Future research should address the role of the group coach .


To examine the relationship between performance on executive function measures and subsequent mobility outcomes in community-dwelling older adults .


Randomized controlled clinical trial .


Champaign-Urbana , Illinois .


Community-dwelling older adults ( N = 179 ; mean age 66.4 ) .


A 12-month exercise trial with two arms : an aerobic exercise group and a stretching and strengthening group .


Established cognitive tests of executive function ( flanker task , task switching , and a dual-task paradigm ) and the Wisconsin card sort test .


Mobility was assessed using the timed 8-foot up and go test and times to climb up and down a flight of stairs .


Participants completed the cognitive tests at baseline and the mobility measures at baseline and after 12 months of the intervention .


Multiple regression analyses were conducted to determine whether baseline executive function predicted postintervention functional performance after controlling for age , sex , education , cardiorespiratory fitness , and baseline mobility levels .


Selective baseline executive function measurements , particularly performance on the flanker task ( = 0.15-0 .17 ) and the Wisconsin card sort test ( = 0.11-0 .16 ) consistently predicted mobility outcomes at 12 months .


The estimates were in the expected direction , such that better baseline performance on the executive function measures predicted better performance on the timed mobility tests independent of intervention .


Executive functions of inhibitory control , mental set shifting , and attentional flexibility were predictive of functional mobility .


Given the literature associating mobility limitations with disability , morbidity , and mortality , these results are important for understanding the antecedents to poor mobility function that well-designed interventions to improve cognitive performance can attenuate .


Despite the growing penetration of the Internet , little is known about the usage and browsing patterns of those in poverty .


We report on a randomized controlled trial that sheds light on the Internet use and browsing patterns among the urban poor .


The data come from 312 participants in Boston , Massachusetts , from Click to Connect , a study that examined the impact of an intervention that provided computers , Internet , and training to people from lower socioeconomic position ( SEP ) .


Data were gathered through pre - and posttest surveys and Internet use tracking software that generated approximately 13 million network activity files and more than 5.5 million records .


Internet use increased among intervention participants , with most of their time spent on social and participatory media sites or Internet portals .


Differential patterns of use by gender and race/ethnicity were observed .


Purposive searching for health information was low among all participants .


Most of the visits to health-related sites were to local hospitals ' sites suggesting the influence of possible preexisting relationships and trust .


Social networking sites were frequently visited , with three sites enjoying similar popularity among all groups .


Our data show that the availability of Internet can lead to significant increase in its use among low SEP groups .


Low SEP members used the Internet for participation and engagement , but the sites visited differed by group .


Harnessing the power of social networking sites and shareware sites may be a way to increase access to health information .


The role of human chorionic gonadotropin ( hCG ) supplementation on the intrafollicular steroid milieu has been studied .


The objective of the study was to assess the impact on steroid levels in follicular fluids ( FFs ) after different doses of hCG supplementation to recombinant FSH for controlled ovarian stimulation .


This was a prospective randomized dose-response study conducted at Copenhagen University Hospital , Rigshospitalet , Denmark .


From 62 in vitro fertilization patients , 334 FFs were selected for analyses .


Patients were treated using a GnRH agonist protocol with recombinant FSH 150 IU/d and randomized from stimulation day 1 to supplementation with hCG : D0 , 0 IU/d ; D50 , 50 IU/d ; D100 , 100 IU/d ; and D150 , 150 IU/d .


Intrafollicular hormone concentrations in relation to treatment groups , follicular sizes , and embryo quality were measured .


In large follicles , hCG supplementation induced a nearly 3-fold increase of estradiol ( nanomoles per liter ) [ D0 : 1496 ; D50 : 3138 ; D100 : 4338 ; D150 : 4009 ( P < .001 ) ] , a significant 3-fold increase of androstenedione , and a 5-fold increase of T ( nanomoles per liter ) [ D0 : 15 ; D50 : 38 ; D100 : 72 ; D150 : 56 ( P < .001 ) ] .


The estradiol to T ratio decreased significantly , with the lowest ratio in D100 and the highest in D0 .


Large follicles giving rise to good-quality embryos had significantly higher estradiol and progesterone levels and estradiol to T , estradiol to androstenedione , and progesterone to estradiol ratios , compared with small follicles , leading to poor-quality embryos .


Increasing doses of hCG supplementation markedly stimulated the intrafollicular concentration of both estradiol and androgens , with a shift toward a more androgenic milieu .


In large follicles with oocytes giving rise to good-quality embryos , the FFs were significantly more estrogenic than in small follicles with oocytes developing into poor quality embryos .


The aim of this study was to describe dose regimens , dose escalation and clinical outcomes in TNF - inhibitor ( TNFi ) - naive patients with PsA treated with infliximab in routine rheumatology care .


We conducted an observational cohort study based on the nationwide Danish Rheumatologic Database ( DANBIO ) and Center for Rheumatology Research ( ICEBIO ) registries .


Stratified by country , characteristics of patients treated with 3 mg infliximab/kg body weight , 3-5 mg/kg or 5 mg/kg every 8 weeks were described .


Outcomes were evaluated by ACR 20 % , 50 % and 70 % ( ACR20/50/70 ) responses and European League Against Rheumatism good response after 6 months , disease activity after 12 months , Kaplan-Meier plots and regression analyses .


Four hundred and sixty-two patients ( 376 Danish , 86 Icelandic ) received treatment with infliximab .


In Danish patients , the starting dose was 3 mg/kg in 110 patients ( 29 % ) , 3-5 mg/kg in 157 ( 42 % ) , 5 mg/kg in 38 ( 10 % ) and unregistered in 71 ( 19 % ) .


In Icelandic patients , corresponding numbers were 64 ( 74 % ) , 17 ( 27 % ) , 0 ( 0 % ) and 5 ( 6 % ) .


Patients with a higher body weight received lower doses per kilogram .


Danish patients received higher doses than Icelandic patients at baseline [ median 3.1 ( interquartile range 3.0-3 .8 ) vs 2.3 ( 2.1-2 .9 ) mg/kg , P < 0.05 ] and after 12 months [ 3.3 ( 3.0-4 .5 ) vs 2.9 ( 2.2-3 .5 ) mg/kg , P < 0.0001 ] .


After 12 months , 58 % of Danish and 66 % of Icelandic patients maintained treatment .


Danish patients had shorter drug survival than Icelandic patients ( 1183 vs 483 days ) .


In univariate analyses stratified by country , time until dose escalation , response rates , drug survival and 1-year 's disease activity were independent of starting dose .


Drug survival was shorter among patients not receiving concomitant MTX .


In clinical practice , > 70 % of Icelandic and Danish PsA patients treated with infliximab received sustained doses below the 5 mg/kg every 8 weeks recommended in international guidelines .


Lower starting doses did not affect drug survival or response .


Many studies comparing different intravenous fluid types usually do not use equipotent volumes of 3:1 crystalloid : colloid ratio in such comparisons .


Conflicting results emanate from such studies .


This study was designed to compare the efficacy of equipotent volumes of crystalloid , colloid and combination of crystalloid/colloid in spinal anaesthesia-induced hypotension prophylaxis .


Pregnant women scheduled for elective Caesarean section were prospectively randomized to three groups to each received either 1 500 ml of Ringers lactate , or 500 ml of 6 % pentastarch or a combination of 250 ml of 6 % pentastarch and 750 ml of Ringers lactate intravenous fluid preload , before spinal anaesthesia .


Hemodynamic variables were monitored .


First 10 minutes , crystalloid showed better efficacy in hypotension prophylaxis over the other regimen .


In the next 30 minutes however , there were no significant differences between the groups .


Crystalloids proved more effective than colloid or their combination in hypotension prophylaxis in the first 10 minutes after spinal anaesthesia .


Current U.S. guidelines suggest that pregnant women should exercise regularly during pregnancy , and we examined the neurodevelopment of the children whose mothers had taken that advice .


This Norwegian study included 188 children whose mothers had followed a structured exercise protocol and 148 control children whose mothers had not .


Their cognitive , language and motor skills were assessed at 18 months of age by the Bayley Scales of Infant Development-III and daily life functioning with the Ages and Stages Questionnaire .


No significant differences were found between the two groups .


Subgroup analyses revealed that the children whose mothers had exercised had a slightly lower motor composite score ( mean : 97.6 , 95 % CI : 96.0-99 .2 ) than the control group ( mean : 100.0 , 95 % CI : 98.6-101 .5 ) ( p = 0.03 ) .


Boys in the intervention group had lower fine motor scores ( mean : 10.6 , 95 % CI : 10.3-11 .0 ) than boys in the control group ( mean : 11.5 , 95 % CI : 11.0-11 .9 ) ( p = 0.01 ) .


Our main finding was that regular moderate exercise during pregnancy does not adversely affect neurodevelopment in children .


The lower motor scores in the subgroup analyses are probably clinically insignificant , but the lower fine motor scores for boys in the intervention group warrant further research .


Intimate Partner Violence ( IPV ) is prevalent among recent mothers and negatively impacts their physical and emotional health .


Furthermore , the negative influence of IPV on parenting capacity and children 's development is well described .


However , it is unclear whether there is any relationship between IPV and method of infant feeding .


Little is known about how women who are subjected to IPV make decisions about infant feeding or whether living in this context impacts on their experience of breastfeeding .


With what is known about the importance of breastfeeding , particularly for vulnerable populations , research is essential to inform clinical practice and to develop appropriate community support strategies .


This paper describes an analysis of data from a pragmatic cluster randomised controlled trial : Improving maternal and child health nurse care for vulnerable mothers ( MOVE ) .


The MOVE trial was conducted in the north-western suburbs of Melbourne , Australia from April 2010-April 2011 and involved 80 maternal and child health centres , 160 nurses and 2621 women who completed a survey .


Intimate partner violence was measured using the Composite Abuse Scale .


Ninety-six per cent ( n = 2111 ) of participating women initiated breastfeeding , with 80 % ( n = 1776 ) and 74 % ( n = 1537 ) indicating ` any ' breastfeeding at 3 and 6 months respectively .


Respondents tended to be older , well-educated with a household income > $ 70,000 per annum compared to the general population .


The characteristics of women from the IPV and non-IPV groups were similar and together were comparable to all women who gave birth in north-west Melbourne .


The reported prevalence of IPV in this survey was 6.3 % ( n = 138 ) , which may be an underestimate .


Breastfeeding rates did not significantly differ between IPV and non-IPV groups .


Our findings suggest that women who experience IPV are just as likely to breastfeed as the broader population of women .


While this analysis provide 's a snapshot of breastfeeding rates for this group of women , it does not capture women 's experience of IPV as it relates to feeding a baby .


In order to better identify infant feeding in the context of IPV , qualitative research is also necessary to investigate in a way that fully engages victims/survivors , giving them the opportunity to give voice to their experiences .


To evaluate efficacy and safety of intravitreal aflibercept injection ( IAI ) in subjects who were previously treated with ranibizumab and/or bevacizumab for active exudative age-related macular degeneration ( AMD ) .


Patients ( n = 26 ) were enrolled in a 12-month prospective , interventional , single arm , investigator-initiated study with planned 6-month interim analysis .


Patients with active exudative AMD , previously treated with ranibizumab and/or bevacizumab , were treated with 2mg IAI every month for the first 3months , followed by a fixed dosing schedule of 2mg IAI every 2months .


The primary study endpoint was the mean absolute change from baseline central subfield thickness ( CST ) at month 12 as measured by SDOCT .


Secondary outcomes included mean change from baseline best-corrected visual acuity ( BCVA ) score , percentage of subjects who gained or lost greater than or equal to 15 letters of vision , percentage of subjects who are 20/40 or better , percentage of subjects who are 20/200 or worse , and the incidence of adverse events ( AE ) and serious AEs .


Planned 6-month interim analysis demonstrated a mean decrease in CST of 38.6 m ( p < 0.001 ) and a mean increase in ETDRS BCVA of +5.9 letters ( p < 0.001 ) .


Fifteen percent of subjects experienced a greater than 15-letter improvement in visual acuity , 84.6 % of patients gained visual acuity , and no patient lost 3 lines of vision from baseline .


Forty-two percent of subjects were 20/40 or better , and 11.5 % of subjects were 20/200 or worse at month 6 .


No serious ocular or systemic AEs were encountered .


IAI-treated eyes demonstrated improved short-term functional and anatomic endpoints in subjects with active exudative AMD switching from previous anti-VEGF treatment when given in a fixed dosing scheme for 6months .


NCT01617148 .


In the immediate postoperative period surgical breast cancer patients can face many problems including functional limitation of the shoulder , edema , pain and depression .


Although those symptoms can alleviate during the stages of the therapeutic route , most of the time concur significantly to the everyday life discomforts decreasing sharply the quality of life .


Therefore , is essential to pay attention to the functional problems of breast cancer patients in order to ensure a quick and complete physical and psychosocial recovery .


Aim of this study , comparing 2 groups of patients , one that underwent to early physical rehabilitation program ( EPRP ) and one as a control group , is to evaluate : functional improvements of the glenohumeral joint mobility , antalgic effect of EPRP , improvements and/or worsening of quality of life .


Randomized controlled study .


Inpatient and outpatient clinic , Breast Unit , `` San Giuseppe Moscati '' Hospital , Avellino , Italy .


Seventy women planned for Madden 's modified radical mastectomy or for segmental mastectomy with axillary dissection in the period from March 2010 to February 2011 .


Patients were randomly assigned to treated and control group .


All participants were evaluated before surgery and postoperatively at fifth day , first , sixth and twelfth month .


Patients of the treated group , underwent first , to assisted cautious mobilization of hand , wrist and elbow and after drainage removal , to twenty physiotherapy sessions under the guide of a physiotherapist .


Within group statistical analysis evidenced that TG regained normal function at 1 year after surgery while CG was unable to do so for flexion , abduction and internal rotation movements .


TG manifested general and statistically significative improvements in QoL .


Improvements in the grade of pain perceived were observed starting from the first postoperative month .


Postoperative early physical rehabilitation programme in surgical breast cancer patients surgically treated significantly improves glenohumeral joint mobility , reduces pain and widely improves the quality of life .


Early rehabilitation plays a key role in the physical and psycho-social recovery for breast cancer patients surgically treated with axillary dissection .


To evaluate the effect of sibutramine on weight loss in obese adolescents .


A double-blind controlled study lasting 13 months .


The study included 73 obese adolescents of both sexes aged between 10 and 18 years .


Laboratory tests and imaging studies were performed before , during wash-out , and at the end of 13 months .


The percentage of patients who lost 10 % of their initial weight in the placebo group was 46 % , and in the sibutramine group was 75 % .


When placebo was used , average weight rose by 1.61 kg , and BMI decreased by 0.24 kg/m ( 2 ) whereas with the use of sibutramine , weight decreased by 4.47 kg , and average BMI decreased , 2.38 kg/m ( 2 ) , with p < 0.001 .


Sibutramine induced significantly more weight loss in obese adolescents compared with placebo , without significant side effects .


The weight loss curve was different depending on the moment sibutramine was introduced .


This finding indicates that the best time to start sibutramine is when adhesion begins to fail .


To determine if recommending strict rest improved concussion recovery and outcome after discharge from the pediatric emergency department ( ED ) .


Patients aged 11 to 22 years presenting to a pediatric ED within 24 hours of concussion were recruited .


Participants underwent neurocognitive , balance , and symptom assessment in the ED and were randomized to strict rest for 5 days versus usual care ( 1-2 days rest , followed by stepwise return to activity ) .


Patients completed a diary used to record physical and mental activity level , calculate energy exertion , and record daily postconcussive symptoms .


Neurocognitive and balance assessments were performed at 3 and 10 days postinjury .


Sample size calculations were powered to detect clinically meaningful differences in postconcussive symptom , neurocognitive , and balance scores between treatment groups .


Linear mixed modeling was used to detect contributions of group assignment to individual recovery trajectory .


Ninety-nine patients were enrolled ; 88 completed all study procedures ( 45 intervention , 43 control ) .


Postdischarge , both groups reported a 20 % decrease in energy exertion and physical activity levels .


As expected , the intervention group reported less school and after-school attendance for days 2 to 5 postconcussion ( 3.8 vs 6.7 hours total , P < .05 ) .


There was no clinically significant difference in neurocognitive or balance outcomes .


However , the intervention group reported more daily postconcussive symptoms ( total symptom score over 10 days , 187.9 vs 131.9 , P < .03 ) and slower symptom resolution .


Recommending strict rest for adolescents immediately after concussion offered no added benefit over the usual care .


Adolescents ' symptom reporting was influenced by recommending strict rest .


Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials .


This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in `` real world '' chronic hepatitis C patients in Italy .


Independent observational multicentre study including consecutive patients receiving Peg-interferon/ribavirin in the 18 months before ( retrospective phase ) and after ( prospective phase ) the start of the study .


4176 patients were eligible .


The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase .


Sustained virological response was achieved by 1036 patients ( 50.5 % ) during the retrospective phase : 325 were genotypes 1/4 ( 34.1 % ) and 684 were genotypes 2/3 ( 67.2 % ) and by 800 patients ( 38.6 % ) during the prospective phase : 300 were genotypes 1/4 ( 28.4 % ) and 473 were genotypes 2/3 ( 51.5 % ) .


During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates ; cirrhosis and - glutamil-transpeptidase > 2 times the normal limit were associated with poorer response .


The response to Peg-interferon/ribavirin therapy in `` real world '' clinical practice is distinctly lower than in registration trials .


The difference in response rates was more pronounced among easy-to-treat than among difficult-to-treat hepatitis C virus genotypes .


Alzheimer 's disease is characterized by amyloid-beta plaques , neurofibrillary tangles , gliosis , and neuronal loss .


Solanezumab , a humanized monoclonal antibody , preferentially binds soluble forms of amyloid and in preclinical studies promoted its clearance from the brain .


In two phase 3 , double-blind trials ( EXPEDITION 1 and EXPEDITION 2 ) , we randomly assigned 1012 and 1040 patients , respectively , with mild-to-moderate Alzheimer 's disease to receive placebo or solanezumab ( administered intravenously at a dose of 400 mg ) every 4 weeks for 18 months .


The primary outcomes were the changes from baseline to week 80 in scores on the 11-item cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-cog11 ; range , 0 to 70 , with higher scores indicating greater cognitive impairment ) and the Alzheimer 's Disease Cooperative Study-Activities of Daily Living scale ( ADCS-ADL ; range , 0 to 78 , with lower scores indicating worse functioning ) .


After analysis of data from EXPEDITION 1 , the primary outcome for EXPEDITION 2 was revised to the change in scores on the 14-item cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-cog14 ; range , 0 to 90 , with higher scores indicating greater impairment ) , in patients with mild Alzheimer 's disease .


Neither study showed significant improvement in the primary outcomes .


The modeled difference between groups ( solanezumab group minus placebo group ) in the change from baseline was -0.8 points for the ADAS-cog11 score ( 95 % confidence interval [ CI ] , -2.1 to 0.5 ; P = 0.24 ) and -0.4 points for the ADCS-ADL score ( 95 % CI , -2.3 to 1.4 ; P = 0.64 ) in EXPEDITION 1 and -1.3 points ( 95 % CI , -2.5 to 0.3 ; P = 0.06 ) and 1.6 points ( 95 % CI , -0.2 to 3.3 ; P = 0.08 ) , respectively , in EXPEDITION 2 .


Between-group differences in the changes in the ADAS-cog14 score were -1.7 points in patients with mild Alzheimer 's disease ( 95 % CI , -3.5 to 0.1 ; P = 0.06 ) and -1.5 in patients with moderate Alzheimer 's disease ( 95 % CI , -4.1 to 1.1 ; P = 0.26 ) .


In the combined safety data set , the incidence of amyloid-related imaging abnormalities with edema or hemorrhage was 0.9 % with solanezumab and 0.4 % with placebo for edema ( P = 0.27 ) and 4.9 % and 5.6 % , respectively , for hemorrhage ( P = 0.49 ) .


Solanezumab , a humanized monoclonal antibody that binds amyloid , failed to improve cognition or functional ability .


( Funded by Eli Lilly ; EXPEDITION 1 and 2 ClinicalTrials.gov numbers , NCT00905372 and NCT00904683 . )


To explore the effect of caffeine on voice , as evidenced by acoustic and aerodynamic measures , based on the fact that caffeine is considered to be a systemic dehydrating agent .


The participants in this investigation were 58 females ranging in age from 18 to 35 years , who self-reported normal vocal production .


The participants abstained from caffeine ingestion for 24 hours and from ingesting foods and liquids for 12 hours prior to the test .


They were randomly assigned to one of two groups , control and experimental , and were individually tested .


After the preliminary phase , participants in the experimental group ingested a 100 mg caffeine tablet ; participants in the control group ingested placebo , and followed the same protocol as the experimental group .


All participants were retested 30 minutes after ingesting caffeine or placebo .


Differences were not identified in any of the acoustic or aerodynamic measures across both groups .


These results suggest that a conservative ( 100 mg ) dosage of caffeine may not have an impact on vocal acoustics and aerodynamics .


To evaluate the efficacy and safety of carbamazepine , pregabalin , and venlafaxine in patients with painful diabetic neuropathy ( PDN ) .


Our study was performed as a randomized , double-blind , parallel-group clinical trial between December 2012 and December 2013 at Kermanshah University of Medical Sciences , Kermanshah , Iran .


Two hundred and fifty-seven patients with clinically definite PDN were randomized to receive , carbamazepine , venlafaxine , or pregabalin .


The primary outcome was subjective pain as assessed by the visual analogue scale ( VAS ) .


Secondary outcomes consisted of sleep , mood , and work interference assessments , and a percentage of patients achieving at least 50 % reduction in pain intensity .


Means of VAS scores for carbamazepine , pregabalin , and venlafaxine treatment groups at the baseline ( 74.5 , 82.3 , and 74.5 ) and endpoint ( 39.6 , 33.4 , and 46.6 ) revealed significant reduction , although pregabalin was more efficacious than carbamazepine , and venlafaxine .


Improvements in means scores of sleep , mood , and work interferences were identified in all treatment groups .


This study showed the efficacy of venlafaxine , pregabalin , and carbamazepine in pain reduction in patients with diabetic neuropathy , although pregabalin was shown to be superior to carbamazepine , and venlafaxine in relieving pain , no significant superiority was shown between carbamazepine , and venlafaxine .


To compare outcomes of thoracoscopic clipping ( TC ) versus transcatheter occlusion ( TO ) for patent ductus arteriosus ( PDA ) .


One hundred patients were enrolled in the study from May 2010 to December 2011 .


Those patients were randomized into 2 groups : group one received TC , group two received TO .


There were no significant differences concerning width or length of the ductus ( P > 0.05 ) .


However the median age and median weight of patients in the TO group were greater than in the TC group ( P < 0.05 ) .


Mean operative time was 32 12 min in the TC group versus 20 3 min in the TO group ( P < 0.05 ) .


There were no deaths in either group .


There were no complications in the TC group whereas three patients in the TO group had complications and required subsequent operation .


Median postoperative stay was 3.5 days ( IQR : 3.0-4 .3 ) in the TC group versus 3 days ( IQR : 2.0-4 .0 ) in the TO group ( P < 0.05 ) .


There was no residual shunting in either group .


Average cost for one patient was $ 645 232 in the TC group versus $ 1,260 204 in the TO group ( P < 0.001 ) .


Thoracoscopic clipping is safer than transcatheter occlusion for PDA repair , with the same effectiveness and lower cost .


Acute effects of physical exercise on the deformational behavior of knee articular cartilage and changes in cartilage volume are definite .


However , conclusive effects of different exercises on the loss of articular cartilage volume have not been proved .


In this parallel-group randomized controlled trial , we tested whether 12 weeks of swimming , powerstriding , cycling , and running exercises would decrease the cartilage volume significantly and whether there would be a difference in the loss of cartilage volume after different types of exercises .


From October 2012 to January 2013 we evaluated 120 healthy volunteer students in Biomechanics Laboratory of Tongji University .


Body mass index ( BMI ) , right lower limb strength , and right knee cartilage magnetic resonance imaging ( MRI ) were obtained before exercise .


MRI were conducted in East Hospital .


The study was approved by Tongji University Ethical Committee , all subjects were randomly assigned to the running , powerstriding , cycling , swimming , and control groups by a drawing of lots .


Each group contained 24 samples .


At the end of 12 weeks of regular exercises , the same measurement procedures were applied .


Cartilage volume was calculated with OSIRIS software based on the quantitative-MRI .


Pre - and post-exercise comparisons were carried out using paired t-tests and one-way analysis of variance ( ANOVA ) was used to compare differences of cartilage volume loss between groups with Student-Newman-Keuls procedure for multiple comparisons .


Running , cycling , and swimming groups resulted in a significant decrease in BMI .


The quadriceps peak torque increased significantly in the swimming and cycling groups .


Total cartilage volume significantly decreased in the running and cycling groups after 12 weeks of training , without any significant change in the nonimpact swimming , low-impact powerstriding , and control groups .


Loss of total cartilage volume in the running and cycling groups were 2.21 % ( 3.03 ) and 1.50 % ( 0.42 ) .


Twelve weeks of regular physical exercises ( i.e. , running and cycling ) decrease the total knee cartilage volume .


Swimming and powerstriding are recommended for the healthy youth .


This finding suggests that articular cartilage has the functional adaptation for exercises , and some sports could be the risk factors for the initiation of osteoarthritis ( OA ) in young healthy adults .


Sleep disruption and fatigue are ubiquitous among cancer patients and are sources of stress that may compromise treatment outcomes .


Previously , we showed that a cognitive behavioral stress management ( CBSM ) intervention reduced anxiety and other stress-related processes in women undergoing primary treatment for breast cancer .


This study examined secondary outcomes from a CBSM intervention trial for women with early-stage breast cancer to test if CBSM would improve sleep quality and fatigue among these patients at a single site in southern Florida .


CBSM-related effects have already been demonstrated for indicators of psychosocial adaptation ( e.g. , general and cancer-related anxiety ) .


Patients were randomized to CBSM ( n = 120 ) or a 1-day psychoeducation control group ( n = 120 ) .


The Pittsburgh Sleep Quality Index ( PSQI ) and Fatigue Symptom Inventory were completed prior to randomization and 6 and 12months after the baseline assignment .


In latent growth analyses , women in CBSM reported greater improvements in PSQI sleep quality scores than controls , although there were no significant differences between conditions on PSQI total scores .


Women in CBSM also reported greater reductions in fatigue-related daytime interference than controls , though there were no significant differences in changes in fatigue intensity .


Changes in sleep quality were associated with changes in fatigue .


Future work may consider integrating sleep and fatigue content into stress management interventions for women with early-stage breast cancer .


Glycemic control in the perioperative period decreases mortality and morbidity , but data are scarce with regard to the effects of glucose control approaches on survival .


We assessed long-term survival in patients treated with 2 strategies of glucose control after first-time isolated coronary artery bypass graft .


In a previously published trial , patients were prospectively randomized to strict ( 90-120 mg/dL ) or liberal ( 121-180 mg/dL ) glucose control protocols .


The aim of this study was to assess long-term data on survival and health-related quality of life based on the original prospective randomized study population .


No differences were found in cumulative survival between the strict ( 95.5 % ) and liberal ( 93.5 % ) target range groups ( log-rank = 0.32 , p = 0.57 ) over a mean follow-up of 40.0 4.4 months .


Physical health-related quality of life significantly improved in all patients from baseline to 6 months after surgery ( F = 17.73 , p < 0.001 ) , and there were no differences in improvement of health-related quality of life between the 2 target range groups ( F = 0.15 , p = 0.70 ) .


These results support our previous findings and indicate that a liberal glycemic control strategy after coronary artery bypass leads to survival rates and improvements in health-related quality of life that are similar to those achieved with a strict target range .


In addition , the liberal strategy is superior in glucose control and target range management .


Asthma is often poorly controlled .


Home visitation by community health workers ( CHWs ) to improve control among adults has not been adequately evaluated .


To test the hypothesis that CHW home visits for adults with uncontrolled asthma improve outcomes relative to usual care .


Randomized parallel group study with 1-year follow-up , conducted 2008 through 2011 at homes of low-income adults aged 18 to 65 years with uncontrolled asthma living in King County , Washington .


The CHWs provided a mean of 4.9 home visits during a 1-year period to assess asthma control , self-management , and home environment and to support asthma self-management practices .


Primary prespecified outcomes were symptom-free days ( number of 24-hour periods in prior 2 weeks without asthma symptoms ) , asthma-related quality of life ( Mini Asthma Quality of Life Questionnaire ) , and asthma-related unscheduled health care use .


Of 463 individuals who completed eligibility screening , 443 were eligible , 366 participated ( 177 in intervention and 189 in control groups ) , and 333 completed the study ( 91 % ) .


The intervention group had significantly greater increases in mean symptom-free days per 2 weeks ( 2.02 [ 95 % CI , 0.94-3 .09 ] ; P < .001 ) and quality of life ( 0.50 [ 95 % CI , 0.28-0 .71 ] points ; P < .001 ) relative to the control group , adjusted for age , sex , race/ethnicity , and education level .


The number needed to treat to increase symptom-free days by 2 days per 2 weeks was 7.4 and to improve quality of life by 0.5 points was 2.6 .


Mean urgent health care use episodes in the past 12 months decreased significantly and similarly in both groups , from a mean of 3.46 to 1.99 episodes in the intervention group ( mean change , -1.47 [ 95 % CI , -2.28 to -0.67 ] ; P < .001 ) and from a mean of 3.30 to 1.96 episodes in the control group ( mean change , -1.34 [ 95 % CI , -2.00 to -0.72 ] ; P < .001 ) ( P = .83 comparing groups ) .


The provision of in-home asthma self-management support by CHWs to low-income adults with uncontrolled asthma improves asthma control and quality of life but not unscheduled health care use .


Additional studies are needed to confirm these findings and determine the value of wider implementation of this approach .


clinicaltrials.gov Identifier : NCT01783028 .


Maternal smoking during pregnancy adversely affects offspring lung development , with lifelong decreases in pulmonary function and increased asthma risk .


In a primate model , vitamin C blocked some of the in-utero effects of nicotine on lung development and offspring pulmonary function .


To determine if newborns of pregnant smokers randomized to receive daily vitamin C would have improved results of pulmonary function tests ( PFTs ) and decreased wheezing compared with those randomized to placebo .


Randomized , double-blind trial conducted in 3 sites in the Pacific Northwest between March 2007 and January 2011 .


One hundred fifty-nine newborns of randomized pregnant smokers ( 76 vitamin C treated and 83 placebo treated ) and 76 newborns of pregnant nonsmokers were studied with newborn PFTs .


Follow-up assessment including wheezing was assessed through age 1 year , and PFTs were performed at age 1 year .


Pregnant women were randomized to receive vitamin C ( 500 mg/d ) ( n = 89 ) or placebo ( n = 90 ) .


The primary outcome was measurement of newborn pulmonary function ( ratio of the time to peak tidal expiratory flow to expiratory time [ TPTEF : TE ] and passive respiratory compliance per kilogram [ Crs/kg ] ) within 72 hours of age .


Secondary outcomes included incidence of wheezing through age 1 year and PFT results at age 1 year .


A subgroup of pregnant smokers and nonsmokers had genotyping performed .


Newborns of women randomized to vitamin C ( n = 76 ) , compared with those randomized to placebo ( n = 83 ) , had improved pulmonary function as measured by TPTEF : TE ( 0.383 vs 0.345 [ adjusted 95 % CI for difference , 0.011-0 .062 ] ; P = .006 ) and Crs/kg ( 1.32 vs 1.20 mL/cm H2O/kg [ 95 % CI , 0.02-0 .20 ] ; P = .01 ) .


Offspring of women randomized to vitamin C had significantly decreased wheezing through age 1 year ( 15/70 [ 21 % ] vs 31/77 [ 40 % ] ; relative risk , 0.56 [ 95 % CI , 0.33-0 .95 ] ; P = .03 ) .


There were no significant differences in the 1-year PFT results between the vitamin C and placebo groups .


The effect of maternal smoking on newborn lung function was associated with maternal genotype for the 5 nicotinic receptor ( rs16969968 ) ( P < .001 for interaction ) .


Supplemental vitamin C taken by pregnant smokers improved newborn PFT results and decreased wheezing through 1 year in the offspring .


Vitamin C in pregnant smokers may be an inexpensive and simple approach to decrease the effects of smoking in pregnancy on newborn pulmonary function and respiratory morbidities .


clinicaltrials.gov Identifier : NCT00632476 .


Researchers face myriad challenges in the design and implementation of randomized , controlled trials .


Apart from summaries on limitations , these challenges are rarely documented in detail to inform future research projects .


To describe methodological challenges encountered during randomized , controlled trials ( WinFood Study ) designed to assess the efficacy of locally produced complementary foods based on traditional animal-source foods ( edible termites and spiders ) to support growth and nutritional status in Kenyan and Cambodian infants .


In a randomized , controlled design , infants received WinFood or corn-soy blend ( CSB ) for 9 months from 6 to 15 months of age .


Lean mass accrual and blood nutrition indicators ( lipid profile , iron and zinc status ) were measured cross-sectionally at 9 and 15 months of age , respectively .


Lean mass was determined by measuring deuterium oxide enrichment in saliva samples following a standard dose of deuterium solution ( 0.5 g/kg body weight ) to infants .


Blood nutrition indicators were determined following the drawing of 3 mL of blood by venipuncture .


Challenges included rapid depletion of food rations , high rate of loss to follow-up , delayed ethical approval , lack of local food-processing capacity , low capacity among staff to draw blood , and lack of laboratory capacity to perform both deuterium oxide and micronutrient status measurements .


Spillage of deuterium oxide solution during dosing was a major challenge in the Kenya context .


A high rate of morbidity among infants made some assessments very difficult , especially drawing of blood and saliva samples .


The challenges were largely contextual .


Improvement of local laboratory capacity , training of staff and sensitization of the communities and the Ethics Review Committee are highly recommended .


To identify novel metabolic markers for diabetes development in American Indians .


Using an untargeted high-resolution liquid chromatography-mass spectrometry , we conducted metabolomics analysis of study participants who developed incident diabetes ( n = 133 ) and those who did not ( n = 298 ) from 2,117 normoglycemic American Indians followed for an average of 5.5 years in the Strong Heart Family Study .


Relative abundances of metabolites were quantified in baseline fasting plasma of all 431 participants .


Prospective association of each metabolite with risk of developing type 2 diabetes ( T2D ) was examined using logistic regression adjusting for established diabetes risk factors .


Seven metabolites ( five known and two unknown ) significantly predict the risk of T2D .


Notably , one metabolite matching 2-hydroxybiphenyl was significantly associated with an increased risk of diabetes , whereas four metabolites matching PC ( 22:6 / 20:4 ) , ( 3S ) -7 - hydroxy-2 ' ,3 ' ,4 ' ,5 ' ,8 - pentamethoxyisoflavan , or tetrapeptides were significantly associated with decreased risk of diabetes .


A multimarker score comprising all seven metabolites significantly improved risk prediction beyond established diabetes risk factors including BMI , fasting glucose , and insulin resistance .


The findings suggest that these newly detected metabolites may represent novel prognostic markers of T2D in American Indians , a group suffering from a disproportionately high rate of T2D .


Cervical radicular syndrome ( CRS ) due to a herniated disc can be safely treated by surgical decompression of the spinal root .


In the vast majority of cases this relieves pain in the arm and restores function .


However , conservative treatment also has a high chance on relieving symptoms .


The objective of the present study is to evaluate the ( cost - ) effectiveness of surgery versus prolonged conservative care during one year of follow-up , and to evaluate the timing of surgery .


Predisposing factors in favour of one of the two treatments will be evaluated .


Patients with disabling radicular arm pain , suffering for at least 2 months , and an MRI-proven herniated cervical disc will be randomised to receive either surgery or prolonged conservative care with surgery if needed .


The surgical intervention will be an anterior discectomy or a posterior foraminotomy that is carried out according to usual care .


Surgery will take place within 2-4 weeks after randomisation .


Conservative care starts immediately after randomisation .


The primary outcome measure is the VAS for pain or tingling sensations in the arm one year after randomisation .


In addition , timing of surgery will be studied by correlating the primary outcome to the duration of symptoms .


Secondary outcome measures encompass quality of life , costs and perceived recovery .


Predefined prognostic factors will be evaluated .


The total follow-up period will cover two years .


A sample size of 400 patients is needed .


Statistical analysis will be performed using a linear mixed model which will be based on the ` intention to treat ' principle .


In addition , a new CRS questionnaire for patients will be developed , the Leiden Cervical Radicular Syndrome Functioning ( LCRSF ) scale .


The outcome will contribute to better decision making for the treatment of cervical radicular syndrome .


NTR3504 .


There are no direct comparisons of paliperidone extended-release ( ER ) , aripiprazole and ziprasidone in efficacy and metabolic influence in patients with first-episode schizophrenia .


The present study examined the efficacy and metabolic influence of paliperidone ER , aripiprazole and ziprasidone in patients with first-episode schizophrenia in China .


Subjects were recruited from outpatient and 254 patients entered the trial .


These patients received treatment randomly with paliperidone ER , aripiprazole and ziprasidone and were assessed at baseline , 13 , 26 and 52 weeks , respectively with Positive and Negative Syndrome Scale ( PANSS ) , 7-item Clinical Global Impressions-Severity ( CGI-S ) , anthropometric ( weight , body mass index and waist circumference ) and metabolic ( fasting blood glucose , HbA1c , cholesterol , high density lipoproteins ( HDL ) , low density lipoproteins and triglycerides ) measures .


A total of 203 patients completed the trial .


Paliperidone group had significant greater reduction in PANSS than aripiprazole group and ziprasidone group from 13 weeks , although the a reduction in PANSS of each group was more than 20 % .


There was no difference in CGI-S among the three groups , and all three groups had a significant reduction from baseline in CGI-S .


Aripiprazole group increased in weight and body mass index despite no statistical change in waist circumference .


Other two groups showed no changes in anthropometric measure .


At the end of the study , two glucose metabolic indices ( fasting blood glucose and HbA1c ) of aripiprazole group were significantly higher than that of baseline .


In lipid metabolism , aripiprazole group reduced triglycerides significantly and had no changes in other indices .


Paliperidone group reduced HDL and increased triglycerides despite no changes in glucose metabolism .


Ziprasidone group also had no significant changes in glucose metabolism , but reduced cholesterol , low density lipoproteins and increased HDL .


Furthermore , 22 subjects in three groups reached the diagnostic criteria of metabolic syndrome .


Paliperidone ER , aripiprazole and ziprasidone are effective in treating first-episode schizophrenia , and the ranking of efficacy from high to low is paliperidone ER > aripiprazole > ziprasidone .


Paliperidone ER can impair lipid metabolism potentially but had no influence on glucose metabolism .


Aripiprazole can damage glucose metabolism and has little influence on lipid metabolism .


Ziprasidone is considered an atypical antipsychotic with no evidence of harm to glucose and lipid metabolism .


Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients , but there is no clear evidence to support the superiority of any perioperative transfusion strategy in patients with cancer .


In a randomized , controlled , parallel-group , double-blind ( patients and outcome assessors ) superiority trial in the intensive care unit of a tertiary oncology hospital , the authors evaluated whether a restrictive strategy of erythrocyte transfusion ( transfusion when hemoglobin concentration < 7 g/dl ) was superior to a liberal one ( transfusion when hemoglobin concentration < 9 g/dl ) for reducing mortality and severe clinical complications among patients having major cancer surgery .


All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and randomly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy .


The primary outcome was a composite endpoint of mortality and morbidity .


A total of 198 patients were included as follows : 101 in the restrictive group and 97 in the liberal group .


The primary composite endpoint occurred in 19.6 % ( 95 % CI , 12.9 to 28.6 % ) of patients in the liberal-strategy group and in 35.6 % ( 27.0 to 45.4 % ) of patients in the restrictive-strategy group ( P = 0.012 ) .


Compared with the restrictive strategy , the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16 % ( 3.8 to 28.2 % ) and a number needed to treat of 6.2 ( 3.5 to 26.5 ) .


A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy .


Opioid substitution treatment ( OST ) has multiple benefits for heroin injectors and is an evidence-based major component of international treatment .


The current qualitative study sought to explore participants ' attitudes to and reasons for participating in a feasibility randomised trial in primary care offering ` same day ' OST ( methadone ) for injecting heroin users compared to usual care .


Twenty injecting heroin users ( 8 intervention and 12 controls ; 16 males and 4 females ) were interviewed ; purposive sampling was used to select a maximum variation sample from those who agreed ; and analysis used thematic methods .


Motivation to join the trial included the need to secure treatment set against some ambivalence due to previous negative experiences of trying to obtain OST .


Positive effects of securing methadone via the trial , included self-reported improvements in health and self-care ; reduction in crime , stress and drug use .


Completing the baseline questionnaires at recruitment appeared to enhance motivation for treatment for all participants .


For some control participants , this motivation seemed to increase a sense of self-efficacy and cognitive dissonance generated was resolved by seeking treatment from their GP .


Self-determination theory suggests that behaviour change may have been initiated during the recruitment appointment , resulting in an increased determination to seek treatment amongst control participants .


Taking part in the ` script in a day ' trial enabled participants in the intervention arm to gain same-day access to methadone and reduce their drug use .


For those in the control arm , completing the baseline questionnaires at recruitment appeared to create cognitive dissonance between their current health state and own aspirations , so increasing motivation for treatment .


Over 50 % obtained and were still in receipt of OST ( methadone or buprenorphine ) at the 3month follow-up .


We suggest that a regular ` health evaluation ' for injecting heroin users not in treatment , paired with low-barrier access to treatment , may be a way of exploring this and encouraging more into obtaining OST more quickly and at the best time for them .


This intervention should be delivered without pressure for change .


This trial is registered with International Standard Randomised Controlled Trial Number Register : SCript In a Day for injecting drug users : feasibility trial : ISRCTN16846554 .


A variety of sensory stimuli relieve restless legs syndrome symptoms .


Because systematic evaluations of sensory stimulation in restless legs syndrome are largely lacking , we performed a randomized crossover study to evaluate the effect of external sensory stimulation on restless legs syndrome symptoms .


Eighteen patients underwent 3 consecutive suggestive immobilization tests with the order of the following 3 conditions randomly assigned : no electrical stimulation ( condition 1 ) , tactile and proprioceptive sensory stimulation ( condition 2 ) , and tactile sensory stimulation only ( condition 3 ) .


Restless legs syndrome symptoms were quantified by visual analog scales , and periodic leg movements during wake were measured .


Baseline visual analogue scale score was 4.5 ( range 0-60 ) in condition 1 , 10.5 ( range 0-96 ) in condition 2 , and 8.5 in condition 3 ( p = 0.21 ) .


There was a tendency towards a higher maximum visual analogue scale score and visual analogue scale score at the end of the suggested immobilization test in the conditions with tactile sensory stimulation , though not significant ( p = 0.74 and p = 0.29 , respectively ) .


Fifteen patients suffered from periodic leg movements during wake .


Median indices were 18 ( range 0-145 ) in condition 1 , 26 ( range 0-190 ) in condition 2 , and 49 ( range 0-228 ) in condition 3 ( p = 0.76 ) .


We found a tendency towards less leg discomfort in the conditions in which an external sensory input was applied .


This potential benefit of sensory stimuli on restless legs syndrome severity merits further investigation as this could open new ways towards a better pathophysiological understanding and non-pharmacological treatments .


It is unclear whether an intensive program of weight loss combined with exercise prevents the onset of knee pain among those at high risk .


We examined whether an intensive lifestyle intervention ( ILI ) prevents incident knee pain compared with a diabetes mellitus support and education ( DSE ) comparison group among overweight adults with diabetes mellitus .


We conducted a secondary analysis of the Action for Health in Diabetes ( Look AHEAD ) study , which is a randomized intervention trial of adults who were obese and had type 2 diabetes mellitus starting in 2001 .


We studied a subcohort of 2,889 subjects who reported no knee pain at baseline but were at high risk due to obesity .


Risk ratios ( RRs ) were calculated to examine the association of ILI versus DSE with incident knee pain at year 1 and year 4 .


All analyses were adjusted for potential confounders .


Age , sex , and body mass index were similar among ILI and DSE participants with no knee pain at baseline .


At year 1 , ILI participants were 15 % less likely to develop knee pain compared with DSE participants ( RR 0.85 , 95 % confidence interval 0.74-0 .98 ) .


At year 4 , this difference decreased to 5 % and was no longer statistically significant .


An ILI of diet and exercise may prevent the development of knee pain among those at high risk in the short term .


Health care providers may consider recommending diet and exercise as a means to prevent the development of knee pain among those at high risk .


The effect of maraviroc on the maintenance and the function of HIV-1-specific T cell responses remains unknown .


Subjects recently infected with HIV-1 were randomized to receive anti-retroviral treatment with or without maraviroc intensification for 48 weeks , and were monitored up to week 60 .


PBMC and in vitro-expanded T cells were tested for responses to the entire HIV proteome by ELISpot analyses .


Intracellular cytokine staining assays were conducted to monitor the ( poly ) - functionality of HIV-1-specific T cells .


Analyses were performed at baseline and week 24 after treatment start , and at week 60 ( 3 months after maraviroc discontinuation ) .


Maraviroc intensification was associated with a slower decay of virus-specific T cell responses over time compared to the non-intensified regimen in both direct ex-vivo as well as in in-vitro expanded cells .


The effector function profiles of virus-specific CD8 T cells were indistinguishable between the two arms and did not change over time between the groups .


Maraviroc did not negatively impact any of the measured parameters , but was rather associated with a prolonged maintenance of HIV-1-specific T cell responses .


Maraviroc , in addition to its original effect as viral entry inhibitor , may provide an additional benefit on the maintenance of virus-specific T cells which may be especially important for future viral eradication strategies .


Low level laser ( light ) therapy ( LLLT ) has been demonstrated to promote hair growth in males .


A double-blind randomized controlled trial was undertaken to define the safety and physiologic effects of LLLT on females with androgenic alopecia .


Forty-seven females ( 18-60 years old , Fitzpatrick I-IV , and Ludwig-Savin Baldness Scale I-2 , I-3 , I-4 , II-1 , II-2 baldness patterns ) were recruited .


A transition zone scalp site was selected ; hairs were trimmed to 3mm height ; the area was tattooed and photographed .


The active group received a `` TOPHAT655 '' unit containing 21 , 5mW diode lasers ( 6555nm ) and 30 LEDS ( 65520nm ) , in a bicycle-helmet like apparatus .


The placebo group unit appeared identical , containing incandescent red lights .


Patients treated at home every other day16 weeks ( 60 treatments , 67J/cm ( 2 ) irradiance/25minute treatment , 2.9 J dose ) , with follow up and photography at 16 weeks .


A masked 2.85 cm ( 2 ) photographic area was evaluated by another blinded investigator .


The primary endpoint was the percent increase in hair counts from baseline .


Forty-two patients completed the study ( 24 active , 18 sham ) .


No adverse events or side effects were reported .


Baseline hair counts were 228.2133.4 ( N = 18 ) in the sham and 209.6118.5 ( N = 24 ) in the active group ( P = 0.642 ) .


Post Treatment hair counts were 252.1143.3 ( N = 18 ) in the sham group and 309.9166.6 ( N = 24 ) in the active group ( P = 0.235 ) .


The change in hair counts over baseline was 23.930.1 ( N = 18 ) in the sham group and 100.353.4 ( N = 24 ) in the active group ( P < 0.0001 ) .


The percent hair increase over the duration of the study was 11.0548.30 ( N = 18 ) for the sham group and 48.0717.61 ( N = 24 ) for the active group ( P < 0.001 ) .


This demonstrates a 37 % increase in hair growth in the active treatment group as compared to the placebo group .


LLLT of the scalp at 655nm significantly improved hair counts in women with androgenetic alopecia at a rate similar to that observed in males using the same parameters .


Idiopathic interstitial pneumonias such as idiopathic pulmonary fibrosis or fibrotic nonspecific interstitial pneumonia are irreversible progressive pulmonary diseases that often have fatal outcomes .


Although the etiology of idiopathic interstitial pneumonias is not yet fully understood , anti-fibrotic and anti-inflammatory agents have shown limited therapeutic effectiveness .


Reactive oxygen species and their cytotoxic effects on the lung epithelial cells have been reported to participate in the pathophysiology of the disease .


Because superoxide dismutase catalyzes the detoxification of reactive oxygen species , we developed lecithinized superoxide dismutase for the treatment of patients with idiopathic interstitial pneumonias .


A multicenter , randomized , placebo-controlled trial was conducted as a pilot study to investigate the safety and effectiveness of 40 or 80 mg lecithinized superoxide dismutase in patients with progressive idiopathic interstitial pneumonias who presented with either idiopathic pulmonary fibrosis or corticosteroid-resistant fibrotic nonspecific interstitial pneumonia and showed arterial oxygen tension compatible with stage III or IV on the Japanese severity grading scale for idiopathic interstitial pneumonias .


Before and following infusion of lecithinized superoxide dismutase for 28 days , the primary endpoint of forced vital capacity and the secondary endpoints of lactate dehydrogenase , surfactant protein-A , surfactant protein-D and Krebs von den Lungen-6 levels were measured in the serum .


The primary endpoint of forced vital capacity did not improve significantly in the lecithinized superoxide dismutase groups in comparison with the placebo group .


The secondary endpoints of lactate dehydrogenase and surfactant protein-A levels were significantly attenuated by 28 days in the higher-dose ( 80 mg ) group .


However , these changes returned to the baseline levels by 56 days after the cessation of lecithinized superoxide dismutase .


Adverse events and mortality in the drug-treated groups did not differ from those in the placebo group .


Treatment with lecithinized superoxide dismutase is safe and improves the levels of serum markers such as lactate dehydrogenase and surfactant protein-A in patients with advanced idiopathic interstitial pneumonias with severe respiratory dysfunction .


Considering the results of the current study , further investigations into the effects and treatment potential of long-term administration of lecithinized superoxide dismutase may be warranted .


University hospital Medical Information Network ( UMIN ) clinical trials registry no. 000000752 .


To evaluate the desensitizing efficacy of 2 % sodium fluoride solution ( NaF ) , diode laser ( DL ) , a DL and NaF association and a solution of hydroxyl-ethyl-methacrylate and glutaraldehyde ( HEMA-G : Gluma desensitizer ) in cervical dentin hypersensitivity ( CDH ) .


262 teeth of 24 subjects ( 16 females and eight males ; age 21 to 64 years , mean 38 years ) , each having at least two CHD teeth for each quadrant , were included in this prospective , split mouth , clinical study .


Teeth of each oral quadrant were randomized in four groups ( SG ) to study the effectiveness of NaF ( SG-1 ) , of DL ( SG-2 ) NaF-DL combination ( SG-3 ) and HEMA-G ( SG-4 ) .


The subjects were asked to rate the sensitivity experienced during air stimulation by placing a mark on a visual analogue scale ( VAS ) before treatment ( baseline ) , immediately after treatment , and after 1 , and 6 months .


The outcomes showed a significant reduction of discomfort compared to baseline values for teeth of SG-3 immediately post treatment ( 82.6 % ) ( P < 0.001 ) , after 1 month ( 69.5 % ) ( P < 0.001 ) and after 6 months ( 60.8 % ) ( P < 0.001 ) , respectively , compared with the reduction scores of 51.6 % ( P < 0.001 ) , 29.7 % ( P < 0.05 ) and 4.7 % ( P > 0.05 ) , recorded for SG-1 ; 72.2 % , ( P < 0.001 ) , 62.5 % ( P < 0.001 ) , and 47.2 % ( P < 0.05 ) , recorded for SG-2 ; 77.4 % ( P < 0.001 ) , 56.1 % ( P < 0.001 ) , and 27.3 % ( P < 0.05 ) , recorded for SG-4 .


NIMH Project Accept ( HPTN 043 ) is a community - randomized trial to test the safety and efficacy of a community-level intervention designed to increase testing and lower HIV incidence in Tanzania , Zimbabwe , South Africa and Thailand .


The evaluation design included a longitudinal study with community members to assess attitudinal and behavioral changes in study outcomes including HIV testing norms , HIV-related discussions , and HIV-related stigma .


A cohort of 657 individuals across all sites was selected to participate in a qualitative study that involved 4 interviews during the study period .


Baseline and 30-month data were summarized according to each outcome , and a qualitative assessment of changes was made at the community level over time .


Members from intervention communities described fewer barriers and greater motivation for testing than those from comparison communities .


HIV-related discussions in intervention communities were more grounded in personal testing experiences .


A change in HIV-related stigma over time was most pronounced in Tanzania and Zimbabwe .


Participants in the intervention communities from these two sites attributed community-level changes in attitudes to project specific activities .


The Project Accept intervention was associated with more favorable social norms regarding HIV testing , more personal content in HIV discussions in all study sites , and qualitative changes in HIV-related stigma in two of five sites .


To evaluate the efficacy of autologous cytokine-induced killer ( CIK ) cells in patients with renal cell carcinoma ( RCC ) .


20 patients diagnosed with TNM stage I or II RCC were randomly divided into two groups , a CIK cell treatment group and a control group .


The endpoint was progression-free survival ( PFS ) evaluated by Kaplan-Meier analyses .


CD3 ( + ) , CD3 ( + ) / CD8 ( + ) , CD3 ( + ) / CD4 ( + ) , and CD3 ( + ) / CD56 ( + ) levels increased after CIK cell culture ( P < 0.01 ) .


The median PFS in CIK cell treatment group was significantly longer than that in control group ( PFS , 32.2 months versus 21.6 months ; log-rank , P = 0.032 ) , all patients were alive during the course of followup , and there are no statistically significant differences between two groups in OS ( log-rank , P = 0.214 ) .


Grade III or greater adverse events were not observed .


CIK cells treatment could prolong survival in patients with RCC after radical nephrectomy and showed acceptable curative effect with potential enhancement of cellular immune function .


This trial is registered with Clinicaltrials.gov NCT01799083 .


At the end of 2 previous trials , an excess of stroke and bleeding was observed in patients with AF randomized to a new oral anticoagulant ( NOAC ) who transitioned to a vitamin K antagonist ( VKA ) .


The ENGAGE AF-TIMI 48 ( Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 ) trial compared once-daily edoxaban to warfarin for stroke prevention in patients with AF .


An end-of-trial transition plan was developed to minimize the risks of stroke due to inadequate anticoagulation and bleeding from excessive anticoagulation during this critical period .


All patients on the blinded study drug at the trial 's conclusion were included in this analysis .


In pre-specified analyses , stroke , bleeding , and death that occurred through 30 days after the end-of-trial visit were stratified by randomized treatment allocation and open-label anticoagulant selected post-trial .


Of the 13,642 patients taking the blinded study drug at the end of the trial , 9,304 ( 68.2 % ) were transitioned to open-label VKA and 4,258 patients ( 31.2 % ) to an NOAC .


There were 21 strokes evenly distributed across the 3 randomized treatment arms : warfarin 7 ( 1.90 % / year ) , edoxaban high dose 7 ( 1.89 % / year ) , edoxaban low dose 7 ( 1.85 % / year ) .


Major bleeding was also similar across the 3 treatment arms : warfarin 11 ( 2.98 % / year ) , edoxaban high dose 10 ( 2.69 % / year ) , edoxaban low dose 18 ( 4.76 % / year ) .


In patients transitioned to VKA , 85 % of patients had at least 1 INR 2 by day 14 after the transition and 99 % by day 30 .


The ENGAGE AF-TIMI 48 transition plan protected patients from an excess of thrombotic and bleeding events and should be helpful in clinical practice when patients are transitioned between oral anticoagulants .


( Global Study to Assess the Safety and Effectiveness of Edoxaban [ DU-176b ] vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ EngageAFTIMI48 ] ; NCT00781391 ) .


This prospective multicenter study examined whether elevated fecal calprotec tin ( FC ) concentrations after stopping TNF-blocking therapy can predict clinical or endoscopic relapse .


In addition , we evaluated the impact of histological remission on the relapse risk .


We enrolled inflammatory bowel disease ( IBD ) patients who were in clinical , endoscopic , and FC-based ( < 100 g/g ) remission after a minimum 11 months of TNF-blocking therapy .


The patients were followed-up for 12 months after the discontinuation of TNF-blocking therapy .


FC was collected monthly for the first 6 months and thereafter every second month .


Ileocolonoscopy was performed at inclusion , at 4 months , at the study end , and at the time of clinical relapse .


Of 52 enrolled patients , 49 ( 16 Crohn 's disease , 33 ulcerative colitis/IBD unclassified ) provided the stool samples requested and comprised the study group .


During the follow-up , 15/49 ( 31 % ) relapsed , whereas 34 ( 69 % ) remained in remission .


Patients relapsing showed constantly elevated FC levels for a median of 94 ( 13-317 ) days before the relapse .


Significant increase in median FC levels was seen 2 ( p = 0.0014 ) , 4 ( p = 0.0056 ) , and 6 ( p = 0.0029 ) months before endoscopic relapse .


Constantly normal FC concentrations during the follow-up were highly predictive for clinical and endoscopic remission .


Normal FC concentrations in patients with remission were associated with histological remission .


FC seems to increase and remain elevated before clinical or endoscopic relapse , suggesting that it can be used as a surrogate marker for predicting and identifying patients requiring close follow-up in clinical practice .


Experimental pain models in human healthy volunteers are advantageous for early evaluation of analgesics .


All efforts to develop nonsteroidal anti-inflammatory drugs ( NSAIDs ) which are devoid of gastrointestinal and cardiovascular system effects are still far from achieving a breakthrough .


Hence we evaluated the analgesic activity of an ayurvedic drug , Boswellia serrata by using validated human pain models which has shown its analgesic activity both in-vitro and preclinical studies to evaluate the analgesic activity of single oral dose ( 125 mg , 2 capsules ) of Boswellia serrata compared to placebo using mechanical pain model in healthy human subjects .


After taking written informed consent , twelve healthy subjects were randomized ( 1:1 ) to receive single oral dose of Boswellia serrata ( Shallaki ( ) ) 125 mg , 2 capsules or identical placebo in a crossover design .


Mechanical pain was assessed using Ugo basile analgesymeter ( by Randall Selitto test ) at baseline and at 1 hr , 2 hrs and 3 hrs after test drug administration .


Pain Threshold force and time and Pain Tolerance force and time were evaluated .


Statistical analysis was done by paired t-test .


Twelve healthy volunteers have completed the study .


Mean percentage change from baseline in Pain Threshold force and time with Boswellia serrata when compared to placebo had significantly increased [ Force : 9.7 11.0 vs 2.9 3.4 ( P = 0.05 ) and time : 9.7 10.7 vs 2.8 3.4 ( P = 0.04 ) ] at third hr .


Mean Percentage change from baseline in Pain Tolerance force and time with Boswellia serrata when compared to placebo had significantly ( P 0.01 ) increased at 1 hr , 2 hrs and 3 hrs .


In the present study , Boswellia serrata significantly increased the Pain Threshold and Pain Tolerance force and time compared to placebo .


Both study medications were well tolerated .


Further multiple dose studies may be needed to establish the analgesic efficacy of the drug .


First - and second-year medical students have limited exposure to basic surgical skills .


An introductory , comprehensive , simulation-based curriculum in basic laparoscopic skills may improve medical students ' knowledge and technical and nontechnical skills and may raise their interest in a career in surgery .


The purpose of this study was to ( 1 ) design a comprehensive , simulation-based training curriculum ( STC ) aimed to introduce junior medical students to basic laparoscopic skills and ( 2 ) compare structured and supervised learning and practice to a self-directed approach .


Twenty-four , pre-clerkship medical students were allocated randomly to either a supervised ( STC ) or a self-directed learning and practice ( SDL ) group .


Participants in the STC group received structured training in cognitive , and basic technical and nontechnical domains of laparoscopic surgery , whereas the SDL group was invited to engage in SDL in the same domains .


At post-training assessment , basic knowledge about laparoscopic surgery , and attitudes toward nontechnical skills were equivalent between STC and SDL groups .


The STC group outperformed ( meanstandard deviation ) the SDL group on a peg transfer task ( 5813 vs 8119seconds ; P = .005 ) .


Participants in the STC group showed significant within-group improvements in knowledge , technical skill , and in 4 of 5 domains of nontechnical skills , whereas participants in the SDL group showed significant within-group improvement in technical skill and in 1 of 5 domains of nontechnical skills .


Participation in the STC resulted in significant gains in knowledge , technical skill , and attitudes toward nontechnical skills .


Exposure of junior medical students to this curriculum before their clinical rotations is expected to enhance learning , maintain motivation , and increase interest in surgery as a future career .


Tricuspid annular plane systolic excursion ( TAPSE ) is a widely used clinical measure of right ventricular ( RV ) systolic performance .


However , postsurgical changes in the pattern of RV contraction may limit the utility of TAPSE for assessing global RV function .


We retrospectively examined pre - and postoperative TAPSE and RV fractional area change ( FAC ) in patients undergoing 3 different types of aortic valve replacement ( AVR ) .


Fifty-two patients enrolled in the Placement of AoRTic TraNscathetER Valve Trial at our institution were randomized to receive open AVR or transcatheter AVR ( TAVR ) by either the transapical or transfemoral access routes .


Thirty-seven of these patients had analyzable transthoracic echocardiography ( TTE ) before and after AVR .


Using M-mode echocardiography , TAPSE was measured in the apical four-chamber view .


Using two-dimensional echocardiography , RV FAC was measured in the apical four-chamber view .


The mean change in TAPSE was -0.70.6 cm for open AVR ( P = 0.002 ) , -0.20.4 cm for transapical TAVR ( P = 0.26 ) , and 0.10.5 cm for transfemoral TAVR ( P = 0.64 ) .


The mean change in RV FAC was -15 % for open AVR ( P = 0.91 ) , 24 % for transapical TAVR ( P = 0.37 ) , and 710 % for transfemoral TAVR ( P = 0.07 ) .


The normal pattern of RV contraction was unchanged by transapical and transfemoral TAVR , while open AVR led to a significant decrease in TAPSE with preserved RV FAC .


Thus , RV FAC is a preferable method for assessing RV function in the postoperative patient .


The objective of this 2-arm parallel single-center trial was to compare placement time and numbers of failures of mandibular lingual retainers bonded with an indirect procedure vs a direct bonding procedure .


Sixty-four consecutive patients at the postgraduate orthodontic clinic of the University of Geneva in Switzerland scheduled for debonding and mandibular fixed retainer placement were randomly allocated to either an indirect bonding procedure or a traditional direct bonding procedure .


Eligibility criteria were the presence of the 4 mandibular incisors and the 2 mandibular canines , and no active caries , restorations , fractures , or periodontal disease of these teeth .


The patients were randomized in blocks of 4 ; the randomization sequence was generated using an online randomization service ( www.randomization.com ) .


Allocation concealment was secured by contacting the sequence generator for treatment assignment ; blinding was possible for outcome assessment only .


Bonding time was measured for each procedure .


Unpaired t tests were used to assess differences in time .


Patients were recalled at 1 , 2 , 4 , and 6months after bonding .


Mandibular fixed retainers having at least 1 composite pad debonded were considered as failures .


The log-rank test was used to compare the Kaplan-Meier survival curves of both procedures .


A test of proportion was applied to compare the failures at 6months between the treatment groups .


Sixty-four patients were randomized in a 1:1 ratio .


One patient dropped out at baseline after the bonding procedure , and 3 patients did not attend the recalls at 4 and 6months .


Bonding time was significantly shorter for the indirect procedure ( 32131seconds , meanSD ) than for the direct procedure ( 40140seconds ) ( per protocol analysis of 63 patients : mean difference = 80seconds ; 95 % CI = 62.4-98 .1 ; P < 0.001 ) .


The 6-month numbers of failures were 10 of 31 ( 32 % ) with the indirect technique and 7 of 29 ( 24 % ) with the direct technique ( log rank : P = 0.35 ; test of proportions : risk difference = 0.08 ; 95 % CI = -0.15 to 0.31 ; P = 0.49 ) .


No serious harm was observed except for plaque accumulation .


Indirect bonding was statistically significantly faster than direct bonding , with both techniques showing similar risks of failure .


This trial was not registered .


The protocol was not published before trial commencement .


No funding or conflict of interest to be declared .


Internal nasal valve collapse is a preventable complication of rhinoplasty , for which the spreader graft is the gold standard .


More recently , the spreader flap technique has been espoused as an alternative to spreader grafting .


Here , we evaluated the efficacy of this technique in a randomized trial setting .


The autospreader was used in 32 patients who were candidates for primary rhinoplasty ; 34 who did not undergo a spreader flap procedure were recruited as a control group .


Acoustic rhinometry was used in every patient preoperatively and 1 year postoperatively .


Average volume and minimal cross-sectional area ( MCA ) of the nose and findings were collected .


Also , the pre - and postoperative patients ' subjective assessment about their satisfaction from their appearance and nasal obstruction were evaluated according to visual analog scale ( VAS ) .


Among the study group patients , 46 ( 69.7 % ) were female and 20 ( 30.3 % ) were male subjects .


Their mean age was 50/5 6/24 years .


The difference in MCA in the control group was -0.1 and +0.6 ( on right and left sides , respectively ) , and in the spreader flap group it was -0.03 and +0.05 , which showed an increase in MCA in the left side and a decrease in the opposite side of both groups .


However , their difference was not statistically significant ( p = 0.50 ) .


Also , the differences between preoperative and postoperative VAS were not significant in either nasal obstruction ( p = 0.68 ) and cosmetic satisfaction ( p = 0.38 ) .


Spreader flap is an attractive technique in preserving the middle vault in nasal plastic surgery .


However , its effect needs more evaluation .


The Protocolized Care for Early Septic Shock study is a randomised , multicentre , prospective , three-arm , parallel-group trial of alternative resuscitation strategies for early septic shock .


To state our analysis plan for trial data .


Our plan is to guide data collection and analysis using pre-existing definitions and testing , with local consensus-based efforts where needed .


We examine protocolised care ( two experimental approaches ) and compare this to usual `` wild type '' care .


Our plan is to address three aims ( clinical efficacy , biology of illness and recovery , and costs and cost-effectiveness ) and four hypotheses , and we specify rules for handling data and determining outcomes .


By using measures to maintain study conduct and analysis rigour , we hope to improve understanding of early septic shock resuscitation and care of patients .


Cluster randomized trials ( CRTs ) are increasingly used to evaluate quality improvement interventions aimed at health care providers .


In trials testing emergency department ( ED ) interventions , migration of emergency physicians ( EPs ) between hospitals is an important concern , as contamination may affect both internal and external validity .


We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator ( tPA ) in stroke ( the INSTINCT trial ) .


INSTINCT was a prospective , cluster randomized , controlled trial .


Twenty-four Michigan community hospitals were randomly selected in matched pairs for study .


Contamination was defined at the cluster level , with substantial contamination defined a priori as greater than 10 % of EPs affected .


Nonadherence , total crossover ( contamination + nonadherence ) , migration distance , and characteristics were determined .


Three hundred seven EPs were identified at all sites .


Overall , 7 ( 2.3 % ) changed study sites .


One moved between control sites , leaving 6 ( 2.0 % ) total crossovers .


Of these , 2 ( 0.7 % ) moved from intervention to control ( contamination ) ; and 4 ( 1.3 % ) moved from control to intervention ( nonadherence ) .


Contamination was observed in 2 of 12 control sites , with 17 % and 9 % contamination of the total site EP workforce at follow-up , respectively .


Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites .


The mobile nature of EPs should be considered in the design of quality improvement CRTs .


Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design .


To investigated the effect of a hyperoncotic CPB-prime with hydroxyethyl starch ( HES ) 6 % ( 130/0 .4 ) on extravascular lung water ( EVLW ) and post-pump cardiac and pulmonary functions .


This study plan approved by the hospital ethics committee review .


In 40 randomized patients undergoing elective coronary artery bypass graft surgery ( CABG ) , a colloid prime ( COP :42.5 mmHg , HES-group , n = 20 ) and a crystalloid prime ( Ringer 's lactate , crystalloid group , n = 20 ) of equal volume were compared with respect to the effects on cardiopulmonary function .


Cardiac index ( CI ) , mean arterial pressure ( MAP ) , pulmonary capillary wedge pressure ( PCWP ) , systemic vascular resistance index ( SVRI ) , pulmonary artery pressure ( PAP ) , pulmonary vascular resistance index ( PVRI ) , alveolo-arterial oxygen difference ( AaDO2 ) , pulmonary shunt fraction ( Qs/QT ) , extravascular lung water ( EVLW ) , COP , fluid balance and body weight were evaluated peri-operatively .


Pre-operative demographic and clinical data , CPB-time , crossclamp time and the number of anastomoses were comparable for both groups .


During CPB , COP was reduced by 22 % in the HES-group [ ( 16.7 3.9 ) vs ( 21.5 2.2 ) mmHg , P < 0.05 ] while it was reduced by more than 50 % of the pre-CPB value [ 10.7 2.0 vs ( 22.7 1.9 ) mmHg , P < 0.05 ] in the crystalloid group ( P < 0.05 HES-group vs. crystalloid group ) .


Post-CPB EVLW was unchanged in the HES-group but it was elevated by 21 % in the crystalloid group ( P < 0.05 HES-group vs crystalloid group ) , CI was higher in the HES-group [ ( 3.3 0.3 ) vs ( 2.7 0.7 ) L/min , P < 0.05 ] .


Fluid balance was less in the HES-group ( 715 544 vs 1 951 487 , P < 0.05 ) .


Post-operative weight gain could be prevented in the HES-group but not in the crystalloid group ( 1.4 1.1 vs -0.3 1.3 , P < 0.05 ) .


No significant differences were seen for MAP , PAP , PCWP , SVRI , PVRI , AaDO2 and ( Qs/QT ) between the two groups at any time .


Hyperoncotic CPB-prime using HES 6 % improves CI and prevents EVLW accumulation in the early post-pump period , while pulmonary function is unchanged .


Schizophrenia is a highly heterogeneous disorder with positive and negative symptoms being characteristic manifestations of the disease .


While these two symptom domains are usually construed as distinct and orthogonal , little is known about the longitudinal pattern of negative symptoms and their linkage with the positive symptoms .


This study assessed the temporal interplay between these two symptom domains and evaluated whether the improvements in these symptoms were inversely correlated or independent with each other .


This post hoc analysis used data from a multicenter , randomized , open-label , 1-year pragmatic trial of patients with schizophrenia spectrum disorder who were treated with first - and second-generation antipsychotics in the usual clinical settings .


Data from all treatment groups were pooled resulting in 399 patients with complete data on both the negative and positive subscale scores from the Positive and Negative Syndrome Scale ( PANSS ) .


Individual-based growth mixture modeling combined with interplay matrix was used to identify the latent trajectory patterns in terms of both the negative and positive symptoms .


Pearson correlation coefficients were calculated to examine the relationship between the changes of these two symptom domains within each combined trajectory pattern .


We identified four distinct negative symptom trajectories and three positive symptom trajectories .


The trajectory matrix formed 11 combined trajectory patterns , which evidenced that negative and positive symptom trajectories moved generally in parallel .


Correlation coefficients for changes in negative and positive symptom subscale scores were positive and statistically significant ( P < 0.05 ) .


Overall , the combined trajectories indicated three major distinct patterns : ( 1 ) dramatic and sustained early improvement in both negative and positive symptoms ( n = 70 , 18 % ) , ( 2 ) mild and sustained improvement in negative and positive symptoms ( n = 237 , 59 % ) , and ( 3 ) no improvement in either negative or positive symptoms ( n = 82 , 21 % ) .


This study of symptom trajectories over 1 year shows that changes in negative and positive symptoms were neither inversely nor independently related with each other .


The positive association between these two symptom domains supports the notion that different symptom domains in schizophrenia may depend on each other through a unified upstream pathological disease process .


Depression symptoms are now recognized to be the predominant cause of disability for bipolar disorder ( BD ) patients .


The treatment strategies for the depressed phase of BD remain more anecdotal than data-based .


Olanzapine has been investigated as an alternative to antidepressants and a mood stabilizer for acute bipolar depression .


The purpose of this study was to assess the efficacy of olanzapine monotherapy for bipolar I depression .


Sixty-eight patients with bipolar I depression were randomly assigned to treatment with olanzapine ( mean final dose 14.4 mg/day ) ( n = 34 ) or placebo ( n = 34 ) in a double-blind parallel-group study design .


Planned assessments included Montgomery-Asberg Depression Rating Scale ( MADRS ) , Young Mania Rating Scale ( YMRS ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , Clinical Global Impressions-Improvement scale ( CGI-I ) , Hamilton Depression scale ( HAMD ) , Hamilton Anxiety scale ( HAMA ) , and Treatment Emergent Symptom Scale ( TESS ) .


Of the 68 patients who were randomly assigned , 57 ( 83.8 % ) completed treatments .


Improvements in MADRS total score , CGI-S , CGI-I , and HAMD in the olanzapine group were significantly greater relative to those in the placebo group during the 8-week follow-up period ( p < 0.001 , p = 0.0017 , p = 0.007 , and p < 0.001 , respectively ) .


Rates of categorical treatment response and remission in the olanzapine group ( 50.0 % and 35.3 % , respectively ) were significantly higher than those in the placebo group ( 20.6 % , p = 0.011 and 11.8 % , p = 0.022 , respectively ) .


At the 8-week treatment , the mean weight and the total cholesterol , triglyceride , and low-density lipoprotein cholesterol levels increased significantly in the olanzapine group ( p = 0.037 , p = 0.029 , p = 0.030 , and p = 0.028 , respectively ) .


Olanzapine is effective in the treatment of bipolar I depression but is associated with significant metabolic side effects .


Metformin treatment is associated with improved outcome after myocardial infarction in patients with diabetes .


In animal experimental studies metformin preserves left ventricular function .


To evaluate the effect of metformin treatment on preservation of left ventricular function in patients without diabetes presenting with ST-segment elevation myocardial infarction ( STEMI ) .


Double-blind , placebo-controlled study conducted among 380 patients who underwent primary percutaneous coronary intervention ( PCI ) for STEMI at the University Medical Center Groningen , The Netherlands , between January 1 , 2011 , and May 26 , 2013 .


Metformin hydrochloride ( 500 mg ) ( n = 191 ) or placebo ( n = 189 ) twice daily for 4 months .


The primary efficacy measure was left ventricular ejection fraction ( LVEF ) after 4 months , assessed by magnetic resonance imaging .


A secondary efficacy measure was the N-terminal pro-brain natriuretic peptide ( NT-proBNP ) concentration after 4 months .


The incidence of major adverse cardiac events ( MACE ; the combined end point of death , reinfarction , or target-lesion revascularization ) was recorded until 4 months as a secondary efficacy measure .


At 4 months , all patients were alive and none were lost to follow-up .


LVEF was 53.1 % ( 95 % CI , 51.6 % -54.6 % ) in the metformin group ( n = 135 ) , compared with 54.8 % ( 95 % CI , 53.5 % -56.1 % ) ( P = .10 ) in the placebo group ( n = 136 ) .


NT-proBNP concentration was 167 ng/L in the metformin group ( interquartile range [ IQR ] , 65-393 ng/L ) and 167 ng/L in the placebo group ( IQR , 74-383 ng/L ) ( P = .66 ) .


MACE were observed in 6 patients ( 3.1 % ) in the metformin group and in 2 patients ( 1.1 % ) in the placebo group ( P = .16 ) .


Creatinine concentration ( 79 mol/L [ IQR , 70-87 mol/L ] vs 79 mol/L [ IQR , 72-89 mol/L ] , P = .61 ) and glycated hemoglobin ( 5.9 % [ IQR , 5.6 % -6.1 % ] vs 5.9 % [ IQR , 5.7 % -6.1 % ] , P = .15 ) were not significantly different between both groups .


No cases of lactic acidosis were observed .


Among patients without diabetes presenting with STEMI and undergoing primary PCI , the use of metformin compared with placebo did not result in improved LVEF after 4 months .


The present findings do not support the use of metformin in this setting .


clinicaltrials.gov Identifier : NCT01217307 .


This phase III , 52-week study compared fostamatinib with placebo ( for 24 weeks ) in patients with active rheumatoid arthritis ( RA ) and an inadequate response to methotrexate ( MTX ) therapy .


Patients taking MTX were randomized ( 1:1:1 ) to receive fostamatinib 100 mg twice daily for 52 weeks ( group A ) , fostamatinib 100 mg twice daily for 4 weeks and then 150 mg once daily ( group B ) , or placebo for 24 weeks and then fostamatinib 100 mg twice daily ( group C ) .


At week 24 , the co-primary end points were change from baseline in the American College of Rheumatology 20 % ( ACR20 ) improvement response rates and change in the modified total Sharp/van der Heijde score of radiographic damage ( SHS ) .


In this study , 918 patients were randomized and received 1 dose of study drug ( fostamatinib or placebo ) ; the demographic and baseline clinical characteristics were well balanced .


Following treatment with both fostamatinib regimens , a statistically significant difference in the ACR20 improvement response was achieved at week 24 as compared with that in patients receiving placebo ( 49.0 % [ group A ] and 44.4 % , [ group B ] versus 34.2 % ; P < 0.001 and P = 0.006 , respectively ) , but there was no statistically significant difference in the SHS between either fostamatinib group and placebo ( P = 0.25 and P = 0.17 , respectively ) .


The most common adverse events in patients in groups A , B , and C were hypertension ( 15.8 % , 15.1 % , and 3.9 % , respectively ) and diarrhea ( 13.9 % , 15.1 % , and 3.9 % , respectively ) .


Elevated blood pressure ( 140/90 mm Hg ) occurred at 1 visit in 44.2 % , 41.6 % , and 19.3 % of patients in each respective group .


With the use of either fostamatinib regimen in patients with RA , statistically significant , but not clinically significant , improvements in the ACR20 improvement response over placebo were achieved at 24 weeks , whereas a significant difference in the SHS was not seen .


The overall level of response to treatment with fostamatinib was lower than had been observed in the phase II program , but similar adverse events were reported .


Despite the use of evidence-based preventive measures , delirium affects about 40 % of patients following cardiac surgery with the potential for serious clinical complications and anxiety for caregivers .


There is some evidence that family involvement as a core component of delirium management may be beneficial since familiarity helps patients stay in contact with reality , however , this merits further investigation .


There is also currently a gap in the scientific literature regarding objective indicators that could enhance early detection and monitoring of delirium .


Therefore , this randomized pilot trial examines the acceptability , feasibility , and preliminary efficacy of an experimental nursing intervention to help family caregivers manage post-cardiac surgery delirium in their relatives .


It also explores the validity of a new and innovative measure that has potential as an indicator for delirium .


In this two-group randomized pilot study ( n = 30 ) , the control group will receive usual care and the intervention group will receive the experimental intervention aimed at reducing delirium severity .


The intervention nurse 's objective will be to foster the family caregiver 's self-efficacy in behaving in a supportive manner during delirium episodes .


Data will be collected from standard delirium assessment scales and a novel measure of delirium , i.e. , cerebral oximetry obtained using near infrared spectroscopy , as well as medical records and participants ' responses to questionnaires .


New strategies for early detection , monitoring , and management of delirium are needed in order to improve outcomes for both patients and families .


The present article exposes feasibility issues based on the first few months of the empirical phase of the study that may be useful to the scientific community interested in improving the care of patients with delirium .


Another potentially important contribution is in the exploration of cerebral oximetry , a promising measure as an objective indicator for early detection and continuous monitoring of delirium .


The proposed pilot study will build towards a larger trial with the potential to improve knowledge about delirium management and monitoring .


This pilot study was registered at Controlled Trials on March 27th 2013 and was assigned #ISRCTN 95736036 .


To compare the effect of 40 seconds versus 2 minutes brushing on saliva and dental biofilm fluid fluoride in children ages 4-5 years over 1 hour .


This was a single-blind , cross-over , randomised , two-period clinical study in healthy children .


Three days before the start of each treatment subjects received a thorough brushing and then refrained from all oral hygiene procedures .


At treatment visits , after collecting baseline biofilm and saliva samples , staff brushed the occlusal surfaces of the subject 's posterior teeth with a pea-sized amount ( 0.25 g ) of NaF/silica toothpaste for the randomised time .


Samples were taken at 5 minutes , 15 minutes , 30 minutes and 60 minutes after brushing and analysed for fluoride using a microanalytical methodology .


There was a minimum 4-day washout period between treatments .


Log changes from baseline biofilm fluid and saliva fluoride were statistically significant ( P < 0.05 ) for both brushing times at all post-brushing time-points [ except 60 minutes saliva where P = 0.06 ( t-test ) ] .


Statistically significantly greater ln-AUC ( area under the curve ) was found for biofilm fluid and salivary fluoride after brushing for 2 minutes compared with brushing for 40 seconds over the 1-hour test period .


There was a statistically significantly higher concentration of fluoride in the log change from baseline saliva levels after 5 , 15 , 30 and 60 minutes for the 2-minute brushing time compared with 40 seconds brushing time .


There was no statistically significant difference in concentration of log change from baseline fluoride levels in biofilm fluid at each individual time-point ( 5 , 15 , 30 and 60 minutes ) for the 2-minute brushing time compared with the 40-second brushing time , but significant differences were observed for 15 , 30 and 60 minutes in favour of 2-minute brushing time when log biofilm fluid value was analysed .


The findings provide further evidence for the benefits of increased duration of brushing with respect to fluoride delivery .


Repeated blood donation produces iron deficiency .


Changes in dietary iron intake do not prevent donation-induced iron deficiency .


Prolonging the interdonation interval or using oral iron supplements can mitigate donation-induced iron deficiency .


The most effective operational methods for reducing iron deficiency in donors are unknown .


` Strategies To Reduce Iron Deficiency ' ( STRIDE ) was a two-year , randomized , placebo-controlled study in blood donors .


692 donors were randomized into one of two educational groups or one of three interventional groups .


Donors randomized to educational groups either received letters thanking them for donating , or , suggesting iron supplements or delayed donation if they had low ferritin .


Donors randomized to interventional groups either received placebo , 19-mg or 38-mg iron pills .


Iron deficient erythropoiesis was present in 527 % of males and 746 % of females at enrolment .


Adverse events within 60 days of enrolment were primarily mild gastrointestinal symptoms ( 64 % ) .


The incidence of de-enrolment within 60 days was more common in the interventional groups than in the educational groups ( P = 0002 ) , but not more common in those receiving iron than placebo ( P = 068 ) .


The prevalence of iron deficient erythropoiesis in donors enrolled in the STRIDE study is comparable to previously described cohorts of regular blood donors .


De-enrolment within 60 days was higher for donors receiving tablets , although no more common in donors receiving iron than placebo .


We investigated whether screen-detected and apparently asymptomatic adults with endomysial antibodies ( EmA ) benefit from a gluten-free diet ( GFD ) .


We performed a prospective trial of 3031 individuals at risk for celiac disease based on screens for EmA .


Of 148 seropositive individuals , 40 fulfilled inclusion criteria and were assigned randomly to groups placed on a GFD or gluten-containing diets .


We evaluated ratios of small-bowel mucosal villous height : crypt depth , serology and laboratory test results , gastrointestinal symptom scores , physiologic well-being , perception of health by a visual analog scale , bone mineral density , and body composition at baseline and after 1 year .


Thereafter , the group on the gluten-containing diet started a GFD and was evaluated a third time ; subjects in the GFD group remained on this diet .


After 1 year on the GFD , the mean mucosal villous height : crypt depth values increased ( P < .001 ) , levels of celiac-associated antibodies decreased ( P < .003 ) , and gastrointestinal symptoms improved to a greater extent than in patients on gluten-containing diets ( P = .003 ) .


The GFD group also had reduced indigestion ( P = .006 ) , reflux ( P = .05 ) , and anxiety ( P = .025 ) , and better health , based on the visual analog scale ( P = .017 ) , than the gluten-containing diet group .


Only social function scores improved more in the gluten-containing diet group than in the GFD group ( P = .031 ) .


There were no differences between groups in laboratory test results , bone mineral density , or body composition .


Most measured parameters improved when patients in the gluten-containing diet group were placed on GFDs .


No subjects considered their experience to be negative and most expected to remain on GFDs .


GFDs benefit asymptomatic EmA-positive patients .


The results support active screening of patients at risk for celiac disease .


Clinicaltrials.gov no : NCT01116505 .


Statin therapy reduces low-density lipoprotein ( LDL ) cholesterol levels and the risk of cardiovascular events , but whether the addition of ezetimibe , a nonstatin drug that reduces intestinal cholesterol absorption , can reduce the rate of cardiovascular events further is not known .


We conducted a double-blind , randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter ( 1.3 to 2.6 mmol per liter ) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter ( 1.3 to 3.2 mmol per liter ) if they were not receiving lipid-lowering therapy .


The combination of simvastatin ( 40 mg ) and ezetimibe ( 10 mg ) ( simvastatin-ezetimibe ) was compared with simvastatin ( 40 mg ) and placebo ( simvastatin monotherapy ) .


The primary end point was a composite of cardiovascular death , nonfatal myocardial infarction , unstable angina requiring rehospitalization , coronary revascularization ( 30 days after randomization ) , or nonfatal stroke .