In contrast , changes in fasting and 2-h insulin ( -3.4 mUl ( -1 ) , P = 0.035 and -26.6 , P = 0.003 , respectively ) , homeostasis model assessment-estimated insulin resistance ( -1.0 , P = 0.036 ) , total cholesterol ( -0.55 mmoll ( -1 ) , P = 0.041 ) , low-density lipoprotein ( LDL ) cholesterol ( -0.36 mmoll ( -1 ) , P = 0.008 ) and visceral fat area ( -5.5 cm ( 2 ) , P = 0.030 ) were significantly greater in the intervention than in control subjects .


The overall effects of PA were analyzed by quartiles of daily steps of all subjects .


There were significant reductions in total and LDL cholesterol and visceral fat area between the highest ( daily steps over 6520 ) and the lowest quartile ( 1780-2810 daily steps ) .


The changes associated with PA remained significant after adjustments of baseline , sex , age and body weight change .


Habitual and structured PAs with the acceleration levels of 0.3-0 .7 g and daily steps over 6520 , equivalent to walking at 2-3kmh ( -1 ) for 90min daily , standing for the relative PA intensity of 30-35 % of the maximal oxygen uptake , are clinically beneficial for overweight/obese and physically inactive individuals with a high risk for T2D .


Palliative care incorporates comprehensive support of family caregivers because many of them experience burden and distress .


However , evidence-based support initiatives are few .


We evaluated a one-to-one psychoeducational intervention aimed at mitigating the distress of caregivers of patients with advanced cancer receiving home-based palliative care .


We hypothesised that caregivers would report decreased distress as assessed by the General Health Questionnaire ( GHQ ) .


A randomised controlled trial comparing two versions of the delivery of the intervention ( one face-to-face home visit plus telephone calls versus two visits ) plus standard care to a control group ( standard care only ) across four sites in Australia .


Recruitment to the one visit condition was 57 , the two visit condition 93 , and the control 148 .


We previously reported non-significant changes in distress between times 1 ( baseline ) and 2 ( 1-week post-intervention ) but significant gains in competence and preparedness .


We report here changes in distress between times 1 and 3 ( 8-week post-death ) .


There was significantly less worsening in distress between times 1 and 3 in the one visit intervention group than in the control group ; however , no significant difference was found between the two visit intervention and the control group .


These results are consistent with the aim of the intervention , and they support existing evidence demonstrating that relatively short psychoeducational interventions can help family caregivers who are supporting a dying relative .


The sustained benefit during the bereavement period may also have positive resource implications , which should be the subject of future inquiry .


Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy .


We designed a large scale clinical trial to compare a novel thin strut , cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer ( O-SES , Orsiro ; Biotronik , Blach , Switzerland ) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent ( EES ) ( Xience Prime/Xpedition stent , Abbott Vascular , IL ) in an all-comers patient population .


The multicenter BIOSCIENCE trial ( NCT01443104 ) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents ( SES ) or durable polymer EES at 9 sites in Switzerland .


Patients with chronic stable coronary artery disease or acute coronary syndromes , including non-ST-elevation and ST-elevation myocardial infarction , were eligible for the trial if they had at least 1 lesion with a diameter stenosis > 50 % appropriate for coronary stent implantation .


The primary end point target lesion failure ( TLF ) is a composite of cardiac death , target vessel myocardial infarction , and clinically driven target lesion revascularization within 12 months .


Assuming a TLF rate of 8 % at 12 months in both treatment arms and accepting 3.5 % as a margin for noninferiority , inclusion of 2,060 patients would provide more than 80 % power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05 .


Clinical follow-up will be continued through 5 years .


The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF .


Asthma guidelines recommend monitoring of asthma control .


However , in a substantial proportion of children , asthma is poorly controlled and the best monitoring strategy is not known .


We studied two monitoring strategies for their ability to improve asthma outcomes in comparison with standard care ( SC ) : web-based monthly monitoring with the ( Childhood ) Asthma Control Test ( ACT or C-ACT ) and 4-monthly monitoring of FENO .


In this randomised controlled , partly blinded , parallel group multicentre trial with a 1-year follow-up , children aged 4-18 with a doctor 's diagnosis of asthma treated in seven hospitals were randomised to one of the three groups .


In the web group , treatment was adapted according to ACT obtained via a website at 1-month intervals ; in the FENO group according to ACT and FENO , and in the SC group according to the ACT at 4-monthly visits .


The primary endpoint was the change from baseline in the proportion of symptom-free days ( SFD ) .


Two-hundred and eighty children ( mean age 10.4 years , 66 % boys ) were included ; 268 completed the study .


Mean changes from baseline in SFD were similar between the groups : -2.1 % ( web group , n = 90 ) , +8.9 % ( FENO group , n = 91 ) versus 0.15 % ( SC , n = 87 ) , p = 0.15 and p = 0.78 .


Daily dose of inhaled corticosteroids ( ICS ) decreased more in the web-based group compared with both other groups ( -200 g/day , p < 0.01 ) , while ACT and SFD remained similar .


The change from baseline in SFD did not differ between monitoring strategies .


With web-based ACT monitoring , ICS could be reduced substantially while control was maintained .


NTR 1995 .


Depressive symptoms are common in schizophrenia and can worsen outcomes and increase suicide risk .


Lurasidone is an atypical antipsychotic agent indicated for the treatment of schizophrenia and for the treatment of major depressive episodes associated with bipolar I disorder .


This post hoc analysis evaluated the effect of lurasidone on depressive symptoms in patients with schizophrenia .


Patient-level data were pooled from 4 similarly designed , double-blind , placebo-controlled , 6-week registration studies of lurasidone ( 40-160 mg/d ) in adult patients with an acute exacerbation of schizophrenia .


Changes in depressive symptoms , measured by the Montgomery-sberg Depression Rating Scale ( MADRS ) , were analyzed for the overall sample and for subgroups of patients stratified by baseline MADRS scores .


MADRS assessments at baseline and endpoint ( day 42 or last observation carried forward [ LOCF ] ) were available for 1330 patients .


Patients receiving lurasidone experienced significantly greater decreases in MADRS score ( -2.8 , least-squares [ LS ] mean change , LOCF ) compared with patients receiving placebo ( -1.4 , P < .001 , effect size 0.24 ) .


Analysis of change in MADRS score ( LOCF ) by baseline symptom severity ( MADRS score of 12 , 14 , 16 , 18 ) showed significantly greater improvement for lurasidone-treated patients across all severity groups ; effect sizes ranged from 0.25 to 0.34 .


Among patients with a baseline MADRS score of 12 , depressive symptom remission ( defined as MADRS score < 10 at LOCF endpoint ) was attained by 45.0 % of lurasidone-treated patients and 36.3 % of patients receiving placebo ( P < .05 ) .


In a pooled analysis of short-term , placebo-controlled studies , lurasidone significantly improved depressive symptoms in patients with schizophrenia .


Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe acute pancreatitis to prevent gut-derived infections , but evidence to support this strategy is limited .


We conducted a multicenter , randomized trial comparing early nasoenteric tube feeding with an oral diet at 72 hours after presentation to the emergency department in patients with acute pancreatitis .


We enrolled patients with acute pancreatitis who were at high risk for complications on the basis of an Acute Physiology and Chronic Health Evaluation II score of 8 or higher ( on a scale of 0 to 71 , with higher scores indicating more severe disease ) , an Imrie or modified Glasgow score of 3 or higher ( on a scale of 0 to 8 , with higher scores indicating more severe disease ) , or a serum C-reactive protein level of more than 150 mg per liter .


Patients were randomly assigned to nasoenteric tube feeding within 24 hours after randomization ( early group ) or to an oral diet initiated 72 hours after presentation ( on-demand group ) , with tube feeding provided if the oral diet was not tolerated .


The primary end point was a composite of major infection ( infected pancreatic necrosis , bacteremia , or pneumonia ) or death during 6 months of follow-up .


A total of 208 patients were enrolled at 19 Dutch hospitals .


The primary end point occurred in 30 of 101 patients ( 30 % ) in the early group and in 28 of 104 ( 27 % ) in the on-demand group ( risk ratio , 1.07 ; 95 % confidence interval , 0.79 to 1.44 ; P = 0.76 ) .


There were no significant differences between the early group and the on-demand group in the rate of major infection ( 25 % and 26 % , respectively ; P = 0.87 ) or death ( 11 % and 7 % , respectively ; P = 0.33 ) .


In the on-demand group , 72 patients ( 69 % ) tolerated an oral diet and did not require tube feeding .


This trial did not show the superiority of early nasoenteric tube feeding , as compared with an oral diet after 72 hours , in reducing the rate of infection or death in patients with acute pancreatitis at high risk for complications .


( Funded by the Netherlands Organization for Health Research and Development and others ; PYTHON Current Controlled Trials number , ISRCTN18170985 . )


An explicit goal of Patient Aligned Care Teams ( PACTs ) within the Veterans Health Administration is to promote continuity of care in primary care clinics and thereby reduce Emergency Department ( ED ) utilization ; however , there has been little research to guide PACTs on how to accomplish this .


The overall goal of this study is to examine the impact of a primary care-based nurse telephone support program [ DISPO ED ] on Veterans treated and released from the ED who are at high risk for repeat visits .


This study is a two group randomized , controlled trial to evaluate DISPO ED for Veterans treated and released from the ED who are at high risk for repeat visits .


We define high risk as those who have had an ED visit or hospitalization during the 6 month period before the index ED visit and have 2 chronic conditions .


Veterans are randomized to nurse telephone support or usual care .


The primary outcome is repeat ED use within 30 days ; secondary outcomes are patient satisfaction with care and total costs .


The results of this randomized , controlled trial with an Effectiveness-Implementation Type I Hybrid design will be directly relevant to the care of more than 500,000 high risk patients seen in Veterans ' Affairs Medical Center ( VAMC ) EDs annually .


Results will also be informative to health systems outside VA aiming to reduce ED use through accountable care organizations .


Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable .


We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin .


However , its relative safety and efficacy as compared with conventional phototherapy are unknown .


We conducted a randomized , controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large , urban Nigerian maternity hospital .


The primary end point was efficacy , which was defined as a rate of increase in total serum bilirubin of less than 0.2 mg per deciliter per hour for infants up to 72 hours of age or a decrease in total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy ; we prespecified a noninferiority margin of 10 % for the difference in efficacy rates between groups .


The need for an exchange transfusion was a secondary end point .


We also assessed safety , which was defined as the absence of the need to withdraw therapy because of hyperthermia , hypothermia , dehydration , or sunburn .


We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy .


Filtered sunlight was efficacious on 93 % of treatment days that could be evaluated , as compared with 90 % for conventional phototherapy , and had a higher mean level of irradiance ( 40 vs. 17 W per square centimeter per nanometer , P < 0.001 ) .


Temperatures higher than 38.0 C occurred in 5 % of the infants receiving filtered sunlight and in 1 % of those receiving conventional phototherapy ( P < 0.001 ) , but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion .


Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety .


( Funded by the Thrasher Research Fund , Salt Lake City , and the National Center for Advancing Translational Sciences of the National Institutes of Health ; Clinical Trials.gov number , NCT01434810 . )


To assess any changes in the Functional Communicative Profile ( FCP ) and in the Social Cognitive Performance ( SCP ) of children with Autism Spectrum Disorders , based on two short periods of intervention .


The study was conducted with 21 children with Autism Spectrum Disorder diagnoses , randomly allocated into two groups , who received the same short-term intervention types ( 6 weeks with the mother and 6 weeks with the support of an educational software program ) .


The intervention process was conducted by speech-language pathologists who were part of a graduate program in this area .


Samples of 15-minute interaction sessions between the child and speech-language pathologist were used to assess the changes in the FCP and the SCP .


The statistic analysis pointed out differences only in Group 1 for the variables `` percentage of communicative space used '' and `` use of the mediating object '' .


With the intervention sessions structured over 12 weeks , it was possible to observe a few changes in the children 's FCP and in the SCP .


Therefore , we point out the need for new research studies of longer duration .


Urticaria is a distressing condition associated with diverse clinical presentations .


Chronic spontaneous urticaria ( CsU ) is characterized by wheals and angioedema .


Its treatment requires an algorithmic approach to identify the optimum medication .


Cetirizine is commonly used in the treatment of urticaria .


Rupatadine is a selective non-sedating H1 - antihistamine approved for the treatment of CsU .


This trial was conducted to ascertain whether the properties of rupatadine offer advantages over cetirizine .


Seventy patients with CsU were enrolled .


Parameters assessed included : ( i ) mean number of wheals ( MNW ) ; ( ii ) pruritus ; ( iii ) mean total symptom score ( MTSS ) ; ( iv ) size of wheal ; ( v ) interference of wheals with sleep ; and ( vi ) sedation .


Patients with CsU were divided randomly into two groups .


Routine investigations were performed at baseline and at the end of the study .


Evaluations of MTSS , MNW , and pruritus revealed statistically significant differences at week 3 compared with baseline in the cetirizine group .


However , greater reductions in these parameters were obtained with rupatadine .


In patients receiving rupatadine , reductions in the MNW , size of wheals , and intensity of erythema were also significant at six weeks ( P < 0.001 ) and were significantly greater than those in the cetirizine group ( P < 0.05 ) .


Improvements in MTSS , MNW , size of wheals , intensity of erythema , and differential eosinophil count imply that rupatadine is a particularly attractive therapeutic modality compared with cetirizine for the treatment of CsU .


This study evaluated the feasibility , acceptability , and initial efficacy of an intervention based on Schachter 's externality theory ; the Regulation of Cues ( ROC ) program .


44 overweight and obese 8-12-year-old children and their parents were randomly assigned to a 4-month ROC program or the control group .


Outcomes were assessed at baseline , posttreatment , and 4 months posttreatment and included acceptability and feasibility , body weight , and eating behaviors .


The ROC program had moderate to high acceptability ratings .


Significant improvements were found for the ROC group compared with the control group on child food responsiveness at posttreatment and eating in the absence of hunger at 4 months posttreatment .


Improvements were seen for the ROC group compared with the control group on body weight measures and food responsiveness , although these only approached significance .


The ROC intervention may be useful with overweight and obese children .


Larger , fully powered studies are needed to further evaluate the efficacy of this model .


Although the use of bortezomib alone and in combination with steroids has shown efficacy in AL amyloidosis , its role in combination with high-dose melphalan and autologous stem cell transplantation ( HDM/SCT ) is unknown .


In this study , we evaluated bortezomib in combination with dexamethasone ( BD ) for induction chemotherapy prior to HDM/SCT .


This was a single-center , prospective , randomized controlled trial comparing induction therapy consisting of two BD cycles followed by HDM/SCT ( BD+HDM / SCT ) with HDM/SCT alone in the treatment of patients with newly diagnosed AL amyloidosis .


The hematological and organ responses of the patients were assessed every three months post HDM/SCT .


Fifty-six patients newly diagnosed with renal ( 100 % ) , cardiac ( 57.1 % ) , liver ( 7.1 % ) , or nervous system ( 8.9 % ) AL amyloidosis were enrolled in this study ; 28 patients were assigned to each arm .


Two patients died within 100days of HDM/SCT ( 3.6 % treatment-related mortality ) .


The overall hematologic response rates in the BD+HDM / SCT arm and HDM/SCT arm at three , six and twelve months were 78.5 % versus 50 % , 82.1 % versus 53.5 % and 85.7 % versus 53.5 % , respectively .


In the BD+HDM / SCT arm , 15 ( 53.5 % ) patients achieved a hematologic response after BD and before HDM/SCT .


An intention-to-treat analysis revealed a higher rate of complete remission in the BD+HDM / SCT arm at both 12 and 24months ( 67.9 % and 70 % , respectively ) than with the HDM/SCT-only therapy ( 35.7 % and 35 % , respectively , P = 0.03 ) .


After a median follow-up of 28months , the survival rates at 24months post-treatment start were 95.0 % in the BD+HDM / SCT group and 69.4 % in the HDM/SCT alone group ( P = 0.03 ) .


Our preliminary data suggest that the outcome of treating AL amyloidosis with BD induction and HDM/SCT was superior to the outcome of the HDM/SCT treatment alone .


This trial has been registered at clinicaltrials.gov with the number NCT01998503 .


The prevalence of fibromyalgia increases worldwide and is characterized by widespread and chronic pain .


Treatment is difficult and includes both drug and non-drug approaches .


Milnacipran , an antidepressant , is used for fibromyalgia , with a possible beneficial effect on central pain modulation .


Our hypothesis is that the efficacy of milnacipran in fibromyalgia depends on the performance of pain inhibitory controls .


A randomized , double blind , clinical trial ( NCT01747044 ) with two parallel groups , in 48 women with fibromyalgia , is planned in the Clinical Pharmacology Center , University Hospital , Clermont-Ferrand , France .


Conditioned pain modulation ( estimated with thermal stimuli using a numeric pain rating scale ) , the primary endpoint measure , is evaluated before and one month after treatment with milnacipran or placebo .


Secondary outcome measures include the predictability of pain descending pathways performance for milnacipran efficacy , tolerance and cognitive function .


Data analysis is performed using mixed models ; the tests are two-sided , with a type I error set at alpha = 0.05 .


Not only will this trial allow estimation of the beneficial effect of milnacipran on pain and on descending pain pathways but it will also evaluate whether the performance of this modulatory system could be predictive of its efficacy in alleviating pain .


This method would allow clinicians to take a pro-active attitude by performing a rapid psychophysical test before starting milnacipran treatment and would avoid unnecessary prescription while preventing therapeutic failure in patients who often face this recurrent problem .


ClinicalTrials.gov NCT01747044 .


Opioid maintenance treatment is the option of choice to stabilize opioid-dependent patients .


Whilst efficacy of methadone and buprenorphine has been studied extensively , fewer data on slow-release oral morphine are available .


This study analyzes the effects of slow-release oral morphine compared to methadone with regard to self-reported mental symptoms , drug use and satisfaction with treatment .


The study was carried out as an open-label randomized crossover trial in 14 treatment sites in Switzerland and Germany .


It comprised 2 crossover periods of 11 weeks each .


For measuring mental symptoms , the Symptom Checklist-27 ( SCL-27 ) was used .


Drug and alcohol use was assessed by the number of consumption days , and treatment satisfaction by a visual analogue scale .


A total of 157 patients were included for the analyses ( per-protocol sample ) .


Statistically significantly better outcomes for morphine as compared to methadone treatment were found for overall severity of mental symptoms ( SCL-27 Global Severity Index ) , as well as 5 of the 6 syndrome groups of the SCL-27 , and for treatment satisfaction .


There were no statistically significant differences with regard to drug or alcohol use between groups .


This study supports positive effects of slow-release oral morphine compared to methadone on patient-reported outcomes such as mental symptoms and treatment satisfaction with comparable effects on concomitant drug use .


Slow-release oral morphine represents a meaningful alternative to methadone for treatment of opioid dependence .


To document the anatomical effects of clear lens extraction by phacoemulsification versus trabeculectomy on anterior chamber angle in patients with primary angle-closure glaucoma ( PACG ) .


Gonioscopy and ultrasound biomicroscopy ( UBM ) were performed pre-operatively , and at 1 year after clear lens extraction or trabeculectomy in PACG eyes .


Fifty PACG eyes of 50 patients were included .


Twenty-six eyes had clear lens extraction by phacoemulsification , while 24 eyes underwent trabeculectomy .


The mean extent of synechial angle closure was significantly reduced from 272.357.3 to 253.370.5 ( p = 0.007 ) by phacoemulsification , but it was only reduced from 285.064.6 to 283.155.5 ( p = 0.32 ) by trabeculectomy .


The mean angle-opening distance at 500 microns from sclera spur ( AOD500 ) measured by UBM was significantly increased from 220.393.8 microns to 388.9134.1 microns ( p < 0.001 ) by clear lens extraction , but decreased from 220.979.8 microns to 214.570.2 microns ( p = 0.11 ) by trabeculectomy .


The mean anterior chamber depth ( ACD ) measured by UBM was significantly increased from 1,983.8176.8 microns to 3335.0174.2 microns ( p < 0.001 ) by clear lens extraction , but decreased from 2,000.2214.5 microns to 1975.8218.2 microns ( p = 0.001 ) by trabeculectomy .


Compared to trabeculectomy , clear lens extraction resulted in a significant reduction in synechial angle closure , and an increase in anterior chamber angle width and anterior chamber depth in PACG eyes without cataract .


Human immunodeficiency virus ( HIV ) - infected pregnant women are at increased risk of malaria and its complications .


In vitro and in vivo data suggest that the HIV protease inhibitors lopinavir/ritonavir may have potent antimalarial activity .


We sought to evaluate whether lopinavir/ritonavir-based antiretroviral therapy ( ART ) reduced the risk of placental malaria .


HIV-infected , ART-naive pregnant women were enrolled between gestational weeks 12 and 28 and randomly assigned to receive lopinavir/ritonavir-based or efavirenz-based ART .


Women received daily trimethoprim-sulfamethoxazole prophylaxis and insecticide-treated bed nets at enrollment and were followed up to 1 year after delivery .


The primary outcome was placental malaria , defined by the detection of malaria parasites , using microscopy or polymerase chain reaction ( PCR ) analysis of placental blood specimens .


Secondary outcomes included placental malaria , defined by histopathologic results ; adverse birth outcomes ; incidence of malaria ; and prevalence of asymptomatic parasitemia .


Analyses were done using an intention-to-treat approach .


Of 389 subjects randomly assigned to a treatment group , 377 were followed through to delivery .


There was no significant difference in the risk of placental malaria , as defined by thick smear or PCR findings , between the lopinavir/ritonavir-based and efavirenz-based ART arms ( 7.4 % vs 9.8 % ; P = .45 ) .


Similarly , there were no differences in secondary outcomes between the 2 treatment arms .


Lopinavir/ritonavir-based ART did not reduce the risk of placental or maternal malaria or improve birth outcomes , compared with efavirenz-based ART .


NCT00993031 .


TAK-085 is an omega-3 preparation that contains eicosapentaenoic acid ethyl-ester ( EPA-E ) and docosahexaenoic acid-ethyl ester used in the management of hypertriglyceridemia .


The aim of the study was to evaluate the long-term safety ( adverse events [ AEs ] , laboratory parameters , vital signs , weight , and electrocardiograms ) and effects on lipid profiles , especially triglyceride levels , of TAK-085 in Japanese patients with hypertriglyceridemia ( triglyceride levels 150 mg/dL and < 750 mg/dL ) .


In this multicenter , open-label , randomized study , adults with hypertriglyceridemia undergoing lifestyle modification received TAK-085 2 g ( 2 g once daily ; n = 165 ) or 4 g ( 2 g twice daily ; n = 171 ) , or EPA-E 1.8 g ( 0.6 g three times daily ; n = 167 ) for 52 weeks .


Patients were stratified for co-administration of a statin .


TAK-085 was well tolerated throughout the 52-week study .


Overall , no substantial differences were found in the tolerability of TAK-085 2 g , TAK-085 4 g , and EPA-E 1.8 g with incidence rates for AEs of 83.6 % , 86.0 % , and 89.2 % , respectively .


Most AEs were mild or moderate in severity .


Triglyceride levels decreased from baseline in all groups by week 4 , and the decreases were maintained throughout the study .


At week 52 the reduction in triglycerides with TAK-085 2 g ( -13.9 % ) was similar to that with EPA-E 1.8 g ( -12.1 % ) , whereas the reduction seen with TAK-085 4 g ( -25.5 % ) was greater than that with EPA-E 1.8 g , as assessed by point estimates and 95 % confidence intervals .


TAK-085 was safe and well tolerated for up to 52 weeks of treatment in Japanese patients with hypertriglyceridemia undergoing lifestyle modification .


Reductions in triglyceride levels achieved after 4 weeks were maintained at 52 weeks .


Various procedures have been used for the management of neglected and resistant clubfoot .


The aim of our study was to assess the clinical and radiological correction by Joshi 's external stabilization system ( JESS fixator ) and Simons subtalar release in resistant and neglected idiopathic congenital talipes equinovarus in children between the ages of 1 and 2 years .


A total of 50 resistant and neglected clubfeet were randomly divided into two equal groups of 25 feet each .


Group I was treated with JESS fixator and group II was treated with complete subtalar release as described by Simons .


Assessment of correction achieved was done both clinically and radiologically .


Functional outcome was assessed with Ponseti scale .


The change in clinical deformity and radiological correction of deformity were statistically significant within each group , but not significant when compared to each other .


In group I excellent results were obtained in 17 ( 68 % ) and good in 8 ( 32 % ) of the feet .


In group II , excellent results were found in 16 ( 64 % ) and good in 9 ( 36 % ) feet out of the 25 feet .


Pin-site infections were seen in two cases in group I and serious skin problems occurred in two feet in group II .


We conclude that there were no statistical significant differences between the outcomes of the two techniques in this short-term follow-up of 2.4 years .


Thus , functional distraction using JESS can be utilized as an alternative method in cases of neglected and resistant clubfoot .


Carbon dioxide ( CO2 ) insufflation during colonoscopy can significantly decrease abdominal pain and bloating after the procedure , but its impact on the frequency and duration of toilet use remains unknown .


The aim of this study was to assess the impact of CO2 insufflation on toilet use after screening colonoscopy .


From 138 average-risk individuals who underwent screening colonoscopy during March to August 2013 , 120 were enrolled and randomized to receive either CO2 or air insufflation at colonoscopy .


Both the colonoscopist and participant were blinded to the type of gas used .


Abdominal pain and distension were assessed using a visual analog scoring system .


The frequency and duration of toilet visits during a 2-hour postcolonoscopy period were recorded using a radiofrequency identification system .


Baseline characteristics were similar in both groups in terms of age , sex , and procedure time .


In the 2 hours after colonoscopy , 50 participants ( 83 % ) in the air group and 18 participants ( 30 % ) in the CO2 group ( P < 0.001 ) used the toilet at least once .


The mean ( SD ) duration of each toilet visit was 5.934.65 minutes in the air group and 1.532.84 minutes in the CO2 group ( P < 0.001 ) .


The abdominal discomfort score was lower in the CO2 group than in the air group both at the end of the colonoscopy ( P < 0.001 ) and 2 hours later ( P < 0.001 ) .


Insufflation with CO2 can significantly reduce abdominal discomfort and toilet use after colonoscopy .


Use of this technique may help reduce patient burden and allow more efficient use of space in the endoscopy unit .


Ginsenosides are the proposed bioactive constituent of ginseng , especially for the attenuation of postprandial glycemia ( PPG ) .


The efficacious proportion of total and specific ginsenosides , remains unknown .


Alcohol extraction of whole ginseng root can be used to selectively manipulate the ginsenoside profile with increasing alcohol concentrations producing high yields of total ginsenosides and varying their individual proportions .


We aimed to compare the acute efficacy of different ethanol-extraction preparations of American ginseng ( AG ) and Korean red ginseng ( KRG ) , with their whole-root origins , on PPG and insulin parameters in healthy adults .


Following an overnight fast , 13 healthy individuals ( Gender : 5M :8 F , with mean SD , age : 28.9 9.2 years , BMI : 26.3 2.7 kg/m ( 2 ) and fasting plasma glucose : 4.21 0.04 mmol/L ) randomly received 3g of each of the following 10 different ginseng treatments on separate visits : whole root KRG and AG ; 30 % , 50 % or 70 % ethanol extracts of KRG and AG and 2 cornstarch placebos .


Treatments were consumed 40 min prior to a 50 g oral glucose challenge test with capillary blood samples collected at baseline , 15 , 30 , 45 , 60 , 90 and 120 min .


Insulin samples were collected at 0 , 30 , 60 and 120 min .


There was no difference in attenuation of PPG among the tested ginseng preparations .


Measures of Insulin Sensitivity Index ( ISI ) showed increased insulin sensitivity ( IS ) with KRG-30 % and AG-50 % extracts compared to placebo ( p < 0.05 ) .


The insulin sensitizing effects of KRG-30 % and AG-50 % extracts suggest that other root parts , including other ginsenosides not typically measured , may influence PPG and insulin parameters .


There is potential for AG and KRG extracts to modulate IS , an independent predictor of type 2 diabetes .


Bonafide psychotherapy is an effective treatment for generalised anxiety disorder compared to no-treatment .


Rather than creating increasing numbers of new overall treatment-packets within a medical meta-model , an additional approach to investigating clinical research designs may be to increase the understanding of already effective psychotherapies .


Treatment manuals and protocols allow a relatively high degree of freedom for the way therapists implement the overall treatment manuals .


There is a systematic lack of knowledge on how therapists should customise these overall protocols .


The present study experimentally examines three ways of conducting a bonafide psychotherapy based on a 15 session time-limited cognitive-behavioural therapy ( CBT ) protocol and their relation to the therapists ' protocol adherence and treatment efficacy .


This trial will investigate three different methods of customising a bonafide CBT-protocol using dyadic peer-tutoring methodology ( primings ) .


The individuals with GAD will be randomly assigned to one of three priming conditions ( resource priming , supportive resource priming , or adherence priming ) .


The participant treatment allocation will be performed randomly .


Therapists will be assigned to a peer-tutoring partner and priming condition based on a mutual agreement .


Treatment outcomes will be assessed at the following times : observer based in-session outcomes , session-by-session post-session outcomes , treatment outcome at post assessment and treatment outcome at 6-month follow-up .


The proposed trial addresses the clinically relevant question of how to customise a bonafide psychotherapy protocol using tandem peer-tutoring methodology ( three priming conditions ) .


Through the development and testing of the proposed priming procedures , this study describes levels of adherence and how to conduct an overall treatment protocol in a more systematised way .


From ClinicalTrials.gov Identifier : NCT02039193 .


De-escalating natalizumab ( NTZ ) to interferon beta 1b ( IFN B 1B ) is a possible treatment option in multiple sclerosis ( MS ) patients interrupting NTZ because of increased risk of progressive multifocal leukoencephalopathy ( PML ) .


The aim of this study was to evaluate satisfaction and adherence to treatment , behavioral and fatigue changes in patients switched to IFN B 1B compared to continued NTZ treatment .


A 1 year , prospective , randomized , rater-blinded , parallel-group study .


Nineteen relapsing remitting ( RR ) MS patients , randomly assigned to undergo either NTZ ( n = 10 ) or IFN B 1B ( n = 9 ) treatment , who had previously received NTZ for at least 12 months with disease stability and fearing or at risk for PML were included .


Patients underwent behavioral and treatment assessments at baseline , after 24-week and 1 year follow-up .


Behavioral assessment included measures of cognition , fatigue and quality of life .


Treatment assessment included measures of satisfaction , persistence and adherence to treatment .


Clinical-radiological disease activity and safety were also assessed .


Baseline characteristics of patients were similar between groups except for Euro Quality Visual Analogue Scale , being higher in the NTZ group ( p = 0.04 ) .


Within-group comparisons at the three time points , as well as interaction analysis of treatment effect over time did not show any statistically significant differences in behavioral or treatment assessments , but a coherent trend favoring NTZ over IFN B 1B .


De-escalating NTZ to IFN B 1B is feasible and associated with overall good patient related outcome and persistently stable behavioral measures .


Three randomised controlled trials have provided strong evidence that Weight Watchers ( ) is an effective weight-loss programme but there is insufficient evidence to determine whether three other weight-loss programmes are also effective .


To examine whether other group-based weight-loss programmes were not inferior to Weight Watchers .


A prospective cohort study using a non-inferiority analysis of 3290 adults referred through primary care .


METHOD Participants who met the eligibility criteria for primary care obesity management treatment chose a free programme ( Weight Watchers , Rosemary Conley Diet and Fitness Clubs , Slimming World or a NHS group programme ) lasting 3 months ; they were weighed at 3 months ( programme end ) and self-reported their weight at 12 months .


At 3 months , weight loss achieved through Rosemary Conley and Slimming World was not inferior to Weight Watchers .


The NHS group programme was inferior .


At 12 months Slimming World and Rosemary Conley were not inferior to Weight Watchers , although participants using Slimming World lost significantly more weight than those using Weight Watchers .


Data on the NHS group programme were inconclusive .


In the short term all commercial weight-loss programmes appear to result in similar weight loss but the NHS alternative appears to produce less weight loss .


At 12 months Slimming World led to greater weight loss but the differences between commercial programmes was small and of minor clinical importance .


Our aim is to compare the hemodynamic effects of combined psoas compartment-sciatic nerve block ( PCSNB ) with continuous spinal anaesthesia ( CSA ) in elderly high-risk patients undergoing hip replacement surgery .


Seventy patients over the age of 60 with ASA III or IV physical status were randomly allocated to two groups : In the PCSNB group , ultrasound-guided psoas compartment block was performed with modified Winnie technique using 30 mL of 0.25 % bupivacaine with 1:200.000 epinephrine ( 5 gr/mL ) and iliac crest block was performed using the same local anaesthetic solution ( 5 mL ) .


All patients in the PCSNB group needed continuing infusion of propofol ( 2 mg/kg/h ) during operation .


In the CSA group , CSA was performed in the L3-L4 interspaced with the patient in lateral decubitus position using 2.5 mg of isobaric bupivacaine 0.5 % .


When sensory block was not reached to the level of T12 within 10 minutes in the CSA group , additional 2.5 mg of isobaric bupivacaine 0.5 % was administered through the catheter at 5-min intervals by limiting the total dose of 15 mg until a T12 level of the sensory block was achieved .


The PCSNB group had significantly higher mean arterial blood pressure values at the beginning of surgery and at 5 ( th ) , 10 ( th ) and 20 ( th ) minutes of surgery compared to the CSA group ( P = 0.038 , P = 0.029 , P = 0.012 , P = 0.009 respectively ) .


There were no significant differences between groups in terms of heart rate and peripheral oxygen saturation values during surgery and the postoperative period ( P > 0.05 ) .


Arterial hypotension required ephedrine was observed in 13 patients in the CSA and 4 patients in the PCSNB group ( P = 0.012 ) .


CSA and PCSNB produce satisfactory quality of anaesthesia in elderly high-risk patients with fewer hemodynamic changes in PCSNB cases compared with CSA cases .


Australian New Zealand Clinical Trials Registry : ACTRN12614000658617 , Registered 24 June 2014 .


Mandibular advancement splints ( MAS ) are often preferred to CPAP treatment for OSA but are not always equally efficacious .


High therapeutic CPAP pressure has been associated with MAS treatment failure in a Japanese population .


We sought to assess the relationship between CPAP pressure and MAS treatment response in an Australian population .


Therapeutic CPAP pressure and MAS treatment response were obtained from a one-month crossover trial of both treatments .


Predictive utility of CPAP pressure to identify MAS treatment response was assessed .


Seventy-eight OSA patients were included ( age 49.3 11.1 years , BMI 29.1 5.8 kg/m ( 2 ) ) with predominantly moderate-severe OSA ( AHI 30.0 12.7 / h ) .


CPAP pressure was lower in MAS responders ( MAS AHI < 10/h ) 9.7 1.6 vs. 11.7 2.4 cm H O , p < 0.01 , with area under ROC curve of 0.74 ( 95 % CI 0.63-0 .86 ) , p < 0.01 .


The best cutoff value of 10.5 cm H O useful for discriminating MAS responders and non-responders in the previous Japanese population , was inadequate for prediction in the current population ( 0.47 negative predictive value [ NPV ] ) .


However a cutoff of 13 cm H O identified MAS non-responders ( 1.0 NPV ) .


Multivariate regression identified CPAP pressure ( odds ratio [ 95 % confidence interval ] 0.53 [ 0.33-0 .87 ] , age ( 0.93 [ 0.87-0 .99 ] ) and AHI ( 0.92 [ 0.86-0 .97 ] ) as predictors of MAS treatment response ( model r ( 2 ) = 0.54 , p < 0.001 ) .


In Australian patients , the majority of whom are Caucasian , a higher therapeutic CPAP pressure requirement in conjunction with age and OSA severity characteristics may be useful to indicate likelihood of success with MAS as an alternative therapy .


Since the results from the randomized TARGIT A trial were published , intraoperative radiotherapy ( IORT ) is used more often .


IORT can be provided as accelerated partial breast irradiation ( APBI ) or as a boost .


The definition of suitable patients for IORT as APBI differs between different national societies ( e.g. ESTRO and ASTRO ) and different inclusion criteria of trials and so does the eligibility of patients .


This analysis identifies eligible patients for IORT according to available consensus statements and inclusion criteria of the ongoing TARGIT trials .


Between 01/03 - 12/09 , 1505 breast cancer cases were treated at the breast cancer center at the University Medical Center Mannheim .


Complete data sets for age , stage ( T , N , and M ) , histology and hormone receptor status were available in 1108 cases .


Parameters to identify eligible patients are as follows : ESTRO : > 50 years , invasive ductal carcinoma/other favorable histology ( IDC ) , T1-2 ( 3 cm ) , N0 , any hormone receptor status , M0 ; ASTRO : 60 years , IDC , T1 , N0 , positive estrogen hormone receptor status , M0 ; TARGIT E `` elderly '' , risk adapted radiotherapy with IORT followed by external beam radiotherapy in case of risk factors in final histopathology , phase II : 70 years , IDC , T1 , N0 , any hormone receptor status , M0 ; TARGIT C `` consolidation '' , risk adapted radiotherapy , phase IV : 50 years , IDC , T1 , N0 , positive hormone receptor status , M0 ; TARGIT BQR `` boost quality registry '' : every age , every histology , T1-2 ( max .


3.5 cm ) , any hormone receptor status , N0 / + , M0 / + .


Out of the 1108 cases , 379 cases ( 34.2 % ) were suitable for IORT as APBI regarding the ESTRO and 175 ( 15.8 % ) regarding the ASTRO consensus statements .


82 ( 7.4 % ) patients were eligible for the TARGIT E trial , 258 ( 23.3 % ) for the TARGIT C trial and 671 ( 60.6 % ) for the TARGIT BQR registry .


According to the consensus statements of ASTRO ( 45.1 % ) and ESTRO ( 41.4 % ) about half of the eligible patients were treated with IORT as APBI .


From the eligible patients fulfilling the criteria for IORT boost ( 35 % ) about one third was eventually treated .


Patient selection for IORT should be restrictive .


For IORT as APBI the TARGIT trials are even more restrictive including patients than the ESTRO and ASTRO consensus statements .


Cell-culture-derived ( CC ) influenza vaccine production methods could provide benefits over classical embryonated-egg technology , including a higher production capacity and the faster creation of a supply that meets demand .


A CC-inactivated split-virus influenza A/Indonesia/5 / 2005 ( H5N1 ) vaccine derived from the EB66 cell line ( hereafter , `` CC-H5N1 '' ) was investigated in a phase 1 randomized , blinded study .


Healthy adults ( n = 521 ) received 2 vaccine doses ( days 0 and 21 ) of either investigational CC-H5N1 vaccine ( 1.9 g or 3.75 g of hemagglutinin antigen [ HA ] with the AS03 adjuvant system or 15 g of plain HA ) , embryonated-egg-derived vaccines ( 3.75 g of HA with AS03 or 15 g of plain HA ) , or placebo .


Assessment of the adjuvant effect and immunogenicity was performed using Center for Biologics Evaluation and Research acceptability criteria 21 days after dose 2 .


Safety was assessed until month 12 .


AS03-adjuvanted CC-H5N1 elicited a homologous hemagglutination inhibition antibody response that satisfied immunogenicity criteria 21 days after dose 2 and persisted at month 12 .


Adjuvant effect and immune response against a drift-variant strain were demonstrated .


No vaccine-related serious adverse events were reported .


The immunogenicity and safety of the CC-H5N1 formulation containing 3.75 g of HA and AS03 appeared to be similar to those for the licensed egg-derived AS03-adjuvanted control vaccine .


The feasibility of the EB66 cell line to produce an immunogenic influenza vaccine with acceptable safety profile was demonstrated .


Antigen sparing was achieved through combination with AS03 adjuvant .


This CC-H5N1 might contribute to the rapid access of vaccine in the event of an influenza A ( H5N1 ) pandemic .


NCT01236040 .


The aim of this study was to evaluate a tailored physical activity protocol performed in a work environment with a group of female workers employed in manual precision tasks to reduce upper limb pain .


Sixty female subjects were randomly assigned to an intervention group or a control group .


The IG was administered of a 6-month , twice-a-week , tailored exercise program , whereas the CG received no intervention .


The IG showed a reduction on shoulder pain accompanied by increases on the range of motion measures .


In addition , reductions in upper limb pain and neck disability were detected with concomitant increases in grip strength .


This study indicated positive effects of a tailored workplace exercise protocol in female workers exposed to moderate risk for work-related musculoskeletal disorders , showing clinically meaningful reductions of pain symptoms and disability on upper limb and neck regions .


Sayana Press ( SP ) , a subcutaneous formulation of depot medroxyprogesterone acetate ( DMPA ) prefilled in a Uniject injection system , could potentially improve and expand contraceptive injection services , but acceptability of SP is unknown .


HIV-positive women need contraception to avoid unintended pregnancy and risk of vertical HIV transmission .


We assessed acceptability of SP versus intramuscular DMPA ( DMPA-IM ) among HIV-positive women and their care providers in Rakai , Uganda .


Women were randomized to DMPA-IM or SP at baseline , received the alternate product at 3 months , and chose their preferred method at 6 months .


We determined preferences among new and experienced contraceptive injectable users who had tried both types of injection during the trial , and from providers before and after providing both types of injectables to clients .


Among 357 women randomized , 314 were followed up at 6 months ( 88 % ) .


Although SP caused more skin irritation than DMPA-IM ( 3.8 % vs. 0 % at 6 months , p = .03 ) , it was associated with marginally fewer side effects ( 30.4 % vs. 40.4 % at 6 months , p = .06 ) .


Participants reported high levels of willingness to recommend the DMPA contraception to a friend and satisfaction with the injection received , and these did not differ by injection type .


Sixty-four percent of women and 73 % of providers preferred SP to DMPA-IM at 6 months ; women 's preferences did not differ by previous experience with injectable contraception .


SP is acceptable to HIV-positive women and health care providers in this rural Ugandan population .


SP appears to be acceptable to HIV-positive women and their care providers in Rakai , Uganda , and strategies for appropriate rollout of this innovative technology should be explored .


The aim of this randomised clinical trial was to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education vs ` treatment as usual ' in patients treated with an implantable cardioverter defibrillator ( ICD ) .


In this study 196 patients with first time ICD implantation ( mean age 57.2 ( standard deviation ( SD ) = 13.2 ) ; 79 % men ) were randomised ( 1:1 ) to comprehensive cardiac rehabilitation vs ` treatment as usual ' .


Altogether 144 participants completed the 12 month follow-up .


The intervention consisted of twelve weeks of exercise training and one year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes .


Two primary outcomes , general health score ( Short Form-36 ( SF-36 ) ) and peak oxygen uptake ( VO ) , were used .


Post-hoc analyses included SF-36 and ICD therapy history .


Comprehensive cardiac rehabilitation significantly increased VO2 uptake after exercise training to 23.0 ( 95 % confidence interval ( CI ) 20.9-22 .7 ) vs 20.8 ( 95 % CI 18.9-22 .7 ) ml/min/kg in the control group ( p = 0.004 ( multiplicity p = 0.015 ) ) .


Comprehensive cardiac rehabilitation significantly increased general health ; at three months ( mean 62.8 ( 95 % CI 58.1-67 .5 ) vs 64.4 ( 95 % CI : 59.6-69 .2 ) ) points ; at six months ( mean 66.7 ( 95 % CI 61.5-72 .0 ) vs 61.9 ( 95 % CI 56.1-67 .7 ) points ) ; and 12 months ( mean 63.5 ( 95 % CI 57.7-69 .3 ) vs 62.1 ( 95 % CI 56.2-68 .0 ) ) points ( p < 0.05 ) .


Explorative analyses showed a significant difference between groups in favour of the intervention group .


No significant difference was seen in ICD therapy history .


Comprehensive cardiac rehabilitation combining exercise training and a psycho-educational intervention improves VO-uptake and general health .


Furthermore , mental health seems improved .


No significant difference was found in the number of ICD shocks or anti-tachycardia pacing therapy .


The immune system has been implicated as one mechanism underlying the benefits of acupuncture therapy .


Evidence suggests that acupuncture can ameliorate symptoms of chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) , but the association between clinical response and the immune system has not been investigated .


We investigated 12 CP/CPPS patients participating in a prospective randomized clinical trial comparing acupuncture versus sham acupuncture for effects on cellular immunity .


Blood samples were taken before the first needling and after the last of 20 treatment sessions ( week 10 ) .


Patients also completed questionnaires examining their CP/CPPS symptoms and mood status at the baseline and end of study visits .


At the end of study 8 of 12 participants ( 67 % ) were classified as treatment responders , four participants each from the acupuncture and sham groups .


The acupuncture group averaged a 5 % increase in natural killer cell levels compared to corresponding sham ( -13 % ; p = 0.03 ) .


Similarly , patients randomized to acupuncture reported a reduction in other white blood cell parameters examined , supporting the possibility that immunity might be important in the pathophysiology of CP/CPPS .


The specific effect of acupuncture on CP/CPPS remains unclear .


Further research is warranted to examine the mechanisms by which acupuncture therapy may improve clinical symptoms in patients with CP/CPPS .


ClinicalTrials.gov number , NCT00260637 ) .


Limited data is available on long-term atrial fibrillation ( AF ) free survival after multi-electrode catheter pulmonary vein isolation ( PVI ) .


The aim of this study was to compare point-by-point PVI to multi-electrode PVI in terms of procedural characteristics and long-term AF free survival .


460 consecutive patients were randomly allocated : 230 patients underwent conventional , point-by-point ablation with a radiofrequency ablation catheter ( cPVI group ) and 230 patients underwent multi-electrode , phased radiofrequency ablation ( MER group ) .


Median follow-up was 43 months .


Mean age was 56 years , 82 % of patients had paroxysmal AF .


Baseline characteristics did not differ among catheter groups .


Acute electrical PVI was achieved in 99.7 % of pulmonary veins , with no differences among catheter groups .


Procedure time and ablation time were significantly shorter in the MER group .


There were significantly less complications in the MER group ( 4.8 % vs. 1.3 % , P = 0.025 ) .


After a mean of 1.5 procedures , AF free survival without the use of antiarrhythmic drugs was 74 % at 1 year and 46 % at 5 years follow-up and did not differ among catheter groups ( cPVI group 45 % , MER group 48 % , P = 0.777 ) .


In multivariate analysis , BMI , AF duration and CHADSVASc score were predictors of AF free survival .


Multi-electrode ablation was superior in procedure duration and ablation time , with less complications .


However , both conventional point-by-point PVI and multi-electrode PVI achieved a high acute PVI success rate and showed a comparable long-term AF free survival .


To determine whether supplementation with the long-chain omega-3 polyunsaturated fatty acids eicosapentaenoic ( EPA ) and docosahexaenoic acid ( DHA ) affects behavioral symptoms and cognitive impairments in children 6-12 years of age diagnosed with attention-deficit/hyperactivity disorder ( ADHD ) .


The randomized , double-blind placebo-controlled 16 weeks trial was conducted with 95 children diagnosed with ADHD according to DSM-IV criteria .


Behavior was assessed by parents , teachers and investigators using standardized rating scales and questionnaires .


Further outcome variables were working memory , speed of information processing and various measures of attention .


For a subgroup of 81 participants , erythrocyte membrane fatty acid composition was analyzed before and after the intervention .


Supplementation with the omega-3 fatty acid mix increased EPA and DHA concentrations in erythrocyte membranes and improved working memory function , but had no effect on other cognitive measures and parent - and teacher-rated behavior in the study population .


Improved working memory correlated significantly with increased EPA , DHA and decreased AA ( arachidonic acid ) .


Transfusion with red blood cells ( RBC ) may be needed during hip revision surgery but the appropriate haemoglobin concentration ( Hb ) threshold for transfusion has not been well established .


We hypothesized that a higher transfusion threshold would improve ambulation after hip revision surgery .


The trial was registered at Clinicaltrials.gov ( NCT00906295 ) .


Sixty-six patients aged 18 years or older undergoing hip revision surgery were randomized to receive RBC at a Hb threshold of either 7.3 g/dL ( restrictive group ) or 8.9 g/dL ( liberal group ) .


Postoperative ambulation was assessed using Timed Up and Go-test ( TUG ) and ability to walk was also assessed daily by a physiotherapist blinded to the allocation .


Fifty-three patients were able to perform the TUG and included in the analysis .


The TUG could be completed in a median of 36 sec vs. 30 sec in the restrictive group and the liberal group , respectively ( P = 0.02 ) .


The mean difference in TUG was 14.5 sec ( 95 % CI 2.8-26 .2 sec ) .


No difference was found in the day patients could perform TUG or walk 10 meters .


The Hb at the day of testing was 10.2 g/dL in the restrictive group and 9.9 g/dL in the liberal group .


Only 26 patients received RBC .


A Hb transfusion threshold of 8.9 g/dL was associated with a statistically significantly faster TUG after hip revision surgery compared to a threshold of 7.3 g/dL but the clinical importance is questionable and the groups did not differ in Hb at the time of testing .


Although acute treatments have been shown to be effective in treating early-onset depression , only one-third or thereabouts reach a remission within 3 months .


Unfortunately , delayed time to remission in early-onset depression leads to poorer therapeutic outcomes .


Clearly , there is a need to identify , diagnose , and provide effective treatment of a depressed patient quickly .


A sophisticated understanding of depression subscales and their change over time with treatment could enhance pathways to individualized treatment approaches for childhood depression .


Previous studies have found that the clinician-measured instrument , Children 's Depression Rating Scale-Revised ( CDRS-R ) measures multiple subscales ( or components ) of depression .


The aim of this study was to see how these subscales may change over the course of a 12-week study .


This knowledge will help determine if dimensions/subscales of childhood depression ( paralleling the adult literature ) using the subscales derived from factor analysis procedure is useful .


We examined two clinical trials in which youth ( n = 234 ) with major depressive disorder ( MDD ) were treated openly with fluoxetine for eight sessions spread over 12 weeks .


The CDRS-R was completed based on clinician interviews with parent and child at each session .


Classical test theory and component analysis with associated parallel analysis ( oblique rotation ) were conducted on each week 's scores .


Although more factors were needed for the baseline and first two therapy sessions , a two-factor solution sufficed thereafter .


Depressed facial affect , listless speech , and hypoactivity best defined Factor I , whereas sleep problems , appetite disturbance , physical symptoms , irritability , guilt , and weeping best defined Factor II .


All other symptoms cross-loaded almost equally on the two factors .


The scale 's reliability ( internal consistency ) improved from baseline to exit sessions ( = 0.65-0 .91 ) .


As a result , the clinicians ' assessments of the various symptoms became more highly related to one another .


This caused the first eigenvalue to increase from 3.24 to 7.38 and the variance explained to increase ( % ) from 19 % to 43 % over sessions .


These two factors may reflect 1 ) clinician-observed signs and 2 ) reported symptoms of depression .


Factor analysis of CDRS-R data in a single session consistently generates a complex and difficult to interpret structure of at least three factors .


This makes it very difficult to understand what these factors measure .


However , when gathered over additional sessions , the CDRS-R structure tends to simplify to two factors .


The reasons for this simplification are as yet unclear and in need of further study .


This study was conducted to determine the effects of folate supplementation on inflammatory factors and biomarkers of oxidative stress among women with polycystic ovary syndrome ( PCOS ) .


This randomized , double-blind , placebo-controlled clinical trial was conducted among 69 women diagnosed with PCOS and aged 18-40year old .


Participants were randomly assigned to three groups receiving the following : ( 1 ) folate-1 : 1mg/d folate supplements ( N = 23 ) ; ( 2 ) folate-5 : 5mg/d folate supplements ( N = 23 ) and ( 3 ) placebo ( N = 23 ) for 8weeks .


Fasting blood samples were taken at the beginning of the study and after 8weeks to measure homocysteine ( Hcy ) , inflammatory factors including high-sensitivity C-reactive protein ( hs-CRP ) , nitric oxide ( NO ) , biomarkers of oxidative stress including total antioxidant capacity ( TAC ) , glutathione ( GSH ) , malondialdehyde ( MDA ) and homoeostatic model assessment-beta cell function ( HOMA-B ) .


Supplementation with 5mg/d folate resulted in reduced plasma Hcy ( -223 vs -186 and 116m , respectively , P < 005 ) , HOMA-B ( -763 vs 143 and 1366 , respectively , P < 005 ) , serum hs-CRP ( -2122 vs -2624 and 7298g/l , respectively , P < 005 ) and plasma MDA concentrations ( -048 vs -024 and 069m , respectively , P < 001 ) compared with folate-1 and placebo groups .


Furthermore , a significant rise in plasma TAC ( 064 vs -353 and -21547 mm , respectively , P < 001 ) and GSH levels ( 1621 vs 1958 and -1582 m , respectively , P < 001 ) was also observed following the administration of 5mg/d folate supplements compared with folate-1 and placebo groups .


In conclusion , folate supplementation ( 5mg/d ) in women with PCOS had beneficial effects on inflammatory factors and biomarkers of oxidative stress .


Teenage passengers affect teenage driving performance , possibly by social influence .


To examine the effect of social norms on driving behavior , male teenagers were randomly assigned to drive in a simulator with a peer-aged confederate to whom participants were primed to attribute either risk-accepting or risk-averse social norms .


It was hypothesized that teenage drivers would engage in more risky driving behavior in the presence of peer passengers than no passengers , and with a risk-accepting compared with a risk-averse passenger .


66 male participants aged 16 to 18 years holding a provisional driver license were randomized to drive with a risk-accepting or risk-averse passenger in a simulator .


Failure to Stop at a red light and percent Time in Red ( light ) were measured as primary risk-relevant outcomes of interest at 18 intersections , while driving once alone and once with their assigned passenger .


The effect of passenger presence on risky driving was moderated by passenger type for Failed to Stop in a generalized linear mixed model ( OR = 1.84 , 95 % CI [ 1.19 , 2.86 ] , p < .001 ) , and percent Time in Red in a mixed model ( B = 7.71 , 95 % CI [ 1.54 , 13.87 ] , p < .05 ) .


Exposure of teenage males to a risk-accepting confederate peer increased teenage males ' risky simulated driving behavior compared with exposure to a risk-averse confederate peer .


These results indicate that variability in teenage risky driving could be partially explained by social norms .


Transcutaneous electrical tibial nerve stimulation ( TENS ) is of growing interest for the treatment of fecal incontinence ( FI ) , but its mechanism of action remains uninvestigated .


We aimed to further assess the anorectal response to TENS in a dynamic model .


We performed a placebo-controlled , randomized , double-blinded crossover study in 19 patients suffering from FI to assess the effects of TENS on anorectal function .


Anorectal physiology and perception were recorded through two sequences of rectal isobaric distension using an electronic barostat device to measure anal and rectal pressures , rectal volumes , and perception scores .


Maximal rectal pressure and volume variation were affected by TENS , with higher mean maximal rectal pressure ( 5.33 and 4.06 mmHg in the active and sham TENS respectively , p < 0.0001 ) and lower volume variation ( 11.45 and 14.7 mL in the active and sham stimulation respectively , p < 0.05 ) .


Rectal compliance was not modified by active TENS .


Pressure of the upper anal canal was significantly lower with raised isobaric distension in sequences assigned to active TENS .


Acute TENS modified anorectal physiology by strengthening the myogenic response to distension rather than increasing muscle relaxation and related rectal compliance in patients with FI .


To compare the incidence of wound complications between suture and staple skin closure after cesarean delivery .


This prospective , randomized clinical trial conducted at three hospitals in the United States between 2010 and 2012 included women undergoing cesarean delivery at 23 weeks of gestation or greater through a low-transverse skin incision .


Women were randomized to closure of the skin incision with suture or staples after stratifying by body mass index and primary compared with repeat cesarean delivery .


The primary outcome was incidence of wound complications , predefined as a composite of infection , hematoma , seroma , separation of 1 cm or longer , or readmission for wound complications .


Analysis was according to the intention-to-treat principle ; results were stratified by randomization group and adjusted for hospital by including it as a covariate .


A total of 746 women were randomized , 370 to suture and 376 to staple closure .


The median gestational age was 39 weeks .


Fifty-eight women ( 7.8 % ) had wound complications-4 .9 % in the suture group and 10.6 % in the staple group ( adjusted odds ratio [ OR ] 0.43 , 95 % confidence interval [ CI ] 0.23-0 .78 ) ; this was largely the result of the decreased incidence of wound separation in the respective groups ( 1.6 % compared with 7.4 % ; adjusted OR 0.20 , 95 % CI 0.07-0 .51 ) .


Suture closure of the skin incision at cesarean delivery is associated with a 57 % decrease in wound complications compared with staple closure .


Clinicaltrials.gov , www.clinicaltrials.gov , NCT01211600 .


I.


The purpose of this study was to compare physical activity ( PA ) outcomes in a sample of high school ( HS ) physical education ( PE ) lessons from schools that adopted traditional versus modified block schedule formats .


We used the System for Observing Fitness Instruction Time ( SOFIT ) to conduct observations of 168 HS PE lessons delivered by 22 PE teachers in 4 schools .


T-tests and multilevel models were used to explore variability in moderate PA and vigorous PA. .


PA outcomes were significantly different between modified block and traditional schools .


Students who attended traditional schools engaged in more vigorous PA in PE lessons .


Modified block lessons lost more scheduled lesson time due to poor transition to and from the locker room .


PA outcomes were positively associated with fitness and teacher promotion of PA and negatively associated with lost time , class size , management , and knowledge .


Although PE proponents widely advocate for more PE minutes , this study showed that greater time scheduled in PE does not necessarily result in more student accrual of moderate to vigorous physical activity ( MVPA ) minutes .


This study evaluated whether a nutrition-education program in child-care centers improved children 's at-home daily consumption of fruits and vegetables , at-home use of low-fat/fat-free milk , and other at-home dietary behaviors .


Twenty-four child-care centers serving low-income families were matched by region , type , and size , and then randomly assigned to either an intervention or control condition .


In the 12 intervention centers , registered dietitian nutritionists provided nutrition education to children and parents separately during a 6 - to 10-week period .


They also held two training sessions for center staff , to educate them on healthy eating and physical activity policies at the centers , and distributed weekly parent newsletters that included activities and recipes .


Parents ( n = 1,143 ) completed a mail or telephone survey at baseline and follow-up to report information on their child 's fruit , vegetable , and milk consumption and other dietary behaviors at home .


This study used general and generalized linear mixed models to evaluate program impacts , while accounting for the clustering of children within centers .


This study included child age , child sex , household size , respondent race/ethnicity , respondent age , and respondent sex as covariates .


The program had a substantial impact on children 's at-home daily consumption of vegetables and use of low-fat/fat-free milk .


This study also found a significant increase in the frequency of child-initiated vegetable snacking , which might have contributed to the significant increase in vegetable consumption .


The program did not have a significant impact on fruit consumption or parental offerings of fruits and vegetables , child-initiated fruit snacking , or child fruit consumption .


This intervention in child-care settings that emphasized children , parents , and teachers significantly increased at-home vegetable and low-fat/fat-free milk consumption among low-income preschoolers .


Greater skeletal muscle fat infiltration occurs with age and contributes to numerous negative health outcomes .


The primary purpose was to determine whether intermuscular adipose tissue ( IMAT ) can be influenced by an exercise intervention and if a greater reduction in IMAT occurs with eccentric versus traditional resistance training .


Seventy-seven older adults ( age 75.5 6.8 ) with multiple comorbidities and a history of falling completed a three-month exercise intervention paired with either eccentric or traditional resistance training .


MRI of the mid-thigh was examined at three time points to determine changes in muscle composition after intervention .


No differences in IMAT were observed over time , and there were no differences in IMAT response between intervention groups .


Participants in the traditional group lost a significant amount of lean tissue ( P = 0.007 ) in the nine months after intervention , while participants in the eccentric group did not ( P = 0.32 ) .


When IMAT levels were partitioned into high and low IMAT groups , there were differential IMAT responses to intervention with the high group lowering thigh IMAT .


There is no decrease in thigh IMAT after a three-month exercise intervention in older adults at risk for falling and no benefit to eccentric training over traditional resistance training for reducing IMAT in these individuals .


Healing is an event that is fundamental to the success of total knee arthroplasty .


The aims of the present study were to compare the rates of complications related to wound healing between two groups of volunteers submitted to total knee arthroplasty and to evaluate the effects of postoperative oxygen supplementation by means of a nasal catheter .


A total of 109 patients who underwent total knee arthroplasty were randomized into two groups , namely , groups that did and did not receive postoperative oxygen supplementation via a nasal catheter .


The surgical wound was monitored every day during the hospital stay and on the 7th , 14th , 21st , 30th and 42nd postoperative days .


Characteristics related to healing were observed , including hyperemia , dehiscence , necrosis , phlyctenules and deep and superficial infection .


There were no cases of deep infection .


Hyperemia was statistically correlated with the total number of complications in the groups , with oxygen demonstrated to be a protective factor against hyperemia .


Approximately 30 % of the patients who exhibited hyperemia had other complications , independent of oxygen supplementation .


Oxygen supplementation following total knee arthroplasty was shown to be effective in diminishing hyperemia around the operative wound .


The development of hyperemia was a precursor to other complications , irrespective of whether oxygen supplementation was used .


To explore the clinical effect of Erlong Xizhu acupuncture for retinitis pigmentosa .


Methods Sixty patients with retinitis pigmentosa were randomly divided into an Erlong Xizhu acupuncture group and a conventional acupuncture group , 30 cases in each one .


In the conventional acupuncture group , Tongziliao ( GB 1 ) , Sizhukong ( TE 23 ) , Taiyang ( EX-HN 5 ) were acupunctured as the main acupoints by uniform reinforcing-reducing manipulation ; acupoints based on syndrome differentiation were coordinated by acupuncture manipulation of reinforcing deficiency and reducing excess .


The treatment in the Erlong Xizhu acupuncture group was the same as that in the conventional group , except acupuncture manipulation at the main acupoints replaced by Erlong Xizhu acupuncture .


In the two groups , treatment was given once a day , 10 days as one session and there were 2 days at the interval between sessions .


The change of the vision and visual field and the efficacy were observed after 3 sessions in the two groups .


The total effective rate on enhancing the vision of patients in the Erlong Xizhu acupuncture group was 93.10 % ( 54/58 ) , which was superior to 81.36 % ( 48/59 ) in the conventional acupuncture group ( P < 0.01 ) .


And the effective rate on improving the visual field was 91.38 % ( 53/58 ) in the Erlong Xizhu acupuncture group , which was better than 83.05 % ( 49/59 ) in the conventional acupuncture group ( P < 0.01 ) .


On the comprehensive effect , the effective rate was 90.00 % ( 27/30 ) in the Erlong Xizhu acupuncture group , which was better than 63.34 % ( 19/30 ) in the conventional acupuncture group ( P < 0.05 ) .


The clinical effect of Erlong Xizhu acupuncture is superior to that of conventional acupuncture for retinitis pigmentosa and it is worthy of promoting .


A significant number of individuals suffer from plantar heel pain ( PHP ) and many go on to have chronic symptoms and continued disability .


Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed .


Currently , there is a wide variation in treatment , cost , and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches .


Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear .


The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention ( ePT ) following initial presentation to podiatry versus usual podiatric care ( uPOD ) in individuals with PHP .


A parallel-group , block-randomized clinical trial will compare ePT and uPOD .


Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy , exercise , and modalities , or podiatric care consisting primarily of a stretching handout , medication , injections , and orthotics .


Treatment in each group will be directed by practice guidelines and a procedural manual , yet the specific intervention for each participant will be selected by the treating provider .


Between-group differences in the Foot and Ankle Ability Measure 6 months following the initial visit will be the primary outcome collected by an independent investigator .


In addition , differences in the European Quality of Life -- Five Dimensions , Numeric Pain Rating Scale , Global Rating of Change ( GROC ) , health-related costs , and cost-effectiveness at 6 weeks , 6 months , and 1 year will be compared between groups .


The association between successful outcomes based on GROC score and participant expectations of recovery generally , and specific to physical therapy and podiatry treatment , will also be analyzed .


This study will be the first pragmatic trial to investigate the clinical outcomes and cost-effectiveness of ePT and uPOD in individuals with PHP .


The results will serve to inform clinical practice decisions and management guidelines of multiple disciplines .


ClinicalTrials.gov : NCT01865734 .


To evaluate the efficacy and safety of canagliflozin , a sodium glucose co-transporter 2 inhibitor , in Asian patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled by metformin or metformin in combination with sulphonylurea .


In this 18-week , randomized , double-blind , placebo-controlled phase III study , patients ( N = 676 ) received canagliflozin 100 or 300mg or placebo once daily .


The primary efficacy endpoint was change in glycated haemoglobin ( HbA1c ) level from baseline at week 18 .


Additional endpoints included change in fasting plasma glucose ( FPG ) and percent change in body weight .


Adverse events ( AEs ) were recorded throughout the study .


Efficacy and safety were assessed in the overall population and in two strata based on background therapy .


At week 18 , canagliflozin 100 and 300mg provided significant reductions from baseline in HbA1c compared with placebo ( -0.97 , -1.06 and -0.47 % , respectively ; p < 0.001 ) .


Relative to placebo , canagliflozin 100 and 300mg also significantly reduced FPG ( -1.0 and -1.4 mmol/l ) and body weight [ -2.2 % ( -1.5 kg ) and -2.3 % ( -1.6 kg ) ] .


Both canagliflozin doses lowered systolic blood pressure ( BP ) compared with placebo .


The overall incidence of AEs was 38.6 , 43.2 and 42.0 % with canagliflozin 100 and 300mg and placebo , respectively .


The incidence of genital mycotic infections and urinary tract infections was low and similar across groups .


Efficacy and safety findings in the two strata were generally consistent with the overall population .


Canagliflozin provided glycaemic improvements and reductions in body weight and systolic BP , and was generally well tolerated in Asian patients with T2DM on metformin or metformin in combination with sulphonylurea .


Fish oil intake reduces serum triglycerides ; however , little is known about the effects of dietary fish intake on lipoprotein subclasses .


We aimed at assessing the effect of fatty and lean fish intake on the lipoprotein subclasses in an intervention study .


The intervention study included 33 patients with coronary heart disease , who were aged 61.0 5.8 ( mean SD ) years .


The subjects were randomly assigned to a fatty fish ( n = 11 ) , lean fish ( n = 12 ) , or control ( n = 10 ) diet for 8 weeks .


Fish diets included at least 4 fish meals per week .


Subjects in the control group consumed lean beef , pork , and chicken .


Lipoprotein subclasses and their lipid components were determined by nuclear magnetic resonance spectroscopy .


Concentrations of n-3 fatty acids and docosahexaenoic acid increased in the fatty fish group .


The concentrations of cholesterol , cholesterol esters , and total lipids in very large high-density lipoproteins ( HDLs ) increased in the fatty fish group ( overall difference P = .005 , P = .002 , and P = .007 , respectively ; false discovery rate P = .04 , P = .04 , and P = .05 , respectively ) .


The mean size of HDL particles increased in the fatty fish group ( 9.8 0.3 nm at baseline and 9.9 0.4 nm at end of study ; overall difference P = .004 , false discovery rate P = .04 ) .


The fish diets did not affect very-low-density lipoprotein or low-density lipoprotein size .


Fatty fish intake at least 4 times per week increases HDL particle size which might have beneficial effect in patients with coronary heart disease .


The purpose of our study is to present a surgical technique of primary porous orbital ball implantation with overlying mucus membrane graft ( MMG ) for reconstruction of severely contracted socket and to evaluate prosthesis retention and motility in comparison to dermis fat graft ( DFG ) .


Prospective comparative study .


A total of 24 patients of severe socket contracture ( Grade 2-4 Krishna 's classification ) were subdivided into two groups , 12 patients in each group .


In Group I , DFG have been used for reconstruction .


In Group II , porous polyethylene implant with MMG has been used as a primary procedure for socket reconstruction .


In Group I DFG was carried out in usual procedure .


In case of Group II , vascularized scar tissues were separated 360 and were fashioned into four strips .


A scleral capped porous polyethylene implant was placed in the intraconal space and four strips of scar tissue were secured to the scleral cap and extended part overlapped the implant to make a twofold barrier between the implant and MMG .


Patients were followed-up as per prefixed proforma .


Prosthesis motility and retention between the two groups were measured .


In Group I , four patients had recurrence of contracture with fall out of prosthesis .


In Group II stable reconstruction was achieved in all the patients .


In terms of prosthesis motility , maximum in Group I was 39.2 % and Group II , was 59.3 % .


The difference in prosthesis retention ( P = 0.001 ) and motility ( P = 0.004 ) between the two groups was significant .


Primary socket reconstruction with porous orbital implant and MMG for severe socket contracture is an effective method in terms of prosthesis motility and prosthesis retention .


Female adolescents at high pregnancy risk frequently visit the emergency department ( ED ) and lack primary providers .


It is unclear if current methods of ED referral are successful .


The objective of this pilot study was to assess the potential effect and feasibility of a standardized , enhanced method of referral of sexually active females from an ED for family planning ( FP ) .


We conducted an ED-based intervention study using an enhanced referral process , which included a wallet card advertising a walk-in , adolescent-friendly FP clinic and a standardized ED physician monologue .


ED physicians were instructed to disseminate the enhanced process to sexually active females ages 12-19 years ( intervention group ) .


Patients receiving the intervention were prospectively enrolled .


The control group consisted of patients who , on retrospective review , came to the ED during the enrollment period and were eligible but were not enrolled .


We used the electronic medical record ( EMR ) to identify and randomly select missed eligible patients ( control group ) and accumulated one control for each case .


The primary outcome was FP follow-up within 2 months , measured by EMR review .


The intervention ( n = 101 ) and control groups ( n = 101 ) were similar in age , prior ED visits ( 54 % versus 56 % ) , and previous FP visits ( 28 % versus 28 % ) .


The absolute difference in follow-up to a FP clinic between the enhanced referral group ( 7 % ; 7/101 ) compared with the nonenhanced referral group ( 5 % ; 5/101 ) was only 2 % ( 95 % confidence interval -5 % to 9 % ) .


Feasibility of the intervention was modest , with a best-case scenario of 59/160 ( 37 % ) of eligible patients captured .


An enhanced referral initiative relying on physician participation did not substantially increase follow-up rates to a FP clinic and showed modest feasibility .


More research is required to identify effective means of ED-based referral for preventive reproductive care .


Commonly used trivalent vaccines contain one influenza B virus lineage and may be ineffective against viruses of the other B lineage .


We evaluated the efficacy of a candidate inactivated quadrivalent influenza vaccine ( QIV ) containing both B lineages .


In this multinational , phase 3 , observer-blinded study , we randomly assigned children 3 to 8 years of age , in a 1:1 ratio , to receive the QIV or a hepatitis A vaccine ( control ) .


The primary end point was influenza A or B confirmed by real-time polymerase chain reaction ( rt-PCR ) .


Secondary end points were rt-PCR-confirmed , moderate-to-severe influenza and rt-PCR-positive , culture-confirmed influenza .


The vaccine efficacy and the effect of vaccination on daily activities and utilization of health care resources were assessed in the total vaccinated cohort ( 2584 children in each group ) and the per-protocol cohort ( 2379 children in the QIV group and 2398 in the control group ) .


In the total vaccinated cohort , 62 children in the QIV group ( 2.40 % ) and 148 in the control group ( 5.73 % ) had rt-PCR-confirmed influenza , representing a QIV efficacy of 59.3 % ( 95 % confidence interval [ CI ] , 45.2 to 69.7 ) , with efficacy against culture-confirmed influenza of 59.1 % ( 97.5 % CI , 41.2 to 71.5 ) .


For moderate-to-severe rt-PCR-confirmed influenza , the attack rate was 0.62 % ( 16 cases ) in the QIV group and 2.36 % ( 61 cases ) in the control group , representing a QIV efficacy of 74.2 % ( 97.5 % CI , 51.5 to 86.2 ) .


In the per-protocol cohort , the QIV efficacy was 55.4 % ( 95 % CI , 39.1 to 67.3 ) , and the efficacy against culture-confirmed influenza 55.9 % ( 97.5 % CI , 35.4 to 69.9 ) ; the efficacy among children with moderate-to-severe influenza was 73.1 % ( 97.5 % CI , 47.1 to 86.3 ) .


The QIV was associated with reduced risks of a body temperature above 39C and lower respiratory tract illness , as compared with the control vaccine , in the per-protocol cohort ( relative risk , 0.29 [ 95 % CI , 0.16 to 0.56 ] and 0.20 [ 95 % CI , 0.04 to 0.92 ] , respectively ) .


The QIV was immunogenic against all four strains .


Serious adverse events occurred in 36 children in the QIV group ( 1.4 % ) and in 24 children in the control group ( 0.9 % ) .


The QIV was efficacious in preventing influenza in children .


( Funded by GlaxoSmithKline Biologicals ; ClinicalTrials.gov number , NCT01218308 . )


To compare the analgesic effects of buprenorphine and butorphanol in domestic cats .


2-phase positive-controlled randomized masked clinical trial .


39 healthy female cats ( 10 in phase 1 and 29 in phase 2 ) .


Cats admitted for ovariohysterectomy received buprenorphine ( 4 in phase 1 ; 14 in phase 2 ) or butorphanol ( 6 in phase 1 ; 15 in phase 2 ) .


In phase 1 , cats were premedicated with buprenorphine ( 0.02 mg/kg [ 0.009 mg/lb ] , IM ) or butorphanol ( 0.4 mg/kg [ 0.18 mg/lb ] , IM ) , in combination with medetomidine .


Anesthesia was induced with propofol ( IV ) and maintained with isoflurane in oxygen .


After extubation , medetomidine was antagonized with atipamezole .


A validated multidimensional composite scale was used to assess signs of pain after surgery starting 20 minutes after extubation and continuing for up to 360 minutes , and pain score comparisons were made between the 2 groups .


Phase 2 proceeded similar to phase 1 with the following addition : during wound closure , cats from the butorphanol and buprenorphine groups received butorphanol ( 0.4 mg/kg , IM ) or buprenorphine ( 0.02 mg/kg , IM ) , respectively .


Phase 1 of the study was stopped after 10 cats were ovariohysterectomized because 9 of 10 cats required rescue analgesia at the first evaluation .


In phase 2 , at the first pain evaluation , pain scores from the buprenorphine group were lower , and all cats from the butorphanol group required rescue analgesia .


None of the cats from the buprenorphine group required rescue analgesia at any time .


Buprenorphine ( 0.02 mg/kg , IM ) given before surgery and during wound closure provided adequate analgesia for 6 hours following ovariohysterectomy in cats , whereas butorphanol did not .


Family-centered rounds ( FCR ) are becoming the status quo for inpatient pediatric medical care ; however , barriers still exist .


The use of facilitators in FCR is gaining popularity .


Although facilitators can increase comfort with FCR , the choice of preferred facilitator has not been studied by using rigorous methodology .


In this study , we performed a randomized trial of facilitated FCR with bunnies and clowns , 2 commonly mentioned facilitators , and compared their results with the usual care condition .


The 3 floor teams were randomized to have rounds facilitated with bunnies and clowns or the usual care model facilitated by distracted residents and overbearing attending physicians .


Infection control procedures were instituted .


Outcome measures were parent satisfaction scores , use of anxiolytic agents during examinations as part of FCR , resident satisfaction , and the number of times presenters were interrupted by their attending .


Differences between the experimental and control groups were analyzed by using ttests , chi2 statistics , and multiple regression analysis .


Qualitative analyses were also performed by using participant-observers .


Bunnies had the best overall improvement in parent satisfaction , anxiety , and resident satisfaction .


Both intervention groups were successful at reducing attending interruptions .


The clown arm was suspended by the Data Safety Monitoring Board before study completion due to adverse events .


Facilitated FCR has the potential to improve satisfaction among parents , patients , and residents , and to decrease attending interruptions .


Care needs to be taken , however , to avoid unanticipated adverse effects from potentially emotionally damaging interventions .


Tularemia was not identified in any of our treatment conditions .


This study assessed oral health status for preschool-aged children in the Navajo Nation to obtain data on baseline decayed , missing , and filled tooth surfaces ( dmfs ) and dental caries patterns , describe sociodemographic correlates of children 's baseline dmfs measures , and compare the children 's dmfs measures with previous dental survey data for the Navajo Nation from the Indian Health Service and the National Health and Nutrition Examination Survey ( NHANES ) .


The analyzed study sample included 981 child/caregiver dyads residing in the Navajo Nation who completed baseline dmfs assessments for an ongoing randomized clinical trial involving Navajo Nation Head Start Centers .


Calibrated dental hygienists collected baseline dmfs data from child participants ages 3-5 years ( 488 males and 493 females ) , and caregivers completed a basic research factors questionnaire .


Mean dmfs for the study population was 21.33 ( SD = 19.99 ) and not appreciably different from the 1999 Indian Health Service survey of Navajo Nation preschool-aged children ( mean = 19.02 , SD = 16.59 , P = 0.08 ) .


However , only 69.5 percent of children in the current study had untreated decay compared with 82.9 percent in the 1999 Indian Health Service survey ( P < 0.0001 ) .


Study results were considerably higher than the 16.0 percent reported for 2-4-year-old children in the whites-only group from the 1999-2004 NHANES data .


Age had the strongest association with dmfs , followed by child gender , then caregiver income and education .


Dental caries in preschool-aged Navajo children is extremely high compared with other US population segments , and dmfs has not appreciably changed for more than a decade .


To compare the post cataract surgery anti-inflammatory effect of bromfenac monotherapy and of bromfenac and betamethasone combination therapy in diabetes mellitus patients .


A prospective study approved by the Institutional Review Board .


Fifty-one eyes of 51 patients were randomly allocated to either bromfenac 0.1 % monotherapy ( n = 23 ) or combined therapy with bromfenac 0.1 % and betamethasone 0.1 % ( n = 28 ) .


After surgery , monotherapy group was administered bromfenac alone for 8 weeks , while the combined therapy group was administered both bromfenac and betamethasone for 2 weeks , bromfenac alone for the next 6 weeks .


The amount of change from preoperative values in anterior chamber flare and foveal thickness were compared between the 2 groups .


There was no significant difference in change in anterior chamber flare between the 2 groups .


The increase in foveal thickness 4 weeks postoperatively was significantly larger in the bromfenac group ( p = 0.0356 ) .


Four patients of the bromfenac group , all with a history of diabetic macular edema , developed macular edema after surgery .


Bromfenac and betamethasone combination exhibited a stronger anti-inflammatory effect after cataract surgery patients with diabetes mellitus .


In particular , patients with a history of diabetic macular edema were susceptible to foveal thickening and macular edema , and a combined treatment is desirable .


The role of implantable loop recorders ( ILRs ) in the evaluation strategy for recurrent syncope in France is limited by lack of knowledge of the cost .


To compare a conventional evaluation strategy for syncope with the early use of an ILR in low-risk patients , in terms of diagnostic yield , cost and impact on quality of life ( QoL ) .


National prospective randomized open-label multicenter study of patients with a single syncope ( if severe and recent ) or at least two syncopes in the past year .


Seventy-eight patients ( 32 men ) were randomized to the ILR strategy ( ILR group , n = 39 ) or the conventional evaluation strategy ( CONV group , n = 39 ) : mean age 66.214.8 years ; 4.36.4 previous syncopes .


After 14 months of follow-up , a certain cause of syncope was established in 18 ( 46.2 % ) patients in the ILR group and two ( 5 % ) patients in the CONV group ( P < 0.001 ) .


Advanced cardiological tests were performed less frequently in the ILR group than in the CONV group ( 0.030.2 vs. 0.20.5 tests per patient ; P = 0.05 ) .


Patients in the ILR group were hospitalized for a non-significantly shorter period than patients in the CONV group ( 5.73.2 vs. 8.01.4 days ) .


There was no difference between the two groups in terms of QoL main composite score .


In patients with unexplained syncope , the early use of an ILR has a superior diagnostic yield compared with the conventional evaluation strategy , with lower healthcare-related costs .


More severe influenza disease and poor vaccine immunogenicity is reported in HIV-infected patients .


We measured antibody avidity after influenza vaccination in HIV patients to assess vaccine efficacy .


Two dosing strategies ( Group1 : single dose , n = 28 .


Group2 : single dose plus booster , n = 36 ) with an AS03A-adjuvanted H1N12009 pandemic influenza vaccine ( Arepanrix , GSK ) were assessed in HIV patients .


Serum hemagglutination inhibition ( HAI ) titers and antibody avidity reported as an avidity index ( AI ) were measured at days 21 and 42 and at 6months .


Baseline HIV parameters were similar among all participants .


Eighteen participants had measurable baseline HAI titers .


In these subjects , AI was at ~ 9 at baseline and was not significantly increased by one or two vaccine doses .


In those without detectable baseline antibodies , immunization induced modest antibody titers [ Group1 HAI , 61 ( 26-144 ) ; Group2 HAI , 46 ( 28-76 ) ] with high AI after one dose at day 21 [ Group1 AI , 8.8 ( 7.3-10 .7 ) ; Group2 AI , 8.9 ( 7.8-10 .1 ) ] .


A second dose of vaccine generated significantly higher HAI titers at day 42 [ Group1 HAI , 41 ( 18-90 ) ; Group2 HAI , 92 ( 64-132 ) ] and persisted to 6months [ Group1 HAI , 9 ( 6-13 ) ; Group2 HAI , 19 ( 13-30 ) ] .


All subjects who produced detectable HAI titers after vaccination generated high antibody avidity ( AI , 9-10 ) , which persisted up to 6months .


In participants initially seronegative , two doses of vaccine enabled a greater percentage of subjects to respond to the vaccine and elicited higher HAI titers .


All subjects who produced detectable HAI titers also rapidly generated high AI in the short and long term .


We demonstrate that high avidity antibodies can be achieved after vaccination and support a two-dose immunization strategy for HIV-positive subjects .


The present paper aims to investigate the effect of psoriatic arthritis ( PsA ) disease duration on the outcome of treatment with etanercept ( ETN ) in patients with PsA who also have moderate-to-severe psoriasis .


Patients from the PRESTA trial who received 1 ETN 50 mg once weekly ( QW ) dose and had 1 post-baseline value were evaluated .


Baseline and after-treatment changes were compared between patients with PsA 2 years versus PsA > 2 years in efficacy measures ( physician global assessment [ PGA ] arthritis , swollen joint count and Psoriasis Area and Severity Index [ PASI ] ) and patient reported outcomes ( PROs ; joint pain , arthritis activity , Euro-Qol [ EQ-5D ] utility and visual analogue score [ VAS ] ) using linear regression analysis .


Baseline efficacy measures were similar between the PsA 2 years ( n = 103 ) and PsA > 2 years ( n = 269 ) groups , with the exception of PGA arthritis ( p = 0.006 ) .


At week 24 , improvements in efficacy measures were observed in both groups but were significantly greater for PGA arthritis in the PsA 2 years group ( p = 0.03 ) .


Quality of life ( QoL ) , measured using PROs , was generally lower at baseline in patients with PsA > 2 years .


Clinically meaningful improvements were seen in QoL with ETN treatment in both groups , but the change from baseline scores at week 24 were significantly higher in PsA 2 years group for joint pain ( p = 0.007 ) , arthritis activity ( p = 0.01 ) , EQ-5D utility ( p = 0.046 ) and EQ-5D VAS ( p = 0.04 ) responses .


PsA patients responded to ETN 50 mg QW treatment irrespective of disease duration ; however , patients with shorter PsA duration had greater improvements in arthritis scores and several PRO measures .


To compare anaesthetic induction in healthy dogs using propofol or ketofol ( a propofol-ketamine mixture ) .


Prospective , randomized , controlled , ` blinded ' study .


Seventy healthy dogs ( 33 males and 37 females ) , aged 6-157 months and weighing 4-48 kg .


Following premedication , either propofol ( 10 mg mL ( -1 ) ) or ketofol ( 9 mg propofol and 9 mg ketamine mL ( -1 ) ) was titrated intravenously until laryngoscopy and tracheal intubation were possible .


Pulse rate ( PR ) , respiratory rate ( f ( R ) ) and arterial blood pressure ( ABP ) were compared to post-premedication values and time to first breath ( TTFB ) recorded .


Sedation quality , tracheal intubation and anaesthetic induction were scored by an observer who was unaware of treatment group .


Mann-Whitney or t-tests were performed and significance set at p 0.05 .


Induction mixture volume ( mean SD ) was lower for ketofol ( 0.2 0.1 mL kg ( -1 ) ) than propofol ( 0.4 0.1 mL kg ( -1 ) ) ( p < 0.001 ) .


PR increased following ketofol ( by 35 20 beats minute ( -1 ) ) but not consistently following propofol ( 4 16 beats minute ( -1 ) ) ( p < 0.001 ) .


Ketofol administration was associated with a higher mean arterial blood pressure ( MAP ) ( 82 10 mmHg ) than propofol ( 77 11 ) ( p = 0.05 ) .


TTFB was similar , but ketofol use resulted in a greater decrease in f ( R ) ( median ( range ) : ketofol -32 ( -158 to 0 ) propofol -24 ( -187 to 2 ) breaths minute ( -1 ) ) ( p < 0.001 ) .


Sedation was similar between groups .


Tracheal intubation and induction qualities were better with ketofol than propofol ( p = 0.04 and 0.02 respectively ) .


Induction of anaesthesia with ketofol resulted in higher PR and MAP than when propofol was used , but lower f ( R ) .


Quality of induction and tracheal intubation were consistently good with ketofol , but more variable when using propofol .


Unfractionated ( UF ) heparin is the most common anticoagulant used during hemodialysis .