Concordance between investigator - and IRC-assessed progression and objective response was assessed .


The IRC analysis demonstrated a statistically significant increase in PFS ( hazard ratio [ HR ] = 0.451 ; 95 % confidence interval [ CI ] = 0.351 to 0.580 , p < 0.0001 ) consistent with the benefit reported by investigators ( HR = 0.484 ; 95 % CI = 0.388 to 0.605 , p < 0.0001 ) .


The concordance rate , defined by agreement on progression status , was 74.2 % overall , and comparable between treatment arms ( bevacizumab , 75.2 % vs. placebo , 73.1 % ) .


IRC-assessed ORR was significantly improved with bevacizumab ( bevacizumab , 74.8 % vs. placebo , 53.7 % ; p < 0.0001 ) , consistent with the investigator-assessed results .


The concordance rate for objective response was 79.8 % overall , and comparable between treatment arms ( bevacizumab , 78.9 % vs. placebo , 80.6 % ) .


IRC-determined results were highly consistent with those determined by investigators , demonstrating that bevacizumab plus GC provides a significant improvement in PFS and ORR .


These results suggest that investigators can reliably assess disease progression and objective response in recurrent ovarian cancer using RECIST , without the necessity of a full IRC review .


To explore the impacts on the fine movement of upper extremity with flaccid paralysis in stroke treated with acupuncture and motor imagery .


Sixty-two cases of flaccid paralysis of upper extremity in stroke were randomized into an observation group ( 30 cases ) and a control group ( 32 cases ) .


In the control group , the conventional western medication and the passive movement of the extremity were applied .


Additionally , the penetrating needling technique was used at the head points [ penetrating needling from Baihui ( GV 20 ) to Taiyang ( EX-HN 5 ) ] and the local affected extremity [ penetrating needling from Jianyu ( LI 15 ) to Binao ( LI1 14 ) , from Quchi ( LI 11 ) to Shaohai ( HT 3 ) , from Waiguan ( TE 5 ) to Neiguan ( PC 6 ) , etc ] .


The needles were retained for 30 min .


In the observation group , on the basic treatment as the control group , during the needle retaining , the motor imagery therapy was supplemented .


The treatment was given once a day , 5 treatments a week , for 4 weeks totally in the either group .


The scores in the action research arm test ( ARAT ) and the modified Fugl-Meyer assessment ( FMA ) were recorded at the moment of enrollment , in 2 and 4 weeks of treatment , in the 6th and 8th weeks , as well as after 90 days separately .


( 1 ) ARAT score : since the 2nd week , ARAT scores in the observation group were all improved significantly as compared with those in the control group at the each time points ( all P < 0.05 ) .


In the observation group , the scores were improved significantly in the pair comparison at the time points ( all P < 0.05 ) .


In the control group , the score in the 2nd week was not different significantly as compared with that before treatment ( P > 0.05 ) , but the scores at the rest time points were improved significantly in the pair comparison ( all P < 0.05 ) ; ( 2 ) FMA score : in the 2nd week and on the 90th day , FMA score in the observation group was higher significantly than those in the control group ( both P < 0.05 ) .


In the observation group , the scores were all improved significantly in the pair comparison at the time points ( all P < 0.05 ) .


In the control group , except that in comparison between the 90th day and the 8th week ( P > 0.05 ) , the results were all P < 0.05 at the rest time points .


The early intervention of the combined therapy of acupuncture and motor imagery effectively promotes the recovery of the coordination function and the fine movement of upper extremity , especially the improvements of the fine movement in stroke at flaccid paralysis stage .


The efficacy is better than the single acupuncture treatment .


This paper attempts to describe the patterns of exercise and the perceived benefits and barriers to exercise in an urban south Indian population .


Study participants were recruited from the baseline survey of the D-CLIP ( Diabetes Community Lifestyle Improvement Program ) .


Frequency , duration , type and location of exercise were assessed using a questionnaire , while a Likert type scale was used to assess perceived benefits of and barriers to exercise .


Quality of life was measured using the EQ-5D .


Out of 1281 participants ( 63.7 % males ) , 24.1 % reported doing 150min of exercise/week ( `` exercisers '' ) compared to 75.9 % `` non-exercisers '' .


Exercisers were significantly older ( 47 vs. 43 years ) , better educated ( 68.8 % vs. 60 % ) , had a higher monthly income ( 41 % vs. 29.2 % ) , consumed more fruits ( 38.2 % vs. 25.6 % ) and vegetables ( 84.1 % vs. 77.7 % ) and had better perceived state of health ( 81.1 % vs. 76.8 % ) , compared to non-exercisers .


Exercisers had significantly lower HOMA-IR , higher Matsuda index and lower prevalence of low HDL cholesterol compared to non-exercisers .


However , there were no significant differences in cardio-metabolic risk factors like diabetes , hypertension and obesity between the two groups .


Walking was the most common type of exercise .


Both exercisers and non-exercisers perceived the benefits of exercising , but barriers weighed more heavily on exercise behaviour .


Urgent steps are needed to improve overall exercise levels in India by addressing barriers and improving the quality of exercise performed so as to enhance overall metabolic health .


To investigate if a six-year intensive lifestyle intervention in people with pre-diabetes lead to reduction of cardiovascular events and cardiovascular disease ( CVD ) mortality in subsequent 23 years .


Five hundreds and nineteen subjects with normal glucose tolerance ( NGT ) and 577 subjects with impaired glucose tolerance ( IGT ) in Da Qing city were recruited in the study in 1986 .


The IGT subjects randomly assigned to either the no-intervention group or one of three lifestyle intervention groups ( diet , exercise , or diet plus exercise ) to receive a 6-year lifestyle intervention .


In 2009 , the participants were followed up to assess the primary outcomes of cardiovascular events and CVD mortality by a questionnaire and medical records .


Subjects in IGT no-intervention group had the highest incidences of cardiovascular events ( 44.44 % ) and CVD mortality ( 20.00 % ) , while those in NGT group had the lowest incidences of cardiovascular events ( 29.59 % ) and CVD mortality ( 7.52 % ) after 23-year follow-up .


The incidences of cardiovascular events and CVD mortality in IGT intervention subjects were 37.84 % and 12.53 % , respectively .


The multivariable analyses showed that , after controlling of age , gender , BMI smoking , blood pressure and cardiovascular event at baseline , the CVD mortality and incidence of cardiovascular events in IGT no-intervention group was 1.89 ( HR = 1.89 , 95 % CI 1.11-3 .22 , P = 0.02 ) and 1.38 ( HR = 1.38 , 95 % CI 1.01-1 .90 , P = 0.04 ) times of those in NGT group .


However , the CVD mortality and incidence of cardiovascular events were not different in the IGT intervention group compared with those in the NGT group ( HR = 1.39 , 95 % CI 0.89-2 .18 , P = 0.15 and HR = 1.25 , 95 % CI 0.98-1 .59 , P = 0.07 , respectively ) .


Subjects with IGT were at high risk for cardiovascular events and mortality .


A six-year lifestyle intervention in this population can reduce both the incidence of cardiovascular event and CVD mortality .


Anesthesia induction using propofol ( 3 mg/kg ) and remifentanil ( 2 g/kg ) without the use of muscle relaxants has been associated with a lower incidence of successful intubation .


Dexmedetomidine has been found to effectively decrease the requirements for propofol and remifentanil and to attenuate the hemodynamic response to intubation .


Therefore , in this study , we examined intubating conditions and hemodynamic changes in children after induction with dexmedetomidine ( 1 g/kg ) combined with propofol ( 3 mg/kg ) and remifentanil ( 2 g/kg ) .


This randomized , double-blinded , and placebo-controlled study included 60 ASA physical status I children aged 5 to 10 years .


The children were randomly allocated to a dexmedetomidine group ( group D ) or a placebo group ( group P ) .


After IV administration of atropine ( 0.01 mg/kg ) , anesthesia was induced with an infusion of dexmedetomidine ( 1 g/kg ) over 2 minutes for group D , whereas normal saline was infused for group P. Propofol ( 3 mg/kg ) was then injected IV over 20 to 30 seconds , followed by an infusion of remifentanil ( 2 g/kg ) over 1 minute for both groups .


One minute later , laryngoscopy and tracheal intubation were performed .


For group D and group P , tracheal intubation was successful in 90 % ( 27/30 ) and 53 % ( 16/30 ) of patients ( P = 0.0034 ) , respectively .


Excellent conditions were present in 22 of 27 and 8 of 16 of intubations , respectively , resulting in an overall incidence of excellent conditions of 73 % ( 22/30 ) and 27 % ( 8/30 ) , respectively ( P = 0.0007 ) .


Systolic blood pressure significantly increased after the IV injection of dexmedetomidine compared with baseline readings ( P = 0.012 , with a confidence interval of 2-22 mm Hg ) .


A single dose of dexmedetomidine ( 1 g/kg ) improved intubation conditions in children after induction with propofol ( 3 mg/kg ) and remifentanil ( 2 g/kg ) without muscle relaxants .


Dexmedetomidine did not affect the hemodynamic response to intubation .


Carbapenem-resistant Enterobacteriaceae ( CRE ) are emerging .


In attempt to eradicate CRE colonization , we conducted a semirandomized , prospective , controlled trial using oral nonabsorbable antibiotics .


Consecutive hospitalized CRE carriers were studied .


Patients whose rectal isolates were gentamicin sensitive but colistin resistant were treated with gentamicin .


Patients whose isolates were colistin sensitive but gentamicin resistant were treated with colistin .


Patients whose isolates were sensitive to both drugs were randomized to 3 groups of oral antibiotic treatment : gentamicin , colistin , or both .


Patients whose isolates were resistant to both drugs , and those who did not consent , were followed for spontaneous eradication .


One hundred fifty-two patients were included ; 102 were followed for spontaneous eradication for a median duration of 140 days ( controls ) , and 50 received 1 of the 3 drug regimens : gentamicin , 26 ; colistin , 16 ; both drugs , 8 , followed for a median duration of 33 days .


Eradication rates in the 3 treatment groups were 42 % , 50 % , and 37.5 % , respectively , each significantly higher than the 7 % spontaneous eradication rate in the control group ( P < .001 , P < .001 , and P = .004 , respectively ) with no difference between the regimens .


No significant adverse effects were observed .


Oral antibiotic treatment with nonabsorbable drugs to which CRE is susceptible appears to be an effective and safe for eradication of CRE colonization and , thereby , may reduce patient-to-patient transmission and incidence of clinical infection with this difficult-to-treat organism .


Energy expenditure ( EE ) increases with overfeeding , but it is unclear how rapidly this is related to changes in body composition , increased body weight , or diet .


The objective was to quantify the effects of excess energy from fat or protein on energy expenditure of men and women living in a metabolic chamber .


We conducted a randomized controlled trial in 25 participants who ate 40 % excess energy for 56 d from 5 % , 15 % , or 25 % protein diets .


Twenty-four-hour EE ( 24EE ) and sleeping EE ( SleepEE ) were measured on days 1 , 14 , and 56 of overfeeding and on day 57 while consuming the baseline diet ( usually day 57 ) .


Metabolic and molecular markers of muscle metabolism were measured in skeletal muscle biopsy specimens .


In the low-protein diet group whose excess energy was fat , the 24EE and SleepEE did not increase during the first day of overfeeding .


When extra energy contained protein , both 24EE and SleepEE increased in relation to protein intake ( r = 0.50 , P = 0.02 ) .


The 24EE over 8 wk in all 3 groups was correlated with protein intake ( r = 0.60 , P = 0.004 ) but not energy intake ( r = 0.16 ; P = 0.70 ) .


SleepEE was unchanged by overfeeding in the low-protein diet group , and baseline surface area predicted increased 24EE in this group .


Protein and fat oxidation were reciprocally related during overfeeding .


Observed 24EE was higher than predicted on days 1 ( P 0.05 ) , 14 ( P = 0.0001 ) , and 56 ( P = 0.0007 ) .


There was no relation between change in fat mass and change in EE .


Excess energy , as fat , does not acutely increase 24EE , which rises slowly as body weight increases .


Excess energy as protein acutely stimulates 24EE and SleepEE .


The strongest relation with change in 24EE was the change in energy expenditure in tissue other than muscle or fat-free mass .


This article describes a study that aimed to validate the Self-care in Chronic Conditions Partners in Health Scale instrument in the Mexican population .


The instrument has been validated in Australia for use as a screening tool by primary healthcare professionals to assess the self-care skills and abilities of people with a chronic illness .


Validation was conducted using baseline data for 552 people with diabetes , hypertension and cancer aged 18 or older who were users of healthcare centres in Tampico , Tamaulipas , Mexico .


Results show high reliability and validity of the instrument and three themes were identified : knowledge , adherence , and dealing with and managing side effects .


The findings suggest the scale is useful as a generic self-rated clinical tool for assessing self-management in a range of chronic conditions , and provides an outcome measure for comparing populations and change in patient self-management knowledge and behaviour .


The authors recommend validating the scale in other Latin-American settings with more research into the effect of gender on self - management .


Non-invasive near-infrared spectroscopy ( NIRS ) offers the possibility to determine regional cerebral oxygen saturation ( rSO2 ) in patients with cardiac arrest .


Limited data from recent studies indicate a potential for early prediction of neurological outcome .


Sixty cardiac arrest patients were prospectively enrolled , 22 in-hospital cardiac arrest ( IHCA ) and 38 out-of-hospital cardiac arrest ( OHCA ) patients respectively .


NIRS of frontal brain was started after return of spontaneous circulation ( ROSC ) during admission to ICU and was continued until normothermia .


Outcome was determined at ICU discharge by the Pittsburgh Cerebral Performance Category ( CPC ) and 6 months after cardiac arrest .


A good outcome ( CPC 1-2 ) was achieved in 23 ( 38 % ) patients , while 37 ( 62 % ) had a poor outcome ( CPC 3-5 ) .


Patients with good outcome had significantly higher rSO2 levels ( CPC 1-2 : rSO2 68 % ; CPC 3-5 : rSO2 58 % ; p < 0.01 ) .


For good and poor outcome median rSO2 within the first 24h period was 66 % and 59 % respectively and for the following 16h period 68 % and 59 % ( p < 0.01 ) .


Outcome prediction by area of rSO2 below a critical threshold of rsO2 = 50 % within the first 40h yielded 70 % specificity and 86 % sensitivity for poor outcome .


On average , rSO2 within the first 40h after ROSC is significantly lower in patients with poor outcome , but rSO2 ranges largely overlap between outcome groups .


Our data indicate limited potential for prediction of poor outcome by frontal brain rSO2 measurements .


This study aimed to examine whether reductions in sitting time through alternating 30-min bouts of sitting and standing can reduce postprandial glucose , insulin , and triglyceride responses .


Twenty-three overweight/obese sedentary office workers ( 17 males and six females ; mean SD : age , 48.2 7.9 yr ; body mass index , 29.6 4.0 kg m ( -2 ) ) undertook two short-term ( 5 d ) experimental conditions in an equal , randomized ( 1:1 ) order .


In a simulated office environment , participants performed typical occupational tasks for 8 h d ( -1 ) while in a 1 ) seated work posture ( control condition ) or 2 ) interchanging between a seated and standing work posture every 30 min using an electric , height-adjustable workstation ( intervention condition ) .


Fasting and postprandial blood samples after a mixed test drink were collected hourly for 4 h on days 1 and 5 of each condition to assess serum insulin , plasma glucose , and triglycerides .


Dietary intake ( kJ d ( -1 ) ) and physical activity were standardized during each condition .


The trial was registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12611000632998 ) .


After adjustment for time ( days 1 and 5 ) , incremental area under the analyte time curve differed significantly between conditions for plasma glucose ( P = 0.007 ) but not for serum insulin or plasma triglycerides .


Adjusted mean glucose incremental area under the analyte time curve was lowered by 11.1 % after the intervention condition ( 6.38 mM h ( -1 ) ( confidence interval , 5.04-7 .71 ) ) relative to the control condition ( 7.18 mM h ( -1 ) ( confidence interval , 5.85-8 .52 ) ) .


No temporal changes ( days 1 vs 5 ) between conditions were observed .


Alternating standing and sitting in 30-min bouts results in modest beneficial effects on postprandial glucose responses in overweight/obese office workers .


Pneumococcal conjugate vaccines ( PCV ) reduce disease due to Streptococcus pneumoniae .


We aimed to determine the efficacy of different PCV schedules in Gambian children .


We reanalysed data from a randomised placebo-controlled trial .


Infants aged 6-51 weeks were allocated to three doses of nine-valent PCV ( n = 8718 ) or placebo ( n = 8719 ) and followed until age 30 months .


We categorised participants to compare : ( a ) a first dose at age 6 or 10 weeks , ( b ) intervals of 1 or 2 months between doses , and ( c ) different intervals between second and third doses .


The primary endpoint was first episode of radiologic pneumonia ; other endpoints were hospitalisation and mortality .


Using the placebo group as the reference population , Poisson regression models were used with follow-up after the first dose to estimate the efficacy of each schedule and from age 6 weeks to estimate the incidence rate difference between schedules .


Predicted efficacy in the groups aged 6 weeks ( n = 2467 , 154 events ) or 10 weeks ( n = 2420 , 106 events ) at first dose against radiologic pneumonia were 32 % ( 95 % CI 19-43 % ) and 33 % ( 95 % CI 21-44 % ) , against hospitalisation 14 % ( 95 % CI 3-23 % ) and 17 % ( 95 % CI 7-26 % ) , and against mortality 17 % ( 95 % CI -3 to 33 % ) and 16 % ( 95 % CI -3 to 32 % ) respectively .


Predicted efficacy in the groups with intervals of 1 month ( n = 2701 , 133 events ) or 2 months ( n = 1351 , 58 events ) between doses against radiologic pneumonia were 33 % ( 95 % CI 20-44 % ) and 36 % ( 95 % CI 24-46 % ) , against hospitalisation 15 % ( 95 % CI 5-24 % ) and 18 % ( 95 % CI 8-27 % ) , and against mortality 17 % ( 95 % CI -2 to 33 % ) and 13 % ( 95 % CI -8 to 29 % ) respectively .


Efficacy did not differ by interval between second and third doses , nor did the incidence rate difference between schedules .


We found no evidence that efficacy or effectiveness of PCV9 differed when doses were given with modest variability around the scheduled ages or intervals between doses .


Data are scarce on the advantage of ultrasound-guided spinal anaesthesia in patients with easily identifiable bony landmarks .


In this study , we compared the use of ultrasound to the landmark method in patients with no anticipated technical difficulty , presenting for caesarean delivery under spinal anaesthesia .


A total of 150 pregnant women were recruited in this randomized , controlled study .


Ultrasound examination and spinal anaesthesia were performed by three anaesthetists with experience in ultrasound-guided neuraxial block .


Patients were randomized to either the Ultrasound Group ( n = 75 ) or the Landmark Group ( n = 75 ) .


In both groups the level of L3-4 or L4-5 was identified by ultrasound ( transverse and longitudinal approach ) or palpation .


The primary outcome was the procedure time , measured from the time of skin puncture by the introducer to the time of viewing cerebrospinal fluid at the hub of the spinal needle .


Secondary outcomes were the number of skin punctures , number of passes , and incidence of successful spinal blockade .


The average procedure time , number of skin punctures and needle passes , were similar in both groups .


The number of patients with successful spinal anaesthesia after one puncture was not statistically different between the groups .


The present results indicate that when performed by anaesthetists experienced in both ultrasound and landmark techniques , the use of ultrasound does not appear to increase the success rate of spinal anaesthesia , or reduce the procedure time or number of attempts in obstetric patients with easily palpable spines .


Low-dose computed tomography ( LDCT ) lung screening has been associated with a 20 % reduction in lung cancer mortality .


A major barrier to the adoption of lung screening is the potential negative psychological impact of a false-positive ( FP ) screen , occurring in 20 % to 50 % of those screened .


The objective of this study was to assess the impact of abnormal findings on health-related quality of life ( HRQoL ) and anxiety in the American College of Radiology ( ACRIN ) / National Lung Screening Trial ( NLST ) .


The NLST was a randomized screening trial comparing LDCT with chest X-ray screening ( CXR ) .


This study was part of the original protocol .


A total of 2812 participants at 16 of 23 ACRIN sites who had baseline HRQoL assessments were asked to complete the Short Form-36 and the State Trait Anxiety Inventory ( form Y-1 ) questionnaires to assess short-term ( 1 month ) and long-term ( 6 months ) effects of screening .


FP were lung cancer-free at 1 year , and true-positives ( TP ) were not .


Of the total participants , 1024 ( 36.4 % ) participants were FP , 63 ( 2.2 % ) were TP , 344 ( 12.2 % ) had significant incidental findings ( SIFs ) , and 1381 ( 49.1 % ) had negative screens .


Participants had been randomized to LDCT ( n = 1947 ) and CXR ( n = 865 ) .


Short-term and long-term HRQoL and state anxiety did not differ across participants with FP , SIF , or negative screens .


Short-term and long-term HRQoL were lower and anxiety was higher for TP participants compared to participants with FP , SIF , and negative screens .


In a large multicenter lung screening trial , participants receiving a false-positive or SIF screen result experienced no significant difference in HRQoL or state anxiety at 1 or at 6 months after screening relative to those receiving a negative result .


To determine if brief primary care interventions can affect children 's media viewing habits and exposure to violence .


English - and Spanish-speaking parents of 2 - to 12-year-old children presenting to a pediatric primary care clinic participated in a randomized controlled trial .


There were 2 intervention groups ; one group viewed 5 minutes from the Play Nicely program and another received a handout , `` Pulling the Plug on TV Violence . ''


There were 2 control groups ; the primary control group received standard primary care , and the alternative control group viewed a program about obesity prevention .


The outcome measure was parental report of changes in media viewing habits and changes in exposure to violence .


A total of 312 of 443 parents who were randomized completed a 2-week follow-up survey .


Compared with the primary control group , parents in the video intervention group were more likely to report a change in their children 's media viewing habits ( odds ratio [ OR ] 3.29 ; 95 % confidence interval [ CI ] 1.66-6 .51 ) and a change in their children 's exposure to violence ( OR 4.26 ; 95 % CI 1.95-9 .27 ) .


Compared with the primary control group , parents in the handout group were more likely to report a change in their children 's media viewing habits ( OR 4.35 ; 95 % CI 2.20-8 .60 ) and a change in their children 's exposure to violence ( OR 3.35 ; 95 % CI 1.52-7 .35 ) .


Brief primary care interventions can affect children 's media viewing habits and children 's exposure to violence .


These results have implications for how to improve primary care services related to decreasing children 's media exposure and violence prevention .


Dual-chamber implantable cardioverter-defibrillators ( ICDs ) may improve specificity and reduce the risk of inappropriate shocks , and enhance atrial arrhythmia ( AT/AF ) detection to permit stroke prevention compared with single-chamber ICDs , but at additional expense and risk .


Patients ( n = 100 ) receiving primary prevention ICDs at two USA and two Israeli centres were randomized to dual-chamber or single-chamber devices between December 2008 and December 2010 and were followed for 1 year .


Programming in both groups included : delayed detection to avoid therapy for non-sustained episodes ; high detection cut-off rates to avoid treating slower , better tolerated arrhythmias ; minimized right ventricular pacing ; and routine use of supraventricular-ventricular tahcycardia discriminators and antitachycardia pacing .


The primary outcome was the proportion of patients with inappropriate shocks .


One patient in each group ( 2 % ) received inappropriate shocks ( P = 1.00 ) .


Death occurred in two patients in the single-chamber arm , and in none of the patients in the dual-chamber arm ( P = 0.15 ) .


New AT/AF was detected in 12 patients ( 24 % ) in the dual-chamber group , vs. no patients in the single-chamber group ( P < 0.001 ) .


Among US participants , the mean cost of dual - vs. single-chamber ICD implantation was $ 16 579 vs. $ 14 249 , respectively ( P < 0.001 ) ; there was no difference in the quality of life ( EQ-5D index difference 0.013 , P = 0.769 ; EQ VAS difference 3.3 , P = 0.49 ) .


When optimal programming is utilized , inappropriate shocks are rare in primary prevention patients with both single - and dual-chamber ICDs .


The routine use of dual-chamber ICDs increases the expense without reducing inappropriate shocks or improving the quality of life at 1 year .


clinicaltrials.gov Identifier : NCT00787800 .


The zinc content of maize , a major global food staple , is generally insufficient alone to meet the requirements of young children .


The primary objective of this study was to determine whether substitution of biofortified maize ( 34 g zinc/g grain ) for control maize ( 21 g zinc/g ) was adequate to meet zinc physiologic requirements in young children for whom maize was the major food staple .


A secondary objective was to compare total daily zinc absorption when maize flour was fortified with zinc oxide to a total concentration of 60 g zinc/g .


Participants included 60 rural Zambian children with a mean age of 29 mo who were randomly assigned to receive 1 of 3 maize types ( control , biofortified , or fortified ) all of which were readily consumed ( > 100 g on 1 d ) .


Total daily zinc intake ( from maize and low-zinc relish ) was determined from duplicate diet collections .


Multiplication by fractional absorption of zinc , measured by a dual isotope ratio technique , determined the total daily zinc absorption on the day the test meals were given .


The mean SD total daily zinc intake ( milligrams per day ) from the biofortified maize ( 5.0 2.2 ) was higher ( P < 0.0001 ) than for the control maize ( 2.3 0.9 ) .


Intake of zinc from the fortified maize ( 6.3 2.6 ) did not differ from the biofortified maize .


Fractional absorption of zinc from control maize ( 0.28 0.10 ) did not differ from the biofortified maize ( 0.22 0.06 ) .


Total daily absorption of zinc ( milligrams per day ) from the biofortified maize ( 1.1 0.5 ) was higher ( P = 0.0001 ) than for the control maize ( 0.6 0.2 ) , but did not differ from the fortified maize ( 1.2 0.4 ) .


These results indicate that feeding biofortified maize can meet zinc requirements and provide an effective dietary alternative to regular maize for this vulnerable population .


This trial was registered at clinicaltrials.gov as NCT02208635 .


Duck viral hepatitis ( DVH ) is an acute disease of young ducklings with few convenient and effective veterinary drugs to treat .


In pathology , present study mainly focused on the immune mechanism , but very few studies have concerned with the role of oxidative stress in the pathogenesis of DVH .


To study the antioxidative and hepatoprotective effects of icariin and its phosphorylated derivative against DVH , we prepared phosphorylated icariin ( p-icariin ) using the sodium trimetaphosphate-sodium tripolyphosphate method .


Ducklings were drunk with icariin and p-icariin after being challenged with duck hepatitis virus 1 ( DHV-1 ) .


We recorded the number of dead ducklings , gross pathological changes in the liver , and changes in indices of oxidative stress and liver injury .


The correlations between these indices were also analyzed .


Exposure to DHV-1 induced significant oxidative damage in ducklings .


Administration of icariin or p-icariin attenuated liver pathological injury and significantly increased the survival rate , with better outcomes in ducklings treated with p-icariin than in those treated with icariin .


Icariin and p-icariin also attenuated the changes in oxidative stress and liver injury .


We found positive correlations among indices of oxidative stress ( malondialdehyde and inducible nitric oxide synthase ) and liver injury ( alanine aminotransferase , alkaline phosphatase , and lactate dehydrogenase ) , suggesting that DHV-1 causes significant oxidative damage , which is related to the extent of hepatic injury .


Icariin and p-icariin improved the survival and attenuated oxidative stress and liver dysfunction induced by DHV-1 .


These outcomes were better in ducklings treated with p-icariin than in those treated by icariin .


The clinical effects of both components were related to their antioxidant activities .


The evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited .


The main objective of the Tolerability and Efficacy of Antipsychotics ( TEA ) trial is to compare the benefits and harms of quetiapine versus aripiprazole in children and adolescents with psychosis in order to inform rational , effective and safe treatment selections .


The TEA trial is a Danish investigator-initiated , independently funded , multi-centre , randomised , blinded clinical trial .


Based on sample size estimation , 112 patients aged 12-17 years with psychosis , antipsychotic-nave or treated for a limited period are , 1:1 randomised to a 12 - week , double-blind intervention with quetiapine versus aripiprazole .


Effects on psychopathology , cognition , health-related quality of life , and adverse events are assessed 2 , 4 , and 12 weeks after randomisation .


The primary outcome is change in the positive symptom score of the Positive and Negative Syndrome Scale .


The recruitment period is 2010-2014 .


Antipsychotics are currently the only available pharmacologic treatments for psychotic disorders .


However , information about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents .


The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable population .


Here , we account for the trial design , address methodological challenges , and discuss the estimation of sample size .


ClinicalTrials.gov : NCT01119014 .


To compare DBT and FFDM in the classification of microcalcification clusters ( MCs ) using BI-RADS .


This Institutional Review Board-approved study was undertaken in three centres .


A total of 107 MCs evaluated with both DBT and FFDM were randomised for prospective reading by six experienced breast radiologists and classified using BI-RADS .


The benign/malignant ratio of MC was 66/41 .


Of 11/107 discordant results , DBT classified MCs as R2 whereas FFDM classified them as R3 in 9 and R4 in 2 .


Three of these ( 3/107 = 2.8 % ) were malignant ; 8 ( 7.5 % ) were nonmalignant and were correctly classified as R2 on DBT but incorrectly classified as R3 on FFDM .


Estimated sensitivity and specificity , respectively , were 100 % ( 95 % CI : 91 % to 100 % ) and 94.6 % ( 95 % CI : 86.7 % to 98.5 % ) for FFDM and 91.1 % ( 95 % CI : 78.8 % to 97.5 % ) and 100 % ( 95 % CI : 94.8 % to 100 % ) for DBT .


Overall intra - and interobserver agreements were 0.75 ( 95 % CI : 0.61-0 .84 ) and 0.73 ( 95 % CI : 0.62-0 .78 ) .


Most MCs are scored similarly on FFDM and DBT .


Although a minority ( 11/107 ) of MCs are classified differently on FFDM ( benign MC classified as R3 ) and DBT ( malignant MC classified as R2 ) , this may have clinical relevance .


The BI-RADS classification of MC differs for FFDM and DBT in 11/107 cases DBT assigned lower BI-RADS classes compared to FFDM in 11 clusters In 4/107 DBT may have missed some malignant and high-risk lesions In 7/107 the ` underclassification ' on DBT was correct , potentially avoiding unnecessary biopsies DBT may miss a small proportion of malignant lesions .


To compare the use of low pneumoperitoneum pressure ( LPP ; 8mm Hg ) vs standard pneumoperitoneum pressure ( SPP ; 12mm Hg ) during mini-laparoscopic hysterectomy ( MLH ) .


Randomized controlled trial ( Canadian Task Force classification I ) .


Tertiary care center .


Forty-two consecutive women scheduled to undergo MLH to treat benign uterine disease .


Women were randomly selected to undergo MLH using LPP ( n = 20 ) or SPP ( n = 22 ) .


MLH was performed via 3-mm ancillary ports .


The primary outcome was to evaluate changes in abdominal and shoulder-tip pain via a 100-mm visual analog scale at 1 , 3 , and 24hours postoperatively .


All procedures were completed via mini-laparoscopy without the need to increase intra-abdominal pressure or convert to conventional laparoscopy or open surgery .


Intraoperatively , 1 episode of severe bradycardia occurred in the LPP group , whereas no intraoperative complications were recorded in the SPP group ( p = .47 ) .


No postoperative complications were recorded ( p > .99 ) .


Abdominal pain was similar between groups at each time point .


Incidence and intensity of shoulder-tip pain at 1 and 3hours postoperatively was lower in the LPP group than in the SPP group ( p < .05 ) , whereas no between-group differences were observed at 24hours ( p > .05 ) .


Rescue analgesic requirement did not differ statistically between the LPP and SPP groups ( 20 % vs 41 % , respectively ; p = .19 ; odds ratio , 2.7 ; 95 % confidence interval , 0.69-11 .08 ) .


In experienced hands , use of LPP is safe and feasible .


During performance of MLH , compared with SPP , LPP is asimple method that offers advantages of less shoulder-tip pain .


To verify the clinical efficacy of shu-stream point acupuncture combined with fire needle therapy in the treatment of hand osteoarthritis .


Eighty cases were randomized into an acupuncture group ( shu-stream point acupuncture combined with fire needle therapy ) and a medication group ( votalin emulgel ) .


For the 42 cases in the acupuncture group , acupuncture at shu-stream points on the three yang meridians of the hand including Sanjian ( LI 3 ) , Zhongzhu ( TE 3 ) , Houxi ( SI 3 ) and fire needle at Ashi points were applied , the treatments were given once every other day , 15 times as a treatment course .


For the 38 cases in the medication group , votalin emulgel was prescribed for local embrocation , twice a day , 30 days as a treatment course .


The visual analogue scale ( VAS ) of arthralgia , joint function score and the duration of morning stiffness , joint tenderness , swelling were observed before and after treatment in both groups .


After two courses of clinical treatment , the VAS score of arthralgia , joint function score and the duration of morning stiffness , joint tenderness , swelling were statistically significant differences as compared with before treatment ( all P < 0.01 ) , the efficacy in the acupuncture group was superior to that in the medication group ( all P < 0.01 ) .


The cured-markedly effective rate and total effective rate were 61.9 % ( 26/42 ) and 95.2 % ( 40/42 ) in the acupuncture group , and 36.8 % ( 14/38 ) and 76.3 % ( 29/38 ) in the medication group respectively , with statistically significant differences between the two groups ( both P < 0.05 ) .


Shu-stream point acupuncture combined with fire needle therapy achieves a significant efficacy in the treatment of hand osteoarthritis .


The comparative outcome with GreenLight ( GL ) photoselective vaporisation of the prostate and transurethral resection of the prostate ( TURP ) in men with lower urinary tract symptoms due to benign prostatic obstruction ( BPO ) has been questioned .


The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS ( XPS ) to TURP for International Prostate Symptom Score ( IPSS ) and maximum flow rate ( Qmax ) at 6 mo and the proportion of patients who were complication free .


Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO .


180-W GL XPS system or TURP .


Measurements used were IPSS , Qmax , prostate volume ( PV ) , postvoid residual ( PVR ) and complications , perioperative parameters , and reintervention rates .


Noninferiority was evaluated using one-sided tests at the 2.5 % level of significance .


The statistical significance of other comparisons was assessed at the ( two-sided ) 5 % level .


The study demonstrated the noninferiority of XPS to TURP for IPSS , Qmax , and complication-free proportion .


PV and PVR were comparable between groups .


Time until stable health status , length of catheterisation , and length of hospital stay were superior with XPS ( p < 0.001 ) .


Early reintervention rate within 30 d was three times higher after TURP ( p = 0.025 ) ; however , the overall postoperative reintervention rates were not significantly different between treatment arms .


A limitation was the short follow-up .


XPS was shown to be noninferior ( comparable ) to TURP in terms of IPSS , Qmax , and proportion of patients free of complications .


XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. .


ClinicalTrials.gov , identifier NCT01218672 .


Traditional cardiovascular risk factors lead to endothelial injury and activation of leukocytes and platelets that initiate and propagate atherosclerosis .


We proposed that clopidogrel therapy in patients with stable coronary artery disease imparts a pleiotropic effect that extends beyond antiplatelet aggregation to other atheroprotective processes .


Forty-one subjects were randomized in a double-blind , placebo-controlled , crossover study to receive either clopidogrel 75 mg daily or placebo for 6 weeks and then transitioned immediately to the other treatment for an additional 6 weeks .


We assessed ( 1 ) endothelial function as flow-mediated dilation of the brachial artery , ( 2 ) arterial stiffness and central augmentation index using applanation tonometry , ( 3 ) vascular function as fingertip reactive hyperemia index , ( 4 ) inflammation by measuring plasma CD40 ligand and serum high-sensitivity c-reactive protein levels , ( 5 ) oxidative stress by measuring plasma aminothiols , and ( 6 ) circulating progenitor cells , at baseline and at the end of each 6-week treatment period .


Clopidogrel therapy resulted in a significant reduction in soluble CD40 ligand ( P = 0.03 ) , a prothrombotic and proinflammatory molecule derived mainly from activated platelets .


However , clopidogrel therapy had no effect on endothelial function , arterial stiffness , inflammatory and oxidative stress markers , or progenitor cells .


Our findings suggest a solitary antiplatelet effect of clopidogrel therapy in patients with stable coronary artery disease , with no effect on other subclinical markers of cardiovascular disease risk .


Clade B DNA and recombinant modified vaccinia Ankara ( MVA ) vaccines producing virus-like particles displaying trimeric membrane-bound envelope glycoprotein ( Env ) were tested in a phase 2a trial in human immunodeficiency virus ( HIV ) - uninfected adults for safety , immunogenicity , and 6-month durability of immune responses .


A total of 299 individuals received 2 doses of JS7 DNA vaccine and 2 doses of MVA/HIV62B at 0 , 2 , 4 , and 6 months , respectively ( the DDMM regimen ) ; 3 doses of MVA/HIV62B at 0 , 2 , and 6 months ( the MMM regimen ) ; or placebo injections .


At peak response , 93.2 % of the DDMM group and 98.4 % of the MMM group had binding antibodies for Env .


These binding antibodies were more frequent and of higher magnitude for the transmembrane subunit ( gp41 ) than the receptor-binding subunit ( gp120 ) of Env .


For both regimens , response rates were higher for CD4 ( + ) T cells ( 66.4 % in the DDMM group and 43.1 % in the MMM group ) than for CD8 ( + ) T cells ( 21.8 % in the DDMM group and 14.9 % in the MMM group ) .


Responding CD4 ( + ) and CD8 ( + ) T cells were biased toward Gag , and > 70 % produced 2 or 3 of the 4 cytokines evaluated ( ie , interferon , interleukin 2 , tumor necrosis factor , and granzyme B ) .


Six months after vaccination , the magnitudes of antibodies and T-cell responses had decreased by < 3-fold .


DDMM and MMM vaccinations with virus-like particle-expressing immunogens elicited durable antibody and T-cell responses .


AR-13324 is a small-molecule inhibitor of Rho kinase and a norepinephrine transporter .


The objective of this 28-day study was to evaluate the ocular hypotensive efficacy and safety of AR-13324 ophthalmic solution compared with a positive control , latanoprost ophthalmic solution , in patients with open-angle glaucoma ( OAG ) or ocular hypertension ( OHT ) .


Double-masked , randomized study in 22 private practice ophthalmology clinics .


Participants were required to be adults with a diagnosis of OAG or OHT with unmedicated intraocular pressure ( IOP ) in the range of 22 to 36 mmHg .


Patients were randomized to receive AR-13324 ophthalmic solution 0.01 % , daily ( pm ) , AR-13324 ophthalmic solution 0.02 % daily ( pm ) , or latanoprost 0.005 % daily ( pm ) for 28 days .


The primary efficacy endpoint was the mean diurnal IOP across subjects within the treatment group at day 28 .


Randomized and treated were 224 patients , 213 ( 95.1 % ) of whom completed the study .


On day 28 , mean diurnal IOP was 20.1 , 20.0 , and 18.7 mmHg in the AR-13324 0.01 % , 0.02 % , and latanoprost groups , respectively , representing a decrease from unmedicated baseline of 5.5 , 5.7 , and 6.8 mmHg ( P < 0.001 ) .


The 5.7-mmHg reduction in IOP by AR-13324 0.02 % did not meet the criterion for noninferiority to latanoprost .


The most frequently reported adverse event was conjunctival/ocular hyperemia , with a combined incidence of 52 % , 57 % , and 16 % , respectively .


On day 28 at 08:00 hours , the incidence of mild to moderate hyperemia by biomicroscopy was 18 % , 24 % , and 11 % , respectively .


AR-13324 0.02 % was less effective than latanoprost by approximately 1 mmHg in patients with unmedicated IOPs of 22 to 35 mmHg .


The major safety finding was ocular hyperemia , which was more common for both concentrations of AR-13324 than for latanoprost .


Gamisoyo-San ( GSS ) is a well-known Traditional Korean Medicine shown to be effective on mood disorders .


The purpose of this research is to examine the effect of Gamisoyo-San on generalized anxiety disorder by its differently manufactured preparations .


Multicenter , randomized , double-blinded , placebo-controlled study was set for 147 patients with generalized anxiety disorder recruited from November 1st 2009 to December 16th 2010 .


They were given Gamisoyo-San individual extract mixture ( extraction done for each crude materia medica separately ) or Gamisoyo-San multi-compound extract ( extraction done for whole materia medica at once ) or controlled medication .


Hamilton Rating Scale for Anxiety ( HAM-A ) , Korean State-Trait Anxiety Inventory ( K-STAI ) , Penn State Worry Questionnaire ( PSWQ ) , Korean Beck Depression Inventroy ( K-BDI ) , Symptom Checklist-90-Revised ( SCL-90-R ) , and Korean WHO Quality of Life Scale Abbreviated Version ( WHOQOL-BREF ) were evaluated .


We also applied Pattern Identification tool for ` JingJi and ZhengChong ( , Traditional Korean Medicine term which correlates with generalized anxiety disorder ) ' to patients to evaluate different responses among 9 patterns .


HAM-A scores of Gamisoyo-San multi-compound extract group showed greater decrease compared to Gamisoyo-San individual extract mixture group and placebo group , but the difference was insignificant .


WHOQOL-BREF scores of Gamisoyo-San multi-compound extract group showed significant increase compared to Gamisoyo-San individual extract mixture group and placebo group .


In Heart blood deficiency pattern , the Gamisoyo-San multi-compound extract group showed significant decrease in K-BDI compared to the Gamisoyo-San individual extract mixture group .


Gamisoyo-San did not improve anxiety level of GAD patients .


However , it can be useful to improve quality of life , and reduce depressive , obsessive-compulsive , somatic symptoms of generalized anxiety disorder .


Gamisoyo-San multi-compound seemed more effective than Gamisoyo-San individual extract mixture , especially in Heart blood deficiency pattern .


The purpose of this pilot clinical trial was to assess the feasibility of recruiting older adults with lumbar spinal stenosis ( LSS ) into a clinical trial that used different dosages of flexion-distraction manipulation .


This randomized controlled trial used a 4-group design .


Three groups consisted of chiropractic flexion-distraction manipulation applied at different dosages ( 8 , 12 , or 18 treatments ) .


The fourth group was given 8 treatments of placebo care .


Feasibility measures included recruitment goals , adherence to various treatment schedules , credibility of the placebo treatment , and rates of adverse events .


The primary outcome measure was the Swiss Spinal Stenosis Questionnaire , a validated self-report of LSS symptom severity and physical function .


The recruitment and adherence goals of the study were met with a total of 60 subjects randomized ( n = 15 per group ) and most subjects attending at least 75 % of their scheduled visits .


No adverse events were reported by any of the subjects in the trial .


Our placebo treatment did not appear to be credible ; most subjects correctly guessed that they were receiving a placebo treatment .


Between-group effect size estimates were small , indicating larger samples are needed for future studies .


This pilot study showed that it is feasible to recruit patients with LSS and that most subjects will adhere to a 6-week treatment schedule .


The information gained from this trial will be useful to inform the design of larger trials .


It is often assumed that animations ( i.e. , videos ) will lead to higher learning compared to static media ( i.e. , pictures ) because they provide a more realistic demonstration of the learning task .


To investigate whether learning basic life support ( BLS ) and cardiopulmonary resuscitation ( CPR ) from video produce higher learning outcomes compared to pictures in reciprocal learning .


A randomized controlled trial .


A total of 128 students ( mean age : 17 years ) constituting eight intact classes from a secondary school learned BLS in reciprocal roles of doer and helper with tablet PCs .


Student pairs in each class were randomized over a Picture and a Video group .


In the Picture group , students learned BLS by means of pictures combined with written instructions .


In the Video group , BLS was learned through videos with on-screen instructions .


Informational equivalence was assured since instructions in both groups comprised exactly the same words .


BLS assessment occurred unannounced , three weeks following intervention .


Analysis of variance demonstrated no significant differences in chest compression depths between the Picture group ( M = 42 mm , 95 % CI = 40-45 ) and the Video group ( M = 39 mm , 95 % CI = 36-42 ) .


In the Picture group significantly higher percentages of chest compressions with correct hand placement were achieved ( M = 67 % , CI = 58-77 ) compared to the Video group ( M = 53 % , CI = 43-63 ) , P = .03 , ( p ) ( 2 ) = .03 .


No other significant differences were found .


Results do not support the assumption that videos are superior to pictures for learning BLS and CPR in reciprocal learning .


Target volumes and organs-at-risk ( OARs ) for radiotherapy ( RT ) planning are manually defined , which is a tedious and inaccurate process .


We sought to assess the feasibility , time reduction , and acceptability of an atlas-based autosegmentation ( AS ) compared to manual segmentation ( MS ) of OARs .


A commercial platform generated 16 OARs .


Resident physicians were randomly assigned to modify AS OAR ( AS+R ) or to draw MS OAR followed by attending physician correction .


Dice similarity coefficient ( DSC ) was used to measure overlap between groups compared with attending approved OARs ( DSC = 1 means perfect overlap ) .


40 cases were segmented .


Mean SD segmentation time in the AS+R group was 19.7 8.0 min , compared to 28.5 8.0 min in the MS cohort , amounting to a 30.9 % time reduction ( Wilcoxon p < 0.01 ) .


For each OAR , AS DSC was statistically different from both AS+R and MS ROIs ( all Steel-Dwass p < 0.01 ) except the spinal cord and the mandible , suggesting oversight of AS/MS processes is required ; AS+R and MS DSCs were non-different .


AS compared to attending approved OAR DSCs varied considerably , with a chiasm mean SD DSC of 0.37 0.32 and brainstem of 0.97 0.03 .


Autosegmentation provides a time savings in head and neck regions of interest generation .


However , attending physician approval remains vital .


Weight discrimination is associated with increased risk of obesity .


The mechanism of this relationship is unknown , but being overweight is a highly stigmatized condition and may be a source of chronic stress that contributes to the development and pathophysiology of obesity .


The objective of this study was to test whether weight stigma is associated with physiological risk factors linked to stress and obesity , including hypercortisolism and oxidative stress , independent of adiposity .


We examined the frequency of experiencing situations involving weight stigma and consciousness of weight stigma in relation to hypothalamic -- pituitary -- adrenal axis activity and oxidative stress ( F-isoprostanes ) in 45 healthy overweight to obese women .


Independent of abdominal fat , weight stigma was significantly related to measures of cortisol ( including salivary measures of cortisol awakening response and serum morning levels ) as well as higher levels of oxidative stress .


Perceived stress mediated the relationship between weight stigma consciousness and the cortisol awakening response .


These preliminary findings show that weight stigma is associated with greater biochemical stress , independent of level of adiposity .


It is possible that weight stigma may contribute to poor health underlying some forms of obesity .


To determine the impact of adjunctive Buchang Naoxintong Capsule ( , NXT ) on dual antiplatelet therapy in patients with cytochrome P450 2C19 * 2 ( CYP2C19 * 2 ) polymorphism undergoing percutaneous coronary intervention ( PCI ) .


Ninety patients with CYP2C19 * 2 polymorphism were enrolled , and their genotypes were confirmed by polymerase chain reaction ( PCR ) .


The patients were randomly assigned to receive either adjunctive NXT ( triple group , 45 cases ) or dual antiplatelet therapy ( dual group , 45 cases ) using a computer-generated randomization sequence and sealed envelopes .


Platelet function was assessed at baseline and 7 days after treatment with conventional aggregometry .


Subsequent major adverse cardiovascular events ( MACE , including sudden cardiac arrest and acute coronary syndrome ) were recorded during a 12-month follow-up .


Baseline platelet function measurements were similar in both groups .


After 7 days , percent inhibitions of maximum platelet aggregation and late platelet aggregation were significantly greater in the triple versus dual group ( 42.3 % 16.0 % vs. 20.8 % 15.2 % , P < 0.01 , and 54.7 % 18.3 % vs. 21.5 % 29.2 % , P < 0.01 , respectively ) .


During the 12-month follow-up , the rate of subsequent MACE ( 6/45 ) was significantly lower in the triple group compared with the dual group ( 14/45 ; P < 0.05 ) .


Adjunctive NXT to maintenance dose clopidogrel ( 75 g ) could enhance the antiplatelet effect and decrease subsequent MACE in patients with the CYP2C19 * 2 polymorphism undergoing PCI .


To investigate the safety , efficacy , and pharmacokinetic profile of dexmedetomidine in preterm and full-term neonates 28 to 44 weeks gestational age .


Forty-two intubated , mechanically ventilated patients ( n = 42 ) were grouped by gestational age into group I ( n = 18 ) , 28 to < 36 weeks , and group II ( n = 24 ) , 36 to 44 weeks .


Within each age group , there were 3 escalating dose levels , including a loading dose ( LD , g/kg ) followed by a maintenance dose ( MD , g kg ( -1 ) h ( -1 ) ) for 6-24 hours : level 1 , 0.05 LD/MD ; level 2 , 0.1 LD/MD ; and level 3 , 0.2 LD/MD .


The primary endpoint was the number of patients requiring sedation as determined by the Neonatal Pain , Agitation , Sedation Scale .


During dexmedetomidine infusion , 5 % of Neonatal Pain , Agitation , Sedation Scale scores were > 3 , indicating agitation/pain , with 4 patients ( 10 % ) requiring more sedation and 17 ( 40 % ) requiring more analgesia .


Though there was significant variability in pharmacokinetic variables , group I appeared to have lower weight-adjusted plasma clearance ( 0.3 vs 0.9 L h ( -1 ) kg ( -1 ) ) and increased elimination half-life ( 7.6 vs 3.2 hours ) compared with group II .


Fifty-six adverse events ( AEs ) were reported in 26 patients ( 62 % ) ; only 3 AEs ( 5 % ) were related to dexmedetomidine .


There were no serious AEs and no AEs or hemodynamic changes requiring dexmedetomidine discontinuation .


Dexmedetomidine is effective for sedating preterm and full-term neonates and is well-tolerated without significant AEs .


Preterm neonates had decreased plasma clearance and longer elimination half-life .


Behavioral change interventions have demonstrated short-term efficacy in reducing sexually transmitted infection ( STI ) / human immunodeficiency virus ( HIV ) risk behaviors ; however , few have demonstrated long-term efficacy .


To evaluate the efficacy of a telephone counseling prevention maintenance intervention ( PMI ) to sustain STI/HIV-preventive behaviors and reduce incident STIs during a 36-month follow-up .


In a 2-arm randomized supplemental treatment trial at 3 clinics serving predominantly minority adolescents in Atlanta , Georgia , 701 African American adolescent girls aged 14 to 20 years received a primary treatment and subsequently received a different ( supplemental ) treatment ( PMI ) to enhance effects of the primary treatment .


Participants in the experimental condition ( n = 342 ) received an adapted evidence-based STI/HIV intervention ( HORIZONS ) and a PMI consisting of brief telephone contacts every 8 weeks over 36 months to reinforce and complement prevention messages .


Comparison-condition participants ( n = 359 ) received HORIZONS and a time - and dose-consistent PMI focused on general health .


The primary outcomes were percentage of participants with a laboratory-confirmed incident chlamydial infection and percentage of participants with a laboratory-confirmed gonococcal infection during the 36-month follow-up .


Behavioral outcomes included the following : ( 1 ) proportion of condom-protected sexual acts in the 6 months and 90 days prior to assessments ; ( 2 ) number of sexual episodes during the past 90 days in which participants engaged in sexual intercourse while high on drugs and/or alcohol ; and ( 3 ) number of vaginal sex partners in the 6 months prior to assessments .


During the 36-month follow-up , fewer participants in the experimental condition than in the comparison condition had incident chlamydial infections ( 94 vs 104 participants , respectively ; risk ratio = 0.50 ; 95 % CI , 0.28 to 0.88 ; P = .02 ) and gonococcal infections ( 48 vs 54 participants , respectively ; risk ratio = 0.40 ; 95 % CI , 0.15 to 1.02 ; P = .06 ) .


Participants completing more telephone contacts had a lower risk of chlamydial infection ( risk ratio = 0.95 ; 95 % CI , 0.90 to 1.00 ; P = .05 ) .


Participants in the experimental condition reported a higher proportion of condom-protected sexual acts in the 90 days ( mean difference = 0.08 ; 95 % CI , 0.06 to 0.11 ; P = .02 ) and 6 months ( mean difference = 0.08 ; 95 % CI , 0.06 to 0.10 ; P = .04 ) prior to assessments and fewer episodes of sexual acts while high on drugs and/or alcohol ( mean difference = -0.61 ; 95 % CI , -0.98 to -0.24 ; P < .001 ) .


Sustaining the long-term impact of an STI/HIV intervention is achievable with brief , tailored telephone counseling .


clinicaltrials.gov Identifier : NCT00279799 .


The first description of the simplified acute physiology score ( SAPS ) II dates back to 1993 , but little is known about its accuracy in daily practice .


Our purpose was to evaluate the accuracy of scoring and the factors that affect it in a nationwide survey .


Twenty clinical scenarios , covering a broad range of illness severities , were randomly assigned to a convenience sample of physicians or nurses in Swiss adult intensive care units ( ICUs ) , who were asked to assess the SAPS II score for a single scenario .


These data were compared to a reference that was defined by five experienced researchers .


The results were cross-matched with demographic characteristics and data on the training and quality control for the scoring , structural and organisational properties of each participating ICU .


A total of 345 caregivers from 53 adult ICU providers completed the SAPS II evaluation of one clinical scenario .


The mean SAPS II scoring was 42.6 23.4 , with a bias of +5.74 ( 95 % CI 2.0-9 .5 ) compared to the reference score .


There was no evidence of bias variation according to the case severity , ICU size , linguistic area , profession ( physician vs. nurse ) , experience , initial SAPS II training , or presence of a quality control system .


This nationwide survey revealed substantial variability in the SAPS II scoring results .


On average , SAPS II scoring was overestimated by more than 13 % , irrespective of the profession or experience of the scorer or of the structural characteristics of the ICUs .


Stereoscopic vision is a critical part of the human visual system , conveying more information than two-dimensional , monoscopic observation alone .


This study aimed to quantify the contribution of stereoscopy in assessment of radiographic data , using widely available three-dimensional ( 3D ) - capable display monitors by assessing whether stereoscopic viewing improved the characterisation of cerebral aneurysms .


Nine radiology registrars were shown 40 different volume-rendered ( VR ) models of cerebral computed tomography angiograms ( CTAs ) , each in both monoscopic and stereoscopic format and then asked to record aneurysm characteristics on short multiple-choice answer sheets .


The monitor used was a current model commercially available 3D television .


Responses were marked against a gold standard of assessments made by a consultant radiologist , using the original CT planar images on a diagnostic radiology computer workstation .


The participants ' results were fairly homogenous , with most showing no difference in diagnosis using stereoscopic VR models .


One participant performed better on the monoscopic VR models .


On average , monoscopic VRs achieved a slightly better diagnosis by 2.0 % .


Stereoscopy has a long history , but it has only recently become technically feasible for stored cross-sectional data to be adequately reformatted and displayed in this format .


Scant literature exists to quantify the technology 's possible contribution to medical imaging - this study attempts to build on this limited knowledge base and promote discussion within the field .


Stereoscopic viewing of images should be further investigated and may well eventually find a permanent place in procedural and diagnostic medical imaging .


Vaccines against pandemic A/H1N1 influenza should provide protective immunity in children , because they are at greater risk of disease than adults .


This study was conducted to identify the optimal dose of an MF59-adjuvanted , egg-derived , A/H1N1 influenza vaccine for young children .


Children 6-11 months ( N = 144 ) and 12-35 months ( N = 186 ) of age received vaccine formulations containing either 3.75 g antigen with half the standard dose of MF59 or 7.5 g antigen with a standard dose of MF59 , or a nonadjuvanted formulation containing 15 g antigen ( children 12-35 months only ) .


Participants were given 2 primary vaccine doses 3 weeks apart , followed by 1 booster dose of MF59-adjuvanted seasonal influenza vaccine 1 year later .


Immunogenicity was assessed by hemagglutination inhibition and microneutralization assays .


All vaccine formulations were highly immunogenic and met all 3 European licensure criteria after 2 doses .


MF59-adjuvanted vaccines met all licensure criteria after 1 dose in both age cohorts , while nonadjuvanted vaccine did not meet all criteria after 1 dose in children 12-35 months .


A single booster dose was highly immunogenic , and stable antibody persistence was observed in response to all vaccines .


All vaccines were well tolerated .


In this study , a single dose of 3.75 g antigen with half the standard dose of MF59 was shown to be optimal , providing adequate levels of immediate and long-term antibodies in pediatric subjects 6-35 months of age .


These data demonstrated that MF59 adjuvant allowed for reduced antigen content and promoted significant long-term antibody persistence in children , with a satisfactory safety profile .


First , to evaluate the clinical effectiveness of a virtual reality ( VR ) - based telerehabilitation program in the balance recovery of individuals with hemiparesis after stroke in comparison with an in-clinic program ; second , to compare the subjective experiences ; and third , to contrast the costs of both programs .


Single-blind , randomized , controlled trial .


Neurorehabilitation unit .


Chronic outpatients with stroke ( N = 30 ) with residual hemiparesis .


Twenty 45-minute training sessions with the telerehabilitation system , conducted 3 times a week , in the clinic or in the home .


First , Berg Balance Scale for balance assessment .


The Performance-Oriented Mobility Assessment balance and gait subscales , and the Brunel Balance Assessment were secondary outcome measures .


Clinical assessments were conducted at baseline , 8 weeks ( posttreatment ) , and 12 weeks ( follow-up ) .


Second , the System Usability Scale and the Intrinsic Motivation Inventory for subjective experiences .


Third , cost ( in dollars ) .


Significant improvement in both groups ( in-clinic group [ control ] and a home-based telerehabilitation group ) from the initial to the final assessment in the Berg Balance Scale ( p ( 2 ) = .68 ; P = .001 ) , in the balance ( p ( 2 ) = .24 ; P = .006 ) and gait ( p ( 2 ) = .57 , P = .001 ) subscales of the Tinetti Performance-Oriented Mobility Assessment , and in the Brunel Balance Assessment ( control : ( 2 ) = 15.0 ; P = .002 ; experimental : ( 2 ) = 21.9 ; P = .001 ) .


No significant differences were found between the groups in any balance scale or in the feedback questionnaires .


With regard to subjective experiences , both groups considered the VR system similarly usable and motivating .


The in-clinic intervention resulted in more expenses than did the telerehabilitation intervention ( $ 654.72 per person ) .


First , VR-based telerehabilitation interventions can promote the reacquisition of locomotor skills associated with balance in the same way as do in-clinic interventions , both complemented with a conventional therapy program ; second , the usability of and motivation to use the 2 interventions can be similar ; and third , telerehabilitation interventions can involve savings that vary depending on each scenario .


Transfusion thresholds for acute upper gastrointestinal bleeding are controversial .


So far , only three small , underpowered studies and one single-centre trial have been done .


Findings from the single-centre trial showed reduced mortality with restrictive red blood cell ( RBC ) transfusion .


We aimed to assess whether a multicentre , cluster randomised trial is a feasible method to substantiate or refute this finding .


In this pragmatic , open-label , cluster randomised feasibility trial , done in six university hospitals in the UK , we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding , irrespective of comorbidity , except for exsanguinating haemorrhage .


We randomly assigned hospitals ( 1:1 ) with a computer-generated randomisation sequence ( random permuted block size of 6 , without stratification or matching ) to either a restrictive ( transfusion when haemoglobin concentration fell below 80 g/L ) or liberal ( transfusion when haemoglobin concentration fell below 100 g/L ) RBC transfusion policy .


Neither patients nor investigators were masked to treatment allocation .


Feasibility outcomes were recruitment rate , protocol adherence , haemoglobin concentration , RBC exposure , selection bias , and information to guide design and economic evaluation of the phase 3 trial .


Main exploratory clinical outcomes were further bleeding and mortality at day 28 .


We did analyses on all enrolled patients for whom an outcome was available .


This trial is registered , ISRCTN85757829 and NCT02105532 .


Between Sept 3 , 2012 , and March 1 , 2013 , we enrolled 936 patients across six hospitals ( 403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy ) .


Recruitment rate was significantly higher for the liberal than for the restrictive policy ( 62 % vs 55 % ; p = 004 ) .


Despite some baseline imbalances , Rockall and Blatchford risk scores were identical between policies .


Protocol adherence was 96 % ( SD 10 ) in the restrictive policy vs 83 % ( 25 ) in the liberal policy ( difference 14 % ; 95 % CI 7-21 ; p = 0005 ) .


Mean last recorded haemoglobin concentration was 116 ( SD 24 ) g/L for patients on the restrictive policy and 118 ( 20 ) g/L for those on the liberal policy ( difference -20 [ 95 % CI -120 to 70 ] ; p = 050 ) .


Fewer patients received RBCs on the restrictive policy than on the liberal policy ( restrictive policy 133 [ 33 % ] vs liberal policy 247 [ 46 % ] ; difference -12 % [ 95 % CI -35 to 11 ] ; p = 023 ) , with fewer RBC units transfused ( mean 12 [ SD 21 ] vs 19 [ 28 ] ; difference -07 [ -16 to 03 ] ; p = 012 ) , although these differences were not significant .


We noted no significant difference in clinical outcomes .


A cluster randomised design led to rapid recruitment , high protocol adherence , separation in degree of anaemia between groups , and non-significant reduction in RBC transfusion in the restrictive policy .


A large cluster randomised trial to assess the effectiveness of transfusion strategies for acute upper gastrointestinal bleeding is both feasible and essential before clinical practice guidelines change to recommend restrictive transfusion for all patients with acute upper gastrointestinal bleeding .


NHS Blood and Transplant Research and Development .


Workplace stress and burnout are pervasive problems , affecting employee performance and personal health .


To evaluate the effects of the Transcendental Meditation program on psychological distress and burnout among staff at a residential therapeutic school for students with severe behavioral problems .


A total of 40 secondary schoolteachers and support staff at the Bennington School in Vermont , a therapeutic school for children with behavioral problems , were randomly assigned to either practice of the Transcendental Meditation program or a wait-list control group .


The Transcendental Meditation course was provided by certified instructors .


Outcome measures were assessed at baseline and four months , and included perceived stress , depression , and burnout .


A multivariate analysis of covariance was used to determine overall effects .


Analysis of the 4-month intervention data indicated a significant improvement in the main outcomes of the study resulting from practice of the Transcendental Meditation program compared with controls ( Wilks [ 3,28 ] = 0.695 ; p = 0.019 ) .


Results of univariate F tests indicated a significant reduction of all main outcome measures : perceived stress ( F [ 1,32 ] = 13.42 ; p = < 0.001 ) ; depression ( F [ 1,32 ] = 6.92 ; p = 0.013 ) ; and overall teacher burnout ( F [ 1,32 ] = 6.18 ; p = 0.018 ) .


Effect sizes ranged from 0.40 to 0.94 .


The Transcendental Meditation program was effective in reducing psychological distress in teachers and support staff working in a therapeutic school for students with behavioral problems .


These findings have important implications for employees job performance as well as their mental and physical health .


To perform a prospective , blinded , randomized interventional trial in patients with recurrent abdominal pain .


The primary endpoint was to determine the abdominal pain intensity after 2 weeks of fructose restricted diet .


Secondary endpoints were changes of pain frequency and a secondary symptom score ( SSS ) .


103 individuals with recurrent abdominal pain for more than 3 months were randomized .


51 patients were allocated to group A ( diet ) and 52 to group B ( no diet ) .


2 weeks later the patients underwent hydrogen breath test and were assigned to the test positive or negative group to identify patients with fructose malabsorption .


2 weeks after intervention the pain score decreased significantly from a median 5.5 in group A to 4 and did not change significantly in group B ( 5.3 to 5 ) .


In group A both patients with positive and negative breath tests had a significant lower pain score ( -2 and -1.75 , respectively ) .


Frequency of abdominal pain decreased in both groups but without significant difference , SSS improved only in group A from median 6 to 3.5 .


Positive breath test was no predicting factor , neither was abdominal pain during the test .


Fructose restricted diet in children and adolescents with recurrent abdominal pain may be of benefit to improve both abdominal pain symptoms and other secondary symptoms .


Since a negative breath test result does not exclude a positive response to fructose restriction , the hydrogen breath test does not seem to be the appropriate diagnostic mean to predict the response to the diet .


The objective of the current study was to examine predictors and moderators of response to two HIV sexual risk interventions of different content and duration for individuals in substance abuse treatment programs .


Participants were recruited from community drug treatment programs participating in the National Institute on Drug Abuse Clinical Trials Network ( CTN ) .


Data were pooled from two parallel randomized controlled CTN studies ( one with men and one with women ) each examining the impact of a multi-session motivational and skills training program , in comparison to a single-session HIV education intervention , on the degree of reduction in unprotected sex from baseline to 3 - and 6 - month follow-ups .


The findings were analyzed using a zero-inflated negative binomial ( ZINB ) model .


Severity of drug use ( p < .01 ) , gender ( p < .001 ) , and age ( p < .001 ) were significant main effect predictors of number of unprotected sexual occasions ( USOs ) at follow-up in the non-zero portion of the ZINB model ( men , younger participants , and those with greater severity of drug/alcohol abuse have more USOs ) .


Monogamous relationship status ( p < .001 ) and race/ethnicity ( p < .001 ) were significant predictors of having at least one USO vs. none ( monogamous individuals and African Americans were more likely to have at least one USO ) .


Significant moderators of intervention effectiveness included recent sex under the influence of drugs/alcohol ( p < .01 in non-zero portion of model ) , duration of abuse of primary drug ( p < .05 in non-zero portion of model ) , and Hispanic ethnicity ( p < .01 in the zero portion , p < .05 in the non-zero portion of model ) .


These predictor and moderator findings point to ways in which patients may be selected for the different HIV sexual risk reduction interventions and suggest potential avenues for further development of the interventions for increasing their effectiveness within certain subgroups .


The effect of eating speed on energy intake by weight status is unclear .


To examine whether the effect of eating speed on energy intake is the same in normal-weight and overweight/obese subjects .


The effect of slow and fast eating speed on meal energy intake was assessed in a randomized crossover design .


Thirty-five normal-weight ( aged 33.312.5 years ; 14 women and 21 men ) subjects and 35 overweight/obese ( 44.113.0 years ; 22 women and 13 men ) subjects were studied on 2 days during lunch in a metabolic kitchen .


The subjects consumed the same meal , ad libitum , but at different speeds during the two eating conditions .


The weight and energy content of the food consumed was assessed .


Perceived hunger and fullness were assessed at specific times using visual analog scales .


Effect of eating speed on ad libitum energy intake , eating rate ( energy intake/meal duration ) , energy density ( energy intake per gram of food and water consumed ) , and satiety were assessed by mixed-model repeated measures analysis .


Meal energy intake was significantly lower in the normal-weight ( 804.5438.9 vs 892.6330.2 kcal ; P = 0.04 ) but not the overweight/obese ( 667.3304.1 vs 724.8355.5 kcal ; P = 0.18 ) subjects during the slow vs the fast eating condition .


Both groups had lower meal energy density ( P = 0.005 and P = 0.001 , respectively ) and eating rate ( P < 0.0001 in both groups ) during the slow vs the fast eating condition .


Both groups reported less hunger ( P = 0.01 and P = 0.03 , respectively ) , and the normal-weight subjects reported more fullness ( P = 0.02 ) at 60 minutes after the meal began during the slow compared with the fast eating condition .


There was no eating speed by weight status interaction for any of the variables .


Eating slowly significantly lowered meal energy intake in the normal-weight but not in the overweight/obese group .


It lowered eating rate and energy density in both groups .


Eating slowly led to lower hunger ratings in both groups and increased fullness ratings in the normal-weight group at 60 minutes from when the meal began .


Real-time adherence monitoring is now possible through medication storage devices equipped with cellular technology .


We assessed the effect of triggered cell phone reminders and counseling using objective adherence data on antiretroviral therapy ( ART ) adherence among Chinese HIV-infected patients .


We provided ART patients in Nanning , China , with a medication device ( Wisepill ) to monitor their ART adherence electronically .


After 3 months , we randomized subjects within optimal ( 95 % ) and suboptimal ( < 95 % ) adherence strata to intervention vs. control arms .


In months 4-9 , intervention subjects received individualized reminders triggered by late dose taking ( no device opening by 30 minutes past dose time ) and counseling using device-generated data .


Controls received no reminders or data-informed counseling .


We compared postintervention proportions achieving optimal adherence , mean adherence , and clinical outcomes .


Of 120 subjects enrolled , 116 ( 96.7 % ) completed the trial .


Preintervention optimal adherence was similar in intervention vs. control arms ( 63.5 % vs. 58.9 % , respectively ; P = 0.60 ) .


In the last intervention month , 87.3 % vs. 51.8 % achieved optimal adherence [ risk ratio ( RR ) : 1.7 , 95 % confidence interval ( CI ) : 1.3 to 2.2 ] and mean adherence was 96.2 % vs. 89.1 % ( P = 0.003 ) .


Among preintervention suboptimal adherers , 78.3 % vs. 33.3 % ( RR : 2.4 , CI : 1.2 to 4.5 ) achieved optimal adherence and mean adherence was 93.3 % vs. 84.7 % ( P = 0.039 ) .


Proportions were 92.5 % and 62.9 % among optimal adherers , respectively ( RR : 1.5 , CI : 1.1 to 1.9 ) and mean adherence was 97.8 % vs. 91.7 % ( P = 0.028 ) .


Postintervention clinical outcomes were not significant .


Real-time reminders significantly improved ART adherence in this population .


This approach seems promising for managing HIV and other chronic diseases and warrants further investigation and adaptation in other settings .


There is interest in including recommendations for the replacement of the sodium lost in sweat in individualized hydration plans for athletes .


Although the regional absorbent-patch method provides a practical approach to measuring sweat sodium losses in field conditions , there is a need to understand the variability of estimates associated with this technique .


Sweat samples were collected from the forearms , chest , scapula , and thigh of 12 cyclists during 2 standardized cycling time trials in the heat and 2 in temperate conditions .


Single measure analysis of sodium concentration was conducted immediately by ion-selective electrodes ( ISE ) .


A subset of 30 samples was frozen for reanalysis of sodium concentration using ISE , flame photometry ( FP ) , and conductivity ( SC ) .


Sweat samples collected in hot conditions produced higher sweat sodium concentrations than those from the temperate environment ( P = .0032 ) .


A significant difference ( P = .0048 ) in estimates of sweat sodium concentration was evident when calculated from the forearm average ( mean 95 % CL ; 64 12 mmol/L ) compared with using a 4-site equation ( 70 12 mmol/L ) .


There was a high correlation between the values produced using different analytical techniques ( r2 = .95 ) , but mean values were different between treatments ( frozen FP , frozen SC > immediate ISE > frozen ISE ; P < .0001 ) .


Whole-body sweat sodium concentration estimates differed depending on the number of sites included in the calculation .


Environmental testing conditions should be considered in the interpretation of results .


The impact of sample freezing and subsequent analytical technique was small but statistically significant .


Nevertheless , when undertaken using a standardized protocol , the regional absorbent-patch method appears to be a relatively robust field test .


Neurotoxic effects of brain irradiation include cognitive impairment in 50 % to 90 % of patients .


Prior studies have suggested that donepezil , a neurotransmitter modulator , may improve cognitive function .


A total of 198 adult brain tumor survivors 6 months after partial - or whole-brain irradiation were randomly assigned to receive a single daily dose ( 5 mg for 6 weeks , 10 mg for 18 weeks ) of donepezil or placebo .


A cognitive test battery assessing memory , attention , language , visuomotor , verbal fluency , and executive functions was administered before random assignment and at 12 and 24 weeks .


A cognitive composite score ( primary outcome ) and individual cognitive domains were evaluated .


Of this mostly middle-age , married , non-Hispanic white sample , 66 % had primary brain tumors , 27 % had brain metastases , and 8 % underwent prophylactic cranial irradiation .


After 24 weeks of treatment , the composite scores did not differ significantly between groups ( P = .48 ) ; however , significant differences favoring donepezil were observed for memory ( recognition , P = .027 ; discrimination , P = .007 ) and motor speed and dexterity ( P = .016 ) .


Significant interactions between pretreatment cognitive function and treatment were found for cognitive composite ( P = .01 ) , immediate recall ( P = .05 ) , delayed recall ( P = .004 ) , attention ( P = .01 ) , visuomotor skills ( P = .02 ) , and motor speed and dexterity ( P < .001 ) , with the benefits of donepezil greater for those who were more cognitively impaired before study treatment .


Treatment with donepezil did not significantly improve the overall composite score , but it did result in modest improvements in several cognitive functions , especially among patients with greater pretreatment impairments .


Cryotherapy has been used to enhance recovery after orthopaedic surgery .


Several cooling devices are available but few can guarantee a fixed temperature during a prolonged time and therefore have been criticized .


The arrival of new advanced cryotherapy devices made it possible to test the effect of prolonged cooling on rehabilitation after joint replacement .


The hypotheses of this randomized controlled trial ( RCT ) were that advanced cryotherapy devices compared with cold packs result in ( 1 ) better postoperative pain control resulting in a lower consumption of narcotics ; ( 2 ) better early ROM ; and ( 3 ) less postoperative bleeding and swelling .


A priori sample size calculation had determined that to detect a difference of 2 points on the VAS , a sample size of 50 subjects per group at followup would be required , given a study power of 80 % .


One hundred sixteen patients were included and randomly allocated to receive advanced cryotherapy ( n = 58 ) or use of cold packs ( n = 58 ) .


The primary outcomes for the study were to evaluate pain with the VAS and analgesics consumption .


Secondary outcomes were postoperative ROM , swelling , and blood loss .


One hundred ( 50 in each group ) patients had complete data available for analysis .


No statistically significant differences in VAS , need for analgesics , nor in secondary outcomes were observed , except for substantially reduced flexion at 6 weeks in the advanced cryotherapy group ( 114 versus 120 ) .


Advanced cryotherapy with a continuous temperature for a prolonged period does not deliver expected results of superior early recovery after knee arthroplasty .


Greater sample sizes are required to fully determine significant differences between the two techniques for these study parameters .


Immobilization of the knee in extension during the prolonged cryotherapy session resulted in lower active flexion at 6 weeks after surgery for the advanced cryotherapy group .


Advanced cryotherapy should not be used in fast track knee arthroplasty if the economic cost is higher than the price of cold packs or offers no other concomitant advantages .


Level II , therapeutic study .


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


We aim to test the effectiveness , accuracy , and usefulness of an automated feedback system in facilitating skill acquisition in virtual reality surgery .


We evaluate the performance of the feedback system through a randomized controlled trial of 24 students allocated to feedback and nonfeedback groups .


The feedback system was based on the Melbourne University temporal bone surgery simulator .


The study was conducted at the simulation laboratory of the Royal Victorian Eye and Ear Hospital , Melbourne .


The study participants were medical students from the University of Melbourne , who were asked to perform virtual cortical mastoidectomy on the simulator .


The extent to which the drilling behavior of the feedback and nonfeedback groups differed was used to evaluate the effectiveness of the system .


Its accuracy was determined through a postexperiment observational assessment of recordings made during the experiment by an expert surgeon .


Its usability was evaluated using students ' self-reports of their impressions of the system .


A Friedman 's test showed that there was a significant improvement in the drilling performance of the feedback group , ( 2 ) ( 1 ) = 14.450 , P < .001 .


The postexperiment assessment demonstrated that the system provided timely feedback ( when trainee behavior was detected ) 88.6 % of the time and appropriate feedback ( accurate advice ) 84.2 % of the time .


Participants ' opinions about the usefulness of the system were highly positive .


The automated feedback system was observed to be effective in improving surgical technique , and the provided feedback was found to be accurate and useful .


The efficacy of warm-up and stretching in weight-lifting remains unknown , especially for the weight-lifter 's stability and balance during lifting .


13 subjects were randomly assigned a 10-minute stretching routine ( SR ) or a 10-minute warm-up routine ( WR ) and compared against 5 controls ( no stretching or warm-up ) .


Before and after the individually assigned routine , the participants ' centre of pressure ( CoP ) was assessed using plantar-pressure sensors .


The subjects were measured during 10 repetitions of air squat ( no load , `` AS '' ) , front squat ( FS ; 20 kg/15 kg bar ) , overhead squat ( OHS ; m : 20 kg / f : 15 kg bar ) , and a deadlift lifting exercise ( `` DL '' ; 20 kg/15 kg bar ) .


The impact on CoP dynamics of the warm-up and stretching routines were examined with repeated two-factor analysis of variances ( ANOVA ) of the mean and the coefficient of variance ( CV , shown in % ) , as proxies for stability and balance .


After stretching , the SR athletes shifted the mean CoP towards the toes ( 1 cm ; p < 0.01 ) while the WR athletes shifted the CoP towards the heels ( 1 cm ; p < 0.01 ) during AS .


For the remaining exercises , the SR athletes shifted the CoP towards the heels ( between 0.8 cm and 5.7 cm ) compared to WR ( 1.9 cm towards the heels in FS , no significant change in OHS ( 1 mm ) and DL ( 3 mm ) ) .


The controls did not show any change between pre - and post-datasets .


After stretching , the CV decreased for the AS and OHS exercises ( AS : 10.2 % to 7.0 % , OHS 9.8 % to 7.8 % ) , but increased after WR ( AS : 7.1 % to 10.1 % ) or did not change significantly ( OHS ) .


Both WR and SR resulted in increased CV values for FS and DL .


No change of CV was observed in the controls .


SR had a stronger impact on CoP during the assessed exercises than either WR or controls .


A reduction in CV after SR exercises ( AS , OHS ) suggests a clear improvement in stability and balance during weight-lifting .


The lack of a significant effect for complex movements ( OHS ) suggests only a limited effect of a 10-minute warm-up routine on CoP features .


10 minutes stretching might therefore be more efficient for improving stability than a general 10 minute warm-up .


Effective diabetes prevention strategies that can be implemented in daily practice , without huge amounts of money and a lot of personnel are needed .


The Dutch Diabetes Federation developed a protocol for coaching people with impaired fasting glucose ( IFG ; according to WHO criteria : 6.1 to 6.9 mmol/l ) to a sustainable healthy lifestyle change : ` the road map towards diabetes prevention ' ( abbreviated : Road Map : RM ) .


This protocol is applied within a primary health care setting by a general practitioner and a practice nurse .


The feasibility and ( cost - ) effectiveness of care provided according to the RM protocol will be evaluated .


A cluster randomised clinical trial is performed , with randomisation at the level of the general practices .


Both opportunistic screening and active case finding took place among clients with high risk factors for diabetes .


After IFG is diagnosed , motivated people in the intervention practices receive 3-4 consultations by the practice nurse within one year .


During these consultations they are coached to increase the level of physical activity and healthy dietary habits .


If necessary , participants are referred to a dietician , physiotherapist , lifestyle programs and/or local sports activities .


The control group receives care as usual .


The primary outcome measure in this study is change in Body Mass Index ( BMI ) .


Secondary outcome measures are waist circumference , physical activity , total and saturated fat intake , systolic blood pressure , blood glucose , total cholesterol , HDL cholesterol , triglycerides and behaviour determinants like risk perception , perceived knowledge and motivation .


Based on a sample size calculation 120 people in each group are needed .


Measurements are performed at baseline , and after one ( post-intervention ) and two years follow up .


Anthropometrics and biochemical parameters are assessed in the practices and physical activity , food intake and their determinants by a validated questionnaire .


The cost-effectiveness is estimated by using the Chronic Disease Model ( CDM ) .


Feasibility will be tested by interviews among health care professionals .


The results of the study will provide valuable information for both health care professionals and policy makers .


If this study shows the RM to be both effective and cost-effective the protocol can be implemented on a large scale .


ISRCTN41209683 .


Ethical approval number : NL31342 .075.10 .


Bronchodilator therapy represents a potentially valuable therapeutic option to increase exercise tolerance and enhance lung function in mild to moderate chronic obstructive pulmonary disease ( COPD ) .


To determine effects of tiotropium on pulmonary hyperinflation and exercise tolerance in patients with symptomatic Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) 1 and 2 COPD who experienced inspiratory capacity decrease greater than or equal to 100 ml during incremental and constant work rate treadmill exercise .


This 22-week , randomized , double-blind , two-period crossover study evaluated the efficacy of once-daily tiotropium bromide ( 18 g ) versus placebo in patients with GOLD 1 and 2 COPD .


Primary endpoint was between-group ( tiotropium vs. placebo ) difference in inspiratory capacity at isotime ( i.e. , at the time the shortest test ended ) during constant work rate treadmill exercise from baseline to the end of a 6-week treatment period .


Key secondary endpoints included differences in exercise duration and exertional dyspnea .


Safety was assessed by recording adverse events .


Study population comprised 48 patients with GOLD 1 COPD and 78 patients with GOLD 2 COPD .


Resting inspiratory capacity significantly improved with tiotropium versus placebo in the overall ( P < 0.0001 ) , GOLD 1 ( P = 0.0183 ) , and GOLD 2 ( P < 0.0001 ) groups .


Isotime inspiratory capacity was significantly enhanced during exercise in the overall ( P = 0.0087 ) and GOLD 2 ( P = 0.0494 ) groups after tiotropium versus placebo .


Tiotropium versus placebo significantly enhanced exercise duration in the GOLD 2 group ( P = 0.0070 ) but not in the GOLD 1 or overall patient groups .


In the overall group , increase in exercise duration seen with tiotropium was well correlated with the increase in isotime inspiratory capacity ( r = 0.463 , P < 0.0001 ) .


Resting and exercise hyperinflation were ameliorated by bronchodilator therapy with tiotropium in the overall GOLD 1 plus 2 COPD group .


Exercise tolerance was enhanced in GOLD 2 , but not GOLD 1 , COPD .


Clinical trial registered with www.clinicaltrials.gov ( NCT01072396 ) .


Standard therapy for newly diagnosed glioblastoma is radiotherapy plus temozolomide .


In this phase 3 study , we evaluated the effect of the addition of bevacizumab to radiotherapy-temozolomide for the treatment of newly diagnosed glioblastoma .


We randomly assigned patients with supratentorial glioblastoma to receive intravenous bevacizumab ( 10 mg per kilogram of body weight every 2 weeks ) or placebo , plus radiotherapy ( 2 Gy 5 days a week ; maximum , 60 Gy ) and oral temozolomide ( 75 mg per square meter of body-surface area per day ) for 6 weeks .


After a 28-day treatment break , maintenance bevacizumab ( 10 mg per kilogram intravenously every 2 weeks ) or placebo , plus temozolomide ( 150 to 200 mg per square meter per day for 5 days ) , was continued for six 4-week cycles , followed by bevacizumab monotherapy ( 15 mg per kilogram intravenously every 3 weeks ) or placebo until the disease progressed or unacceptable toxic effects developed .


The coprimary end points were investigator-assessed progression-free survival and overall survival .


A total of 458 patients were assigned to the bevacizumab group , and 463 patients to the placebo group .


The median progression-free survival was longer in the bevacizumab group than in the placebo group ( 10.6 months vs. 6.2 months ; stratified hazard ratio for progression or death , 0.64 ; 95 % confidence interval [ CI ] , 0.55 to 0.74 ; P < 0.001 ) .


The benefit with respect to progression-free survival was observed across subgroups .


Overall survival did not differ significantly between groups ( stratified hazard ratio for death , 0.88 ; 95 % CI , 0.76 to 1.02 ; P = 0.10 ) .


The respective overall survival rates with bevacizumab and placebo were 72.4 % and 66.3 % at 1 year ( P = 0.049 ) and 33.9 % and 30.1 % at 2 years ( P = 0.24 ) .


Baseline health-related quality of life and performance status were maintained longer in the bevacizumab group , and the glucocorticoid requirement was lower .


More patients in the bevacizumab group than in the placebo group had grade 3 or higher adverse events ( 66.8 % vs. 51.3 % ) and grade 3 or higher adverse events often associated with bevacizumab ( 32.5 % vs. 15.8 % ) .


The addition of bevacizumab to radiotherapy-temozolomide did not improve survival in patients with glioblastoma .


Improved progression-free survival and maintenance of baseline quality of life and performance status were observed with bevacizumab ; however , the rate of adverse events was higher with bevacizumab than with placebo .


( Funded by F. Hoffmann-La Roche ; ClinicalTrials.gov number , NCT00943826 . )


Metabolic syndrome ( MetS ) is associated with low-grade inflammation , which may harmfully affect bone .


Resveratrol ( RSV ) possesses anti-inflammatory properties , and rodent studies suggest bone protective effects .


This study sought to evaluate effects of RSV treatment on bone in men with MetS .


The study was conducted at Aarhus University Hospital as a randomized , double-blinded , placebo-controlled trial assessing changes in bone turnover markers , bone mineral density ( BMD ) , and geometry .


The study population comprised 74 middle-aged obese men with MetS recruited from the general community , of which 66 completed all visits .


Mean age of participants was 49.3 6.3 years and mean body mass index was 33.7 3.6 kg/m ( 2 ) .


Oral treatment with 1.000 mg RSV ( RSV ( high ) ) , 150 mg RSV ( RSV ( low ) ) , or placebo daily for 16 weeks .


Prespecified primary endpoint was change in bone alkaline phosphatase ( BAP ) .


BAP increased dose dependently with RSV ( R = 0.471 , P < .001 ) , resulting in a significantly greater increase in BAP in the RSV ( high ) group compared with placebo at all time-points ( week 4 , 16.4 4.2 % , P < .001 ; week 8 , 16.5 4.1 % , P < .001 ; week 16 , 15.2 3.7 % , P < .001 ) .


Lumbar spine trabecular volumetric bone mineral density ( LS vBMD ( trab ) ) also increased dose dependently with RSV ( R = 0.268 , P = .036 ) , with a significant increase of 2.6 1.3 % in the RSV ( high ) group compared with placebo ( P = .043 ) .


In addition , changes in BAP and LS vBMD ( trab ) were positively correlated ( R = 0.281 , P = .027 ) .


No consistent changes were detected in bone density at the hip .


Our data suggest that high-dose RSV supplementation positively affects bone , primarily by stimulating formation or mineralization .


Future studies of longer duration comprising populations at risk of osteoporosis are needed to confirm these results .


To study the safety and feasibility of fast track surgery ( FTS ) in the promotion of postoperative recovery for gastric cancer patients undergoing gastrectomy .


From January to December in 2013 , 71 gastric cancer patients were prospectively enrolled and randomized into the FTS group and the control group .


Patient in the FTS group received FTS management and those in the control group received routine management .


The postoperative recovery and stress were compared between the two groups .


FTS was associated with shorter time to bowel function return [ ( 67.819.7 ) h vs. ( 90.020.6 ) h , P < 0.01 ] , shorter hospital stay [ ( 13.53.0 ) d vs. ( 17.87.3 ) d , P = 0.01 ] , lower hospital cost [ ( 23.83.7 ) thousand Yuan vs. ( 27.86.1 ) thousand Yuan , P < 0.05 ] , and less stress response ( lower pain score , WBC count , C-reactive protein , all P < 0.01 ) .


The postoperative complications including ileus , infection , anastomotic leakage were similar ( all P > 0.05 ) .


Fast track surgery decreases postoperative stress response and promotes recovery .


Deficits in quadriceps strength and voluntary activation are common following knee injury .


These deficits are hypothesized to generate from a neural level , however , it remains unclear how corticomotor pathways are affected following acute injury .


The purpose of this investigation was to examine whether corticomotor alterations of the quadriceps were present following a simulated knee joint injury using an experimental effusion model .


Participants completed two testing sessions , an experimental knee effusion and control session , separated by 7days .


The central activation ratio was used to assess change in quadriceps activation .


Corticomotor excitability was assessed pre - and post-intervention via active motor thresholds ( AMTs ) and motor evoked potentials ( MEPs ) normalized to maximal muscle responses .


MEPs were assessed at different percentages of AMT , and associated slopes between these percentages were analysed .