and clinical score showed significant improvement ( p < 0.05 ) 1 week post-infusion , with no significant difference between MNC and CD34 + cell groups .


Four patients ( control , 1 ; MNC , 1 ; CD34 + , 2 ) started at over 18 % ICG-R15 but can be overturned after PVE .


Daily hepatic volume growth ( mL/day ) was 2.5 for MNC and 4.9 for CD34 + groups , resulting in significant increase over controls ( 1.1 ; p < 0.05 ) .


We found no correlation between the number of applied CD34 + cells and daily gains in left lateral lobe volume .


Improvements in liver volume , liver function , clinical score and ICG-R15 suggest that autologous stem cell transplantation is a promising method for liver regeneration .


The aim of this study was to investigate the agreement between body composition measurements made with two methods-single-frequency bioelectrical impedance analysis ( SF-BIA ) and bioelectrical impedance spectroscopy ( BIS ) .


The body composition measurements using SF-BIA and BIS were performed seven times during 6 months on 41 patients ( 13 men and 28 women ) with metabolic syndrome who were taking part in a dietary intervention study .


The mean [ standard deviation ( SD ) ] fat mass ( FM ) and median [ interquartile range ( IQR ) ] FM % measured with SF-BIA were 32.7 ( 6.7 ) kg and 36.3 ( 30.3-39 .3 ) % , respectively , compared with 38.2 ( 8.7 ) kg and 40.9 ( 35.5-45 .6 ) % , respectively , using BIS .


The median ( IQR ) fat-free mass ( FFM ) was 60.0 ( 53.3-73 .5 ) kg according to SF-BIA and 55.4 ( 48.8-66 .5 ) kg according to BIS .


These results obtained with the two methods were significantly different ( P < 0.001 ) .


Still highly significant correlations were found between the results obtained with SF-BIA and BIS for FM and FFM ( all r0 .89 , P < 0.001 ) .


Using Bland-Altman analysis , the bias was found to be -5.4 ( 4.1 ) kg for FM , -5.5 ( 3.7 ) % for FM % , and 5.4 ( 4.1 ) kg for FFM .


Rather wide limits of agreement were found for FM , FM % , and FFM .


Body composition data obtained using SF-BIA and BIS in subjects with metabolic syndrome were highly correlated but not interchangeable .


FM was systematically lower when using SF-BIA than when using BIS .


Generics have the potential to contain drug therapy costs ; successful implementation of generic substitution policy largely depends on consumers ' willingness to choose generics .


This study aims to analyse the opinions , experiences and preferences of Polish patients towards generic medicines .


The study was performed in Poland .


The survey was conducted in June 2013 by means of face-to-face interviews .


Respondents were drawn from the general population according to a population structure .


The study covered a representative sample of 1,000 Poles ; the results can be generalized to apply to the Polish population at large .


Fifty-two percent of respondents declared to be more often choosing generics , twenty-three percent did not have any specific preferences , and twenty-five percent were more willing to choose brand-name medicines .


Past experience with cheaper generic medicines , secondary or lower education , low income and residence in specific regions of Poland were all significantly associated with an increased willingness to choose generics .


Respondents ' attitudes towards generics were mostly influenced by the opinions of doctors and pharmacists .


According to respondents , attitudes towards generics among doctors , pharmacists , family and friends , and in the mass media were mostly positive .


There was no relationship between the preference of respondents for generics and factors such as their age , life stage , gender , household size or urban/rural locality .


As a result of substituting a brand-name drug with its generic equivalent , 72 % of respondents reported that they had not noticed any difference in drug effectiveness ; 21 % had experienced a reduced effectiveness of treatment or increased side effects at least once ; and 7 % claimed the generic worked better .


The majority of respondents who used cheaper substitutes claimed that generics represented good or very good quality .


The study demonstrates that , when choosing medicines , Poles rely mainly on the opinions of their doctors and pharmacists .


Therefore , it is recommended that : ( 1 ) the option of using generics be promoted when writing prescriptions , and ( 2 ) the obligation on pharmacists to inform customers of their option to purchase generics be enforced .


Insertion of a nasopharyngeal airway ( NPA ) during endoscopic sedation is only recommended in the event of respiratory problems .


We evaluated the safety and efficacy of routine insertion of an NPA during sedation in gastrointestinal ( GI ) endoscopy .


Between July 2009 and April 2012 , patients with colonoscopy or expected longer-lasting or therapeutic upper GI endoscopy were pseudo-randomized in a weekly alternating fashion to perform sedation ( midazolam in combination with propofol ) with or without NPA insertion .


The primary outcome measure was respiratory depression ( oxygen saturation < 90 % ) .


Secondary measures included hypotension ( systolic blood pressure < 90 mm Hg ) , bradycardia ( heart rate < 40 beats/min ) or nasopharyngeal damage after NPA insertion .


216 ( 106 females , mean age 60.7 9.65 years ) were enrolled .


Colonoscopy was performed in 131 patients and upper endoscopy in 85 patients .


In 105 patients an NPA was used ( intervention group ) .


Five ( 4.7 % ) of those patients showed minor nasopharyngeal injury .


Respiratory depression ( 13.5 vs. 1.9 % , p = 0.002 ) and hypotension ( 11 vs. 5 % , p = 0.09 ) occurred more frequently in the control than in the intervention group .


The routine placement of an NPA can reduce the frequency of hypoxemic events during endoscopic sedation with minor risks for nasopharyngeal injury .


Chronic hypoxia is a risk factor for cardiovascular disease , but its association with blood pressure ( BP ) remains unclear .


We performed this study to clarify the hypothesis that chronic hypoxia is associated with abnormal BP variability in patients with pneumoconiosis .


We recruited 19 patients with pneumoconiosis and 30 age - and BP level-matched control subjects .


We used simultaneous pulse oximetry and ambulatory BP monitoring for all subjects .


We evaluated their BP levels and variability by determining the SD and coefficient of variation ( CV ) of the BP data .


The dipper pattern was defined as nocturnal BP fall 10 % ; the nondipper pattern was defined as nocturnal BP fall 0 % but < 10 % ; the riser pattern was defined as nocturnal BP fall < 0 % .


Pearson and Spearman correlation coefficients were used to calculate the correlations between parameters .


In patients with pneumoconiosis , the daytime systolic BP ( SBP ) level was lower , the CV in 24-hour SBP ( P < 0.05 ) and diastolic BP ( P < 0.001 ) were higher than that in control subjects .


And although not statistically significant ( P = 0.13 ) , the odds ratio of riser pattern was 3.73 in patients with pneumoconiosis , and their nighttime pulse rate was significantly higher ( P < 0.05 ) than that in control subjects .


The median daytime pulse oximetry oxygen saturation was inversely associated with mean ( r = -0.30 ; P < 0.01 ) and SD ( r = -0.38 ; P < 0.001 ) in daytime SBP .


The median nighttime pulse oximetry oxygen saturation was inversely associated ( r = -0.55 ; P < 0.001 ) and the mean nighttime pulse rate was associated ( r = 0.51 ; P < 0.001 ) with CV in nighttime SBP .


Partial pressure of oxygen was inversely associated with CV in daytime SBP ( r = -0.24 ; P < 0.05 ) .


Exaggerated BP variability was seen in patients with pneumoconiosis , and the measures of hypoxia were associated with large fluctuations in ambulatory BP .


Chronic and intermittent hypoxia could be the contributing factors of these findings .


Clinical Trial Number UMIN000000894 ( University Hospital Medical Information Network Clinical Trials Registry website ) .


The goal of this study was to investigate the extent to which sample length affected the reliability of total number of words ( TNW ) , number of different words ( NDW ) , and mean length of C-units in morphemes ( MLCUm ) in parent-elicited conversational samples for 3-year-olds .


Participants were sixty 3-year-olds .


A 22-min language sample was collected from each child during free play with the parent in the laboratory .


Samples of 1 , 3 , 7 , and 10 min were extracted from the 22-min samples .


TNW , NDW , and MLCUm were computed from each shorter sample and the 22-min sample .


TNW and NDW were adjusted by number of minutes for comparisons .


The differences and correlations between each shorter sample cut and the 22-min sample on MLCUm and adjusted TNW and NDW were computed .


The shorter samples and the 22-min samples significantly differed in adjusted TNW and NDW , but not in MLCUm .


TNW reached an acceptable reliability level ( i.e. , r = .90 ) in 7-min samples .


NDW and MLCUm approached the acceptable reliability level ( rs = .88 ) in 7-min samples and reached it in 10-min samples .


For conversational language samples with similar collection procedures , samples of 7 to 10 min are desirable for calculating TNW , NDW , and MLCUm in 3-year-olds .


Off-midline procedures seem to be the best method of primary wound closure after excision of a pilonidal sinus .


Primary wound closure with a Limberg flap was compared to secondary wound healing .


From January 2006 to July 2012 , 102 patients with given informed consent ( mean age 28 years , men 81 % ) who had excision of a pilonidal sinus in three hospitals in Switzerland were randomised to group L ( Limberg flap , n = 51 ) or to group E ( excision only , n = 51 ) .


Primary endpoint was duration of incapacity for work .


Follow-up was at 3 weeks and at 1 year postoperative ( 95 % follow-up ) .


Both groups were comparable with regard to patient characteristics .


The median ( range ) operation time was 60 ( 30-80 ) min in group L vs. 30 ( 10-75 ) min in group E ( p < 0.001 ) .


No significant differences were found in postoperative pain and painkiller intake ; pain , percentage of patients at work and overall satisfaction at 3 weeks postoperative ; and overall duration of incapacity for work and overall satisfaction at 1-year follow-up .


The complication rate was 49 % in group L vs. 12 % in group E ( p < 0.001 ) .


Complications in group L were seroma ( 6 % ) , wound dehiscence ( 45 % ) , skin necrosis ( 10 % ) , hematoma ( 6 % ) , infection ( 4 % ) and recurrent disease ( 13 % ) .


Complications in group E were recurrent disease ( 6 % ) and wound healing disorder ( 6 % ) .


After excision of a pilonidal sinus , primary wound closure with a Limberg flap has no advantage over secondary wound healing .


The main reason for this conclusion is the relatively high complication rate of primary wound closure with a Limberg flap .


To observe capillary blood flow at acupoints during acupuncture treatment of primary dysmenorrhea and gain new insights into its analgesic mechanism .


Patients with primary dysmenorrhea were enrolled and randomly assigned to a treatment or control group .


Subjects ' symptoms were differentiated into various Traditional Chinese Medicine ( TCM ) syndromes and treated for 10 sessions with puncturing acupuncture or self-pressing right-hand Hegu ( LI 4 ) , adding other acupoints based on syndrome .


Laser speckle was used to compare the change in the vasomotor amplitude and perfusion of the capillaries in Hegu ( LI 4 ) before and during the treatment .


Each subject was required to finish the period pain symptoms observation form , verbal rating scales , numerical rating scale , pain rating index , face rating scale , Zung self-rating depression scale , Zung self-rating anxiety scale , and numerical rating scale before and after treatments .


After 10 sessions , the symptom scores , pain index ( PI ) , and visual analog scale ( VAS ) decreased significantly in treatment group .


The volume of blood flow in Hegu ( LI 4 ) declined slightly .


No significant evidence supported that needling caused capillary contraction , but the capillary vasomotor amplitude at Hegu ( LI 4 ) increased remarkably .


Acupuncture can increase the capillary blood flow , thus promoting the flow of Qi and blood in terms ofTCM theory , which facilitates pain relief .


Caring for a family member with dementia is extremely stressful , and contributes to psychiatric and physical illness among caregivers .


Therefore , a comprehensive programme called Resources for Enhancing Alzheimer 's Caregiver Health II ( REACH II ) was developed in the United States to enhance the health of Alzheimer 's caregivers .


REACH II causes a clear reduction of the stress and burdens faced by informal caregivers at home .


The aim of this protocol is to adapt , apply , and evaluate this proven intervention programme in a German-speaking area for the first time .


This newly adapted intervention is called Deutsche Adaption der Resources for Enhancing Alzheimer 's Caregiver Health ( DeREACH ) .


A total of 138 informal caregivers at home are recruited in a single-centred , randomised controlled trial .


The intervention ( DeREACH ) consists of nine home visits and three telephone contacts over six months , all of which focus on safety , psychological well-being and self-care , social support , problem behaviour and preventive health-related behaviours .


A complex intervention assessment on effectiveness will be adopted when the primary outcome - namely , the reduction of caregiver burden - and other secondary outcomes , including changes with regard to anxiety and depression , somatisation , health-related quality of life , and perceived social support , are measured at baseline , as well as immediately and three months after the intervention .


The change from baseline to post-intervention assessment with regard to the primary outcome will be compared between treatment and control group using t-tests for independent samples .


It is anticipated that this study will show that DeREACH effectively reduces caregiver burden and therefore works under the conditions of a local German health-care system .


If successful , this programme will provide an effective intervention programme in the German-speaking area to identify and develop the personal capabilities of informal caregivers to cope with the burdens of caring for people with dementia .


Episodes of patient deterioration on hospital units are expected to increasingly contribute to morbidity and healthcare costs .


To determine if real-time alerts sent to the rapid response team ( RRT ) improved patient care .


Randomized , controlled trial .


Eight medicine units ( Barnes-Jewish Hospital ) .


Five hundred seventy-one patients .


Real-time alerts generated by a validated deterioration algorithm were sent real-time to the RRT ( intervention ) or hidden ( control ) .


Intensive care unit ( ICU ) transfer , hospital mortality , hospital duration .


ICU transfer ( 17.8 % vs 18.2 % ; odds ratio : 0.972 ; 95 % confidence interval [ CI ] : 0.635-1 .490 ) and hospital mortality ( 7.3 % vs 7.7 % ; odds ratio : 0.947 ; 95 % CI : 0.509-1 .764 ) were similar for the intervention and control groups .


The number of patients requiring transfer to a nursing home or long-term acute care hospital was similar for patients in the intervention and control groups ( 26.9 % vs 26.3 % ; odds ratio : 1.032 ; 95 % CI : 0.712-1 .495 ) .


Hospital duration ( 8.49.5 days vs 9.411.1 days ; P = 0.038 ) was statistically shorter for the intervention group .


The number of RRT calls initiated by the primary care team was similar for the intervention and control groups ( 19.9 % vs 16.5 % ; odds ratio : 1.260 ; 95 % CI : 0.823-1 .931 ) .


Real-time alerts sent to the RRT did not reduce ICU transfers , hospital mortality , or the need for subsequent long term care .


However , hospital length of stay was modestly reduced .


Insufficient fasting prior to endoscopic procedures performed under sedation may result in potential aspiration of gastric contents .


Fasting as per ASA guidelines is recommended prior to these procedures .


However , the effect of chewing gum on fasting status has been a subject of debate and often leads to procedural delays .


Evaluation of the effect of chewing gum on the gastric volume and pH.


In this randomized controlled prospective observer blinded trail , ASA I-III patients aged more than 18 years scheduled for esophagogastroduodenoscopy ( EGD ) or a combined EGD and colonoscopy under conscious sedation were studied .


Patients randomized to the chewing gum group ( Group-C ) were allowed to chew gum until just before the start of their procedure ; the remaining patients were included into Group-NC .


After sedation and endoscope insertion , stomach contents were aspirated under vision of a gastroenterologist ( blinded to groups ) .


Volume and pH of gastric contents aspirated from 67 patients ( 34 in Group-C and 33 in Group-NC ) were analyzed .


The demographic parameters of the groups were comparable .


Gastric volume ( median-interquartile range ) was statistically higher in Group-C ( 13 ml ( 7.75-40 .75 ) vs Group-NC 6 ml ( 1.00-14 .00 ) ( P < 0.001 ) ] .


The mean pH in both groups was comparable : 2.84 2.11 in Group-C and 3.79 2.53 in Group-NC ( P = 0.141 ) .


Although our results show gastric volume in patients chewing gum was statistically higher , clinical relevance of such a small difference is questionable .


Thus patients who chewed gum inadvertently prior to procedure should not be denied or delayed administration of sedative and anesthetic medications .


Bladder dysfunction influences recovery of urinary continence after radical prostatectomy .


We performed a multicenter , randomized , double-blind study evaluating solifenacin vs placebo on return to continence in patients who were still incontinent 7 to 21 days after catheter removal after robot-assisted radical prostatectomy .


A wireless personal digital assistant was given to patients the day of catheter removal .


Encrypted answers were transmitted daily to dedicated servers .


After a 7 to 21-day treatment-free washout period , patients requiring 2 to 10 pads per day for 7 consecutive days were randomized ( 1:1 ) to 5 mg solifenacin daily or placebo .


The primary end point was time from first dose to continence defined as 0 pads per day or a dry security pad for 3 consecutive days .


Secondary end points included proportion of patients continent at end of study , average change in pads per day number and quality of life assessments .


A total of 1,086 screened patients recorded personal digital assistant information .


Overall 640 patients were randomized to solifenacin vs placebo and 17 failed to take medication .


There was no difference in time to continence ( p = 0.17 ) .


Continence was achieved by study end in 91 of 313 ( 29 % ) vs 66 of 309 ( 21 % ) , respectively ( p = 0.04 ) .


Pads per day change from baseline was -3.2 and -2.9 , respectively ( p = 0.03 ) .


Dry mouth was the only common adverse event seen in 6.1 % and 0.6 % , respectively .


Constipation rates were similar .


The overall rate of continence in the entire population from screening to end of study was 73 % .


There was no effect on primary outcome but some secondary end points benefited the solifenacin arm .


The study provides level 1B clinical evidence for continence outcomes after robot-assisted radical prostatectomy .


Sickness absence due to poor mental health is a common problem in many Western countries .


To facilitate return to work , it may be important to identify individuals on sick leave and at risk of having a mental disorder and subsequently to offer appropriate treatment .


Psychoeducation alone has not previously been used as a return to work intervention , but may be a promising tool to facilitate return to work .


Therefore , the aim of the study is to evaluate the effectiveness of psychoeducation designed specifically to facilitate return to work for individuals on sick leave and at risk of having a mental disorder .


The psychoeducation was a supplement to the various standard offers provided by the job centres .


The study is a randomised controlled trial , in which individuals on sick leave either receive psychoeducation and standard case management or standard case management alone .


Participants were individuals with mental health symptoms , who had been on sick leave from part-time or full-time work or unemployment for about 4-8 weeks .


The psychoeducational intervention was group-based and the course consisted of 2 hour sessions once a week for 6 weeks .


The course was given by psychiatric nurses , a psychologist , a social worker , a physiotherapist and a person who had previously been on sick leave due to mental health problems .


The sessions focused on stress and work life , and the purpose was to provide individuals on sick leave the skills to understand and improve their mental functioning.The primary outcome is the duration of sickness absence measured by register data .


Secondary outcomes include psychological symptoms , mental health-related quality of life , and locus of control .


These outcomes are measured by questionnaires at the start of the intervention and at 3 and 6 months follow-up .


On the basis of this trial , the effect of psychoeducation for individuals on sick leave and at risk of having a mental disorder will be studied .


The results will contribute to the continuing research on sickness absence and mental health .


It will primarily show whether psychoeducation can lead to faster and sustainable return to work .


Clinical Trial.gov NCT01637363 .


Registered 6 July 2012 .


To evaluate if addition of L-carnitine therapy to standard varicocelectomy adds any extra benefit in terms of improvement in semen parameters or deoxyribonucleic acid ( DNA ) damage .


One hundred patients enrolled in this study and were randomly divided into 2 groups ( 50 patients in each group ) .


In group 1 , standard inguinal varicocelectomy and , in group 2 , standard inguinal varicocelectomy plus oral antioxidant therapy ( oral L-carnitine , 250 mg 3 times a day ) were performed for 6 months .


For all patients , routine semen analysis and DNA damage test of spermatozoa ( by 2 methods of terminal deoxynucleotidyl transferase dUTP nick end labeling and protamine damage assay ) were performed at baseline and at 3 and 6 months postoperatively .


In both groups , the improvement in semen analysis parameters and DNA damage was observed , but there was not any statistically significant difference between the 2 groups in these parameters , although the slope of improvement in DNA damage was slightly better in group 2 ( that was not statistically significant ) .


We observed that addition of 750 mg of L-carnitine orally daily to standard inguinal varicocelectomy does not add any extra benefit in terms of improvement in semen analysis parameters or DNA damage .


Modulation of immunologic interactions in cancer tissue is a promising therapeutic strategy .


To investigate the immunogenicity of human epidermal growth factor receptor 2 ( HER2 ) - positive and triple-negative ( TN ) breast cancers ( BCs ) , we evaluated tumor-infiltrating lymphocytes ( TILs ) and immunologically relevant genes in the neoadjuvant GeparSixto trial .


GeparSixto investigated the effect of adding carboplatin ( Cb ) to an anthracycline-plus-taxane combination ( PM ) on pathologic complete response ( pCR ) .


A total of 580 tumors were evaluated before random assignment for stromal TILs and lymphocyte-predominant BC ( LPBC ) .


mRNA expression of immune-activating ( CXCL9 , CCL5 , CD8A , CD80 , CXCL13 , IGKC , CD21 ) as well as immunosuppressive factors ( IDO1 , PD-1 , PD-L1 , CTLA4 , FOXP3 ) was measured in 481 tumors .


Increased levels of stromal TILs predicted pCR in univariable ( P < .001 ) and multivariable analyses ( P < .001 ) .


pCR rate was 59.9 % in LPBC and 33.8 % for non-LPBC ( P < .001 ) .


pCR rates 75 % were observed in patients with LPBC tumors treated with PMCb , with a significant test for interaction with therapy in the complete ( P = .002 ) and HER2-positive ( P = .006 ) , but not the TNBC , cohorts .


Hierarchic clustering of mRNA markers revealed three immune subtypes with different pCR rates ( P < .001 ) .


All 12 immune mRNA markers were predictive for increased pCR .


The highest odds ratios ( ORs ) were observed for PD-L1 ( OR , 1.57 ; 95 % CI , 1.34 to 1.86 ; P < .001 ) and CCL5 ( OR , 1.41 ; 95 % CI , 1.23 to 1.62 ; P < .001 ) .


Immunologic factors were highly significant predictors of therapy response in the GeparSixto trial , particularly in patients treated with Cb .


After further standardization , they could be included in histopathologic assessment of BC .


Randomized studies of adjuvant chemotherapy using gemcitabine suggest a survival benefit after resection of pancreatic cancer .


S-1 has also been shown to prolong survival in patients with unresectable pancreatic cancer .


This study compared the effects of adjuvant chemotherapy with S-1 or gemcitabine after resection of pancreatic cancer in a randomized trial .


Patients who had undergone resection of pancreatic cancer were registered in this randomized clinical trial .


The primary endpoint was disease-free survival ( DFS ) .


Expression levels of thymidylate synthase ( TS ) and dihydropyrimidine dehydrogenase ( DPD ) mRNAs in cancer tissues were measured as indicators of fluoropyrimidine sensitivity .


Of 57 patients registered , 29 were allocated to the S-1 group and 28 to gemcitabine .


DFS tended to be better with S-1 ( median 146 ( 90 per cent c.i. 88 to 284 ) months versus 105 ( 70 to 284 ) months in the gemcitabine group ; P = 0188 ) , with a similar pattern for overall survival : 215 ( 95 per cent c.i. 144 to 423 ) and 180 ( 133 to 428 ) months respectively ( P = 0293 ) .


When patients were divided into subgroups based on high or low DPD and TS expression , those with a DPD level below the median of 088 or a TS level of at least 200 had a significant prolongation of DFS after S-1 treatment compared with gemcitabine ( P = 0008 and P = 0035 respectively ) .


Overall , S-1 did not improve DFS compared with gemcitabine after pancreatic cancer resection , but there seemed to be a DFS advantage in patients with low expression of DPD or high expression of TS .


Reference number : UMIN000009118 ( http://www.umin.ac.jp/ctr/ ) .


We conducted a randomized controlled trial to evaluate the clinical efficacy and safety of intravenous doripenem ( DRPM ) in patients with biliary tract infection requiring biliary drainage in comparison with imipenem/cilastatin ( IPM/CS ) .


After the initial collection of bile , patients were randomly assigned by the registration system of the Clinical Research Organization to receive intravenous drip infusion of DRPM 0.5 g or IPM/CS 0.5 g three times daily in a randomized , open-label manner .


A total of 127 patients were enrolled in the trial ( DRPM 62 , IPM/CS 65 ) .


The characteristics of the 122 patients evaluated for efficacy were well balanced , except for the percentage of patients previously receiving antimicrobials , which was higher in the DRPM group than in the IPM/CS group .


The clinical response rate was not significantly different between the DRPM group ( 93.1 % , 54/58 patients ) and the IPM/CS group ( 93.8 % , 60/64 ) .


Non-inferiority assessment using confidence intervals demonstrated the non-inferiority of DRPM-IPM/CS .


The incidence of adverse events , for which a causal relationship with either treatment was not ruled out , was 3.3 % ( 2/60 ) in the DRPM group and 3.1 % ( 2/65 ) in the IPM/CS group , and none was serious .


The clinical efficacy of DRPM in treating moderate or severe biliary tract infection requiring drainage was comparable to that of IPM/CS .


DRPM was associated with no serious adverse events and a low incidence of adverse events .


The results of this trial demonstrate that DRPM is a useful therapeutic option for moderate or severe biliary tract infection .


Our randomized trial compared early and delayed intrauterine device ( IUD ) insertion following medical abortion .


In this planned substudy , we explore if endometrial thickness and initial IUD position were associated with IUD expulsion .


We also describe IUD movement within the uterus during the 6 months after insertion .


We recruited women undergoing medical abortion and choosing the copper IUD for contraception ( n = 156 ) .


Participants were randomly assigned to early insertion 1 week after mifepristone or delayed insertion 4-6 weeks later .


We measured endometrial thickness by transvaginal sonogram 1 week after abortion and IUD distance from the fundal aspect of the endometrial cavity three times : at insertion , 6-8 weeks later and at 6 months .


We analyzed endometrial thickness in 113 women , baseline IUD position in 114 women and IUD movement in 65 women .


Women who expelled IUDs ( n = 15 ) had slightly thicker endometria ( p = .007 ) and slightly lower baseline IUD positions ( p = .03 ) than those who retained IUDs , but no clear cutoffs emerged in the receiver operating characteristic curve analysis .


Retained IUDs commonly moved up and down throughout the 6 months ( from 14 mm towards the fundus to 32 mm towards the cervix ) .


Overall , retained IUDs moved a median of 2mm towards the cervix between insertion and exit ( p < .0001 ) .


After medical abortion , the risk of IUD expulsion increases with thicker endometria and lower baseline position .


Since no clear cutoffs emerged in the analysis and expulsion remained uncommon even with thicker endometria , we do not recommend restricting IUD insertion based on ultrasound data .


Copper T IUDs often move within the uterus without expelling .


Expulsion is uncommon , and we do not recommend restricting IUD insertion based on ultrasound data .


Previous studies observed the surprising finding that saturated fat was inversely associated with atherosclerosis progression in postmenopausal women , whereas polyunsaturated fat ( PUFA ) and carbohydrates were positively associated .


Whether certain genes modify the association of diet with atherosclerotic progression is unknown .


Using Haplotype-tagging single nucleotide polymorphisms , we evaluated gene-diet interactions with 3 preselected genes involved in fatty acid and carbohydrate metabolism : sterol regulatory element binding protein-1 ( SREBP1 ) , insulin-induced gene-1 ( INSIG1 ) , and SREBP cleavage-activating protein ( SCAP ) .


Diet was assessed at baseline .


Quantitative coronary angiography was performed at baseline and after a mean of follow-up of 3.09 years in 2,227 coronary segments in 234 postmenopausal women .


Global effects of each gene and gene-diet interactions for different fats , total fat , and carbohydrate were evaluated .


Global tests revealed no main effects between SCAP , INSIG1 , and SREBP1 haplotypes and progression of atherosclerosis ( P = .87 , P = .58 , and P = .44 ) .


After correction for 5 nutrients evaluated ( Bonferroni-corrected 2-tailed = .01 ) , no significant gene-nutrient interactions were seen , except for a borderline global interaction between SREBP1 and PUFA intake ( P interaction = .013 ) .


This interaction was specific to the G-C haplotype ( frequency 35 % ) and was driven by n-6 rather than n-3 PUFA ( P for interaction < .0001 ) .


The interaction was robust to estimated isocaloric replacement of PUFA with any other nutrient .


Per each 5 % energy from n-6 PUFA , a 0.21-mm greater decline in mean minimal coronary artery diameter was seen among women per each copy of the second most frequent haplotype of SREBP1 .


We observed an interaction between SREBP1 and PUFA consumption that might explain the positive association of PUFA with atherosclerosis progression in this cohort .


In spite of the major focus on risky , single-occasion drinking by young people in Australia , little is known about the specific circumstances of risky drinking occasions .


This study examines drinking behaviours and drinking contexts for the most recent risky , single-occasion drinking episode in a representative sample of young risky drinkers in Victoria , Australia .


A representative sample of 802 young risky drinkers was recruited across metropolitan Melbourne and surveyed about their drinking and related behaviours .


Specific questions focused on participants ' most recent high-risk ( > 10 Australian standard drinks for males , > 7 Australian standard drinks for females ) drinking occasion in terms of self-reported amount drunk , alcohol expenditure ( including buying rounds ) and drinking partners for up to 10 different drinking settings .


Participants reported drinking a mean of 13 Australian standard drinks on their last episode of risky , single-occasion drinking ; for half of the participants , this occurred less than 20 days prior to being surveyed .


The majority ( 62 % ) of risky single occasion drinking sessions commenced at private homes in the company of close friends ( 81 % ) .


Around 40 % of the sample reported going to one ( 42 % ) or two ( 37 % ) drinking locations , and only 5 % reported going to more than three drinking locations .


Contrary to public portrayals , a significant amount of risky drinking by young people occurs in private settings .


These contexts are rarely mentioned except in relation to underage drinking .


Further work is needed to understand how these drinking behaviours and contexts link to harm .


We aimed to investigate the influence of perioperative goal-directed fluid therapy ( GDFT ) on the prognosis of elderly patients with gastric cancer and hypertension .


Sixty elderly patients ( > 60 years old ) with primary hypertension who received gastric cancer radical surgery and who were American Society of Anesthesiologists ( ASA ) class II or III were enrolled in the current study .


Selected patients were divided randomly into two arms , comprising a conventional intraoperative fluid management arm ( arm C , n = 30 ) and a GDFT arm ( arm G , n = 30 ) .


Patients in arm C were infused with crystalloids or colloids according to the methods of Miller 's Anesthesia ( 6th edition ) , while those in arm G were infused with 200 mL hydroxyethyl starch over 15 minutes under the FloTrac/Vigileo monitoring system , with stroke volume variation between 8 % and 13 % .


Hemodynamics and tissue perfusion laboratory indicators in patients were recorded continuously from 30 minutes before the operation to 24 hours after the operation .


Compared with arm C , the average intraoperative intravenous infusion quantity in arm G was significantly reduced ( 2,732488 mL versus 3,135346 mL , P < 0.05 ) , whereas average colloid fluid volume was significantly increased ( 1,235360 mL versus 760280 mL , P < 0.05 ) .


In addition , there were more patients exhibiting intraoperatively and postoperatively stable hemodynamics and less patients with low blood pressure in arm G. Postoperative complications were less frequent , and the time of postoperative hospital stay shorter , in arm G. No significant differences were observed in mortality between the two arms .


Our research showed that GDFT stabilized perioperative hemodynamics and reduced the occurrence of postoperative complications in elderly patients who underwent gastric cancer surgery .


Health assessment and medical surveillance of workers exposed to combustion nanoparticles are challenging .


The aim was to evaluate the feasibility of using exhaled breath condensate ( EBC ) from healthy volunteers for ( 1 ) assessing the lung deposited dose of combustion nanoparticles and ( 2 ) determining the resulting oxidative stress by measuring hydrogen peroxide ( H ( 2 ) O ( 2 ) ) and malondialdehyde ( MDA ) .


Fifteen healthy nonsmoker volunteers were exposed to three different levels of sidestream cigarette smoke under controlled conditions .


EBC was repeatedly collected before , during , and 1 and 2hr after exposure .


Exposure variables were measured by direct reading instruments and by active sampling .


The different EBC samples were analyzed for particle number concentration ( light-scattering-based method ) and for selected compounds considered oxidative stress markers .


Subjects were exposed to an average airborne concentration up to 4.310 ( 5 ) particles/cm ( 3 ) ( average geometric size 60-80nm ) .


Up to 1010 ( 8 ) particles/mL could be measured in the collected EBC with a broad size distribution ( 50 ( th ) percentile 160nm ) , but these biological concentrations were not related to the exposure level of cigarette smoke particles .


Although H ( 2 ) O ( 2 ) and MDA concentrations in EBC increased during exposure , only H2O2 showed a transient normalization 1hr after exposure and increased afterward .


In contrast , MDA levels stayed elevated during the 2hr post exposure .


The use of diffusion light scattering for particle counting proved to be sufficiently sensitive to detect objects in EBC , but lacked the specificity for carbonaceous tobacco smoke particles .


Our results suggest two phases of oxidation markers in EBC : first , the initial deposition of particles and gases in the lung lining liquid , and later the start of oxidative stress with associated cell membrane damage .


Future studies should extend the follow-up time and should remove gases or particles from the air to allow differentiation between the different sources of H ( 2 ) O ( 2 ) and MDA .


Chronic heart failure ( CHF ) patients often present with ( pre ) diabetes , which negatively influences prognosis .


Unlike the proven effect of exercise on glucose regulation in the general population , its effect in CHF is unclear .


Therefore , this study aimed at investigating the effect of exercise training on glucose regulation in stable CHF patients .


Twenty-two CHF patients were randomized into training ( EX , n = 15 ) and control ( CON , n = 7 ) groups .


Before and after a 12-week training intervention involving endurance and resistance training , glucose tolerance ( 2-hour oral glucose tolerance test ) , exercise tolerance ( cardiopulmonary exercise test ) , muscle strength ( isokinetic dynamometer ) , heart function ( echocardiography ) , glycated hemoglobin , body composition ( dual-energy x-ray absorptiometry ) , and quality of life ( EQ5D ) were assessed .


At baseline , glucose levels 2 hours after glucose intake were elevated in both groups .


Whereas area under the glucose curve did not change , area under the insulin curve decreased following training ( EX , -13 23 % vs CON , +22 33 % ; P < .05 ) .


Changes in the ratio of mitral peak velocity of early filling/early diastolic mitral annular velocity and waist-to-hip fat mass ratio were related to changes in the insulin curve .


Exercise training resulted in improved oxygen uptake at the second ventilatory threshold ( EX , +10 5 % vs CON , -8 5 % ; P < .05 ) and isokinetic strength endurance of the upper leg ( EX , +25 9 % vs CON , -6 5 % ; P < 0.05 ) .


Lean body tissue was increased by 2.2 0.5 % in EX versus 0.2 0.6 % in CON ( P < .05 ) .


Our data suggest that exercise training attenuates worsening of glucose regulation typically seen in a stable CHF population .


Low systolic blood pressure ( SBP ) is associated with poor outcomes in heart failure and complicates management .


In a post hoc analysis , we investigated the efficacy and safety of ivabradine in the SHIFT population divided by tertiles of baseline SBP .


The analysis comprised 2110 patients with SBP < 115 mmHg , 1968 with 115 SBP < 130 mmHg , and 2427 with SBP 130 mmHg .


Patients with low SBP were younger , had lower ejection fraction , and were less likely to be at target beta-blocker dose than patients in the other SBP groups .


Ivabradine was associated with a similar relative risk reduction of the composite outcome in the three SBP groups [ SBP < 115 mmHg , hazard ratio ( HR ) = 0.84 , 95 % confidence interval ( CI ) 0.72-0 .98 ; 115 SBP < 130 mmHg , HR = 0.86 , 95 % CI 0.72 to 1.03 ; SBP 130 mmHg , HR = 0.77 , 95 % CI 0.66 to 0.92 ; P interaction = 0.68 ] .


Similar results were found for cardiovascular mortality ( P interaction = 0.91 ) , hospitalization because of heart failure ( P interaction = 0.79 ) , all-cause mortality ( P interaction = 0.90 ) , and heart failure mortality ( P interaction = 0.18 ) .


There was no evidence for a difference in safety profile according to SBP group .


The efficacy and safety of ivabradine is independent of SBP .


This may have implications for the management of HF patients with low SBP and elevated heart rate .


Studies demonstrate that lowering low-density lipoprotein cholesterol ( LDL-C ) using a statin is associated with significant reduction in cardiovascular events .


Whether visit-to-visit variability in LDL-C levels affects cardiovascular outcomes is unknown .


This study sought to evaluate the role of visit-to-visit variability in LDL-C levels on cardiovascular outcomes .


We evaluated patients with coronary artery disease and LDL-C < 130 mg/dl enrolled in the TNT ( Treating to New Targets ) trial , randomly assigned to receive atorvastatin 80 mg/day versus 10 mg/day and with at least one post-baseline measurement of LDL-C .


Visit-to-visit LDL-C variability was evaluated from 3 months into random assignment through the use of various measurements of LDL-C variability : SD , average successive variability ( ASV ) , coefficient of variation , and variation independent of mean , with the first 2 measurements used as the primary measurements .


Primary outcome was any coronary event , and secondary outcomes were any cardiovascular event , death , myocardial infarction , or stroke .


Among 9,572 patients , SD and ASV were significantly lower with atorvastatin 80 mg/day versus 10 mg/day ( SD : 12.03 9.70 vs. 12.52 7.43 ; p = 0.005 ; ASV : 12.84 10.48 vs. 13.76 8.69 ; p < 0.0001 ) .


In the adjusted model , each 1-SD increase in LDL-C variability ( by ASV ) increased the risk of any coronary event by 16 % ( hazard ratio [ HR ] : 1.16 ; 95 % confidence interval [ CI ] : 1.10 to 1.23 ; p < 0.0001 ) , any cardiovascular event by 11 % ( HR : 1.11 ; 95 % CI : 1.07 to 1.15 ; p < 0.0001 ) , death by 23 % ( HR : 1.23 ; 95 % CI : 1.14 to 1.34 ; p < 0.0001 ) , myocardial infarction by 10 % ( HR : 1.10 ; 95 % CI : 1.02 to 1.19 ; p = 0.02 ) , and stroke by 17 % ( HR : 1.17 ; 95 % CI : 1.04 to 1.31 ; p = 0.01 ) , independent of treatment effect and achieved LDL-C levels .


Results were largely consistent when adjusted for medication adherence .


In subjects with coronary artery disease , visit-to-visit LDL-C variability is an independent predictor of cardiovascular events .


To evaluate whether vagus nerve stimulation ( VNS ) as adjunct to best medical practice ( VNS + BMP ) is superior to BMP alone in improving long-term health-related quality of life ( HRQoL ) .


PuLsE ( Open Prospective Randomized Long-term Effectiveness ) was a prospective , randomized , parallel-group , open-label , and long-term effectiveness study ( conducted at 28 sites in Europe and Canada ) .


Adults with pharmacoresistant focal seizures ( n = 112 ) received VNS + BMP or BMP ( 1:1 ratio ) .


Medications and VNS parameters could be adjusted as clinically indicated for optimal seizure control while minimizing adverse effects .


Primary endpoint was mean change from baseline HRQoL ( using Quality of Life in Epilepsy Inventory-89 total score ; QOLIE-89 ) .


Secondary endpoints included changes in seizure frequency , responder rate ( 50 % decrease in seizure frequency ) , Centre for Epidemiologic Studies Depression scale ( CES-D ) , Neurological Disorders Depression Inventory-Epilepsy scale ( NDDI-E ) , Clinical Global Impression-Improvement scale ( CGI-I ) , Adverse Event Profile ( AEP ) , and antiepileptic drug ( AED ) load .


The study was prematurely terminated due to recruitment difficulties prior to completing the planned enrollment of n = 362 .


Results for n = 96 who had baseline and at least one follow-up QOLIE-89 assessment ( from months 3-12 ) were included in this analysis .


Mixed model repeated measures ( MMRM ) analysis of variance was performed on change from baseline for the primary and secondary endpoints .


Significant between-group differences in favor of VNS + BMP were observed regarding improvement in HRQoL , seizure frequency , and CGI-I score ( respective p-values < 0.05 , 0.03 , and 0.01 ) .


More patients in the VNS + BMP group ( 43 % ) reported adverse events ( AEs ) versus BMP group ( 21 % ) ( p = 0.01 ) , a difference reflecting primarily mostly transient AEs related to VNS implantation or stimulation .


No significant difference between treatment groups was observed for changes in CES-D , NDDI-E , AEP , and AED load .


VNS therapy as a treatment adjunct to BMP in patients with pharmacoresistant focal seizures was associated with a significant improvement in HRQoL compared with BMP alone .


A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .


The MGuard , a bare metal stent covered with a polymer mesh , was designed to reduce distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction .


In the MGUARD for Acute ST Elevation Reperfusion trial , the primary end point of complete ST-segment resolution was significantly improved with the MGuard compared with control .


We evaluated 1-year clinical and angiographic results .


Patients with ST-segment-elevation myocardial infarction 12 hours undergoing primary percutaneous coronary intervention of a single de novo native lesion were randomized to the MGuard versus any commercially available metallic stent ( 39.8 % drug-eluting ) .


Clinical follow-up was performed through 1 year , and angiography at 13 months was planned in 50 MGuard patients .


There was no difference in major adverse cardiac events ( 1.8 % versus 2.3 % ; P = 0.75 ) at 30 days between the groups .


Major adverse cardiac events at 1 year were higher with the MGuard , driven by greater ischemia-driven target lesion revascularization ( 8.6 % versus 0.9 % ; P = 0.0003 ) .


Conversely , mortality tended to be lower with the MGuard at 30 days ( 0 % versus 1.9 % ; P = 0.04 ) and at 1 year ( 1.0 % versus 3.3 % ; P = 0.09 ) .


Late lumen loss at 13 months in the MGuard was 0.990.80 mm , and binary restenosis was 31.6 % .


In patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention , a trend toward reduced 1-year mortality was present in patients treated with the MGuard stent .


Target lesion revascularization and major adverse cardiac events rates during follow-up were higher in the MGuard group than in the control stent group , and angiographic late loss of the MGuard was consistent with that expected from bare metal stents .


http://www.clinicaltrials.gov .


Unique identifier : NCT01368471 .


L-ornithine is a non-essential , non-protein amino acid .


Although L-ornithine is contained in various foods , the amount is usually small.Recently , studies have shown that orally administered L-ornithine reduced the stress response in animals.From these findings , we speculated that L-ornithine may play a role in the relieve of stress and improve sleep and fatigue symptoms in humans .


Through a randomised , double-blind , placebo-controlled clinical study , we asked if L-ornithine could be beneficial to stress and sleep in healthy workers .


Fifty-two apparently healthy Japanese adults who had previously felt slight stress as well as fatigue were recruited to be study participants and were randomly divided into either the L-ornithine ( 400 mg/day ) or placebo group .


They orally consumed the respective test substance every day for 8 weeks .


Serum was collected for the assessment of cortisol and dehydroepiandrosterone-sulphate ( DHEA-S ) .


Perceived mood and quality of sleep were measured by the Profile of Mood States ( POMS ) , Athens Insomnia Scale ( AIS ) , and Ogri-Shirakawa-Azumi sleep inventory MA version ( OSA-MA ) .


Serum cortisol levels and the cortisol/DHEA-S ratio were significantly decreased in the L-ornithine group in comparison with the placebo group .


Also , anger was reduced and perceived sleep quality was improved in the L-ornithine group .


L-ornithine supplementation has the potential to relieve stress and improve sleep quality related to fatigue , both objectively and subjectively .


Development of new therapies for previously treated small-cell lung cancer ( SCLC ) is a major unmet need .


Here , we describe a randomized , phase II trial of weekly topotecan with or without ziv-aflibercept ( VEGF-trap ) in this clinical setting .


Patients with previously treated SCLC ( one line of platinum-based chemotherapy ) , performance status of 0 to 1 , adequate organ function , treated brain metastases , and no recent vascular events or bleeding diatheses were eligible .


Eligible patients were stratified as platinum-sensitive or platinum-refractory and randomly assigned to receive weekly topotecan 4 mg/m ( 2 ) intravenously ( IV ) with or without ziv-aflibercept 6 mg/kg IV every 21 days .


Progression-free survival ( PFS ) at 3 months was the primary end point .


In 189 randomly assigned patients , treatment arms were well balanced with regard to clinical characteristics .


The 3-month PFS was significantly improved with the addition of ziv-aflibercept in patients who had platinum-refractory disease ( 27 % v 10 % ; P = .02 ) but not in patients with platinum-sensitive disease ( 24 % v 15 % ; P = .22 ) .


Although response rate was low , disease control rate was higher with combination therapy than with topotecan alone in patients who had platinum-sensitive disease ( 37 % v 18 % ; P = .05 ) and in those who had platinum-refractory disease ( 25 % v 15 % ; P = .14 ) .


Overall survival ( OS ) was not significantly improved in either strata .


Grades 3 to 5 toxicities were more common with the addition of ziv-aflibercept .


Ziv-aflibercept improved the 3-month PFS in patients who had platinum-refractory SCLC , but its addition increased toxicity .


OS was similar with combined ziv-aflibercept and topotecan compared with topotecan in both strata .


Late enhancement MRI ( LE-MRI ) and cardiac troponin I ( cTnI ) are sensitive methods to detect subclinical myocardial injury .


We sought to investigate the relation between plasma concentrations of cTnI measured with a high-sensitivity assay ( hs-cTnI ) and the development of unrecognized myocardial infarctions ( UMIs ) detected with LE-MRI .


After approval from the ethics committee and written informed consent were obtained , LE-MRI was performed on 248 randomly selected community-living 70-year-old volunteers and hs-cTnI was determined with a highly sensitive premarket assay .


Five years later these individuals were invited to a second LE-MRI , and 176 of them ( 82 women , 94 men ) , who did not have a hospital diagnosis of MI , constitute the present study population .


LE-MR images were analyzed by 2 radiologists independently and in a consensus reading , blinded to any information on previous disease or assessments .


New or larger UMIs were detected in 37 participants during follow-up .


Plasma concentrations of hs-cTnI at 70 years of age , which were mainly within what is considered to be the reference interval , were related to new or larger UMIs at 75 years of age with an odds ratio of 1.98 per 1 unit increase in ln-transformed cTnI ( 95 % CI , 1.17-3 .35 ; P = 0.010 ) .


Plasma concentrations of hs-cTnI at 70 years of age were associated with the volumes of the UMIs detected at 75 years of age ( P = 0.028 ) .


hs-cTnI in 70-year-old community-living women and men was associated with the development of MRI-detected UMIs within 5 years .


The Relaxin for the Treatment of Acute Heart Failure ( RELAX-AHF ) trial enrolled 1161 patients admitted to the hospital for acute heart failure ( AHF ) to evaluate the therapeutic efficacy of serelaxin , a recombinant form of human relaxin-2 .


We characterized how representative RELAX-AHF clinical trial enrollees were to those patients with AHF found in international registries .


We examined 196 770 AHF admissions from the Acute Decompensated Heart Failure National Registry-United States and Acute Decompensated Heart Failure National Registry-International registries .


Patients were considered RELAX-AHF-type if they met the following criteria : discharge diagnosis of heart failure , systolic blood pressure > 125 mm Hg , dyspnea at rest or with mild exertion , intravenous diuretic use , glomerular filtration rate of 30 to 75 mL/min per 1.73 m ( 2 ) , hemoglobin > 8 g/dL , and no use of intravenous inotropes or vasopressors .


Baseline characteristics and treatments of RELAX-AHF-type and non-RELAX-AHF-type patients were compared .


A Cox model was used to evaluate inpatient mortality .


Among both Acute Decompensated Heart Failure National Registry-United States and Acute Decompensated Heart Failure National Registry-International registries , 20.7 % ( n = 38 485 ) and 16.2 % ( n = 1749 ) of patients met basic criteria for RELAX-AHF entry , respectively .


These patients were more likely to be older , be women , have a previous history of hypertension , have preserved ejection fraction , and have better renal function .


In-hospital mortality was lower in RELAX-AHF-type than in non-RELAX-AHF-type patients , even after multivariable adjustment ( hazard ratio , 0.59 ; 95 % confidence interval , 0.53-0 .66 ; P < 0.0001 ) .


Patients potentially eligible for RELAX-AHF represent 2 in 10 patients with AHF in the United States , Latin America , or Asia-Pacific .


These patients differ significantly from other hospitalized patients based on clinical characteristics and outcomes .


When learning multiple tasks , blocked or random training schedules may be used .


We assessed the effects of blocked and random schedules on the acquisition and retention of laparoscopic skills .


Thirty-six laparoscopic novices were randomized to practice laparoscopic tasks using blocked , random , or no additional training .


Participants performed immediate post-tests , followed by retention tests 6 weeks later .


Outcomes included previously validated Fundamentals of Laparoscopic Surgery ( FLS ) and hand-motion efficiency scores .


Both blocked and random groups had significantly higher FLS and hand-motion efficiency scores over baseline on post-tests for each task ( P < .05 ) and higher overall FLS scores than controls on retention tests ( P < .01 ) .


No difference was seen between the blocked and random groups in the amount of skill acquired or skill retained .


Both blocked and random training schedules can be considered as valid training options to allow programs and learners to tailor training to their individual needs .


We investigated the effects of demographic , lifestyle ( self-reported smoking status and physical activity levels ) , cancer-related treatment factors ( radiation and chemotherapy ) , and diet ( calcium and vitamin D intake ) on bone turnover and the relationship of bone turnover to lumbar spine bone mineral density ( BMD ) Z-scores ( LS-BMD Z-scores ) determined by quantitative computed tomography ( QCT ) in 418 5-year survivors of childhood acute lymphoblastic leukemia ( ALL ) .


Bone turnover was assessed by biomarkers including serum bone-specific alkaline phosphatase ( BALP ) , osteocalcin ( OC ) , and urinary N-telopeptide of type I collagen indexed to creatinine ( NTX/Cr ) .


The 215 males ranged in age from 9 to 36 years ( median age 17 years ) .


Age and tanner score were inversely associated with all biomarkers ( BALP , OC , NTX/Cr ) ( P < 0.001 ) .


Males had higher BALP and OC than females ( P < 0.001 ) .


Body mass index ( BMI ) was inversely associated with OC and NTX/Cr ( P < 0.001 ) .


There was no significant association of biomarkers with lifestyle related factors , ALL treatment-related factors , dietary calcium , vitamin D , or LS-BMD Z-score .


In this population of long-term survivors of ALL , bone turnover was significantly associated with age , gender , tanner stage , and BMI .


ALL-related treatments did not influence bone turnover and bone turnover was not predictive of volumetric LS-BMD Z-score .


The vaccine efficacy ( VE ) of 1 or 2 doses of AS03-adjuvanted influenza A ( H1N1 ) vaccine relative to that of 2 doses of nonadjuvanted influenza A ( H1N1 ) vaccine in children 6 months to < 10 years of age in a multinational study conducted during 2010-2011 .


A total of 6145 children were randomly assigned at a ratio of 1:1:1 to receive 2 injections 21 days apart of A/California/7 / 2009 ( H1N1 ) - AS03 vaccine at dose 1 and saline placebo at dose 2 , 2 doses 21 days apart of A/California/7 / 2009 ( H1N1 ) - AS03 vaccine ( the Ad2 group ) , or 2 doses 21 days apart of nonadjuvanted A/California/7 / 2009 ( H1N1 ) vaccine ( the NAd2 group ) .


Active surveillance for influenza-like illnesses continued from days 14 to 385 .


Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7 / 2009 ( H1N1 ) , using reverse-transcriptase polymerase chain reaction .


Immunogenicity , reactogenicity , and safety were assessed .


There were 23 cases of confirmed 2009 pandemic influenza A ( H1N1 ) ( A [ H1N1 ] pdm09 ) infection for the primary relative VE analysis .


The VE in the Ad2 group relative to that in the NAd2 group was 76.8 % ( 95 % confidence interval , 18.5 % -93.4 % ) .


The benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group , compared with the NAd2 group .


The 4-8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A ( H1N1 ) pdm09 infection , compared with nonadjuvanted vaccine , with no observed increase in medically attended or serious adverse events .


These data support the use of adjuvanted influenza vaccines during influenza pandemics .


Clinical Trials Registration .


NCT01051661 .


To evaluate the efficacy and safety of intravitreal bevacizumab ( IVB ) in eyes with neovascular glaucoma ( NVG ) undergoing Ahmed glaucoma valve ( AGV ) implantation .


This was a multicentre , prospective , randomized clinical trial that enrolled 40 patients with uncontrolled neovascular glaucoma that had undergone panretinal photocoagulation and required glaucoma drainage device implantation .


Patients were randomized to receive IVB ( 1.25 mg ) or not during Ahmed valve implant surgery .


Injections were administered intra-operatively , and 4 and 8 weeks after surgery .


After a mean follow-up of 2.25 0.67 years ( range 1.5-3 years ) , both groups showed a significant decrease in IOP ( p < 0.05 ) .


There was no difference in IOP between groups except at the 18-month interval , when IOP in IVB group was significantly lower ( 14.57 1.72 mmHg vs. 18.37 1.06 mmHg - p = 0.0002 ) .


There was no difference in survival success rates between groups .


At 24 months , there was a trend to patients treated with IVB using less antiglaucoma medications than the control group ( p = 0.0648 ) .


Complete regression of rubeosis iridis was significantly more frequent in the IVB group ( 80 % ) than in the control group ( 25 % ) ( p = 0.0015 ) .


Intravitreal bevacizumab may lead to regression of new vessels both in the iris and in the anterior chamber angle in patients with neovascular glaucoma undergoing Ahmed glaucoma valve implantation .


There is a trend to slightly lower IOPs and number of medications with IVB use during AGV implantation for neovascular glaucoma .


EBV-encoded latent membrane protein 1 ( EBV-LMP1 ) is an important oncogenic protein for nasopharyngeal carcinoma ( NPC ) and has been shown to engage a plethora of signaling pathways .


Correspondingly , an LMP1-targeted DNAzyme was found to inhibit the growth of NPC cells both in vivo and in vitro by suppressing cell proliferation and inducing apoptosis .


However , it remains unknown whether an LMP1-targeted DNAzyme would affect the vasculature of NPC .


Dynamic contrast-enhanced magnetic resonance imaging ( DCE-MRI ) has been applied in the clinical trials of anti-angiogenic drugs for more than ten years , and Ktrans has been recommended as a primary endpoint .


Therefore , the objective of the current study was to use DCE-MRI to longitudinally study the effect of an EBV-LMP1-targeted DNAzyme on the vasculature of patients with NPC .


Twenty-four patients were randomly divided into two groups : a combined treatment group ( radiotherapy + LMP1-targeted DNAzyme ) and a radiotherapy alone group ( radiotherapy + normal saline ) .


DCE-MRI scans were conducted 1 ~ 2 days before radiotherapy ( Pre-RT ) , during radiotherapy ( RT 50 Gy ) , upon completion of radiotherapy ( RT 70 Gy ) , and three months after radiotherapy ( 3 months post-RT ) .


Parameters of vascular permeability and intra - and extravascular volumes were subsequently obtained ( e.g. , Ktrans , kep , ve ) using nordicICE software .


Both Ktrans and kep values for NPC tumor tissues decreased for both groups after treatment .


Moreover , a statistically significant difference in Ktrans values at the pre-therapy and post-therapy timepoints emerged earlier for the combined treatment group ( RT 50 Gy , P = 0.045 ) compared to the radiotherapy alone group ( 3 months post-RT , P = 0.032 ) .


For the kep values , the downward trend observed for both the combined treatment group and the radiotherapy alone group were similar .


In contrast , ve values for all of the tumor tissues increased following therapy .


The EBV-LMP1-targeted DNAzyme that was tested was found to accelerate the decline of Ktrans values for patients with NPC .


Correspondingly , the LMP1-targeted DNAzyme treatments were found to affect the angiogenesis and microvascular permeability of NPC .


ClinicalTrials.gov : NCT01449942 .


Registered 6 October 2011 .


We aimed at comparing the long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis .


Long-term follow-up study of patients included in Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis ( EVA-3S ) , a randomized , controlled trial of carotid stenting versus endarterectomy in 527 patients with recently symptomatic severe carotid stenosis , conducted in 30 centers in France .


The main end point was a composite of any ipsilateral stroke after randomization or any procedural stroke or death .


During a median follow-up of 7.1 years ( interquartile range , 5.1-8 .8 years ; maximum 12.4 years ) , the primary end point occurred in 30 patients in the stenting group compared with 18 patients in the endarterectomy group .


Cumulative probabilities of this outcome were 11.0 % ( 95 % confidence interval , 7.9-15 .2 ) versus 6.3 % ( 4.0-9 .8 ) in the endarterectomy group at the 5-year follow-up ( hazard ratio , 1.85 ; 1.00-3 .40 ; P = 0.04 ) and 11.5 % ( 8.2-15 .9 ) versus 7.6 % ( 4.9-11 .8 ; hazard ratio , 1.70 ; 0.95-3 .06 ; P = 0.07 ) at the 10-year follow-up .


No difference was observed between treatment groups in the rates of ipsilateral stroke beyond the procedural period , severe carotid restenosis ( 70 % ) or occlusion , death , myocardial infarction , and revascularization procedures .


The long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis favored endarterectomy , a difference driven by a lower risk of procedural stroke after endarterectomy .


Both techniques were associated with low and similar long-term risks of recurrent ipsilateral stroke beyond the procedural period .


http://www.clinicaltrials.gov .


Unique identifier : NCT00190398 .


This work evaluates the effect of adding platelet-derived growth factor to autologous adipose tissue grafts in the treatment of human immunodeficiency virus facial lipoatrophy by means of objective measurements .


This is a randomized clinical trial conducted at the Hospital Clinic of Barcelona .


Patients with facial human immunodeficiency virus atrophy were randomized into two groups , one treated with autologous fat injection ( group A ) , and another treated with autologous fat injection with plasma rich in growth factors ( group B ) .


Before the treatment , structural changes were identified in facial soft tissue by means of computed tomography , and clinical changes were also assessed by means of photographic records .


Posttreatment assessments were repeated after 2 and 12 months to compare the results .


Posttreatment complications were recorded .


Forty-nine patients ( 33 men and 16 women ) , with a mean age of 46 years , participated in the study .


In both groups , there was a statistically significant average increase of volume in the facial area measured by computed tomography between the baseline and the 2 - and 12-month posttreatment assessments .


All cases showed an improvement of the clinical facial atrophy grade after treatment , which was statistically significant .


This improvement was related to a statistically significant fat volume increase measured by means of computed tomography .


There was no difference in the volume gain between both groups .


No major complications were observed .


Fat grafting is a safe , effective , and durable treatment for human immunodeficiency virus facial atrophy .


The results of this study show that it is not necessary to add plasma rich in growth factors to the adipose tissue graft to get a better result .


Therapeutic , II .


Longevity of effects and dose equivalence of different botulinum toxin type A ( BoNT-A ) preparations need to be better clarified because BoNT-A units are manufacturer-specific .


These points are of particular importance for new brands emerging in the market .


To assess the field of muscular and anhidrotic effects of 2 commercial preparations of BoNT-A ( incobotulinumtoxinA : Xeomin [ XEO ] ; abobotulinumtoxinA : Dysport [ DYS ] ) administered to the upper third of the face .


Patients were randomized for the side of the forehead ( left or right ) in which the products were administered .


All were treated receiving BoNT-A injections in 10 points ( 5 on each side ) at a dose equivalence of 1.0:2.5 U ( XEO : DYS ) .


Clinical assessments and Minor test were performed at baseline and Days 28 , 84 , 112 , and 140 .


Electromyography was performed at baseline and Days 28 and 140 , and ultrasound was performed only at baseline .


Eighty patients were enrolled in 2 research centers .


Xeomin and DYS presented similar results regarding fields of muscular effects .


However , a larger field of anhidrotic effects was found for DYS .


There was a positive correlation between the muscle thickness and electromyography results .


The results of this study suggest that a lower dose equivalence between DYS and XEO could be established .


In the Surgical Treatment for Ischemic Heart Failure trial , surgical ventricular reconstruction plus coronary artery bypass surgery was not associated with a reduction in the rate of death or cardiac hospitalization compared with bypass alone .


We hypothesized that the absence of viable myocardium identifies patients with coronary artery disease and left ventricular dysfunction who have a greater benefit with coronary artery bypass graft surgery and surgical ventricular reconstruction compared with bypass alone .


Myocardial viability was assessed by single photon computed tomography in 267 of the 1000 patients randomized to bypass or bypass plus surgical ventricular reconstruction in the Surgical Treatment for Ischemic Heart Failure .


Myocardial viability was assessed on a per patient basis and regionally according to prespecified criteria .


At 3 years , there was no difference in mortality or the combined outcome of death or cardiac hospitalization between those with and without viability , and there was no significant interaction between the type of surgery and the global viability status with respect to mortality or death plus cardiac hospitalization .


Furthermore , there was no difference in mortality or death plus cardiac hospitalization between those with and without anterior wall or apical scar , and no significant interaction between the presence of scar in these regions and the type of surgery with respect to mortality .


In patients with coronary artery disease and severe regional left ventricular dysfunction , assessment of myocardial viability does not identify patients who will derive a mortality benefit from adding surgical ventricular reconstruction to coronary artery bypass graft surgery .


To prevent salivary dysfunction in thyroid cancer patients who have undergone radioiodine ablation , massaging the parotid gland ( PG ) is presumed to be helpful for the removal of radioiodine .


The purpose of this study was to evaluate the effect of PG massage in the removal of radioiodine from the PG .


Forty-four patients ( female , 38 ; 49.1 11.0 years ) who underwent total thyroidectomy followed by I-131 ablation were included in this prospective study .


Three serial salivary gland scans were performed 2h after administration of I-123 in thyroid hormone withdrawal status .


The patients were divided into two groups .


There was a 1-min ( or 2-min ) interval between the first and second scans for control , followed by the performance of PG massage for 1 min ( or 2 min ) between the second and third scans .


Changes in uptakes were calculated between the first and second scans ( control ) and between the second and third scans ( massage ) .


The mean change in uptake at the 1-min massage was 0.97 11.27 % , whereas that at the 1-min control was 11.54 5.59 % ( P < 0.001 ) .


The mean change in uptake at the 2-min massage was also significantly lower than that at the 2-min control ( 11.11 6.97 vs. -0.85 9.78 % , P < 0.001 ) .


However , no statistical difference was observed between the mean changes in uptake after 1 - and 2-min massages ( P = 0.573 ) .