The Tx and NoTx groups were similar with respect to most presurgical variables but differed in distribution of gender , blood type , diabetes prevalence , activated partial thromboplastin time ( aPTT ) , hemoglobin ( HGB ) , and microparticle levels .


Stepwise multiple logistic regression was used to evaluate presurgical variables and to develop a model to assess risk factors for transfusion .


CD41 ( + ) PMP and CD235 ( + ) RMP levels were found to be the main risk factors for transfusion .


The Model 's discriminating ability was assessed using receiver operating characteristic curve analysis , which showed that the area under the model curve ( standard error ) was 0.86 0.04 ( 95 % confidence interval , 0.77-0 .94 ) .


According to the model , patients with higher presurgical levels of circulating CD41 ( + ) PMP , CD235a ( + ) RMP , and HGB , as well as a shorter aPTT , are less likely to receive transfusion ( s ) .


Presurgical levels of CD41 ( + ) PMPs and CD235a ( + ) RMPs are the main risk factors for transfusion in CABG , followed by HGB and aPTT .


To examine the effect of a 1-yr school-based intervention program to prevent the development of new cases of eating disorders ( ED ) and symptoms associated with ED among adolescent female and male elite athletes .


All 16 Norwegian Elite Sport High Schools were included ( intervention group [ n = 9 ] and control group [ n = 7 ] ) .


In total , 465 ( 93.8 % ) first-year student athletes were followed during high school ( 2008-2011 , three school years ) .


The athletes completed the Eating Disorder Inventory 2 and questions related to ED before ( pretest ) , immediately after ( posttest 1 ) , and 9 months after the intervention ( posttest 2 ) .


Clinical interviews ( Eating Disorder Examination ) were conducted after the pretest ( all with symptoms [ n = 115 , 97 % ] and a random sample without symptoms [ n = 116 , 97 % ] ) , and at posttest 2 , all athletes were interviewed ( n = 463 , 99.6 % ) .


Among females , there were no new cases of ED in the intervention schools , while 13 % at the control schools had developed and fulfilled the DSM-IV criteria for ED not otherwise specified ( n = 7 ) or bulimia nervosa ( n = 1 ) , P = 0.001 .


The risk of reporting symptoms was lower in the intervention than in the control schools at posttest 1 ( odds ratio [ OR ] = 0.45 , 95 % confidence interval [ CI ] = 0.23-0 .89 ) .


This effect was attenuated by posttest 2 ( OR = 0.57 , 95 % CI = 0.29-1 .09 ) .


The intervention showed a relative risk reduction for current dieting ( OR = 0.10 , 95 % CI = 0.02-0 .54 ) and three or more weight loss attempts ( OR = 0.47 , 95 % CI = 0.25-0 .90 ) .


Among males , there was one new case of ED at posttest 2 ( control school ) and no difference in the risk of reporting symptoms between groups at posttest 1 or 2 .


A 1-yr intervention program can prevent new cases of ED and symptoms associated with ED in adolescent female elite athletes .


To determine the effect of maternal presence on the physiological and behavioral status of the preterm infant when exposed to recorded music versus ambient sound .


Repeated-measures randomized controlled trial .


Special care nursery ( SCN ) in a tertiary perinatal center .


Clinically stable preterm infants ( 22 ) born at > 28 weeks gestation and enrolled at > 32 weeks gestation and their mothers .


Infants were exposed to lullaby music ( 6 minutes of ambient sound alternating with 2x 6 minutes recorded lullaby music ) at a volume within the recommended sound level for the SCN .


The mothers in the experimental group were present for the first 12 minutes ( baseline and first music period ) whereas the mothers in the control group were absent overall .


There was no discernible infant response to music and therefore no significant impact of maternal presence on infant 's response to music over time .


However during the mothers ' presence ( first 12 minutes ) , the infants exhibited significantly higher oxygen saturation than during their absence p = .024 ) and less time spent in quiet sleep after their departure , though this was not significant .


Infants may have been unable to detect the music against the ambient soundscape .


Regardless of exposure to music , the infants ' physiological and behavioral regulation were affected by the presence and departure of the mothers .


Preoperative chemoradiotherapy with infusional fluorouracil , total mesorectal excision surgery , and postoperative chemotherapy with fluorouracil was established by the German CAO/ARO/AIO -94 trial as a standard combined modality treatment for locally advanced rectal cancer .


Here we compare the previously established regimen with an investigational regimen in which oxaliplatin was added to both preoperative chemoradiotherapy and postoperative chemotherapy .


In this multicentre , open-label , randomised , phase 3 study we randomly assigned patients with rectal adenocarcinoma , clinically staged as cT3-4 or any node-positive disease , to two groups : a control group receiving standard fluorouracil-based combined modality treatment , consisting of preoperative radiotherapy of 504 Gy in 28 fractions plus infusional fluorouracil ( 1000 mg/m ( 2 ) on days 1-5 and 29-33 ) , followed by surgery and four cycles of bolus fluorouracil ( 500 mg/m ( 2 ) on days 1-5 and 29 ) ; or to an investigational group receiving preoperative radiotherapy of 504 Gy in 28 fractions plus infusional fluorouracil ( 250 mg/m ( 2 ) on days 1-14 and 22-35 ) and oxaliplatin ( 50 mg/m ( 2 ) on days 1 , 8 , 22 , and 29 ) , followed by surgery and eight cycles of oxaliplatin ( 100 mg/m ( 2 ) on days 1 and 15 ) , leucovorin ( 400 mg/m ( 2 ) on days 1 and 15 ) , and infusional fluorouracil ( 2400 mg/m ( 2 ) on days 1-2 and 15-16 ) .


Randomisation was done with computer-generated block-randomisation codes stratified by centre , clinical T category ( cT1-3 vs cT4 ) , and clinical N category ( cN0 vs cN1-2 ) without masking .


The primary endpoint was disease-free survival , defined as the time between randomisation and non-radical surgery of the primary tumour ( R2 resection ) , locoregional recurrence after R0/1 resection , metastatic disease or progression , or death from any cause , whichever occurred first .


Survival and cumulative incidence of recurrence analyses followed the intention-to-treat principle ; toxicity analyses included all patients treated .


Enrolment of patients in this trial is completed and follow-up is ongoing .


This study is registered with ClinicalTrials.gov , number NCT00349076 .


Of the 1265 patients initially enrolled , 1236 were assessable ( 613 in the investigational group and 623 in the control group ) .


With a median follow-up of 50 months ( IQR 38-61 ) , disease-free survival at 3 years was 759 % ( 95 % CI 724-795 ) in the investigational group and 712 % ( 95 % CI 676-749 ) in the control group ( hazard ratio [ HR ] 079 , 95 % CI 064-098 ; p = 003 ) .


Preoperative grade 3-4 toxic effects occurred in 144 ( 24 % ) of 607 patients who actually received fluorouracil and oxaliplatin during chemoradiotherapy and in 128 ( 20 % ) of 625 patients who actually received fluorouracil chemoradiotherapy .


Of 445 patients who actually received adjuvant fluorouracil and leucovorin and oxaliplatin , 158 ( 36 % ) had grade 3-4 toxic effects , as did 170 ( 36 % ) of 470 patients who actually received adjuvant fluorouracil .


Late grade 3-4 adverse events in patients who received protocol-specified preoperative and postoperative treatment occurred in 112 ( 25 % ) of 445 patients in the investigational group , and in 100 ( 21 % ) of 470 patients in the control group .


Adding oxaliplatin to fluorouracil-based neoadjuvant chemoradiotherapy and adjuvant chemotherapy ( at the doses and intensities used in this trial ) significantly improved disease-free survival of patients with clinically staged cT3-4 or cN1-2 rectal cancer compared with our former fluorouracil-based combined modality regimen ( based on CAO/ARO/AIO -94 ) .


The regimen established by CAO/ARO/AIO -04 can be deemed a new treatment option for patients with locally advanced rectal cancer .


German Cancer Aid ( Deutsche Krebshilfe ) .


Web-based , computer-tailored nutrition education interventions can be effective in modifying self-reported dietary behaviors .


Traditional computer-tailored programs primarily targeted individual cognitions ( knowledge , awareness , attitude , self-efficacy ) .


Tailoring on additional variables such as self-regulation processes and environmental-level factors ( the home food environment arrangement and perception of availability and prices of healthy food products in supermarkets ) may improve efficacy and effect sizes ( ES ) of Web-based computer-tailored nutrition education interventions .


This study evaluated the short - and medium-term efficacy and educational differences in efficacy of a cognitive and environmental feedback version of a Web-based computer-tailored nutrition education intervention on self-reported fruit , vegetable , high-energy snack , and saturated fat intake compared to generic nutrition information in the total sample and among participants who did not comply with dietary guidelines ( the risk groups ) .


A randomized controlled trial was conducted with a basic ( tailored intervention targeting individual cognition and self-regulation processes ; n = 456 ) , plus ( basic intervention additionally targeting environmental-level factors ; n = 459 ) , and control ( generic nutrition information ; n = 434 ) group .


Participants were recruited from the general population and randomly assigned to a study group .


Self-reported fruit , vegetable , high-energy snack , and saturated fat intake were assessed at baseline and at 1 - ( T1 ) and 4-months ( T2 ) postintervention using online questionnaires .


Linear mixed model analyses examined group differences in change over time .


Educational differences were examined with grouptimeeducation interaction terms .


In the total sample , the basic ( T1 : ES = -0.30 ; T2 : ES = -0.18 ) and plus intervention groups ( T1 : ES = -0.29 ; T2 : ES = -0.27 ) had larger decreases in high-energy snack intake than the control group .


The basic version resulted in a larger decrease in saturated fat intake than the control intervention ( T1 : ES = -0.19 ; T2 : ES = -0.17 ) .


In the risk groups , the basic version caused larger decreases in fat ( T1 : ES = -0.28 ; T2 : ES = -0.28 ) and high-energy snack intake ( T1 : ES = -0.34 ; T2 : ES = -0.20 ) than the control intervention .


The plus version resulted in a larger increase in fruit ( T1 : ES = 0.25 ; T2 : ES = 0.37 ) and a larger decrease in high-energy snack intake ( T1 : ES = -0.38 ; T2 : ES = -0.32 ) than the control intervention .


For high-energy snack intake , educational differences were found .


Stratified analyses showed that the plus version was most effective for high-educated participants .


Both intervention versions were more effective in improving some of the self-reported dietary behaviors than generic nutrition information , especially in the risk groups , among both higher - and lower-educated participants .


For fruit intake , only the plus version was more effective than providing generic nutrition information .


Although feasible , incorporating environmental-level information is time-consuming .


Therefore , the basic version may be more feasible for further implementation , although inclusion of feedback on the arrangement of the home food environment and on availability and prices may be considered for fruit and , for high-educated people , for high-energy snack intake .


Netherlands Trial Registry NTR3396 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3396 ( Archived by WebCite at http://www.webcitation.org/6VNZbdL6w ) .


To compare monocular and binocular mesopic contrast sensitivity and through focus following monocular implantation with KAMRA small-aperture inlay ( AcuFocus , Irvine , California , USA ) vs binocular implantation with an accommodating or multifocal intraocular lens ( IOL ) implant .


Three-treatment randomized clinical trial of presbyopia-correcting IOLs with comparison to results from a previous nonrandomized multicenter clinical trial on the KAMRA corneal inlay .


Study population of 507 subjects with KAMRA inlays ; predetermined subgroups included 327 subjects that underwent contrast sensitivity testing and another 114 subjects for defocus curve testing , along with 78 subjects randomized between bilateral Crystalens Advanced Optics ( AO ) ( Bausch + Lomb Surgical , Aliso Viejo , California , USA ) , AcrySof IQ ReSTOR +3.0 D ( Alcon Laboratories , Fort Worth , Texas , USA ) , or Tecnis +4 D Multifocal ( MF ) ( Abbott Medical Optics , Santa Ana , California , USA ) IOL .


KAMRA inlay subjects demonstrated improved intermediate and near vision with minimal to no change to distance vision , better contrast sensitivity in the inlay eye when compared to the multifocals , and better binocular contrast sensitivity when compared to all 3 intraocular lenses .


Crystalens AO was superior in uncorrected intermediate vision compared to the KAMRA inlay , but not in distance-corrected intermediate , and was worse in near vision .


The multifocals were superior in near vision at their respective optimum near focus points , but worse in intermediate vision compared to both KAMRA inlay and Crystalens AO .


The demonstrated performance of these devices should be considered , along with subjects ' visual demands and expectations , degree of crystalline lens dysfunction , and other ocular characteristics , in guiding the selection of small-aperture corneal inlay or specific intraocular lens in the correction of presbyopia .


To compare the effect of two lipid emulsions on the development of retinopathy of prematurity in very low birth weight infants .


Randomized controlled study .


Eighty very low birth weight infants receiving parenteral nutrition from the first day of life were evaluated .


One of the two lipid emulsions were used in the study infants : Group 1 ( n = 40 ) received fish-oil based lipid emulsion ( SmofLipid ) and Group 2 ( n = 40 ) soybean oil based lipid emulsion ( Intralipid ) .


The development of retinopathy of prematurity and the need for laser photocoagulation were assessed .


The maternal and perinatal characteristics were similar in both groups .


The median ( range ) duration of parenteral nutrition [ 14days ( 10-28 ) vs 14 ( 10-21 ) ] and hospitalization [ 34days ( 20-64 ) vs 34 ( 21-53 ) ] did not differ between the groups .


Laboratory data including complete blood count , triglyceride level , liver and kidney function tests recorded before and after parenteral nutrition also did not differ between the two groups .


In Group 1 , two patients ( 5.0 % ) and in Group 2 , 13 patients ( 32.5 % ) were diagnosed with retinopathy of prematurity ( OR : 9.1 , 95 % CI 1.9-43 .8 , p = 0.004 ) .


One patient in each group needed laser photocoagulation , without significant difference .


Multivariate analysis showed that only receiving fish-oil emulsion in parenteral nutrition decreased the risk of development of retinopathy of prematurity [ OR : 0.76 , 95 % CI ( 0.06-0 .911 ) , p = 0.04 ] .


Premature infants with very low birth weight receiving an intravenous fat emulsion containing fish oil developed less retinopathy of prematurity .


Cannabis-dependent participants with depressive disorder are less likely to achieve abstinence with venlafaxine-XR ( VEN-XR ) treatment .


Individuals on VEN-XR reported more severe withdrawal , despite not reducing their smoking behavior .


We hypothesized that withdrawal-like symptoms , likely medication side effects , led to continued marijuana smoking in this group .


We conducted a secondary analysis using Marijuana Withdrawal Checklist ( MWC ) scores and urine THC to test whether severity of withdrawal-like symptoms mediates the relationship between VEN-XR treatment and continued marijuana smoking .


We included 103 participants ( VEN-XR = 51 , Placebo = 52 ) .


Marijuana use was dichotomized into smoking ( THC > 100 ng/ml ) and non-smoking ( THC 100 ng/ml ) weeks .


MWC scores were obtained weekly .


We used three models in a regression based mediation analysis .


The estimated risk of smoking marijuana was greater for individuals on VEN-XR in weeks 7-9 , even when controlling for MWC scores ( week 7 Risk Difference ( RD ) = 0.11 , p = 0.034 ; week 8 RD = 0.20 , p = 0.014 ) , and higher scores mediated this effect .


In weeks 10 and 11 , the estimated effect was stronger ( week 10 RD = 0.03 , p = 0.380 ; week 11 RD = 0.07 , p = 0.504 ) , and worse withdrawal-like symptoms more fully accounted for continued marijuana smoking in the VEN-XR group , according to the models .


Individuals treated with VEN-XR had more severe withdrawal-like symptoms , which mediated their continued marijuana smoking .


Noradrenergic agents , such as VEN-XR , may negatively impact treatment outcomes in cannabis-dependent patients attempting to reduce or stop their use .


NRTI-sparing regimens may avoid long-term mitochondrial , bone and renal toxicities and maintain viral suppression .


In the RADAR study , 85 antiretroviral-nave HIV-infected patients were randomized to receive either raltegravir ( RAL ) ( n = 42 ) or tenofovir/emtricitabine ( TDF/FTC ) ( n = 43 ) , each with ritonavir-boosted darunavir ( DRV/r ) .


Virologic efficacy was assessed at weeks 24 and 48 .


Bone mineral density ( BMD ) was assessed by dual energy X-ray absorptiometry ( DXA ) scan at baseline and week 48 , and bone turnover markers ( BTM ) assessed at weeks 0 , 16 and 48 .


Using an intention-to-treat analysis , 62.5 % of RAL subjects and 83.7 % of TDF/FTC subjects were responders ( VL < 48 copies/mL ) at week 48 ( p = 0.045 ; chi-square test ) .


The proportions of patients achieving VL < 200 copies/mL were similar : 72.5 % and 86.0 % ( p = 0.175 ) .


Premature treatment discontinuation was the main cause for failure .


No treatment-emergent resistance was observed .


Changes from baseline in RAL vs. TDF/FTC for CD4 + ( +199 vs. +216 cells/L , p = 0.63 ) , total cholesterol/HDL ( -0.25 vs. -0.71 mg/dL ( p = 0.270 ) , and eGFR ( -4.4 vs. -7.9 ml/min , p = 0.44 ) were comparable between groups .


Changes in subtotal BMD to week 48 were : +9.2 with RAL vs. -7 g/cm2 with TDF/FTC ( p = 0.002 ) .


Mean CTX changes were +0.04 vs. +0.24 ng/mL ( p = 0.001 ) , and mean P1NP changes were +3.59 vs. +30.09 ng/mL ( p = 0.023 ) .


BTM changes at week 16 predicted change in BMD by week 48 ( R = -0.394 , p = 0.003 for CTX ; and R = -0.477 , p < 0.001 for P1NP ) .


The NRTI-sparing regimen RAL+DRV / r did not achieve similar week 48 virologic efficacy compared with TDF/FTC + DRV/r , but was better with regard to markers of bone health .


ClinicalTrials.gov NCT 00677300 .


Many clinical trials have shown that 3-hydroxy-3-methylglutaryl-coenzyme A ( HMG-CoA ) reductase inhibitors ( statins ) can significantly reduce coronary artery disease in both primary and secondary prevention .


A recent study showed that aggressive lipid-lowering therapy with strong statins could achieve coronary artery plaque regression , as evaluated with gray-scale intravascular ultrasound ( IVUS ) .


However , it is unknown whether coronary plaque regression and stabilization are reinforced when eicosapentaenoic acid ( EPA ) is used with a strong statin .


We aim to assess patients with stable angina or acute coronary syndrome who had undergone successful percutaneous coronary intervention ( PCI ) with integrated backscatter IVUS ( IB-IVUS ) guidance .


They will be randomly allocated to receive pitavastatin ( 4mg ) , or pitavastatin ( 4mg ) plus EPA ( 1800mg ) , and prospectively followed for 6-8 months .


The primary endpoint will be changes in tissue characteristics in coronary plaques , evaluated by IB-IVUS , and secondary endpoints will include absolute changes in coronary plaque volume , serum lipid levels , and inflammatory markers .


The safety profile will also be evaluated .


The combination therapy of EPA and pitavastatin for regression of coronary plaque evaluated by IB-IVUS ( CHERRY ) study will be the first multicenter study using IB-IVUS to investigate the effects of combination therapy with pitavastatin and EPA on coronary plaque volume and tissue characteristics .


The choice between unipolar and bipolar hemiarthroplasty for treatment of displaced intracapsular femoral neck fractures in elderly patients still remains controversial .


Our objective was to compare series of elderly individuals with a displaced femoral neck fracture treated with either a cemented , modular unipolar or bipolar prosthesis with the same femoral component .


A prospective , randomized controlled trial of 175 displaced intracapsular femoral neck fractures in patients over 65 years was randomly allocated to unipolar ( 88 ) and to bipolar ( 87 ) hemiarthroplasty group .


The primary end point was implant survival .


Secondary end points included difference in ambulatory ability and mortality .


Follow-up evaluations were performed at 2 months , at 1 , 3 and 5 years .


Implant and patient survival were followed until 2/2012 .


Survival analyses were performed using Kaplan-Meier curves with log-rank test .


Data were analyzed using Chi-square test and Student 's t test .


Unipolar hemiarthroplasty group had a significantly higher dislocation rate when compared with bipolar hemiarthroplasty group .


This did not translate into difference in revision rates at 8 years .


Prosthetic survival ship was 0.98 ( 95 % Cl 0.94-1 .00 ) in the unipolar group and 0.97 ( 95 % Cl 0.93-1 .00 ) in the bipolar group .


There were no statistically significant differences in ambulatory ability , possibility to return home mortality or early radiological acetabular erosion .


There were significantly more one-time dislocations in the unipolar group , but there was no difference in incidence of revisions due to recurrent dislocations .


The overall mortality rate was 6 % at 30 days , 9 % at 90 days , 16 % at 12 months , and 53 % at 5 years .


There was no difference in mortality between the groups .


However , both provide elderly patients with equal ambulatory ability and low revision rate at medium-term follow-up .


To evaluate if nebulized 4 % lidocaine alone provides adequate laryngopharyngeal anesthesia for office-based diagnostic transnasal tracheoscopy ( TNT ) .


A retrospective chart review ( January 2011 to June 2014 ) and a prospective case series ( July 2014 to December 2014 ) of patients who underwent diagnostic TNT were performed at a university voice and swallowing center .


TNT cases were categorized by method of topical laryngopharyngeal anesthesia : nebulized 4 % lidocaine and 4 % lidocaine drip ( phase I ) and nebulized 4 % lidocaine only ( phase II ) .


TNT was performed a total of 59 times on 38 patients .


Eleven ( 69 % ) of 16 phase I TNT procedures involved significant patient discomfort and severe cough following the lidocaine drip .


Forty-two ( 98 % ) of 43 phase II TNT procedures were completed comfortably ; 1 case required additional anesthesia by lidocaine drip .


Retrospectively , 100 % ( n = 8 ) of patients who underwent both phase I and phase II TNTs were noted to prefer anesthesia with nebulizer alone .


In a prospective case series of 14 phase II TNT cases , 6 ( 86 % ) of 7 patients who previously underwent phase I TNT reported preference for anesthesia with nebulizer alone .


Nebulized lidocaine appears to provide sufficient laryngopharyngeal anesthesia for diagnostic TNT .


It is preferred by patients over laryngeal drip .


Investigate the 5-year longitudinal changes in bone curvature after acute anterior cruciate ligament ( ACL ) injury , and identify predictors of such changes .


In the KANON-trial ( ISRCTN 84752559 ) , 111/121 young active adults with an acute ACL tear to a previously un-injured knee had serial 1.5 T MR images from baseline ( within 5 weeks from injury ) to 5 years after injury .


Of these , 86 had ACL reconstruction ( ACLR ) performed early or delayed , 25 were treated with rehabilitation alone .


Measures of articulating bone curvature were obtained from computer-assisted segmentation of MR images .


Curvature ( mm ( -1 ) ) was determined for femur , tibia , medial/lateral femur , trochlea , medial/lateral tibia .


Age , sex , treatment , BMI , meniscal injury , osteochondral fracture on baseline MR images were tested for association .


Over 5 years , curvature decreased in each region ( P < 0.001 ) suggesting flattening of convex shapes and increased concavity of concave shapes .


A higher BMI was associated with flattening of the femur ( P = 0.03 ) , trochlea ( P = 0.007 ) and increasing concavity of the lateral tibia ( LT ) ( P = 0.011 ) .


ACLR , compared to rehabilitation alone , was associated with flatter curvature in the femur ( P < 0.001 ) , medial femoral condyle ( P = 0.006 ) and trochlea ( P = 0.003 ) .


Any meniscal injury at baseline was associated with a more flattened curvature in the femur ( P = 0.038 ) , trochlea ( P = 0.039 ) , lateral femoral condyle ( P = 0.034 ) and increasing concavity of the LT ( P = 0.048 ) .


ACL injury is associated with significant changes in articulating bone curvature over a 5 year period .


Higher BMI , baseline meniscal injury and undergoing ACL reconstruction ( as distinct from undergoing rehabilitation alone ) are all associated with flattening of the articulating bone .


To test the effects of integrating health protection and health promotion with a continuous improvement system ( Kaizen ) on proximal employee outcomes ( health promotion , integration , and Kaizen ) and distal outcomes ( workability , productivity , self-rated health and self-rated sickness absence ) .


Twelve units in a county hospital in Sweden were randomized to control or intervention groups using a quasiexperimental study design .


All staff ( approximately 500 ) provided self-ratings in questionnaires at baseline , and a 12 - and 24-month follow-up ( response rate , 79 % to 87.5 % ) .


There was a significant increase in the proximal outcomes over time in the intervention group compared with the control group , and a trend toward improvement in the distal outcomes workability and productivity .


Integration seems to promote staff engagement in health protection and promotion , as well as to improve their understanding of the link between work and health .


Laparoscopy cholecystectomy for the surgical treatment of cholelithiasis has been considered the gold standard .


The referred pain to the shoulder ( omalgia ) may be present to 63 % of the patients and limits outpatient management .


The study was to evaluate the usefulness of acetazolamide associated with ketorolac for reduction of the omalgia to minimally invasive treatment .


We performed a clinical trial , randomized , double blind in patients undergoing laparoscopic cholecystectomy to assess the reduction of post-operative omalgia comparing ketorolac and ketorolaco + acetazolamida .


31 patients in each group were studied .


The study group : 250 mg of acetazolamide before anesthetic induction and 30 mg of ketorolac in the immediate postoperative period .


one tablet of placebo prior to the anesthetic induction and 30 mg of ketorolac in the immediate postoperative .


The presence of omalgia was assessed using the analog visual scale .


The variables recorded included : age , sex , flow of carbon dioxide intra-abdominal pressure , surgical time , urgent or elective surgery , omalgia , severity of pain evaluated by analog visual scale , addition analgesia .


Both groups were homogeneous and statistical analysis showed no differences in the variables studied .


The omalgia in the study group was presented at 9.67 % and in the group control was the 58.06 % ( p < 0.001 ) .


250 mg oral acetazolamide associated 30 mg of ketorolac reduces significantly the development of omalgia in patients undergoing laparoscopic cholecystectomy .


Using a monoclonal antibody with greater affinity for IgE than omalizumab , we examined whether more complete suppression of IgE provided greater pharmacodynamic effects , including suppression of skin prick responses to allergen .


To explore the pharmacokinetics , pharmacodynamics and safety of QGE031 ( ligelizumab ) , a novel high-affinity humanized monoclonal IgG1 anti-IgE .


Preclinical assessments and two randomized , placebo-controlled , double-blind clinical trials were conducted in atopic subjects .


The first trial administered single doses of QGE031 ( 0.1-10mg / kg ) or placebo intravenously , while the second trial administered two to four doses of QGE031 ( 0.2 - 4mg/kg ) or placebo subcutaneously at 2-week intervals .


Both trials included an open-label omalizumab arm .


Sixty of 73 ( 82 % ) and 96 of 110 ( 87 % ) subjects completed the intravenous and subcutaneous studies , respectively .


Exposure to QGE031 and its half-life depended on the QGE031 dose and serum IgE level .


QGE031 had a biexponential pharmacokinetic profile after intravenous administration and a terminal half-life of approximately 20days .


QGE031 demonstrated dose - and time-dependent suppression of free IgE , basophil FcRI and basophil surface IgE superior in extent ( free IgE and surface IgE ) and duration to omalizumab .


At Day 85 , 6weeks after the last dose , skin prick wheal responses to allergen were suppressed by > 95 % and 41 % in subjects treated subcutaneously with QGE031 ( 2mg/kg ) or omalizumab , respectively ( P < 0.001 ) .


Urticaria was observed in QGE031 - and placebo-treated subjects and was accompanied by systemic symptoms in one subject treated with 10mg/kg intravenous QGE031 .


There were no serious adverse events .


These first clinical data for QGE031 , a high-affinity IgG1 anti-IgE , demonstrate that increased suppression of free IgE compared with omalizumab translated to superior pharmacodynamic effects in atopic subjects , including those with high IgE levels .


QGE031 may therefore benefit patients unable to receive , or suboptimally treated with , omalizumab .


Hospitalization for worsening heart failure ( HF ) is known to increase mortality and morbidity risk and has been frequently used as an endpoint in randomized clinical trials .


Whether outpatient management of HF exacerbation carries similar prognostic and therapeutic information is less well known , but could be important for the design of trials that use HF hospitalization as an endpoint .


MADIT-CRT randomized patients with mild HF symptoms to resynchronization therapy vs. control with an average follow-up of 3.3 years and a total of 191 deaths .


HF events were centrally adjudicated for receiving i.v. decongestive therapy in an outpatient setting , or an augmented HF regimen during a hospital stay .


Patients were compared according to whether their first HF was an out - or inpatient event .


The first primary event was non-fatal outpatient HF , non-fatal inpatient HF , and death in 52 , 331 , and 78 patients , respectively .


Patients with inpatient HF tended to be older and more likely to have HF of ischaemic aetiology than subjects who developed outpatient HF events .


The risk of death following either type of non-fatal HF events was extremely high [ hazard ratio ( HR ) 12.4 , 95 % confidence interval ( CI ) 9.1-16 .9 for inpatient HF ; HR 10.7 , 95 % CI 6.1-18 .7 for outpatient HF ] compared with subjects without non-fatal HF events .


Allocation to CRT-D was associated with significant reduction in both types of HF .


Outpatient management of worsening HF portends a high risk of death , similar to inpatient HF events , and may be equally sensitive to the effects of therapy .


These findings suggest that outpatient HF events should be considered in publicly reported outcomes measures and future HF clinical trials .


NCT01294449 .


To observe the effects of anesthetic intervention with small-dose lidocaine and ketamine on early postoperative cognitive function in elderly patients undergoing surgeries for gastrointestinal tumors .


Sixty patients ( ASA I-III , aged 63-82 years ) scheduled for surgeries for gastrointestinal tumors were randomized into intervention group ( n = 30 ) and control group ( n = 30 ) .


After intravenous induction and tracheal intubation , the patients in the interventional group received intravenous infusion of 0.5 mg/kg lidocaine and 0.5 mg/kg ketamine , followed by continuous infusion of lidocaine at the rate of 0.5 mgkg ( -1 ) h ( -1 ) till the end of the operation ; the patients in the control group received saline infusion only .


The cognitive function of the patients was assessed at 3 day before and 2 day after the operation using comprehensive neuro-psychological tests .


Peripheral venous blood was extracted before anesthesia induction ( T0 ) , at the end of the surgery ( T1 ) , and at 1 day ( T2 ) and 2 days ( T3 ) after the operation for measurement of serum S-100 protein , NSE and IL-6 levels using ELISA .


The difference between the test scores before and after the operation ( X values ) was significantly smaller in the intervention group than in the control group ( P < 0.05 ) .


The intervention group showed a significantly lower incidence rate of postoperative cognitive dysfunction ( POCD ) than the control group ( 6.7 % vs 33.3 % , P < 0.05 ) .


Compared with the control group , the intervention group exhibited significantly lower serum levels of S-100 protein , NSE and IL-6 at T1 ( P < 0.05 ) , significantly lower NSE and IL-6 levels at T2 ( P < 0.05 ) time point , and significantly lower IL-6 level at T3 ( P < 0.05 ) .


Intravenous injection of small-dose lidocaine and ketamine during the operation can reduce the incidence of POCD in elderly patients undergoing surgeries for gastrointestinal tumors possibly in relation to decreased serum S-100 , NSE and IL-6 levels .


The impact of interferon beta ( IFN ) therapy on a patient 's quality of life ( QoL ) has not been completely clarified .


This multicenter , independent , observational and longitudinal study was aimed to evaluate the impact of different pharmaceutical formulations of IFN-1a on QoL in patients affected by relapsing-remitting multiple sclerosis ( RRMS ) .


The multiple sclerosis quality of life-54 questionnaire was used to assess patients ' QoL .


394 ( 66 % ) patients completed the two-year study ; 152 were treated with IFN-1a i.m. weekly injected ( group a ) , 152 with IFN-1a 44 g s.c. injected three times a week ( group b ) and 90 were untreated ( group c ) .


After two years , a significant increase was found in the physical health composite score ( = +3.1 in group a , = +3 in group b , p < 0.05 in both ) , mental health composite score ( = +4.7 in group a , = +5.5 in group b , p < 0.001 in both ) , in eight MSQoL sub-items of group a and in seven sub-items in group b. Conversely , the untreated group showed a slight decrease in seven domains .


The variable `` therapy with DMDs '' was associated with improved QoL .


QoL of RRMS could be improved by IFN-1a treatment , despite natural history data which seem to demonstrate that QoL could get worse over the time .


Physical activity is believed to exert a beneficial effect on functional and cognitive rehabilitation of patients with stroke .


Although studies have addressed the impact of physical exercise in cerebrovascular prevention and rehabilitation , the underlying mechanisms leading to improvement are poorly understood .


Training-induced increase of cerebral perfusion is a possible mediating mechanism .


Our exploratory study aims to investigate training-induced changes in blood biomarker levels and magnetic resonance imaging in patients with subacute ischemic stroke .


This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized , controlled PHYS-STROKE trial .


In PHYS-STROKE , 215 patients with subacute stroke ( hemorrhagic and ischemic ) receive either 4weeks of physical training ( aerobic training , 5 times a week , for 50minutes ) or 4weeks of relaxation sessions ( 5 times a week , for 50minutes ) .


A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging ( MRI ) scans and an additional blood draw before and after the PHYS-STROKE intervention .


Imaging scans will address parameters of cerebral perfusion , vessel size imaging , and microvessel density ( the Q factor ) to estimate the degree of neovascularization in the brain .


Blood tests will determine several parameters of immunity , inflammation , endothelial function , and lipometabolism .


Primary objective of this study is to evaluate differential changes in MRI and blood-derived biomarkers between groups .


Other endpoints are next cerebrovascular events and functional status of the patient after the intervention and after 3months assessed by functional scores , in particular walking speed and Barthel index ( co-primary endpoints of PHYS-STROKE ) .


Additionally , we will assess the association between functional outcomes and biomarkers including imaging results .


For all endpoints we will compare changes between patients who received physical fitness training and patients who had relaxation sessions .


This exploratory study will be the first to investigate the effects of physical fitness training in patients with ischemic stroke on MRI-based cerebral perfusion , pertinent blood biomarker levels , and functional outcome .


The study may have an impact on current patient rehabilitation strategies and reveal important information about the roles of MRI and blood-derived biomarkers in ischemic stroke .


NCT01954797 .


We previously reported decreased transfusions and donor exposures in preterm infants randomized to Darbepoetin ( Darbe ) or erythropoietin ( Epo ) compared with placebo .


As these erythropoiesis-stimulating agents ( ESAs ) have shown promise as neuroprotective agents , we hypothesized improved neurodevelopmental outcomes at 18 to 22 months among infants randomized to receive ESAs .


We performed a randomized , masked , multicenter study comparing Darbe ( 10 g/kg , 1/week subcutaneously ) , Epo ( 400 U/kg , 3/week subcutaneously ) , and placebo ( sham dosing 3/week ) given through 35 weeks ' postconceptual age , with transfusions administered according to a standardized protocol .


Surviving infants were evaluated at 18 to 22 months ' corrected age using the Bayley Scales of Infant Development III .


The primary outcome was composite cognitive score .


Assessments of object permanence , anthropometrics , cerebral palsy , vision , and hearing were performed .


Of the original 102 infants ( 946 196 g , 27.7 1.8 weeks ' gestation ) , 80 ( 29 Epo , 27 Darbe , 24 placebo ) returned for follow-up .


The 3 groups were comparable for age at testing , birth weight , and gestational age .


After adjustment for gender , analysis of covariance revealed significantly higher cognitive scores among Darbe ( 96.2 7.3 ; mean SD ) and Epo recipients ( 97.9 14.3 ) compared with placebo recipients ( 88.7 13.5 ; P = .01 vs ESA recipients ) as was object permanence ( P = .05 ) .


No ESA recipients had cerebral palsy , compared with 5 in the placebo group ( P < .001 ) .


No differences among groups were found in visual or hearing impairment .


Infants randomized to receive ESAs had better cognitive outcomes , compared with placebo recipients , at 18 to 22 months .


Darbe and Epo may prove beneficial in improving long-term cognitive outcomes of preterm infants .


Current academic literature suggests that school gardening programmes can provide an interactive environment with the potential to change children 's fruit and vegetable intake .


This is the first cluster randomised controlled trial ( RCT ) designed to evaluate whether a school gardening programme can have an effect on children 's fruit and vegetable intake .


The trial included children from 23 schools ; these schools were randomised into two groups , one to receive the Royal Horticultural Society ( RHS ) - led intervention and the other to receive the less involved Teacher-led intervention .


A 24-hour food diary ( CADET ) was used to collect baseline and follow-up dietary intake 18months apart .


Questionnaires were also administered to evaluate the intervention implementation .


A total of 641 children completed the trial with a mean age of 8.1 years ( 95 % CI : 8.0 , 8.4 ) .


The unadjusted results from multilevel regression analysis revealed that for combined daily fruit and vegetable intake the Teacher-led group had a higher daily mean change of 8g ( 95 % CI : -19 , 36 ) compared to the RHS-led group -32 g ( 95 % CI : -60 , -3 ) .


However , after adjusting for possible confounders this difference was not significant ( intervention effect : -40 g , 95 % CI : -88 , 1 ; p = 0.06 ) .


The adjusted analysis of process measures identified that if schools improved their gardening score by 3 levels ( a measure of school gardening involvement - the scale has 6 levels from 0 ` no garden ' to 5 ` community involvement ' ) , irrespective of group allocation , children had , on average , a daily increase of 81g of fruit and vegetable intake ( 95 % CI : 0 , 163 ; p = 0.05 ) compared to schools that had no change in gardening score .


This study is the first cluster randomised controlled trial designed to evaluate a school gardening intervention .


The results have found very little evidence to support the claims that school gardening alone can improve children 's daily fruit and vegetable intake .


However , when a gardening intervention is implemented at a high level within the school it may improve children 's daily fruit and vegetable intake by a portion .


Improving children 's fruit and vegetable intake remains a challenging task .


ISRCTN11396528 .


Epidermal growth factor receptor tyrosine kinase inhibitors are effective as first-line therapy for advanced non-small cell lung cancer patients harboring epidermal growth factor receptor mutations .


However , it is unknown whether second-line platinum-based chemotherapy after epidermal growth factor receptor tyrosine kinase inhibitor therapy could lead to better outcomes .


We evaluated the efficacy of second-line platinum-based chemotherapy after gefitinib for advanced non-small cell lung cancers harboring epidermal growth factor receptor mutations ( the NEJ002 study ) .


Seventy-one non-small cell lung cancers , treated with gefitinib as first-line therapy and then receiving platinum-based chemotherapy as second-line therapy were evaluated in NEJ002 .


Patients were evaluated for antitumor response to second-line chemotherapy by computed tomography according to the criteria of the Response Evaluation Criteria in Solid Tumors group ( version 1.0 ) .


Of the 71 patients receiving platinum-based chemotherapy after first-line gefitinib , a partial response was documented in 25.4 % ( 18/71 ) , stable disease in 43.7 % ( 31/71 ) and progression of disease in 21.1 % ( 15/71 ) .


The objective response and disease control rates were 25.4 % ( 18/71 ) and 69 % ( 49/71 ) , respectively .


There was no significant difference between first - and second-line chemotherapy in objective response and disease control rates for advanced non-small cell lung cancer harboring activating epidermal growth factor receptor mutations .


In the analysis of epidermal growth factor receptor mutation types , the objective responses of deletions in exon 19 and a point mutation in exon 21 ( L858R ) were 27.3 % ( 9/33 ) and 28.1 % ( 9/32 ) , respectively , but these differences between objective response rates were not significant .


The efficacy of second-line platinum-based chemotherapy followed at progression by gefitinib was similar to first-line platinum-based chemotherapy , and epidermal growth factor receptor mutation types did not influence the efficacy of second-line platinum-based chemotherapy .


This study aims to compare histopathological results of conventional surgery and transoral radiofrequency ablation in patients with early stage laryngeal carcinoma .


Between January 2006 and May 2010 , 36 patients ( 34 males , 2 females ; mean age 61.6 years ; range 43 to 77 years ) who underwent partial laryngectomy in our clinic were retrospectively analyzed .


All patients were randomized to partial laryngectomy with radiofrequency ablation or conventional surgery .


Hoarseness due to early stage T1 and selected T2N0 vocal cord lesions was an indication for surgery .


Of 20 patients receiving conventional surgery , 14 underwent partial laryngectomy , while six patients underwent cordectomy for the excision of tumors .


Tumors were excised by transoral radiofrequency ablation in 16 patients .


We observed thermal artifacts in four patients undergoing conventional surgery and in 13 patients undergoing transoral radiofrequency ablation .


There was also hemorrhage in 16 patients undergoing conventional surgery and in seven patients undergoing transoral radiofrequency ablation .


Histopathological examination revealed that the surgical margins were safe in 10 patients after radiofrequency ablation .


The specimens obtained from six patients showed thermal artifacts which complicated histopathological examination .


Sixteen ( 80 % ) of 20 conventional surgery patients and nine ( 56 % ) of 16 radiofrequency ablation patients had safe surgical margins .


In radiofrequency ablation , the surgical zone must be larger than in conventional surgery due to the high risk of tissue damage and complicated histopathological examination .


Serum vascular endothelial growth factor-C ( VEGF-C ) , transforming growth factor - ( TGF - ) , and interleukin ( IL ) -6 promote angiogenesis and metastases in colon cancer .


We hypothesized that patients who received propofol-epidural anaesthesia ( PEA ) would exhibit decreases in VEGF-C , TGF - , and IL-6 and an increase in IL-10 compared with patients who received general anaesthesia ( GA ) .


Colon cancer surgery patients were randomly assigned to the PEA ( n = 20 ) or GA ( n = 20 ) group .


Serum VEGF-C , TGF - , IL-6 , and IL-10 levels before surgery and 24 h after surgery were measured .


Patients who received PEA showed decreases in VEGF-C [ 526 ( 261 ) vs 834 ( 304 ) pg ml ( -1 ) , P = 0.001 ] , TGF - ( P = 0.027 ) , and IL-6 ( P = 0.007 ) and an increase in IL-10 ( P = 0.001 ) 24 h after surgery compared with patients subjected to GA. .


The visual analogue scale scores at rest and during coughing at 2 and 24 h after operation were significantly lower in PEA patients ( P < 0.05 ) .


PEA reduces serum concentrations of factors associated with angiogenesis during colon cancer surgery .


ChiCTR-TRC-13003146 ( www.chictr.org ) .


Cytomegalovirus ( CMV ) infection is a leading cause of illness and death in patients who have undergone allogeneic hematopoietic-cell transplantation .


Available treatments are restricted by clinically significant toxic effects and drug resistance .


In this phase 2 study , we evaluated the effect of letermovir ( also known as AIC246 ) , a new anti-CMV drug with a novel mechanism of action , on the incidence and time to onset of prophylaxis failure in CMV-seropositive recipients of allogeneic hematopoietic-cell transplants from matched related or unrelated donors .


From March 2010 through October 2011 , we randomly assigned 131 transplant recipients in a 3:1 ratio to three sequential study cohorts according to a double-blind design .


Patients received oral letermovir ( at a dose of 60 , 120 , or 240 mg per day , or matching placebo ) for 12 weeks after engraftment .


The primary end point was all-cause prophylaxis failure , defined as discontinuation of the study drug because of CMV antigen or DNA detection , end-organ disease , or any other cause .


Patients underwent weekly surveillance for CMV infection .


The reduction in the incidence of all-cause prophylaxis failure was dose-dependent .


The incidence of prophylaxis failure with letermovir , as compared with placebo , was 48 % versus 64 % at a daily letermovir dose of 60 mg ( P = 0.32 ) , 32 % at a dose of 120 mg ( P = 0.01 ) , and 29 % at a dose of 240 mg ( P = 0.007 ) .


Kaplan-Meier time-to-onset profiles for prophylaxis failure showed a significant difference in the comparison of letermovir at a dose of 240 mg per day with placebo ( P = 0.002 ) .


The safety profile of letermovir was similar to placebo , with no indication of hematologic toxicity or nephrotoxicity .


Letermovir , as compared with placebo , was effective in reducing the incidence of CMV infection in recipients of allogeneic hematopoietic-cell transplants .


The highest dose ( 240 mg per day ) had the greatest anti-CMV activity , with an acceptable safety profile .


( Funded by AiCuris ; ClinicalTrials.gov number , NCT01063829 . )


Bleeding from peptic ulcers can be effectively and safely treated with endoscopic hemoclips therapy .


However , due to certain limiting factors of hemoclips , application of combination with another endoscopic method may give better results .


The aim of this study was to examine the efficacy and safety of endoscopic hemoclips therapy and to evaluate potential benefits of this therapy combined with epinephrine in the treatment of bleeding peptic ulcers .


This prospective randomized study included 70 patients with bleeding gastric or duodenal ulcer .


In 34 of the patients endoscopic hemoclips therapy was applied ( group I ) , and in 36 of them a combined therapy of hemoclips and epinephrine ( group II ) .


Initial hemostasis was achieved in most patients treated with endoscopic hemoclips therapy ( 94.1 % ) as well as in the patients treated with combination therapy ( 97.2 % ) .


After initial hemostasis achieved rebleeding occurred in 3 ( 9.3 % ) patients treated with hemoclips and in 2 ( 5.7 % ) patients treated with combination therapy , but this difference was not statistically significant ( p > 0.05 ) .


The difference in the achieved final hemostasis between the group I ( 91.1 % ) and the group II ( 94.4 % ) was not statistically significant .


Also , the differences between the two groups of patients in the need for blood transfusions , length of hospital stay , need for surgery and mortality were not statistically significant ( p > 0.05 ) .


Endoscopic hemoclips therapy is effective and safe in treatment of bleeding peptic ulcers .


Combination therapy of hemoclips and epinephrine has no advantage over hemoclips monotherapy .


To assess whether vaginal misoprostol or oral nonsteroidal anti-inflammatory drugs ( NSAIDs ) reduce pain during and 30 minutes after hysterosalpingography ( HSG ) .


Randomized prospective , controlled , parallel-group study ( Canadian Task Force classification I ) .


University teaching hospital .


One hundred sixty-eight women with primary infertility who underwent HSG for evaluation of infertility .


Patients were randomly assigned to 1 of 3 groups .


Group 1 received 200 g misoprostol vaginally 6 hours before HSG ; group 2 , 50 mg diclofenac potassium orally 45 to 60 minutes before HSG ; and group 3 , no medication .


The primary outcome of the study was to evaluate the severity of pain during and 30 minutes after the procedure using a visual analog scale ( VAS ) ranging from 1 ( very favorable ) to 10 ( very unfavorable ) .


The secondary outcomes were to assess the rate of completion and the vasovagal effects including nausea , vomiting , sweating , weakness , syncope , hypotension , and bradycardia .


There was no statistically significant difference in the median ( 25 % -75 % ) VAS pain scores between women administered vaginal misoprostol ( median , 6.7 cm ; range , 4.7-9 cm ) and the control group ( median , 6.7 cm ; range , 4.6-8 .8 cm ) during the HSG .


However , women in the NSAID group ( median , 5.5 cm ; range , 3-7 .6 cm ) reported less pain than did those in the misoprostol group ( p = .009 ) and the control group ( p = .03 ) .


At 30 minutes after HSG , there was no significant difference in the median VAS pain scores between patients administered NSAIDs ( median , 2.3 cm ; range , 1.4-4 .2 ) or misoprostol ( median , 2.3 cm ; range , 1.2-4 .4 ) and the control group ( median , 2.2 cm ; range , 1.3-4 .4 ) .


There is no benefit in terms of pain reduction with the use of misoprostol during HSG or at 30 minutes after the procedure .


However , NSAIDs are associated with pain relief during the HSG procedure .


Oral glucocorticoids can prevent acute mountain sickness ( AMS ) .


Whether inhaled budesonide ( BUD ) can prevent AMS remains unknown .


Our aim was to investigate the effectiveness of BUD in AMS prevention .


Eighty subjects were randomly assigned to receive budesonide ( BUD , inhaled ) , procaterol tablet ( PT ) , budesonide/formoterol ( BUD/FM , inhaled ) , or placebo tablet ( n = 20 in each group ) .


Subjects were treated for 3 days before ascending from 500 m to 3700 m within 2.5 h by air .


Lake Louis AMS questionnaire , blood pressure , heart rate , and oxygen saturation ( SpO2 ) were examined at 20 , 72 , and 120 h after high-altitude exposure .


Pulmonary function was measured at 20 h after exposure .


Compared with placebo , BUD significantly reduced the incidence of AMS ( 70 % vs. 25 % at 20 h , p < 0.05 ; both 10 % vs. 5 % at 72 and 120 h , both p > 0.05 ) without side effects .


The relative risk was 0.357 , and the risk difference was 0.45 .


Mean SpO2 was higher in BUD , BUD/FM , and PT groups than in the placebo group at 20 h ( p < 0.05 ) .


SpO2 in all 80 subjects dropped after ascent ( 98.1 % to 88.12 % , p < 0.01 ) and increased gradually , but it was still lower at 120 h than at baseline ( 92.04 % vs. 98.1 % , p < 0.01 ) .


Pulmonary function did not differ among the four groups at 20 h.


BUD can prevent AMS without side effects .


The alleviation of AMS may be related to increased blood oxygen levels rather than pulmonary function .


The effects of supplementation of the omega-3 fatty acids eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) on prevalence and severity of depression were evaluated in patients after a myocardial infarction .


A cross-sectional evaluation ( posttest-only design ) within the prospective , randomized , controlled , multicenter OMEGA trial was performed in patients after myocardial infarction at 12 months ' follow-up ( N = 2,081 ; age , mean = 64 years ; men , 76.7 % ; women , 21.8 % ) from April 2005 to June 2007 .


Patients received supplementation with ethyl esters 90 ( 460-mg EPA and 380-mg DHA ) or placebo for 12 months .


Depression was assessed with the Beck Depression Inventory-II ( BDI-II ) ; a BDI-II cutoff score of 14 was used as diagnosis of depression .


When the total population was evaluated , no effects of EPA/DHA supplementation on depressive symptoms according to BDI-II score ( mean [ SD ] ) could be demonstrated : EPA/DHA ( n = 1,046 ) , 7.1 ( 6.9 ) ; placebo ( n = 1,035 ) , 7.1 ( 7.0 ) ; P = .7 .


The post hoc analyses of depressed patients with and without antidepressants revealed a tendency toward an antidepressant effect in patients with EPA/DHA supplementation as monotherapy : EPA/DHA ( n = 125 ) , 19.4 ( 5.8 ) ; placebo ( n = 113 ) , 19.9 ( 5.1 ) ; P = .07 .


However , in depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants , a clinically relevant antidepressant effect was demonstrated : EPA/DHA ( n = 33 ) , 20.9 ( 7.1 ) ; placebo ( n = 29 ) , 24.9 ( 8.5 ) ; P < .05 .


EPA/DHA supplementation in the total sample of patients after myocardial infarction had no effect on depressive symptoms .


The clinically relevant antidepressant effect in the subgroup of depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants that was revealed in the post hoc analysis might provide a basis for a controlled , prospective trial of omega-3 augmentation of antidepressants in patients after myocardial infarction .


ClinicalTrials.gov identifier : NCT00251134 .


This paper seeks to determine the relevance and likely salience of cognitive behaviour therapy ( CBT ) as a treatment for melancholic depression .


The findings of a randomised trial comparing 12-week outcome of 18 patients with melancholic depression receiving antidepressant medication and 11 receiving CBT were evaluated , and qualitative explanations for the outcomes were provided principally by the treating CBT practitioners .


In the trial , CBT showed no improvement in depression severity in the first four weeks and then some level of improvement over the subsequent eight weeks .


Outcome was superior for those receiving antidepressant medication at 12 weeks and was first demonstrated at four weeks .


The benefits of CBT appeared to be in settling anxiety , dealing with cognitive processing of having a melancholic depression and addressing any personality vulnerabilities .


While a pilot study , our qualitative reports indicate that CBT may provide a useful role in managing melancholia as an adjunct to antidepressant medication .


Future studies examining such a combination treatment model should seek to determine if indicative data provided here argue for a sequencing model of CBT being introduced after medication has addressed core biological underpinnings .


This study identified distinct tobacco use trajectories across 18months in 943 veteran smokers with posttraumatic stress disorder ( PTSD ) in order to describe quit and relapse patterns , examine associations between trajectory groups on baseline characteristics and cessation service utilization , and explore group differences in mental health outcomes .


Veterans who participated in a multisite , randomized trial of integrated smoking cessation care were grouped using k-means clustering based on reported daily tobacco use between baseline and 18months .


Four trajectory clusters were identified : no reduction ( 62 % ) , temporary reduction ( 11 % ) , late sustained reduction ( 9 % ) and early sustained reduction ( 18 % ) .


Median quit times in the early , late , temporary , and no reduction groups were 451 , 141.5 , 97 , and 2days , respectively .


Compared to the early reduction group , the temporary reduction group exhibited higher baseline depression ( p < 0.01 ) and anxiety ( p < 0.01 ) , but did not differ in treatment received , with both groups attending significantly more cessation visits ( p < 0.001 ) and more likely to receive recommended pharmacotherapy ( p < 0.001 ) than the no reduction group between baseline and 6months .


The early reduction group exhibited lower depression relative to the no reduction ( p < 0.01 ) and temporary reduction ( p < 0.01 ) groups across all assessments between baseline and 18months .


Differences were not observed between groups in depressive or PTSD symptom change over time between baseline and 18months .


Tobacco use trajectories among treated smokers with PTSD vary distinctly .


Characteristics of identified subgroups may lead to targeted interventions among smokers with PTSD and potentially other psychiatric disorders .


Uveal melanoma is the most common primary intraocular malignancy in adults .


Despite successful control of the primary tumor , metastatic disease will ultimately develop in approximately 50 % of patients , with the liver being the most common site for metastases .


The median survival for patients with liver metastases is between 6 and 12months , and no treatment has in randomized trials ever been shown to prolong survival .


A previous phase II trial using isolated hepatic perfusion ( IHP ) has suggested a 14-month increase in overall survival compared with a historic control group consisting of the longest surviving patients in Sweden during the same time period ( 26 versus 12months ) .


This is the protocol for a multicenter phase III trial randomizing patients with isolated liver metastases of uveal melanoma to IHP or best alternative care ( BAC ) .


Inclusion criteria include liver metastases ( verified by biopsy ) and no evidence of extra-hepatic tumor manifestations by positron emission tomography-computed tomography ( PET-CT ) .


The primary endpoint is overall survival at 24months , with secondary endpoints including response rate , progression-free survival , and quality of life .


The planned sample size is 78 patients throughout five years .


Patients with isolated liver metastases of uveal melanoma origin have a short expected survival and no standard treatment option exists .


This is the first randomized clinical trial to evaluate IHP as a treatment option with overall survival being the primary endpoint .


ClinicalTrials.gov registration number : NCT01785316 ( registered 1 February 2013 ) .


EudraCT registration number : 2013-000564-29 .


To compare the influence of low-frequency ( 10-25 Hz ) versus higher ( 60-80 Hz ) frequency stimulation of the pedunculopontine nucleus area ( PPNa ) on akinaesia , freezing of gait and daytime sleepiness .


We included nine patients with Parkinson 's disease ( PD ) and severe gait disorders .


In this double-blind randomised cross-over study , patients were assessed after 24 h of PPNa stimulation .


Assessments included the motor part of the Unified Parkinson 's Disease Rating Scale , the Epworth Sleepiness Scale and a behavioural gait assessment .


Compared with 60-80 Hz , 10-25 Hz PPNa stimulation led to decreased akinaesia , gait difficulties and daytime sleepiness in 7/9 patients .


In one patient , these symptoms were aggravated under 10-25 Hz stimulation compared with 60-80 Hz .


These results are in keeping with the benefits of chronic PPNa stimulation for gait and postural difficulties in patients with PD , and with regard to the influence of patients ' clinical characteristics , differential neuronal loss in the PPNa and electrode location .


We conclude that in patients with PPNa stimulation , low frequency provides a better outcome than high-frequency stimulation .


The present study is a prospective randomized double-blinded study that designed to evaluate and compare the effectiveness of postoperative pain control and incidence of complications between ilioinguinal/iliohypogastric nerve block and intravenous morphine in paediatric patients undergoing unilateral orchidopexy in day surgery unit .


Seventy patients aged 2-12 years were randomly allocated to two groups of thirty five .


One group received intravenous morphine 100 microgram/kg before skin incision and the other group had ilioinguinal/iliohypogastric nerve block with 0.25 ml/kg bupivacaine 0.5 % also before skin incision .


All patients have received standardized anaesthesia .


Postoperative pain was assessed using 0 - 10 scale at 0 , 1 , 2 , 3 and 4 postoperative hours , also the intraoperative fentanyl requirements , time to first postoperative analgesia , the total number of paracetamol doses and any extra analgesic requirements were recorded , side effects like respiratory depression , vomiting , itching , inguinal hematoma and lower limb weakness were assessed during the first 24 hours .


Pain scores were significantly lower in the morphine group compared to the block group on admission and one hour after admission to the postanaesthesia care unit , no significant difference in pain score on 2nd , 3rd and 4th postoperative hours .


The total number of intraoperative fentanyl doses was significantly higher in the block group compared to morphine group , there was no significant difference in the duration of analgesia , number of total paracetamol doses , need for extra analgesics in both groups over the 24 postoperative hours .


None of the seventy patients experienced postoperative respiratory depression , inguinal hematoma or lower limb weakness , but significantly more patients in morphine group experienced vomiting and itching compared to the block group .


Ilioinguinal/iliohypogastric nerve block and intravenous morphine administered following general anaesthesia for unilateral orchidopexy in day surgery unit are safe and effective in controlling postoperative pain , morphine analgesia had a higher incidence of postoperative vomiting and itching .


Right heart evaluation on coronary computed tomography angiography ( CCTA ) is underutilized due to nonopacification of the right heart chambers and poor endocardial resolution .


We analyzed feasibility and reproducibility of right heart functional analysis by measuring CCTA-based tricuspid annular plane systolic excursion ( CT-TAPSE ) on ECG-gated CCTA and correlated the results with 2D transthoracic echocardiography ( TTE ) - derived TAPSE ( Echo-TAPSE ) .


CT-TAPSE was measured on a total population of 41 patients who had CCTA and TTE performed within 6 months of each other .


Two independent CCTA readers performed analysis on reformatted four-chamber view .


Intra - and inter-observer variability analysis was performed on 16 randomly selected patients .


Correlative ( Spearman 's R ) and Bland-Altman analysis was used to assess the level of agreement between the 2 methods and to compare CT-TAPSE with Echo-TAPSE .


CT-TAPSE measured by Readers 1 and 2 on 16 randomly selected patients , demonstrated excellent intra-observer and inter-observer agreement , with very close correlation ( R > 0.80 and 2-tailed P-value of < 0.001 ) .


When tested in the entire study population of 41 patients , CT-TAPSE correlated closely with Echo-TAPSE ( R = 0.738 , P < 0.001 ) .


Bland-Altman analysis indicated that the 2 methods provided similar measures as majority of values lay within the 95 % confidence limits .


Based on abnormal Echo-TAPSE cutoff value of < 16 mm , CT-TAPSE identified impaired right ventricle ( RV ) function with sensitivity of 82 % and specificity of 93 % , respectively .


We demonstrated feasibility and reproducibility of assessing TAPSE on coronary CTA .


RV functional analysis utilizing CT-TAPSE is simple and reproducible methodology , and is in close agreement with Echo-TAPSE .


To observe the therapeutic effect of Yangxue Tongluo Recipe ( YTR ) combined with immunosuppressive agents in the treatment of rheumatoid arthritis ( RA ) .


Totally 88 RA patients were randomly assigned to the treatment group [ 47 cases , YTR combined Methotrexate ( MTX ) + Leflunomide ( LEF ) treatment ] and the control group ( 41 cases , MTX + LEF therapy ) .


All patients received 12-week treatment .


Clinical symptoms and signs , laboratory tests [ erythrocyte sedimentation rate ( ESR ) , rheumatoid factor ( RF ) , and C reactive protein ( CRP ) ] , and adverse reactions were observed before and after treatment .


The total effective rate was 91.5 % ( 43/47 cases ) in the treatment group , and the total effective rate was 75.6 % ( 31/41 cases ) in the control group .


There was statistical difference between the two groups ( P < 0.05 ) .


The morning stiffness , the rest pain , the number of tender joints , the number of swollen joints , tender joint index , swollen joint index , ESR , RF , and CRP were significantly improved in the two groups after treatment ( P < 0.01 ) .


Besides , clinical symptoms and signs , ESR , RF , and CRP were more improved in the treatment group after treatment , when compared with those in the control group ( P < 0.05 ) .


Gastrointestinal discomfort was the main adverse reaction in the two groups , but the occurrence was lower in the treatment group than in the control group ( P > 0.05 ) .


The clinical efficacy of YTR combined MTX + LEF in the treatment of RA was better than using Western medicine alone .


It was more safe with less adverse reactions .


Randomised studies have demonstrated a beneficial effect of pre-surgical treatment with somatostatin analogues ( SSA ) in acromegaly when evaluated early postoperatively .


The objective of this study was to evaluate the long-term surgical cure rates .


Newly diagnosed patients were randomised to direct surgery ( n = 30 ) or 6-month pretreatment with octreotide LAR ( n = 32 ) .


The patients were evaluated 1 and 5 years postoperatively .


Cure was defined as normal IGF1 levels and by normal IGF1 level combined with nadir GH < 2mU/l in an oral glucose tolerance test , all without additional post-operative treatment .


A meta-analysis using the other published randomised study with long-term analyses on preoperative SSA treatment was performed .


The proportion of patients receiving post-operative acromegaly treatment was equal in the two groups .


When using the combined criteria for cure , 10/26 ( 38 % ) macroadenomas were cured in the pretreatment group compared with 6/25 ( 24 % ) in the direct surgery group 1 year postoperatively ( P = 0.27 ) , and 9/22 ( 41 % ) vs 6/22 ( 27 % ) macroadenomas , respectively , 5 years postoperatively ( P = 0.34 ) .


In the meta-analysis , 16/45 ( 36 % ) macroadenomas were cured using combined criteria in the pretreatment group vs 8/45 ( 18 % ) in the direct surgery group after 6-12 months ( P = 0.06 ) , and 15/41 ( 37 % ) vs 8/42 ( 19 % ) , respectively , in the long-term ( P = 0.08 ) .


This study does not prove a beneficial effect of SSA pre-surgical treatment , but in the meta-analysis a trend towards significance can be claimed .


A potential favourable , clinically relevant response can not be excluded .


Patients with chronic severe asthma ( CSA ) have a crippling disease and current available treatments are not satisfactory .


Thus , management of CSA remains a major unmet need .


Although the evidence from existing randomized controlled trials fails to support a definite role for immunomodulatory drugs in these patients due to major methodologic drawbacks , findings with low-dose methotrexate ( MTX ) are encouraging .


However , larger and well-designed clinical trials are required to establish the beneficial role of MTX in CSA , and for the detection of the key characteristics of those who are going to respond to this drug .


Patients will be recruited from the accessible asthmatic patients lists of tertiary referral centers .


All patients will meet the stringent diagnostic criteria for CSA , including the requirement for the regular use of Global Initiative for Asthma ( GINA ) Global Strategy for Asthma Management and Prevention Step 5 medications ( oral prednisone and/or omalizumab ) .


The experimental design of the proposed study will take the form of a double-blind parallel-randomized placebo-controlled trial consisting of a total of eight visits , including run-in and run-out periods .


Patients will be randomly allocated to receive either MTX or a matched placebo once a week as an add-on therapy to their existing medication after run-in .


Physiological , laboratory and clinical assessments will be measured regularly throughout the study and compared with baseline assessments .


We expect that MTX will reduce Step 5 medications dosage in patients with CSA without compromising the overall disease control .


Improvement in several indicators of asthma severity and control will be also investigated .


ClinicalTrials.gov Identifier : NCT02124226 ( assigned 25 April 2014 ) .


Spinal anaesthesia performed at levels higher than the L3-4 intervertebral space may result in spinal cord injury .


Our aim was to establish a protocol to reduce the chance of spinal anaesthesia performed at or above L2-3 .


One hundred and ten consenting patients at 32weeks of gestation or greater scheduled for non-emergency caesarean section under spinal anaesthesia were randomly allocated to have needle insertion performed at an intervertebral space determined by one of two landmark techniques .


In Group A , if the intercristal line intersected an intervertebral space , this space was selected or if the intercristal line intersected a spinous process the space immediately above was selected .


In Group B , if the intercristal line intersected an intervertebral space or a spinous process , the intervertebral space immediately below was chosen .


The actual intervertebral space chosen was identified using ultrasound by a blinded investigator .


In Group A , an intervertebral space at or above L2-3 was marked in 25 ( 45.5 % ) patients compared with 4 ( 7.3 % ) in Group B ( P < 0.001 ) .


In 5/55 ( 9.1 % ) patients in Group A , the intervertebral space initially chosen was L1-2 whereas this occurred in no patient in Group B.


There was no difference between groups in number of needle passes or attempts , onset of block at 5 , 10 and 15min or need for rescue analgesia .


Our data suggest that when performing spinal anaesthesia in pregnant patients , if the intercristal line intersects an intervertebral space then the space below should be chosen and if the intercristal line intersects a spinous process then the interspace below should be chosen .


This will reduce the incidence of spinal anaesthesia performed at or above L2-3 .


The effectiveness of continuous renal replacement therapy ( CRRT ) increases when unplanned circuit failure is prevented .


Adequate anticoagulation is an important component .


Although heparin is the predominating anticoagulant , calcium chelation with citrate is an alternative , but systemic calcium monitoring and supplementation increase the complexity of CRRT .


We assessed efficacy and safety of citrate delivery via integrated software algorithms against an established regional heparin protocol .


Prospective computer randomisation allocated eligible patients to regional citrate or heparin between April and December 2012 .


Citrate fluids were Prismocitrate 18 mmol/L predilution and Prism0cal B22 dialysate .


Hemosol B0 was the default fluid for heparin .


The primary outcome was filter running time .


Electively terminated circuits were censored .


Intention-totreat ( ITT ) and per-protocol analyses were performed .


Filter survival was compared by log-rank tests and hazard ratios were explored with a mixed-effects Cox model .


221 filters were analysed from 30 patients ( of whom 19 were randomly allocated to citrate filters and 11 to heparin filters ) .


Patients randomly allocated to citrate were older , sicker , with a higher male : female ratio , but of similar weight .


Mortality was 37 % in the citrate arm and 27 % in the heparin arm .


All deaths were attributed to underlying disease .


Significant crossover occurred from the citrate arm to use of heparin .


Median filter survival , by ITT , was not significantly different ( citrate , 34 hours ; heparin , 30.7 hours ; P = 0.58 ) .


Per-protocol survival favoured citrate ( citrate , 42.1 hours ; heparin , 24 hours ; ( 2 ) = 8.1 ; P = 0.004 ) .


Considerable variation in filter life existed between patients , and between vascular access sites within patients .


Safety end points were reached in one heparin and three citrate patients .


Although the per-protocol results favoured citrate when it was actually delivered , the significant crossover between treatment arms hampered more definitive conclusions .


Until further studies support improved patient outcomes , increased complexity and complications suggest that anticoagulation choice be made using patient-specific indications .


To assess objective and subjective outcomes of retrograde intrarenal surgery ( RIRS ) and extracorporeal shock wave lithotripsy ( SWL ) for the treatment of intermediate size ( 1-2 cm ) inferior calyceal ( IC ) stones in a prospective randomized fashion .


Between March 2011 and January 2013 , 70 symptomatic adults who had isolated IC stone between 10 and 20 mm underwent RIRS or SWL by computer-generated pseudorandom assignment ( 1:1 ) .


Success rate , mean procedure time , hospital stay , pain score on day 1 and 2 using visual analog scale , analgesic requirement after discharge , complications , retreatment rate , auxiliary procedure , and patient-reported outcomes ( using self-made nonvalidated questionnaire ) were compared .


Baseline parameters and mean stone size ( SWL 16.45 2.28 mm , RIRS 15.05 3.56 mm ; P = .0542 ) were comparable .


Success rate was significantly higher after a single session of RIRS compared with 3 sessions of SWL ( 85 % vs 54 % ; P = .008 ) .


Retreatment rate ( 65 % vs 5.7 % ; P = .0001 ) and auxiliary procedure ( 45 % vs 8 % ; P = .0009 ) were significantly higher in SWL .


Pain score on postoperative day 1 and 2 was significantly higher in RIRS , but patients with SWL required significantly more analgesics afterward .


Most of the complications were of Clavien grade I and/or II in both groups .


Average time to return to normal activity and voiding symptoms were significantly higher in RIRS .


Overall satisfaction score ( 2.17 1.24 vs 2.82 1.17 ; P = .026 ) was significantly higher in RIRS than SWL .


For the treatment of intermediate size IC calculi , RIRS is superior to SWL in terms of objective and subjective outcomes .


To compare macular hole ( MH ) closure and visual acuity improvement after vitrectomy using SF6 versus C3F8 gas tamponade .


The secondary purposes were to report the cumulative incidence of cataract development at 1 year after MH surgery and the proportion of complications .


Prospective , randomized study .


Thirty-one patients were prospectively randomized to the SF6 group and 28 patients to the C3F8 group .


Preoperative data included MH minimum diameter , Early Treatment Diabetic Retinopathy Study ( ETDRS ) best corrected visual acuity ( BCVA ) , cataract staging , and intraocular pressure ( IOP ) measurement .


Postoperative data included optical coherence tomography confirmation of the closure at 6 weeks and 1 year , and ETDRS BCVA and cataract development/extraction , both 1 year after the MH surgery .


Primary MH closure was achieved in 93.3 % in the SF6 group and 92.9 % in the C3F8 group .


Mean ETDRS BCVA improved by 17.7 letters in the SF6 and 16.9 letters in the C3F8 group .


The difference in cumulative incidence of cataract development and extraction between both groups was not statistically significant .


Regardless of the dye used , similar results were achieved .


Finally , the proportion of adverse events was similar in both groups .


MH surgery with SF6 gas achieves results similar to C3F8 in terms of visual acuity improvement , MH closure , cataract development/extraction , and adverse events .


Patients with latent autoimmune diabetes in adults ( LADA ) express autoantibodies against the 65-kDa isoform of GAD ( GADA ) .


Intervention with recombinant human GAD65 formulated with aluminium hydroxide ( GAD-alum ) given twice subcutaneously to LADA patients at intervals of 4 weeks was safe and did not compromise - cell function in a Phase II clinical trial .


GADA affinity has been shown to predict progression to type 1 diabetes .


Here , we asked whether GADA affinity was affected by the GAD65 antigen-specific vaccination and/or associated with - cell function in participants of this trial .


GADA affinity was measured in sera of 46 LADA patients obtained prior to the first week and 20 weeks after the second injection with GAD-alum or placebo using competitive binding experiments with [ 125I ] - labeled and unlabeled human GAD65 .


At baseline , GADA affinities ranged from 1.9 10 ( 7 ) to 5.0 10 ( 12 ) L/mol ( median 2.8 10 ( 10 ) L/mol ) and were correlated with GADA titers ( r = 0.47 ; P = 0.0009 ) , fasting ( r = -0.37 ; P = 0.01 ) and stimulated ( r = -0.40 ; P = 0.006 ) C-peptide concentrations , and HbA1c ( r = 0.39 ; P = 0.007 ) .


No significant changes in affinity were observed from baseline to week 24 .


Patients with GADA affinities in the lower first quartile ( < 4 10 ( 9 ) L/mol ) had better preserved fasting C-peptide concentrations at baseline than those with higher affinities ( mean 1.02 vs. 0.66 nmol/L ; P = 0.004 ) and retained higher concentrations over 30 months of follow-up ( mean 1.26 vs. 0.62 nmol/L ; P = 0.01 ) .


Intervention with GAD-alum in LADA patients had no effect on GADA affinity .


Our data suggest that patients with low GADA affinity have a prolonged preservation of residual - cell function .


Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus ( T2DM ) .


The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM .


A pilot randomized , controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy .


The primary outcome was glycemic control measured with hemoglobin A1c < 7 % at delivery .


Maternal and neonatal outcomes were compared between groups .


In this study , 8 women received metformin and 11 received insulin .


All women in both groups achieved glycemic control by delivery ( HgbA1c : metformin 5.965.88 vs. insulin 6.340.92 % ) .


There were similar rates of cesarean delivery , birth weights , neonatal intensive care unit admissions , respiratory distress syndrome , and neonatal dextrose treatment between groups .


There was one case of fetal macrosomia in the insulin group , one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy .


In this pilot study , glycemic control was achieved in women who received metformin and insulin .


Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM .


This in vitro study compared the effect of a concave with a straight-bevelled cavity margin on the microleakage of Class V composite resin restorations in primary teeth .


Standardised Class V cavity preparations were made in vitro on the buccal ( all margins placed in enamel ) and on the lingual ( margins placed in enamel and cementum ) surfaces of 20 sound primary molars .


The teeth were randomly assigned to two groups of 10 each : in Group 1 , a concave bevel was made with a high-speed No. 04 tungsten carbide bur and in Group 2 , a straight bevel was made with a high-speed No. 556 tungsten carbide bur .


The teeth were restored incrementally with Adper Single Bond 2 ( 3M ) adhesive and Filtek Z 350 ( 3M ) composite resin .


All specimens were subsequently thermocycled and immersed in 50 % silver nitrate solution .


Microleakage of the restorations was then assessed by silver penetration .


A grading scale of 0 to 4 was used as the scoring criterion .


At the enamel margins no statistically significant differences were observed between the two groups ( p >> 0.05 ) .


Occlusal walls in enamel , in both groups , exhibited less leakage than the cervical walls in cementum ( p < 0.01 ) and Group 1 showed better results than Group 2 in decreasing microleakage at the cementum margins ( p < 0.05 ) .


Based on the results , it was concluded that concave-beveled cavity preparations may reduce but did not totally eliminate microleakage at the cementum margins of Class V composite resin restorations in primary teeth .


Computerized tomography DICOM file can be relatively easily transformed to a virtual 3D model .


With the help of additional software we are able to create the mirrored model of an undamaged orbit and on this basis produce an individual implant for the patient Authors decided to apply implants with any thickness , which are authors own invention to obtain volumetric support and more stable orbital wall reconstruction outcome .


Material of choice was ultra-high molecular weight polyethylene ( UHMWPE ) .


The aim of this study was to present and compare functional results of individual reconstructions of orbital wall using either titanium mesh or ultra-high molecular weight polyethylene .


57 consecutive patients affected by orbital wall fracture ( 46 males , 11 females , mean age 3414 year ) were treated in Department of Maxillofacial Surgery from 2010 to 2012 .


In the first group we used patient specific treatment by titanium mesh shaped on a 3D printed model of a mirrored intact orbit ( 37 orbits ) or by individually manufactured UHMW-PE implantby CAM milling in second group ( 20 orbits ) .


All of these patients were subjected to preoperative helical computerized tomography and consultation of an ophthalmologist ( including binocular single vision loss test - BSVL ) .


Further on , patients were operated under general anaesthesia using transconjuctival approach .


BSVL was again evaluated post-operationally in 1 month and 6 months later .


Functional treatment results ( BSVL ) for both groups were similar in 1 month as well as 6 months post operational time .


There was no statistically significant difference between these two groups .


This study of 6 months functional result assessment of pre-bent individual implants and CNC milled ultra-high molecular weight polyethylene of the orbital wall has shown it to be a predictable reconstruction method .


Individually shaped UHMWPE seems to be as good as pre-bent titanium mesh .


To assess the effect of a capsular tension ring ( CTR ) on the postoperative anterior chamber depth ( ACD ) .


Vienna Institute for Research in Ocular Surgery , Department of Ophthalmology , Hanusch Hospital , Vienna , Austria .


Prospective observer - and patient-masked randomized trial .


Bilateral small-incision cataract surgery with implantation of a hydrophobic acrylic single-piece intraocular lens ( IOL ) ( Tecnis ZCB00 ) was performed using a standard technique .


Each patient received a CTR in 1 eye ( CTR group ) and no CTR in the fellow eye ( control group ) .


The ACD was measured preoperatively with biometry ( IOLMaster 500 ) and at 1 hour and 12 weeks postoperatively using partial coherence interferometry ( ACMaster ) .


The subjective refraction was assessed at 12 weeks .


Sixty eyes ( 30 patients ) were included .


Preoperatively , the mean axial length was 23.36 mm 1.55 ( SD ) ( range 21.01 to 29.46 mm ) in the CTR group and 23.37 1.70 mm ( range 21.14 to 28.84 mm ) in the control group and the mean ACD was 3.06 0.45 mm ( range 2.25 to 4.16 mm ) and 3.03 0.47 mm ( range 2.18 to 4.10 mm ) , respectively .


The differences were not statistically significant ( P = .148 and P = .074 , respectively ) .


The mean postoperative ACD was 4.83 0.46 mm ( range 3.84 to 5.76 mm ) in the CTR group and 4.81 0.43 mm ( range 3.67 to 5.65 mm ) in the control group .


The difference between the groups was not statistically significant ( P = .329 ) .


Implantation of a CTR had no significant influence on the postoperative axial IOL position .


No author has a financial or proprietary interest in any material or method mentioned .


Transfused blood may have immunomodulatory and proinflammatory effects .


We report the first randomized study exploring whether leukoreduced red blood cell ( RBC ) transfusion increases circulating proinflammatory mediators , markers of neutrophil activation , and the acute-phase response in critically ill adults .


Eighty-four patients were recruited from six general intensive care units in the United Kingdom as part of a laboratory study nested within a parallel-group randomized trial comparing restrictive and liberal leukoreduced RBC transfusion strategies in critically ill patients aged more than 55years with measured hemoglobin concentrations of not more than 90g/L ( ClinicalTrials.gov NCT00944112 ) .


Forty-one patients received transfusion and 43 did not receive transfusion .


Plasma was sampled at baseline , 6 hours , and 24 hours after randomization or transfusion , and concentrations of interleukin ( IL ) -1 , IL-2 , IL-4 , IL-5 , IL-6 , IL-8 , IL-10 , IL-12-p70 , interferon - , tumor necrosis factor - , human neutrophil elastase , soluble L-selectin , and C-reactive protein were measured using cytokine bead array analysis and an enzyme-linked immunosorbent assay .


Patients who received transfusion did not have significantly different inflammatory biomarker plasma concentrations at the time points compared to those who did not receive transfusion , with the exception of IL-8 concentrations at 24 hours , which were reduced in the transfused group ( p = 0.02 ) .


After adjustment for baseline inflammatory biomarker concentrations , there were no significant differences between patients who received transfusion and those who did not .


Concentrations of measured biomarkers were not significantly increased during the first 24 hours after leukoreduced RBC transfusion .


These data do not support the contention that leukoreduced RBC transfusion is associated with a proinflammatory response in the general adult critically ill population .


To evaluate the influence of estrogen therapy and estrogen-progestin therapy on homocysteine and C-reactive protein levels in postmenopausal women .


In total , 99 postmenopausal women were included in this double-blind , randomized clinical trial and divided into three groups : Group A used estrogen therapy alone ( 2.0 mg of 17-estradiol ) , Group B received estrogen-progestin therapy ( 2.0 mg of 17 - estradiol +1.0 mg of norethisterone acetate ) and Group C received a placebo ( control ) .


The length of treatment was six months .


Serum measurements of homocysteine and C-reactive protein were carried out prior to the onset of treatment and following six months of therapy .


After six months of treatment , there was a 20.7 % reduction in homocysteine levels and a 100.5 % increase in C-reactive protein levels in the group of women who used estrogen therapy .


With respect to the estrogen-progestin group , there was a 12.2 % decrease in homocysteine levels and a 93.5 % increase in C-reactive protein levels .


Our data suggested that hormone therapy ( unopposed estrogen or estrogen associated with progestin ) may have a positive influence on decreasing cardiovascular risk due to a significant reduction in homocysteine levels .


Optimal pain management after video-assisted thoracic surgery ( VATS ) remains an open issue .


We prospectively studied the analgesic effect of intercostal analgegia ( ICA ) by comparison with epidural analgesia .


Twenty-two patients undergoing VATS procedures were randomly divided into ICA ( n = 8 ) or epidural ( n = 14 ) group .


Postoperatively 2 ml x hr ( -1 ) of 0.2 % ropivacaine was delivered continuously through intercostal or epidural catheter .


Moreover , each group received the equal dose of fentanyl ( 0.25 x g ( -1 ) .


kg ( -1 ) x hr ( -1 ) ) intravenously or epidurally .


When no pain relief was achieved , iv fentanyl was given as a rescue .


Requirement of additional fentanyl and pain score using a visual analogue scale ( VAS ) were documented for 19 hours .


The mean pain scores at rest , mobilization and with coghing were slightly higher in the ICA group .


Total additional dose of iv fentanyl was significantly different between the groups ( ICA 147 41 vs Epidural 39 15 g ; P = 0.015 ) .


Pain scores and fentanyl requirements spread over the lower range .


The mean of VAS in ICA group was less than 5 even at coughing , suggesting clinically irrelevant .


In patients with coagulopathy , multimodal approach using intercostal analgesia supplemented by intravenous patient-controlled analgesia may be an alternative to epidural analgesia for postoperative pain management .


A/H3N2 variant ( H3N2v ) influenza may sustain human-to-human transmission , and an available candidate vaccine would be important .


In this phase I , randomized , observer-blind , dose-ranging study , 627 healthy subjects 3 years of age were randomized to receive 2 vaccinations with H3N2c cell-culture-derived vaccine doses containing 3.75 g , 7.5 g , or 15 g hemagglutinin antigen of H3N2v with or without MF59 ( registered trademark of Novartis AG ) adjuvant ( an oil-in-water emulsion ) .


This paper reports Day 43 planned interim data .


Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose ; the Center for Biologics Evaluation Research and Review ( CBER ) licensure criteria were met for all groups .


Subjects with prevaccination hemagglutination inhibition titers < 10 and children 3 - < 9 years achieve CBER criteria only after receiving 2 doses of nonadjuvanted H3N2c vaccine .


Highest antibody titers were observed in the 7.5 g + 0.25 mL MF59 groups in all age cohorts .


MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events , predominately mild or moderate .


A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines , especially for pediatric populations .


ClinicalTrials.gov identifier NCT01855945 ( http://clinicaltrials.gov/ct2/show/NCT01855945 ) .


Insomnia , which is very common in patients with chronic low back pain ( LBP ) , has long been viewed as a pain symptom that did not merit specific treatment .


Recent data suggest that adding insomnia therapy to pain-targeted treatment should improve outcome ; however , this has not been empirically tested in LBP or in any pain condition treated with a standardized pain medication regimen .


We sought to test the hypothesis that adding insomnia therapy to pain-targeted treatment might improve sleep and pain in LBP .


Double-blind , placebo-controlled , parallel-group , 1-mo trial .


Duke University Medical Center Outpatient Sleep Clinic .


Fifty-two adult volunteers with LBP of at least 3 mo duration who met diagnostic criteria for insomnia ( mean age : 42.5 y ; 63 % females ) .


Subjects were randomized to eszopiclone ( ESZ ) 3 mg plus naproxen 500 mg BID or matching placebo plus naproxen 500 mg twice a day .


ESZ SIGNIFICANTLY IMPROVED TOTAL SLEEP TIME ( MEAN INCREASE : ESZ , 95 min ; placebo , 9 min ) ( primary outcome ) and nearly all sleep measures as well as visual analog scale pain ( mean decrease : ESZ , 17 mm ; placebo , 2 mm ) ( primary pain outcome ) , and depression ( mean Hamilton Depression Rating Scale improvement ESZ , 3.8 ; placebo , 0.4 ) compared with placebo .


Changes in pain ratings were significantly correlated with changes in sleep .


The addition of insomnia-specific therapy to a standardized naproxen pain regimen significantly improves sleep , pain , and depression in patients with chronic low back pain ( LBP ) .


The findings indicate the importance of administering both sleep and pain-directed therapies to patients with LBP in clinical practice and provide strong evidence that improving sleep disturbance may improve pain .


clinicaltrials.gov identifier : NCT00365976 .


The present study investigated the immediate effects of low frequency repetitive transcranial magnetic stimulation ( LF-rTMS ) combined with reach-to-grasp ( RTG ) training of the paretic hand in individuals with chronic stroke .


Fourteen participants were randomly assigned to receive LF-rTMS or sham stimulation conditions .


All participants underwent RTG training after the stimulation .


Corticospinal excitability ( CE ) of the non-lesioned hemisphere , the total time of the wolf motor function test ( WMFT ) for dexterity tasks , maximum aperture , and movement time of RTG actions were evaluated at baseline , after the stimulation , and after RTG training .


Significant differences between interaction ( group x time ) were found in the total time of WMFT The CE of non-lesioned hemisphere diminished after LF-rTMS and showed moderate correlation with the reduction in time of RTG actions after the stimulation .


The total time of WMFT and RTG actions reduced after motor training only in the LF-rTMS group .


No change was observed in maximum aperture in either group .


The application of LF-rTMS combined with RTG training enhanced the training effect as evidenced by faster movement for the dexterity tasks of the paretic hand than RTG training alone .


The findings suggested the benefit of LF-rTMS for enhancing the training effects in stroke rehabilitation .


Whether therapeutic drug monitoring of biologic therapy can predict the efficacy of adalimumab to prevent postoperative Crohn 's disease recurrence is unknown .


To investigate whether adalimumab trough levels and anti-adalimumab antibodies correlate with endoscopic and clinical outcomes in a series of patients treated with prophylactic adalimumab monotherapy after resective surgery .


Post hoc analysis of a randomized , mesalamine-controlled trial .


Adalimumab trough levels and antibodies were analysed every 8 weeks for 2 years using an homogeneous mobility shift assay .


At two years , 1/6 patient had clinical recurrence and 1/6 patient had endoscopic and clinical recurrence .


At baseline ( 9.5 vs. 14.4 mcg/mL ) and during follow-up [ 7.5 ( 4.4-9 .8 ) vs. 13.9 ( 8.9-23 .6 ) mcg/mL , p < 0.01 ] , median adalimumab trough levels in patients with clinical or endoscopic recurrence were lower than in those who maintained remission .


Persistent antibodies-against-adalimumab were detected in the patient with both endoscopic and clinical recurrence .


Measurement of adalimumab trough levels and anti-adalimumab antibodies after surgery could be useful to further reduce postoperative recurrence .


We showed previously that rabbit ATG induction induces a strong decrease of CD4 + T cells together with impaired in vitro IL-2 secretion up to 1 year post-transplant .


To further characterize long-term immunological effects of ATG induction 2 and 5 years post-transplant , we used sensitive intracellular cytokine analysis in the same prospective study of 84 renal transplant recipients ( ATG , n = 44 ) .


A significantly increased frequency of severe infectious disease ( HR = 2.0 , p = 0.027 ) as well as suppressed T cell functions were found within 2 years after ATG induction but not beyond ( logistic regression ( logreg ) : CD4 cell IL-10 responses , p = 0.064 ; T cell proliferation , p = 0.038 ) .


Impaired T cell proliferation at 2 years was associated with occurrence of severe infection ( p = 0.017 ) .


Importantly , a strong and persistent decrease of CD4 cell counts ( p < 0.0005 at 5 years ) was independently associated with ATG induction ( logreg p = 0.002 ) but not related to functional CD4 cell impairment ( helper activity/cytokine production ) or an increased risk of infection .


Severe infection up to 2 years after ATG induction was associated with impaired T cell proliferative capacity but not with the profound decline in CD4 cell counts that occurred after ATG induction and persisted up to 5 years .


To compare anxiolysis produced by intranasal clonidine with intranasal midazolam as premedication in children undergoing surgery .


Double-blind randomized controlled study .


Tertiary-care hospital , July 2009 to June 2010 .


60 American Society of Anesthesiologists physical status I-II surgical patients aged 1-10 yr .


Participants randomly allocated to receive either intranasal clonidine 4 mcg/kg ( Group I ) with atropine or intranasal midazolam 0.3 mg/kg ( Group II ) .


Primary : satisfactory anxiolysis at 30 min after drug administration .


Secondary : satisfactory mask acceptance , times of onset of sedation and anxiolysis , drug acceptance , level of sedation , wake-up score and side effects .