In the per-protocol analysis , @ infants were included in group A , @ in group B , @ in group C , and @ in group D. @ ( @ % ) infants failed treatment in group A compared with @ ( @ % ) infants in group B ( risk difference -@ % , @ % CI -@ to @ ) , @ ( @ % ) in group C ( -@ % , -@ to @ ) , and @ ( @ % ) in group D ( -@ % , -@ to @ ) .


Treatment failure in groups B , C , and D was within the similarity margin compared with group A.


During the @ days after random allocation , @ ( @ % ) infants died in group A , compared with ten ( @ % ) infants in group B , @ ( @ % ) infants in group C , and @ ( @ % ) infants in group D.


An infant in group A had a serious adverse event other than death ( injection abscess ) .


The three simplified regimens were as effective as injectable procaine benzylpenicillin-gentamicin for @ days on an outpatient basis in young infants with clinical signs of severe infection , without signs of critical illness , and whose caregivers did not accept referral for hospital admission .


Suppression of ovarian estrogen production reduces the recurrence of hormone-receptor-positive early breast cancer in premenopausal women , but its value when added to tamoxifen is uncertain .


We randomly assigned @ premenopausal women , stratified according to prior receipt or nonreceipt of chemotherapy , to receive @ years of tamoxifen , tamoxifen plus ovarian suppression , or exemestane plus ovarian suppression .


The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival , as compared with tamoxifen alone .


In the primary analysis , @ % of the patients had not received chemotherapy previously , and @ % had received chemotherapy and remained premenopausal .


After a median follow-up of @ months , the estimated disease-free survival rate at @ years was @ % in the tamoxifen-ovarian suppression group and @ % in the tamoxifen group ( hazard ratio for disease recurrence , second invasive cancer , or death , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


Multivariable allowance for prognostic factors suggested a greater treatment effect with tamoxifen plus ovarian suppression than with tamoxifen alone ( hazard ratio , @ ; @ % CI , @ to @ ) .


Most recurrences occurred in patients who had received prior chemotherapy , among whom the rate of freedom from breast cancer at @ years was @ % in the tamoxifen-ovarian suppression group and @ % in the tamoxifen group ( hazard ratio for recurrence , @ ; @ % CI , @ to @ ) .


At @ years , the rate of freedom from breast cancer was @ % in the exemestane-ovarian suppression group ( hazard ratio for recurrence vs. tamoxifen , @ ; @ % CI , @ to @ ) .


Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population .


However , for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal , the addition of ovarian suppression improved disease outcomes .


Further improvement was seen with the use of exemestane plus ovarian suppression .


( Funded by Pfizer and others ; SOFT ClinicalTrials.gov number , NCT@ . )


A previous randomized controlled trial showed no clear superiority of vertical scar over inverted T-shaped reduction mammaplasty in terms of health-related quality of life .


No economic evaluation has been undertaken comparing vertical scar reduction and inverted T - shaped reduction .


A total of @ patients were randomized to either vertical scar or inverted T - shaped reduction .


The effectiveness was measured with the Health Utilities Index Mark @ .


Direct and productivity costs were captured parallel to the randomized controlled trial .


Perspectives of the Ministry of Health , patient , and society were considered .


Inverted T - shaped reduction dominated vertical scar reduction from the Ministry of Health perspective by being slightly less costly ( $ @ versus $ @ ) and slightly more effective ( @ quality-adjusted life-years versus @ quality-adjusted life-years ) .


From the societal and patient perspectives , vertical scar reduction was both less costly and less effective .


At the commonly quoted Canadian threshold of $ @,@ per quality-adjusted life-year gained , the probability that vertical scar reduction was cost-effective was @ , @ , and @ percent from the Ministry of Health , patient , and societal perspectives .


Subgroup analysis of reductions less than @ g found that vertical scar reduction was more likely cost-effective .


Vertical scar reduction is more likely than not cost-effective from patient and societal perspectives but not from the Ministry of Health perspective at a willingness-to-pay threshold of $ @,@ per quality-adjusted life-year .


If we limit vertical scar reduction for resections less than @ g per breast , this technique is more likely cost-effective from all perspectives .


Resistance training ( RT ) improves muscle strength and overall physical function in older adults .


RT may be particularly important in the obese elderly who have compromised muscle function .


Whether caloric restriction ( CR ) acts synergistically with RT to enhance function is unknown .


As the primary goal of the Improving Muscle for Functional Independence Trial ( I 'M FIT ) , we determined the effects of adding CR for weight loss on muscle and physical function responses to RT in older overweight and obese adults .


I 'M FIT was a @-mo trial in @ older ( @-@ y ) overweight and obese men and women who were randomly assigned to a progressive , @-d/wk , moderate-intensity RT intervention with a weight-loss intervention ( RT+CR ) or without a weight-loss intervention ( RT ) .


The primary outcome was maximal knee extensor strength ; secondary outcomes were muscle power and quality , overall physical function , and total body and thigh compositions .


Body mass decreased in the RT+CR group but not in the RT group .


Fat mass , percentage of fat , and all thigh fat volumes decreased in both groups , but only the RT+CR group lost lean mass .


Adjusted postintervention body - and thigh-composition measures were all lower with RT+CR except intermuscular adipose tissue ( IMAT ) .


Knee strength , power , and quality and the @-m gait speed increased similarly in both groups .


Adjusted postintervention means for a @-m walk time and self-reported disability were better with RT+CR with no group differences in other functional measures , including knee strength .


Participants with a lower percentage of fat and IMAT at baseline exhibited a greater improvement in the @-m walk and knee strength and power .


RT improved body composition ( including reducing IMAT ) and muscle strength and physical function in obese elderly , but those with higher initial adiposity experienced less improvement .


The addition of CR during RT improves mobility and does not compromise other functional adaptations to RT. .


These findings support the incorporation of RT into obesity treatments for this population regardless of whether CR is part of the treatment .


This trial was registered at clinicaltrials.gov as NCT@ .


To investigate the effect of two foot placements ( normal or posterior placement ) and three arm positions ( hands on the thighs , arms crossed over chest , and augmented arm position with elbow extended ) on the five times sit-to-stand ( FTSTS ) test times of individuals with chronic stroke .


Cross-sectional study .


Setting .


University-based rehabilitation clinic .


A convenience sample of community-dwelling individuals with chronic stroke ( N = @ ) .


The times in completing the FTSTS with two foot placements and the three arm positions were recorded by stopwatch .


Posterior foot placement led to significantly shorter FTSTS times when compared with normal foot placement in all the @ arm positions ( P @ ) .


In addition , hands on thigh position led to significantly longer FTSTS times than the augmented arm position ( P = @ ) .


Our results showed that foot placement and arm position could influence the FTSTS times of individuals with chronic stroke .


Standardizing the foot placement and arm position in the test procedure is essential , if FTSTS test is intended to be used repeatedly on the same subject .


It is unknown whether intentional weight loss provides long-term benefits for cognitive function .


An ancillary study to a randomized controlled clinical trial was conducted in overweight and obese individuals ( N = @ ) , aged @-@ years at enrollment , with type @ diabetes .


An intensive behavioral intervention designed to promote and maintain weight loss through caloric restriction and increased physical activity was compared with diabetes support and education .


Standardized assessments of cognitive function were collected an average of @ years after trial enrollment .


Participants assigned to intensive lifestyle intervention lost a mean ( SE ) @ % ( @ % ) and @ % ( @ % ) of weight at Years @ and @ , respectively , compared with @ % ( @ % ) and @ % ( @ % ) in the control group ( p < @ ) .


Covariate-adjusted mean composite cognitive function test scores were similar for the two groups ( p = @ ) , and no significant differences were found for any individual cognitive test .


There was some evidence of a differential effect ( nominal interaction p = @ ) for a prespecified comparison : Intensive lifestyle intervention was associated with a relative mean benefit for composite cognitive function of @ ( @ % confidence interval : @ , @ ) SDs among individuals with body mass index less than @ kg/m ( @ ) at baseline compared with a relative mean deficit of @ ( -@ , @ ) SDs among individuals with body mass more than or equal to @ kg/m ( @ ) .


Eight years of intensive lifestyle intervention did not alter cognitive function in obese adults with type @ diabetes ; however , there was evidence for benefit among overweight but not obese individuals .


Changes in cognition were not assessed in this cross-sectional study .


The occurrence of contrast induced acute kidney injury ( CIAKI ) has a pronounced impact on morbidity and mortality .


The aim of the present study was to appraise the diagnostic efficacy of age , estimated glomerular filtration rate ( eGFR ) and ejection fraction ( AGEF ) score ( age/EF ( % ) +@ ( if eGFR was < @ ml min ( -@ ) @ m ( -@ ) ) ) as an predictor of CIAKI in patients with diabetes mellitus ( DM ) and concomitant chronic kidney disease ( CKD ) .


The AGEF score was calculated for @ @ patients with type @ DM and concomitant CKD who had undergone coronary/peripheral arterial angiography .


CIAKI was defined as an increase in sCr concentration of @ mg/dl ( @ mmol/L ) or @ % above baseline at @ hours after exposure to the contrast medium .


Post hoc analysis was performed by stratifying the rate of CIAKI according to AGEF score tertiles .


The diagnostic efficacy of the AGEF score for predicting CIAKI was evaluated with receiver operating characteristic ( ROC ) analysis .


The AGEF score ranged from @ to @ .


The AGEF score tertiles were defined as follows : AGEFlow @ ( n = @ @ ) ; @ < AGEFmid @ ( n = @ @ ) , and ACEFhigh > @ ( n = @ ) .


The incidence of CIAKI was significantly different in patients with low , middle and high AGEF scores ( AGEFlow = @ % , AGEFmid = @ % and AGEFhigh = @ % , P < @ ) .


By multivariate analysis , AGEF score was an independent predictor of CIAKI ( odds ratio = @ , @ % CI : @-@ @ , P < @ ) .


ROC analysis showed that the area under the curve was @ ( @ % CI : @-@ @ , P < @ ) .


The AGEF score is effective for stratifying risk of CIAKI in patients with DM and CKD undergoing coronary/peripheral arterial angiography .


( Clinical Trial identifier : NCT@ ) .


Low back pain ( LBP ) is common in primary care .


Guidelines recommend delaying referrals for physical therapy .


To evaluate whether early physical therapy ( manipulation and exercise ) is more effective than usual care in improving disability for patients with LBP fitting a decision rule .


Randomized clinical trial with @ participants recruited between March @ and November @ .


Participants with no LBP treatment in the past @ months , aged @ through @ years ( mean age , @ years -LSB- SD ,@ -RSB- ) , an Oswestry Disability Index ( ODI ) score of @ or higher , symptom duration less than @ days , and no symptoms distal to the knee in the past @ hours were enrolled following a primary care visit .


All participants received education .


Early physical therapy ( n = @ ) consisted of @ physical therapy sessions .


Usual care ( n = @ ) involved no additional interventions during the first @ weeks .


Primary outcome was change in the ODI score ( range : @-@ ; higher scores indicate greater disability ; minimum clinically important difference , @ points ) at @ months .


Secondary outcomes included changes in the ODI score at @-week and @-year follow-up , and change in pain intensity , Pain Catastrophizing Scale ( PCS ) score , fear-avoidance beliefs , quality of life , patient-reported success , and health care utilization at @-week , @-month , and @-year follow-up .


One-year follow-up was completed by @ participants ( @ % ) .


Using analysis of covariance , early physical therapy showed improvement relative to usual care in disability after @ months ( mean ODI score : early physical therapy group , @ -LSB- @ % CI , @ to @ -RSB- at baseline to @ -LSB- @ % CI , @ to @ -RSB- at @ months ; usual care group , @ -LSB- @ % CI , @ to @ -RSB- at baseline to @ -LSB- @ % CI , @ to @ -RSB- at @ months ; between-group difference , -@ -LSB- @ % CI , -@ to -@ -RSB- , P = @ ) .


A significant difference was found between groups for the ODI score after @ weeks ( between-group difference , -@ -LSB- @ % CI , -@ to -@ -RSB- , P = @ -RSB- ) , but not at @-year follow-up ( between-group difference , -@ -LSB- @ % CI , -@ to @ -RSB- , P = @ ) .


There was no improvement in pain intensity at @-week , @-month , or @-year follow-up ( between-group difference , -@ -LSB- @ % CI , -@ to @ -RSB- at @-week follow-up ; -@ -LSB- @ % CI , -@ to @ -RSB- at @-month follow-up ; and -@ -LSB- @ % CI , -@ to @ -RSB- at @-year follow-up ) .


The PCS scores improved at @ weeks and @ months but not at @-year follow-up ( between-group difference , -@ -LSB- @ % CI , -@ to -@ -RSB- at @-week follow-up ; -@ -LSB- @ % CI , -@ to -@ -RSB- at @-month follow-up ; and -@ -LSB- @ % CI , -@ to @ -RSB- at @-year follow-up ) .


There were no differences in health care utilization at any point .


Among adults with recent-onset LBP , early physical therapy resulted in statistically significant improvement in disability , but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care .


To compare the efficacy difference in treatment of myofasical pain syndrome between sparrow-pecking moxibustion and acupuncture at trigger points so as to provide the reference of the effective therapeutic method for myofascial pain syndrome .


Ninety patients were randomized into a sparrow-pecking moxibustion group and an acupuncture group , @ cases in each one .


The trigger points were selected in pain areas in the two groups .


In the sparrow-pecking moxibustion group , the sparrow-pecking moxibustion was applied , @ min in each time .


In the acupuncture group , the filiform needles were inserted obliquely at @ degrees and retained for @ min in each treatment .


The treatment was given once a day and @ treatments made one session in the two groups .


The short-form McGill pain questionnaire was used as the observation index , and the changes in pain rating index ( PRI ) , present pain intensity ( PPI ) and visual analogue scale ( VAS ) before and after treatment were used for efficacy assessment .


The results of PRI , PPI and VAS after treatment were reduced apparently as compared with those before treatment in the sparrow-pecking moxibustion group and the acupuncture group ( all P < @ ) .


The differences in PRI , PPI and VAS after treatment were not significant in comparison of the two groups ( both P > @ ) .


The curative and remarkably effective rate was @ % ( @/@ ) in the sparrow-pecking moxibustion group , which was better than @ % ( @/@ , P < @ ) in the acupuncture group .


Sparrow-pecking moxibustion at trigger points achieves the superior efficacy on myofascial pain syndrome as compared with acupuncture at trigger points .


This therapy is simpler in operation additionally .


Physical inactivity increases the risk of many chronic diseases including coronary heart disease , type @ diabetes and some cancers .


It is recommended that adults should undertake at least @ minutes of moderate intensity physical activity throughout the week but many adults do not achieve this .


An opportunity for working adults to accumulate the recommended activity levels is through the daily commute .


Employees will be recruited from workplaces in south-west England and south Wales .


In the intervention arm , workplace Walk-to-Work promoters will be recruited and trained .


Participating employees will receive Walk-to-Work materials and support will be provided through four contacts from the promoters over @ weeks .


Workplaces in the control arm will continue with their usual practice .


The intervention will be evaluated by a cluster randomized controlled trial including economic and process evaluations .


The primary outcome is daily minutes of moderate to vigorous physical activity ( MVPA ) .


Secondary outcomes are : overall physical activity ; sedentary time ; modal shift away from private car use during the commute ; and physical activity/MVPA during the commute .


Accelerometers , GPS receivers and travel diaries will be used at baseline and one year follow-up .


Questionnaires will be used at baseline , immediately post intervention , and one year follow-up .


The process evaluation will examine the context , delivery and response to the intervention from the perspectives of employers , Walk-to-Work promoters and employees using questionnaires , descriptive statistics , fieldnotes and interviews .


A cost-consequence study will include employer , employee and health service costs and outcomes .


Time and consumables used in implementing the intervention will be measured .


Journey time , household commuting costs and expenses will be recorded using travel diaries to estimate costs to employees .


Presenteeism , absenteeism , employee wellbeing and health service use will be recorded .


Compared with other forms of physical activity , walking is a popular , familiar and convenient , and the main option for increasing physical activity in sedentary populations .


To our knowledge , this is the first full-scale randomised controlled trial to objectively measure ( using accelerometers and GPS receivers ) the effectiveness of a workplace intervention to promote walking during the commute to and from work .


UK guidelines recommend that patients with schizophrenia are offered access to social activities , however , the impact of such interventions have not been examined in a large randomized trial .


To investigate the effect of an activity group intervention on mental health and global functioning @ months after randomization compared to standard care alone .


Secondary analysis of data from the MATISSE study .


Primary outcomes were global functioning , assessed using the Global Assessment of Functioning ( GAF ) , and mental health symptoms measured using the Positive and Negative Syndrome Scale ( PANSS ) .


About @ participants were randomized to activity groups and @ to standard care alone .


Follow-up data were collected from @ ( @ % ) participants .


Mental health improved significantly among those offered activity groups ( change in PANSS score = -@ , @ % CI -@ to -@ ) but global functioning did not ( change in GAF score = @ , @ % CI -@ to @ ) .


No significant differences were found between treatment arms .


Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits .


There was poor uptake and attendance at activity groups .


Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions .


Hypothermia at @ C for @ hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to @ % to @ % ; longer cooling and deeper cooling are neuroprotective in animal models .


To determine if longer duration cooling ( @ hours ) , deeper cooling ( @ C ) , or both are superior to cooling at @ C for @ hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy .


A randomized , @ factorial design clinical trial performed in @ US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Neonatal Research Network between October @ and November @ .


Neonates were assigned to @ hypothermia groups ; @ C for @ hours , @ C for @ hours , @ C for @ hours , and @ C for @ hours .


The primary outcome of death or disability at @ to @ months is ongoing .


The independent data and safety monitoring committee paused the trial to evaluate safety ( cardiac arrhythmia , persistent acidosis , major vessel thrombosis and bleeding , and death in the neonatal intensive care unit -LSB- NICU -RSB- ) after the first @ neonates were enrolled , then after every subsequent @ neonates .


The trial was closed for emerging safety profile and futility analysis after the eighth review with @ neonates enrolled ( of @ planned ) .


This report focuses on safety and NICU deaths by marginal comparisons of @ hours ' vs @ hours ' duration and @ C depth vs @ C depth ( predefined secondary outcomes ) .


The NICU death rates were @ of @ neonates ( @ % ) for the @ C for @ hours group , @ of @ neonates ( @ % ) for the @ C for @ hours group , @ of @ neonates ( @ % ) for the @ C for @ hours group , and @ of @ neonates ( @ % ) for the @ C for @ hours group .


The adjusted risk ratio ( RR ) for NICU deaths for the @ hours group vs @ hours group was @ ( @ % CI , @-@ @ ) and for the @ C group vs @ C group was @ ( @ % CI , @-@ @ ) .


Safety outcomes were similar between the @ hours group vs @ hours group and the @ C group vs @ C group , except major bleeding occurred among @ % in the @ hours group vs @ % in the @ hours group ( RR , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Futility analysis determined that the probability of detecting a statistically significant benefit for longer cooling , deeper cooling , or both for NICU death was less than @ % .


Among neonates who were full-term with moderate or severe hypoxic ischemic encephalopathy , longer cooling , deeper cooling , or both compared with hypothermia at @ C for @ hours did not reduce NICU death .


These results have implications for patient care and design of future trials .


To evaluate the effectiveness and safety of leuprolide acetate in the treatment of endometriosis .


From Nov. @ to Oct. @ , the patients who confirmed to be endometriosis were randomly divided into test group of @ cases and control group of @ cases .


The test drug was the sustained-release agent of leuprolide acetate .


The control drug was Enantone .


The drugs were used for @ times in total .


After treatment , the ovarian mass volumes measured with type-B ultrasound , the scores of the patient 's subjective symptoms during non-menstrual and menstruation days , the pelvic signs during non-menstrual days , the changes of hormones -LSB- estradiol ( E@ ) , FSH , LH -RSB- , and adverse events were observed .


After the treatment , the rate of changes of ovarian mass volume ( among them , at @ weeks after the first injection , the median was -@ % in the test group , -@ % in the control group , P = @ ) , the distinct improvement rate of symptom scores and pelvic signs during non-menstrual days -LSB- among them , at @ weeks after the first injection , the rate of lower abdomen pain was @ % ( @/@ ) in the test group , @ % ( @/@ ) in the control group , P = @ -RSB- , the hormone ( E@ , FSH , LH ) levels -LSB- among them , at @ weeks after the first injection , the serum level of E@ , was ( @ ) pmol/L in the test group , ( @ ) pmol/L in the control group , P = @ ; the serum level of FSH , was ( @ ) U/L in the test group , ( @ ) U/L in the control group , P = @ ; the serum level of LH , was ( @ ) U/L in the test group , ( @ ) U/L in the control group , P = @ -RSB- , had no statistically significant difference between the two groups ( all P > @ ) .


The distinct improvement rate and improvement rate of symptom ( lower abdomen pain , low back pain ) scores during menstruation days at @ weeks after the first injection , the rates of lower abdomen pain were @ % ( @/@ ) , @ % ( @/@ ) respectively in the test group , @ % ( @/@ ) , @ % ( @/@ ) respectively in the control group , had statistically significant difference between the two groups ( P = @ ) .


There was no serious adverse event occurred in both two groups .


The incidence rate of adverse event was @ % ( @/@ ) in test group , @ % ( @/@ ) in control group , there was no significant difference between the two groups ( P = @ ) .


Leuprolide acetate is effective and safe in the treatment of endometriosis .


To determine whether home-use icterometry improves parental recognition of neonatal jaundice , early care seeking and treatment to minimize risks of bilirubin encephalopathy .


Cluster-randomised controlled trial of community-level icterometry used at home by mothers in Chi Linh , Vietnam .


Rural health-care workers identified and enrolled term newborns .


Post-partum mothers received jaundice education and icterometry instructions and were cluster-randomised by commune .


Cases received icterometers ( icterometer group ( IG ) ) and controls did not ( control group ( CG ) ) .


Subjects received mobile telephone calls from post-natal days @-@ to determine maternal recognition by visual inspection and icterometer detection of jaundice ( @ on five-point scale ) .


Mothers without telephones , premature newborns ( < @ weeks ) or newborns hospitalised > @ days were excluded .


Three hundred fifty-two subjects were enrolled ( @ IG and @ CG ) , of whom @ ( @ % ) were lost to telephone follow-up .


Jaundice was recognised and/or detected in @ ( @ % ) of all newborns .


Icterometry helped @ mothers ( @ % ) detect neonatal jaundice that was not visually recognised by IG mothers .


Detection by IG mothers was not statistically greater than CG mothers ( P = @ ) .


Follow-up care seeking was @ % in both groups ( P = @ ) , and @ % of jaundiced newborns received treatment ( @ % IG vs. @ % CG , P = @ ) .


Newborns who received care had bilirubin measurements that averaged @ mol/L IG vs. @ mol/L CG ( P = @ ) .


There were no deaths .


In this pilot study , home-use icterometry may help improve parental detection of jaundice in rural Vietnam .


However , larger studies are necessary to determine the changes in recognition , care seeking and treatment .


In people with obesity hypoventilation syndrome ( OHS ) , breathing @ % oxygen increases carbon dioxide ( PCO@ ) , but its effect on pH is unknown .


This study investigated the effects of moderate concentrations of supplemental oxygen on PCO@ , pH , minute ventilation ( VE ) and physiological dead space to tidal volume ratio ( VD/VT ) among people with stable untreated OHS , with comparison to healthy controls .


In a double-blind randomised crossover study , participants breathed oxygen concentrations ( FiO@ ) @ and @ , each for @ min , separated by a @ min washout period .


Arterialised-venous PCO@ ( PavCO@ ) and pH , VE and VD/VT were measured at baseline , then every @ min .


Data were analysed using general linear model analysis .


@ participants were recruited ( @ OHS , @ controls ) .


Among OHS participants ( mean SD arterial PCO@ @ @ kPa ; arterial oxygen @ @ kPa ) FiO@ @ and @ maintained oxygen saturation @-@ % .


After @ min of FiO@ @ , PavCO@ change ( PavCO@ ) was @ @ kPa ( p = @ ) , with minimal change in VE and rises in VD/VT of @ @ % ( p = @ ) .


FiO@ @ increased PavCO@ by @ @ kPa ( p = @ ) , induced acidaemia and increased VD/VT by @ @ % ( p = @ ) .


VE fell by @ @ L/min within @ min then recovered individually to varying degrees .


A negative correlation between VE and PavCO@ ( r = -@ , p = @ ) suggested that ventilatory responses were the key determinant of PavCO@ rises .


Among controls , FiO@ @ and @ did not change PavCO@ or pH , but FiO@ @ significantly increased VE and VD/VT .


Commonly used oxygen concentrations caused hypoventilation , PavCO@ rises and acidaemia among people with stable OHS .


This highlights the potential dangers of this common intervention in this group .


Fish and meat intake may affect gestational weight gain , body composition and serum fatty acids .


We aimed to determine whether a longitudinal dietary intervention during pregnancy could increase fish intake , affect serum phospholipid fatty acids , gestational weight gain and body composition changes during pregnancy in women of normal weight participating in the Pregnancy Obesity Nutrition and Child Health study .


A second aim was to study possible effects in early pregnancy of fish intake and meat intake , respectively , on serum phospholipid fatty acids , gestational weight gain , and body composition changes during pregnancy .


In this prospective , randomized controlled study , women were allocated to a control group or to a dietary counseling group that focused on increasing fish intake .


Fat mass and fat-free mass were measured by air-displacement plethysmography .


Reported intake of fish and meat was collected from a baseline population and from a subgroup of women who participated in each trimester of their pregnancies .


Serum levels of phospholipid arachidonic acid ( s-ARA ) , eicosapentaenoic acid ( s-EPA ) , and docosahexaenoic acid ( s-DHA ) were measured during each trimester .


Weekly fish intake increased only in the intervention group ( n = @ ) from the first to the second trimester ( median difference @g , p = @ ) and from the first to the third trimester ( median difference @g , p = @ ) .


In the first trimester , fish intake correlated with s-EPA ( r = @ , p = @ , n = @ ) and s-DHA ( r = @ , p = @ , n = @ ) , and meat intake correlated with s-ARA ( r = @ , p = @ , n = @ ) .


Fat-free mass gain correlated with reported meat intake in the first trimester ( r = @ , p = @ , n = @ ) .


Dietary counseling throughout pregnancy could help women increase their fish intake .


Intake of meat in early pregnancy may increase the gain in fat-free mass during pregnancy .


Physical inactivity is a significant risk factor for cardiovascular disease and remains highly prevalent in middle-aged women .


We hypothesized that an interventionist-led ( IL ) , primary-care-based physical activity ( PA ) and weight loss intervention would increase PA levels and decrease weight to a greater degree than a self-guided ( SG ) program .


We conducted a randomized trial .


Ninety-nine inactive women aged @-@ years and with BMI @ kg/m ( @ ) were recruited from three primary care clinics .


The interventionist-led ( IL ) group ( n = @ ) had @ weekly sessions of @ min discussions with @ min of moderate-intensity PA. .


The self-guided ( SG ) group ( n = @ ) received a manual for independent use .


Assessments were conducted at @ , @ , and @ months ; PA and weight were primary outcomes .


Weight was measured with a standardized protocol .


Leisure PA levels were assessed using the Modifiable Activity Questionnaire .


Differences in changes by group were analyzed with a t-test or Wilcoxon rank-sum test .


Mixed models were used to analyze differences in changes of outcomes by group , using an intention-to-treat principle .


Data from @ women were available for analysis .


At baseline , mean ( SD ) age was @ ( @ ) years and @ % were black .


Mean weight was @ ( @ ) kg and mean BMI was @ ( @ ) kg/m ( @ ) .


Median PA level was @ metabolic equivalent hours per week ( MET-hour/week ) ( IQR @ , @ ) .


At @ months , IL women had a significantly greater increase in PA levels ( @ vs. @ MET-hour/week ; p = @ ) than SG women ; there was no significant difference in weight change .


At @ months , the difference between groups was no longer significant ( @ vs. @ MET-hour/week ; p = @ ) .


Mixed model analysis showed a significant ( p = @ ) difference in PA change between groups at @ months only .


The IL intervention was successful in increasing the physical activity levels of obese , inactive middle-aged women in the short-term .


No significant changes in weight were observed .


To determine the intravitreal anti-vascular endothelial growth factor ( VEGF ) injection techniques and preferences within the retinal community and to identify potential factors associated with the development of sustained intraocular pressure ( IOP ) elevation in patients treated with intravitreal anti-VEGF therapy for neovascular age-related macular degeneration ( AMD ) .


Cross-sectional physician survey .


Five hundred and thirty retina specialists spanning both private and academic practices were surveyed regarding current anti-VEGF intravitreal injection protocols , including the anti-VEGF drug of choice , needle gauge , injection volume , injection technique , and self-reported prevalence of sustained IOP elevation .


Multivariate logistic regressions were performed to assess the potential influence of these factors on long-term IOP .


Two hundred ninety-two specialists ( @ % ) reported believing that intravitreal anti-VEGF therapy may cause sustained IOP elevation .


Of these responses , the most common reported prevalence was @ % -@ % ( @ % ) , followed by @ % -@ % ( @ % ) .


There was no relationship between the frequency of sustained IOP elevation and anti-VEGF drug of choice .


Physicians who injected greater than @ cc in less than @ second were @ times more likely to observe a high frequency of sustained IOP elevation ( P = @ , @ % CI @-@ @ ) .


Based on physician survey data , serial anti-VEGF injections using higher injection volumes with a rapid injection technique may potentially lead to sustained IOP elevation .


The underlying mechanism for this complication may be injury to the trabecular meshwork resulting from rapid elevations in IOP .


Further investigation of the relationship between injection techniques and sustained IOP elevation in the form of retrospective or prospective clinical studies is warranted .


Purified palmitoleic acid ( @-@ ; omega-@ ) has shown lipid-lowering and anti-inflammatory benefits in open label , epidemiologic , and animal studies .


Our objective was to perform the first randomized controlled trial of purified palmitoleic acid supplementation in humans .


Adults with dyslipidemia and evidence of mild systemic inflammation ( high-sensitivity C-reactive protein -LSB- hs-CRP -RSB- between @ and @mg/L ) were randomly allocated to receive either @ mg of cis-palmitoleic acid ( n = @ ) or an identical capsule with placebo ( @mg of medium chain triglycerides , n = @ ) once per day for @days .


Participants were asked to maintain their current diet .


Serum lipids and hs-CRP were drawn at baseline and study completion .


At @days , there were significant mean ( @ % confidence interval -LSB- CI -RSB- ) reductions in CRP ( -@ -LSB- -@ to -@ -RSB- mg/L ) , triglyceride ( -@ -LSB- -@ to -@ -RSB- mg/dL ) , and low-density lipoprotein ( LDL ) ( -@ -LSB- -@ to -@ -RSB- mg/dL ) , and a significant increase in high-density lipoprotein ( HDL ) ( @ -LSB- @ , @ -RSB- mg/dL ) in the intervention group compared with control .


These changes equated to @ % , @ % , and @ % reductions in CRP , triglyceride , and LDL respectively , and a @ % increase in HDL compared with control .


Purified palmitoleic acid may be useful in the treatment of hypertriglyceridemia with the beneficial added effects of decreasing LDL and hs-CRP and raising HDL .


Further study is needed to elucidate mechanisms and establish appropriate human doses .


This double-blind , crossover study evaluated whole plaque fluoride concentration ( F ) , as well as whole plaque calcium concentrations ( Ca ) after brushing with a placebo ( PD - fluoride free ) , low-fluoride ( LFD , @ microg F/g ) and conventional ( CD , @,@ microg F/g ) dentifrices .


Children ( n = @ ) were randomly assigned to brush twice daily with one of the dentifrices , during @ days .


On the @th day , samples were collected at @ and @ hours after brushing .


F and Ca were analyzed with an ion-selective electrode and with the Arsenazo III method , respectively .


Data were analyzed by ANOVA , Tukey 's test and by Pearson correlation coefficient ( P < @ ) .


The use of the fluoridated dentifrices significantly increased plaque -LSB- F -RSB- s @ hour after brushing when compared to PD , returning to baseline levels @ hours after .


Positive and significant correlations were found between plaque -LSB- F -RSB- and ( Ca ) under most of the conditions evaluated .


The mean increase in plaque -LSB- F -RSB- observed @ hour after brushing with the CD were only about @ % higher than those obtained for the LFD .


The use of a LFD promotes proportionally higher increases in plaque -LSB- F -RSB- when compared to a CD .


Plaque F concentrations were also shown to be dependent on plaque Ca concentrations .


Transcutaneous electrical nerve stimulation ( TENS ) is a useful modality for pain control .


TENS has recently been applied to decrease spasticity .


The purpose of this study is to determine whether the addition of TENS to an exercise program reduces spasticity and improves balance and gait in chronic stroke patients .


This was a single-blinded , multicenter , randomized controlled trial .


Thirty-four ambulatory individuals with chronic stroke participated and were randomly allocated to the TENS or Placebo group .


The TENS group performed therapeutic exercise with TENS while the placebo ( non-stimulation ) TENS group performed therapeutic exercise with placebo TENS .


Participants in both groups followed the same @-min exercise regimen @ times per week for a period of @ weeks .


Spasticity ( modified Ashworth scale ) , static ( balance system ) , and dynamic balance ( timed up and go test ) , and gait ability ( gait analyzer ) were measured at @ week before and @ week after the intervention .


Significant differences were observed between the @ groups .


Spasticity improved by @ points in the TENS group .


Anterior-posterior and medial-lateral sway velocity among static balance parameters and dynamic balance showed significant differences between the TENS and Placebo TENS groups ( p = @ ) .


Gait speed and cadence were enhanced significantly in the TENS group ( p = @ ) .


Step and stride length on the paretic side showed a significant difference in the TENS group ( p = @ ) , while only velocity showed a significant difference in the Placebo TENS group ( p = @ ) .


A combination of therapeutic exercise and TENS may reduce spasticity and improve balance , gait , and functional activity in chronic stroke patients .


Tight blood glucose control has become a therapeutical goal for anesthetic management for patients scheduled for cardiac surgery , especially if they are diabetic patients .


This study was created to confirm the benefits of intraoperative GIK solution usage during coronary bypass operation of diabetic patients .


Patients with type @ and @ diabetes mellitus ( DM ) referred for coronary artery bypass grafting ( CABG ) were randomized to receive GIK solution ( GIK -- study group ) in the first @ hours intraoperatively or to receive official Clinical protocol without GIK solution ( non GIK - control group ) .


The primary clinical outcome was the cardiac index ( CI ) since it represents the most sensitive measure of cardiac work in the immediate postoperative period , and the secondary clinical outcomes were the glycemic control , insulin consumption , duration of mechanical ventilation ( MV ) , potassium level and atrial fibrillation ( AF ) appearance .


One hundred diabetic patients , divided into two groups , were included in the study .


The cardiac index did not show a significant difference , although the study group had CI with only minor variations than those of the controlled group , hence the reason we considered the study group as the more stable .


The atrial fibrillation showed a difference between two groups , with @ ( @ % ) patients with postoperative AF in the control group compared with @ ( @ % ) patients with postoperative AF in the study group .


As potassium values were stable in study group , we concluded that it can be one of the reasons for less postoperative AF in this group .


The duration of MV showed a significant difference ( @,@ ) between the two groups as well .


In the study group the average MV time was @,@ minutes , compared with the control group with @,@ minutes .


The average value of glucose was @ mmol/l in the control group vs. @ mmol/l in the study group .


The study group had less insulin consumption in order to maintain target glycemia ( p = @ ) .


In the non GIK group average insulin consumption was @ IJ per patient vs. @ IJ in the GIK group .


Intraoperative GIK solution given to diabetic patients with CABG operation provides more stable CI , shorter time of MV , more stable values of potassium which provides normal rhythm and less AF onset , less insulin to maintain target glycemia .


All the above mentioned provides more stable intraoperative hemodynamic and better recovery of diabetic


High-intensity noninvasive ventilation ( HI-NIV ) is the most effective means of improving several physiological and clinical parameters in subjects with chronic hypercapnic COPD .


Whether the newer hybrid mode using target tidal volume noninvasive ventilation ( target V ( T ) NIV ) provides additional benefits remains unclear .


Subjects with COPD successfully established on long-term HI-NIV were switched to target V ( T ) NIV .


Optimal target V ( T ) settings according to nocturnal transcutaneous P ( CO@ ) measurements were achieved following a randomized crossover trial using @ mL/kg ideal body weight and @ % of individual V ( T ) during HI-NIV , respectively .


The following parameters were compared at the beginning of the trial while subjects were on HI-NIV , and after @ months on optimal target V ( T ) NIV : sleep quality by polysomnography , overnight gas exchange , subjects ' tolerance , overnight pneumotachygraphic measurements during NIV , health-related quality of life ( severe respiratory insufficiency questionnaire ) , exercise capacity ( @-min walk test ) , and lung function .


Ten of @ subjects completed the study .


There were no differences between HI-NIV and target V ( T ) NIV in any of the above-mentioned parameters .


Specifically , the mean overnight transcutaneous P ( CO@ ) was equivalent under each form of ventilation ( both @ @ mm Hg , P = @ ) .


Switching subjects from well-established HI-NIV to target V ( T ) NIV shows no clinical benefits in chronic hypercapnic COPD .


In particular , sleep quality , the control of nocturnal hypoventilation , daytime hypercapnia , overnight ventilation patterns , subjects ' tolerance , health-related quality of life , lung function , and exercise capability were all similar in subjects who underwent HI-NIV and target V ( T ) NIV .


Nevertheless , target V ( T ) NIV might offer some physiological advantages in breathing pattern and might be beneficial in some individual patients .


( German Clinical Trials Register -LSB- www.drks.de -RSB- Registration DRKS@ . )


Patients with cirrhosis and variceal hemorrhage have a high risk of rebleeding .


We performed a prospective randomized trial to compare the prevention of rebleeding in patients given a small-diameter covered stent vs those given hepatic venous pressure gradient ( HVPG ) - based medical therapy prophylaxis .


We performed an open-label study of patients with cirrhosis ( @ % Child class A or B , @ % alcoholic ) treated at @ medical centers in Germany .


Patients were assigned randomly more than @ days after variceal hemorrhage to groups given a small covered transjugular intrahepatic portosystemic stent-shunt ( TIPS ) ( @ mm ; n = @ ) , or medical reduction of portal pressure ( propranolol and isosorbide-@-mononitrate ; n = @ ) .


HVPG was determined at the time patients were assigned to groups ( baseline ) and @ weeks later .


In the medical group , patients with an adequate reduction in HVPG ( responders ) remained on the drugs whereas nonresponders underwent only variceal band ligation .


The study was closed @ months after the last patient was assigned to a group .


The primary end point was variceal rebleeding .


Survival , safety ( adverse events ) , and quality of life ( based on the Short Form-@ health survey ) were secondary outcome measures .


A significantly smaller proportion of patients in the TIPS group had rebleeding within @ years ( @ % ) than in the medical group ( @ % ) ( P = @ ) .


A slightly higher proportion of patients in the TIPS group experienced adverse events , including encephalopathy ( @ % vs @ % for medical treatment ; P = @ ) .


Rebleeding occurred in @ of @ patients ( @ % ) receiving medical treatment before hemodynamic control was possible .


Per-protocol analysis showed that rebleeding occurred in a smaller proportion of the @ responders ( @ % ) than in nonresponders who received variceal band ligation ( @ % ) ( P = @ ) .


Fifteen patients from the medical group ( @ % ) underwent TIPS placement during follow-up evaluation , mainly for refractory ascites .


Survival time and quality of life did not differ between both randomized groups .


Placement of a small-diameter , covered TIPS was straightforward and prevented variceal rebleeding in patients with Child A or B cirrhosis more effectively than drugs , which often required step-by-step therapy .


However , TIPS did not increase survival time or quality of life and produced slightly more adverse events .


Clinical Trial no : ISRCTN @ .


To assess the effects of daily consumption of a synbiotic yogurt drink on the health , growth , and quality of life of healthy children @-@ months of age in out-of-home child care .


Healthy children attending child care centers were enrolled in a prospective , double-blind , placebo-controlled clinical trial .


The intervention was a yogurt drink containing Streptococcus thermophilus , Lactobacillus bulgaricus , and Bifidobacterium animalis subspecies lactis ( BB-@ ) ( @ @ ( @ ) cfu/@ mL serving ) , and @ g of inulin ( synbiotic group ) vs a similar nonsynbiotic-containing acidified milk drink ( placebo group ) once daily for @ weeks .


The end points were days of diarrhea , fever , vomiting , symptoms of upper respiratory tract infection , use of antibiotics , physician visits , child care absenteeism , parental work absenteeism , and quality of life ( PedsQL @ ; Mapi Research Trust , Lyon , France ) .


Compared with placebo ( n = @ ) , children receiving synbiotic ( n = @ ) had significantly fewer days of reported fever ( @ vs @ , P < @ ) , significant improvement in social functioning ( P < @ ; pre-to-end intervention ) , and school functioning ( P < @ ; pre-to-mid intervention ) .


More days with @ loose/watery stools were reported in the synbiotic group ( P < @ ) .


Daily supplementation of children 's diet with yogurt containing probiotic bacteria BB-@ and inulin significantly reduced days of fever and improved social and school functioning .


The increased frequency of bowel movements may be explained by an accelerating effect of BB-@ and inulin on intestinal transit .


Further research on the possible benefits of synbiotics on children 's health is advised .


In older adults with anxiety disorders , chronically elevated cortisol may contribute to cognitive impairment and elevated anxiety .


We conducted a pilot study with mifepristone , a glucocorticoid receptor antagonist , as a potential treatment for late-life anxiety disorders and co-occurring cognitive dysfunction .


Fifteen individuals @years and older with an anxiety disorder plus cognitive dysfunction participated in the @-week study .


In the first week , participants were randomly assigned to mifepristone @mg daily or placebo .


In the subsequent @weeks , all participants received mifepristone @mg .


Mifepristone was then discontinued , and the participants were reassessed @weeks later .


We examined the following : ( @ ) cognitive changes ; ( @ ) worry symptom severity ; ( @ ) safety and tolerability ; and ( @ ) salivary cortisol before , during , and after mifepristone exposure .


Overall safety , tolerability , and high retention supported the feasibility of this research .


Participants with higher baseline cortisol levels ( peak cortisol > @ ng/ml , n = @ ) showed improvements in memory , executive function , and worry severity after @-@weeks of mifepristone with persistent memory and worry improvements @weeks after mifepristone discontinuation .


Individuals with low-to-normal baseline cortisol ( n = @ ) showed little to no improvement .


As expected , cortisol levels rose during mifepristone exposure and returned to pretreatment levels @weeks after mifepristone discontinuation .


In the first week of treatment , there were no differences between placebo-treated and mifepristone-treated participants .


The results of this pilot study warrant further testing of antiglucocorticoid agents in late-life anxiety disorders with co-occurring cognitive dysfunction .


Mifepristone is hypothesized to have benefits in patients with evidence of glucocorticoid excess .


Directions for further study are discussed .


Low physical activity is a major risk factor for several age-related diseases .


Recently , we showed in a randomized controlled trial that a @-week Web-based intervention ( Philips DirectLife ) to increase physical activity was effective in increasing physical activity levels and metabolic health in an inactive population aged @-@ years .


The goal of this paper was to assess how many participants successfully reached the physical activity level as targeted by the intervention and what the effects of the intervention on body composition and metabolic health in these successful individuals were to provide insight in the maximum attainable effect of the intervention .


Among the @ participants in a randomized controlled trial of the Actief en Gezond Oud ( AGO ) study , we assessed the effects of the intervention on metabolic parameters in those who had successfully reached their personalized physical activity target compared with the entire intervention group .


Furthermore , we studied the dose-response effect of increase in physical activity on metabolic outcome within the intervention group .


Of the intervention group , @ of @ ( @ % ) participants successfully reached the physical activity target ( corresponding to a @ % increased daily physical activity on average ) .


This group showed markedly higher effects of the intervention compared to the entire intervention group , with greater decreases in body weight ( @ vs @ kg ) , waist circumference ( @ vs @ cm ) , insulin resistance ( HOMA index : @ vs @ ) , and in cholesterol/HDL ratio ( @ vs @ ) and Framingham risk score ( @ % vs @ % ) .


We found that men compared to women were more likely to be successful .


The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate-to-vigorous activity and body weight loss , BMI reduction , waist circumference reduction , HDL cholesterol increasing , and cholesterol/HDL ratio lowering .


Of the intervention group , @ % ( @/@ ) reached their daily physical activity end goal , which was associated with a markedly better effect on body composition and metabolic health compared to the effect in the entire intervention group .


In this population , men are more likely to be successful in increasing physical activity .


Findings demonstrate that improving the effect of such physical activity interventions requires finding new ways to increase the proportion of the population reaching the targeted goal .


The aim of this clinical study was to determine the efficacy of Uncaria tomentosa ( cat 's claw ) against denture stomatitis ( DS ) .


Fifty patients with DS were randomly assigned into @ groups to receive @ % miconazole , placebo , or @ % U tomentosa gel .


DS level was recorded immediately , after @ week of treatment , and @ week after treatment .


The clinical effectiveness of each treatment was measured using Newton 's criteria .


Mycologic samples from palatal mucosa and prosthesis were obtained to determinate colony forming units per milliliter ( CFU/mL ) and fungal identification at each evaluation period .


Candida species were identified with HiCrome Candida and API @C AUX biochemical test .


DS severity decreased in all groups ( P < @ ) .


A significant reduction in number of CFU/mL after @ week ( P < @ ) was observed for all groups and remained after @ days ( P > @ ) .


C albicans was the most prevalent microorganism before treatment , followed by C tropicalis , C glabrata , and C krusei , regardless of the group and time evaluated .


U tomentosa gel had the same effect as @ % miconazole gel .


U tomentosa gel is an effective topical adjuvant treatment for denture stomatitis .


To explore whether cataract surgery contributes to the progression of wet age-related macular degeneration ( wet AMD ) .


Retrospective cohort study .


Retrospective review was performed of consecutive patients with wet AMD who underwent cataract surgery at the midpoint of a @-year study window .


A control arm included wet AMD eyes treated with anti-vascular endothelial growth factor ( VEGF ) injections that did not undergo cataract surgery for a @-year period .


Best-corrected visual acuity ( BCVA ) , number of anti-VEGF injections , and optical coherence tomography ( OCT ) features were compared between the @ arms .


Forty eyes in the surgical group and @ in the nonsurgical group were included .


BCVA was equivalent in the first half of the study , and became significantly better in the surgical group vs the nonsurgical group ( @ @ vs @ @ logMAR improvement , P = @ ) .


There was no change in the number of injections given @months before vs after the midpoint in the surgical group ( P = @ ) .


The mean OCT central retinal thickness became greater in postsurgical eyes compared to nonsurgical eyes ( @ @ m vs @ @ m , P = @ ) .


Surgical eyes were more likely to develop new or worse cystoid changes after the study midpoint ( @ surgical eyes -LSB- @ % -RSB- vs @ nonsurgical eyes -LSB- @ % -RSB- , P = @ ) .


Cataract surgery leads to vision improvement and does not appear to contribute to worsening of wet AMD .


However , anatomic changes based on OCT analysis suggest a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization .


To assess the efficacy and safety of Reduning injection for fever , rash , and ulcers in children with mild hand , foot , and mouth disease ( HFMD ) .


A stratified-block randomized , double-blind , parallel-controlled , and multicenter clinical trial was conducted with @ patients in five hospitals across China : Quanzhou Children 's Hospital , Shijiazhuang No. @ Hospital , Shanghai Public Health Centre , Hunan Provincial Children 's Hospital , and Kaifeng Children 's Hospital .


Patients were randomized into three groups with @ in each .


Group A was treated with Western Medicine , group B with Reduning injection , a Chinese herbal medicine , and group C with both Reduning injection and Western Medicine .


Results were compared for treatment efficacy and safety on HFMD .


The clinical outcomes were observed as follows : fever and onset time of antifebrile effect ( time to bring the body temperature down > or = @ degrees C after medication ) ; cumulative time for fever recovery ( body temperature recovering to normal and lasting more than @ h without medication ) ; cumulative time for rash disappearance ( without new rashes or ulcers appearing and the original ones fading away ) ; and cumulative time for mouth ulcer disappearance .


For the onset time of the antifebrile effect , there was no statistical difference between groups A and B ( P > @ ) and groups B and C ( P > @ ) .


However , there was a statistical difference between groups A and C ( P < @ ) , and the effect in group C was the best .


For the cumulative time for rash disappearance , there was no statistical difference between groups A and B ( P > @ ) .


There were statistical differences between groups A and C , and groups B and C ( P < @ ) , and the effect in group C was the best .


For the cumulative time for mouth ulcers disappearance , there were no statistical differences among the three groups ( P > @ ) .


Reduning injection with Western Medicine for symptomatic treatment is most effective for mild HFMD .


No adverse reactions were observed .


Oral feedback from clinical educators is the traditional teaching method for improving clinical consultation skills in medical students .


New approaches are needed to enhance this teaching model .


Multisource feedback is a commonly used assessment method for learning among practising clinicians , but this assessment has not been explored rigorously in medical student education .


This study seeks to evaluate if additional feedback on patient satisfaction improves medical student performance .


The Patient Teaching Associate ( PTA ) Feedback Study is a single site randomized controlled , double-blinded trial with two parallel groups.An after-hours general practitioner clinic in Victoria , Australia , is adapted as a teaching clinic during the day .


Medical students from two universities in their first clinical year participate in six simulated clinical consultations with ambulatory patient volunteers living with chronic illness .


Eligible students will be randomized in equal proportions to receive patient satisfaction score feedback with the usual multisource feedback and the usual multisource feedback alone as control .


Block randomization will be performed .


We will assess patient satisfaction and consultation performance outcomes at baseline and after one semester and will compare any change in mean scores at the last session from that at baseline .


We will model data using regression analysis to determine any differences between intervention and control groups .


Full ethical approval has been obtained for the study .


This trial will comply with CONSORT guidelines and we will disseminate data at conferences and in peer-reviewed journals .


This is the first proposed trial to determine whether consumer feedback enhances the use of multisource feedback in medical student education , and to assess the value of multisource feedback in teaching and learning about the management of ambulatory patients living with chronic conditions .


Genetic information given to an individual newly diagnosed with a genetic condition is likely to have important health implications for other family members .


The task of communicating with these relatives commonly falls to the newly diagnosed person .


Talking to relatives about genetic information can be challenging and is influenced by many factors including family dynamics .


Research shows that many relatives remain unaware of relevant genetic information and the possible impact on their own health .


This study aims to evaluate whether a specific genetic counselling intervention for people newly diagnosed with a genetic condition , implemented over the telephone on a number of occasions , could increase the number of at-risk relatives who make contact with genetics services after a new genetic diagnosis within a family .


This is a prospective , multi-centre randomised controlled trial being conducted at genetics clinics at five public hospitals in Victoria , Australia .


A complex genetic counselling intervention has been developed specifically for this trial .


Probands ( the first person in a family to present with a diagnosis of a genetic condition ) are being recruited and randomised into one of two arms - the telephone genetic counselling intervention arm and the control arm receiving usual care .


The number of at-risk relatives for each proband will be estimated from a family pedigree collected at the time of diagnosis .


The primary outcome will be measured by comparing the proportion of at-risk relatives in each arm of the trial who make subsequent contact with genetics services .


This study , the first randomised controlled trial of a complex genetic counselling intervention to enhance family communication , will provide evidence about how best to assist probands to communicate important new genetic information to their at-risk relatives .


This will inform genetic counselling practice in the context of future genomic testing .


To evaluate the efficacy of device-guided slow-paced respiration for reducing the frequency and severity of menopausal hot flushes .


Perimenopausal or postmenopausal women reporting four or more hot flushes per day were recruited into a parallel-group , randomized trial of slow-paced respiration using a portable guided-breathing device .


Women were randomly assigned to use a standard device to practice slowing their resting breathing rate to less than @ breaths per minute for at least @ minutes everyday or use an identical-appearing control device programmed to play relaxing nonrhythmic music while monitoring spontaneous breathing .


The primary outcome , change in hot flush frequency over @ weeks , was assessed using data from validated @-day diaries abstracted by blinded analysts .


Among the @ participants , mean age was @ ( @ ) years .


Women reported an average of @ ( @ ) hot flushes per day at baseline .


After @ weeks , women randomized to paced respiration ( n = @ ) reported an average reduction of @ ( @ % confidence interval -LSB- CI -RSB- @-@ @ ) hot flushes per day ( -@ % ) compared with @ ( @ % CI @-@ @ ) hot flushes per day ( -@ % ) in the music-listening group ( n = @ ) ( P = @ ) .


Paced respiration was associated with a @ % decrease in frequency of moderate-to-severe hot flushes compared with a @ % decrease with music listening ( P = @ ) .


In this randomized trial , women assigned to device-guided slow-paced respiration reported modest improvements in the frequency and severity of their hot flushes , but the paced respiration intervention was significantly less effective than a music-listening intervention in decreasing the frequency and severity of these symptoms .


This analysis investigates incidence and time course of rash in the EURTAC study .


Patients with EGFR mutation-positive non-small-cell lung cancer were randomized @:@ to receive once daily erlotinib or @-weekly cycles of chemotherapy .


Of the @ erlotinib-treated patients , @ reported rash .


Median time to first rash appearance was @ months .


Most patients ( n = @ ) had the same or lower grade rash at final assessment compared with initial assessment .


Of the @ patients with decreased rash grade between initial and final assessments , @ % received no erlotinib dose modification , @ % had no concomitant rash treatment .


Most rash cases were mild , occurred within @ month of erlotinib treatment , and rapidly improved without the need for erlotinib dose alterations .


Gene expression profiling test scores have primarily been used to identify heart transplant recipients who have a low probability of rejection at the time of surveillance testing .


We hypothesized that the variability of gene expression profiling test scores within a patient may predict risk of future events of allograft dysfunction or death .


Patients from the IMAGE study with rejection surveillance gene expression profiling tests performed at @ - to @-month intervals were selected for this cohort study .


Gene expression profiling score variability was defined as the standard deviation of an individual 's cumulative test scores .


Gene expression profiling ordinal score ( range , @-@ ) , threshold score ( binary value = @ if ordinal score @ ) , and score variability were studied in multivariate Cox regression models to predict future clinical events .


Race , age at time of transplantation , and time posttransplantation were significantly associated with future events in the univariate analysis .


In the multivariate analyses , gene expression profiling score variability , but not ordinal scores or scores over threshold , was independently associated with future clinical events .


The regression coefficient P values were < @ , @ , and @ , for gene expression profiling variability , ordinal , and threshold scores , respectively .


The hazard ratio for a @ unit increase in variability was @ ( @ % CI , @-@ @ ) .


The variability of a heart recipient 's gene expression profiling test scores over time may provide prognostic utility .


This information is independent of the probability of acute cellular rejection at the time of testing that is rendered from a single ordinal gene-expression profiling test score .


Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors ( AIs ) and can result in decreased quality of life and discontinuation of therapy .


Omega-@ fatty acids ( O@-FAs ) can be effective in decreasing arthralgia resulting from rheumatologic conditions and reducing serum triglycerides .


Women with early-stage breast cancer receiving an AI who had a worst joint pain/stiffness score @ of @ using the Brief Pain Inventory-Short Form ( BPI-SF ) were randomly assigned to receive either O@-FAs @ g or placebo ( soybean/corn oil ) daily for @ weeks .


Clinically significant change was defined as @-point drop from baseline .


Patients also completed quality-of-life ( Functional Assessment of Cancer Therapy-Endocrine Symptoms ) and additional pain/stiffness assessments at baseline and weeks @ , @ , and @ .


Serial fasting blood was collected for lipid analysis .


Among @ patients registered , @ were evaluable , with @ women in the O@-FA arm and @ in the placebo arm .


Compared with baseline , the mean observed BPI-SF score decreased by @ points at @ weeks and @ points at @ weeks with O@-FAs and by @ and @ points , respectively , with placebo .


In a linear regression adjusting for the baseline score , osteoarthritis , and taxane use , adjusted @-week BPI-SF scores did not differ by arm ( P = @ ) .


Triglyceride levels decreased in patients receiving O@-FA treatment and remained the same for those receiving placebo ( P = @ ) .


No between-group differences were seen for HDL , LDL , or C-reactive protein .


We found a substantial ( > @ % ) and sustained improvement in AI arthralgia for both O@-FAs and placebo but found no meaningful difference between the groups .


Rifamycin SV is under development for treatment of travelers ' diarrhea ( TD ) in a new oral formulation , Rifamycin SV MMX ( RIF-MMX ; Santarus Inc. , San Diego , CA , USA ) , which targets its delivery to the colon , making it a unique rifamycin drug .


This was a randomized , double-blind , phase @ study of adult travelers to Mexico or Guatemala experiencing acute diarrhea .


A total of @ patients received RIF-MMX ( @mg twice daily for @days , n = @ ) or placebo ( n = @ ) in a @:@ ratio .


The primary endpoint was the length of time between the administration of first dose of study drug and passage of the last unformed stool ( TLUS ; after which clinical cure was declared ) .


Other endpoints included eradication of pathogens from the stools , pathogen minimum inhibitory concentration ( MIC ) , and adverse events ( AEs ) .


TLUS was significantly shorter in the RIF-MMX group ( median : @ hours ) compared with placebo ( median : @ hours ; p = @ ) and a larger percentage of RIF-MMX treated patients ( @ % ) achieved clinical cure compared with placebo patients ( @ % ) .


TLUS was significantly shorter in the subgroups of patients with enteroaggregative , enterotoxigenic , or diffusely adherent Escherichia coli infections ( p = @ ) with nonsignificant activity against invasive bacteria ( p = @ ) .


Overall pathogen eradication rates were numerically higher in the RIF-MMX group ( @ % ) compared with placebo ( @ % ) but the difference did not reach significance ( p = @ ) .


In vitro resistance to rifamycin SV was observed in some bacteria remaining after treatment of patients with RIF-MMX but was not associated with lower efficacy in them .


AEs appeared to be more frequent with placebo ( @ % ) than with RIF-MMX ( @ % ) .


RIF-MMX shortened the duration of TD in patients with a broad range of pathogens and was well tolerated .


The unique pharmacokinetic properties of the drug offer evidence that TD pathogens work at the level of the colon .


Ethanol celiac plexus neurolysis ( ECPN ) has been shown to be effective in reducing cancer-related pain in patients with locally advanced pancreatic and periampullary adenocarcinoma ( PPA ) .


This study examined its efficacy in patients undergoing PPA resection .


There were @ patients who participated in this prospective , randomized , double-blind placebo controlled trial .


Patients were stratified by preoperative pain and disease resectability .


They received either ECPN ( @ % ethanol ) or @ % normal saline placebo control .


The primary endpoint was short - and long-term pain and secondary endpoints included postoperative morbidity , quality of life , and overall survival .


Data from @ patients were analyzed .


The primary endpoint , the percentage of PPA patients experiencing a worsening of pain compared with preoperative baseline for resectable patients , was not different between the ethanol and saline groups in either the resectable/pain stratum ( @ % vs @ % , relative risk -LSB- RR -RSB- @ -LSB- @ , @ -RSB- ) , or the resectable/no pain stratum ( @ % vs @ % , RR @ -LSB- @ , @ -RSB- ) .


In multivariable analysis of resected pancreatic ductal adenocarcinoma ( PDA ) patients , there was a significant reduction in pain in the resectable/pain group , suggesting that surgical resection of the malignancy alone ( independent of ECPN ) decreases pain to a significant degree .


In this study , we demonstrated a significant reduction in pain after surgical resection of PPA .


However , the addition of ECPN did not synergize to result in a further reduction in pain , and in fact , its effect may have been masked by surgical resection .


Given this , we can not recommend the use of ECPN to mitigate cancer-related pain in resectable PPA patients .


Atrial fibrillation ( AF ) is a risk factor for ischemic stroke and congestive heart failure .


AF may cause left atrial ( LA ) dyssynchrony as well as electrical and mechanical remodeling .


The aim of this study was to investigate LA dyssynchrony in patients with paroxysmal AF ( PAF ) and its recovery after pulmonary vein isolation ( PVI ) , using a three-dimensional strain method .


Thirty patients with PAF who underwent PVI were enrolled .


Three-dimensional echocardiography was performed before and @months after PVI .


Twenty subjects in whom AF had never been detected served as controls .


LA dyssynchrony was quantified by the standard deviation of time to peak strain ( TP-SD ) from end-diastole by area tracking .


Serial changes in TP-SD , LA volume , and global strain in three-dimensional echocardiography were investigated .


In the PAF group , TP-SD was significantly higher ( @ % vs @ % in controls , P < @ ) and global strain significantly lower ( @ % vs @ % in controls , P = @ ) than in the control group .


TP-SD , global strain , and LA volume all improved significantly from before to after PVI ( TP-SD , from @ % to @ % , P = @ ; global strain , from @ % to @ % , P = @ ; LA volume index , @ to @ mL/m ( @ ) , P = @ ) .


Despite the improvement after PVI , TP-SD was still significantly higher and global strain lower than in controls .


In patients with PAF , impaired LA function was documented by three-dimensional echocardiography .


Despite early LA structural reverse remodeling , LA dyssynchrony was still observed @ months after PVI .


These results may affect medical therapy after successful PVI .


To evaluate the relative pain with @ U.S. Food and Drug Administration-approved bandage soft contact lenses ( SCLs ) applied after photorefractive keratectomy ( PRK ) .


Joint Warfighter Refractive Surgery Center , Lackland Air Force Base , Texas , USA .


Prospective comparative case series .


Patients having PRK were randomized to a senofilcon A ( Acuvue Oasys ) , balafilcon A ( Purevision ) , or lotrafilcon A ( Air Optix ) bandage SCL in each eye postoperatively .


Patients were evaluated @ and @ days postoperatively and completed a survey rating absolute pain in each eye on a visual analog scale .


The study enrolled @ patients .


At @ and @ days , eyes with the senofilcon A lens had the lowest pain scores followed by eyes with the lotrafilcon A lens and then eyes with the balafilcon A lens .


Averaging qualitative results from @ and @ days showed that eyes with the senofilcon A lens were reported as having more pain by @ % of patients , eyes with the lotrafilcon A lens by @ % , and eyes with the balafilcon A lens by @ % ; @ % reported no difference ( P < @ ) .


Quantitatively , the senofilcon A lens was @ % more comfortable than the lotrafilcon A lens and @ % more comfortable than the balafilcon A lens on average .


The lotrafilcon A lens was @ % more comfortable than the balafilcon A lens on average ( P < @ ) .


There was a statistically and clinically significant difference in post-PRK pain between the @ bandage SCLs .


The senofilcon A lens caused the least pain .


In an unselected group of women with signs of preterm labour , maintenance tocolysis is not effective in the prevention of preterm birth and does not improve neonatal outcome .


Among women with signs of preterm labour , those who are fetal fibronectin positive have an increased risk of preterm birth .


We investigated whether maintenance tocolysis with nifedipine would delay delivery and improve neonatal outcome in women with threatened preterm labour and a positive fetal fibronectin status .


Women with a singleton pregnancy in threatened preterm labour ( @ ( +@ ) to @ ( +@ ) weeks ) with a positive fetal fibronectin test were randomised to nifedipine or placebo .


Study medication was continued until @ completed weeks ' gestation .


The primary endpoint was prolongation of pregnancy of sevendays .


Secondary endpoints were gestational age at delivery and length of NICU admission .


Of the @ participants , @ received nifedipine and @ placebo .


Prolongation of pregnancy by > @days occurred in @/@ ( @ % ) in the nifedipine group and @/@ ( @ % ) in the placebo group ( relative risks , RR @ -LSB- @-@ @ -RSB- ) .


Gestational age at delivery was @ weeks for nifedipine and @ weeks for placebo ( P = @ ) .


Length of NICU admission -LSB- median ( interquartile ranges , IQR ) -RSB- was @ ( @-@ ) days and @ ( @-@ ) days in nifedipine and placebo groups , respectively ( P = @ ) .


In women with threatened preterm labour who are fetal fibronectin positive , maintenance tocolysis with nifedipine does not seem to prolong pregnancy , nor reduce length of NICU admission .


Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics .


Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo component only adds to this complexity .


The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial , to determine the number of patients needed to be screened and allocated in order to include one participant into the trial , and to identify reasons associated with participation in a placebo-controlled randomized surgical trial .


Data were extracted from an ongoing placebo-controlled randomized controlled trial ( RCT ) on meniscectomy versus placebo surgery .


We calculated the number of patients needed to be screened in order to include the required number of participants into the RCT .


Participating patients were asked about their rationale for joining the study and which type of information was most useful for deciding upon participation .


A total of @ patients entered the screening group , of which @ patients fulfilled the inclusion and exclusion criteria .


@ patients declined to participate in the study due to various reasons and @ were later excluded ( no meniscus lesion on the magnetic resonance imaging scan or withdrawn consent ) .


A total of @ patients were finally included in the RCT .


To include one patient into the RCT , @ individuals needed to be screened .


A total of @ % of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research ( @ % ) .


Patients are willing to participate in an orthopedic placebo-controlled surgical trial .


Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment .


The aim of the study was to determine whether low-level laser therapy ( LLLT ) has an analgesic effect in patients with recurrent aphthous stomatitis ( RAS ) .


A randomized single-blinded placebo-controlled trial was conducted with LLLT ( wavelength , @ nm ; power , @ mW ; pulse frequency , @ Hz ; duration , @ seconds per treatment ; dose , @ J/cm ( @ ) ) in @ patients with RAS .


The intervention group was treated with LLLT on @ occasions , with a @-day interval .


The control group was treated similarly , without any laser power .


Pain perception ( visual analog scale -LSB- VAS -RSB- rating ) and patients ' experience of eating , drinking , and brushing teeth was registered .


VAS rating decreased ( day @ until day @ ) from @ to @ ( LLLT ) and from @ to @ ( placebo ) ( P < @ ) .


LLLT also relieved the difficulty of drinking , eating , and brushing teeth .


LLLT reduced the pain and the inconvenience of eating , drinking , and brushing teeth for patients with RAS , compared with placebo .


Children in care often have poor outcomes .


There is a lack of evaluative research into intervention options .


To examine the efficacy of Multidimensional Treatment Foster Care for Adolescents ( MTFC-A ) compared with usual care for young people at risk in foster care in England .


A two-arm single ( assessor ) blinded randomised controlled trial ( RCT ) embedded within an observational quasi-experimental case-control study involving @ young people aged @-@ years ( trial registration : ISRCTN @ ) .


The primary outcome was the Child Global Assessment Scale ( CGAS ) .


Secondary outcomes were ratings of educational attendance , achievement and rate of offending .


The MTFC-A group showed a non-significant improvement in CGAS outcome in both the randomised cohort ( n = @ , adjusted mean difference @ , @ % CI -@ to @ , P = @ ) and in the trimmed observational cohort ( n = @ , adjusted mean difference @ , @ % CI -@ to @ , P = @ ) .


No significant effects were seen in secondary outcomes .


There was a possible differential effect of the intervention according to antisocial behaviour .


There was no evidence that the use of MTFC-A resulted in better outcomes than usual care .


The intervention may be more beneficial for young people with antisocial behaviour but less beneficial than usual treatment for those without .


To study the mutual pharmacokinetic interactions between macitentan , an endothelin receptor antagonist , and sildenafil in healthy male subjects .


In this open-label , randomized , three way crossover study , @ healthy male subjects received the following oral treatments : A ) a loading dose of @mg macitentan on day @ followed by @mg once daily for @ days , B ) sildenafil @mg three times a day for @ days and a single @mg dose on day @ and C ) both treatments A and B concomitantly .


Plasma concentration-time profiles of macitentan and its active metabolite ACT-@ ( treatments A and C ) and sildenafil and its N-desmethyl metabolite ( treatments B and C ) were determined on day @ and analyzed non-compartmentally .


The pharmacokinetics of macitentan were not affected by sildenafil .


In the presence of sildenafil Cmax and AUC of the metabolite ACT-@ decreased with geometric mean ratios ( @ % confidence interval ( CI ) ) of @ ( @ , @ ) and @ ( @ % CI @ , @ ) , respectively .


In the presence of macitentan , plasma concentrations of sildenafil were higher than during treatment with sildenafil alone , resulting in increased Cmax and AUC values .


The respective geometric mean ratios were @ ( @ % CI @ , @ ) and @ ( @ % CI @ , @ ) .


The pharmacokinetics of N-desmethylsildenafil were not affected by macitentan .


All treatments were well tolerated .


A minor , not clinically relevant , pharmacokinetic interaction was observed between macitentan and sildenafil .


Based on these results , no dose adjustment of either compound appears necessary during concomitant treatment with macitentan and sildenafil .


To compare clinical effects of spinal leveraging manipulation and medicine for the treatment of degenerative scoliosis in pain and function .


From July @ to June @ , @ patients with degenerative scoliosis were randomly divided into spinal leveraging manipulation group and medicine group by coin tossing .


In manipulation group , there were @ males and @ females aged from @ to @ years old with an average of ( @ ) , the courses of diseases ranged from @ to @ months with an average of ( @ ) , spinal leveraging manipulation ( following meridian to straighten tendon , relieving spasm , osteopathy and massage , clearing and activating the channels and collaterals ) were performed for @ min , once a day , @ days for a period treatment , totally @ courses .


In medicine group , there were @ males and @ females aged from @ to @ years old with an average of ( @ ) the courses of diseases ranged from @ to @ months with an average of ( @ ) , celecoxib with eperisone hydrochloride were orally taken , @ days for a period treatment , totally @ courses .


VAS score , Cobb angle and ODI score were measured .


After treatment , VAS score in manipulation group was ( @ ) , ( @ ) in medicine group , and had significant meaning ( t = @ , P < @ ) ; there was significant differences in Cobb angle between manipulation group ( @ ) and medicine group ( @ ) ( t = @ , P < @ ) ; and had obviously meaning in ODI score between manipulation group ( @ ) and medicine group ( @ ) ( t = @ , P < @ ) .


Spinal leveraging manipulation for degenerative scoliosis could regulate muscle balance on both side of spine , correct coronal imbalances in spine , recover normal sequence of spine , reduce and remove opperssion and stimulation of nerve root , relieve pain in leg and waist and further improve quality of life .


To evaluate the efficacy ofprobiotics , Lactobacillus casei ( Shirvta strain ) , in reducing the incidence ofventilator - associated pneumonia ( VAP ) in medical patients who received mechanical ventilation at Siriraj Hospital .


A prospective , randomized , open-label controlled trial was conducted in @ adult hospitalized patients in medical wards who were expected to receive mechanical ventilation for @ hours or longer : The patients were randomized to the probiotics group or the control group .


All patients received regular care for mechanical ventilation .


The patients in the probiotics group received @ ml of Lactobacillus casei ( Shirota strain ) for oral care after having standard oral care once daily and additional @ ml of the aforementionedfermented dairy product was given via enteralfeeding once daily .


The primary outcomes were incidence of VAP and incidence rate of VAP episodes per @,@ ventilator-days .


The secondary outcomes were length ofhospital stay , mortality at day @ and @ , incidence ofdiarrhea , andpresence of resistant bacteria in oropharyngeal and rectal swab samples taken from the patients at baseline , day @ and day @ after enrollment .


The baseline characteristics of the patients in the probiotics group ( @ ) and the control group ( @ ) were not significantly different .


The patients in the probiotics group were less likely to develop VAP compared with the control group ( @ % vs. @ % , p = @ ) , respectively .


The incidence rates of VAP in the probiotics and control groups were @ and @ episodes per @,@ ventilator-days , respectively ( p = @ ) .


A trend of lower prevalence of some resistant bacteria cultured from oropharyngeal swabs in the probiotics group than that in the control group was observed .


Overall @ - and @-day mortality and length of hospital stay of the patients in both groups were not significantly different .


Administration of probiotics containing Lactobacillus casei ( Shirota strain ) has a tendency to reduce the incidence of VAP and colonization with resistant bacteria in oropharyngeal cavity without significant effects on mortality and length of hospital stay .


Angiogenesis is crucial for glioblastoma growth , and anti-vascular endothelial growth factor agents are widely used in recurrent glioblastoma patients .


The number of circulating endothelial cells ( CECs ) is a surrogate marker for endothelial damage .


We assessed their kinetics and explored their prognostic value in patients with recurrent glioblastoma .


In this side study of the BELOB trial , @ patients with recurrent glioblastoma were randomised to receive single-agent bevacizumab or lomustine , or bevacizumab plus lomustine .


Before treatment , after @ weeks and after @ weeks of treatment , CECs were enumerated .


The number of CECs increased during treatment with bevacizumab plus lomustine , but not during treatment in the single-agent arms .


In patients treated with lomustine single agent , higher absolute CEC numbers after @ weeks ( logCEC hazard ratio ( HR ) @ , @ % CI @-@ @ ) and @ weeks ( logCEC HR @ , @ % CI @-@ @ ) of treatment were associated with improved overall survival ( OS ) .


Absolute CEC numbers in patients receiving bevacizumab plus lomustine or bevacizumab single agent were not associated with OS .


CEC numbers increased during treatment with bevacizumab plus lomustine but not during treatment with either agent alone , suggesting that this combination induced the greatest vascular damage .


Although the absolute number of CECs was not associated with OS in patients treated with bevacizumab either alone or in combination , they could serve as a marker in glioblastoma patients receiving lomustine single agent .


Patients with traumatic knee complaints regularly consult their general practitioner ( GP ) .


MRI might be a valuable diagnostic tool to assist GPs in making appropriate treatment decisions and reducing costs .


Therefore , this study will assess the cost-effectiveness of referral to MRI by GPs compared with usual care , in patients with persistent traumatic knee complaints .


This is a multi-centre , open-labelled randomised controlled non-inferiority trial in combination with a concurrent observational cohort study .


Eligible patients ( aged @-@ years ) have knee complaints due to trauma ( or sudden onset ) occurring in the preceding @ months and consulting their GP .


Participants are randomised to : @ ) an MRI group , i.e. GP referral to MRI , or @ ) a usual care group , i.e. no MRI .


Primary outcomes are knee-related daily function , medical costs ( healthcare use and productivity loss ) , and quality of life .


Secondary outcomes are disability due to knee complaints , severity of knee pain , and patients ' perceived recovery and satisfaction .


Outcomes are measured at baseline and at @ , @ , @ , @ and @ months follow-up .


Also collected are data on patient demographics , GPs ' initial working diagnosis , GPs ' preferred management at baseline , and MRI findings .


In the Netherlands , the additional diagnostic value and cost-effectiveness of direct access to knee MRI for patients presenting with traumatic knee complaints in general practice is unknown .


Although GPs increasingly refer patients to MRI , the Dutch clinical guideline ` Traumatic knee complaints ' for GPs does not recommend referral to MRI , mainly because the cost-effectiveness is still unknown .


Cervical spondylotic myelopathy ( CSM ) is the most common cause of spinal cord dysfunction in the world .


There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM .


To determine whether ventral surgery is associated with superior Short Form-@ Physical Component Summary outcome at the @-year follow-up compared with dorsal ( laminectomy/fusion or laminoplasty ) surgery for the treatment of CSM , to investigate whether postoperative sagittal balance is an independent predictor of overall outcome , and to compare health resource use for ventral and dorsal procedures .


The study is a randomized , controlled trial with a nonrandomized arm for patients who are eligible but decline randomization .


Two hundred fifty patients ( @ randomized ) with CSM from @ sites will be recruited over @ months .


The primary outcome is the Short Form-@ Physical Component Summary score .


Secondary outcomes include disease-specific outcomes , overall health-related quality of life ( EuroQOL @-dimension questionnaire ) , and health resource use .


This will be the first randomized , controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM .


A National Institutes of Health-funded ( @R@AR@-@ ) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol .


Study investigators , coordinators , and major stakeholders were able to attend and discuss strengths of , limitations of , and concerns about the study .


The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute ( CE-@-@ ) .


The trial began enrollment on April @ , @ .


Silicone excipients are commonly used ingredients because of their emollient and skin-conditioning effects , and their ability to form uniform , water-resistant , yet permeable films .


Based on comparisons with organic materials and conflicting knowledge from silicones used in scar treatment , the misconception still exists that silicone topical excipients are occlusive substances that may block the passive loss of water through the upper skin layers .


Therefore , @ types of common silicone excipients and @ water-in - ( oil-plus-silicone ) or W / ( O + Si ) creams , containing @ % ( w/w ) of the respective silicones , were investigated as a function of time and compared to petrolatum .


Transepidermal water loss ( TEWL ) and skin hydration measurements were carried out after a single topical application on forearm skin of @ healthy young female volunteers .


Both petrolatum and silicones significantly decreased TEWL @ min after application , but the measurements for the silicones were not significantly different from the untreated control values .


The tested silicones did not moisturize the skin .


Petrolatum formed an occlusive layer , creating an increase in skin hydration for more than @ h.


The results measured for the W / ( O + Si ) creams indicated that they moisturized the skin , without any effect on TEWL .


A clear difference was shown between the skin occlusive properties of petrolatum and the water vapor permeability of the common silicone excipient materials .


The aim of this study is to evaluate the effectiveness of life review ( LR ) based on specific positive events in non-depressed older adults taking part in an active aging program .


Fifty-five older adults were randomly assigned to an experimental group or an active control ( AC ) group .


A six-session individual training of LR based on specific positive events was carried out with the experimental group .


The AC group undertook a `` media workshop '' of six sessions focused on learning journalistic techniques .


Pre-test and post-test measures included life satisfaction , depressive symptoms , experiencing the environment as rewarding , and autobiographical memory ( AM ) scales .


LR intervention decreased depressive symptomatology , improved life satisfaction , and increased specific memories .


The findings suggest that practice in AM for specific events is an effective component of LR that could be a useful tool in enhancing emotional well-being in active aging programs , thus reducing depressive symptoms .


Although colonoscopy is the accepted standard for detection of colorectal adenomas and cancers , many adenomas and some cancers are missed .


To avoid interval colorectal cancer , the adenoma miss rate of colonoscopy needs to be reduced by improvement of colonoscopy technique and imaging capability .


We aimed to compare the adenoma miss rates of full-spectrum endoscopy colonoscopy with those of standard forward-viewing colonoscopy .


We did an international , multicentre , randomised trial at three sites in Israel , one site in the Netherlands , and two sites in the USA between Feb @ , @ , and March @ , @ .


Patients aged @-@ years referred for colorectal cancer screening , polyp surveillance , or diagnostic assessment underwent same-day , back-to-back tandem colonoscopy with standard forward-viewing colonoscope and the full-spectrum endoscopy colonoscope .


The patients were randomly assigned ( @:@ ) , via computer-generated randomisation with block size of @ , to which procedure was done first .


The endoscopist was masked to group allocation until immediately before the start of colonoscopy examinations ; patients were not masked .


The primary endpoint was adenoma miss rates .


We did per-protocol analyses .


This trial is registered with ClinicalTrials.gov , number NCT@ .


@ participants were enrolled .


@ participants were included in the per-protocol analyses : @ ( @ % ) were randomly assigned to receive standard forward-viewing colonoscopy first , and @ ( @ % ) to receive full-spectrum endoscopy colonoscopy first .


By per-lesion analysis , the adenoma miss rate was significantly lower in patients in the full-spectrum endoscopy group than in those in the standard forward-viewing procedure group : five ( @ % ) of @ vs @ ( @ % ) of @ adenomas were missed ( p < @ ) .


Standard forward-viewing colonoscopy missed @ adenomas in @ patients ; of those , three ( @ % ) were advanced adenomas .


Full-spectrum endoscopy missed five adenomas in five patients in whom an adenoma had already been detected with first-pass standard forward-viewing colonoscopy ; none of these missed adenomas were advanced .


One patient was admitted to hospital for colitis detected at colonoscopy , whereas five minor adverse events were reported including vomiting , diarrhoea , cystitis , gastroenteritis , and bleeding .


Full-spectrum endoscopy represents a technology advancement for colonoscopy and could improve the efficacy of colorectal cancer screening and surveillance .


Patients with previous coronary artery bypass grafting ( CABG ) who underwent percutaneous coronary intervention ( PCI ) have an increased repeat revascularization rate , but data on contemporary second-generation drug-eluting stents ( DES ) are scarce .


We evaluated @-year clinical outcome following secondary revascularization by PCI in patients of the TWENTE trial and non-enrolled TWENTE registry , and compared patients with previous CABG versus patients without previous CABG .


Of all @ consecutive patients , @ ( @ % ) had previously undergone CABG ( on average @ years ago ) .


CABG patients were older ( @ years vs. @ years , P < @ ) and more often had diabetes ( @ % vs. @ % , P = @ ) and previous PCI ( @ % vs. @ % , P < @ ) compared to patients without previous CABG .


Nevertheless , a higher target vessel revascularization ( TVR ) rate following PCI in the CABG patients ( @ % vs. @ % , P < @ ) was the only significant difference in clinical outcome at @-year follow-up ( available for @ % ) .


Among CABG patients , the TVR rate was significantly higher in patients treated for graft lesions ( n = @ ; @ % in vein grafts ) than in patients treated for native coronary lesions only ( n = @ ) ( @ % vs. @ % , P = @ ) .


Among @ patients with PCI of native coronary lesions only , there was only a non-significant difference in TVR between patients with previous CABG versus patients without previous CABG ( @ % vs. @ % , P = @ ) .


Patients with previous CABG showed a favorable safety profile after PCI with second-generation DES .


Nevertheless , their TVR rate was still much higher , driven by more repeat revascularizations after PCI of degenerated vein grafts .


In native coronary lesions , there was no such difference .


The aim of this study was to compare endothelial cell loss and graft success @ months after endothelial keratoplasty ( EK ) with paired donor corneas stored in Optisol GS and Life@C solutions and their associated storage chambers .


Donor pairs were stored , one in Optisol GS and the other in Life@C , and prepared for Descemet stripping automated EK or Descemet membrane EK .


Matched pairs of recipients with Fuchs dystrophy were randomized to @ member of each donor pair .


Clarity of recipient stroma , intraocular pressure , and complications were followed for @ months .


Central endothelial images of the donor cornea at screening and @ and @ months after EK were analyzed by a masked central reading center .


Dual grading of endothelial cell density was performed using the center method .


Differences in endothelial cell density and cell loss were examined by paired analysis .


Thirty-two pairs were enrolled , and @ were analyzed ( @ had improper matching or loss to follow-up ) .


Donor age was @ @ years , median death-to-surgery time was @ days ( range , @-@ days ) , @ recipient pairs had Descemet membrane EK , and @ had Descemet stripping automated EK .


Recipient age was comparable in the Optisol GS and Life@C groups ( @ vs. @ years , respectively , P = @ ) .


Six-month central endothelial cell loss did not differ significantly between the Life@C and Optisol GS groups ( @ @ % vs. @ @ % , respectively , P = @ ) .


All recipient corneas were clear at @ months in both groups .


Endothelial cell loss and graft success were comparable at @ months for paired donor corneas stored in Optisol GS and Life@C.Clinical Trial Registration-URL : http://www.clinicaltrials.gov .


Unique identifier : NCT@ .


To evaluate the process of implementation of a social and physical environmental intervention and to explore differences regarding this process between both interventions .


Context , recruitment , dose delivered , fidelity , reach , dose received , satisfaction , and implementation barriers were investigated .