This post hoc analysis of the SONIC trial evaluated different composite remission measures at week 26 in a subgroup of patients with Crohn 's disease activity index ( CDAI ) scores , CRP , and endoscopic data available at baseline and week 26 ( N = 188 ) .


Assessed composite remission measures were : CR ( CDAI < 150 ) and MH ( absence of any mucosal ulcerations ) , previously referred to as ` deep remission ; ' and alternative composite endpoints : CR+CRP norm ( CRP < 0.8 mg/dL ) ; CRPnorm + MH ; and CR+CRP norm + MH .


Among analysed patients , 136/188 ( 72.3 % ) achieved CR and 90/188 ( 47.9 % ) achieved MH at week 26 .


All composite outcomes were significantly greater ( Bonferroni significance level , P0 .016 ) with combination therapy ( i.e. infliximab and azathioprine ; 52.3-63 .6 % ) vs. azathioprine monotherapy ( 12.9-29 .0 % ; p 0.005 for all comparisons ) .


Composite remission rates including MH were significantly greater with combination therapy ( 52.3-56 .9 % ) vs. infliximab ( 25.6-32 .3 % ; P0 .015 for all comparisons except CRPnorm + MH , P = 0.017 ) and vs. azathioprine monotherapy ( 12.9-20 .4 % ; P0 .002 for all comparisons ) .


Median serum trough infliximab concentrations among patients who achieved MH or CR+MH were greater when compared with those among patients who did not achieve MH ( P = 0.018 ) or CR+MH ( P = 0.053 ) .


Among the subgroup of patients with early Crohn 's disease , MH alone or in combination with composite remission criteria significantly improved clinical outcomes of patients who received combination therapy .


Combination therapy was more effective in achieving various composite remission measures vs. azathioprine or infliximab monotherapy .


These data illustrate that ` deep remission ' is achievable with combination therapy in a high percentage of patients with early Crohn 's disease .


ClinicalTrials.gov number : NCT00094458 .


We compared the immunogenicity and reactogenicity of Cervarix or Gardasil human papillomavirus ( HPV ) vaccines in adults infected with the human immunodeficiency virus ( HIV ) .


This was a double-blind , controlled trial randomizing HIV-positive adults to receive 3 doses of Cervarix or Gardasil at 0 , 1.5 , and 6 months .


Immunogenicity was evaluated for up to 12 months .


Neutralizing anti-HPV-16 / 18 antibodies were measured by pseudovirion-based neutralization assay .


Laboratory tests and diary cards were used for safety assessment .


The HPV-DNA status of the participants was determined before and after immunization .


Ninety-two participants were included in the study .


Anti-HPV-18 antibody titers were higher in the Cervarix group compared with the Gardasil group at 7 and 12 months .


No significant differences in anti-HPV-16 antibody titers were found among vaccine groups .


Among Cervarix vaccinees , women had higher anti-HPV-16 / 18 antibody titers compared to men .


No sex-specific differences in antibody titers were found in the Gardasil group .


Mild injection site reactions were more common in the Cervarix group than in the Gardasil group ( 91.1 % vs 69.6 % ; P = .02 ) .


No serious adverse events occurred .


Both vaccines were immunogenic and well tolerated .


Compared with Gardasil , Cervarix induced superior vaccine responses among HIV-infected women , whereas in HIV-infected men the difference in immunogenicity was less pronounced .


This study sought to evaluate the effect of macitentan on hospitalization of patients with symptomatic pulmonary arterial hypertension ( PAH ) .


PAH is a progressive , life-threatening disease often requiring hospitalization .


In the multicenter , double-blind , randomized , event-driven , phase III SERAPHIN ( Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome ) trial , patients with symptomatic PAH were randomized ( 1:1:1 ) to receive placebo or 3 mg or 10 mg of macitentan .


Effects of macitentan on the risk , rate , and number of hospital days for all-cause and PAH-related hospitalizations were compared with those for placebo .


Risk and causes of hospitalizations unrelated to PAH were investigated .


Of 742 randomized patients , 250 received placebo , 250 received 3 mg of macitentan , and 242 received 10 mg of macitentan ; the overall median duration of treatment was 115 weeks .


Risk of all-cause hospitalization was reduced by 18.9 % ( p = 0.1208 ) and 32.3 % ( p = 0.0051 ) in the macitentan 3-mg and 10-mg arm , respectively .


Rates of all-cause hospitalizations and numbers of hospital days were reduced by 20.5 % ( p = 0.0378 ) and 30.6 % ( p = 0.0278 ) , respectively , with 3 mg of macitentan and by 33.1 % ( p = 0.0005 ) and 31.0 % ( p = 0.0336 ) , respectively , with 10 mg of macitentan .


Risk of PAH-related hospitalizations were reduced by 42.7 % ( p = 0.0015 ) and 51.6 % ( p < 0.0001 ) in the macitentan 3-mg and 10-mg arms , respectively .


Rate of PAH-related hospitalizations and numbers of hospital days were reduced by 44.5 % ( p = 0.0004 ) and 53.3 % ( p = 0.0001 ) , respectively , with 3 mg of macitentan , and reduced by 49.8 % ( p < 0.0001 ) and 52.3 % ( p = 0.0003 ) , respectively , with 10 mg of macitentan .


Risk of non-PAH-related hospitalization was similar between treatment arms .


Macitentan 10 mg significantly reduced the risk and rate of all-cause hospitalization , which was driven by reductions in the risk and rate of PAH-related hospitalization .


( Study of Macitentan [ ACT-064992 ] on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension ; NCT00660179 ) .


Sequential compression devices ( SCDs ) reduce deep venous thrombosis in postsurgical patients , but the use is hindered by poor compliance .


General and orthopedic surgery patients ( n = 67 ) were randomized to standard - or battery-powered SCDs .


Compliance was documented hourly .


Nurses and patients were issued a survey to assess barriers to compliance and device satisfaction .


Compliance with standard SCDs was 47 % compared with 85 % with battery-powered SCDs ( P < .001 ) .


The most common barriers identified by nurses and patients were ambulation and transfers , which were mitigated with the battery-powered device .


A majority ( 79 % ) of those issued a battery-powered device reported no major problems compared with only 14 % of patients issued a standard device ( P < .005 ) .


The dual venous thromboembolism prevention strategies of early mobilization and SCD utilization can be met with the appropriate equipment .


The aim of this study was to evaluate the cost effectiveness of ranibizumab compared with verteporfin photodynamic therapy ( vPDT ) or no treatment ( observation ) in patients with visual impairment due to myopic choroidal neovascularization ( CNV ) .


A Markov model with health states defined by best-corrected visual acuity and a 3-month cycle length was developed .


It had a healthcare provider ( UK National Health Service and personal social services ) perspective , a lifetime time horizon , and was based on 2011 prices ; future costs and health outcomes were discounted at 3.5 % per annum .


Baseline characteristics were based on the phase III RADIANCE ( Ranibizumab and vPDT Evaluation in Myopic CNV ) study , and year 1 health-state transitions were based on this and the VIP ( Verteporfin in Photodynamic Therapy ) study .


Extensive sensitivity analyses tested the robustness of the model .


The lifetime cost of treating myopic CNV with ranibizumab was 12,866 , whereas vPDT and observation were associated with total costs of 14,421 and 8,163 , respectively .


Ranibizumab treatment produced higher cumulative quality-adjusted life-years ( QALYs ; 12.99 ) than vPDT ( 12.60 ) or observation ( 12.45 ) .


Ranibizumab treatment was therefore dominant , with greater health gains and lower overall costs than vPDT .


Ranibizumab was cost effective compared with observation , with an incremental cost-effectiveness ratio of 8,778 / QALY .


In the probabilistic sensitivity analysis , ranibizumab had a 100 % and 88 % probability of being cost effective compared with vPDT and observation , respectively , at a willingness-to-pay threshold of 20,000 / QALY .


This study indicates that ranibizumab therapy is dominant over vPDT for the treatment of visual impairment due to CNV secondary to pathologic myopia in the UK healthcare setting and cost effective compared with observation .


To evaluate the efficacy and safety of combinations of empagliflozin/linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin .


Subjects were randomized to a combination of empagliflozin 25 mg/linagliptin 5 mg ( n = 137 ) , empagliflozin 10 mg/linagliptin 5 mg ( n = 136 ) , empagliflozin 25 mg ( n = 141 ) , empagliflozin 10 mg ( n = 140 ) , or linagliptin 5 mg ( n = 132 ) as add-on to metformin for 52 weeks .


The primary end point was change from baseline in HbA1c at week 24 .


At week 24 , reductions in HbA1c ( mean baseline 7.90-8 .02 % [ 62.8-64 .1 mmol/mol ] ) with empagliflozin/linagliptin were superior to those with empagliflozin or linagliptin alone as add-on to metformin ; adjusted mean ( SE ) changes from baseline were -1.19 % ( 0.06 ) ( -13.1 mmol/mol [ 0.7 ] ) with empagliflozin 25 mg/linagliptin 5 mg , -1.08 % ( 0.06 ) ( -11.8 mmol/mol [ 0.7 ] ) with empagliflozin 10 mg/linagliptin 5 mg , -0.62 % ( 0.06 ) ( -6.8 mmol/mol [ 0.7 ] ) with empagliflozin 25 mg , -0.66 % ( 0.06 ) ( -7.2 mmol/mol [ 0.7 ] ) with empagliflozin 10 mg , and -0.70 % ( 0.06 ) ( -7.6 mmol/mol [ 0.7 ] ) with linagliptin 5 mg ( P < 0.001 for all comparisons ) .


In these groups , respectively , 61.8 , 57.8 , 32.6 , 28.0 , and 36.1 % of subjects with baseline HbA1c 7 % ( 53 mmol/mol ) had HbA1c < 7 % ( < 53 mmol/mol ) at week 24 .


Efficacy was maintained at week 52 .


The proportion of subjects with adverse events ( AEs ) over 52 weeks was similar across treatment arms ( 68.6-73 .0 % ) , with no hypoglycemic AEs requiring assistance .


Combinations of empagliflozin/linagliptin as second-line therapy for 52 weeks significantly reduced HbA1c compared with the individual components and were well tolerated .


Cannabis use is high amongst young people who have recently had their first episode of psychosis , and is associated with worse outcomes .


To date , interventions to reduce cannabis consumption have been largely ineffective , and it has been suggested that longer treatment periods are required .


In a pragmatic single-blind randomized controlled trial 110 participants were randomly allocated to one of three conditions : a brief motivational interviewing and cognitive behavioural therapy ( MI-CBT ) intervention ( up to 12 sessions over 4.5 months ) with standard care from an early intervention service ; a long MI-CBT intervention ( up to 24 sessions over 9 months ) with standard care ; or standard care alone .


The primary outcome was change in cannabis use as measured by Timeline Followback .


Neither the extended nor the brief interventions conferred benefit over standard care in terms of reductions in frequency or amount of cannabis use .


Also the interventions did not result in improvements in the assessed clinical outcomes , including symptoms , functioning , hospital admissions or relapse .


Integrated MI and CBT for people with cannabis use and recent-onset psychosis does not reduce cannabis use or improve clinical outcomes .


These findings are consistent with those in the published literature , and additionally demonstrate that offering a more extended intervention does not confer any advantage .


Many participants were not at an action stage for change and for those not ready to reduce or quit cannabis , targeting associated problems rather than the cannabis use per se may be the best current strategy for mental health services to adopt .


Emerging evidence has suggested that platelet-rich plasma ( PRP ) might be of assistance in the treatment of degenerative conditions of the joints .


The aim of the present study was to compare the use of PRP and hyaluronic acid ( HA ) in the treatment of temporomandibular joint ( TMJ ) osteoarthritis ( OA ) with long-term follow-up data .


Patients meeting the Research Diagnostic Criteria for TMJ-OA were randomly assigned to 1 of 2 study groups that received either PRP or HA .


The outcome variables were maximum nonassisted ( voluntary ) mouth opening ( MVMO ) , joint sounds , and pain index scores .


Other variables , including patient age and gender , were evaluated in relation to the outcomes .


Descriptive and bivariate statistics were computed , and the P value was set at .05 .


A total of 50 patients with TMJ-OA were enrolled in the study ( 29 women and 21 men , age range 31 to 49 years , mean age 38.6 ) .


In group I , 25 patients received 3 injections of 1 mL of PRP .


In group II , 25 patients received 3 injections of 1 mL of low-molecular-weight HA .


Between-group comparisons of the outcome variables over time revealed significant improvements in group II at 1 and 3 months .


At 6 and 12 months , the PRP group exhibited better performance compared with the HA group in terms of the recurrence of pain and joint sounds .


The improvements obtained with the PRP injections in group I were maintained during the follow-up period .


At the end of the follow-up period , the median MVMO in group I was 41.0 mm .


In group II , the median MVMO was 39.0 mm .


PRP performed better than HA acid in the treatment of TMJ-OA during long-term follow-up in terms of pain reduction and increased interincisal distance .


Future studies will focus on the synergistic actions of HA and PRP in the treatment of TMJ-OA .


Intensive insulin therapy for tight glycemic control in critically ill surgical patients has been shown to reduce mortality ; however , intensive insulin therapy is associated with iatrogenic hypoglycemia and increased variability of blood glucose levels .


The incretin glucagon-like peptide-1 ( 7-36 ) amide is both insulinotropic and insulinomimetic and has been suggested as an adjunct to improve glycemic control in critically ill patients .


We hypothesized that the addition of continuous infusion of glucagon-like peptide-1 to intensive insulin therapy would result in better glucose control , reduced requirement of exogenous insulin administration , and fewer hypoglycemic events .


Prospective , randomized , double-blind , placebo-controlled clinical trial .


Surgical or burn ICU .


Eighteen patients who required intensive insulin therapy .


A 72-hour continuous infusion of either glucagon-like peptide-1 ( 1.5 pmol/kg/min ) or normal saline plus intensive insulin therapy .


The glucagon-like peptide-1 cohort ( n = 9 ) and saline cohort ( n = 9 ) were similar in age , Acute Physiology and Chronic Health Evaluation score , and history of diabetes .


Blood glucose levels in the glucagon-like peptide-1 group were better controlled with much less variability .


The coefficient of variation of blood glucose ranged from 7.2 % to 30.4 % in the glucagon-like peptide-1 group and from 19.8 % to 56.8 % in saline group .


The mean blood glucose coefficient of variation for the glucagon-like peptide-1 and saline groups was 18.0 % 2.7 % and 30.3 % 4.0 % ( p = 0.010 ) , respectively .


The 72-hour average insulin infusion rates were 3.37 0.61 and 4.57 1.18 U/hr ( p = not significant ) .


The incidents of hypoglycemia ( 2.78 mmol/L ) in both groups were low ( one in the glucagon-like peptide-1 group , three in the saline group ) .


Glucagon-like peptide-1 ( 7-36 ) amide is a safe and efficacious form of adjunct therapy in patients with hyperglycemia in the surgical ICU setting .


Improved stability of blood glucose is a favorable outcome , which enhances the safety of intensive insulin therapy .


Larger studies of this potentially valuable therapy for glycemic control in the ICU are justified .


In a randomized controlled trial of a preoperative education intervention conducted for Chinese cardiac patients , we observed a greater effect on symptoms of anxiety and depression than that reported with regard to similar interventions in western care settings .


The objective of this qualitative study was to help explain the findings of the trial by exploring Chinese patients ' experience of seeking and receiving information before cardiac surgery .


Semi-structured interviews were conducted with a purposive sample of 20 trial participants before discharge ( ten from the preoperative education group ; ten from the usual care control group ) .


Data were analyzed using a thematic analysis approach .


A total of five themes were generated : the role of reputation and hierarchy ; gaining strength from knowledge ; information as a low priority ; being kept in the dark ; and learning through peer support .


In health care systems where service users are given relatively little information , interventions designed to inform patients about their treatment are likely to have a much greater impact on their psychological health .


Providers of services for patients undergoing cardiac surgery in China should be encouraged to incorporate information giving into routine practice , tailored according to individual need .


To compare two incision angles ( 60 vs 40 ) of mediolateral episiotomy in primiparous Egyptian women , regarding the incidence of anal sphincter injury as well as episiotomy-related pain and dyspareunia .


The current prospective randomized controlled trial ( ClinicalTrials.gov , NCT01930721 ) was conducted at Ain Shams University Maternity Hospital .


Eligible women were randomized into two groups : group 1 included women who had the episiotomy incision made at an angle of 60 to the midline ; and group 2 included women who had the episiotomy incision made at an angle of 40 to the midline .


Primary outcome measures were differences in short-term related pain and rate of third/fourth degree perineal tears .


A total of 330 primiparous women were recruited .


The shortest distance to the outer edge of the anal epithelium was significantly shorter in women of group 2 when compared to that in women of group 1 .


Out of the included 330 women , 13 ( 4 % ) had third/fourth-degree perineal tears ( 4 [ 2.4 % ] in group 1 in contrast to nine [ 5.5 % ] in group 2 ) .


This difference was not significant A 60-angled mediolateral episiotomy was associated with significantly higher rates of moderate/severe episiotomy-related pain post-partum .


The rates of moderate/severe episiotomy-related pain and dyspareunia assessed 6 months post-partum were also higher among women of group 1 , when compared to group 2 ; the latter two differences did not reach statistical significance , however .


When compared to the 40-angled mediolateral episiotomies , 60-angled ones were associated with significantly higher short-term-related pain .


Although they were also associated with lower rate of third/fourth-degree perineal tears and higher rate of long-term related pain and dyspareunia , these differences did not reach a statistically significant level .


A suboptimal level of seasonal influenza vaccination among pregnant minority women is an intractable public health problem , requiring effective message resonance with this population .


We evaluated the effects of randomized exposure to messages which emphasize positive outcomes of vaccination ( `` gain-frame '' ) , or messages which emphasize negative outcomes of forgoing vaccination ( `` loss-frame '' ) .


We also assessed multilevel social and community factors that influence maternal immunization among racially and ethnically diverse populations .


Minority pregnant women in metropolitan Atlanta were enrolled in the longitudinal study and randomized to receive intervention or control messages .


A postpartum questionnaire administered 30 days postpartum evaluated immunization outcomes following baseline message exposure among the study population .


We evaluated key outcomes using bivariate and multivariate analyses .


Neither gain - [ OR = 0.5176 , ( 95 % CI : 0.203,1.322 ) ] nor loss-framed [ OR = 0.5000 , 95 % CI : ( 0.192,1.304 ) ] messages were significantly associated with increased likelihood of immunization during pregnancy .


Significant correlates of seasonal influenza immunization during pregnancy included healthcare provider recommendation [ OR = 3.934 , 95 % CI : ( 1.331,11.627 ) ] , use of hospital-based practices as primary source of prenatal care [ OR = 2.584 , 95 % CI : ( 1.091,6.122 ) ] , and perceived interpersonal support for influenza immunization [ OR = 3.405 , 95 % CI : ( 1.412,8.212 ) ] .


Dissemination of vaccine education messages via healthcare providers , and cultivating support from social networks , will improve seasonal influenza immunization among pregnant minority women .


This randomised clinical trial assessed the effects of a 16-week cognitive remediation programme ( NEUROCOM ) combined with an early intervention service ( EIS ) vs. EIS alone .


One hundred and seventeen patients with first episode psychosis were randomly assigned to 4 months cognitive remediation combined with EIS vs. EIS alone .


Statistical analysis of effect was based on intention to treat .


A total of 98 patients ( 83.8 % ) participated in post-training assessments at 4 months and 92 ( 78.6 % ) in 12-month follow-up assessments .


No effects were found on the primary outcome measure functional capacity .


At the post-training assessment , the intervention group had improved significantly on Rosenberg Self-Esteem Scale ( Cohen 's d = 0.54 , P = 0.01 ) , Positive and Negative Symptoms Scale ( PANSS ) , General Psychopathology Scale ( Cohen 's d = 0.51 , P = 0.05 ) and the verbal learning domain ( Cohen 's d = 0.46 , P = 0.02 ) .


At follow-up assessment , the intervention group retained the significant improvements on the verbal learning domain ( Cohen 's d = 0.58 , P < 0.05 ) .


Furthermore , significant improvements were observed on the working memory domain ( Cohen 's d = 0.56 , P = 0.01 ) and PANSS positive symptoms ( Cohen 's d = 0.44 , P = 0.04 ) , while improvement on the composite score was marginally significant ( Cohen 's d = 0.34 , P = 0.05 ) .


In accordance with other cognitive remediation programmes , this programme demonstrates some immediate and long-term effect on cognitive functioning , symptoms and self-esteem .


In previous studies , we identified two urinary proteomic classifiers , termed HF1 and HF2 , which discriminated subclinical diastolic left ventricular ( LV ) dysfunction from normal .


HF1 and HF2 combine information from 85 and 671 urinary peptides , mainly up - or down-regulated collagen fragments .


We sought to validate these classifiers in a population study .


In 745 people randomly recruited from a Flemish population ( 49.8 years ; 51.3 % women ) , we measured early and late diastolic peak velocities of mitral inflow ( E and A ) and mitral annular velocities ( e ' and a ' ) by conventional and tissue Doppler echocardiography , and the urinary proteome by capillary electrophoresis coupled with mass spectrometry .


In the analyses adjusted for sex , age , body mass index , blood pressure , heart rate , LV mass index and intake of medications , we expressed effect sizes per 1-SD increment in the classifiers .


HF1 was associated with 0.204 cm/s lower e ' peak velocity ( 95 % confidence interval , 0.057-0 .351 ; p = 0.007 ) and 0.145 higher E/e ' ratio ( 0.023-0 .268 ; p = 0.020 ) , while HF2 was associated with a 0.174 higher E/e ' ratio ( 0.046-0 .302 ; p = 0.008 ) .


According to published definitions , 67 ( 9.0 % ) participants had impaired LV relaxation and 96 ( 12.9 % ) had elevated LV filling pressure .


The odds of impaired relaxation associated with HF1 was 1.38 ( 1.01-1 .88 ; p = 0.043 ) and that of increased LV filling pressure associated with HF2 was 1.38 ( 1.00-1 .90 ; p = 0.052 ) .


In a general population , the urinary proteome correlated with diastolic LV dysfunction , proving its utility for early diagnosis of this condition .


To evaluate the pharmacokinetics and thermal and mechanical antinociceptive effects of a fentanyl constant rate infusion ( CRI ) in conscious cats .


8 healthy adult cats .


At a 14-day interval , 7 cats received a loading dose ( LD ) of fentanyl ( 5 g/kg , IV [ administered at 0 hours ] ) followed by fentanyl infusion ( 5 g/kg/h , IV ) for 2 hours or similar administrations of equivalent volumes of 0.9 % saline ( NaCl ) solution .


One cat received only the fentanyl treatment .


For both treatments , sedation and adverse events were evaluated and mechanical threshold ( MT ) and thermal threshold ( TT ) testing was performed prior to ( baseline ) and at predetermined times up to 26 hours after LD administration ; plasma fentanyl concentrations were determined at similar times when the cats received fentanyl .


Fentanyl induced mild sedation during the infusion .


The only adverse effect associated with fentanyl LD administration was profuse salivation ( 1 cat ) .


Saline solution administration did not significantly change MT or TT over time .


For the duration of the CRI , MT and TT differed significantly between treatments , except for TT 1 hour after LD administration .


For the fentanyl treatment , MT and TT were significantly higher than baseline at 0.25 to 0.75 hours and at 0.25 to 1 hour , respectively .


During the fentanyl CRI , mean SD plasma fentanyl concentration decreased from 4.41 1.86 ng/mL to 2.99 1.28 ng/mL and was correlated with antinociception ; plasma concentrations < 1.33 0.30 ng/mL were not associated with antinociception .


Fentanyl CRI ( 5 g/kg/h ) induced mechanical and thermal antinociception in cats .


To investigate the performance of the MI Sxscore in a multicentre randomised trial of patients undergoing primary percutaneous coronary intervention ( PPCI ) .


The MI Sxscore was prospectively determined among 1132 STEMI patients enrolled into the COMFORTABLE AMI trial , which randomised patients to treatment with bare-metal ( BMS ) or biolimus-eluting ( BES ) stents .


Patient - ( death , myocardial infarction , any revascularisation ) and device-oriented ( cardiac death , target-vessel MI , target lesion revascularisation ) major adverse cardiac events ( MACEs ) were compared across MI Sxscore tertiles and according to stent type .


The median MI SXscore was 14 ( IQR : 9-21 ) .


Patients were divided into tertiles of Sxscorelow ( 10 ) , Sxscoreintermediate ( 11-18 ) and Sxscorehigh ( 19 ) .


At 1 year , patient-oriented MACE occurred in 15 % of the Sxscorehigh , 9 % of the Sxscoreintermediate and 5 % of the Sxscorelow tertiles ( p < 0.001 ) , whereas device-oriented MACE occurred in 8 % of the Sxscorehigh , 6 % of the Sxscoreintermediate and 4 % of the Sxscorelow tertiles ( p = 0.03 ) .


Addition of the MI Sxscore to the TIMI risk score improved prediction of patient - ( c-statistic value increase from 0.63 to 0.69 ) and device-oriented MACEs ( c-statistic value increase from 0.65 to 0.70 ) .


Differences in the risk for device-oriented MACE between BMS and BES were evident among Sxscorehigh ( 13 % vs. 4 % HR 0.33 ( 0.15-0 .74 ) , p = 0.007 rather than those in Sxscorelow : 4 % vs. 3 % HR 0.68 ( 0.24-1 .97 ) , p = 0.48 ) tertiles .


The MI Sxscore allows risk stratification of patient - and device-oriented MACEs among patients undergoing PPCI .


The addition of the MI Sxscore to the TIMI risk score is of incremental prognostic value among patients undergoing PPCI for treatment of STEMI .


To compare the efficacy and tolerance of sodium picosulphate/magnesium citrate ( PMC ) and polyethylene glycol ( PEG ) in a single or split dose regimen for colonoscopy bowel preparation .


A prospective , randomized , endoscopist-blinded , multicenter study .


The patients were randomly assigned to receive PMC ( PMC4/0 ) or PEG ( PEG4/0 ) in a single dose 4L day before colonoscopy or a split dose 2 +2 L PMC ( PMC2/2 ) or 3 +1 L PEG ( PEG3/1 ) one day before and in the morning before the colonoscopy .


Each patient was interviewed to determine his/her subjective tolerance of the preparation before the procedure .


The quality of bowel cleansing was assessed in a blinded test performed by multiple endoscopists using the Aronchick scale .


A total of 600 patients were enrolled , 88.2 % were included in the analysis .


Satisfactory bowel cleansing ( Aronchick score 1 and 2 ) was significantly more frequent when a split dose was used irrespective of the solution type ( 81.6 % PMC2/2 , 87.3 % PEG3/1 vs. 73.0 % PEG4/0 , p = 0.024 ) .


In single dose regimens , PMC performed better than PEG ( 82.6 % vs. 73.0 % ) .


Single or split dose PMC preparations were comparable .


A PMC based solution was generally better tolerated than PEG regardless of the regimen used ( p < 0.001 ) .


Nausea was reported mostly after the 4L PEG ( 32.8 % , p < 0.001 ) , incontinence after a split PMC dose ( 34.4 % , p = 0.002 ) , and bloating after the 4L PEG ( 38.0 % , p < 0.001 ) .


There was no significant difference in the prevalence of vomiting .


Colonic preparation with PMC yields similar results as a split PEG dose , regardless of whether PMC is administered in single or separate doses .


PMC is better tolerated than any PEG-based preparation .


A single 4L PEG the day before the colonoscopy is less appropriate for bowel cleansing .


Chronic obstructive pulmonary disease ( COPD ) is a heterogeneous disease and likely includes a subgroup that is biologically comparable to asthma .


Studying asthma-associated gene expression changes in COPD could add insight into COPD pathogenesis and reveal biomarkers that predict a favorable response to corticosteroids .


To determine whether asthma-associated gene signatures are increased in COPD and associated with asthma-related features .


We compared disease-associated airway epithelial gene expression alterations in an asthma cohort ( n = 105 ) and two COPD cohorts ( n = 237 , 171 ) .


The T helper type 2 ( Th2 ) signature ( T2S ) score , a gene expression metric induced in Th2-high asthma , was evaluated in these COPD cohorts .


The T2S score was correlated with asthma-related features and response to corticosteroids in COPD in a randomized , placebo-controlled trial , the Groningen and Leiden Universities study of Corticosteroids in Obstructive Lung Disease ( GLUCOLD ; n = 89 ) .


The 200 genes most differentially expressed in asthma versus healthy control subjects were enriched among genes associated with more severe airflow obstruction in these COPD cohorts ( P < 0.001 ) , suggesting significant gene expression overlap .


A higher T2S score was associated with decreased lung function ( P < 0.001 ) , but not asthma history , in both COPD cohorts .


Higher T2S scores correlated with increased airway wall eosinophil counts ( P = 0.003 ) , blood eosinophil percentage ( P = 0.03 ) , bronchodilator reversibility ( P = 0.01 ) , and improvement in hyperinflation after corticosteroid treatment ( P = 0.019 ) in GLUCOLD .


These data identify airway gene expression alterations that can co-occur in asthma and COPD .


The association of the T2S score with increased severity and `` asthma-like '' features ( including a favorable corticosteroid response ) in COPD suggests that Th2 inflammation is important in a COPD subset that can not be identified by clinical history of asthma .


To compare the efficacy and safety of oral paracetamol and oral ibuprofen for the pharmacological closure of patent ductus arteriosus ( PDA ) in preterm infants .


This prospective , randomized , controlled study enrolled 90 preterm infants with gestational age 30 weeks , birthweight 1250 g , and postnatal age 48 to 96 hours who had echocardiographically confirmed significant PDA .


Each enrolled patient received either oral paracetamol ( 15 mg/kg every 6 hours for 3 days ) or oral ibuprofen ( initial dose of 10 mg/kg , followed by 5 mg/kg at 24 and 48 hours ) .


Spontaneous closure rate for the entire study group was 54 % .


After the first course of treatment , the PDA closed in 31 ( 77.5 % ) of the patients assigned to the oral ibuprofen group vs 29 ( 72.5 % ) of those enrolled in the oral paracetamol group ( P = .6 ) .


The reopening rate was higher in the paracetamol group than in the ibuprofen group , but the reopening rates were not statistically different ( 24.1 % [ 7 of 29 ] vs 16.1 % [ 5 of 31 ] ; P = .43 ) .


The cumulative closure rates after the second course of drugs were high in both groups .


Only 2 patient ( 2.5 % ) in the paracetamol group and 3 patients ( 5 % ) in the ibuprofen group required surgical ligation .


This randomized , controlled clinical study compared oral paracetamol with ibuprofen in preterm infants and demonstrated that paracetamol may be a medical alternative in the management of PDA .


Select cases of intractable obsessive-compulsive disorder ( OCD ) have undergone neurosurgical ablation for more than half a century .


However , to our knowledge , there have been no randomized clinical trials of such procedures for the treatment of any psychiatric disorder .


To determine the efficacy and safety of a radiosurgery ( gamma ventral capsulotomy [ GVC ] ) for intractable OCD .


In a double-blind , placebo-controlled , randomized clinical trial , 16 patients with intractable OCD were randomized to active ( n = 8 ) or sham ( n = 8 ) GVC .


Blinding was maintained for 12 months .


After unblinding , sham-group patients were offered active GVC .


Patients randomized to active GVC had 2 distinct isocenters on each side irradiated at the ventral border of the anterior limb of the internal capsule .


The patients randomized to sham GVC received simulated radiosurgery using the same equipment .


Scores on the Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) and the Clinical Global Impression-Improvement ( CGI-I ) Scale .


Response was defined as a 35 % or greater reduction in Y-BOCS severity and `` improved '' or `` much improved '' CGI-I ratings .


Three of 8 patients randomized to active treatment responded at 12 months , while none of the 8 sham-GVC patients responded ( absolute risk reduction , 0.375 ; 95 % CI , 0.04-0 .71 ) .


At 12 months , OCD symptom improvement was significantly higher in the active-GVC group than in the sham group ( Y-BOCS , P = .046 ; Dimensional Y-BOCS , P = .01 ) .


At 54 months , 2 additional patients in the active group had become responders .


Of the 4 sham-GVC patients who later received active GVC , 2 responded by post-GVC month 12 .


The most serious adverse event was an asymptomatic radiation-induced cyst in 1 patient .


Gamma ventral capsulotomy benefitted patients with otherwise intractable OCD and thus appears to be an alternative to deep-brain stimulation in selected cases .


Given the risks inherent in any psychiatric neurosurgery , such procedures should be conducted at specialized centers .


clinicaltrials.gov Identifier : NCT01004302 .


Vitamin K-dependent factors protect against vascular and renovascular calcification , and vitamin K antagonists may be associated with a decreased glomerular filtration rate ( GFR ) .


This study analyzed changes in GFR during long-term treatment with warfarin or dabigatran etexilate ( DE ) in patients enrolled in the RE-LY ( Randomized Evaluation of Long Term Anticoagulation Therapy ) trial .


Of the 18,113 patients in the RE-LY study randomized to receive DE ( 110 mg or 150 mg twice daily ) or warfarin , 16,490 patients with atrial fibrillation had creatinine values measured at baseline and at least 1 follow-up visit .


Changes in GFR for up to 30 months were evaluated .


GFR declined in all treatment groups .


After an average of 30 months , the mean SE decline in GFR was significantly greater with warfarin ( -3.68 0.24 ml/min ) compared with DE 110 mg ( -2.57 0.24 ml/min ; p = 0.0009 vs. warfarin ) and DE 150 mg ( -2.46 0.23 ml/min ; p = 0.0002 vs. warfarin ) .


A decrease in GFR > 25 % was less likely with DE 110 mg ( hazard ratio : 0.81 [ 95 % confidence interval : 0.69 to 0.96 ] ; p = 0.017 ) or DE 150 mg ( hazard ratio : 0.79 [ 95 % confidence interval : 0.68 to 0.93 ] ; p = 0.0056 ) than with warfarin in the observation period > 18 months .


Patients with poor international normalized ratio control ( i.e. , time in therapeutic range < 65 % ) exhibited a faster decline in GFR .


A more pronounced decline in GFR was associated with previous warfarin use and with the presence of diabetes .


Patients with atrial fibrillation receiving oral anticoagulation exhibited a decline in renal function that was greater in those taking warfarin versus DE , and it was amplified by diabetes and previous vitamin K antagonist use .


( Randomized Evaluation of Long Term Anticoagulant Therapy [ RE-LY ] With Dabigatran Etexilate ; NCT00262600 ) .


Combination antiretroviral therapy ( ART ) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4 cell counts .


We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda .


Randomized clinical trial .


We performed a planned secondary analysis comparing viral load suppression ( HIV-1 RNA 400 copies/ml ) , safety , and HIV transmission to infants in a trial designed to test the hypothesis that lopinavir/ritonavir versus efavirenz-based ART would reduce placental malaria ( PROMOTE , ClinicalTrials.gov , NCT00993031 ) .


HIV-infected , ART-naive pregnant women at 12-28 weeks gestation and any CD4 cell count were randomized .


ART was provided and participants were counseled to breastfeed for 1 year postpartum .


The median age of the 389 study participants was 29 years ; median CD4 cell count was 370 cells/l .


At delivery , virologic suppression was 97.6 % in the efavirenz arm and 86.0 % in the lopinavir/ritonavir arm ( P < 0.001 ) .


At 48 weeks postpartum , 91.0 % of women on efavirenz and 88.4 % on lopinavir/ritonavir had viral suppression ( P = 0.49 ) .


Grade 1 or 2 gastrointestinal adverse events were higher among women on lopinavir/ritonavir versus efavirenz .


Only two infants acquired HIV ( both in the lopinavir/ritonavir arm ) , and HIV-free infant survival was similar between study arms : 92.9 % ( lopinavir/ritonavir ) versus 97.2 % ( efavirenz ) ( P = 0.10 ) .


Virologic suppression at delivery was higher with an efavirenz versus lopinavir/ritonavir-based regimen .


However , women in both arms achieved high levels of virologic suppression through 1 year postpartum and the risk of transmission to infants was low .


The safety and efficacy of sirukumab , an anti-interleukin-6 ( IL-6 ) monoclonal antibody , were evaluated in a 2-part , placebo-controlled phase II study of patients with active rheumatoid arthritis ( RA ) despite methotrexate therapy .


In Part A ( proof-of-concept ) , 36 patients were randomised to placebo or sirukumab 100mg every 2weeks ( q2w ) through week 10 , with crossover treatment during weeks 12-22 .


In Part B ( dose finding ) , 151 patients were randomised to sirukumab ( 100mg q2w , 100mg q4w , 50mg q4w , or 25mg q4w ) through week 24 , or placebo through week 10 with crossover to sirukumab 100mg q2w ( weeks 12-24 ) .


The proportion of patients with an American College of Rheumatology 50 ( ACR50 ) response and the change from baseline in the 28-joint count disease activity score using C-reactive protein ( DAS28-CRP ) were determined .


Safety was evaluated through week 38 in both parts .


The primary endpoint ( ACR50 at week 12 in Part B ) was achieved only with sirukumab 100mg q2w versus placebo ( 26.7 % vs 3.3 % ; p = 0.026 ) .


Greater improvements in mean DAS28-CRP at week 12 were observed with sirukumab 100mg q2w versus placebo in Parts A ( 2.1 vs 0.6 , p < 0.001 ) and B ( 2.2 vs 1.1 ; p < 0.001 ) .


The incidence of adverse events ( AEs ) was similar for sirukumab-treated and placebo-treated patients through week 12 in Part A ( 70.6 % and 63.2 % , respectively ) and B ( 67.8 % and 66.7 % , respectively ) .


Infections were the most common type of AE ; one death occurred ( Part B , sirukumab 100mg q2w , brain aneurysm ) .


Sirukumab-treated patients experienced improvements in the signs/symptoms of RA .


Safety results through 38weeks were consistent with other IL-6 inhibitors .


NCT00718718 .


To evaluate the validity of the Yo-Yo Intermittent Recovery Test Level 1 ( YYIR1 ) for the direct assessment and the indirect estimation of maximal oxygen consumption ( VO2max ) in female soccer players compared with a maximal laboratory treadmill test ( LTT ) .


Eighteen female soccer players ( 21.5 3.4 y , 165.6 7.5 cm , 63.3 7.4 kg ; mean SD ) completed an LTT and a YYIR1 in random order ( 1 wk apart ) .


Their VO2max was directly measured via portable spirometry during both tests and indirectly estimated from a published non-gender-specific formula ( YYIR1-F1 ) .


The measured VO2max values in LTT and YYIR1 were 55.0 5.3 and 49.9 4.9 mL kg-1 min-1 , respectively , while the estimated VO2max values from YYIR1-F1 corresponded to 45.2 3.4 mL kg-1 min-1 .


Large positive correlations between the VO2max values from YYIR1 and LTT ( r = .83 , P < .001 , 90 % confidence interval = .64 -.92 ) and YYIR1-F1 and LTT ( r = .67 , P = .002 , .37 -.84 ) were found .


However , the YYIR1 significantly underestimated players ' VO2max by 9.4 % compared with LTT ( P < .001 ) with Bland-Altman 95 % limits of agreement ranging from -20.0 % to 1.4 % .


A significant underestimation from the YYIR1-F1 ( P < .001 ) was also identified ( 17.8 % with Bland-Altman 95 % limits of agreement ranging from -31.8 % to -3.8 % ) .


The YYIR1 and YYIR1-F1 are not accurate methods for the direct assessment or indirect estimation of VO2max in female soccer players .


The YYIR1-F1 lacks gender specificity , which might have been the reason for its larger error .


An improper balance of regulatory/effector T ( Treg/Teff ) cells is central to the development of autoimmune diseases , including type 1 diabetes .


We previously showed that low-dose interleukin 2 ( IL2 ) induced Treg cell expansion and activation and clinical improvement in patients with hepatitis-C-virus-induced vasculitis .


We aimed to establish which low doses of IL2 would be safe and induce Treg cells in patients with type 1 diabetes , considering that : ( 1 ) type 1 diabetes might be linked to alteration of the IL2/IL2R activation pathway ; ( 2 ) activation of pathogenic Teff cells by IL2 could exacerbate disease ; and ( 3 ) the safety of low-dose IL2 is not known in type 1 diabetes .


This was a single-centre phase 1/2 study .


24 adult patients ( 18-55 years ) with established insulin-dependent type 1 diabetes and at least one diabetes-related autoantibody were enrolled and randomly assigned ( in a 1:1:1:1 ratio , by computer-generated randomisation list , with block size four ) to placebo or IL2 at 0.33 MIU/day , 1 MIU/day , or 3 MIU/day for a 5-day course and were followed up for 60 days .


All investigators and participants were masked to assignment .


The primary outcome was change in Treg cells , measured by flow cytometry , and expressed as a percentage of CD4 + T cells , from day 1 to day 60 .


This trial is registered with ClinicalTrials.gov , number NCT01353833 .


Six patients were assigned to each group between June 1 , 2011 , and Feb 3 , 2012 .


IL2 was well tolerated at all doses , with no serious adverse events .


However , there was a dose-response association for non-serious adverse events during the treatment phase ( days 1-6 ) ; one patient in the placebo group , three patients in the 0.33 MIU group , five patients in the 1 MIU group , and six patients in the 3 MIU group had non-serious adverse events .


The most common adverse events in the treatment phase were injection-site reaction ( no patients with placebo vs three patients with 0.33 MIU and 1 MIU vs two patients with 3 MIU ) and influenza-like syndrome ( no patients with placebo vs one patient with 0.33 MIU and 1 MIU vs four patients with 3 MIU ) .


After the treatment phase , adverse events did not differ between groups .


IL2 did not induce deleterious changes in glucose-metabolism variables .


IL2 induced a dose-dependent increase in the proportion of Treg cells , significant at all doses compared with placebo ( placebo mean increase 0.5 % [ SD 0.4 ] ; 0.33 MIU 2.8 % [ 1.2 ] , p = 0.0039 ; 1 MIU 3.9 % [ 1.8 ] , p = 0.0039 ; 3 MIU 4.8 % [ 1.9 ] p = 0.0039 ) .


We have defined a well-tolerated and immunologically effective dose range of IL2 for application to type 1 diabetes therapy and prevention , which could be relevant to other disorders in which a Treg cell increase would be desirable .


The objective of this research was to compare the effects of different causal attributions for overweight and obesity , among individuals with overweight and obesity , on weight-related beliefs , stigmatising attitudes and policy support .


In Study 1 , an online sample of 95 US adults rated the extent to which they believed various factors caused their own weight status .


In Study 2 , 125 US adults read one of three randomly assigned online passages attributing obesity to personal responsibility , biology , or the ` food environment . '


All participants in both studies were overweight or obese .


All participants reported beliefs about weight loss , weight-stigmatising attitudes , and support for obesity-related policies .


In Study 1 , biological attributions were associated with low weight-malleability beliefs and blame , high policy support , but high internalised weight bias .


` Food environment ' attributions were not associated with any outcomes , while ` personal responsibility ' attributions were associated with high prejudice and blame .


In Study 2 , participants who received information about the food environment reported greater support for food-related policies and greater self-efficacy to lose weight .


Emphasising the role of the food environment in causing obesity may promote food policy support and health behaviours without imposing the negative consequences associated with other attributions .


The aim of this study was to evaluate the impact of Quality and Outcomes Framework ( QOF ) , a major pay-for-performance programme in the United Kingdom , on prescribing of long-acting reversible contraceptives ( LARC ) in primary care .


Negative binomial interrupted time series analysis using practice level prescribing data from April 2007 to March 2012 .


The main outcome measure was the prescribing rate of long-acting reversible contraceptives ( LARC ) , including hormonal and non hormonal intrauterine devices and systems ( IUDs and IUSs ) , injectable contraceptives and hormonal implants .


Prescribing rates of Long-Acting Reversible Contraception ( LARC ) were stable before the introduction of contraceptive targets to the QOF and increased afterwards by 4 % annually ( rate ratios = 1.04 , 95 % CI = 1.03 , 1.06 ) .


The increase in LARC prescribing was mainly driven by increases in injectables ( increased by 6 % annually ) , which was the most commonly prescribed LARC method .


Of other types of LARC , the QOF indicator was associated with a step increase of 20 % in implant prescribing ( RR = 1.20 , 95 % CI = 1.09 , 1.32 ) .


This change is equivalent to an additional 110 thousand women being prescribed with LARC had QOF points not been introduced .


Pay for performance incentives for contraceptive counselling in primary care with women seeking contraceptive advice has increased uptake of LARC methods .


To investigate the efficacy and safety of sedation with dexmedetomidine in upper gastrointestinal endoscopy .


Patients with ASA physical status I-II undergoing elective upper gastrointestinal endoscopy were randomly allocated to receive dexmedetomidine or midazolam for conscious sedation .


Continuous peripheral oxygen saturation ( SpO2 ) , heart rate , mean arterial pressure ( MAP ) , Ramsay Sedation Scale ( RSS ) and numeric rating scale pain scores were recorded before , during and after the procedure .


Patients completed a post-procedure satisfaction questionnaire .


Patients in the midazolam group ( n = 30 ) experienced a significant decrease in MAP during sedation compared with pre-sedation values .


Patients in the dexmedetomidine group ( n = 30 ) had significantly higher SpO2 and RSS scores during sedation than those in the midazolam group .


Overall satisfaction was higher in the dexmedetomidine group than the midazolam group .


There were no clinically significant complications in either group .


Dexmedetomidine has a good safety profile and is an effective sedative for use in upper gastrointestinal endoscopy .


To evaluate the sedation and analgesia power and security of sufentanil in intensive care unit ( ICU ) , and to compare the effect with fentanyl .


A multicenter randomized controlled trial was conducted .


Critical adult patients in ICU from 11 hospitals in Henan Province from June 2011 to January 2012 who needed analgesia based sedation were enrolled .


These patients were randomly divided into two groups with 300 cases in each group using the envelope method according to the hospital number and time sequence number of inclusion .


Exclusion criteria included the time of analgesia duration < 48 hours and who were under continuous renal replacement therapy ( CRRT ) treatment during analgesia .


544 cases were enrolled finally , and there were 282 cases in sufentanil group and 262 in fentanyl group .


Before using the drug , there was no statistically significant difference in age , body weight , acute physiology and chronic health evaluation II ( APACHEII ) score , Glasgow coma scale ( GCS ) between sufentanil group and fentanyl group , and were comparable .


The goal of analgesia was faces pain scale ( FPS ) 2 .


If the dosage of sufentanil and fentanyl exceeded the upper limited dose ( sufentanil 0.3 gkg ( -1 ) h ( -1 ) , fentanyl 2 gkg ( -1 ) h ( -1 ) ) but FPS could not meet ( still > 2 ) , and maintained the upper limited doses of sufentanil and fentanyl and added midazolam , and FPS2 or Ramsay 3 could meet the standard .


The analgesia duration of all cases was 48-168 hours .


Related data were collected for statistical analysis .


( 1 ) Compared with the data before the analgesia , the mean arterial pressure ( MAP ) of sufentanil analgesia after analgesia at different time points were significantly decreased ( F = 6.061 , P < 0.001 ) and closed to the normal level , FPS at different time point score were decreased significantly after analgesia ( F = 259.389 , P < 0.001 ) , and the changes in pulse oxygen saturation ( SpO ( 2 ) ) , respiratory rate and pulse were not found .


( 2 ) Compared with before the analgesia , the white blood cell count ( WBC ) , neutrophil percentage ( N ) , platelet count ( PLT ) , aspartate transaminase ( AST ) , creatinine ( Cr ) , arterial partial pressure of carbon dioxide ( PaCO ( 2 ) ) , blood lactic acid , blood sugar , C-reactive protein ( CRP ) were markedly reduced after sufentanil analgesia ( WBC : 10.8 4.2 10 ( 9 ) / L vs. 14.2 11.510 ( 9 ) / L , F = 49.879 , P < 0.001 ; N : 0.806 0.104 vs. 0.815 0.128 , F = 5.768 , P = 0.017 ; PLT : 160.4 77.0 10 ( 9 ) / L vs. 166.1 89.010 ( 9 ) / L , F = 6.568 , P = 0.011 ; AST : 61.3 10.1 U/L vs. 90.9 26.9 U/L , F = 6.706 , P = 0.010 ; Cr : 86.7 71.8 mol/L vs. 119.6 56.0 mol/L , F = 30.303 , P < 0.001 ; PaCO ( 2 ) : 39.4 7.2 mmHg vs. 41.7 22.6 mmHg , F = 4.389 , P = 0.037 ; blood lactic acid : 1.9 1.2 mmol/L vs. 2.7 2.5 mmol/L , F = 4.883 , P = 0.028 ; blood sugar : 8.0 5.4 mmol/L vs. 9.7 7.6 mmol/L , F = 9.724 , P = 0.002 ; CRP : 64.8 20.7 mg/L vs. 114.0 55.9 mg/L , F = 4.883 , P = 0.028 ) .


But there were no statistically significant differences in red blood cell count ( RBC ) , prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) , fibrinogen ( FIB ) , thrombin time ( TT ) , alanine aminotransferase ( ALT ) , total bilirubin ( TBil ) , albumin ( ALB ) , total protein ( TP ) blood urea nitrogen ( BUN ) , and arterial partial pressure of oxygen ( PaO ( 2 ) ) before and after sufentanil analgesia ( all P > 0.05 ) .


( 3 ) There was no statistically significant difference in effectiveness of sufentanil and five times dose of fentanyl ( P > 0.05 ) .


There was no statistically significant difference in the proportion of sedative drugs midazolam usage [ 18.4 % ( 52/282 ) vs. 24.8 % ( 65/262 ) , ( 2 ) = 1.151 , P = 0.283 ] and the rate of analgesia success [ 44.3 % ( 125/282 ) vs. 48.9 % ( 128/262 ) , ( 2 ) = 0.571 , P = 0.450 ] and analgesia success [ 16.3 % ( 46/282 ) vs. 15.3 % ( 40/262 ) , ( 2 ) = 0.066 , P = 0.798 ] between sufentanil and fentanyl group .


( 4 ) Comparison of adverse reactions : the incidence of hypotension in sufentanil group was significantly lower than that in fentanyl group [ 3.2 % ( 9/282 ) vs. 6.9 % ( 18/262 ) , ( 2 ) = 3.900 , P = 0.048 ] , and other common adverse reactions , such as respiratory depression/pause , nausea/vomiting and dizziness , pruritus , allergy , slow heart beat ( bradycardia ) and metabolic reactions had no statistically significant difference .


Addiction or tetanus of skeletal muscles was not found in both groups .


Compared with fentanyl , the analgesia efficacy of sufentanil is stronger .


Sufentanil has less physiological interference and lower incidence of adverse reactions for ICU patients .


After 9/11/2001 , most FDNY workers had persistent lung function decline but some exposed workers recovered .


We hypothesized that the protease/anti-protease balance in serum soon after exposure predicts subsequent recovery .


We performed a nested case-control study measuring biomarkers in serum drawn before 3/2002 and subsequent forced expiratory volume at one second ( FEV1 ) on repeat spirometry before 3/2008 .


Serum was assayed for matrix metalloproteinases ( MMP-1 ,2,3,7,8,9,12 and 13 ) and tissue inhibitors of metalloproteinases ( TIMP-1 ,2,3,4 ) .


The representative sub-cohort defined analyte distribution and a concentration above 75th percentile defined elevated biomarker expression .


An FEV1 one standard deviation above the mean defined resistance to airway injury .


Logistic regression was adjusted for pre-9 / 11 FEV1 , BMI , age and exposure intensity modeled the association between elevated biomarker expression and above average FEV1 .


FEV1 in cases and controls declined 10 % of after 9/11/2001 .


Cases subsequently returned to 99 % of their pre-exposure FEV1 while decline persisted in controls .


Elevated TIMP-1 and MMP-2 increased the odds of resistance by 5.4 and 4.2 fold while elevated MMP-1 decreased it by 0.27 fold .


Resistant cases displayed healing , returning to 99 % of pre-exposure values .


High TIMP-1 and MMP-2 predict healing .


MMP/TIMP balance reflects independent pathways to airway injury and repair after WTC exposure .


Postoperative shivering is a frequent complication of surgery in developing countries and there is no satisfying method to treat it , letalone to cure it .


We studied whether intravenous amino acid ( AA ) infusion can cure postoperative shivering in the postanesthesia care unit .


Sixty postanesthesia care unit patients with shivering grade 2 or higher and tympanic temperature < 36C received randomly either infusion of Novamin 18 AAs ( 2 mL/kg/h ) , pethidine ( 0.5 mg/kg ) , or tramadol ( 1 mg/kg ) .


Tympanic temperature , shivering grade , and thermal comfort were assessed every 5min for 60min .


Blood glucose and lactic acid concentrations were measured before and after treatment .


Postoperative nausea and vomiting were also recorded .


Shivering stopped within 5min in the pethidine and tramadol groups versus 90 % stopped within 15min in AA group .


There were five cases of reshivering in the tramadol group versus none in the AA or pethidine groups .


Tympanic temperature increased slowly in all patients but increased significantly faster in the AA group .


Thermal comfort improved significantly faster in the AA group versus the other two groups , thermal comfort was significantly higher in the tramadol versus the pethidine group 35min .


Blood glucose concentration in AA group increased to 135.189.18 mg/dL .


There were some cases of nausea and vomiting in pethidine and tramadol groups but none in the AA group .


Novamin infusion can stop postoperative shivering and alleviates hypothermia and improves thermal comfort more effectively than tramadol and pethidine with less nausea and vomiting and causes a clinically acceptable blood glucose increase with no reshivering episodes .


Inflammation is one of the main contributory factors to the etiopathogenesis of multiple sclerosis ( MS ) .


Dietary interventions with Lipia citriadora ( lemon verbena ) extracts have been proved to be effective in the prevention of inflammatory diseases .


The aim of this study is to evaluate the effect of lemon verbena supplementation in pro- and anti- inflammatory serum biomarkers of patients with different clinical subtypes of multiple sclerosis .


The effect of lemon verbena supplementation ( 10 % w/w verbascoside ) was evaluated in a randomized , double-blinded placebo-controlled study with 30 participants classified in relapsing-remitting ( n = 10 ) , primary progressive ( n = 5 ) and secondary progressive ( n = 15 ) MS presentations .


Serum cytokine and C reactive protein levels were assessed in intervention and control groups for each MS clinical subtype after 28 days of dietary supplementation .


Serum levels of C reactive protein and 8 cytokines / inflammatory ( IFN - , IL-12 , IL-23 , IL-6 , TNF - , TGF - , IL-4 and IL-10 ) markers were studied .


Secondary progressive MS - supplemented patients showed C reactive protein concentrations significantly lower compared to the placebo group ( p.


Most diabetic and hypertensive patients , principally the elderly , do not achieve adequate disease control and consume 5 % -15 % of annual health care budgets .


Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension .


To evaluate the economic cost and the incremental cost-effectiveness ratio ( ICER ) per quality-adjusted life-year ( QALY ) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country .


A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group ( n = 100 ) and an intervention group ( n = 100 ) .


The control group received the usual care offered by the Primary Health Care Unit ( medical and nurse consultations ) .


The intervention group received the usual care plus a pharmaceutical care intervention .


The intervention and control groups were compared with regard to the direct costs of health services ( i.e. , general practitioner , specialist , nurse , and pharmacist appointments ; emergency room visits ; and drug therapy costs ) and the ICER per QALY .


These evaluations used the health system perspective .


No statistically significant difference was found between the intervention and control groups in total direct health care costs ( $ 281.97 $ 49.73 per patient vs. $ 212.28 $ 43.49 per patient , respectively ; P = 0.089 ) ; pharmaceutical care added incremental costs of $ 69.60 ( $ 7.90 ) per patient .


The ICER per QALY was $ 53.50 ( 95 % CI = $ 51.60 - $ 54.00 ; monetary amounts are given in U.S. dollars ) .


Every clinical parameter evaluated improved for the pharmaceutical care group , whereas these clinical parameters remained unchanged in the usual care group .


The difference in differences ( DID ) tests indicated that for each clinical parameter , the patients in the intervention group improved more from pre to post than the control group ( P < 0.001 ) .


While pharmaceutical care did not significantly increase total direct health care costs , significantly improved health outcomes were seen .


The mean ICER per QALY gained suggests a favorable cost-effectiveness .


One important public health issue associated with opioid use today is the risk of hepatitis C ( HCV ) infection .


Although methadone maintenance may help to decrease HCV-related risk practices , HCV risk behaviors persist and are strongly associated with specific substance use patterns , mental status and social context .


The ANRS-Methaville study gave us the opportunity to better disentangle the different relationships between these various factors and HCV risk practices .


The ANRS-Methaville multisite randomized trial was designed to assess the feasibility of initiating methadone in primary care by comparing it with methadone initiation in specialized centers .


This study recruited 195 participants initiating methadone maintenance and followed up for 12months .


Longitudinal data from this trial was used to acquire a greater understanding of HCV risk practices and their pattern of correlates in this population .


We selected 176 patients who had data on HCV risk practices at M0 and M12 , accounting for 312 visits .


HCV risk practices were defined as follows : sharing needles or syringes , sharing drug paraphernalia , getting a tattoo or having a piercing in a non-professional context , sharing toiletry items .


To identify factors associated with HCV risk practices , we performed a mixed logistic regression analysis .


HCV risk practices were reported by 19 % and 15 % of participants at baseline and M12 , respectively .


After adjustment for age , cocaine use and alcohol dependence as well as suicidal risk , living in a couple with a non-drug user and in a couple with a drug user were both independent predictors of HCV risk practices ( OR [ CI95 % ] = 4.16 [ 1.42-12 .12 ] ; OR [ CI95 % ] = 9.85 [ 3.13-31 .06 ] , respectively ) .


Identifying individuals at risk of HCV transmission during methadone treatment such as stimulant users , alcohol dependent individuals , and those at suicidal risk is necessary to optimize response to treatment .


Innovative prevention approaches tailored to couples are also urgently needed and could decrease HCV-risk in this population .


The trial is registered with the French Agency of Pharmaceutical Products ( ANSM ) under the number 2008-A0277-48 , the European Union Drug Regulating Authorities Clinical Trials .


Number Eudract 2008-001338-28 , the ClinicalTrials.gov Identifier : NCT00657397 and the International Standard Randomised Controlled Trial Number Register ISRCTN31125511 .


National Surgical Adjuvant Breast and Bowel Project R-04 was designed to determine whether the oral fluoropyrimidine capecitabine could be substituted for continuous infusion 5-FU in the curative setting of stage II/III rectal cancer during neoadjuvant radiation therapy and whether the addition of oxaliplatin could further enhance the activity of fluoropyrimidine-sensitized radiation .


Patients with clinical stage II or III rectal cancer undergoing preoperative radiation were randomly assigned to one of four chemotherapy regimens in a 2x2 design : CVI 5-FU or oral capecitabine with or without oxaliplatin .


The primary endpoint was local-regional tumor control .


Time-to-event endpoint distributions were estimated using the Kaplan-Meier method .


Hazard ratios were estimated from Cox proportional hazard models .


All statistical tests were two-sided .


Among 1608 randomized patients there were no statistically significant differences between regimens using 5-FU vs capecitabine in three-year local-regional tumor event rates ( 11.2 % vs 11.8 % ) , 5-year DFS ( 66.4 % vs 67.7 % ) , or 5-year OS ( 79.9 % vs 80.8 % ) ; or for oxaliplatin vs no oxaliplatin for the three endpoints of local-regional events , DFS , and OS ( 11.2 % vs 12.1 % , 69.2 % vs 64.2 % , and 81.3 % vs 79.0 % ) .


The addition of oxaliplatin was associated with statistically significantly more overall and grade 3-4 diarrhea ( P < .0001 ) .


Three-year rates of local-regional recurrence among patients who underwent R0 resection ranged from 3.1 to 5.1 % depending on the study arm .


Continuous infusion 5-FU produced outcomes for local-regional control , DFS , and OS similar to those obtained with oral capecitabine combined with radiation .


This study establishes capecitabine as a standard of care in the pre-operative rectal setting .


Oxaliplatin did not improve the local-regional failure rate , DFS , or OS for any patient risk group but did add considerable toxicity .


To compare the safety and efficacy of Ozil Intelligent Phaco torsional microcoaxial phacoemulsification surgeries performed using 30-degree and 45-degree aperture angled tips .


Maltepe University School of Medicine Department of Ophthalmology , Istanbul , Turkey .


Comparative case series .


Eyes were assigned to 2.2 mm microcoaxial phacoemulsification using the torsional mode with a 45-degree ( Group 1 ) or 30-degree ( Group 2 ) aperture angled tip .


A quick-chop surgical technique was used .


The primary outcome measures were ultrasound time ( UST ) , cumulative dissipated energy ( CDE ) , longitudinal and torsional ultrasound ( US ) amplitudes , mean surgical time , mean balanced salt solution volume used , and mean central corneal thickness ( CCT ) changes .


The mean UST , CDE , and longitudinal and torsional US amplitudes were 58.21 seconds 33.81 ( SD ) , 7.74 6.23 , 0.45 0.30 , and 26.30 12.60 in Group 1 and 63.83 23.42 seconds , 12.36 6.75 , 0.23 0.26 , and 44.65 14.38 in Group 2 , respectively .


The mean CDE and torsional amplitudes were significantly lower in Group 1 ( P = .002 and P = .001 , respectively ) .


The mean balanced salt solution volume was 73.30 19.87 cc in Group 1 and 74.30 19.44 cc in Group 2 ( P = .821 ) .


The mean CCT change was 52.40 38.08 m and 99.35 47.14 m , respectively ( P < .001 ) .


Torsional phacoemulsification performed with a 45-degree aperture angled tip provided more effective lens removal with a lower CDE and less CCT change than a 30-degree aperture angled tip .


To evaluate the intra-operative and postoperative outcome of paediatric cataract surgery with primary posterior capsulotomy ( PPC ) and anterior vitrectomy using intra-operative preservative-free triamcinolone acetonide .


In this prospective , interventional case-control study , 20 Children who underwent cataract surgery for both eyes were enrolled and their eyes were randomized into two groups .


Group A consists of 20 eyes in which standard phacoaspiration with PPC with intracameral triamcinolone was used , and Group B consists of 20 eyes in which triamcinolone were not used .


Intra-operative complications and postoperative outcome like intraocular pressure ( IOP ) , posterior synechiae , pigment deposits and posterior capsule opacification ( PCO ) were studied .


In both groups , age range varied between 2-8 years comprising 18 males and two females .


The mean postoperative IOP did not show any significant variation during 6-month follow-up .


In study group , all the 20 eyes were quiet at 2 weeks , while there was cellular reaction 1 + in four eyes ( 20 % ) and nil in 16 eyes ( 80 % ) at 2 week in the control group ( p = 0.035 ) .


Pigment deposits on IOL optic was seen in two eyes ( 10 % ) of the study group while in control group , IOL deposits were present in 14 eyes ( 70 % ) ( p = 0.001 ) .


Posterior capsule opacification was seen in two eyes ( 10 % ) in control group at 3 months while none occurred in study group .


Intra-operative use of preservative-free triamcinolone acetonide led to less anterior chamber inflammation and pigment deposits on IOL optic postoperatively compared to those eyes where it was not used .


To determine whether allopregnanolone ( AP ) may mediate seizure reduction in progesterone-treated women with epilepsy .


The NIH Progesterone Trial compared the efficacy of adjunctive cyclic natural progesterone therapy vs placebo treatment of intractable seizures in 294 subjects , randomized 2:1 to progesterone or placebo , stratified by catamenial vs noncatamenial designation .


Treatments were compared on proportions of 50 % responders , and changes in seizure frequency from 3 baseline to 3 treatment cycles .


Serum AP levels were measured by radioimmunoassay from 155 women with intractable focal-onset seizures who had baseline and treatment-phase midluteal serum samples drawn each cycle for hormone measurements .


There was no significant correlation between percentage changes in AP levels and seizure frequencies from baseline to treatment for either the catamenial or noncatamenial stratum .


There was a significant correlation for the subset of subjects who showed a significantly greater responder rate in the post hoc analysis of the trial , i.e. , subjects who had a 3-fold or greater increase in average daily seizure frequency perimenstrually compared with the midfollicular and midluteal phases ( C1 3 : r = -0.442 , p = 0.013 , and specifically for C1 3 progesterone-treated subjects [ r = -0.452 , p = 0.035 ] , but not other groups [ C1 3 placebo : r = -0.367 ; C1 < 3 progesterone : r = 0.099 ; C1 < 3 placebo : r = 0.131 ; p = not significant ] ) .


The findings support AP as a mediator of seizure reduction in progesterone-treated women who have a substantial level of perimenstrually exacerbated seizures .


To compare the relative bioavailability , safety and tolerability of oral methotrexate ( MTX ) and subcutaneous ( SC ) MTX administered via an auto-injector ( MTXAI ) in patients with rheumatoid arthritis ( RA ) .


In this randomised , multicenter , open-label , three-way crossover study , patients 18years with adult RA undergoing treatment with MTX for 3months were assigned to receive MTX 10 , 15 , 20 and 25mg weekly in a random sequence of three treatments : oral , SC into the abdomen and SC into the thigh .


For 24h after administration of each treatment , blood samples were collected for pharmacokinetic analysis and injection sites were assessed .


Forty-seven patients completed the study .


Systemic exposure of oral MTX plateaued at doses 15mg/week .


In contrast , SC MTX demonstrated a linear increase in systemic exposure that was greater than oral MTX at each dose .


No unexpected AEs were noted for either formulation .


Unlike oral MTX , the systemic exposure of SC MTX did not plateau over the doses studied , particularly at doses 15mg/week .


In this study , higher systemic MTX exposure was not associated with increases in AEs .


Patients with an inadequate clinical response to oral MTX may benefit from higher drug exposure by switching to SC MTX .


NCT01618968 .


Total knee arthroplasty ( TKA ) is associated with varying degrees of pain .


A considerable proportion ( 25-40 % ) of patients experience severe pain , despite a comprehensive multimodal analgesic regimen .


We hypothesized that adductor canal block ( ACB ) would reduce pain in this patient category compared with placebo .


Fifty patients with severe pain , defined as having a visual analogue scale ( VAS ) pain score of > 60 during active flexion of the knee on the first or the second postoperative day after TKA , were included in this randomized , double-blind , placebo-controlled trial .


All the patients had received a comprehensive multimodal analgesic regimen .


Group A received an ACB with ropivacaine 0.75 % , 30 ml at time 0 and isotonic saline after 45 min .


Group B received an ACB with isotonic saline at time 0 and ropivacaine 0.75 % , 30 ml after 45 min .


A 32-mm difference in VAS pain score , during active flexion of the knee ( primary endpoint ) , was observed in favour of Group A , 95 % confidence interval ( CI ) : 23-42 , P < 0.0001 .


At rest , the difference in VAS pain score was 15 mm in favour of Group A , 95 % CI : 8-23 mm , P = 0.0001 .


Individual patient analysis revealed that 25 % of the patients had no effect during active flexion .


At rest , however , only 8 % had more than mild pain after ACB compared with 57 % at inclusion .


ACB reduced VAS with 32 mm , during active flexion of the knee , in patients with severe pain after TKA , but a large proportion ( 78 % ) still had at least moderate , movement-related pain .


Clinical trial registration www.clinicaltrials.gov , NCT01549704 .


Radial arterial catheterization in pediatric patients is occasionally difficult despite ultrasound guidance .


We therefore assessed the factors affecting catheterization and tested an intervention designed to improve its success .


For initial assessment , we performed multiple logistic regression analyses using 102 pediatric patients .


Dependent variables included first-attempt and overall success or failure ; independent variables were systolic blood pressure , weight , ASA physical status , trisomy 21 , arterial diameter , and subcutaneous depth of the radial artery ( < 2 , 2-4 , 4 mm ) .


The effect of subcutaneous arterial depth on cannulation success was assessed using Kaplan-Meier curves with log-rank and Dunn tests .


We then assessed catheterization success in 60 patients who were randomized to no treatment or subcutaneous saline injection , as necessary , to increase the subcutaneous arterial depth from < 2 to 2 to 4 mm .


Subcutaneous arterial depth of 2 to 4 mm was derived as a significant independent predictor of initial and overall success from the multiple logistic regression analyses .


The 2 to 4 mm group had a significantly shorter catheterization time compared with the other 2 groups in the log-rank test ( 2-4 vs < 2 mm group ; P = 0.01 , 2-4 vs 4 mm group ; P < 0.001 ) , and higher success rate in the first attempt ( < 2 [ 43.8 % ] vs 2-4 mm [ 76.9 % ] , P = 0.02 ; 2-4 [ 76.9 % ] vs 4.0 mm [ 19.4 % ] , P < 0.001 ) , and the overall attempt ( < 2 [ 62.5 % ] vs 2-4 mm [ 89.7 % ] , P = 0.04 ; 2-4 [ 89.7 % ] vs 4.0 mm [ 51.6 % ] , P = 0.002 ) .


Injecting subcutaneous saline to bring arterial depth from < 2 mm to 2 to 4 mm significantly shortened catheterization time ( P = 0.002 ) , and improved the success rate in the first-attempt ( saline injection [ 85.0 % ] vs < 2 mm [ 30.0 % ] , P < 0.001 ) , and the overall attempt ( saline injection [ 90.0 % ] vs < 2 mm [ 55.0 % ] , P = 0.02 ) .


Ultrasound-guided radial artery catheterization in pediatric patients was fastest and most reliable when the artery was 2 to 4 mm below the skin surface .


For arteries located < 2 mm below the skin surface , increasing the depth to 2 to 4 mm by subcutaneous saline injection reduced catheterization time and improved the success rate .


The purpose of this study was to assess the efficacy and safety of trabectedin for advanced breast cancer .


In an open-label , phase II , multicenter study , women with advanced breast cancer previously treated with 2 lines of chemotherapy for advanced disease , including both anthracyclines and taxanes , were randomized ( 1:1 ) to 3-hour infusions of trabectedin 1.3 mg/m ( 2 ) once every 3 weeks ( 1/3 treatment arm ) or 0.58 mg/m ( 2 ) every week for 3 of 4 weeks ( 3/4 treatment arm ) .


The primary end point was objective response .


Secondary end points included time to progression ( TTP ) , progression-free survival ( PFS ) , and overall survival ( OS ) .


Fifty-two women ( median age , 50 years ; median chemotherapy agents , 4 ) were enrolled .


Relative trabectedin dose intensities were 81 % and 76 % in the 1/3 and 3/4 treatment arms , respectively .


Objective response rates were 12 % ( 3 of 25 ) and 4 % ( 1 of 27 ) , respectively .


Stable disease was observed in 14 ( 56 % ) and 11 ( 41 % ) patients in the 1/3 and 3/4 treatment arms , respectively , with median durations of 3.5 and 3.7 months .


Median TTP and PFS were higher in the 1/3 treatment arm ( 3.1 months each ) than in the 3/4 treatment arm ( 2.0 months each ) .


At a median follow-up of 7 months in both treatment arms , median OS was not reached in the 1/3 treatment arm and was 9.4 months in the 3/4 treatment arm .


The most frequent drug-related adverse events in the 1/3 and 3/4 treatment arms , respectively , were alanine aminotransferase ( ALT ) level increases ( 68 % vs. 63 % ) , nausea ( 56 % vs. 59 % ) , and asthenia ( 56 % vs. 48 % ) .


Neutropenia and increases in ALT levels were the most frequent grade 3/4 events .


Both types of events were usually transient and reversible .


In the population studied , trabectedin showed a manageable safety profile for both regimens analyzed .


There were higher objective response rates and a longer PFS in the 1/3 treatment arm compared with the 3/4 treatment arm .


Endotracheal intubation is a method necessary for controlling and maintaining airway during general anesthesia .


Cough and hoarseness are common complications after endotracheal intubation .


Inflammation has an important role in postoperative cough and hoarseness outbreak .


Also it has been stated that green tea has anti-inflammatory properties .


Therefore , the current study has been conducted to investigate green tea gargling solution effect on cough and hoarseness after coronary artery bypass graft ( CABG ) surgery .


In this single-blind , randomized , & controlled clinical trial , we enrolled 121 patients undergoing CABG admitted to the ICU .


The intervention group participants were asked to gargle 30 cc of green tea solution .


The control group patients gargled 30 cc of distilled water .


An hour after extubation , the intervention group patients were asked to gargle 30 cc of green tea and the control group patients were required to gargle 30 cc of distilled water every 6 hour up to 24 hour ( each patient for 4 times ) .


Moreover , the cough and hoarseness questionnaire was also filled in 6 , 12 , and 24 hours after endotracheal extubation .


The results showed no significant differences among the patients in both groups regarding age , gender , body mass index , smoking history , and anesthesia duration .


There was a significant difference between the two groups in terms of cough 12 hours after removing the endotracheal tube .


At other times , there was no significant difference between the two groups considering cough and hoarseness .


The present study results showed that green tea gargling does not decrease hoarseness .


Though , cough occurrence was less in the intervention group than the other group .


To investigate the genetic influence of 48 type 2 diabetes susceptibility variants on disease progression measured as risk of early prescription redemption of glucose lowering drugs in screen-detected patients with type 2 diabetes .


We studied type 2 diabetes progression in 1,480 patients with screen-detected type 2 diabetes from the ADDITION-Denmark study using information of redeemed prescriptions from the Register of Medicinal Products Statistics from 2001-2009 in Denmark .


Patients were cluster randomized by general practitioners , who were randomized to treat type 2 diabetes according to either a conventional or a multifactorial intensive treatment algorithm .


We investigated the genetic influence on diabetes progression by constructing a genetic risk score ( GRS ) of all 48 validated type 2 diabetes susceptibility variants , a GRS of 11 variants linked to - cell function and a GRS of 3 variants linked to insulin sensitivity and assessed the association between number of risk alleles and time from diagnosis until first redeemed prescription of either any glucose lowering drug or an insulin drug .


The GRS linked to insulin sensitivity only nominally increased the risk of an early prescription redemption with an insulin drug by 39 % ( HR [ 95 % C.I. ] = 1.39 [ 1.09-1 .77 ] , p = 0.009 ] in patients randomized to the intensive treatment group .


Furthermore , the strongest univariate predictors of diabetes progression for the intensive treatment group ( measured as time to first insulin ) were younger age ( HR [ 95 % C.I. ] = 0.96 [ 0.93-0 .99 ] ) , increased BMI ( 1.05 [ 1.01-1 .09 ] ) , increased HbA1c ( 1.50 [ 1.36 -.66 ] ) , increased TG ( 1.24 [ 1.11-1 .39 ] ) and reduced fasting serum HDL ( 0.37 [ 0.17-0 .80 ] ) at baseline .


Similar results were obtained for the conventional treatment group .


Higher levels of HbA1c , fasting circulating levels of triglyceride , lower HDL , larger BMI and younger age are significant determinants of early pharmacological intervention in type 2 diabetes .


However , known common type 2 diabetes-associated gene variants do not appear to significantly affect disease progression .


To determine optimum duration of intraurethral 2 % lidocaine jelly for pain relief during outpatient rigid cystoscopy .


This prospective randomized study was conducted between June 2012 and November 2013 .


Four hundred consecutive adult males requiring diagnostic rigid cystoscopy were randomized into four groups depending on intraurethral 2 % lidocaine jelly dwell time before rigid cystoscopy : jelly was instilled 5 , 10 , 15 , and 20 minutes before start of the procedure in group A , B , C , and D patients , respectively .


The patients ' age , patient-reported preoperative anxiety score , patient-reported intraoperative pain score , the surgeon-reported patient 's pain score , and the duration of rigid cystoscopy were recorded and analyzed .


The mean age , patient-reported preoperative anxiety score , and duration of rigid cystoscopy were similar between the four groups with no significant difference noted between them .


The least and highest mean patient-reported and surgeon-reported intraoperative pain scores were reported in group C ( 1.490.82 and 1.580.67 ) patients and group A ( 4.861.24 and 4.041.11 ) patients , respectively , while no significant difference was found in these scores between group C and D patients .


For male patients undergoing diagnostic rigid cystoscopy , an intraurethral dwell time of 15 minutes ( of 20mL 2 % lidocaine jelly ) provided optimum pain relief .


The intervention completion rate is an important metric in behavioral and intervention research ; trials with limited intervention completion rates may have reduced internal validity .


We examined intervention completion rates among 530 African Americans who had been randomized to an integrated ( INT ) or disease-specific ( DSE ) risk education protocol as part of a comparative effectiveness trial from September 2009 to August 2012 .


The interventions were developed by an academic-community partnership using community-based participatory research .


Intervention completion rates were determined based on attendance at all four intervention sessions .


Intervention completers were participants who completed all four sessions and noncompleters were those who did not complete any session or only completed one to three sessions following randomization .


Seventy-three percent of participants were intervention completers and 27 % were noncompleters .


There were no differences in intervention completion based on randomization to INT ( 72 % ) or DSE ( 75 % ) , sociodemographic factors , or body mass index ( BMI ) in the total sample .


Different factors were associated significantly with intervention completion within study groups .


Among participants randomized to INT , the odds of intervention completion were greater with higher levels of intrinsic motivation , less exposure to information about diet and cardiovascular disease , and greater BMI .


Among participants randomized to DSE , the odds of completing the intervention were associated significantly with older age and greater dietary self-efficacy .


Many African Americans are likely to complete risk education interventions .


Psychologic characteristics should be considered when determining intervention completion rates following randomization in behavioral and intervention trials .


The purpose was to determine whether a brachytherapy boost improves outcomes in patients with advanced nasopharyngeal carcinoma treated with standard chemo-radiotherapy .


Patients with nasopharyngeal carcinoma WHO grades I-III and TNM stages III or non-metastatic stage IV were eligible for this phase III study .


Patients were randomized to either arm ( A ) induction chemotherapy , followed by external beam radiotherapy ( EBRT ) with concomitant cisplatin ( n = 139 ) or arm ( B ) , the same schedule plus a brachytherapy boost to the nasopharynx ( n = 135 ) .


The EBRT doses given were 70 Gy to the primary tumour and positive lymph nodes and 46 Gy to the negative neck .


The additional brachytherapy boost in arm ( B ) was given by either low dose-rate ( LDR - 11 Gy ) or high dose-rate ( HDR - 3 fractions of 3.0 Gy ) brachytherapy .


The primary endpoint was 3-year overall survival ( OS ) and secondary endpoints were : local control , regional control , distant metastasis and grade 3-4 adverse events .


274 patients were randomized between September 2004 and December 2008 .


The two arms were comparable with regard to age , gender , stage and grade .


273 patients completed treatment .


Median follow-up was 29 months ( 0.2-67 months ) .


The effect of treatment arm , country , age , gender , WHO pathology , stage ( T3-4 , N2-3 versus other ) and chemotherapy on overall survival ( OS ) , disease-free survival ( DFS ) and local recurrence-free survival ( LRFS ) was studied .


Stage significantly affected OS ( p = 0.024 ) and DFS ( p = 0.018 ) while age significantly affected OS ( p = 0.014 ) .


None of the other factors studied were significant .


The 3-year LRFS was 60.5 % and 54.4 % in arms A and B respectively ( p = 0.647 ) .


The 3-year regional control rate in the neck was 59.7 % and 54.3 % respectively ( p = 0.7 ) .


Distant metastasis developed in 59.7 % of patients in arm A and 55.4 % in arm B ( p = 0.377 ) .


Patients with T1/T2 N + had a 3 year LRFS of 51.8 % in Arm A ( 62 patients ) versus 57.9 % in Arm B ( 67 patients ) ( p = 0.343 ) .


The grade 3-4 toxicity rate was 21.6 % ( 30/139 ) and 24.4 % ( 33/135 ) respectively ( p = 0.687 ) .


The addition of a brachytherapy boost to external beam radiotherapy and chemotherapy did not improve outcome in loco-regionally advanced nasopharyngeal carcinoma .


This randomized controlled trial of outpatients with breast cancer ( stage I or II ) evaluated the effects of a 3-week educational intervention on patient levels of fatigue .


Norwegian outpatients were randomized into an intervention group ( n = 79 ) and a control group ( n = 81 ) .


Women with fatigue ( > 2.5 on a 0-10 numeric rating scale , NRS ) completed the Fatigue Questionnaire ( FQ ) and the Lee Fatigue Scale ( LFS ) at baseline ( after treatment ) ( T1 ) , immediately after intervention ( T2 ) and 3 months after intervention ( T3 ) .


The mean fatigue score ( NRS ) at study entry was 6.1 ( SD 1.7 ) and 36 % ( n = 57 ) had a score 7 .


There were no statistically significant differences between the fatigue measures of women in the intervention and control group at T2 or T3 in the overall sample after the intervention .


Using an NRS cut-off of 5 , there was a borderline difference for women who scored < 5 for chronic fatigue on FQ ( p = 0.062 ) and a significant difference for energy on LFS ( p = 0.042 ) where the women in the intervention group had less fatigue .


Using an NRS cut-off score of 6 , there was a borderline difference for women who scored < 6 for fatigue on FQ ( p = 0.062 ) and a significant difference for energy on LFS ( p = 0.021 ) where women in the intervention group had more energy than those in the control group .


Further research is needed to identify psycho-educational interventions to reduce levels of fatigue and to tailor an intervention based on the level of fatigue .


Fatigue measurements should be chosen more carefully .


Heavy alcohol consumption in HIV patients is an increasing health concern .


Applying the drinking motivational model to HIV primary care patients , drinking motives ( drinking to cope with negative affect , for social facilitation , and in response to social pressure ) were associated with alcohol consumption at a baseline interview .


However , whether these motives predict continued heavy drinking or alcohol dependence in this population is unknown .


Participants were 254 heavy-drinking urban HIV primary care patients ( 78.0 % male ; 94.5 % African American or Hispanic ) participating in a randomized trial of brief drinking-reduction interventions .


Drinking motive scales , as well as measures of alcohol consumption and alcohol dependence , were administered at baseline .


Consumption and dependence measures were re-administered at the end of treatment two months later .


Regression analyses tested whether baseline drinking motive scale scores predicted continued heavy drinking and alcohol dependence status at the end of treatment , and whether motives interacted with treatment condition .


Baseline drinking to cope with negative affect predicted continued heavy drinking ( p < 0.05 ) and alcohol dependence , the latter in both in the full sample ( adjusted odds ratio [ AOR ] = 2.14 ) and among those with baseline dependence ( AOR = 2.52 ) .


Motives did not interact with treatment condition in predicting alcohol outcomes .


Drinking to cope with negative affect may identify HIV patients needing targeted intervention to reduce drinking , and may inform development of more effective interventions addressing ways other than heavy drinking to cope with negative affect .


We compared transcatheter aortic-valve replacement ( TAVR ) , using a self-expanding transcatheter aortic-valve bioprosthesis , with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery .


We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center .


Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors .


Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve ( TAVR group ) or to surgical aortic-valve replacement ( surgical group ) .


The primary end point was the rate of death from any cause at 1 year , evaluated with the use of both noninferiority and superiority testing .


A total of 795 patients underwent randomization at 45 centers in the United States .


In the as-treated analysis , the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group ( 14.2 % vs. 19.1 % ) , with an absolute reduction in risk of 4.9 percentage points ( upper boundary of the 95 % confidence interval , -0.4 ; P < 0.001 for noninferiority ; P = 0.04 for superiority ) .


The results were similar in the intention-to-treat analysis .


In a hierarchical testing procedure , TAVR was noninferior with respect to echocardiographic indexes of valve stenosis , functional status , and quality of life .


Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke .


In patients with severe aortic stenosis who are at increased surgical risk , TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement .


( Funded by Medtronic ; U.S. CoreValve High Risk Study ClinicalTrials.gov number , NCT01240902 . )


Omega-3 fatty acid supplements have been reported to inhibit exercise-induced bronchoconstriction ( EIB ) .


It has not been determined whether omega-3 supplements inhibit airway sensitivity to inhaled mannitol , a test for bronchial hyperresponsiveness ( BHR ) and model for EIB in people with mild to moderate asthma .


In a double-blind , crossover trial , subjects with asthma who had BHR to inhaled mannitol ( n = 23 ; 14 men ; mean age , 28 years ; one-half taking regular inhaled corticosteroids ) were randomized to omega-3 supplements ( 4.0 g/d eicosapentaenoic acid and 2.0 g/d docosahexaenoic acid ) or matching placebo for 3 weeks separated by a 3-week washout .


The primary outcome was the provoking dose of mannitol ( mg ) to cause a 15 % fall in FEV1 ( PD15 ) .


Secondary outcomes were sputum eosinophil count , spirometry , Asthma Control Questionnaire ( ACQ ) score , serum triacylglyceride level , and lipid mediator profile in urine and serum .


PD15 ( geometric mean , 95 % CI ) to mannitol following supplementation with omega-3s ( 78 mg , 51-119 mg ) was not different from placebo ( 88 mg , 56-139 mg , P = .5 ) .


There were no changes in sputum eosinophils ( mean SD ) in a subgroup of 11 subjects ( omega-3 , 8.4 % 8.2 % ; placebo , 7.8 % 11.8 % ; P = .9 ) .


At the end of each treatment period , there were no differences in FEV1 % predicted ( omega-3 , 85 % 13 % ; placebo , 84 % 11 % ; P = .9 ) or ACQ score ( omega-3 , 1.1 % 0.5 % ; placebo , 1.1 % 0.5 % ; P = .9 ) ( n = 23 ) .


Omega-3s caused significant lowering of blood triglyceride levels and expected shifts in serum fatty acids and eicosanoid metabolites , confirming adherence to the supplements ; however , no changes were observed in urinary mast cell mediators .


Three weeks of omega-3 supplements does not improve BHR to mannitol , decrease sputum eosinophil counts , or inhibit urinary excretion of mast cell mediators in people with mild to moderate asthma , indicating that dietary omega-3 supplementation is not useful in the short-term treatment of asthma .


ClinicalTrials.gov ; No. : NCT00526357 ; URL : www.clinicaltrials.gov .


Catecholamines and inflammatory mediators , with elevated levels after brain death , are associated with reduced function and survival of transplanted organs .


Enteral nutrition reduces tissue damage and may benefit organs .


To evaluate the effects of immunomodulating enteral nutrition in organ donors .


Prospective , randomized , open-label study .


Intensive care unit .


Thirty-six brain-dead organ donors .


Donors were randomized to receive enteral nutrition containing omega-3 polyunsaturated fatty acid , antioxidants , and glutamine or standard care ( fasting ) .


Donors received hormonal replacement therapy of corticosteroid , levothyroxine , dextrose , and insulin .


Gastrointestinal assimilation ( measured by 13 carbon-labeled uracil breath analysis ) , quantity of organs recovered , resting energy expenditure , urine level of urea nitrogen , and serum levels of albumin , prealbumin , interleukin 6 , tumor necrosis factor - , and C-reactive protein were evaluated .


Thirteen patients ( 36 % ) assimilated 13C-labeled uracil .


Resting energy expenditure was significantly higher than predicted between 10 and 14 hours after baseline in 33 donors ( P = .007 ) .


Other measures were not conclusively different between fed and fasting groups .


No adverse events occurred that were related to the enteral feeding .


About 30 % of donors metabolized 13C-labeled uracil , although no difference in oxidation rate was found between fasting and fed donors .


Corticosteroid administration lowers plasma levels of interleukin 6 and most likely contributes to greater than predicted resting energy expenditure .


Thus energy needs may not be met during fasting if hormones are given .


Consequences of this possible energy deficit warrant further study .


Over 45 % of American women 20-39 years old are at risk for type 2 diabetes , cardiovascular disease , and other health conditions because they are overweight or obese .


The prevalence of overweight and obesity is disproportionately high among low-income women .


This paper describes the study design and rationale of a community based intervention ( Mothers In Motion , MIM ) aimed to prevent weight gain among low-income overweight and obese mothers 18-39 years old by promoting stress management , healthy eating , and physical activity .


Peer recruiters approach participants from 5 Special Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) in Michigan .


The MIM delivers theory-based , culturally-sensitive intervention messages via a combination of DVDs and peer support group teleconferences ( PSGTs ) .


The DVD features African American and white overweight and obese WIC mothers who participated in a healthy lifestyle intervention patterned after MIM .


The PSGTs are led by paraprofessionals from Michigan State University Extension and WIC providers in Michigan who are trained in motivational interviewing and group facilitation skills .


Participants are randomly assigned to an intervention ( n = 350 ) or comparison group ( n = 175 ) .


The intervention group receives a 16-week intervention on a weekly or bi-weekly basis .


Participants are asked to watch 10 MIM DVD chapters at home and join 10 PSGT sessions by phone .


The comparison group receives printed educational materials .


The primary outcome is body weight .


Secondary outcomes include dietary fat , fruit , and vegetable intake ; physical activity ; stress , and affect .


Mediators are self-efficacy , emotional coping response , social support , and autonomous motivation .


Telephone interviews and in-person data collection at WIC offices occur at 3 time points : baseline , immediately , and 3 months after the 16-week intervention .


If MIM shows effectiveness , it could have a favorable impact on public health and community programs .


The DVDs and PSGTs will be disseminated in WIC , Extension , clinical practice that promote healthy lifestyles for similar target audiences to make a broad contribution to the prevention of weight gain in low-income mothers .


Also , our methodology can be adapted by researchers and community stakeholders to help other low-income populations prevent weight gain .


Clinical Trials Number : NCT01839708 .


Deep sedation of surgical patients may be associated with hypoventilation , airway collapse , and hypercarbia , although the extent of hypercarbia is rarely quantified .


In this prospective , randomized , controlled clinical pilot study , we assessed the efficacy of nasal continuous positive airway pressure ( nCPAP ) for reducing arterial partial pressure of carbon dioxide ( PaCO2 ) among deeply sedated , spontaneously ventilated patients undergoing total knee arthroplasty ( TKA ) under subarachnoid block ( SAB ) , versus standard airway management in a control group .


Forty ASA status I-III patients underwent deep sedation with propofol to level 2 on the Modified Observers Assessment of Alertness/Sedation Scale during TKA performed under SAB .


Nasal or oral airways were placed at the discretion of the anesthesia team , but they were not used in conjunction with nCPAP .


Baseline arterial blood gas analysis ( ABG-1 ) was performed after Modified Observers Assessment of Alertness/Sedation Scale level 2 was reached .


Patients were then randomized to receive nCPAP ( nCPAP group , N = 20 ) or standard oxygen mask management ( control group , N = 20 ) .


A second ABG ( ABG-2 ) was performed 30 minutes later to assess the effect of nCPAP on PaCO2 .


The primary efficacy end point was change in PaCO2 from baseline to the 30-minute time point .