No obvious differences in clinical efficacy and safety were observed between the two dosing schedules , giving flexibility in maintenance administration schedules .


To explore the efficacy of electric acupoint stimulation on shivering in cesarean section .


Eighty cases of parturients , under the America Society of Anesthesiologists ( ASA ) physical status II , were randomized into a transcutaneous electrical acupoint stimulation ( TEAS ) assisted anesthesia group ( group A ) and an anesthesia group ( group B ) .


Spinal-epidural anesthesia ( CSEA ) puncture was applied to both groups and 8 mg of 0.75 % bubivacaine was given by spinal injection , the block level was T4 T8 .


In group A , TEAS was applied before CSEA at paired acupoints-ipsilateral Hegu ( LI 4 ) - Laogong ( PC 8 ) and Sanyinjiao ( SP 6 ) - Zusanli ( ST 36 ) till ending the surgery .


The 4 pair of bilateral acupoints were fixed with self-adhesive electrodes and connected with Han 's acupoint and nerve stimulator ( HANS , LH402H ) , the frequency was 2 Hz / 15 Hz , the intensity was 10 - 30 mA and the form was densedisperse wave within the patients ' tolarance .


The heart rate ( HR ) , mean arterial pressure ( MAP ) , oxyhemoglobin saturation ( SPO ) and shivering degree were recorded before anesthesia ( To ) , 1 min after anesthesia puncture ( Ti ) , 1 min after the delivery ( Tz ) , during abdomen closure ( T3 ) and at the end of surgery ( T4 ) .


The occurrence rate of shivering was 35.0 % ( 14/40 ) in group A , which was lower to 67.5 % ( 27/40 , P < 0.05 ) in group B ; the degree of shivering was lighter in group A than that in group B at T2 , T3 and T4 ( all P < 0.01 ) .


In group A , HR was faster at T1 and T2 compared to that at To ( all P < 0.05 ) , while at T3 and T4 , the HR was the same with that before anesthesia ( all P > 0.05 ) .


In group B , the HR was faster at T1 , T2 , T3 and T4 compared to that at T0 ( P < 0.05 , P < 0.01 ) .


In both groups , the MAP was lower at T1 , T2 ( P < 0.05 , P < 0.01 ) and resumed to that before anesthesia at T3 and T4 ( all P > 0.05 ) ; there was no statistical significance of SPO2 in both groups ( all P > 0.05 ) .


TEAS can reduce the occurrence rate of shivering and steady the heart rate in cesarean section .


There is increasing recognition of the potential use of reminiscence in maintaining or improving the quality of life of people with dementia .


Despite being used widely in dementia care , evidence on the effectiveness of reminiscence remains uncertain .


This study aims to evaluate the effectiveness of a structured education-based reminiscence programme-the Dementia Education Programme Incorporating Reminiscence for Staff-for people with dementia residing in long-stay care settings in Ireland .


Dementia Education Programme Incorporating Reminiscence for Staff is a two-group , single-blind , cluster randomised trial conducted in long-stay residential care settings in Ireland .


The primary outcome was the self-rated quality of life of residents as measured by the Quality of Life-Alzheimer 's Disease instrument .


Using an intention-to-treat analysis , we found that the estimated effect of the intervention on the quality of life of residents was a non-significant 3.54 ( p = 0.1 ; 95 % confidence interval -0.83 , 7.90 ) , expressed as the difference in mean improvement between the intervention and control groups .


However , the per-protocol analysis yielded a significant effect for the intervention on the quality of life of residents of 5.22 ( p = 0.04 ; 95 % confidence interval 0.11 , 10.34 ) .


Reminiscence may , in certain circumstances , be an effective care option for people with dementia in long-stay settings with potential to impact positively on the quality of life of residents .


Infection after shoulder surgery can have devastating consequences .


Recent literature has implicated Propionibacterium acnes as a causative agent for postoperative shoulder infections .


Axillary hair removal has been suggested as a method for infection prevention , although data quantifying its effect on the bacterial load around the shoulder are lacking .


We clipped one randomly selected axilla in 85 healthy male volunteers with commercially available surgical clippers .


Aerobic and anaerobic culture specimens were taken from the clipped and unclipped axillae .


Each shoulder was then prepared with 2 % chlorhexidine gluconate and 70 % isopropyl alcohol .


Repeated culture specimens were then taken from both axillae .


Cultures were held for 14days and recorded with a semiquantitative system ( 0-4 points ) .


Results were compared by the Wilcoxon signed rank test .


There was no difference in the burden of P. acnes between the clipped and unclipped axillae before or after surgical preparation ( P = .109 , P = .344 , respectively ) .


There was a significantly greater bacterial burden in the clipped shoulder compared with the unclipped shoulder before preparation ( P < .001 ) but not after preparation ( P = .285 ) .


There was a significant reduction in total bacterial load and P. acnes load for both axillae after surgical preparation ( P < .001 for all ) .


Removal of axillary hair has no effect on the burden of P. acnes in the axilla .


Clipped axillae had a higher total bacterial burden .


A 2 % chlorhexidine gluconate surgical preparation is effective at removal of all bacteria and specifically P. acnes from the axilla .


Major depressive disorder ( MDD ) is one of the most common psychiatric disorders , conferring considerable individual , family , and community burden .


To date , treatments for MDD have been derived from the monoamine hypothesis , and there is a paucity of emerging antidepressants , especially with novel mechanisms of action and treatment targets .


N-acetylcysteine ( NAC ) is a redox-active glutathione precursor that decreases inflammatory cytokines , modulates glutamate , promotes neurogenesis , and decreases apoptosis , all of which contribute to the neurobiology of depression .


Participants with a current episode of MDD diagnosed according to DSM-IV-TR criteria ( N = 252 ) were treated with NAC or placebo in addition to treatment as usual for 12 weeks and were followed to 16 weeks .


Data were collected between 2007 and 2011 .


The omnibus interaction between group and visit for the Montgomery-Asberg Depression Rating Scale ( MADRS ) , the primary outcome measure , was not significant ( F , .


= 1.98 , P = .067 ) , and the groups did not separate at week 12 ( t. = -1.12 , P = .265 ) .


However , at week 12 , the scores on the Longitudinal Interval Follow-Up Evaluation-Range of Impaired Functioning Tool ( LIFE-RIFT ) differed from placebo ( P = .03 ) .


Among participants with a MADRS score 25 , NAC separated from placebo at weeks 6 , 8 , 12 , and 16 ( P < .05 ) .


Additionally , the rate of change between baseline and week 16 was significant ( t. = -2.11 , P = .036 ) .


NAC treatment was superior to placebo at week 16 for secondary readouts of function and clinical impression .


Remission and response were greater in the NAC group at week 16 , but not at week 12 .


The NAC group had a greater rate of gastrointestinal and musculoskeletal adverse events .


Being negative at the week 12 end point , and with some positive secondary signals , the study provides only limited support for the role of NAC as a novel adjunctive therapy for MDD .


These data implicate the pathways influenced by NAC in depression pathogenesis , principally oxidative and inflammatory stress and glutamate , although definitive confirmation remains necessary .


www.anzctr.org.au Identifier : ACTRN12607000134426 .


Prevention and early detection measures for melanoma , such as sun avoidance and skin examinations , are important , but are practiced inconsistently .


In this replication of the Project SCAPE trial , we sought to determine whether tailored print materials were more effective at improving adherence than generic print materials for patients at increased risk of skin cancer .


Participants were randomized to receive personalized mailed communications about their skin cancer risk and recommended sun protection , or generic mailings .


Participants were Caucasian adults , at moderate or high risk for skin cancer , recruited in outpatient primary care .


The main outcomes were overall sun protection behaviors and specific protective behaviors including use of sunscreen , shirt , hat , sunglasses , shade , and sun avoidance ; recent sunburns ; and skin self-examination and provider skin examination .


One hundred ninety-two ( 93.2 % ) subjects completed the study .


Six outcome variables showed significant intervention condition effects in mixed effects models : overall sun protection behavior ( P = 0.025 ) ; sunscreen use ( P = 0.026 ) ; use of sunglasses ( P = 0.011 ) ; sunburns in the past three months ( P = 0.033 ) ; recency of last skin self-exam ( P = 0.017 ) ; and frequency of skin exams by health care provider ( P = 0.016 ) .


Relative to generic communications , tailored risk communications resulted in improved adherence to six skin cancer protective behaviors , including a composite sun protection behavior measure , sunburns , and health care provider skin examinations .


Tailored interventions can be more effective in improving patient prevention behaviors than nontailored , generic information for patients at moderate to high risk of skin cancer .


Existing anthelmintic drugs ( eg , albendazole and mebendazole ) have low efficacy against the intestinal nematode species Trichuris trichiura and the drug pipeline is exhausted .


We aimed to investigate the strategy of combination chemotherapy with existing drugs to establish whether their efficacy could be enhanced and broadened .


In this randomised controlled trial , we compared three drug combinations and one standard drug alone in children aged 6-14 years in two schools on Pemba Island , Tanzania infected with T trichiura and concomitant intestinal nematodes .


We assigned children , via a randomisation list with block sizes of either four or eight , to orally receive albendazole ( 400 mg ) plus ivermectin ( 200 g/kg ) ; albendazole ( 400 mg ) plus mebendazole ( 500 mg ) ; albendazole ( 400 mg ) plus oxantel pamoate ( 20 mg/kg ) ; or mebendazole ( 500 mg ) alone .


The primary endpoints were the proportion of children cured of T trichiura infection and the reduction of T trichiura eggs in stool based on geometric means , both analysed by available case .


This study is registered with ISRCTN , number ISRCTN80245406 .


We randomly assigned 440 eligible children infected with T trichiura between Sept 2 , and Oct 18 , 2013 , to one of the four treatment groups ( 110 children per group ) .


Data for 431 children were included in the analysis for the primary endpoints .


Albendazole plus oxantel pamoate ( 74 of 108 children cured [ 685 % , 95 % CI 596-774 ] ; egg reduction 992 % , 987-996 ) and albendazole plus ivermectin ( 30 of 109 cured [ 275 % , 190-360 ] ; egg reduction 945 % , 917-963 ) were significantly more effective against T trichiura than mebendazole alone ( nine of 107 cured [ 84 % , 31-138 ] ; egg reduction 585 % , 452-709 ) .


Albendazole plus mebendazole had similar low efficacy ( nine of 107 cured [ 84 % , 31-138 ; egg reduction 516 % , 350-653 ) to mebendazole alone .


About a fifth of the children reported adverse events , which were mainly mild .


Abdominal cramps and headache were the most common adverse events after treatment ; abdominal cramps were reported by 13 ( 120 % ) children for albendazole plus ivermectin , 10 ( 93 % ) for albendazole plus mebendazole , 20 ( 182 % ) for albendazole plus oxantel pamoate , and 16 ( 145 % ) for mebendazole ; headaches were reported by 5 ( 46 % ) children for albendazole plus ivermectin , 6 ( 56 % ) for albendazole plus mebendazole , 12 ( 109 % ) for albendazole plus oxantel pamoate , and 7 ( 64 % ) for mebendazole .


Our head-to-head comparison of three combination chemotherapies showed the highest efficacy for albendazole plus oxantel pamoate for the treatment of infection with T trichiura .


Further studies should investigate the combination of albendazole plus oxantel pamoate so that it can be considered for soil-transmitted helminthiasis control programmes .


Medicor Foundation and Swiss National Science Foundation .


This trial aimed to evaluate the short-term effectiveness of acupuncture plus stretching to reduce pain and improve range of motion in patients afflicted by cervical myofascial pain syndrome .


Randomized , blinded , placebo-controlled crossover study .


Nineteen patients ( 11 females , eight males , 33 14 years ) with myofascial neck pain in randomized order received the following treatments with one week washout between : acupuncture , acupuncture plus stretching , and placebo laser acupuncture .


Mechanical pain threshold ( MPT , measured with a pressure algometer ) represented the primary outcome .


Secondary outcomes were motion-related pain ( Visual Analogue Scale , VAS ) and cervical range of motion ( ROM , recorded by means of an ultrasonic 3D movement analysis system ) .


Outcomes were assessed immediately prior as well as 5 , 15 and 30 min post treatment .


Friedman tests with post hoc Bonferroni-Holm correction were applied to compare differences between treatments .


Both acupuncture as well as acupuncture plus stretching increased MPT by five , respectively , 11 percent post treatment .


However , only acupuncture in combination with stretching was superior to placebo ( p < 0.05 ) .


There were no significant differences between interventions at 15 and 30 min post treatment .


VAS did not differ between treatments at any measurement .


Five minutes after application of acupuncture plus stretching , ROM was significantly increased in the frontal and the transversal plane compared to placebo ( p < 0.05 ) .


The combination of acupuncture and stretching could represent a suitable treatment option to improve cervical movement behavior and reduce trigger point pain in the short-term .


However , additional studies further discriminating the placebo effects are still warranted .


HIV and malaria infections occur in the same individuals , particularly in sub-Saharan Africa .


We examined whether daily multivitamin supplementation ( vitamins B complex , C , and E ) or vitamin A supplementation altered malaria incidence in HIV-infected women of reproductive age .


HIV-infected pregnant Tanzanian women recruited into the study were randomly assigned to daily multivitamins ( B complex , C , and E ) , vitamin A alone , both multivitamins and vitamin A , or placebo .


Women received malaria prophylaxis during pregnancy and were followed monthly during the prenatal and postpartum periods .


Malaria was defined in 2 ways : presumptive diagnosis based on a physician 's or nurse 's clinical judgment , which in many cases led to laboratory investigations , and periodic examination of blood smears for malaria parasites .


Multivitamin supplementation compared with no multivitamins significantly lowered women 's risk of presumptively diagnosed clinical malaria ( relative risk : 0.78 , 95 % confidence interval : 0.67 to 0.92 ) , although multivitamins increased their risk of any malaria parasitemia ( relative risk : 1.24 , 95 % confidence interval : 1.02 to 1.50 ) .


Vitamin A supplementation did not change malaria incidence during the study .


Multivitamin supplements have been previously shown to reduce HIV disease progression among HIV-infected women , and consistent with that , these supplements protected against development of symptomatic malaria .


The clinical significance of increased risk of malaria parasitemia among supplemented women deserves further research , however .


Preventive measures for malaria are warranted as part of an integrated approach to the care of HIV-infected individuals exposed to malaria .


The use of intravenous proton-pump inhibitors ( PPIs ) has shown to reduce recurrent bleeding and improve patient outcome after endoscopic hemostasis on patients with peptic ulcer .


However , the efficacy of oral PPI is uncertain .


Studies from Asia indicated that even oral PPI can achieve the same therapeutic effect .


This study is designed to compare the efficacy of high-dose intravenous PPI to oral PPI in preventing recurrent bleeding after endoscopic hemostasis .


This is a single-center , randomized-controlled , double-blind , and double-dummy study .


Patients had Forrest IA/IB or IIA/IIB peptic ulcer bleeding and received endoscopic hemostasis before recruitment into the study .


They were randomized to receive either ( i ) esomeprazole IV bolus at a dose of 80 mg plus infusion at 8 mg/h for 72 h and oral placebo every 12 h ( IVP group ) , or ( ii ) IV placebo bolus plus infusion for 72 h and high-dose oral esomeprazole at a dose of 40 mg every 12 h ( ORP group ) .


Patients were followed up for 30 days after index bleeding .


The primary end point was defined as the 30-day recurrent bleeding after successful endoscopic hemostasis .


A total of 118 patients were randomized to the IVP group and 126 to the ORP group in this study .


In all , 39.8 % in the IVP and 42.9 % in the ORP group used non-steroidal anti-inflammatory drug and/or aspirin before bleeding .


In the IVP group ( vs. ORP ) , Forrest IA represented 1.7 % ( 5.6 % ) , IB 41.5 % ( 38.1 % ) , IIA 52.5 % ( 50.8 % ) , and IIB 4.2 % ( 5.6 % ) .


Recurrent bleeding in 30 days was reported in 7.7 % of patients in the IVP group and 6.4 % of patients in the ORP group , and the difference of recurrent bleeding was -1.3 % ( 95 % CI : -7.7 % , 5.1 % ) .


There was no difference in blood transfusion , repeated endoscopic therapy , and hospital stay between the two groups .


High-dose oral esomeprazole at 40 mg BID may be considered as a useful alternative to IV bolus plus infusion of esomeprazole in the management of ulcer bleeding in patients who are not candidates for high-dose IV infusion .


However , as this study was stopped prematurely and was not designed as an equivalency trial , a much larger study would be necessary to document whether there is equivalency or non-inferiority of the two treatments in a heterogeneous patient population .


The genetic polymorphism of drug metabolizing enzymes of the cytochrome P450 ( CYP ) families , especially CYP2D6 and CYP2C19 , is the most important cause of variable responses of many drugs .


Enzyme activity ranges from complete deficiency , so called poor metabolizers ( PMs ) , to an ultrafast metabolism .


While PMs and extensive metabolizers ( EMs ) can be well distinguished by genotyping , phenotyping is necessary to subdivide EMs from intermediate metabolizers ( IMs ) .


The aim of the study was to evaluate if messenger RNA ( mRNA ) concentration for CYP-enzymes in peripheral blood leukocytes ( PBLs ) will be predictive of systemic enzyme activity , allowing an easy and safe determination of metabolic activity .


The genotype , phenotype , and mRNA-expression in PBLs were evaluated in 124 healthy Caucasian volunteers ( males and females , age range 23 - 59 years ) on three occasions ( every 4 weeks ) .


Genotyping was performed by Taqman allelic discrimination on the most common null alleles for CYP2D6 ( * 3 , * 4 , * 6 , * 7 , and * 8 ) and CYP2C19 ( * 2 and * 3 ) .


For phenotyping CYP2D6 , dextromethorphan/dextrorphan metabolic ratios were determined in collected urine ( 8 hours ) after administration of 30 mg dextromethorphan .


For phenotyping CYP2C19 , we used the plasma concentration ratio of omeprazole/hydroxyomeprazole 4 hours after ingestion of 40 mg omeprazole .


mRNA-expression in PBLs for CYP2D6 and CYP2C19 was measured by Taqman real-time PCR before medication and 4 hours afterwards .


Genotyping for CYP2D6 and CYP2C19 showed a regular distribution of EMs and PMs compared to studies of a comparable population .


The median dextromethorphan/dextrorphan metabolic ratio was 0.47 in EMs/IMs and 2.29 in PMs .


The median omeprazole/hydroxyomeprazole metabolic ratio was 3.06 in EMs/IMs and 35.29 in PMs .


CYP2D6 and CYP2C19 mRNA expression was detected without evidence of correlation to the respective metabolic ratio .


The results do not support the concept of using mRNA expression profiles for CYP2D6 and CYP2C19 enzymes in PBLs for prediction of systemic enzyme activity .


Lipid emulsions containing fish oil , as source of long chain omega 3 fatty acids , have recently became available for parenteral nutrition in infants , but scanty data exist in extremely low birth weight preterms .


The objective of this study was to compare plasma fatty acids and lipid tolerance in preterm infants receiving different doses of a 15 % fish oil vs. a soybean oil based lipid emulsion .


Preterm infants ( birth weight 500-1249g ) were randomized to receive parenteral nutrition with MOSF ( 30 % Medium-chain triglycerides , 25 % Olive oil , 30 % Soybean oil , 15 % Fish oil ) or S ( S , 100 % Soybean oil ) both at two levels of fat intake : 2.5 or 3.5 gkg ( -1 ) d ( -1 ) , named 2.5 Fat and 3.5 Fat respectively .


Plasma lipid classes and their fatty acid composition were determined on postnatal day 7 and 14 by gas chromatography together with routine biochemistry .


We studied 80 infants .


MOSF infants had significantly higher plasma phospholipid Docosahexaenoic acid and Eicosapentaenoic and lower Arachidonic acid .


Plasma phospholipids , triglycerides and free cholesterol were all significantly higher in the MOSF-3 .5 Fat group , while cholesterol esters were lower with MOSF than with S.


The area under the curve of total bilirubin was significantly lower with MOSF than with S.


The use of a lipid emulsion with 15 % FO resulted in marked changes of plasma long-chain fatty acids .


Whether the benefits of increasing Docosahexaenoic acid outweigh the potential negative effect of reduced Arachidonic acid should be further studied .


MOSF patients exhibited reduced lipid tolerance at 3.5 gkg ( -1 ) d ( -1 ) fat intake .


The trial was conducted between January 2008 and December 2012 so we had not registered it in a public trials registry as it is now required for trials that started after July 2008 .


Meningococcal disease is rare but can cause death or disabilities .


Although the Advisory Committee on Immunization Practices has recommended meningococcal vaccination for at-risk children aged 9 through 23 months , it has not endorsed universal vaccination .


Health insurance payments for the vaccination of children who are not at risk are likely to be limited.Use of infant meningococcal vaccines by these families will thus depend on the preferences of physicians who might recommend vaccination to parents , as well as parents ' preferences .


To quantify pediatricians ' preferences for specific features of hypothetical infant meningococcal vaccines .


A sample of pediatricians ( n = 216 ) completed a Web-enabled , discrete choice experiment survey in which respondents chose between pairs of hypothetical vaccines in a series of trade-off questions .


The questions described vaccines with six attributes .


A random-parameters logit regression model was used to estimate the relative importance weights physicians place on vaccine features .


These weights were used to calculate the predicted probability that a physician chooses hypothetical vaccines with given characteristics .


Pediatricians ' choices indicated that increases in vaccine effectiveness were among the most important factors in their vaccine recommendations , followed by increases in the number of injections .


The age at which protection begins and the number of additional office visits were less important .


Whether a booster was required after 5 years was the least important factor in vaccine recommendations .


The results suggest that virtually all ( 99.9 % ) physicians in the sample would recommend a vaccine even with the least-preferred features rather than no infant meningococcal vaccine .


Physicians ' responses indicate a strong preference for infant meningococcal vaccination .


The perceived risk of serious bleeding is an obstacle to the use of oral anticoagulation in East Asia .


The efficacy and safety of apixaban in East Asian patients with atrial fibrillation are unknown .


ARISTOTLE included 18,201 patients with nonvalvular atrial fibrillation randomized to apixaban 5mg twice daily or warfarin .


The efficacy and safety of apixaban and warfarin among patients recruited from East Asia ( n = 1,993 ) were compared with those recruited from outside East Asia ( n = 16,208 ) .


Compared with warfarin , apixaban resulted in a consistent reduction in stroke or systemic embolism in East Asian ( hazard ratio [ HR ] 0.74 , 95 % CI 0.50-1 .10 ) and non-East Asian ( HR 0.81 , 95 % CI 0.66-0 .99 ) patients ( interaction P = .70 ) .


Consistent benefits of apixaban over warfarin were also seen for major bleeding in East Asian ( HR 0.53 , 95 % CI 0.35-0 .80 ) and non-East Asian ( HR 0.72 , 95 % CI 0.62-0 .83 ) patients ( interaction P = .17 ) .


There was a greater reduction in major or clinically relevant nonmajor bleeding with apixaban compared with warfarin in East Asian ( HR 0.49 , 95 % CI 0.35-0 .67 ) than in non-East Asian ( HR 0.71 , 95 % CI 0.63-0 .79 ) patients ( interaction P = .03 ) .


Numerically higher rates of intracranial bleeding were seen in East Asian patients with warfarin but not with apixaban .


Apixaban resulted in similar reductions in stroke or systemic embolism and major bleeding and greater reductions in major or clinically relevant nonmajor bleeding in patients from East Asia .


Warfarin is associated with more intracranial bleeding , particularly in patients from East Asia .


Inhibition of tumor angiogenesis by the interruption of VEGF pathway signaling is of therapeutic value in several solid tumors .


Preclinical evidence supports similar importance of the pathway in non-Hodgkin lymphoma .


In this randomized phase II trial , we compared the efficacy and toxicity of rituximab with bevacizumab versus single-agent rituximab , in patients with previously-treated follicular lymphoma .


Patients ( n = 60 ) were randomized ( 1:1 ) to receive rituximab ( 375 mg/m ( 2 ) intravenously [ I.V. ] weekly for 4 weeks ) either as a single agent or with bevacizumab ( 10 mg/kg I.V. on days 3 and 15 ) .


Patients with an objective response or stable disease at week 12 received 4 additional doses of rituximab ( at months 3 , 5 , 7 , and 9 ) ; patients who received rituximab/bevacizumab also received bevacizumab 10 mg/kg I.V. every 2 weeks for 16 doses .


After a median follow-up of 34 months , PFS was improved in patients who received rituximab/bevacizumab compared with patients who received rituximab alone ( median 20.7 vs. 10.4 months respectively ; HR , 0.40 ( 95 % confidence interval [ CI ] , 0.20-0 .80 ) ; P = .007 ) .


Overall survival was also improved numerically ( 73 % vs. 53 % at 4 years ) , but did not reach statistical significance ( HR , 0.40 ( 95 % CI , 0.15-1 .05 ) ; P = .055 ) .


The addition of bevacizumab increased the toxicity of therapy , but both regimens were well tolerated ( no grade 4 toxicity ) .


The addition of bevacizumab to rituximab significantly improved PFS .


The role of angiogenesis inhibition in the treatment of follicular lymphoma requires further definition in larger clinical trials .


Apremilast , an oral phosphodiesterase 4 inhibitor , regulates inflammatory mediators .


Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 ( PALACE 1 ) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug ( DMARD ) and/or biologic therapy .


In the 24-week , placebo-controlled phase of PALACE 1 , patients ( N = 504 ) were randomised ( 1:1:1 ) to placebo , apremilast 20 mg twice a day ( BID ) or apremilast 30 mg BID .


At week 16 , patients without 20 % reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose .


Patients on background concurrent DMARDs continued stable doses ( methotrexate , leflunomide and/or sulfasalazine ) .


Primary outcome was the proportion of patients achieving 20 % improvement in modified American College of Rheumatology response criteria ( ACR20 ) at week 16 .


At week 16 , significantly more apremilast 20 mg BID ( 31 % ) and 30 mg BID ( 40 % ) patients achieved ACR20 versus placebo ( 19 % ) ( p < 0.001 ) .


Significant improvements in key secondary measures ( physical function , psoriasis ) were evident with both apremilast doses versus placebo .


Across outcome measures , the 30-mg group generally had higher and more consistent response rates , although statistical comparison was not conducted .


The most common adverse events were gastrointestinal and generally occurred early , were self-limiting and infrequently led to discontinuation .


No imbalance in major adverse cardiac events , serious or opportunistic infections , malignancies or laboratory abnormalities was observed .


Apremilast was effective in the treatment of psoriatic arthritis , improving signs and symptoms and physical function .


Apremilast demonstrated an acceptable safety profile and was generally well tolerated .


NCT01172938 .


To define longitudinal childhood wheeze phenotypes and identify their early-life risk factors .


Current wheeze was recorded 23 times up to age 7 years in a birth cohort at high risk for allergy ( n = 620 ) .


Latent class analysis of wheeze responses identified 5 classes .


Multinomial logistic regression estimated associations of probability-weighted wheezing classes with early-life factors .


All phenotypes were compared with never/infrequent wheezers .


Lower respiratory tract infection ( LRTI ) by 1 year ( relative risk [ RR ] , 3.00 ; 95 % CI , 1.58-5 .70 ) , childcare by 1 year ( RR , 1.51 ; 95 % CI , 1.02-2 .22 ) , and higher body mass index ( RR , 2.51 ; 95 % CI , 1.09-5 .81 ) were associated with increased risk of early transient wheeze , whereas breastfeeding was protective ( RR , 0.54 ; 95 % CI , 0.32-0 .90 ) .


LRTI ( RR , 6.54 ; 95 % CI , 2.55-16 .76 ) and aeroallergen sensitization ( RR , 4.95 ; 95 % CI , 1.74-14 .02 ) increased the risk of early persistent wheeze .


LRTI ( RR , 5.31 ; 95 % CI , 2.71-10 .41 ) , eczema ( RR , 2.77 ; 95 % CI , 1.78-4 .31 ) , aeroallergen sensitization ( RR , 5.60 ; 95 % CI , 2.86-10 .9 ) , and food sensitization ( RR , 2.77 ; 95 % CI , 1.56-4 .94 ) increased the risk of intermediate-onset wheeze , whereas dog exposure at baseline ( RR , 0.52 ; 95 % CI , 0.32-0 .84 ) and first-born status ( RR , 0.49 ; 95 % CI , 0.32-0 .76 ) were protective .


Heavy parental smoking at birth ( RR , 3.18 ; 95 % CI , 1.02-9 .88 ) increased the risk of late-onset wheeze , whereas breastfeeding reduced it ( RR , 0.34 ; 95 % CI , 0.12-0 .96 ) .


All wheeze classes except early transient had greater risk of wheeze at age 12 years compared with never/infrequent wheezers .


We found distinct early-life risk factor profiles for each wheeze phenotype .


These findings provide insight into possible wheeze mechanisms and have implications for identifying preventive strategies and addressing clinical management of early-life wheeze .


The authors sought to compare the newest U.S. Food and Drug Administration-approved botulinum toxin type A product , incobotulinumtoxinA , to onabotulinumtoxinA for upper face wrinkles .


This is the first prospective , split-face , randomized , double-blind study addressing three types of facial wrinkles using a 1:1 dose ratio .


The study was designed , institutional review board approval was obtained , and 45 patients were enrolled .


A three-judge independent reviewer panel compared photographs of patients to the upper face validated assessment scales , selecting a grade ranging from 0 ( no lines ) to 4 ( very severe ) for the degree of glabellar lines , crow 's feet , and forehead lines for each side of the face for photographs taken before treatment and 3 days , 2 weeks , 3 months , and 4 months after treatment .


For toxin comparison , the difference in the magnitude of the degree of wrinkle scale at each period compared to before treatment was calculated and statistical analysis performed .


Individual wrinkle types and all three wrinkle types combined were analyzed .


Both products offered significant reduction in individual and combined wrinkles at comparable time points ; however , onabotulinumtoxinA had significantly greater combined dynamic wrinkle reduction at 3 days ( p < 0.010 ) , 2 weeks ( p < 0.008 ) , 3 months ( p < 0.013 ) , and 4 months ( p < 0.045 ) .


For identical dosage , both onabotulinumtoxinA and incobotulinumtoxinA are safe and effective in reducing dynamic wrinkles in the upper face ; however , for the authors ' dosages , onabotulinumtoxinA had statistically greater efficacy at 3 days , 2 weeks , 3 months , and 4 months .


Therapeutic , II .


To investigate the efficacy of a single prophylactic dose of ampicillin combined with metronidazole to prevent postcesarean section infections compared with a multiple day regimen in low-resource settings .


An evaluator-blinded randomized , controlled , noninferiority trial .


Two rural hospitals in Tanzania .


Of 181 enrolled eligible women with an indication for cesarean section , information on 176 was analyzed by intention-to-treat .


The women were randomly assigned to either the intervention group who received a single dose of ampicillin and metronidazole , or to the control group who received a multiple-day regimen of ampicillin/amoxicillin and metronidazole .


The primary outcome was maternal postcesarean infection .


Secondary outcomes were severity of these infections , other maternal complications , and the duration of hospital stay .


In the intervention group ( n = 89 ) , six women ( 6.7 % ) developed a wound infection compared with nine ( 10.3 % ) in the control group ( n = 87 ) ( difference 3.60 ; 95 % CI -4.65 to 11.85 ) ( p = 0.40 ) .


A single dose of prophylactic ampicillin and metronidazole is equally effective as a multiple-day regimen in preventing postcesarean wound infections in low-resource settings , therefore it can be considered as a good strategy in low-resource settings .


The reduced quantity of prophylactic antibiotics will reduce costs without increasing the risk of maternal infection .


Nonvalvular atrial fibrillation is common in elderly patients , who face an elevated risk of stroke but difficulty sustaining warfarin treatment .


The oral factor Xa inhibitor rivaroxaban was noninferior to warfarin in the Rivaroxaban Once Daily , Oral , Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) .


This prespecified secondary analysis compares outcomes in older and younger patients .


There were 6229 patients ( 44 % ) aged 75 years with atrial fibrillation and 2 stroke risk factors randomized to warfarin ( target international normalized ratio = 2.0-3 .0 ) or rivaroxaban ( 20 mg daily ; 15 mg if creatinine clearance < 50 mL/min ) , double blind .


The primary end point was stroke and systemic embolism by intention to treat .


Over 10 866 patient-years , older participants had more primary events ( 2.57 % versus 2.05 % / 100 patient-years ; P = 0.0068 ) and major bleeding ( 4.63 % versus 2.74 % / 100 patient-years ; P < 0.0001 ) .


Stroke/systemic embolism rates were consistent among older ( 2.29 % rivaroxaban versus 2.85 % warfarin per 100 patient-years ; hazard ratio = 0.80 ; 95 % confidence interval , 0.63-1 .02 ) and younger patients ( 2.00 % versus 2.10 % / 100 patient-years ; hazard ratio = 0.95 ; 95 % confidence interval , 0.76-1 .19 ; interaction P = 0.313 ) , as were major bleeding rates ( 75 years : 4.86 % rivaroxaban versus 4.40 % warfarin per 100 patient-years ; hazard ratio = 1.11 ; 95 % confidence interval , 0.92-1 .34 ; < 75 years : 2.69 % versus 2.79 % / 100 patient-years ; hazard ratio = 0.96 ; 95 % confidence interval , 0.78-1 .19 ; interaction P = 0.336 ) .


Hemorrhagic stroke rates were similar in both age groups ; there was no interaction between age and rivaroxaban response .


Elderly patients had higher stroke and major bleeding rates than younger patients , but the efficacy and safety of rivaroxaban relative to warfarin did not differ with age , supporting rivaroxaban as an alternative for the elderly .


The aim of this study was to investigate if argon plasma cleaning increases the shear bond strength between zirconia and veneering ceramic surfaces .


Ninety tablets of densely sintered yttriastabilized tetragonal zirconia polycrystal were divided into three groups according to cleaning treatment ( steam cleaning or plasma of Argon for 375 or 750 seconds ) .


Groups were divided into two subgroups according to the application of a ceramic liner ( A = liner , B = no liner ) .


Within subgroup A , argon plasma cleaning significantly decreased shear bond strength .


In subgroup B , the plasma treatment increased the shear bond strength , but the differences were not statistically significant .


Subgroup A demonstrated lower shear bond strength compared to subgroup B.


Argon plasma cleaning was suggested to improve the bond between ceramic and zirconia surfaces ; however , when plasma cleaning was followed by a glassy liner application , the veneering ceramic/zirconia bond was significantly reduced .


To identify variables that predict adherence with annual eye examinations using the Compliance with Annual Diabetic Eye Exams Survey ( CADEES ) , a new questionnaire designed to measure health beliefs related to diabetic retinopathy and annual eye examinations .


Questionnaire development .


Three hundred sixteen adults with diabetes .


We developed the CADEES based on a review of the literature , the framework of the Health Belief Model , expert opinion , and pilot study data .


To examine content validity , we analyzed participant responses to an open-ended question asking for reasons why people do not obtain annual eye examinations .


We evaluated construct validity with principal components analysis and examined internal consistency with Cronbach 's .


To assess predictive validity , we used multivariate logistic regression with self-reported adherence as the dependent variable .


Associations with self-reported adherence ( defined as having a dilated eye examination in the past year ) .


The content analysis showed that CADEES items covered 89 % of the reasons given by participants for not obtaining an annual eye examination .


The principal components analysis identified 3 informative components that made up 32 % of the variance .


Multivariate logistic regression modeling revealed several significant predictors of adherence , including beliefs concerning whether insurance covered most of the eye examination cost ( P < 0.01 ) , whether there were general barriers that make it difficult to obtain an eye examination ( P < 0.01 ) , whether obtaining an eye examination was a top priority ( P = 0.02 ) , and whether diabetic eye disease can be seen with an examination ( P = 0.05 ) .


Lower hemoglobin A1c levels ( P < 0.01 ) , having insurance ( P = 0.01 ) , and a longer duration of diabetes ( P = 0.02 ) also were associated with adherence .


A multivariate model containing CADEES items and demographic variables classified cases with 72 % accuracy and explained approximately 24 % of the variance in adherence .


The CADEES showed good content and predictive validity .


Although additional research is needed before finalizing a shorter version of the survey , our findings suggest that researchers and clinicians may be able to improve adherence by ( 1 ) counseling newly diagnosed patients , as well as those with uncontrolled blood glucose , on the importance of annual eye examinations and ( 2 ) discussing perceived barriers and misconceptions .


In many units , the standard mesh ratio is 1.5:1 , but in our unit we have a 1:1 mesher , which does not expand the skin but provides regular fenestrations .


There is some evidence that the unexpanded 1.5:1 meshed graft compares favourably with sheet grafts from a cosmetic perspective whilst reducing the risk of graft failure secondary to a subgraft haematoma , but none comparing the 1:1 meshed graft with the sheet graft .


We conducted a randomized trial to compare surgical outcomes in unfenestrated sheet grafts with 1:1 meshed grafts .


All patients aged 16 years undergoing skin grafts with either a sheet or a 1:1 mesh for burn reconstruction were included .


Patients on steroids , those with conditions that impair healing , and burns > 20 % were excluded .


Patients were randomized into the sheet grafting or mesh graft using a computer-generated allocation system .


The mean percentage of graft loss was assessed by a Visitrak overlay system .


At 3-4 months , 7-8 months and at 1 year , photos were taken for scar assessment using the Vancouver Scar Score ( VSS ) .


Out of 72 patients , 48 patients ( 24 sheet vs. 24 mesh ) completed the trial at 12 months .


The mean age was 58 years ( range 21-90 ) .


There was no total loss of graft in either group .


The mean percentage of graft loss due to haematoma formation was higher in the sheet graft group ( 10 % ) compared to the 1:1 mesh group ( 6 % ) ( P < 0.062 ) .


The VSS score was 5 in both groups at 12 months .


There was no significant difference in scar quality between the treatment groups .


These results show that the 1:1 mesh graft is superior to the sheet graft with regard to graft loss , although this result is not statistically significant .


There are comparable findings in terms of cosmetic perspective at 12 months post-operatively in both arms of the trial .


No data from controlled trials exists regarding the inflammatory response in patients with de novo heart failure ( HF ) complicating ST-elevation myocardial infarction ( STEMI ) and a possible role in the recovery of contractile function .


We therefore explored the time course and possible associations between levels of inflammatory markers and recovery of impaired left ventricular function as well as levosimendan treatment in STEMI patients in a substudy of the LEvosimendan in Acute heart Failure following myocardial infarction ( LEAF ) trial .


A total of 61 patients developing HF within 48 hours after a primary PCI-treated STEMI were randomised double-blind to a 25 hours infusion of levosimendan or placebo .


Levels of IL-6 , CRP , sIL-6R , sgp130 , MCP-1 , IL-8 , MMP-9 , sICAM-1 , sVCAM-1 and TNF - were measured at inclusion ( median 22 h , interquartile range ( IQR ) 14 , 29 after PCI ) , on day 1 , day 2 , day 5 and 6 weeks .


Improvement in left ventricular function was evaluated as change in wall motion score index ( WMSI ) by echocardiography .


Only circulating levels of IL-8 at inclusion were associated with change in WMSI from baseline to 6 weeks , r = 0.41 ( p = 0.002 ) .


No association , however , was found between IL-8 and WMSI at inclusion or peak troponin T. Furthermore , there was a significant difference in change in WMSI from inclusion to 6 weeks between patients with IL-8 levels below , compared to above median value , 0.44 ( IQR 0.57 , 0.19 ) vs. 0.07 ( IQR 0.27 , 0.07 ) , respectively ( p < 0.0001 ) .


Levosimendan did not affect the levels of inflammary markers compared to control .


High levels of IL-8 in STEMI patients complicated with HF were associated with less improvement in left ventricular function during the first 6 weeks after PCI , suggesting a possible role of IL-8 in the reperfusion-related injury of post-ischemic myocardium .


Further studies are needed to confirm this hypothesis .


ClinicalTrials.gov NCT00324766 .


To evaluate the effect of an intervention based on the Precede-Proceed Model on attitudes towards prevention of Domestic Violence among Iranian girls .


The randomised controlled trial was conducted during 2010-11 at 10 high schools in District 17 ofTehran Municipality in Iran .


The subjects were divided into two equal groups of cases and controls .


Components of the Precede-Proceed Model for planning , implementation and evaluation of the study .


After need assessment , an appropriate environmental and educational intervention was implemented in the intervention group .


Changes in predisposing , reinforcing , enabling factors and especially attitudes towards prevention of Domestic Violence immediately and two months after the intervention were assessed in by questionnaires based on the Precede-Proceed Model .


SPSS 18 was used for statistical analyses .


There were 510 students who comprised the study population , with 255 individuals in each of the two groups .


The intervention had significantly positive effect on predisposing , enabling and reinforcing factors immediately and two months after the intervention ( p < 0.05 ) .


Repeated measures analysis of variance showed a significant positive increase in attitude score in the intervention group from baseline to two months ( p < 0.001 ) .


The Precede-Proceed Model is one of the most widely used health planning models for identifying factors that influence health behaviours associated with domestic violence .


Implementation of an educational programme based on the model among young girls was effective in changing attitude towards domestic violence .


High-dose immunosuppressive therapy and autologous hematopoietic stem cell transplantation ( HSCT ) have shown efficacy in systemic sclerosis in phase 1 and small phase 2 trials .


To compare efficacy and safety of HSCT vs 12 successive monthly intravenous pulses of cyclophosphamide .


The Autologous Stem Cell Transplantation International Scleroderma ( ASTIS ) trial , a phase 3 , multicenter , randomized ( 1:1 ) , open-label , parallel-group , clinical trial conducted in 10 countries at 29 centers with access to a European Group for Blood and Marrow Transplantation-registered transplant facility .


From March 2001 to October 2009 , 156 patients with early diffuse cutaneous systemic sclerosis were recruited and followed up until October 31 , 2013 .


HSCT vs intravenous pulse cyclophosphamide .


The primary end point was event-free survival , defined as time from randomization until the occurrence of death or persistent major organ failure .


A total of 156 patients were randomly assigned to receive HSCT ( n = 79 ) or cyclophosphamide ( n = 77 ) .


During a median follow-up of 5.8 years , 53 events occurred : 22 in the HSCT group ( 19 deaths and 3 irreversible organ failures ) and 31 in the control group ( 23 deaths and 8 irreversible organ failures ) .


During the first year , there were more events in the HSCT group ( 13 events [ 16.5 % ] , including 8 treatment-related deaths ) than in the control group ( 8 events [ 10.4 % ] , with no treatment-related deaths ) .


At 2 years , 14 events ( 17.7 % ) had occurred cumulatively in the HSCT group vs 14 events ( 18.2 % ) in the control group ; at 4 years , 15 events ( 19 % ) had occurred cumulatively in the HSCT group vs 20 events ( 26 % ) in the control group .


Time-varying hazard ratios ( modeled with treatmenttime interaction ) for event-free survival were 0.35 ( 95 % CI , 0.16-0 .74 ) at 2 years and 0.34 ( 95 % CI , 0.16-0 .74 ) at 4 years .


Among patients with early diffuse cutaneous systemic sclerosis , HSCT was associated with increased treatment-related mortality in the first year after treatment .


However , HCST conferred a significant long-term event-free survival benefit .


isrctn.org Identifier : ISRCTN54371254 .


To analyse if predictors of radiographic progression differ between patients treated with or without prednisolone in early rheumatoid arthritis ( RA ) .


Radiographs of hands and feet were assessed using the modified Sharp/van der Heijde score and radiographic progression was defined as an increase in the total Sharp score above 5.8 ( the smallest detectable change ) .


Prospective , randomised study of patients with early RA .


Secondary level of care ; six participating centres from southern Sweden ; both urban and rural populations .


In all , 225 patients , 64 % women , with a diagnosis of RA according to the American College of Rheumatology criteria , were included if they were between 18 and 80years of age and had a disease duration of less than 1year .


The patients were randomised to 7.5 mg prednisolone daily for 2years ( P-group ; n = 108 ) or no prednisolone ( NoP-group ; n = 117 ) when they started with their first disease-modifying anti-rheumatic drug and were prospectively followed for 2years .


The frequency of patients with radiographic progression after 2years was 26 % in the P-group and 39 % in the NoP-group ( p = 0.033 ) .


Relevant interactions between treatment and rheumatoid factor ( RF ) ( p = 0.061 ) and between treatment and anti-cyclic citrullinated peptide 2 ( anti-CCP ) ( p = 0.096 ) were found .


RF and anti-CCP independently predicted radiographic progression only in the NoP-group , OR ( 95 % CI ) 9.4 ( 2.5 to 35.2 ) , p = 0.001 and OR ( 95 % CI ) 8.7 ( 2.5 to 31.3 ) , p = 0.001 , respectively .


The presence of RF and anti-CCP predicted radiographic progression in patients not treated with prednisolone but failed to predict progression in patients treated with this drug .


The data suggest that early treatment with prednisolone may modulate not only inflammation but also autoimmunity-associated pathogenetic mechanisms .


ISRCTN20612367 .


Black individuals with lung cancer ( LC ) experience higher mortality because they present with more advanced disease and are less likely to undergo curative resection for early-stage disease .


The National Lung Screening Trial ( NLST ) demonstrated improved LC mortality by screening high-risk patients with low-dose computed tomography ( LDCT ) .


The benefit of LDCT screening in black individuals is unknown .


Examine results of the NLST by race .


This was a secondary analysis of a randomized trial ( NCT00047385 ) performed in 33 U.S. centers .


Overall and lung cancer-specific mortality were measured .


Screening with LDCT reduced LC mortality in all racial groups but more so in black individuals ( hazard ratio [ HR ] , 0.61 vs. 0.86 ) .


Smoking increased the likelihood of death from LC , and when stratified by race black smokers were twice as likely to die as white smokers ( HR , 4.10 vs. 2.25 ) .


Adjusting for sociodemographic and behavioral characteristics , black individuals experienced higher all-cause mortality than white individuals ( HR , 1.35 ; 95 % confidence interval , 1.22-1 .49 ) ; however , black individuals screened with LDCT had a reduction in all-cause mortality .


Black individuals were younger , were more likely to be current smokers , had more comorbidities , and had fewer years of formal education than white individuals ( P < 0.05 ) .


Black individuals screened with LDCT had decreased mortality from lung cancer .


However , the demographics associated with improved LC survival were less commonly found in black individuals .


The overall mortality in the NLST was higher for black individuals than white individuals , but improved in black individuals screened , suggesting that this subgroup may have had improved access to care .


To realize the reductions in mortality from LC screening , dissemination efforts need to be tailored to meet the needs of this community .


Vasopressor administration is recommended to prevent hypotension during spinal anaesthesia ( SA ) for elective Caesarean delivery .


We aimed to test the superior efficacy and ensure safety of a hydroxyethyl starch ( HES ) vs a Ringer 's lactate ( RL ) preloading , when combined with a phenylephrine-based prophylaxis .


A total of 167 healthy parturients undergoing elective Caesarean delivery under SA were included in this multicentre , randomized , double-blind study .


Patients received 500 ml of 6 % HES ( 130/0 .4 ) +500 ml of RL ( HES group ) or 1000 ml of RL ( RL group ) i.v. before SA .


After SA , i.v. phenylephrine boluses were titrated when systolic arterial pressure ( SAP ) was below 95 % of baseline .


The primary outcome was the incidence of maternal hypotension ( SAP < 80 % of baseline ) .


The incidence of both hypotension and symptomatic hypotension ( i.e. with dizziness , nausea/vomiting , or both ) was significantly lower in the HES group vs the RL group : 36.6 % vs 55.3 % ( one-sided P = 0.025 ) and 3.7 % vs 14.1 % .


There was no significant difference in total phenylephrine requirements [ median ( range ) : 350 ( 50-1800 ) vs 350 ( 50-1250 ) g ] .


The decrease in maternal haemoglobin value the day after surgery was similar in the two groups [ 1.2 ( 1.0 ) vs 1.0 ( 0.9 ) g dl ( -1 ) ] .


There was no detectable placental transfer of HES in six umbilical cord blood samples analysed in the HES group .


Neonatal outcomes were comparable between the groups .


Compared with a pure RL preloading , a mixed HES-RL preloading significantly improved prevention of both hypotension and symptomatic hypotension based on early phenylephrine bolus administration and did not induce adverse effects .


NCT00694343 ( http://clinicaltrials.gov ) .


The aim of this study was to compare the efficacy of HES 130/0 .4 coloading compared to normal saline solution for prevention of hypotension during spinal anesthesia for elective caesarean section .


Prospective , randomized .


One hundred and twenty ASA I and II patients scheduled for elective caesarean section were recruited .


Patients were randomized to receive either 500mL of HES 130/0 .4 ( Voluven ( ) ) coloading ( GroupV ) or 500mL of normal saline solution coloading ( GroupC ) .


Spinal anesthesia technique and ephedrine administration were standardized in both groups .


The primary endpoint was the incidence of maternal hypotension during spinal anesthesia for elective caesarean section .


Hypotension occurred in 43 patients in group C and 24 patients in group V ( p = 0.001 ) .


Ephedrine consumption was significantly lower in group V ( P = 0.005 ) .


Nausea , vomiting and headache incidence was higher in group C ( p = 0.006 ) .


Apgar scores and umbilical blood gazes were comparable between groups .


HES 130/0 .4 coload was more effective than normal saline solution to prevent hypotension following spinal anesthesia for elective cesarean section .


HES 130/0 .4 coload reduced the incidence , the duration of longest hypotension , the need for ephedrine and the adverse maternal effects .


Newer approaches for understanding suicidal behavior suggest the assessment of suicide-specific beliefs and cognitions may improve the detection and prediction of suicidal thoughts and behaviors .


The Suicide Cognitions Scale ( SCS ) was developed to measure suicide-specific beliefs , but it has not been tested in a military setting .


Data were analyzed from two separate studies conducted at three military mental health clinics ( one U.S. Army , two U.S. Air Force ) .


Participants included 175 active duty Army personnel with acute suicidal ideation and/or a recent suicide attempt referred for a treatment study ( Sample 1 ) and 151 active duty Air Force personnel receiving routine outpatient mental health care ( Sample 2 ) .


In both samples , participants completed self-report measures and clinician-administered interviews .


Follow-up suicide attempts were assessed via clinician-administered interview for Sample 1 .


Statistical analyses included confirmatory factor analysis , between-group comparisons by history of suicidality , and generalized regression modeling .


Two latent factors were confirmed for the SCS : Unloveability and Unbearability .


Each demonstrated good internal consistency , convergent validity , and divergent validity .


Both scales significantly predicted current suicidal ideation ( s > 0.316 , ps < 0.002 ) and significantly differentiated suicide attempts from nonsuicidal self-injury and control groups ( F ( 6 , 286 ) = 9.801 , p < 0.001 ) .


Both scales significantly predicted future suicide attempts ( AORs > 1.07 , ps < 0.050 ) better than other risk factors .


Self-report methodology , small sample sizes , predominantly male samples .


The SCS is a reliable and valid measure that predicts suicidal ideation and suicide attempts among military personnel better than other well-established risk factors .


Standard clips do not consistently prevent the migration of covered self-expanding metal stents ( SEMS ) .


The aims of this study were to assess the efficacy and safety of the over-the-scope clip ( OTSC ) system for anchoring SEMS to the esophagus , and to evaluate a novel OTSC removal technique .


This was a single-center , retrospective , cohort study of consecutive patients undergoing SEMS anchoring with OTSC .


Removal of the OTSC was accomplished using an inject-and-resect technique .


A total of 12 patients were included .


The indications for endoscopic stenting were : tracheo-esophageal fistula ( n = 7 ) , postoperative leak or fistula ( n = 4 ) , perforation ( n = 1 ) .


Successful application of the OTSC system was accomplished in all patients ( 100 % ) .


Stent migration during follow-up ( mean 3 weeks , range 2-4 weeks ) occurred in two patients ( 16.7 % ) .


After healing of the underlying condition , the stent was removed in six patients ( 50.0 % ) .


In four patients ( 33.3 % ) , the anchored stent was left indefinitely in order to treat the underlying condition .


There were no complications associated with deployment of the OTSC or SEMS removal .


Although endoscopic anchoring of fully covered SEMS with the OTSC was feasible , easy to accomplish , safe , and prevented stent migration in most cases , larger studies are needed to confirm these encouraging early findings .


The inject-and-resect technique was safe and efficient for OTSC and stent removal in all cases in which it was attempted .


Botulinum toxin type A ( BTX-A ) is widely used for the clinical treatment of masseteric hypertrophy .


Until now , few reports have discussed how to prolong the duration of its effectiveness .


This study evaluated that purposely adjusting the masticatory movements is possible of postponing the masseter muscle rehypertrophy .


Ninety-eight patients were randomly and equally divided into 2 groups , and 35 U BTX-A per side was injected into the masseters .


The thickness and volume of the masticatory muscles were measured by ultrasound and computerized tomography , respectively .


Patients in Group 1 were instructed to strengthen their masticatory effort during the denervated atrophic stage of the masseter ( the interval was evaluated by real-time ultrasound monitoring ) , whereas patients in Group 2 were not given this instruction .


When the masseter muscle began to recover , patients in both groups were instructed to reduce their chewing .


The duration of the masseter muscle rehypertrophy was significantly prolonged in Group 1 patients .


The thickness and the volume of the other masticatory muscles were significantly increased in Group 1 but were either slightly decreased or insignificantly different in Group 2 .


Purposely strengthening masticatory muscle movement during the denervated atrophic stage of the masseter can prolong the duration of masseter rehypertrophy .


The aim of this prospective randomized study was to evaluate the efficacy of estrogen in preventing intrauterine adhesions following hysteroscopic septal resection and to investigate its effect on reproductive outcome .


After hysteroscopic septal resection , 90 women received either estrogen or placebo ( n = 45 per group ) for 30 days .


A second-look hysteroscopy was performed after 2 months .


All pregnancies occurring during the study period were recorded .


Adhesions developed in three of 43 ( 6.9 % ) patients in the control group compared to none in the estrogen group .


This difference was not statistically significant ( P = 0.24 ) .


Regarding reproductive outcome , the differences between the two groups were also not significant .


Estrogen treatment was not found to prevent intrauterine adhesions or improve reproductive outcome after hysteroscopic septal resection .


A preliminary report showed that autologous blood is an effective and easily applicable technique that can control actively bleeding gastroduodenal ulcers .


The aim of this study was to test whether an endoscopic injection of autologous blood is comparable to an endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers .


A total of 100 patients with actively bleeding gastroduodenal ulcers were assigned randomly to either an autologous blood injection ( group A , n = 50 ) or a diluted epinephrine injection ( group B , n = 50 ) along the edges of the ulcers .


Groups were compared for rates of initial hemostasis , rebleeding , and complications .


All patients initially achieved hemostasis ( 100 % ) .


Rebleeding occurred in four patients from group A ( 8 % ) and five patients from group B ( 10 % ) .


Two patients in group B developed cardiovascular complications ( arrhythmia and ischemic heart attack ) , whereas none in group A developed complications .


Autologous blood is effective , comparable to diluted epinephrine in achieving initial hemostasis from actively bleeding gastroduodenal ulcers , associated with an 8 % rebleeding rate , and led to no complications .


The objective of this study was to determine the effects of the N-methyl-d-aspartate ( NMDA ) receptor antagonist , memantine ( 0 , 20 , 40mg/d ) , upon alcohol drinking and craving in heavy drinkers with or without a family history ( FH ) of alcoholism , and to explore the modulatory influence of the presence of impulsivity on these outcomes .


Ninety-two , nontreatment-seeking , heavy drinkers received memantine or placebo for 8days .


On the eighth day , they received a priming dose of alcohol followed by a 3-hour period of alcohol access .


Memantine at a dose of 20mg reduced alcohol craving but did not influence alcohol drinking .


No effects of FH were observed .


In participants with higher baseline levels of impulsivity , 40mg of memantine reduced alcohol craving but increased alcohol drinking and alcohol-induced stimulation .


NMDA receptor signaling may play divergent roles in mediating alcohol cue-induced craving and alcohol drinking in heavy drinkers .


The potential efficacy of memantine as monotherapy for alcohol use disorders may be limited by its tendency to disinhibit drinking in some individuals .


To explore the surgical techniques in posterolateral mini-incision total hip arthroplasty and clinical efficacy .


A total of 94 patients ( 98 hips ) had posterolateral mini-incision total hip arthroplasty , from December 2006 to December 2008 , and were randomly divided into a posterolateral miniincision total hip arthroplasty group ( Group A ) and a conventional group of posterolateral incision for total hip arthroplasty ( Group B ) .


Forty-nine patients ( 50 hips ) in Group A had posterolateral small incision total hip arthroplasty [ 26 males , 23 females , between 37.0 and 95.0 years ( average 68.9 years ) , body mass index ( BMI ) between 20.3 and 29.7 ( average BMI 25.4 ) ] .


Forty-five patients ( 48 hips ) in Group B had the conventional posterolateral incision [ 27 males , 18 females , between 45.0 and 92.0 years ( average 69.7 years ) , BMI between 18.7 and 34.1 ( average BMI 26.9 ) ] .


The incision length , blood loss , drainage , operation time , and postoperative Harris scores were compared between the 2 groups .


The incision length was 6.0 ~ 10.5 ( average length 7.4 ) cm , average blood loss was 387.6 ( 140.0 ~ 1000.0 ) mL , average drainage was 143.1 ( 63.0 ~ 375.0 ) mL , average blood transfusion was 77.6 ( 0 ~ 400.0 ) mL , average operation time was 84.6 ( 63.0 ~ 130.0 ) min , and vitalock abduction angle imaging after the operation was 41.6 ( averagely 38.0 ~ 57.0 ) in Group A.


The incision length was 15.0 ~ 23.0 ( average length 20.0 ) cm , average blood loss was 513.1 ( 210.0 ~ 1350.0 ) mL , average drainage was 152.3 ( 70.0 ~ 520.0 ) mL , average blood transfusion was 142.2 ( 0 ~ 800.0 ) mL , average operation time was 84.0 ( 71.0 ~ 115.0 ) min , and postoperative radiographic acetabular cup abduction angle was 42.3 ( 37.0 ~ 54.0 ) in Group B.


The follow-up showed that the prosthesis of the 2 groups was in a good position , Harris score was significantly improved with no complications after total hip arthroplasty in the 2 groups .


With the correct selection of indications and adept operation skills and other circumstances , posterolateral mini-incision total hip arthroplasty may do little damage to the soft tissue with a small scar on the skin .


The imaging evaluation after the operation and the Harris score show no difference between the 2 groups .


Patients are satisfied with their joint function and postoperative recovery .


In randomised trials of medical interventions , the most reliable analysis follows the intention-to-treat ( ITT ) principle .


However , the ITT analysis requires that missing outcome data have to be imputed .


Different imputation techniques may give different results and some may lead to bias .


In anti-obesity drug trials , many data are usually missing , and the most used imputation method is last observation carried forward ( LOCF ) .


LOCF is generally considered conservative , but there are more reliable methods such as multiple imputation ( MI ) .


To compare four different methods of handling missing data in a 60-week placebo controlled anti-obesity drug trial on topiramate .


We compared an analysis of complete cases with datasets where missing body weight measurements had been replaced using three different imputation methods : LOCF , baseline carried forward ( BOCF ) and MI .


561 participants were randomised .


Compared to placebo , there was a significantly greater weight loss with topiramate in all analyses : 9.5 kg ( SE 1.17 ) in the complete case analysis ( N = 86 ) , 6.8 kg ( SE 0.66 ) using LOCF ( N = 561 ) , 6.4 kg ( SE 0.90 ) using MI ( N = 561 ) and 1.5 kg ( SE 0.28 ) using BOCF ( N = 561 ) .


The different imputation methods gave very different results .


Contrary to widely stated claims , LOCF did not produce a conservative ( i.e. , lower ) efficacy estimate compared to MI .


Also , LOCF had a lower SE than MI .


To investigate the effects of 80-kilovoltage ( kV ) tube voltage coronary computed tomographic angiography ( CCTA ) with a reduced amount of contrast agent on qualitative and quantitative image quality parameters and on radiation dose in patients with a body mass index ( BMI ) < 23.0 kg/m ( 2 ) .


One hundred and twenty consecutive patients with a BMI < 23.0 kg/m ( 2 ) and a low calcium load undergoing retrospective electrocardiogram ( ECG ) - gated dual-source CCTA were randomized into two groups [ standard-tube voltage ( 120-kV ) vs. low-tube voltage ( 80-kV ) ] .


The injection flow rate of contrast agent ( 350 mg I/mL ) was adjusted to body weight of each patient ( 4.5-5 .5 mL/s in the 120-kV group and 2.8-3 .8 mL/s in the 80-kV group ) .


Radiation and contrast agent doses were evaluated .


Quantitative image quality parameters and figure of merit ( FOM ) of coronary artery were evaluated .


Each coronary segment was evaluated for image quality on a 4-point scale .


Compared with the 120-kV group , effective dose and amount of contrast agent in the 80-kV group were decreased by 57.8 % and 30.5 % ( effective dose :2.7 0.5 vs. 6.4 1.3 mSv ; amount of contrast agent :57.1 3.2 vs. 82.1 6.1 mL ; both p < 0.0001 ) , respectively .


Image noise was 22.7 2.1 HU for 120-kV images and 33.2 5.2 HU for 80-kV images ( p < 0.0001 ) .


Signal-to-noise ratio ( SNR ) and contrast-to-noise ratio ( CNR ) in the proximal right coronary artery ( RCA ) and left main coronary artery ( LMA ) were all lower in 80-kV than 120-kV images ( SNR in the proximal RCA : 16.5 1.8 vs. 19.4 2.8 ; SNR in the LMA : 16.3 2.0 vs. 19.6 2.7 ; CNR in the proximal RCA : 19.4 2.3 vs. 22.9 3.0 ; CNR in the LMA : 18.8 2.4 vs. 22.7 2.9 ; all p < 0.0001 ) .


FOM were all significantly higher in 80-kV than 120-kV images ( proximal RCA : 146.7 45.1 vs. 93.4 32.0 ; LMA : 139.1 47.2 vs. 91.6 31.1 ; all p < 0.0001 ) .


There was no significant difference in image quality score between the two groups ( 3.3 0.8 vs. 3.3 0.8 , p = 0.068 ) despite decreased SNR and CNR of coronary artery in the 80-kV group .


The 80-kV protocol significantly reduces radiation and contrast agent doses in CCTA in patients with a low BMI < 23.0 kg/m ( 2 ) and a low calcium load while maintaining image quality .


GVAX pancreas , granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells , induces T-cell immunity to cancer antigens , including mesothelin .


GVAX is administered with low-dose cyclophosphamide ( Cy ) to inhibit regulatory T cells .


CRS-207 , live-attenuated Listeria monocytogenes-expressing mesothelin , induces innate and adaptive immunity .


On the basis of preclinical synergy , we tested prime/boost vaccination with GVAX and CRS-207 in pancreatic adenocarcinoma .


Previously treated patients with metastatic pancreatic adenocarcinoma were randomly assigned at a ratio of 2:1 to two doses of Cy/GVAX followed by four doses of CRS-207 ( arm A ) or six doses of Cy/GVAX ( arm B ) every 3 weeks .


Stable patients were offered additional courses .


The primary end point was overall survival ( OS ) between arms .


Secondary end points were safety and clinical response .


A total of 90 patients were treated ( arm A , n = 61 ; arm B , n = 29 ) ; 97 % had received prior chemotherapy ; 51 % had received two regimens for metastatic disease .


Mean number of doses ( standard deviation ) administered in arms A and B were 5.5 4.5 and 3.7 2.2 , respectively .


The most frequent grade 3 to 4 related toxicities were transient fevers , lymphopenia , elevated liver enzymes , and fatigue .


OS was 6.1 months in arm A versus 3.9 months in arm B ( hazard ratio [ HR ] , 0.59 ; P = .02 ) .


In a prespecified per-protocol analysis of patients who received at least three doses ( two doses of Cy/GVAX plus one of CRS-207 or three of Cy/GVAX ) , OS was 9.7 versus 4.6 months ( arm A v B ; HR , 0.53 ; P = .02 ) .


Enhanced mesothelin-specific CD8 T-cell responses were associated with longer OS , regardless of treatment arm .


Heterologous prime/boost with Cy/GVAX and CRS-207 extended survival for patients with pancreatic cancer , with minimal toxicity .


To determine the effects of tai chi training on functional performance and walking with and without the addition of the performance of a cognitive task , in older adults living in supportive housing facilities .


Secondary data analysis comparing a single-blind , randomized controlled trial of tai chi training with an attention-matched educational control intervention with crossover to tai chi .


Two supportive housing facilities .


Sixty-six men and women living in supportive housing facilities entered the study , and 57 aged 877 completed all study procedures .


Interventions consisted of two 1-hour-long instructor-led group sessions per week for 12 weeks .


Tai chi training consisted of movements based upon the Yang-style short form .


Educational sessions consisted of lectures and discussions of age-related health topics .


Subjects were tested for physical function ( Short Physical Performance Battery , SPPB ) , balance ( Berg Balance Scale , BBS ) , mobility ( timed up-and-go , TUG ) , and walking speed under normal and cognitive dual-task conditions .


The tai chi group exhibited greater improvement in SPPB scores ( baseline 8.12.9 , follow-up 9.02.6 ) than controls ( baseline 8.22.6 , follow-up 8.22.6 ) ( P = .005 ) .


Tai chi also increased normal and dual-task walking speed ( P < .001 ) yet did not affect BBS ( P = .02 ) or TUG ( P = .02 ) after accounting for multiple comparisons .


The dual-task cost ( percentage change ) to walking speed was unaffected .


After the crossover tai chi intervention , the control group improved performance in the SPPB , BBS , and TUG , and increased walking speed under normal and dual-task conditions ( P = .008 ) .


Tai chi training may be a safe and effective therapy to help improve physical function and dual-task walking in very old adults living in supportive housing facilities .


To assess the efficacy and safety of a 24-week course of abatacept in the treatment of active lupus nephritis and to assess the potential of abatacept to induce `` clinical tolerance , '' defined as sustained clinical quiescence of lupus nephritis after discontinuation of immunosuppressive therapy .


Patients with active lupus nephritis ( n = 134 ) were enrolled in a randomized , double-blind phase II add-on trial in which they received either abatacept or placebo in conjunction with the Euro-Lupus Nephritis Trial regimen of low-dose cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) .


The primary efficacy outcome was the frequency of complete response at week 24 .


Thereafter , patients who met either complete or partial response criteria continued blinded treatment through week 52 .


During this phase of the study , subjects in the abatacept treatment group in whom a complete response was achieved at week 24 discontinued immunosuppressive therapy other than prednisone ( 10 mg/day ) .


There were no statistically significant differences between groups with respect to the primary outcome or any of the secondary outcomes , including measures of safety .


A complete response was achieved in 33 % of the subjects in the treatment group and in 31 % of the subjects in the control group at week 24 .


Fifty percent of the subjects in the treatment group who met complete response criteria and therefore discontinued immunosuppressive therapy at week 24 maintained their complete response status through week 52 .


The addition of abatacept to a regimen of CYC followed by AZA did not improve the outcome of lupus nephritis at either 24 or 52 weeks .


No worrisome safety signals were encountered .


The aim of this study was to evaluate the effects of umbilical cord milking ( UCM ) on the need for packed red blood cell ( PRBC ) transfusion and hematologic and hemodynamic parameters in very-low-birth-weight infants .


The infants were randomized into 2 groups : group 1 ( UCM ) and group 2 ( control ) .


The primary outcome was the number of PRBC transfusions during the first 35 days of life .


The secondary outcome measures were the hemodynamic variables during the first 24 hours of life .


A total of 44 infants were included with 22 infants in each group .


Two of 21 infants in group 1 and 4 of 21 infants in group 2 received transfusion in the first 3 days of life ( P = 0.384 ) .


The number and volume of PRBC transfusions were similar in both groups .


However , the levels of hemoglobin ( Hb ) at the first and 24th hour of life were significantly higher in group 1 .


Phlebotomy volume was found as a statistically significant risk factor for the need for PRBC transfusion ( P = 0.005 ) .


UCM in delivery room results in a higher Hb level in the first day of life .


In these groups of infants , phlebotomy losses may impact the transfusion need .


Previous studies comparing endoscopic ultrasound-guided fine-needle aspiration ( EUS-FNA ) results with different gauge needles have all been carried out with the stylet in place and show no clear advantage to the larger 22-G needle .


Similar data for stylet-free EUS-FNA ( SF-EUS-FNA ) are unavailable .


The aim of the present study was to determine whether diagnostic yield and specimen adequacy is superior with the 22-G needle as compared to the 25-G needle .


All patients 18 years referred for solid-lesion EUS-FNA were eligible .


Patients with suspected diagnosis of lymphoma , gastrointestinal stromal tumor , sarcoidosis , significant coagulopathy ( international normalized ratio > 1.5 or platelets < 50000/mm ( 3 ) ) , use of clopidogrel within 7 days of EUS , and pregnancy were excluded .


The two needles were compared regarding diagnostic yield , sample adequacy , bloodiness , ease of puncture , visibility , number of passes , failures , and complications .


One hundred and twenty consecutive patients were included and 126 lesions were sampled .


Sensitivity , specificity , positive predictive value and negative predictive value for the 22-G SF-EUS-FNA were 83 % , 100 % , 100 % and 56 % , respectively , and for the 25-G SF-EUS-FNA were 88.8 % , 100 % , 100 % and 76.5 % , respectively ( P = NS ) .


There were no significant differences between the 22-G and the 25-G FNA needles in sample adequacy , bloodiness , ease of puncture , FNA failure , visibility , number of passes and complications ; and no significant differences between either needle were found in relation to lesion site .


For SF-EUS-FNA , the larger 22-G needle offers no advantage over the smaller 25-G needle .


This study was designed with the aim of defining a new surgical procedure for varicose veins and for comparison with classic crossectomy in terms of reducing the recurrence rate of varicose veins .


Double-blind randomized clinical trial .


For easy access , we selected 150 patients who came to the Phlebology Consultation Unit meeting inclusion criteria .


With their informed consent , they were included in a study group using random table numbers .


Group 1 : ( CS ) Classic saphenectomy , 75 patients .


Group 2 : ( HCWVS ) High crossectomy without vascular sectioning .


Both groups were monitorised at 12 and 24 months by Eco-Doppler study .


The incidence of varicose vein recurrence at 12 month follow-up was 69.3 % in the group of patients undergoing CS , while in the group receiving HCWVS it was 29.3 % ( p < 0.0001 ) .


These differences , though minor , remained statistically significant at 24 months of evolution ( 76 % vs. 48 % , p = 0.0004 ) .


The most common recurrence type was type I , with statistically significant differences at 12 and 24 months .


We believe that saphenectomy with crossectomy without vascular sectioning is the appropriate procedure to treat varicose veins , reducing type 1 or reticular relapse rate and maintaining the principles of classic surgery to reduce type 2 or truncular recurrence rate .


This technique should be implemented with procedures based on saphenous sclerosis with foam art the saphenous femoral junction , in order to assess the recurrence rate of type 2 or truncular varicose veins .


A group-based eating disorder prevention program wherein young women explore the costs of pursuing the thin ideal reduces eating disorder risk factors and symptoms .


However , it can be challenging to identify school clinicians to effectively deliver the intervention .


The present study compares the effects of a new Internet-based version of this prevention program , which could facilitate dissemination , to the group-based program and to educational video and educational brochure control conditions at 1 - and 2-year follow-up .


Female college students with body dissatisfaction ( n = 107 ; M age = 21.6 , SD = 6.6 ) were randomized to these 4 conditions .


Internet participants showed reductions in eating disorder risk factors and symptoms relative to the 2 control conditions at 1 - and 2-year follow-up ( M - d = .34 and .17 , respectively ) , but the effects were smaller than parallel comparisons for the group participants ( M - d = .48 and .43 , respectively ) .


Yet the Internet intervention produced large weight gain prevention effects relative to the 2 control conditions at 1 - and 2-year follow-up ( M - d = .80 and .73 , respectively ) , which were larger than the parallel effects for the group intervention ( M - d = .19 and .47 , respectively ) .


Although the effects for the Internet versus group intervention were similar at posttest , results suggest that the effects faded more quickly for the Internet intervention .


However , the Internet intervention produced large weight gain prevention effects , implying that it might be useful for simultaneously preventing eating disordered behavior and unhealthy weight gain .


Financial incentives and peer networks could be delivered through eHealth technologies to encourage older adults to walk more .


We conducted a 24-week randomized trial in which 92 older adults with a computer and Internet access received a pedometer , daily walking goals , and weekly feedback on goal achievement .


Participants were randomized to weekly feedback only ( Comparison ) , entry into a lottery with potential to earn up to $ 200 each week walking goals were met ( Financial Incentive ) , linkage to four other participants through an online message board ( Peer Network ) , or both interventions ( Combined ) .


Main outcomes were the proportion of days walking goals were met during the 16-week intervention and 8-week follow-up .


We conducted a content analysis of messages posted by Peer Network and Combined arm participants .


During the 16-week intervention , there were no differences in the proportion of days walking goals were met in the Financial Incentive ( 39.7 % ; p = .78 ) , Peer Network ( 24.9 % ; p = .08 ) , and Combined ( 36.0 % ; p = .77 ) arms compared with the Comparison arm ( 36.0 % ) .


During 8 weeks of follow-up , the proportion of days walking goals were met was lower in the Peer Network arm ( 18.7 % ; p = .025 ) but not in the Financial Incentive ( 29.3 % ; p = .50 ) or Combined ( 24.8 % ; p = .37 ) arms , relative to the Comparison arm ( 34.5 % ) .


Messages posted by participants focused on barriers to walking and provision of social support .


Financial incentives and peer networks delivered through eHealth technologies did not result in older adults walking more .


Children can find anaesthesia induction especially distressing and postoperative psychological and physical morbidity are common .


Preparation programmes for general anaesthesia ( GA ) are highly effective in reducing this distress .


A Phase II study has already verified the effectiveness of a prototype preoperative GA-coping computer game to help children cope with induction in a dental GA setting .


The biggest patient users of pediatric GA services in the UK are children who need to have teeth removed ( estimated to be 100,000 yearly ) .


Tooth decay is the most common disease in children worldwide .


This study is a Phase III randomized controlled trial ( RCT ) and will evaluate the effectiveness of the new internet version of this game .


The Phase III RCT will use a double-blind three-armed design .


The clinical trial will recruit up to 210 children and will compare the web-based game against standard care and another non-medical game .


At least 53 patients in each group will be required for 90 % statistical power .


Distress will be assessed through an evaluation of the child 's behaviour during the visit and later parental reports of physical and psychological morbidity .


The satisfaction of parents and children will be measured ; the mode of usage of the web-based game will be automatically recorded and the impact on the service ( for example , recovery time and throughput ) will be reported.The Phase III study primary outcome will measure : ( 1 ) patient experience : acceptance of anaesthetic induction , child cooperation and distress , reduction of peri - and postoperative morbidity , child and family satisfaction , and ( 2 ) service improvement : anaesthetic time and improvement in throughput .


Measures will be administered at baseline , at the time of the GA treatment visit , and at 48hours and one week postoperatively .


This study aims to determine the effectiveness of an online GA-coping game for children and families undergoing tooth extraction under GA. .


ISRCTN18265148 ( registered 24 November 2013 ) .


Patients with advanced-stage , low-tumour-burden follicular lymphoma have conventionally undergone watchful waiting until disease progression .


We assessed whether rituximab use could delay the need for chemotherapy or radiotherapy compared with watchful waiting and the effect of this strategy on quality of life ( QoL ) .


Asymptomatic patients ( aged 18 years ) with low-tumour-burden follicular lymphoma ( grades 1 , 2 , and 3a ) were randomly assigned centrally ( 1:1:1 ) , by the minimisation approach stratified by institution , grade , stage , and age , to watchful waiting , rituximab 375 mg/m ( 2 ) weekly for 4 weeks ( rituximab induction ) , or rituximab induction followed by a maintenance schedule of 12 further infusions given at 2-monthly intervals for 2 years ( maintenance rituximab ) .


On Sept 30 , 2007 , recruitment into the rituximab induction group was closed and the study was amended to a two-arm study .


The primary endpoints were time to start of new treatment and QoL at month 7 ( ie , 6 months after completion of rituximab induction ) .


All randomly assigned patients were included in the analysis of time to start of new treatment on an intention-to-treat basis .


The main study is now completed and is in long-term follow-up .


The study is registered with ClinicalTrials.gov , NCT00112931 .


Between Oct 15 , 2004 , and March 25 , 2009 , 379 patients from 118 centres in the UK , Australia , New Zealand , Turkey , and Poland were randomly assigned to watchful waiting or maintenance rituximab .


84 patients were recruited to the rituximab induction group before it was closed early .


There was a significant difference in the time to start of new treatment , with 46 % ( 95 % CI 39-53 ) of patients in the watchful waiting group not needing treatment at 3 years compared with 88 % ( 83-92 ) in the maintenance rituximab group ( hazard ratio [ HR ] 021 , 95 % CI 014-031 ; p < 00001 ) .


78 % ( 95 % CI 69-87 ) of patients in the rituximab induction group did not need treatment at 3 years , which was significantly more than in the watchful waiting group ( HR 035 , 95 % CI 022-056 ; p < 00001 ) , but no different compared with the maintenance rituximab group ( 075 , 041-134 ; p = 033 ) .


Compared with the watchful waiting group , patients in the maintenance rituximab group had significant improvements in the Mental Adjustment to Cancer scale score ( p = 00004 ) , and Illness Coping Style score ( p = 00012 ) between baseline and month 7 .


Patients in the rituximab induction group did not show improvements in their QoL compared with the watchful waiting group .


There were 18 serious adverse events reported in the rituximab groups ( four in the rituximab induction group and 14 in the maintenance rituximab group ) , 12 of which were grade 3 or 4 ( five infections , three allergic reactions , and four cases of neutropenia ) , all of which fully resolved .


Rituximab monotherapy should be considered as a treatment option for patients with asymptomatic , advanced-stage , low-tumour-burden follicular lymphoma .


Cancer Research UK , Lymphoma Research Trust , Lymphoma Association , and Roche .


Narrow-band imaging ( NBI ) endoscopy improves the detection of intestinal metaplasia .


However , strategies to improve the visibility and diagnostic performance of NBI should be sought , as endoscopic views are often obscured by the presence of mucus .


To compare the visibility and diagnostic performance of NBI endoscopy according to pronase premedication in patients with precancerous conditions of the stomach .


Consecutive outpatients with a previous diagnosis of precancerous condition of the stomach were invited to undergo a surveillance NBI endoscopy between June and December 2012 .


Enrolled subjects were randomly assigned to pronase or control groups before NBI endoscopy .


The visibility score and diagnostic performance of NBI endoscopy were compared between the two groups .


Patients ' endoscopic and histopathological characteristics were similar between the two groups .


Visibility score in the proximal part of the stomach and satisfaction score of the endoscopist were significantly higher in the pronase group than in the control group ( p = 0.014 and p = 0.034 , respectively ) .


The diagnostic performance of NBI endoscopy to detect intestinal metaplasia was not different in either group ( both p > 0.1 ) .


However , the negative predictive value of NBI endoscopy was much improved over that of white light endoscopy only in the pronase group ( p = 0.013 ) .


Pronase premedication increased the visibility of the proximal part of the stomach and the satisfaction score during NBI endoscopy .


Furthermore , negative predictive value of NBI endoscopy was much improved compared with that of white light endoscopy after pronase premedication .


The incidence , predictors , and prognostic impact of post-discharge bleeding ( PDB ) after percutaneous coronary intervention ( PCI ) with drug-eluting stent ( DES ) implantation are unclear .


This study sought to characterize the determinants and consequences of PDB after PCI .


The prospective ADAPT-DES ( Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents ) study was used to determine the incidence and predictors of clinically relevant bleeding events occurring within 2 years after hospital discharge .


The effect of PDB on subsequent 2-year all-cause mortality was estimated by time-adjusted Cox proportional hazards regression .


Among 8,582 `` all-comers '' who underwent successful PCI with DES in the ADAPT-DES study , PDB occurred in 535 of 8,577 hospital survivors ( 6.2 % ) at a median time of 300 days ( interquartile range : 130 to 509 days ) post-discharge .


Gastrointestinal bleeding ( 61.7 % ) was the most frequent source of PDB .


Predictors of PDB included older age , lower baseline hemoglobin , lower platelet reactivity on clopidogrel , and use of chronic oral anticoagulation therapy .


PDB was associated with higher crude rates of all-cause mortality ( 13.0 % vs. 3.2 % ; p < 0.0001 ) .


Following multivariable adjustment , PDB was strongly associated with 2-year mortality ( hazard ratio [ HR ] : 5.03 ; p < 0.0001 ) , with an effect size greater than that of post-discharge myocardial infarction ( PDMI ) ( HR : 1.92 ; p = 0.009 ) .


After successful PCI with DES in an unrestricted patient population , PDB is not uncommon and has a strong relationship with subsequent all-cause mortality , greater that that associated with PDMI .


Efforts to reduce PDB may further improve prognosis after successful DES implantation .


( Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents [ ADAPT-DES ] ; NCT00638794 ) .


Determine the association of children 's susceptibility to large food portion sizes with appetite regulation and obesity .


Normal-weight and obese non-Hispanic black children ( n = 100 ) aged 5-6 years were observed in four dinner conditions of varying portion size ; portions of all foods ( except milk ) offered were : 100 % ( 677 kcal ) , 150 % ( 1015 kcal ) , 200 % ( 1353 kcal ) , or 250 % ( 1691 kcal ) of those in the reference condition ( 100 % ) .


Condition order was randomly assigned to 2-4 children who ate together at each meal .


Child height and weight were measured and caregiver reports of child appetite were obtained .


Hierarchical growth curve models were used to estimate associations of meal energy intake with portion size condition , child weight status , and appetite regulation traits , controlling for demographics .


Total energy intake increased across conditions of increasing food portion size ( P < 0.001 ) .


The effect of portion size condition on total energy intake varied with food responsiveness ( P = 0.05 ) and satiety responsiveness ( P < 0.05 ) , but not weight status ( P = 0.682 ) .


Children with lower satiety responsiveness and greater food responsiveness showed greater increases in meal energy across conditions .


Children with poorer appetite regulation may be more vulnerable to obesogenic dietary environments offering large food portions than other children .


Compression therapy is highly effective in the treatment of post-thrombotic syndrome and venous leg ulcer .


On average , 50-60 % of the patients cooperate with compression therapy .


Therefore , it is necessary to improve the user-friendliness .


This prospective study investigated whether the use of donning devices can contribute to improving user-friendliness .


Forty patients aged > 65 years with severe chronic venous insufficiency ( CVI ; C4-C6 ) successively donned compression stockings in a randomized order : one 40mmHg ( CS40 ) or two superimposed 20mmHg ( CS20 +20 ) , each with open toe ( CS-o-t ) and closed toe ( CS-c-t ) , using donning devices ( three foot slips for CS-o-t ; two foot slips and three frames for CS-c-t ) .


The study endpoint was that the stocking was completely donned and correctly positioned on the patient 's leg .


The success rate and its association with age , sex , first time versus second time user , body mass index , abdominal circumference , ability to reach the forefoot with the hand , and hand grip strength were analyzed .


Additionally , subjective evaluation by the patients was performed .


Without donning devices , success with CS40-c-t was 60 % ( 24/40 patients ) and with CS20 +20 - c-t 70 % ( 28/40 patients ) ( p = .220 ) .


Using donning devices increased success rates significantly .


With CS40-o-t the success rate was 88 % ( 35/40 patients ; p = .001 ) and with CS40-c-t it was 90 % ( 36/40 patients ; p = .002 ) .


With CS20 +20 - o-t and CS20 +20 - c-t , the success rate was 88 % ( 35/40 patients ; p = .016 ) .


The proportion of patients who successfully used either CS40 or CS20 +20 increased from 73 % to 93 % .


Relevant for the patients ' success was the ability to reach the forefoot with the hand , and hand grip strength .


Subjectively , donning with a device was rated significantly better than without .


Donning devices significantly improve the ability of elderly patients with CVI to don compression stockings successfully .


However , there are differences in user-friendliness among the devices .


In August 2010 , the U.S. Food and Drug Administration issued draft guidelines for developing antibiotics for treating acute bacterial skin and skin structure infections ( ABSSSI ) , with the outcome measure of such treatment relying primarily on the cessation of spread or on the decrease in size of skin lesions at 48-72h after the initiation of such treatment .


In 2012 , the Foundation for the National Institutes of Health proposed an interim outcome measure defined as a reduction in lesion size by 20 % at a 48-72h examination .


These recent changes make it necessary to identify reliable methods for measuring the lesions in acute infections of the skin .


In the first study of the Efficacy and Safety of 6-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs. 10-day Oral Linezolid Therapy ( ESTABLISH-1 ) , the sizes of ABSSSI lesions were evaluated with the two methodologies of : ( 1 ) Digital planimetry ( DP ) of photographed lesions , and ( 2 ) a ruler technique ( RT ) with measurement of the longest head-to-toe length and greatest perpendicular width of lesions , to compare the respective response rates of lesions to the two antimicrobial regimens in the study .


The RT method and DP showed similar percentages of subjects in which treatment stopped the spread of ABSSSI lesions ( 93.2 % vs. 94.2 % , respectively ) but showed less agreement for a reduction in lesion size , of 20 % ( 87.7 % vs. 62.0 % , respectively ) across all categories of lesions ( cellulitis/erysipelas , major cutaneous abscess , and acute wound infection ) at 48-72h after the initiation of treatment .


The results of the ESTABLISH-1 study show that both the RT method and DP are consistent and reliable techniques for measuring the sizes of ABSSSI lesions .


Ultimately , changes in lesion size , rather than the absolute value of lesion size , will be used to assess the outcomes of treatment for ABSSSI in clinical research .


Goshajinkigan ( GJG ) is used for the treatment of several neurological symptoms .


We investigated the efficacy of GJG and mecobalamin ( B12 ) against neurotoxicity associated with docetaxel ( DOC ) in breast cancer patients .


Sixty breast cancer patients were treated with DOC .


Thirty-three patients ( GJG group ) received oral administration of 7.5 g/day GJG and 27 patients ( B12 group ) received oral administration of 1500 g/day B12 .


Neuropathy was evaluated according to DEB-NTC ( Neurotoxicity Criteria of Debiopharm ) , Common Terminology Criteria for Adverse Events ( NCI-CTC ) ver .


3.0 , and a visual analogue scale ( VAS ) .


This study employed a randomized open design .


The incidence of neuropathy was 39.3 % in the GJG group , and 88.9 % in the B12 group ( p < 0.01 ) .


In the GJG group , grade 1 DEB-NTC was observed in 2 cases , grade 2 in 5 cases and grade 3 in 5 cases .


Grade 1 NCI-CTC was observed in 7 cases , grade 2 in 6 cases , and VAS was 2.7 2.2 .


In the B12 group , grades 1 , 2 and 3 DEB-NTC were observed in one case , 12 cases and 12 cases , respectively ; and grades 1 , 2 and 3 NCI-CTC were observed in 11 cases , 12 cases and one case , and VAS was 4.9 2.4 .


Concomitant administration of GJG is useful in preventing neuropathy in breast cancer patients treated with a DOC regimen .


Remote ischemic preconditioning ( RIPC ) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery , but uncertainty about clinical outcomes remains .


We conducted a prospective , double-blind , multicenter , randomized , controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol .


The trial compared upper-limb RIPC with a sham intervention .


The primary end point was a composite of death , myocardial infarction , stroke , or acute renal failure up to the time of hospital discharge .


Secondary end points included the occurrence of any individual component of the primary end point by day 90 .


A total of 1403 patients underwent randomization .


The full analysis set comprised 1385 patients ( 692 in the RIPC group and 693 in the sham-RIPC group ) .


There was no significant between-group difference in the rate of the composite primary end point ( 99 patients [ 14.3 % ] in the RIPC group and 101 [ 14.6 % ] in the sham-RIPC group , P = 0.89 ) or of any of the individual components : death ( 9 patients [ 1.3 % ] and 4 [ 0.6 % ] , respectively ; P = 0.21 ) , myocardial infarction ( 47 [ 6.8 % ] and 63 [ 9.1 % ] , P = 0.12 ) , stroke ( 14 [ 2.0 % ] and 15 [ 2.2 % ] , P = 0.79 ) , and acute renal failure ( 42 [ 6.1 % ] and 35 [ 5.1 % ] , P = 0.45 ) .


The results were similar in the per-protocol analysis .


No treatment effect was found in any subgroup analysis .