We investigated skin microcirculation and its association with HbA1c and the incidence of ischaemic foot ulcer in patients with type 1 diabetes formerly randomised ( 1982-1984 ) to intensified conventional treatment ( ICT ) or standard treatment ( ST ) with insulin for a mean of 7.5 years .


We re-determined the skin microcirculation of 72 patients ( ICT 35 vs ST 37 ) from the original Stockholm Diabetes Intervention Study with iontophoresis topically applied with the following vasoactive stimuli : acetylcholine ( ACh ) ( endothelial-dependent vasodilatation ) , sodium nitroprusside ( SNP ) ( endothelial-independent vasodilatation ) , and capsaicin ( C-nociceptive-dependent vasodilatation ) .


HbA1c levels ( mean of 14 values/patient ) were prospectively collected between 1990 and 1995 and tested for association with skin microcirculation .


The patients were followed until first hospitalisation for an ischaemic foot ulcer or until 2011 .


During the median 28years of follow-up , three patients developed ischaemic foot ulcers in the ICT group compared with ten in the ST group ( logrank , p = 0.035 ) .


At the time of iontophoresis , HbA1c was lower in the ICT group ( median 57mmol/mol [ minimum-maximum 40-79mmol / mol ] ) compared with the ST group ( 68mmol/mol [ 41-96mmol / mol ] , p < 0.01 ) ( DCCT : ICT 7.4 % [ 5.8-9 .4 % ] vs ST 8.4 % [ 5.9-10 .9 % ] ) .


Stimulated blood flow was higher in the ICT vs ST group with significantly increased perfusion units ( PU ) for : ACh ( 8.1 PU [ 4.6-24 .7 PU ] vs 5.3 PU [ 1.7-21 .4 PU ] , p < 0.01 ) ; SNP ( 8.1 PU [ 2.2-20 .1 PU ] vs 5.6 PU [ 2.3-19 .2 PU ] , p = 0.03 ) ; and capsaicin ( 5.0 PU [ 1.7-22 .9 PU ] vs 3.4 PU [ 1.5-8 .4 PU ] , p < 0.01 ) .


HbA1c was associated with vasodilatation induced by ACh ( b = -0.02 , p < 0.01 ) and capsaicin ( b = -0.02 , p = 0.03 ) .


HbA1c was independently associated with ACh ( b = -1.48 , p < 0.01 ) and capsaicin-induced vasodilatation ( b = -1.45 , p < 0.01 ) .


Improved glycaemic control in patients with type 1 diabetes is associated with an improvement in skin microcirculation and with a lower incidence of ischaemic foot ulcers .


ClinicalTrials.gov NCT01957930 .


Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia ( FM ) .


Exercise is an effective treatment , with benefits potentially mediated through changes in autonomic modulation .


Strengthening is one of the less studied exercises in FM , and the acute and chronic effects of strengthening on the autonomic system remain unknown .


The objective of this study was to assess the chronic effects of strengthening exercises ( STRE ) on autonomic modulation , pain perception and the quality of life ( QOL ) of FM patients .


Eighty sedentary women with FM ( ACR 1990 ) were randomly selected to participate in STRE or flexibility ( FLEX ) exercises in a blinded controlled trial .


The intensity of STRE was set at 45 % of the estimated load of 1 Repetition Maximum ( RM ) in 12 different exercises .


Outcomes were Visual Analog Scale ( VAS ) for pain , Heart Rate Variability ( HRV ) analysis , treadmill test , the sit and reach test ( Wells and Dillon 's Bench ) , maximal repetitions test and handgrip dynamometry ; and quality of life by the Fibromyalgia Impact Questionnaire ( FIQ ) , the Beck and Idate Trait-State Inventory ( IDATE ) , a short-form health survey ( SF-36 ) .


The STRE group was more effective to strength gain for all muscles and pain control after 4 and 16 weeks ( p < 0.05 ) .


The FLEX group showed higher improvements in anxiety ( p < 0.05 ) .


Both groups showed improvements in the QOL , and there was no significant difference observed between the groups .


There was no change in the HRV of the STRE and FLEX groups .


Strengthening exercises show greater and more rapid improvements in pain and strength than flexibility exercises .


Despite the benefits in fitness , pain , depression , anxiety and quality of life , no effect was observed on the autonomic modulation in both groups .


This observation suggests that changes in autonomic modulation are not a target tobe clinically achieved in fibromyalgia .


ClinicalTrials.gov NCT02004405 .


A prospective study was performed .


To test the hypothesis that different pedicle screw insertion positions would increase the likelihood of superior adjacent segment degeneration ( ASD ) .


Lumbar fusion surgery is a widely accepted treatment of lumbar diseases , such as lumbar stenosis , trauma , tumor , and spondylolisthesis .


Fusion and clinical success rates have increased because of improvements in instrumentation and bone graft material .


In contrast , numerous complications and problems of fusion surgery have been reported , with ASD being one of the most important .


This prospective study included 210 patients with low-grade isthmic spondylolisthesis .


From January 1999 to December 2003 , patients were randomized underwent posterolateral fusion using 2 different pedicle screw insertion positions .


The patients were followed up postoperatively and were assessed with regard to radiological and clinical outcomes .


Radiological outcomes were assessed mainly on the basis of disc degeneration , facet joint degeneration , and bone fusion .


Clinical outcomes were evaluated mainly with the use of visual analogue scale for pain and the Oswestry Disability Index .


A total of 178 of 210 ( 84.7 % ) patients were available for at least 9-year radiological and clinical follow-up data : 85.3 % ( 87/102 ) patients in group A and 84.3 % ( 91/108 ) patients in group B. Bone fusion was achieved in all patients at the last follow-up .


ASD was proven in 110 ( 61.8 % ) of 178 patients .


The incidences of radiographical and symptomatic ASD were 57.9 % ( 103/178 ) and 3.9 % ( 7/178 ) , respectively .


The incidence of ASD in group B was significantly lower than that in group A. Results of clinical outcomes showed lower visual analogue scale and Oswestry Disability Index scores in 2 groups than preoperative scores , but group B had greater improvement on the Oswestry Disability Index scores than group A in patients with ASD .


The degeneration of superior adjacent segment is closely related to the position of the pedicle screws during lumbar fusion surgery .


The position of the pedicle screw farther from the facet joint surface can reduce the degeneration of superior adjacent segment .


3 .


To evaluate the clinical efficacy and safety of acupuncture and moxibustion for the treatment of active Crohn 's disease ( CD ) .


Ninety-two patients were equally and randomly divided into the treatment group and received herb-partitioned moxibustion combined with acupuncture , and the control group received wheat bran-partitioned moxibustion combined with superficial acupuncture .


The patients received three treatment sessions per week for 12 wk and were followed up for 24 wk .


The main outcome was evaluated using the CD Activity Index ( CDAI ) score , and the secondary outcomes were evaluated using laboratory indicators such as hemoglobin ( HGB ) , C-reactive protein ( CRP ) , erythrocyte sedimentation rate , quality-of-life , endoscopic ratings , and intestinal histology scores .


The CDAI scores of both the treatment and control groups were significantly reduced after treatment compared with those measured before treatment .


However , the degree of improvement in the treatment group was significantly greater than that of the control group .


The improvement in symptoms in patients of the treatment group was sustained at follow-up , whereas that of the control group was not .


The overall efficacy of the treatment was significantly greater than that of the control .


Both groups demonstrated significant improvements in quality-of-life ratings after treatment , but the improvement was significantly greater in the treatment group than in the control group .


In addition , the patients in the treatment group showed significantly increased HGB and significantly decreased CRP levels and histopathological scores at the end of treatment , whereas the control group did not exhibit significant changes .


Moxibustion with acupuncture provided significant therapeutic benefits in patients with active CD beyond the placebo effect and is therefore an effective and safe treatment for active CD .


Closed minimal extracorporeal circulation ( MECC ) systems currently do not represent the standard of surgical care for open-heart surgery .


Yet , considering the beneficial results reported for coronary artery bypass graft ( CABG ) surgery , we used an MECC system in aortic valve replacement ( AVR ) and analysed the effects on intraoperative microvascular perfusion in comparison with conventional open extracorporeal circulation ( CECC ) .


In the current study , we analysed alterations in microvascular perfusion at 4 predefined time points ( T1-T4 ) during surgical AVR utilizing orthogonal polarization spectral ( OPS ) imaging .


Twenty patients were randomized for being operated on utilizing either MECC or CECC .


Changes in functional capillary density ( FCD , cm/cm ( 2 ) ) , mircovascular blood flow velocity ( mm/s ) and vessel diameter ( m ) were analysed by a blinded investigator .


After the start of extracorporeal circulation and aortic cross-clamping ( T2 ) , both groups showed a significant drop in FCD , but with a significantly higher FCD in the MECC group ( 153.1 15.0 cm/cm in the CECC group vs 160.8 12.2 cm/cm in the MECC group , P = 0.034 ) .


During the late phase of the cardiopulmonary bypass ( CPB ) ( T3 ) , the FCD was still significantly depressed in both treatment groups ( 153.5 14.6 cm/cm in the CECC group , P < 0.05 vs ` T1 ' ; 159.5 12.4 cm/cm in the MECC group , P < 0.05 versus ` T1 ' ) .


After termination of CPB ( T4 ) , the FCD recovered in both groups to baseline values .


Microvascular blood flow velocity tended to remain at a higher level in the MECC group , whereas haemodilution during CPB was significantly reduced in the MECC group .


The use of MECC in AVR did not affect procedural safety and , resulted in beneficial preservation of microvascular blood flow velocity and significantly reduced haemodilution during CPB .


In contrast to CABG surgery , the use of MECC did not improve FCD during surgical AVR .


Clinical advantages possibly resulting from attenuated haemodilution and preservation of microvascular blood flow velocity require further validation in larger patient cohorts .


To compare pelvic ultrasound simulators ( PSs ) with live models ( LMs ) for training in transvaginal sonography ( TVS ) .


The authors conducted a prospective , randomized controlled trial of 145 eligible medical students trained in TVS in 2011-2012 with either a PS or an LM .


A patient educator was used for LM training .


Simulated intrauterine and ectopic pregnancy models were used for PS training .


Students were tested using a standardized patient who evaluated their professionalism .


A proctor , blinded to training type , scored their scanning technique .


Digital images were saved for blinded review .


Students rated their training using a Likert scale ( 0 = not very well ; 10 = very well ) .


The primary outcome measure was students ' overall performance on a 40-point assessment tool for professionalism , scanning technique , and image acquisition .


Poisson regression and Student t test were used for comparisons .


A total of 134 students participated ( 62 trained using a PS ; 72 using an LM ) .


Mean overall test scores were 56 % for the PS group and 69 % for the LM group ( P = .001 ) .


A significant difference was identified in scanning technique ( PS , 60 % versus LM , 73 % ; P = .001 ) and image acquisition ( PS , 37 % versus LM , 59 % ; P = .001 ) .


None was observed for professionalism .


The PS group rated their training experience at 4.4 , whereas the LM group rated theirs at 6.2 ( P < .001 ) .


Simulators do not perform as well as LMs for training novices in TVS , but they may be useful as an adjunct to LM training .


Expectancies regarding treatment assignment may influence outcomes in placebo-controlled trials above and beyond actual treatment assignment .


For smoking pharmacotherapies , guessing enrollment in the active medication treatment is associated with higher abstinence rates .


However , placebo-controlled trials of smoking pharmacotherapies rarely assess perceived treatment assignment and those that do only collect this information after reaching full dosage .


To determine the temporal relationship between treatment expectancies and smoking-related variables , we assessed the impact of treatment guess during a placebo-controlled laboratory study of varenicline on measures of craving , smoking reward , and smoking reinforcement .


We hypothesized that treatment guess at mid-titration would influence smoking-related measures at full dosage , above and beyond actual medication effects .


We also explored factors related to guess stability and differences in blind fidelity between mid-drug titration and full dosage .


Eighty-eight participants completed laboratory assessments at baseline , mid-titration , and full dosage that involved self-report and behavioral measures of tonic craving , cue-provoked craving , smoking reward , and smoking reinforcement .


Participants guessed treatment assignment at mid-titration and full dosage .


Generalized linear models confirmed that , beyond actual treatment assignment , treatment guess improved model fit for both self-report and behavioral smoking-related measures .


Further , accuracy of treatment guess improved from titration to full dosage , and specific demographic factors ( e.g. , gender , race ) were associated with type of treatment guess and guess stability across time .


These results reinforce the importance of assessing perceived treatment assignment repeatedly during placebo-controlled trials and suggest that treatment expectancies during titration can affect outcomes once full dosage has been reached .


We evaluated chr6q25 .3 organic cation transporter gene ( SLC22A1 , SLC22A2 , SLC22A3 ) variation and response to smoking cessation therapies .


The corresponding proteins are low-affinity transporters of choline , acetylcholine and monoamines , and smoking cessation pharmacotherapies expressed in multiple tissues .


We selected 7 common polymorphisms for mega-regression analysis .


We assessed additive model association of polymorphisms with 7-day point prevalence abstinence overall and by assigned pharmacotherapy at end of treatment and at 6 months among European-ancestry participants of 7 randomized controlled trials adjusted for demographic , population genetic , and trial covariates .


Initial results were obtained in 6 trials with 1,839 participants .


Nominally statistically significant associations of 2 SLC22A2 polymorphisms were observed : ( 1 ) with rs316019 at 6 months , overall ( [ c. 808T > G ; p.Ser270Ala ] , OR = 1.306 , 95 % CI = 1.034-1 .649 , p = .025 ) , and among those randomized to nicotine replacement therapy ( NRT ) ( OR = 1.784 , 95 % CI = 1.072-2 .970 , p = .026 ) ; and ( 2 ) with rs316006 ( c.1502-529A > T ) among those randomized to varenicline ( OR = 1.420 , 95 % CI = 1.038-1 .944 , p = .028 , OR = 1.362 , 95 % CI = 1.001-1 .853 , p = .04 ) at end of treatment and 6 months .


Individuals randomized to NRT from a seventh trial were genotyped for rs316019 ; rs316019 was associated with a nominally statistically significant effect on abstinence overall at 6 months among 2,233 participants ( OR = 1.249 , 95 % CI = 1.007-1 .550 , p = .043 ) .


The functional OCT2 Ser270Ala polymorphism is nominally statistically significantly associated with abstinence among European-ancestry treatment-seeking smokers after adjustments for pharmacotherapy , demographics , population genetics , and without adjustment for multiple testing of 7 SNPs .


Replication of these preliminary findings in additional randomized controlled trials of smoking cessation therapies and from multiple continental populations would describe another pharmacogenetic role for SLC22A2/OCT2 .


Presbyphonia is common among elderly individuals , yet few studies have evaluated behavioral treatment approaches for presbyphonia .


The primary aim of this study was to assess the short-term efficacy of two types of voice therapy-vocal function exercises ( VFE ) and phonation resistance training exercise ( PhoRTE ) therapy-in the treatment of presbyphonia .


The secondary aim was to determine if differences in adherence and treatment satisfaction existed between the two therapy approaches .


Prospective , randomized , controlled .


Preliminary data from 16 elderly participants with presbyphonia randomly assigned to VFE , PhoRTE , or a no-treatment control group ( CTL ) were analyzed .


Before and after a 4-week intervention period , participants completed the Voice-Related Quality of Life ( V-RQOL ) questionnaire and a perceived phonatory effort ( PPE ) task .


Additionally , participants receiving treatment completed weekly practice logs and a posttreatment satisfaction questionnaire .


Preliminary data revealed VFE and PhoRTE groups demonstrated a significant improvement in V-RQOL scores .


However , only PhoRTE demonstrated a significant reduction in PPE , as suggested by the study 's causal model .


The CTL group did not demonstrate significant changes .


Numerically , VFE registered slightly greater adherence to home practice recommendations than did PhoRTE , but PhoRTE perceived greater treatment satisfaction than VFE .


Findings provide new evidence regarding the efficacy of voice therapy exercises in the treatment of age-related dysphonia and suggest PhoRTE therapy as another treatment method for improved voice-related quality of life and reduced perceived vocal effort in this population .


To determine whether a flexible vaccination regimen provides protection against challenge exposure with a virulent Leptospira borgpetersenii serovar Hardjo isolate .


Fifty-five 4-week-old calves seronegative for antibodies against L borgpetersenii serovar Hardjo .


Calves were assigned to 3 groups and administered 2 doses of adjuvant ( control calves ; n = 11 ) , 1 dose of serovar Hardjo bacterin and 1 dose of adjuvant ( 22 ) , or 2 doses of the serovar Hardjo bacterin ( 22 ) ; there was a 16-week interval between dose administrations .


Three weeks after the second dose , all calves were challenge exposed by use of conjunctival instillation of a heterologous strain of L borgpetersenii serovar Hardjo for 3 consecutive days .


Urine samples for leptospiral culture were collected for 5 weeks after challenge exposure ; at that time , all calves were euthanized and kidney samples collected for leptospiral culture .


Antibody titers increased in both leptospiral-vaccinated groups of calves .


A significant increase in antibody titers against L borgpetersenii serovar Hardjo was detected after administration of the second dose of L borgpetersenii serovar Hardjo bacterin and challenge exposure .


In 10 of 11 adjuvant-treated control calves , serovar Hardjo was isolated from both urine and kidney samples .


Leptospira borgpetersenii serovar Hardjo was not isolated from the urine or kidney samples obtained from any of the 21 remaining calves that received 1 dose of bacterin or the 20 remaining calves that received 2 doses of bacterin .


Protection in young calves was induced by vaccination with 1 or 2 doses of a serovar Hardjo bacterin .


An athlete is thought to reduce head acceleration after impact by contracting the cervical musculature , which increases the effective mass of the head .


To compare the odds of sustaining higher magnitude in-season head impacts between athletes with higher and lower preseason performance on cervical muscle characteristics .


Cohort study ; Level of evidence , 2 .


Forty-nine high school and collegiate American football players completed a preseason cervical testing protocol that included measures of cervical isometric strength , muscle size , and response to cervical perturbation .


Head impact biomechanics were captured for each player using the Head Impact Telemetry System .


A median split was used to categorize players as either high or low performers for each of the following outcome measures : isometric strength ( peak torque , rate of torque development ) , muscle size ( cross-sectional area ) , and response to cervical perturbation ( stiffness , angular displacement , muscle onset latency ) .


The odds of sustaining moderate and severe head impacts were computed against the reference odds of sustaining mild head impacts across cervical characteristic categorizations .


Linemen with stronger lateral flexors and composite cervical strength had about 1.75 times ' increased odds of sustaining moderate linear head impacts rather than mild impacts compared with weaker linemen .


Players who developed extensor torque more quickly had 2 times the increased odds of sustaining severe linear head impacts ( odds ratio [ OR ] , 2.10 ; 95 % CI , 1.08-4 .05 ) rather than mild head impacts .


However , players with greater cervical stiffness had reduced odds of sustaining both moderate ( OR , 0.77 ; 95 % CI , 0.61-0 .96 ) and severe ( OR , 0.64 ; 95 % CI , 0.46-0 .89 ) head impacts compared with players with less cervical stiffness .


The study findings showed that greater cervical stiffness and less angular displacement after perturbation reduced the odds of sustaining higher magnitude head impacts ; however , the findings did not show that players with stronger and larger neck muscles mitigate head impact severity .


To develop a new radiography-based score to assess the potential of bacteria to cause odontogenic infections derived from the occurrence of bacteria at small or large radiographical lesions .


The patients analyzed were a sub-population from a large randomized clinical trial comparing moxifloxacin and clindamycin in the treatment of inflammatory infiltrates and odontogenic abscesses .


Routine radiographs were used to analyze the area of the periapical radiolucent lesions .


Lesions were stratified by their radiographically measured area as large ( > 9 mm ( 2 ) ) or small ( 9 mm ( 2 ) ) .


A risk ratio was calculated for each species from the frequency of their occurrence in large vs in small lesions .


Fifty-one patients , 19 with abscesses and 32 with infiltrates , were evaluated .


Overall , the radiographical lesion areas ranged from 0.4-46 .2 mm ( 2 ) ( median = 9 mm ( 2 ) ) .


An increased risk ( risk ratio > 1 ) to occur at large abscess lesions was observed for Prevotella ( P. ) oralis , P. buccae , P. oris , P. intermedia , Fusobacterium nucleatum and Streptococcus ( Strep . )


anginosus group .


An increased risk to occur at large infiltrate lesions was found for Strep .


salivarius , Strep .


parasanguis , Strep .


anginosus group , Capnocytophaga spp. , Neisseria ( N. ) sicca , Neisseria spp. , Staphylococcus ( Staph . )


aureus , P. intermedia , P. buccae , Prevotella spp .


and P. melaninogenica .


The radiography-based score suggests that certain Prevotella spp. , F. nucleatum and Strep .


anginosus groups play a crucial role in the pathogenesis of odontogenic abscesses , and that various streptococci , Neisseria spp. , Capnocytophaga spp. , Staph .


aureus and Prevotella spp .


are involved in the pathogenesis of odontogenic infiltrates .


The role of fixed airflow obstruction ( FAO ) in asthma is unclear .


To assess the relationship between FAO and clinical features of asthma and the effect of FAO on treatment response .


Post hoc descriptive analysis of data stratified by FAO category ( screening post-albuterol FEV1/FVC < lower limit of normal [ LLN ] [ FAO + ] or LLN [ FAO - ] ) from two 12-week , randomized , placebo-controlled studies of budesonide/formoterol or the monocomponents in mild-moderate ( study I ; aged 6 years ; NCT00651651 ; placebo run-in ) or moderate-severe ( study II ; 12 years ; NCT00652002 ; budesonide run-in ) asthma patients .


At baseline , FAO + versus FAO - patients were more likely male and had longer asthma duration and worse pulmonary function .


During the treatment period , lung function and asthma control measures with placebo were generally worse in FAO + versus FAO - patients .


Budesonide was effective on most end points in both FAO + and FAO - patients .


In contrast to FAO - patients , FAO + patients were unresponsive to formoterol monotherapy in both study populations .


Consistently greater improvements in most end points ( including worsening of asthma as predefined by specific lung function parameters or clinical symptoms ) were observed moving from formoterol to budesonide to budesonide/formoterol in both FAO + and FAO - patients , with generally greater than additive effects on lung function with budesonide/formoterol in FAO + patients .


FAO + patients tended to be more impaired and at greater risk for an asthma event versus FAO - patients .


While FAO + patients were non-responsive to formoterol monotherapy , they retained responsiveness to budesonide and had the greatest lung function and control responses to budesonide/formoterol that were similar to or greater than responses of FAO - patients .


Inhibition of inflammatory cytokines may have therapeutic effects in diabetic retinopathy ( DR ) .


To compare aqueous and vitreous levels of 17 inflammatory cytokines in patients treated preoperatively with topical ketorolac tromethamine , 0.45 % , or placebo before pars plana vitrectomy for complications related to proliferative DR ( PDR ) .


A prospective , randomized , placebo-controlled , patient-masked interventional study performed in a university academic hospital included 20 eyes from 20 patients undergoing pars plana vitrectomy for complications of PDR .


Eyes were randomized to ketorolac tromethamine , 0.45 % ( Acuvail ) , or placebo 4 times daily for 3 days before pars plana vitrectomy .


Undiluted aqueous and vitreous samples were taken at the time of surgery and immediately frozen at -80 C.


Aqueous and vitreous levels of prostaglandin E2 and 16 other inflammatory cytokines implicated in the pathogenesis of DR.


Prostaglandin E2 , platelet-derived growth factor ( PDGF ) AA , eotaxin , vascular endothelial growth factor , interferon - inducible protein of 10 kDa , monocyte chemoattractant protein 1 , growth-related oncogene , interleukin 6 , interleukin 8 ( IL-8 ) , and tumor necrosis factor were detectable in the aqueous and vitreous of at least half of the eyes , and these cytokines were analyzed further .


Aqueous levels were lower in the ketorolac group for all cytokines detected , but only the difference in IL-8 was statistically significant ( 52 % reduction ; P = .04 ) .


Levels of IL-8 ( 41 % reduction ; P = .002 ) and PDGF-AA ( 21 % reduction ; P = .009 ) were significantly lower in the vitreous of patients treated with ketorolac .


Topical ketorolac tromethamine , 0.45 % , significantly lowered aqueous IL-8 levels and vitreous IL-8 and PDGF-AA levels in this series of eyes , suggesting that it may cause meaningful inhibition of inflammatory cytokines implicated in the pathogenesis of DR.


clinicaltrials.gov Identifier : NCT01609881 .


The effects of the DASH ( Dietary Approaches to Stop Hypertension ) diet on inflammation in childhood metabolic syndrome ( MetS ) have still to be identified .


To examine the effects of the DASH diet on markers of systemic inflammation in adolescents with MetS .


In this randomized , cross-over clinical trial , 60 postpubescent girls with MetS were randomly assigned to receive either the DASH diet menu cycles or usual dietary advice ( UDA ) for 6 weeks .


After a 4-week washout period , participants were crossed over to the alternate arm .


The DASH diet was designed to maintain the current body weight .


This diet contained high amounts of fruit , vegetables and low-fat dairy products and was low in saturated fats and cholesterol .


UDA consisted of general oral advice and written information about healthy food choices based on the Healthy Eating Plate .


Compliance to the DASH diet was assessed through quantification of plasma vitamin C levels .


Fasting venous blood samples were taken 4 times from each participant : at baseline and at the end of each study arm .


Circulating levels of biomarkers of systemic inflammation were quantified according to standard protocols .


Mean ( SD ) age and weight of participants was 14.2 years ( 1.7 ) and 69 kg ( 14.5 ) , respectively .


Serum vitamin C levels tended to increase during the DASH phase compared with the UDA phase ( 16.8 12.9 vs. -13.8 9.7 ng/dl , respectively , p = 0.06 ) indicating a relatively good compliance to the DASH diet .


Adherence to the DASH diet , compared to the UDA , had a significant effect on serum high-sensitivity C-reactive protein levels ( p = 0.002 ) .


This effect remained significant even after adjustment for weight changes and after further controlling for changes in lipid profiles .


We did not observe any significant effect of intervention on levels of serum tumor necrosis factor-alpha , interleukin ( IL ) -2 , IL-6 and adiponectin , in either the crude or adjusted models .


There were no significant group * time interactions for any dependent variable , except for IL-6 ; this was close to the significant level .


In summary , consumption of the DASH eating pattern for 6 weeks may reduce circulating levels of hs-CRP among adolescents with MetS .


Other inflammatory markers were not affected by the DASH diet .


Abiraterone acetate plus prednisone significantly improved radiographic progression-free survival compared with placebo plus prednisone in men with chemotherapy-naive castration-resistant prostate cancer at the interim analyses of the COU-AA-302 trial .


Here , we present the prespecified final analysis of the trial , assessing the effect of abiraterone acetate plus prednisone on overall survival , time to opiate use , and use of other subsequent therapies .


In this placebo-controlled , double-blind , randomised phase 3 study , 1088 asymptomatic or mildly symptomatic patients with chemotherapy-naive prostate cancer stratified by Eastern Cooperative Oncology performance status ( 0 vs 1 ) were randomly assigned with a permuted block allocation scheme via a web response system in a 1:1 ratio to receive either abiraterone acetate ( 1000 mg once daily ) plus prednisone ( 5 mg twice daily ; abiraterone acetate group ) or placebo plus prednisone ( placebo group ) .


Coprimary endpoints were radiographic progression-free survival and overall survival analysed in the intention-to-treat population .


The study is registered with ClinicalTrials.gov , number NCT00887198 .


At a median follow-up of 49.2 months ( IQR 47.0-51 .8 ) , 741 ( 96 % ) of the prespecified 773 death events for the final analysis had been observed : 354 ( 65 % ) of 546 patients in the abiraterone acetate group and 387 ( 71 % ) of 542 in the placebo group .


238 ( 44 % ) patients initially receiving prednisone alone subsequently received abiraterone acetate plus prednisone as crossover per protocol ( 93 patients ) or as subsequent therapy ( 145 patients ) .


Overall , 365 ( 67 % ) patients in the abiraterone acetate group and 435 ( 80 % ) in the placebo group received subsequent treatment with one or more approved agents .


Median overall survival was significantly longer in the abiraterone acetate group than in the placebo group ( 34.7 months [ 95 % CI 32.7-36 .8 ] vs 30.3 months [ 28.7-33 .3 ] ; hazard ratio 0.81 [ 95 % CI 0.70-0 .93 ] ; p = 0.0033 ) .


The most common grade 3-4 adverse events of special interest were cardiac disorders ( 41 [ 8 % ] of 542 patients in the abiraterone acetate group vs 20 [ 4 % ] of 540 patients in the placebo group ) , increased alanine aminotransferase ( 32 [ 6 % ] vs four [ < 1 % ] ) , and hypertension ( 25 [ 5 % ] vs 17 [ 3 % ] ) .


In this randomised phase 3 trial with a median follow-up of more than 4 years , treatment with abiraterone acetate prolonged overall survival compared with prednisone alone by a margin that was both clinically and statistically significant .


These results further support the favourable safety profile of abiraterone acetate in patients with chemotherapy-naive metastatic castration-resistant prostate cancer .


Janssen Research & Development .


Chronic low back pain is one of the four most common diseases in the world with great socioeconomic impact .


Supervised exercise therapy is one of the treatments suggested for this condition ; however , the recommendation on the best type of exercise is still unclear .


The Pilates method of exercise is effective in reducing pain and disability in these patients , as well as the analgesia promoted by interferential current .


Currently , the literature lacks information on the efficacy of the association of these two techniques in the short - and medium-term than performing one of the techniques isolated .


The objective of this study will be to evaluate the efficacy of adding interferential current to the Pilates method exercises for the treatment of patients with chronic nonspecific low back pain in the short - and medium-term .


This study will be a randomized controlled trial with two arms and blinded evaluator , conducted at an outpatient Physical Therapy Department in Brazil .


Patients with nonspecific chronic low back pain and pain equal to or greater than 3 in the Pain Numerical Rating Scale ( 0/10 ) will be randomly assigned to one of two groups : Group with active interferential current + Pilates ( n = 74 ) will be submitted to the active interferential current associated to the modified Pilates exercises , and Group with sham interferential current + Pilates ( n = 74 ) will be submitted to the sham interferential current associated with the modified Pilates exercises during 18 sessions .


The outcomes pain intensity , pressure pain threshold , general and specific disability , global perceived effect and kinesiophobia will be evaluated by a blinded assessor at baseline , six weeks and six months after randomization .


Because of the study design , blinding of the participants and the therapists involved in the study will not be possible .


The results of this study could contribute to the process of clinical decision - making for the improvement of pain and disability in participants with nonspecific chronic low back pain .


ClinicalTrials.gov NCT01919268 .


To verify the regulatory effects of acupuncture on exercise tolerance in patients with chronic obstructive pulmonary disease ( COPD ) at stable phase .


Thirty cases of COPD were randomly divided into a treatment group ( 16 cases ) and a placebo group ( 14 cases ) .


Based on specified aerobic exercise , acupuncture was applied in the treatment group and placebo acupuncture was used in the placebo group .


The acupoints included Danzhong ( CV 17 ) , Rugen ( ST 18 ) , Guanyuan ( CV 4 ) , Zhongwan ( CV 12 ) , Tianshu ( ST 25 ) and so on .


The needle did not penetrate into the skin for the placebo group .


The treatment was required for 2 to 3 times per week for totally 5 weeks .


The indices of exercise tolerance , including 6-min walking distance ( 6-MWD ) , exercise time , maximum oxygen uptake ( VO2max ) forced expiratory volume in 1 second ( FEV1 ) / forced vital capacity ( FVC ) , maximum ventilatory volume ( MVV ) , St. George respiratory questionnaire ( SGRQ ) were observed in two groups before and after treatment .


( 1 ) Exercise tolerance : the differences of 6-MWD and exercise time were statistically significant between groups , which were more superior in the treatment group ( both P < 0.01 ) ; the VO2max was significantly increased after treatment in the treatment group ( P < 0.05 ) , but there was no difference between two groups ( P > 0.05 ) .


( 2 ) Pulmonary ventilation function : the differences of FEV1 % , FEV1/FVC and MVV % were statistically significant between groups , which were more superior in the treatment group ( P < 0.05 , P < 0.01 ) ; ( 3 ) SGRQ : the SGRQ was significantly improved after treatment in the treatment group ( P < 0.05 ) , but there was no difference between two groups ( P > 0.05 ) .


The acupuncture could improve the exercise tolerance in patients with chronic obstructive pulmonary disease at stable phase , and shorten the onset time of aerobic exercise .


Besides , acupuncture combined with aerobic exercise could effectively improve the pulmonary function .


Currently , task time and errors are often used as performance parameters in laparoscopic training .


Training with the focus on task time improvement alone results in fast , but possibly less controlled , instrument movements and therefore suboptimal tissue handling skills .


Twenty-five medical students were randomly assigned in two groups .


Both groups performed a tissue manipulation task six times .


During this training session , the time feedback group ( n = 13 ) received real-time visual feedback of the task time .


The force feedback group ( n = 12 ) received real-time visual feedback of the tissue manipulation force .


After the training sessions , participants in both groups performed an entirely different task without visual feedback .


Task time , force , and motion parameters of this posttest were used to compare the technical skills of the medical students .


The training data of the group that received force feedback showed a learning curve for the mean and max absolute force , max force area , force volume , task time , and path length of both instruments .


The data from the group that received time feedback showed a learning curve for the max force , task time , and path length of both instruments .


In the posttest , the parameters of mean absolute force ( p = 0.039 ) , max force ( p = 0.041 ) , and force volume ( p = 0.009 ) showed a significant difference in favor of the group that received force feedback .


The learning curves and the posttest indicate that training with visual force feedback improves tissue handling skills with no negative effect on the task time and instrument motions .


Conventional laparoscopic training with visual time feedback improves instrument motion and task time , but it does not improve tissue manipulation skills .


To determine the association of body mass index ( BMI ) on complications , recurrence , and survival in GOG LAP2 , a randomized comparison of laparoscopic versus open staging in clinically early stage uterine cancer ( EC ) .


An ancillary data analysis of GOG LAP2 was performed .


Categorical variables were compared using Pearson chi-square test and continuous variables using the Wilcoxon-Mann-Whitney and Kruskal-Wallis tests by BMI group .


Survival was estimated using the Kaplan-Meier method .


Cox proportional hazards model was used to evaluate independent prognostic factors on survival .


Statistical tests were two-tailed with = 0.05 , except where noted .


Statistical analyses utilized R programming language .


2596 women were included .


BMI ( kg/m ( 2 ) ) groups were < 25 ( 29.5 % ) , 25-30 ( 28.2 % ) , 30-35 ( 21 % ) , 35-40 ( 10.9 % ) , and 40 ( 10.4 % ) .


Stage ( p = 0.021 ) , grade ( p < 0.001 ) , and histology ( p = 0.005 ) differed by BMI .


Obese women were less likely to have high risk ( HR ) disease ( + lymph nodes/ovaries/cytology ) or tumor features that met GOG99 high intermediate risk ( HIR ) criteria ( p < 0.001 ) .


Adjuvant therapy ( p = 0.151 ) and recurrence ( p = 0.46 ) did not vary by BMI .


Hospitalization > 2days , antibiotic use , wound infection , and venous thrombophlebitis were higher with BMI 40 .


BMI ( p = 0.016 ) , age ( p < 0.0001 ) , race ( p = 0.033 ) , and risk group ( p < 0.0001 ) predicted all-cause mortality .


BMI was not predictive of disease-specific survival ( p = 0.79 ) , but age ( p = 0.032 ) and risk group ( p < 0.0001 ) were significant factors .


Obese women have greater surgical risk and lower risk of metastatic disease .


BMI is associated with all-cause but not disease-specific mortality , emphasizing the detrimental effect of obesity ( independent of EC ) , which deserves particular attention .


To evaluate the efficacy of corneal debridement in the treatment of clinically diagnosed cases of microsporidial keratoconjunctivitis .


Prospective , double-masked randomized clinical trial .


Patients with clinical features such as multifocal , coarse , raised , punctate , round to oval epithelial lesions in the cornea in slit-lamp examination with mild to moderate conjunctival congestion , suggestive of microsporidial superficial keratoconjunctivitis , were included in the prospective study .


All patients were randomized into 2 groups .


Group 1 patients underwent debridement with the help of a sterile # 15 blade on a Bard-Parker handle , whereas only conjunctival swabs were taken from Group 2 patients .


All patients were treated with ocular lubricants .


One hundred and twenty patients with clinical features suggestive of microsporidial superficial keratoconjunctivitis were included in the study .


The mean age was 34.3 13.6 years ( Group 1 ) and 35.8 16.2 years ( Group 2 ) ( P = .59 ) .


The mean duration of symptoms was 6.8 3.9 days ( Group 1 ) and 7.2 4.6 days ( Group 2 ) ( P = .61 ) .


Baseline characteristics showed no difference between the 2 groups .


The primary outcome was the time from the presentation to complete resolution ( ie , absence of corneal lesions ) of the clinical signs and symptoms .


The secondary outcomes were final visual acuity and residual corneal side effects and/or scarring , if any .


The mean resolution time of the corneal lesions was 5.7 4.0 days ( Group 1 ) and 5.9 3.9 days ( Group 2 ) ( P = .83 ) .


There was no significant difference in final visual outcome in the 2 groups .


No serious side effects were observed .


Debridement does not have any significant advantage in terms of resolution of the corneal lesions and final visual outcome in cases of microsporidial keratoconjunctivitis .


Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established .


The primary aim of this study is to assess the cost-effectiveness ( cost-utility ) of these management options .


In addition , given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials , we compare different analytical methodologies .


A trial-based economic evaluation to assess the cost-utility of joint protection only , hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective .


Patient-level mean costs and mean quality-adjusted life years ( QALYs ) were calculated for each trial arm .


Incremental cost-effectiveness ratios ( ICERs ) were estimated and cost-effectiveness acceptability curves were constructed .


The base case analysis used a within-the-table analysis methodology .


Two further methods were explored : the at-the-margins approach and a regression-based approach with or without an interaction term .


Mean costs ( QALYs ) were 58.46 ( s.d. 0.662 ) for leaflet and advice , 92.12 ( s.d. 0.659 ) for joint protection , 64.51 ( s.d. 0.681 ) for hand exercises and 112.38 ( s.d. 0.658 ) for joint protection plus hand exercises .


In the base case , hand exercises were the cost-effective option , with an ICER of 318 per QALY gained .


Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches .


This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA .


Our findings showed that hand exercises were the most cost-effective option .


Supervised consumption of opiate substitution treatment is standard practice in the UK yet little is known about the patient experience of this treatment modality .


This study aimed to assess the patient experience of receiving supervised compared with unsupervised consumption of methadone or buprenorphine .


A qualitative study utilising a grounded theory approach to analysis .


Participants ( 29 ) were theoretically sampled from 293 opioid-dependent patients entering a randomised controlled trial of opiate substitution treatment across four urban and community drug treatment services in England .


Multidisciplinary staff were recruited for interviews and focus groups ( 55 ) .


Supervised consumption was accepted by patients , despite causing practical limitations and raising issues of privacy and stigma .


Patients recognised that establishing a daily routine away from illicit drugs was useful early in treatment .


However , having flexibility to move away from supervision was important .


Unsupervised patients reported that they ultimately preferred this treatment approach and appreciated the trust and sense of reward that unsupervised treatment bought .


Clinicians expressed confidence in supervised prescribing and reduced risk for their patients , but also concern that a minority of individuals may remain inappropriately supervised for lengthy time periods .


This study provides an important patient perspective and is the first in-depth qualitative investigation directly comparing supervision with unsupervised treatment to consider both patient and professional perspectives .


Overall , our qualitative findings suggest that flexibly timed discontinuation of supervision may have positive benefits .


To identify eyes of patients with diabetes type 2 that show progression of retinal disease within a 1-year period using noninvasive techniques .


Three hundred seventy-four type 2 diabetic patients with mild nonproliferative diabetic retinopathy ( Early Treatment Diabetic Retinopathy Study [ ETDRS ] level 20 or 35 ) were included in a 12-month prospective observational study to identify retinopathy progression .


Four visits were scheduled at 0 , 3 , 6 , and 12 months .


Microaneurysm ( MA ) activity using the RetmarkerDR and retinal thickness using spectral-domain optical coherence tomography ( SD-OCT ) were assessed by a central reading center at all visits and ETDRS severity level in the first and last visits .


Three hundred thirty-one eyes/patients completed the study .


Microaneurysm formation rate greater than or equal to 2 was present in 68.1 % of the eyes and MA turnover greater than or equal to 6 in 54.0 % at month 6 .


Higher MA turnover values were registered in eyes that showed progression in ETDRS severity level ( P < 0.03 ) .


There were also significant correlations between increased microaneurysm activity and increases in retinal thickness .


Spectral-domain OCT identified clinical macular edema in 24 eyes/patients ( 6.7 % ) and subclinical macular edema in 104 eyes/patients ( 28.9 % ) at baseline .


Progression of retinal thickening was registered in eyes that had either subclinical or clinical macular edema at baseline .


Changes in MA activity measured with RetmarkerDR and in central retinal thickness in eyes with mild nonproliferative diabetic retinopathy and diabetes type 2 are able to identify eyes at risk of progression .


These eyes/patients should be selected for inclusion in future clinical trials of drugs targeted to prevent diabetic retinopathy progression to vision-threatening complications .


( ClinicalTrials.gov number , NCT01145599 . )


We evaluated the association between cardiovascular autonomic neuropathy , and erectile dysfunction and lower urinary tract symptoms in men with type 1 diabetes .


Male type 1 diabetes participants ( 635 ) in the DCCT/EDIC were studied .


Cardiovascular autonomic neuropathy was assessed by standardized cardiovascular reflex tests including changes in respiratory rate variation with deep breathing , Valsalva maneuver ( Valsalva ratio ) and changes in supine to standing diastolic blood pressure .


Erectile dysfunction was assessed by a proxy item from the International Index of Erectile Function , and lower urinary tract symptoms were assessed with the AUASI ( American Urological Association Symptom Index ) .


Multivariable logistic regression models estimated the association between cardiovascular autonomic neuropathy and erectile dysfunction and/or lower urinary tract symptoms , adjusting for time weighted glycemic control , blood pressure , age and other covariates .


Men in whom erectile dysfunction and/or lower urinary tract symptoms developed during EDIC had a significantly lower respiratory rate variation and Valsalva ratio at DCCT closeout and EDIC year 16/17 compared to those without erectile dysfunction or lower urinary tract symptoms .


In adjusted analysis , participants with cardiovascular autonomic neuropathy had 2.65 greater odds of erectile dysfunction and lower urinary tract symptoms ( 95 % CI 1.47-4 .79 ) .


These data suggest that cardiovascular autonomic neuropathy predicts the development of urological complications in men with long-standing type 1 diabetes .


Studies evaluating the mechanisms contributing to these interactions are warranted for targeting effective prevention or treatment .


Physiotherapy treatment of frozen shoulder is varied , but most lack specific focus on the underlying disorder , which is the adhered shoulder capsule .


Although positive effects were found after physiotherapy , the recurrence and prolonged disability of a frozen shoulder are major factors to focus on to provide the appropriate treatment .


We wished to study the effectiveness of a shoulder countertraction apparatus on ROM , pain , and function in patients with a frozen shoulder and compare their results with those of control subjects who received conventional physiotherapy .


A total of 100 participants were randomly assigned to an experimental group and a control group , with each group having 50 participants .


The control group received physiotherapy and the experimental group received countertraction and physiotherapy .


The total treatment time was 20 minutes a day for 5 days per week for 2 weeks .


The outcome measures used were goniometer measurements , VAS , and the Oxford Shoulder Score .


Improvements were seen in the scores for shoulder flexion ( 94.1 19.79 at baseline increased to 161.9 13.05 after intervention ) , abduction ROM ( 90.4 21.18 at baseline increased to 154.8 13.21 after intervention ) , and pain ( 8.00 0.78 at baseline decreased to 3.48 0.71 after intervention ) in the experimental group .


Sixty percent of the participants ( n = 30 ) were improved to the fourth stage of satisfactory joint function according to the Oxford Shoulder Score in the experimental group compared with 18 % ( n = 9 ) in the control group ( p < 0.001 ) .


Incorporating shoulder countertraction along with physiotherapy improves shoulder function compared with physiotherapy alone for the treatment of a frozen shoulder .


Additional studies are needed focusing on this concept to increase the generalizability of the counter-traction apparatus in various groups .


Level II , prospective comparative study .


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


In The Netherlands , excessive alcohol use ( e.g. , binge drinking ) is prevalent among adolescents .


Alcohol use in general and binge drinking in particular comes with various immediate and long term health risks .


Thus , reducing binge drinking among this target group is very important .


This article describes a two-arm Cluster Randomized Controlled Trial ( CRCT ) of an intervention aimed at reducing binge drinking in this target group .


The intervention is a Web-based , computer-tailored game in which adolescents receive personalized feedback on their drinking behavior aimed at changing motivational determinants related to this behavior .


The development of the game is grounded in the I-Change Model .


A CRTC is conducted to test the effectiveness of the game .


Adolescents are recruited through schools , and schools are randomized into the experimental condition and the control condition .


The experimental condition fills in a baseline questionnaire assessing demographic variables , motivational determinants of behavior ( attitude , social influences , self-efficacy , intention ) and alcohol use .


They are also asked to invite their parents to take part in a short parental component that focusses on setting rules and communicating about alcohol .


After completing the baseline questionnaire , the experimental condition continues playing the first of three game scenarios .


The primary follow-up measurement takes place after four months and a second follow-up after eight months .


The control condition only fills in the baseline , four and eight month follow-up measurement and then receives access to the game ( i.e. , a waiting list control condition ) .


The effectiveness of the intervention to reduce binge drinking in the previous 30 days and alcohol use in the last week will be assessed .


Furthermore , intention to drink and binge drink are assessed .


Besides main effects , potential subgroup differences pertaining to gender , age , and educational background are explored .


The study described in this article gives insight into the effectiveness of a possible solution for a prominent public health issue in The Netherlands , which is binge drinking among 16 to 18 year old adolescents .


Dutch Trial Register ( NTR4048 ) .


Trial registered on 06/26/2013 .


To compare clinical outcomes from outpatient with inpatient cervical prostaglandin E2 ripening for low risk labour induction .


Randomised controlled trial .


Two tertiary hospitals in Adelaide , Australia .


Women with uncomplicated term pregnancies , scheduled for induction of labour for reasons of post-dates or for social reasons .


Eight hundred and twenty-seven women were randomised at induction decision to an outpatient or inpatient group .


All women had CTG monitoring before and after vaginal PgE2 administration .


The inpatient women were admitted and the outpatient group was discharged home overnight with instructions to return if labour established or rupture of membranes occurred .


Next morning , outpatient women were admitted for rupture of membranes or further ripening .


After membrane rupture , both groups received routine care .


Oxytocin use , maternal and fetal outcomes , and whether planned outpatient management was achievable .


There were no significant differences in oxytocin use ( 2.5 % difference , CI-4 .3 to 9.4 ) , caesarean sections ( -0.59 % difference , CI-6 .3 to 5.1 ) , epidural use ( 1.5 % difference , CI-5 .1 to 8.2 ) , vaginal delivery within 24 hours ( -8.2 % difference , CI-17 .6 to 1.3 ) or labour complications .


More than half of the randomised women did not receive the intervention as they laboured spontaneously , or did not require ripening .


The post-hoc analysis of women who received ripening also indicated no statistically significant differences in the patterns or results , with the exception of outpatient women having a longer mean length of active labour ( mean difference 66 minutes , CI 4-128 minutes ) .


Outpatient women who received ripening were diagnosed more frequently with non-reassuring CTG monitoring and hyperstimulation , with less than half of the women going home and remaining home overnight .


This study demonstrated no clinical advantage or disadvantage in prostaglandin E2 outpatient cervical ripening .


Uterine stimulation following prostaglandins may preclude a woman from going home or remaining at home overnight and may not be the best agent for outpatient ripening .


Microvascular alterations impair tissue oxygenation during sepsis .


A red blood cell ( RBC ) transfusion increases oxygen ( O2 ) delivery but rarely improves tissue O2 uptake in patients with sepsis .


Possible causes include RBC alterations due to prolonged storage or residual leukocyte-derived inflammatory mediators .


The aim of this study was to compare the effects of two types of transfused RBCs on microcirculation in patients with sepsis .


In a prospective randomized trial , 20 patients with sepsis were divided into two separate groups and received either non-leukodepleted ( n = 10 ) or leukodepleted ( n = 10 ) RBC transfusions .


Microvascular density and perfusion were assessed with sidestream dark field ( SDF ) imaging sublingually , before and 1 hour after transfusions .


Thenar tissue O2 saturation ( StO2 ) and tissue hemoglobin index ( THI ) were determined with near-infrared spectroscopy , and a vascular occlusion test was performed .


The microcirculatory perfused boundary region was assessed in SDF images as an index of glycocalyx damage , and glycocalyx compounds ( syndecan-1 , hyaluronan , and heparan sulfate ) were measured in the serum .


No differences were observed in microvascular parameters at baseline and after transfusion between the groups , except for the proportion of perfused vessels ( PPV ) and blood flow velocity , which were higher after transfusion in the leukodepleted group .


Microvascular flow index in small vessels ( MFI ) and blood flow velocity exhibited different responses to transfusion between the two groups ( P = 0.03 and P = 0.04 , respectively ) , with a positive effect of leukodepleted RBCs .


When within-group changes were examined , microcirculatory improvement was observed only in patients who received leukodepleted RBC transfusion as suggested by the increase in De Backer score ( P = 0.02 ) , perfused vessel density ( P = 0.04 ) , PPV ( P = 0.01 ) , and MFI ( P = 0.04 ) .


Blood flow velocity decreased in the non-leukodepleted group ( P = 0.03 ) .


THI and StO2 upslope increased in both groups .


StO2 and StO2 downslope increased in patients who received non-leukodepleted RBC transfusions .


Syndecan-1 increased after the transfusion of non-leukodepleted RBCs ( P = 0.03 ) .


This study does not show a clear superiority of leukodepleted over non-leukodepleted RBC transfusions on microvascular perfusion in patients with sepsis , although it suggests a more favorable effect of leukodepleted RBCs on microcirculatory convective flow .


Further studies are needed to confirm these findings .


ClinicalTrials.gov , NCT01584999 .


Dermal fillers have continuingly been under development to increase safety , efficacy , and longevity .


Biostimulatory dermal fillers , such as calcium hydroxylapatite fillers , have already been shown to be superior in efficacy compared to nonanimal stabilized hyaluronic acid ( NASHA ) - based fillers .


In this randomized split-face study , we compared a novel biostimulatory polycaprolactone ( PCL ) - based dermal filler with a NASHA-based dermal filler , for safety , efficacy , and duration of cosmetic correction for the treatment of nasolabial folds ( NLFs ) .


Forty subjects received a PCL-based dermal filler in one of their NLFs , and a NASHA-based dermal filler on the contralateral side .


Efficacy was evaluated based on the Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale .


After 6 , 9 , and 12months post-treatment , NLFs treated with the PCL-based dermal filler showed statistically significant improvements on the Wrinkle Severity Rating Scale and greater improvements on the GAIS compared to NLFs treated with the NASHA-based dermal filler .


Both products were found to be equally safe and well tolerated .


Our results suggest that PCL-based dermal fillers offer longer-lasting performance over NASHA-based dermal fillers in NLFs treatment .


A randomized , double-blind , placebo-controlled flexible-dose , parallel group trial was conducted at 26 clinical investigational sites in the United States to examine the safety and efficacy of the selegiline transdermal system ( STS ) ( EMSAM ) in adolescents ( ages 12-17 years ) meeting American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed .


( DSM-IV ) criteria for moderate to severe major depressive disorder ( MDD ) without psychotic features .


Adolescents ( n = 308 ) with moderate to severe MDD were randomized to either STS ( n = 152 ) or placebo ( n = 156 ) .


Two hundred and fifteen ( 69.8 % ) subjects completed the study and 17 ( 5.5 % ) reported discontinuation because of adverse events ( AEs ) .


The primary efficacy outcome measure was the mean change from baseline to end of study ( week 12 last observation carried forward [ LOCF ] ) in the Children 's Depression Rating Scale-Revised ( CDRS-R ) total score .


Secondary outcome measures included end-point Clinical Global Impressions - Severity ( CGI-S ) and Clinical Global Impressions - Improvement ( CGI-I ) .


Patients on STS or placebo had a significant decline from baseline ( p < 0.001 ) on their CDRS-R total score with mean reductionsSD as follows : STS 21.416.6 ; placebo 21.516.5 .


Both groups had similar response rates ( 58.6 % vs. 59.3 % ) defined as CGI-I of 1 or 2 at study end .


However , these between-group efficacy findings were without statistical significance .


The overall incidence of reported AEs was 62.5 % for STS-treated patients and 57.7 % for placebo-treated patients .


Most commonly reported AEs in STS or placebo groups were application site reactions ( STS = 24.3 % ; placebo = 21.8 % ) , headache ( STS = 17.1 % ; placebo = 16.7 % ) , and nausea ( STS = 7.2 % ; placebo = 7.7 % ) .


Treatment groups did not differ on any laboratory parameters , vital signs , or electrocardiogram ( ECG ) findings .


No suspected hypertensive crises were reported in the trial .


These data demonstrated that the STS was safe and well tolerated in this adolescent sample .


However , both STS-treated and placebo-treated subjects demonstrated a decline from baseline in depressive symptoms ( CDRS-R total score ) over the length of the study , without statistical superiority by either group .


Wind farm developments have been hampered by claims that sound from wind turbines causes symptoms and negative health reports in nearby residents .


As scientific reviews have failed to identify a plausible link between wind turbine sound and health effects , psychological expectations have been proposed as an explanation for health complaints .


Building on recent work showing negative expectations can create symptoms from wind turbines , we investigated whether positive expectations can produce the opposite effect , in terms of a reduction in symptoms and improvements in reported health .


60 participants were randomized to either positive or negative expectation groups and subsequently exposed to audible wind farm sound and infrasound .


Prior to exposure , negative expectation participants watched a DVD incorporating TV footage about health effects said to be caused by infrasound produced by wind turbines .


In contrast , positive expectation participants viewed a DVD that outlined the possible therapeutic effects of infrasound exposure .


During exposure to audible windfarm sound and infrasound , symptoms and mood were strongly influenced by the type of expectations .


Negative expectation participants experienced a significant increase in symptoms and a significant deterioration in mood , while positive expectation participants reported a significant decrease in symptoms and a significant improvement in mood .


The study demonstrates that expectations can influence symptom and mood reports in both positive and negative directions .


The results suggest that if expectations about infrasound are framed in more neutral or benign ways , then it is likely reports of symptoms or negative effects could be nullified .


To replicate the associations of leukocyte telomere length ( LTL ) with variants at four loci and to investigate their associations with coronary heart disease ( CHD ) and type II diabetes ( T2D ) , in order to examine possible causal effects of telomere maintenance machinery on disease aetiology .


Four SNPs at three loci BICD1 ( rs2630578 GC ) , 18q12 .2 ( rs2162440 GT ) , and OBFC1 ( rs10786775 CG , rs11591710 AC ) were genotyped in four studies comprised of 2353 subjects out of which 1148 had CHD and 566 T2D .


Three SNPs ( rs12696304 CG , rs10936601G > T and rs16847897 GC ) at the TERC locus were genotyped in these four studies , in addition to an offspring study of 765 healthy students .


For all samples , LTL had been measured using a real-time PCR-based method .


Only one SNP was associated with a significant effect on LTL , with the minor allele G of OBFC1 rs10786775 SNP being associated with longer LTL ( = 0.029 , P = 0.04 ) .


No SNPs were significantly associated with CHD or T2D .


For OBFC1 the haplotype carrying both rare alleles ( rs10786775G and rs11591710C , haplotype frequency 0.089 ) was associated with lower CHD prevalence ( OR : 0.77 ; 95 % CI : 0.61-0 .97 ; P = 0.03 ) .


The TERC haplotype GTC ( rs12696304G , rs10936601T and rs16847897C , haplotype frequency 0.210 ) was associated with lower risk for both CHD ( OR : 0.86 ; 95 % CI : 0.75-0 .99 ; P = 0.04 ) and T2D ( OR : 0.74 ; 95 % CI : 0.61-0 .91 ; P = 0.004 ) , with no effect on LTL .


Only the last association remained after adjusting for multiple testing .


Of reported associations , only that between the OBFC1 rs10786775 SNP and LTL was confirmed , although our study has a limited power to detect modest effects .


A 2-SNP OBFC1 haplotype was associated with higher risk of CHD , and a 3-SNP TERC haplotype was associated with both higher risk of CHD and T2D .


Further work is required to confirm these results and explore the mechanisms of these effects .


To examine whether older adults with vision impairment differentially benefit from cognitive speed of processing training ( SPT ) relative to healthy older adults .


Secondary data analyses were conducted from a randomised trial on the effects of SPT among older adults .


The effects of vision impairment as indicated by ( 1 ) near visual acuity , ( 2 ) contrast sensitivity , ( 3 ) self-reported cataracts and ( 4 ) self-reported other eye conditions ( e.g. , glaucoma , macular degeneration , diabetic retinopathy , optic neuritis , and retinopathy ) among participants randomised to either SPT or a social - and computer-contact control group was assessed .


The primary outcome was Useful Field of View Test ( UFOV ) performance .


Mixed repeated-measures ancovas demonstrated that those randomized to SPT experienced greater baseline to post-test improvements in UFOV performance relative to controls ( p 's < 0.001 ) , regardless of impairments in near visual acuity , contrast sensitivity or presence of cataracts .


Those with other eye conditions significantly benefitted from training ( p = 0.044 ) , but to a lesser degree than those without such conditions .


Covariates included age and baseline measures of balance and depressive symptoms , which were significantly correlated with baseline UFOV performance .


Among a community-based sample of older adults with and without visual impairment and eye disease , the SPT intervention was effective in enhancing participants ' UFOV performance .


The analyses presented here indicate the potential for SPT to enhance UFOV performance among a community-based sample of older adults with visual impairment and potentially for some with self-reported eye disease ; further research to explore this area is warranted , particularly to determine the effects of eye diseases on SPT benefits .


Flu-like symptoms ( FLS ) are commonly experienced by patients receiving interferon gamma-1b which may cause discontinuation or disruption of dosing during initial therapy or on re-initiation following a break in therapy .


In contrast to Type I interferons , the impact of dose-titration on FLS has not been reported and is not a practice described or included in the approved prescribing information for interferon gamma-1b .


The objective of this study was to assess the effect of a 2 week titration regimen on the severity of FLS during the initial 3 weeks of therapy with three times weekly subcutaneous injections of interferon gamma-1b .


Healthy men and women were randomized into a double-blind , two-period , crossover study .


Each study period was 3 weeks in duration and there was a minimum 15 day washout between treatment periods .


Two treatment regimens were compared : No Titration dosing ( full 50mcg/m ( 2 ) subcutaneously [ s.c. ] three times weekly for 3 weeks ) and Titration ( 15mcg/m ( 2 ) s.c. three times weekly during week 1 , 30mcg/m ( 2 ) s.c. three times weekly during week 2 followed by the full dose of 50mcg/m ( 2 ) s.c. three times weekly during week 3 ) .


Subjects remained in the clinic for at least 12 hours following each injection .


FLS was based on a composite score for fever , chills , tiredness and muscle aches assessed at baseline and 4 , 8 and 12 hours following each injection .


Acetaminophen was allowed at the discretion of the PI .


The primary endpoint was the change from baseline in FLS severity at 8 hours averaged over the 3 weeks of treatment .


Additional endpoints included FLS at 4 and 12 hours , individual flu-like symptoms , rates of discontinuation , incidence of FLS and acetaminophen use .


NCT 01929382 .


Of the 40 subjects randomized , there were 15 ( 37.5 % ) discontinuations .


Titration resulted in a significant reduction in FLS severity at 8 hours ( p = 0.023 ) averaged over the 3 week treatment period .


The difference in 3 week FLS severity reflects differences during week 1 treatment , indicating an early peak in FLS severity during the No Titration treatment and subsequent development of tolerance .


In contrast , titration results in near baseline severity scores throughout the treatment period .


Similar trends were seen for 4 and 12 hour FLS severity scores .


Of the individual FLS , difference in fever severity was most marked .


Safety profiles for both regimens were consistent with the approved prescribing information for interferon gamma-1b .


Study limitations included the use of healthy subjects rather than disease subjects , the lack of a validated assessment tool for evaluating FLS and the relatively high discontinuation rate .


A short 2 week , dose-titration regimen reduces FLS severity following interferon gamma-1b treatment initiation in normal subjects .


Little is known about variables associated with overdrainage complications and neurofunctional and health-related quality of life outcomes in idiopathic normal-pressure hydrocephalus ( iNPH ) patients after shunt surgery .


To identify candidate demographic and disease-specific predictors of overdrainage and patient-related outcomes , allowing for more personalized care of patients with iNPH .


This was a secondary analysis of the dataset of the SVASONA study , a multicenter randomized trial comparing gravitational and conventional gravitational valves for treating iNPH .


We evaluated the association between baseline items and the incidence of overdrainage , using different endpoint definitions .


We identified only a few variables associated with a possible increased risk of overdrainage .


Apart from using conventional rather than gravitational valves , longer duration of surgery and female sex were associated with a higher risk of clinical signs and symptoms suggestive of overdrainage ( hazard ratio : 1.02 , 95 % confidence interval : 1.01-1 .04 and 1.84 , 95 % confidence interval : 0.81-4 .16 ) .


The occurrence of clinical symptoms of overdrainage , and the need for exchanging a programmable by a gravitational valve may adversely affect disease-specific outcomes like the Kiefer score .


Few , if any , baseline and treatment characteristics may be helpful in estimating the individual risk of complications and clinical outcomes after shunt surgery for iNPH .


Patients should be informed that longer surgery for any reason may increase the risk of later overdrainage .


Also , women should be counseled about a sex-associated increased risk of the development of clinical symptoms of overdrainage , although the latter can not be distinguished from a generally higher prevalence of headaches in the female population .


Soluble urokinase-type plasminogen activator receptor ( suPAR ) could be a causative factor in idiopathic focal segmental glomerulosclerosis ( FSGS ) .


It is currently unknown to what extent suPAR levels could be affected by treatment with immunosuppressive drugs such as cyclosporin A ( CsA ) and mycophenolate mofetil ( MMF ) .


Treatment with CsA , but not MMF , is accompanied by nephrotoxicity , and since suPAR levels correlate with glomerular filtration rate ( GFR ) , treatment with these drugs could indirectly modulate suPAR levels by their effect on renal function .


We measured suPAR levels in a recent prospective multicenter crossover trial comparing the efficacy of MMF and CsA in pediatric patients with minimal change disease ( MCD ) and frequently relapsing steroid-sensitive nephrotic syndrome ( FR-SSNS ) .


All patients had biopsy-proven MCD and normal renal function ; they were treated with each drug for 1 year in a crossover study design .


Serum suPAR levels were measured before and after 1 year of therapy with MMF ( n = 40 ) and CsA ( n = 35 ) .


The suPAR levels decreased after 1 year of treatment with MMF ( p < 0.05 ) .


Conversely , suPAR levels increased after 1 year of treatment with CsA in the same patients ( p = 0.01 ) .


These changes in suPAR levels were not correlated to the estimated glomerular filtration rate ( eGFR ) or changes in the GFR .


Data from this prospective randomized trial suggest that treatment with MMF and CsA is associated with different effects on suPAR levels in children with MCD and that these are independent of their effects on GFR .


To analyze choroidal thickness ( CT ) in eyes with geographic atrophy ( GA ) secondary to age-related macular degeneration ( AMD ) .


A total of 72 eyes of 72 patients ( mean age , 75.97 7.09 years ) with GA and 37 eyes of 37 healthy controls ( 73.89 6.19 years ) were examined by confocal scanning laser ophthalmoscopy and enhanced depth imaging ( EDI ) spectral-domain optical coherence tomography .


Choroidal thickness was measured at 25 defined points in horizontal and vertical scans .


Geographic atrophy size was determined in fundus autofluorescence ( FAF ) images and GA subtypes were classified based on abnormal FAF in the perilesional zone .


In GA , subfoveal CT ( fCT ) was significantly thinner compared to controls ( 173.03 90.22 vs. 253.95 69.19 m , P < 0.001 ) .


Analysis of averaged measurements of all 25 points obtained per patient ( mCT ) revealed similar results ( 162.07 76.26 vs. 228.00 66.24 m , P < 0.001 ) .


Spatial differences in CT between both groups were largest superior to the fovea .


Addressing `` diffuse-trickling '' ( n = 15 ) and `` non-diffuse-trickling '' ( n = 57 ) GA independently , fCT was 114.67 43.32 and 188.39 93.26 m , respectively ( P = 0.002 ) , with both groups being significantly thinner than controls ( P < 0.001 for `` diffuse-trickling '' and P < 0.001 for '' ?


non-diffuse-trickling '' ) .


Similar results were obtained for mCT , which was 110.21 29.66 m in `` diffuse-trickling , '' 175.72 79.02 m in '' ?


non-diffuse-trickling '' and 228.00 66.24 m in controls .


Differences were significant with P = 0.002 between both GA groups and P 0.001 toward controls for each GA group .


The results indicate that the choroid in eyes with GA is thinner compared to normal eyes of similar age .


Hereby , the extent of thinning is most pronounced in a specific subtype of GA identified by FAF imaging ( `` diffuse trickling '' ) .


Such GA subtype-related differences in choroidal thickness may reflect heterogeneity in the pathogenesis of disease .


( ClinicalTrials.gov number , NCT02051998 . )


Because of the high prevalence of overweight and obesity , there is a need to identify cost-effective approaches for weight loss in primary care and community settings .


To evaluate the long-term cost effectiveness of a commercial weight loss programme ( Weight Watchers ) ( CP ) compared with standard care ( SC ) , as defined by national guidelines .


A Markov model was developed to calculate the incremental cost-effectiveness ratio ( ICER ) , expressed as the cost per quality-adjusted life year ( QALY ) over the lifetime .


The probabilities and quality-of-life utilities of outcomes were extrapolated from trial data using estimates from the published literature .


A health sector perspective was adopted .


Over a patient 's lifetime , the CP resulted in an incremental cost saving of AUD 70 per patient , and an incremental 0.03 QALYs gained per patient .


As such , the CP was found to be the dominant treatment , being more effective and less costly than SC ( 95 % confidence interval : dominant to 6225 per QALY ) .


Despite the CP delaying the onset of diabetes by 10 months , there was no significant difference in the incidence of type 2 diabetes , with the CP achieving < 0.1 % fewer cases than SC over the lifetime .


The modelled results suggest that referral to community-based interventions may provide a highly cost-effective approach for those at high risk of weight-related comorbidities .


This study investigates the effectiveness of Lokomat + conventional therapy in recovering walking ability in non-ambulatory subacute stroke subjects involved in inpatient rehabilitation .


Thirty first-ever stroke patients completed 8 weeks of intervention .


One group ( n = 16 ) received Lokomat therapy twice a week , combined with three times 30min a week of conventional overground therapy .


The second group ( n = 14 ) received conventional assisted overground therapy only , during a similar amount of time ( 3.5 h a week ) .


The intervention was part of the normal rehabilitation program .


Primary outcome measure was walking speed .


Secondary outcome measures assessed other walking - and mobility-related tests , lower-limb strength and quality of life measures .


All outcome measures were assessed before and after the intervention and at wk 24 and wk 36 after start of the intervention .


Patients showed significant ( p < 0.05 ) gains in walking speed , other walking - and mobility related tests , and strength of the paretic knee extensors relative to baseline at all assessments .


However , there were no significant differences in improvements in any of the variables between groups at any time during the study .


These results indicate that substituting Lokomat therapy for some of conventional therapy is as effective in recovering walking ability in non-ambulatory stroke patients as conventional therapy alone .


Implications for Rehabilitation Recovery of walking after stroke is important .


Robot-assisted therapy is currently receiving much attention in research and rehabilitation practice as devices such as the Lokomat seem to be promising assistive devices .


Technical developments , sub-optimal study designs in literature and new therapy insights warrant new effectiveness studies .


RESULTS of a financially and practically feasible study indicate that substituting Lokomat therapy for some of conventional therapy is as effective in recovering walking ability in non-ambulatory stroke patients as compared to conventional overground therapy alone .


Huntington 's disease ( HD ) is a complex , single-gene inherited neurodegenerative condition resulting in symptoms that occur across a wide range of neurological domains , including cognitive , behavioral and motor .


The benefits of regular physical activity for people with HD are widely recognized .


However , a number of factors can prohibit sustained exercise and activity .


The purpose of this trial is to explore the feasibility , acceptability and effectiveness of a physical activity intervention program targeted for people with early - to mid-stage HD .


The proposed trial is a single blind , multisite , exploratory , randomized controlled feasibility trial of a physical activity intervention .


A total of 62 participants with genetically confirmed HD will be recruited .


Each participant will be involved in the trial for 26weeks .


Participants will be randomized immediately following the baseline assessment into either a physical activity intervention or a social contact control intervention .


The physical activity intervention is framed around self-determination theory placed within a broader behaviour change wheel framework .


An HD-specific workbook and individual goal setting will be utilized over six 1:1 sessions , with interim telephone calls .


All participants will be reassessed at 16weeks following the baseline assessment , and then again at a final follow-up assessment 26weeks later .


At the end of the study , all participants will be offered a brief version of the alternative intervention , with one home visit and one follow-up telephone call .


Engaging and supporting people with HD in a regular physical activity program raises a number of challenges .


The physical activity intervention and the comparator social interaction intervention have been developed following consultation with people with HD and their families .


Each are individually tailored and determined on individual needs and goals .


The results from this trial will provide guidance for the development of definitive trials .


The trial was registered with ISRCTN ( http://www.isrctn.com/ISRCTN65378754 ) on 13 March 2014 .


Braces used to treat ( PF ) osteoarthritis ( OA ) may reduce contact stress across the PF joint .


We hypothesised that in PF OA , braces would decrease knee pain and shrink PF bone marrow lesions ( BMLs ) .


Eligible subjects had painful PF OA .


Subjects were randomly allocated to brace or no brace for 6weeks .


Knee MRIs were acquired at baseline and 6weeks .


We measured BMLs on post-contrast fat suppressed sagittal and proton density weighted axial images .


The primary symptom outcome was change in pain at 6weeks during a preselected painful activity , and the primary structural outcome was BML volume change in the PF joint .


Analyses used multiple linear regression .


We randomised 126 subjects aged 40-70years ( mean age 55.5 years ; 72 females ( 57.1 % ) ) .


Mean nominated visual analogue scale ( 0-10cm ) pain score at baseline was 6.5 cm .


94 knees ( 75 % ) had PF BMLs at baseline .


Subjects wore the brace for a mean of 7.4 h/day .


6 subjects withdrew during the trial .


After accounting for baseline values , the brace group had lower knee pain than the control group at 6weeks ( difference between groups -1.3 cm , 95 % CI -2.0 to -0.7 ; p < 0.001 ) and reduced PF BML volume ( difference -490.6 mm ( 3 ) , 95 % CI -929.5 to -51.7 ; p = 0.03 ) but not tibiofemoral volume ( difference -53.9 mm ( 3 ) , 95 % CI -625.9 to 518.2 ; p = 0.85 ) .


A PF brace reduces BML volume in the targeted compartment of the knee , and relieves knee pain .


UK .


ISRCTN50380458 .


Adjunctive psychosocial interventions are efficacious in bipolar disorder , but their incorporation into routine management plans are often confounded by cost and access constraints .


We report here a comparative evaluation of two online programs hosted on a single website ( www.moodswings.net.au ) .


A basic version , called MoodSwings ( MS ) , contains psychoeducation material and asynchronous discussion boards ; and a more interactive program , MoodSwings Plus ( MS-Plus ) , combined the basic psychoeducation material and discussion boards with elements of Cognitive Behavioral Therapy .


These programs were evaluated in a head-to-head study design .


Participants with Bipolar I or II disorder ( n = 156 ) were randomized to receive either MoodSwings or MoodSwings-Plus .


Outcomes included mood symptoms , the occurrence of relapse , functionality , Locus of Control , social support , quality of life and medication adherence .


Participants in both groups showed baseline to endpoint reductions in mood symptoms and improvements in functionality , quality of life and medication adherence .


The MoodSwings-Plus group showed a greater number of within-group changes on symptoms and functioning in depression and mania , quality of life and social support , across both poles of the illness .


MoodSwings-Plus was superior to MoodSwings in improvement on symptoms of mania scores at 12 months ( p = 0.02 ) but not on the incidence of recurrence .


The study did not have an attention control group and therefore could not demonstrate efficacy of the two active arms .


There was notable ( 81 % ) attrition by 12 months from baseline .


This study suggests that both CBT and psychoeducation delivered online may have utility in the management of bipolar disorder .


They are feasible , readily accepted , and associated with improvement .


To characterize change through 5-year follow-up , associated with training , booster , adherence , and other characteristics .


Sample included all individuals randomly assigned to reasoning training ( N = 699 ) .


Piecewise latent growth modeling was used to examine trajectory of performance on outcome measures .


Training resulted in improved reasoning performance through Year 5 .


A significant third annual booster effect was one-half the size of the training effect .


Training adherence resulted in greater training effects .


Higher education , Mini-Mental State Exam ( MMSE ) , better health , and younger age related to higher baseline performance .


Higher MMSE was related to larger training effects , larger linear slopes , and smaller booster effects .


Significant functional outcomes included a training effect for complex reaction time ( CRT ) , and first annual booster effects for the CRT and observed tasks of daily living .


Initial training gain was comparable with magnitude of age-related cognitive decline over 5 years with no training .


Neither age nor gender predicted training or booster effects , indicating the generality of training effects across age ( 65-90 years ) .


Epidemiological studies show that vascular risk factors are the same across the world but their effect vary between different race-ethnic groups .


However , few studies have evaluated differences in recurrent stroke rates in various race-ethnicities .


In > 20000 patients spanning 35 countries encompassing most race-ethnicities , we evaluated the incidence of ischemic and hemorrhagic strokes and myocardial infarction in patients within the context of the largest secondary stroke prevention trial ( Prevention Regimen for Effectively Avoiding Secondary Strokes ) to identify any significant differences .


There were 20332 patients with a recent ischemic stroke randomized in a factorial design to receive the antiplatelet agent clopidogrel vs. aspirin plus extended-release dipyridamole , and 80mg of the anthypertensive telmisartan vs. placebo .


The primary outcome for the trial was the time to any recurrent stroke .


Statistical analysis was used to detect race-ethnic differences in recurrent vascular events .


Mean patient age was 66 ( 86 ) years and 36 % were women .


The study included 58 % European/Caucasian , 33 % Asians , 5 % Latin/Hispanic , and 4 % Black African .


There were 74 % of patients that were hypertensive , and average systolic and diastolic blood pressure was 1441/838mmHg .


There was at least one significant difference in the overall test of all race-ethnic groups in myocardial infarction and symptomatic intracerebral hemorrhage occurrence .


In the Kaplan-Meier hemorrhage and stroke-free survival curves , Asians showed a significantly higher recurrence of ischemic stroke risk in the 135-150mmHg and greater than 150mm Hg blood pressure groups , and a greater risk of hemorrhage recurrence in the greater than 150mmHg blood pressure group .


We found a significant difference in myocardial infarction and symptomatic intracerebral hemorrhage recurrence among different race-ethnic groups .


The risk of recurrent ischemic and hemorrhagic stroke was greater in Asians with high blood pressure .


Whether an insulin infusion should be used for tight control of hyperglycemia in critically ill children remains unclear .


We randomly assigned children ( 16 years of age ) who were admitted to the pediatric intensive care unit ( ICU ) and were expected to require mechanical ventilation and vasoactive drugs for at least 12 hours to either tight glycemic control , with a target blood glucose range of 72 to 126 mg per deciliter ( 4.0 to 7.0 mmol per liter ) , or conventional glycemic control , with a target level below 216 mg per deciliter ( 12.0 mmol per liter ) .


The primary outcome was the number of days alive and free from mechanical ventilation at 30 days after randomization .


The main prespecified subgroup analysis compared children who had undergone cardiac surgery with those who had not .


We also assessed costs of hospital and community health services .


A total of 1369 patients at 13 centers in England underwent randomization : 694 to tight glycemic control and 675 to conventional glycemic control ; 60 % had undergone cardiac surgery .


The mean between-group difference in the number of days alive and free from mechanical ventilation at 30 days was 0.36 days ( 95 % confidence interval [ CI ] , -0.42 to 1.14 ) ; the effects did not differ according to subgroup .


Severe hypoglycemia ( blood glucose , < 36 mg per deciliter [ 2.0 mmol per liter ] ) occurred in a higher proportion of children in the tight-glycemic-control group than in the conventional-glycemic-control group ( 7.3 % vs. 1.5 % , P < 0.001 ) .


Overall , the mean 12-month costs were lower in the tight-glycemic-control group than in the conventional-glycemic-control group .


The mean 12-month costs were similar in the two groups in the cardiac-surgery subgroup , but in the subgroup that had not undergone cardiac surgery , the mean cost was significantly lower in the tight-glycemic-control group than in the conventional-glycemic-control group : - $ 13,120 ( 95 % CI , - $ 24,682 to - $ 1,559 ) .


This multicenter , randomized trial showed that tight glycemic control in critically ill children had no significant effect on major clinical outcomes , although the incidence of hypoglycemia was higher with tight glucose control than with conventional glucose control .


( Funded by the National Institute for Health Research , Health Technology Assessment Program , U.K. National Health Service ; CHiP Current Controlled Trials number , ISRCTN61735247 . )


Cognitive-behavioural therapy ( CBT ) is an effective treatment for body dysmorphic disorder ( BDD ) .


However , most sufferers do not have access to this treatment .


One way to increase access to CBT is to administer treatment remotely via the Internet .


This study piloted a novel therapist-supported , Internet-based CBT program for BDD ( BDD-NET ) .


Uncontrolled clinical trial .


Patients ( N = 23 ) were recruited through self-referral and assessed face to face at a clinic specialising in obsessive-compulsive and related disorders .


Suitable patients were offered secure access to BDD-NET .


BDD-NET is a 12-week treatment program based on current psychological models of BDD that includes psychoeducation , functional analysis , cognitive restructuring , exposure and response prevention , and relapse prevention modules .


A dedicated therapist provides active guidance and feedback throughout the entire process .


The clinician-administered Yale-Brown Obsessive Compulsive Scale for BDD ( BDD-YBOCS ) .


Symptom severity was assessed pretreatment , post-treatment and at the 3-month follow-up .


BDD-NET was deemed highly acceptable by patients and led to significant improvements on the BDD-YBOCS ( p = < 0.001 ) with a large within-group effect size ( Cohen 's d = 2.01 , 95 % CI 1.05 to 2.97 ) .


At post-treatment , 82 % of the patients were classified as responders ( defined as30 % improvement on the BDD-YBOCS ) .


These gains were maintained at the 3-month follow-up .


Secondary outcome measures of depression , global functioning and quality of life also showed significant improvements with moderate to large effect sizes .


On average , therapists spent 10 min per patient per week providing support .


The results suggest that BDD-NET has the potential to greatly increase access to CBT , at least for low-risk individuals with moderately severe BDD symptoms and reasonably good insight .


A randomised controlled trial of BDD-NET is warranted .


Clinicaltrials.gov registration ID NCT01850433 .


To compare the plaque removal efficacy of a water flosser to string floss combined with a manual toothbrush after a single use .


Seventy adult subjects participated in this randomized , single-use , single-blind , parallel clinical study .


Subjects were assigned to one of two groups ; Waterpik Water Flosser plus a manual toothbrush ( WF ) or waxed string floss plus a manual toothbrush ( SF ) .


Each participant brushed for two minutes using the Bass technique .


The WF group added 500 ml of warm water to the reservoir and followed the manufacturer 's instructions , and the SF group used waxed string floss between each tooth , cleaning the mesial and distal surfaces as instructed .


Subjects were observed to ensure they covered all areas and followed instructions .


Scores were recorded for whole mouth , marginal , approximal , facial , and lingual regions for each subject using the Rustogi Modification of the Navy Plaque Index .


The WF group had a 74.4 % reduction in whole mouth plaque and 81.6 % for approximal plaque compared to 57.7 % and 63.4 % for the SF group , respectively ( p < 0.001 ) .


The differences between the groups showed the water flosser was 29 % more effective than string floss for overall plaque removal and approximal surfaces specifically ( p < 0.001 ) .


The WF group was more effective in removing plaque from the marginal , lingual , and facial regions ; 33 % , 39 % , and 24 % , respectively ( p < 0.001 ) .


The Waterpik Water Flosser and manual toothbrush is significantly more effective than a manual brush and string floss in removing plaque from tooth surfaces .


Test the hypotheses that tremor amplitude in musicians with task-specific dystonia is higher at the affected finger ( dystonic tremor , DT ) or the adjacent finger ( tremor associated with dystonia , TAD ) than ( 1 ) in matched fingers of healthy musicians and non-musicians and ( 2 ) within patients in the unaffected and non-adjacent fingers of the affected side within patients .


We measured 21 patients , 21 healthy musicians and 24 non-musicians .


Participants exerted a flexion-extension movement .


Instantaneous frequency and amplitude values were obtained with empirical mode decomposition and a Hilbert-transform , allowing to compare tremor amplitudes throughout the movement at various frequency ranges .


We did not find a significant difference in tremor amplitude between patients and controls for either DT or TAD .


Neither differed tremor amplitude in the within-patient comparisons .


Both hypotheses were rejected and apparently neither DT nor TAD occur in musician 's dystonia of the fingers .


This is the first study assessing DT and TAD in musician 's dystonia .


Our finding suggests that even though MD is an excellent model for malplasticity due to excessive practice , it does not seem to provide a good model for DT .


Rather it seems that musician 's dystonia may manifest itself either as dystonic cramping without tremor or as task-specific tremor without overt dystonic cramping .


To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women .


This multicenter , randomized , double-blinded , double-dummy , noninferiority , positive drug-controlled clinical trial was conducted in five Chinese sites .


Eligible Chinese women with postmenopausal osteoporosis ( N = 236 ) were randomized to Group M or Group A and received menatetrenone 45 mg/day or alfacalcidol 0.5 g/day , respectively , for 1 year .


Additionally , all patients received calcium 500 mg/day .


Posttreatment bone mineral density ( BMD ) , new fracture onsets , and serum osteocalcin ( OC ) and undercarboxylated OC ( ucOC ) levels were compared with the baseline value in patients of both groups .


A total of 213 patients ( 90.3 % ) completed the study .


After 1 year of treatment , BMD among patients in Group M significantly increased from baseline by 1.2 % and 2.7 % at the lumbar spine and trochanter , respectively ( P < 0.001 ) ; and the percentage increase of BMD in Group A was 2.2 % and 1.8 % , respectively ( P < 0.001 ) .


No difference was observed between groups .


There were no changes in femoral neck BMD in both groups .


Two patients ( 1.9 % , 2/108 ) in Group M and four patients ( 3.8 % , 4/105 ) in Group A had new fracture onsets ( P > 0.05 ) .


In Group M , OC and ucOC decreased from baseline by 38.7 % and 82.3 % , respectively ( P < 0.001 ) .


In Group A , OC and ucOC decreased by 25.8 % and 34.8 % , respectively ( P < 0.001 ) .


Decreases in serum OC and ucOC were more obvious in Group M than in Group A ( P < 0.001 ) .


The safety profile of menatetrenone was similar to alfacalcidol .


Menatetrenone is an effective and safe choice in the treatment of postmenopausal osteoporosis in Chinese women .


We explored the effectiveness of mirror therapy ( MT ) in the treatment of unilateral neglect in stroke patients .


This is an open , blinded endpoint , randomized controlled trial carried out from January 2011 to August 2013 .


We included stroke patients with thalamic and parietal lobe lesions with unilateral neglect 48 hours after stroke .


Patients were randomized to the MT group or the control group ( sham MT ) , and both the groups received limb activation .


Patients received treatment for 1-2 hours a day 5 days a week for 4 weeks .


The primary outcome was unilateral neglect assessed by a blinded assessor using the star cancellation test , the line bisection test , and a picture identification task at 1 , 3 , and 6 months .


This study was registered at http://clinicaltrials.gov ( NCT 01735877 ) .


Forty-eight patients were randomized to MT ( n = 27 ) or the control group ( n = 21 ) .


Improvement in scores on the star cancellation test over 6 months was greater in the MT group ( mean difference 23 , 95 % confidence interval [ CI ] 19-28 ; p < 0.0001 ) .


Similarly , improvement in the MT group was observed in the scores on the picture identification task ( mean difference 3.2 , 95 % CI 2.4-4 .0 ; p < 0.0001 ) and line bisection test ( mean difference 8.6 , 95 % CI 2.7-14 .6 ; p = 0.006 ) .


In patients with stroke , MT is a simple treatment that improves unilateral neglect .


This study provides Class I evidence that for patients with neglect from thalamic and parietal lobe strokes , MT improves neglect .