Left atrial pressure was significantly higher in the suction group .


Tracheal suctioning resulted in higher Pao2/FiO2 levels ( 122 21 vs. 78 10 mm Hg ) and ventilator efficiency index ( 0.3 0.05 vs. 0.16 0.03 ) .


Two lambs in the no-suction group required inhaled nitric oxide .


Lung 3-nitrotyrosine levels were higher in the suction group ( 0.65 0.03 ng/g protein ) compared with the no-suction group ( 0.47 0.06 ) .


Tracheal suctioning improves oxygenation and ventilation .


Suctioning does not improve pulmonary/systemic hemodynamics or oxidative stress in an ovine model of acute meconium aspiration with asphyxia .


A randomized controlled trial was conducted to find out whether antiviral therapy in patients with hepatitis B-related hepatocellular carcinoma ( HCC ) improves long-term survival after hepatic resection .


Despite advances in surgery and in multidisciplinary treatment , there is still no effective adjuvant treatment to prevent HCC recurrence after R0 resection for HCC .


Whether antiviral therapy is useful in reducing postoperative HCC recurrence is unclear .


Between May 2007 and April 2008 , patients who received R0 hepatic resection for HBV-related HCC were randomly assigned to receive no treatment ( the control group , n = 100 ) or antiviral therapy ( adefovir 10 mg/d , the antiviral group , n = 100 ) .


The baseline clinical , laboratory , and tumor characteristics of the 2 groups were comparable .


The 1 - , 3 - , and 5-year recurrence-free survival rates for the antiviral group and the control group were 85.0 % , 50.3 % , 46.1 % and 84.0 % , 37.9 % , 27.1 % , respectively .


The corresponding overall survival rates for the 2 groups were 96.0 % , 77.6 % , 63.1 % and 94.0 % , 67.4 % , 41.5 % , respectively .


The recurrence-free survival and overall survival for the antiviral group were significantly better than the control group ( P = 0.026 , P = 0.001 ) .


After adjusting for the confounding prognostic factors in a Cox model , the relative risks of recurrence and death for antiviral treatment were 0.651 [ 95 % confidence interval ( CI ) : 0.451-0 .938 ; P = 0.021 ] and 0.420 ( 95 % CI : 0.271-0 .651 ; P < 0.001 ) .


Antiviral therapy was an independent protective factor of late tumor recurrence ( HR = 0.348 , 95 % CI : 0.177-0 .687 ; P = 0.002 ) but not of early tumor recurrence [ hazard ratio ( HR ) = 0.949 , 95 % CI : 0.617-1 .459 ; P = 0.810 ] .


In patients with hepatitis B-related HCC , adefovir antiviral therapy reduced late HCC recurrence and significantly improved overall survival after R0 hepatic resection .


The effectiveness of simulation is rarely evaluated .


The aim of this study was to assess the impact of a short training course on the ability of anesthesiology residents to comply with current difficult airway management guidelines .


Twenty-seven third-year anesthesiology residents were assessed on a simulator in a `` ca n't intubate , ca n't ventilate '' scenario before the training ( the pretest ) and then randomly 3 , 6 , or 12 months after training ( the posttest ) .


The scenario was built so that the resident was prompted to perform a cricothyrotomy .


Compliance with airway management guidelines and the cricothyrotomy 's duration and technical quality were assessed as a checklist score [ 0 to 10 ] and a global rating scale [ 7 to 35 ] .


After training , all 27 residents ( 100 % ) complied with the airway management guidelines , compared with 17 ( 63 % ) in the pretest ( P < 0.005 ) .


In the pretest and the 3 - , 6 - , and 12-month posttests , the median [ range ] duration of cricothyrotomy was respectively 117 s [ 70 to 184 ] , 69 s [ 43 to 97 ] , 52 s [ 43 to 76 ] , and 62 s [ 43 to 74 ] ( P < 0.0001 vs. in the pretest ) , the median [ range ] checklist score was 3 [ 0 to 7 ] , 10 [ 8 to 10 ] , 9 [ 6 to 10 ] , and 9 [ 4 to 10 ] ( P < 0.0001 vs. in the pretest ) and the median [ range ] global rating scale was 12 [ 7 to 22 ] , 30 [ 20 to 35 ] , 33 [ 23 to 35 ] , and 31 [ 18 to 33 ] ( P < 0.0001 vs. in the pretest ) .


There were no significant differences between performance levels achieved in the 3 - , 6 - , and 12-month posttests .


The training session significantly improved the residents ' compliance with guidelines and their performance of cricothyrotomy .


To study the impact of administration of dydrogesterone in early pregnancy on pregnancy outcome and its correlation with Th1 and Th2 cytokine levels .


Double-blind , randomized , placebo-controlled study .


A medical college and its associated hospital .


Women with either : [ 1 ] a history of idiopathic recurrent pregnancy loss ( RPL ) , in either a dydrogesterone group or a placebo group , or [ 2 ] no history of miscarriage .


Dydrogesterone 20 mg/day from confirmation of pregnancy to 20 weeks of gestation .


Occurrence of another pregnancy loss and concentrations of T-helper ( Th ) 1 ( interferon - and tumor necrosis factor - ) and Th2 ( interleukin ( IL ) -4 and IL-10 ) cytokines in serum at recruitment ( 4-8 weeks of gestation ) and at abortion or 20 weeks of gestation , using commercially available ELISA kits .


Occurrence of another abortion after 3 consecutive abortions was significantly higher ( 29 of 173 ; 16.76 % ) in women with RPL compared with healthy pregnant controls ( 6 of 174 ; 3.45 % ) .


Risk of occurrence of miscarriage after 3 abortions was 2.4 times higher in the placebo group vs. the treatment group ( risk ratio = 2.4 , 95 % CI = 1.3-5 .9 ) .


Mean gestational age at delivery ( excluding those aborted before 20 weeks of gestation ) increased significantly in the dydrogesterone group ( 38.011.96 weeks ) compared with the placebo group ( 37.232.41 weeks ) .


Baby weight was significantly lower in the placebo group ( 2421.4321.6 g ) compared with the healthy pregnant controls ( 2545.3554.3 g ) .


At recruitment , serum IL-4 and tumor necrosis factor - levels were significantly lower in the RPL group compared with the healthy pregnant controls .


However , serum interferon - level was significantly higher in the RPL group ( 8.870.72 pg/mL ) compared with the healthy pregnant controls ( 8.081.27 pg/mL ) .


The present study supports the use of dydrogesterone in women with recurrent abortions to improve pregnancy outcome , such as a reduction in abortions and improved gestational age and baby weight at delivery .


However , these outcomes were not modulated by Th1 and Th2 cytokine production .


CTRI/2010/091 / 000373 .


The aim of this study was to evaluate the feasibility of low-concentration iso-osmolar Iodixanol 270 compared with Iohexol 350 in patients with coronary artery bypass grafts ( CABGs ) undergoing coronary computed tomographic angiography ( CCTA ) .


A total of 80 consecutive patients undergoing CABG follow-up with the use of CCTA were prospectively enrolled , with 40 patients assigned to Iodixanol 270 and 40 patients assigned to Iohexol 350 .


In both groups , the contrast medium was injected at an injection rate of 4.5 mL/s in the patients with a body mass index of greater than 24 kg/m2 and 3.5 mL/s in the patients with a body mass index of 24 kg/m2 or lower .


The contrast volume was determined by the flow rate and scan time .


Image quality score and visualization of bypass grafts were evaluated .


Subjective assessment of image quality for each coronary artery segment was determined using a 4-point grading scale by 2 reviewers , whereas objective evaluation of image quality was conducted by measuring the mean CT attenuation values ( hounsfield unit [ HU ] ) in terms of SD , contrast-noise ratio , and signal-noise ratio in the ascending aorta .


The mean ( SD ) contrast volume for the Iodixanol 270 and Iohexol 350 groups was 66.28 ( 12.00 ) and 64.98 ( 8.12 ) mL , respectively , with no significant difference ( P = 0.57 ) .


The mean ( SD ) CT attenuation value in the Iodixanol 270 group was 414.72 ( 101.47 ) , which was lower than in the Iohexol 350 group , which was 478.85 ( 108.73 ) ( P = 0.01 ) .


The subjective image quality for the Iodixanol 270 group was superior to that for the Iohexol 350 group in the arterial graft vessels ( P = 0.027 ) , whereas there was no significant difference between the 2 groups in the venous graft vessels ( P = 0.377 ) .


There was no significant difference in terms of SD of the ascending aorta , signal-noise ratio , and contrast-noise ratio between the 2 groups .


Low-concentration iso-osmolar Iodixanol 270 provides image quality comparable with that of Iohexol 350 , allowing diagnostic CCTA follow-up of patients with CABGs .


To evaluate the tolerability and immunogenicity of a booster dose of the quadrivalent meningococcal conjugate vaccine MenACWY-CRM ( Menveo , Novartis Vaccines and Diagnostics , Siena , Italy ) administered 3years after primary vaccination of adolescents enrolled in a phase 3 study with either MenACWY-CRM or MenACWY-D ( Menactra , Sanofi Pasteur , Swiftwater , Pennsylvania ) .


A total of 730 healthy adolescents participated , including 622 initial study participants who received primary vaccination with MenACWY-CRM ( n = 367 ) or MenACWY-D ( n = 255 ) 3years previously and 108 age-matched vaccine-nave controls .


A subset of MenACWY-CRM ( n = 83 ) and MenACWY-D ( n = 77 ) recipients were administered a MenACWY-CRM booster dose 3years postprimary vaccination .


Immunogenicity prior to and after the booster dose of MenACWY-CRM was measured by serum bactericidal assay with human complement ( hSBA ) .


Local and systemic reactions and adverse events were monitored in subjects receiving the booster dose .


At 3years postprimary vaccination , 64 % , 82 % , and 65 % of subjects initially vaccinated with MenACWY-CRM ( n = 367 ) showed hSBA titers 8 against serogroups C , W-135 , and Y , respectively ; this was lower for serogroup A ( 28 % ) .


Significantly more MenACWY-CRM recipients had hSBA titers 8 for serogroups W-135 and Y than MenACWY-D recipients ( n = 255 ) .


A MenACWY-CRM booster dose resulted in 99 % -100 % of subjects demonstrating hSBA titers 8 against all serogroups , irrespective of primary vaccination ( MenACWY-CRM , n = 83 ; MenACWY-D , n = 77 ) .


The booster dose was well tolerated without significant adverse events .


MenACWY-CRM can be used to boost adolescents who have received a primary vaccination with either MenACWY-CRM or MenACWY-D .


The effectiveness of clinic-based pulmonary rehabilitation in advanced COPD is well established , but few data exist for less severe patients treated in alternative settings .


The purpose of this study was to investigate whether a novel , community-based exercise program ( CBE ) was feasible and effective for patients with moderate COPD .


Nineteen patients with moderate COPD ( mean FEV1 62 % ) and self-reported exercise impairment were randomized to 12-weeks of progressive endurance and strength training at a local health club under the guidance of a certified personal trainer , or to continuation of unsupervised habitual physical activity .


Outcomes assessed at baseline and 12 weeks included session compliance , intensity adherence , treadmill endurance time , muscle strength , dyspnea , and health status .


Compliance was 94 % and adherence was 83 % .


Comparisons between CBE and control groups yielded the following mean ( SEM ) differences in favor of CBE : endurance time 134 ( 74 ) seconds versus -59 ( 49 ) seconds ( P = 0.041 ) and TDI 5.1 ( 0.8 ) versus -0.2 ( 0.5 ) ( P < 0.001 ) .


The CBE group increased muscle strength ( weight lifted ) by 11.8 kilograms per subject per week of training ( P < 0.001 ) .


SGRQ was not significantly changed .


We demonstrated the feasibility and effectiveness of a novel community-based exercise program involving health clubs and personal trainers for patients with moderate COPD .


ClinicalTrials.gov Identifier NCT01985529 .


Among patients with a proximal vessel occlusion in the anterior circulation , 60 to 80 % of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment .


We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core , a proximal intracranial arterial occlusion , and moderate-to-good collateral circulation .


We randomly assigned participants to receive standard care ( control group ) or standard care plus endovascular treatment with the use of available thrombectomy devices ( intervention group ) .


Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset .


Patients with a large infarct core or poor collateral circulation on computed tomography ( CT ) and CT angiography were excluded .


Workflow times were measured against predetermined targets .


The primary outcome was the score on the modified Rankin scale ( range , 0 [ no symptoms ] to 6 [ death ] ) at 90 days .


A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care ( shift analysis ) .


The trial was stopped early because of efficacy .


At 22 centers worldwide , 316 participants were enrolled , of whom 238 received intravenous alteplase ( 120 in the intervention group and 118 in the control group ) .


In the intervention group , the median time from study CT of the head to first reperfusion was 84 minutes .


The rate of functional independence ( 90-day modified Rankin score of 0 to 2 ) was increased with the intervention ( 53.0 % , vs. 29.3 % in the control group ; P < 0.001 ) .


The primary outcome favored the intervention ( common odds ratio , 2.6 ; 95 % confidence interval , 1.7 to 3.8 ; P < 0.001 ) , and the intervention was associated with reduced mortality ( 10.4 % , vs. 19.0 % in the control group ; P = 0.04 ) .


Symptomatic intracerebral hemorrhage occurred in 3.6 % of participants in intervention group and 2.7 % of participants in control group ( P = 0.75 ) .


Among patients with acute ischemic stroke with a proximal vessel occlusion , a small infarct core , and moderate-to-good collateral circulation , rapid endovascular treatment improved functional outcomes and reduced mortality .


( Funded by Covidien and others ; ESCAPE ClinicalTrials.gov number , NCT01778335 . )


Infants and children who undergo cardiopulmonary bypass and cardiac surgery are at risk of postoperative fluid overload .


Peritoneal dialysis catheter ( PDC ) and peritoneal dialysis are reported to be effective means of postoperative fluid management .


We sought to test the hypothesis that PDC insertion in the operating room at the time of Norwood palliation would decrease the time to achieve a negative fluid balance in a group of neonates with hypoplastic left heart syndrome .


A single center randomized controlled trial was performed .


We randomized neonates with hypoplastic left heart syndrome to prophylactic PDC , with or without dialysis , or standard care ( ie , no PDC ) .


Twenty-two neonates were included ; 10 were randomized to PDC and 12 were randomized to standard care .


The mean time to first postoperative negative fluid balance was 2.70 1.06 days for the prophylactic PDC group and 2.67 0.65 days for the standard care group ( P = .93 ) .


There was no difference between the 2 groups in time to lactate 2 mmol/L , maximum vasoactive-inotrope score on postoperative days 2 to 5 , time to sternal closure , time to first extubation , modified clinical outcome score , or hospital length of stay .


Twenty-one patients ( 95 % ) survived to hospital discharge .


Four patients randomized to prophylactic PDC had 1 or more serious adverse events compared with no patients in the standard care group ( P = .03 ) .


Prophylactic PDC , with or without dialysis , did not decrease the time to achieve a negative fluid balance after the Norwood procedure , did not alter physiological variables postoperatively , and was associated with more severe adverse events .


AWARD-5 was an adaptive , seamless , double-blind study comparing dulaglutide , a once-weekly glucagon-like peptide-1 ( GLP-1 ) receptor agonist , with placebo at 26weeks and sitagliptin up to 104weeks .


The study also included a dose-finding portion whose results are presented here .


Type 2 diabetes ( T2D ) patients on metformin were randomized 3:1:1 to seven dulaglutide doses , sitagliptin ( 100mg ) , or placebo .


A Bayesian algorithm was used for randomization and dose selection .


Patients were adaptively randomized to dulaglutide doses using available data on the basis of a clinical utility index ( CUI ) of glycosylated haemoglobin A1c ( HbA1c ) versus sitagliptin at 52weeks and weight , pulse rate ( PR ) and diastolic blood pressure ( DBP ) versus placebo at 26weeks .


The algorithm randomly assigned patients until two doses were selected .


Dulaglutide 1.5 mg was determined to be the optimal dose .


Dulaglutide 0.75 mg met criteria for the second dose .


Dulaglutide 1.5 mg showed the greatest Bayesian mean change from baseline ( 95 % credible interval ) in HbA1c versus sitagliptin at 52weeks -0.63 ( -0.98 to -0.20 ) % .


Dulaglutide 2.0 mg showed the greatest placebo-adjusted mean change in weight [ -1.99 ( -2.88 to -1.20 ) kg ] and in PR [ 0.78 ( -2.10 to 3.80 ) bpm ] .


Dulaglutide 1.5 mg showed the greatest placebo-adjusted mean change in DBP [ -0.62 ( -3.40 to 2.30 ) mmHg ] .


The Bayesian algorithm allowed for an efficient exploration of a large number of doses and selected dulaglutide doses of 1.5 and 0.75 mg for further investigation in this trial .


To evaluate the anti-inflammatory and analgesic effect of Bromelain ( pineapple extract ) administered orally in the postoperative after extraction of impacted lower molars .


This is a prospective , placebo-controlled , unicentric , double-blind study ; the sample size was 34 patients .


The pre and postoperative outcomes , evaluated on the third ( D3 ) and eighth day ( D8 ) , included inflamtion , pain and oral aperture , as well as the need for analgesics .


One group received Bromelain 150mg per day for three days and 100mg on days 4 to 7 .


The other group received placebo in the same dosage .


All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples .


Although there were no statistically significant differences between the treatment groups , a trend towards less inflammation and improved oral aperture was observed in the group that received Bromelain , compared to the group that received placebo .


This trend can be attributed completely to random reasons , since there is no statistical difference in the results .


Further studies are necessary to analyze different administration patterns and doses of Bromelain for the use in the postoperative of impacted third molars .


Cholera is endemic in Bangladesh with epidemics occurring each year .


The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting .


We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and hand washing to vaccination in this setting .


We did this cluster-randomised open-label trial in Dhaka , Bangladesh .


We randomly assigned 90 clusters ( 1:1:1 ) to vaccination only , vaccination and behavioural change , or no intervention .


The primary outcome was overall protective effectiveness , assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose .


This study is registered with ClinicalTrials.gov , number NCT01339845 .


Of 268,896 people present at baseline , we analysed 267,270 : 94,675 assigned to vaccination only , 92,539 assigned to vaccination and behavioural change , and 80,056 assigned to non-intervention .


Vaccine coverage was 65 % in the vaccination only group and 66 % in the vaccination and behavioural change group .


Overall protective effectiveness was 37 % ( 95 % CI lower bound 18 % ; p = 0002 ) in the vaccination group and 45 % ( 95 % CI lower bound 24 % ; p = 0001 ) in the vaccination and behavioural change group .


We recorded no vaccine-related serious adverse events .


Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban populations with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such populations .


Bill & Melinda Gates Foundation .


The purpose of the study was to evaluate the efficacy of antimicrobial photodynamic therapy ( aPDT ) used as an adjunct to the endodontic re-treatment in the eradication of microorganisms from previously filled root canals .


The study sample consisted of 21 randomly selected patients with root filled and infected root canal system with chronic apical periodontitis on incisors or canines , who have had previously endodontic treatment .


Microbiological samples from the root canals were collected after accessing the canal , following the endodontic re-treatment and after the aPDT procedure .


During instrumentation , the root canals were irrigated with 2.5 % sodium hypochlorite ( NaOCl ) , and the final irrigation protocol included 17 % ethylenediaminetetraacetic acid followed by NaOCl .


Root canals were filled with a phenothiazinium chloride and irradiated with a diode laser ( = 660 nm , 100 mW ) for 1 min .


Microbiological samples from the root canals were cultivated on selective plates , and the identification was done by micromorphology , macromorphology and different API strips as well as bacterial counts ( colony forming units ) .


Fourteen bacteria species were isolated from the root canals initially , with a mean value of 4.57 species per canal .


Although endodontic re-treatment alone produced a significant reduction in the number of bacteria species ( p < 0.001 ) , the combination of endodontic treatment and aPDT was statistically more effective ( p < 0.001 ) .


No bacteria were cultivated from the main root canals of 11 teeth .


The results indicated that the aPDT used as an adjunct to the conventional endodontic therapy achieved a significant further reduction of intracanal microbial load .


Regional anesthesia is a commonly used technique in orthopedic procedures .


Sedation should reduce the patient 's anxiety and fear while increasing regional anesthesia quality .


This study evaluated the hemodynamic changes , level of sedation , both patients ' and surgeons ' levels of satisfaction and potential side effects in patient-controlled sedation using propofol .


This randomized clinical trial studied sixty ASA physical class I-III patients scheduled for total knee replacement surgery under combined spinal-epidural anesthesia .


Patients in Group P ( n = 30 ) received propofol via a patient-controlled analgesia device with the following settings : intravenous propofol bolus dose 400 g.kg ( -1 ) , 5-minute lockout interval and no basal infusion .


In Group S , we infused saline 150 using the same settings .


To determine the level of sedation , we used BIS and Observer 's Assessment of Alertness/Sedation Scale .


For all patients , we recorded the number of requests .


As the final evaluation , we scored surgeons ' and patients ' satisfaction on 4-point scales .


Both BIS values and OAA/S scores were lower in Group P than in Group S. Patients ' satisfaction was higher in Group P , although there was no significant difference with respect to surgeons ' satisfaction between the groups .


The number of requests for sedation was significantly higher in Group S. However , most requests were considered unsuccessful .


This study suggests that patient-controlled sedation with propofol can be used efficiently in orthopedic procedures .


To evaluate outcomes relative to treatment using systemic methotrexate ( MTX ) alone or systemic MTX combined with ultrasound ( US ) - guided local injection of potassium chloride ( KCl ) or MTX in women with live tubal ectopic pregnancies .


Case-control study ( Canadian Task Force classification II-2 ) .


Departments of Obstetrics and Gynecology in 2 hospitals in China .


Eighty-two women with live tubal ectopic pregnancies .


Participants in the study received treatment using either systemic MTX ( n = 37 ; systemic treatment group ) or systemic MTX and US-guided local injection of either MTX or KCl ( n = 45 ; combined treatment group ) .


Patient clinical features and outcomes were compared .


There were no significant differences between the patient groups insofar as baseline gestational age , - human chorionic gonadotropin concentration , or size of conceptus .


The success rate in patients who received combined therapy ( 93.3 % ) was much higher than in those who received only systemic treatment ( 73.0 % ) ( p < .05 ) .


In the combined treatment group , the success rate was similar between women who received locally injected KCl ( 95.2 % ) and those who received locally injected MTX ( 91.7 % ) .


The significantly higher success rate in patients who received combined US-guided local injection and systemic MTX suggests that this is an efficient nonsurgical option in women with tubal pregnancy , high serum - human chorionic gonadotropin concentration , and fetal cardiac activity .


To determine whether an intervention that improves nursing home ( NH ) staff connections , communication , and problem solving ( CONNECT ) would improve implementation of a falls reduction education program ( FALLS ) .


Cluster randomized trial .


Community ( n = 4 ) and Veterans Affairs ( VA ) NHs ( n = 4 ) .


Staff in any role with resident contact ( n = 497 ) .


NHs received FALLS alone ( control ) or CONNECT followed by FALLS ( intervention ) , each delivered over 3 months .


CONNECT used storytelling , relationship mapping , mentoring , self-monitoring , and feedback to help staff identify communication gaps and practice interaction strategies .


FALLS included group training , modules , teleconferences , academic detailing , and audit and feedback .


NH staff completed surveys about interactions at baseline , 3 months ( immediately after CONNECT or control period ) , and 6 months ( immediately after FALLS ) .


A random sample of resident charts was abstracted for fall risk reduction documentation ( n = 651 ) .


Change in facility fall rates was an exploratory outcome .


Focus groups were conducted to explore changes in organizational learning .


Significant improvements in staff perceptions of communication quality , participation in decision-making , safety climate , caregiving quality , and use of local interaction strategies were observed in intervention community NHs ( treatment-by-time effect P = .01 ) but not in VA NHs , where a ceiling effect was observed .


Fall risk reduction documentation did not change significantly , and the direction of change in individual facilities did not relate to observed direction of change in fall rates .


Fall rates did not change in control facilities ( falls/bed per year : baseline , 2.61 ; after intervention , 2.64 ) but decreased by 12 % in intervention facilities ( falls/bed per year : baseline , 2.34 ; after intervention , 2.06 ) ; the effect of treatment on rate of change was 0.81 ( 95 % confidence interval = 0.55-1 .20 ) .


CONNECT has the potential to improve care delivery in NHs , but the trend toward improving fall rates requires confirmation in a larger ongoing study .


To explore the clinical efficacy of gemcitabine concomitant with nedaplatin and drug resistance in the treatment of non-small cell lung cancer ( NSCLC ) and associated molecular predicators .


A total of 68 patients diagnosed with NSCLC by histology served as the study objects and were randomly divided into an observation group treated with gemcitabine concomitant with nedaplatin and a control group with cisplatin concomitant with gemcitabine , 34 cases for each group .


Short-term and long-term efficacies , adverse responses as well as the expression of nucleotide excision repair cross complementing 1 ( ERCC1 ) , ribonucleotide reductase subunit M1 ( RRM1 ) and lung resistance-related protein ( LRP ) in NSCLC tissues in both groups were assessed .


The short-term objective response rate ( ORR ) and disease control rate ( DCR ) were 35.3 % ( 12/34 ) and 76.5 % ( 26/34 ) in the observation group and 38.2 % ( 13/34 ) and 85.3 % ( 29/34 ) in the control group , respectively , the differences not being statistically significant .


The time to progression ( TTP ) in both groups were 1 ~ 12 months , while the median TTP was 135 d and 144 d , respectively .


Though the survival was slightly higher in the control group , there were no significant differences in TTP and survival time .


The rates of decreased hemoglobin , vomiting and nausea as well as renal toxicity were evidently lower in the observation group , while other adverse responses demonstrated no significant difference .


The positive expression rates of ERCC1 , RRM1 and LRP were 47.1 % ( 16/34 ) , 61.8 % ( 21/34 ) and 64.7 % ( 22/34 ) in the observation group , respectively .


Compared with negative ERCC1 expression , ORR had decreasing trend and the overall survival time ( OS ) decreased significantly in patients with positive ERCC1 expression , which were markedly decreased by the positive expressions of RRM1 and LRP .


Gemcitabine concomitant with nedaplatin has significant effects in the treatment of NSCLC , with an adverse response rate obviously lower than for cisplatin concomitant with gemcitabine , suggesting that wider use in the clinic is warranted .


Additionally , the positive expressions of ERCC1 , RRM1 and LRP may increase patient drug resistance , so they can be applied as the chemotherapeutic predicators to guide individualized therapy of NSCLC patients .


Early antiretroviral therapy ( ART ) and virological suppression can affect evolving antibody responses to HIV infection .


We aimed to assess frequency and predictors of seronegativity in infants starting early ART .


We compared HIV antibody results between two of three treatment groups of the Children with HIV Early Antiretroviral Therapy ( CHER ) trial , done from July , 2005 , until July , 2011 , in which infants with HIV infection aged 57-120 weeks with a percentage of CD4-positive T lymphocytes of at least 25 % were randomly assigned to immediate ART for 96 weeks ( ART-96W ) or deferred ART until clinical or immunological progression ( ART-Def ) .


We measured antibody from all available stored samples for ART-96W and ART-Def at trial week 84 using three assays : fourth-generation enzyme immunoassay HIV antigen-antibody combination , HIV-1 and HIV-2 rapid antibody test , and quantitative anti-gp120 IgG ELISA .


We also assessed odds of seropositivity with respect to age of ART initiation and cumulative viral load .


The CHER trial was registered with ClinicalTrials.gov , number NCT00102960 .


The median age of the infants from when samples were taken ( 184 samples from 268 infants ) was 92 weeks ( IQR 906-934 ) .


More specimens from the ART-96W group were seronegative than from the ART-Def group by enzyme immunoassay ( ART-96W 49 [ 46 % ] of 107 vs ART-Def eight [ 11 % ] of 75 ; p < 00001 ) and rapid antibody test ( 54 [ 53 % ] of 101 vs eight [ 11 % ] of 74 ; p < 00001 ) .


Median anti-gp120 IgG concentration was lower in the ART-96W group ( 230 g/L [ IQR 133-13129 ] ) than in the ART-Def group ( 6870 g/L [ 1706-53645 ] ; p < 00001 ) .


If ART was started between 12 and 24 weeks of age , odds of seropositivity were increased 137 times ( 95 % CI 31-602 ; p = 0001 ) compared with starting it between 0 and 12 weeks .


All children starting ART aged older than 24 weeks were seropositive .


Cumulative viral load to week 84 correlated with anti-gp120 IgG concentrations ( coefficient 054 ; p < 00001 ) and increased odds of seropositivity ( odds ratio 159 [ 95 % CI 11-23 ] ) adjusted for ART initiation age .


About half of children starting ART before 12 weeks of age were HIV seronegative by almost 2 years of age .


HIV antibody tests can not be used to reconfirm HIV diagnosis in children starting early ART .


Long-term effects of seronegativity need further study .


Clear guidelines are needed for retesting alongside improved diagnostic tests .


Wellcome Trust , Medical Research Council , and National Institutes of Health .


Topical applications of emollients such as sunflower seed oil and Aquaphor have been shown to reduce the incidence of bloodstream infections and mortality of preterm infants in resource-poor settings .


The causal mechanism for prevention of infection through cutaneous portals of entry is not well understood .


We examined the relationship between skin condition score as a measure of skin barrier integrity and risk for bloodstream infection , and the effect of emollients on that relationship .


Data for this study come from a randomized controlled trial of the impact of topical emollient therapy on nosocomial infections in 491 preterm infants < 33 weeks gestational age at Dhaka Shishu Hospital , Bangladesh .


Latent growth trajectory model with random-coefficient and multivariable logistic regression were utilized .


Rate of deterioration of skin condition was significantly lower ( P < 0.05 ) in both emollient arms compared with the untreated control group .


Adjusted odds ratio of skin score for infection was 1.32 ( 95 % confidence interval : 1.06-1 .65 ) .


Emollients reduced the incidence of infection only when the skin had no signs of deterioration [ Aquaphor incidence rate ratio : 0.43 ( 95 % confidence interval : 0.19-0 .97 ) and sunflower seed oil incidence rate ratio : 0.46 ( 95 % confidence interval : 0.21-0 .99 ) ] .


Skin condition deteriorated progressively after birth and compromised skin condition increased the risk of infection .


Emollients preserved skin integrity and thus prevented infection in preterm neonates .


To optimize benefits of emollients for the prevention of bloodstream infection , use of emollients should begin immediately after birth when the skin is still intact .


To compare gadoxetic acid injection rates of 0.5 mL/s and 1 mL/s for hepatic arterial-phase magnetic resonance ( MR ) imaging .


In this prospective study , 101 consecutive patients with suspected focal liver lesions were included and randomly divided into two groups .


Each group underwent dynamic liver MR imaging using a 3.0-T scanner after an intravenous injection of gadoxetic acid at rates of either 0.5 mL/s ( n = 50 ) or 1 mL/s ( n = 51 ) .


Arterial phase images were analyzed after blinding the injection rates .


The signal-to-noise ratios ( SNRs ) of the liver , aorta , portal vein , hepatic vein , spleen , and pancreas were measured .


The contrast-to-noise ratios ( CNRs ) of the hepatocellular carcinomas ( HCC ) were calculated .


Finally , two experienced radiologists were independently asked to identify , if any , HCCs in the liver on the images and score the image quality in terms of the presence of artifacts and the proper enhancement of the liver , aorta , portal vein , hepatic vein , hepatic artery , spleen , pancreas , and kidney .


The SNRs were not significantly different between the groups ( p = 0.233-0 .965 ) .


The CNRs of the HCCs were not significantly different ( p = 0.597 ) .


The sensitivity for HCC detection and the image quality scores were not significantly different between the two injection rates ( p = 0.082-1 .000 ) .


Image quality and sensitivity for hepatic HCCs of arterial-phase gadoxetic acid-enhanced MR were not significantly improved by reducing the contrast injection rate to 0.5 mL/s compared with 1 mL/s .


Gemcitabine plus a platinum-based agent ( eg , cisplatin or oxaliplatin ) is the standard of care for advanced biliary cancers .


We investigated the addition of cetuximab to chemotherapy in patients with advanced biliary cancers .


In this non-comparative , open-label , randomised phase 2 trial , we recruited patients with locally advanced ( non-resectable ) or metastatic cholangiocarcinoma , gallbladder carcinoma , or ampullary carcinoma and a WHO performance status of 0 or 1 from 18 hospitals across France and Germany .


Eligible patients were randomly assigned ( 1:1 ) centrally with a minimisation procedure to first-line treatment with gemcitabine ( 1000 mg/m ( 2 ) ) and oxaliplatin ( 100 mg/m ( 2 ) ) with or without cetuximab ( 500 mg/m ( 2 ) ) , repeated every 2 weeks until disease progression or unacceptable toxicity .


Randomisation was stratified by centre , primary site of disease , disease stage , and previous treatment with curative intent or adjuvant therapy .


Investigators who assessed treatment response were not masked to group assignment .


The primary endpoint was the proportion of patients who were progression-free at 4 months , analysed by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT00552149 .


Between Oct 10 , 2007 , and Dec 18 , 2009 , 76 patients were assigned to chemotherapy plus cetuximab and 74 to chemotherapy alone .


48 ( 63 % ; 95 % CI 52-74 ) patients assigned to chemotherapy plus cetuximab and 40 ( 54 % ; 43-65 ) assigned to chemotherapy alone were progression-free at 4 months .


Median progression-free survival was 61 months ( 95 % CI 51-76 ) in the chemotherapy plus cetuximab group and 55 months ( 37-66 ) in the chemotherapy alone group .


Median overall survival was 110 months ( 91-137 ) in the chemotherapy plus cetuximab group and 124 months ( 86-160 ) in the chemotherapy alone group .


The most common grade 3-4 adverse events were peripheral neuropathy ( in 18 [ 24 % ] of 76 patients who received chemotherapy plus cetuximab vs ten [ 15 % ] of 68 who received chemotherapy alone ) , neutropenia ( 17 [ 22 % ] vs 11 [ 16 % ] ) , and increased aminotransferase concentrations ( 17 [ 22 % ] vs ten [ 15 % ] ) .


70 serious adverse events were reported in 39 ( 51 % ) of 76 patients who received chemotherapy plus cetuximab ( 34 events in 19 [ 25 % ] patients were treatment-related ) , whereas 41 serious adverse events were reported in 25 ( 35 % ) of 71 patients who received chemotherapy alone ( 20 events in 12 [ 17 % ] patients were treatment-related ) .


One patient died of atypical pneumonia related to treatment in the chemotherapy alone group .


The addition of cetuximab to gemcitabine and oxaliplatin did not seem to enhance the activity of chemotherapy in patients with advanced biliary cancer , although it was well tolerated .


Gemcitabine and platinum-based combination should remain the standard treatment option .


Institut National du Cancer , Merck Serono .


It is widely known that inflammation is related to type 2 diabetes ( T2D ) , but few studies have shown a direct relationship between the immune system and T2D using a reliable biomarker .


Neutrophil : lymphocyte ratio ( NLR ) is an easy-to-analyze inflammation biomarker , but few studies have assessed the relationship between NLR and T2D .


In order to evaluate how NLR is related to T2D , we designed a large-scale cross-sectional and prospective cohort study in an adult population .


Participants were recruited from the Tianjin Medical University General Hospital-Health Management Centre .


Both a baseline cross-sectional ( n = 87,686 ) and a prospective ( n = 38,074 ) assessment were performed .


Participants without a history of T2D were followed up for 6 years ( with a median follow-up of 2.7 years ) .


Adjusted logistic and Cox proportional hazards regression models were used to assess relationships between the quintiles of NLR and T2D ( covariates : age , sex , BMI , smoking status , drinking status , hypertension , hyperlipidemia , and family history of cardiovascular disease , hypertension , hyperlipidemia , or diabetes ) .


The prevalence and incidence of T2D were 4.9 % and 6.8 / 1000 person-years respectively .


The adjusted odds ratio and hazard ratio ( 95 % CI ) of the highest NLR quintile were 1.34 ( 1.21 , 1.49 ) and 1.39 ( 1.09 , 1.78 ) ( both P for trend < 0.01 ) respectively as compared to the lowest quintile of NLR .


Leukocyte , neutrophil , and lymphocyte counts do not significantly predict the eventual development of T2D .


The present study demonstrates that NLR is related to the prevalence and incidence of T2D , and it suggests that NLR may be an efficient and accurate prognostic biomarker for T2D .


To compare the differences in the clinical efficacy on post-stroke upper limb spasmodio hemiplegia among the combined therapy of relaxing needling ( Huici ) technique combined with wheat-grain moxibustion , simple relaxing needling and conventional acupuncture .


Ninety patients were-randomized into a group with the combined therapy of relaxing needling technique combined with wheat-grain moxibustion ( a combined therapy group ) , a simple relaxing needling group and a conventional acupuncture group , 30 cases in each group .


In the combined therapy group , the relaxing needling technique was used in combination with wheat-grain moxibustion .


The relaxing needling technique was applied to Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Shousanli ( LI 10 ) , etc. .


The wheat-grain moxibustion was applied to Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , Mingmen ( GV 4 ) , etc. .


In thel simple relaxing needling group , the relaxing needling technique was used simply .


In the conventional acupuncture group , the conventional lifting , thrusting and rotating technique with filiform needle was adopted at the same acupoints as the simple relaxing needling group .


The treatment was given once every day ; 6 treatments made one session .


Totally 4 sessions were required , with 1 day at intervals .


The modified Ashworth scale ( MAS ) , Fugl-Meyer assessment ( FMA ) and Barthel index ( BD were adopted to assess the upper limb muscle tension , motor functioni and daily life activity .


After treatment , MAS score was all reduced as compared with that before treatment in each group , and FMA score and BI score were increased as compared with those before treatment ( all P < 0.01 ) .


MAS score in the combined therapy group was lower than that in either the simple relaxing needling group or the conventional acupuncture group ( both P < 0.01 ) , and the score in the simple relaxing needling group was lower than that in the conventional acupuncture group ( P < 0.05 ) .


FMA score and BI score in the combined therapy group were higher than those in the simple relaxing needling group and the conventional acupuncture group ( both P < 0.01 ) .


FMA score in the simple relaxing needleing group was higher than that the Enventional acupuncture group ( P < 0.05 ) .


The total effective rate in the combined therapy group was 93.3 % ( 28/30 ) , higher ; than 86.7 % ( 26/30 ) in the simple relaxing needling group ( P < 0.01 ) , and 83.8 % ( 25/30 ) in the conventionaP acupuncture group ( P < 0.01 ) .


The combined therapy of relaxing needling technique and wheat-grain moxibustion achieves more satisfactory efficacy on post-stroke upper limb spasmodic hemiplegia compared with the simple relaxing needling and conventional acupuncture .


To determine if lactate concentrations in jugular venous and auricular arterial blood differ in anesthetized sheep .


Prospective , controlled experimental study .


Twelve healthy adult ewes , 4-7years and weighing 62-77kg .


Jugular venous blood was collected before anesthesia ( PreOv ) for measurement of lactate concentration , packed cell volume and total protein .


Ewes were administered a standard anesthesia protocol .


Jugular venous ( IntraOv ) and auricular arterial ( IntraOa ) blood samples were obtained 40minutes after induction of anesthesia , and again in recovery ( PostOv and PostOa ) .


An additional blood sample was drawn 6weeks post-operatively from non-fasted sheep ( NF_Lact ) .


Lactate concentrations were compared among PreOv , IntraOv and IntraOa , PostOv and PostOa , and between PreOv and NF_Lact with paired t-test and repeated measure analyses of variance ( anova ) with PreOv as a covariate ( p0 .05 ) .


IntraOv lactate concentration had decreased from PreOv There were significant differences between arterial and venous IntraO and PostO lactate concentrations .


There was no significant difference between IntraO and PostO , or PreOv and NF_Lact .


Lactate concentrations were significantly lower in anesthetized sheep compared to non-anesthetized sheep .


Lactate concentrations in venous blood were higher than in arterial blood .


Therefore , anesthetic status and sampling site should be considered when interpreting lactate concentrations , and the sampling site should be consistent for repeated measurements .


This report details enrolment findings related to a Canadian randomized controlled trial comparing immediate to delayed intrauterine contraception ( IUC ) placement after a second trimester abortion .


We report acceptance of IUC , satisfaction with prior contraception , adherence to the CONSORT criteria , and challenges faced in the recruitment process .


Women seeking second trimester abortion and selecting either of two methods of IUC as their preferred contraception method were enrolled and randomized to insertion either immediately post-abortion or four weeks later .


Enrolled participants completed a Contraception Satisfaction Questionnaire detailing prior contraceptive satisfaction .


Among 1813 women assessed , 1500 ( 83 % ) met eligibility criteria and IUC was chosen for post-abortion contraception by over one half of them ( 792/1500 , 53 % ) .


When both types of device were available cost-free , women selected the levonorgestrel-releasing intrauterine system more than 20 times more frequently than a copper IUD .


Participants had an average age of 26.0 ( standard deviation [ SD ] 6.8 ) years , and an average gestational age of 16.1 ( SD 3.1 ) weeks .


Almost one half ( 48.4 % ) had had a prior abortion and 46.9 % had a prior delivery .


Two thirds of participants were using a contraception method at the time of conception , but almost one third of these were using methods in the lowest tiers of effectiveness .


There was a weak correlation between prior contraceptive compliance and education level .


More than one half of eligible women seeking a second-trimester abortion chose IUC for post-abortion contraception .


In Canada , health care for unintended pregnancies is universally subsidized but contraception is not .


Offering comprehensive information on the range of contraceptive methods and providing cost-free IUC is an effective strategy to increase uptake of intrauterine contraception among Canadian women who wish to prevent further unintended pregnancy .


To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus ( T2DM ) patients inadequately controlled on sulfonylurea ( SU ) metformin .


In this randomized , double-blind , two-arm , parallel-group , multicenter study , patients received lixisenatide 20 g once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs metformin .


Primary outcome was change in HbA1c from baseline to Week 24 .


Lixisenatide provided a significant reduction in HbA1c at Week 24 versus placebo ( LS mean : -0.85 % vs. -0.10 % ; p < 0.0001 ) and more patients achieved HbA1c < 7.0 % ( 36.4 % vs. 13.5 % ; p < 0.0001 ) .


Lixisenatide significantly lowered FPG and body weight versus placebo .


In breakfast meal test patients , lixisenatide reduced 2-hour PPG versus placebo ( LS mean : -111.48 vs. -3.80 mg/dL [ -6.19 vs. -0.21 mmol/L ] ; p < 0.0001 ) and glucose excursion ( -94.11 vs. +6.24 mg/dL [ -5.22 vs. +0.35 mmol/L ] ) , and reduced 2-hour glucagon , insulin , proinsulin , and C-peptide .


The percentage of AEs was 68.3 % for lixisenatide and 61.1 % for placebo ; and for SAEs : 3.5 % versus 5.6 % , respectively .


Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo ( 15.3 % vs. 12.3 % , respectively ) ; one severe episode of hypoglycemia was reported with lixisenatide .


Once-daily lixisenatide significantly improved glycemic control , with a pronounced postprandial effect , without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks .


To compare the efficacy of two surgical techniques for controllong nasal width after Le Fort I osteotomy .


Fifty-five patients who received the Le Fort I osteotomy have been included in this study .


They were randomly divided into 2 groups .


The experimental group received extraoral ABS , and the control group received traditional intraoral ABS .


3D photos of the patient 's face were taken before operation and at postoperative 3 months .


Alar width was measured on the 3D photos .


Data was reported as means and standard deviations , and statistic analysis was done by using student t test .


Compared with presurgical data , G. lat-G .


lat increased by ( 2.66 + / - 1.47 ) mm , Al-Al increased by ( 2.20 + / - 1.22 ) mm and Sbal-Sbal increased by ( 1.30 + / - 1.33 ) mm in experimental group .


G. lat-G .


lat increased by ( 1.38 + / - 1.29 ) mm , Al-Al increased by ( 1.06 + / - 0.95 ) mm and Sbal-Sbal increased by ( 0.36 + / - 1.33 ) mm in the control group .


There was significant difference between two groups .


The surgical technique of ABS is the most important factor for determining the postoperative alar width .


Both techniques have better effect on the Sbal-Sbal width control than the G. lat-G .


lat and Al-Al width control .


Traditional intraoral ABS can more effectively control the alar width .


Both techniques can not completely control the alar base widening after Le Fort I osteotomy .


Artemisinin-based combination therapies ( ACTs ) are essential for the effective control of falciparum malaria in endemic countries .


However , in most countries , such choice has been carried out without knowing their effectiveness when deployed in real-life conditions , that is , when treatment is not directly observed .


We report here the results of a study assessing the effectiveness of the two ACTs currently recommended in Burkina Faso for the treatment of uncomplicated malaria , that is , artemether-lumefantrine ( AL ) and artesunate-amodiaquine ( ASAQ ) .


Between September 2008 and January 2010 , 340 children were randomised to one of the two study arms and followed up for 42 days .


Treatment was administered according to routine practices , that is , the first dose was given by study nurses who explained to the parent/guardian how to administer the other doses at home during the following 2 days .


The results showed a significantly higher unadjusted adequate clinical and parasitological response in the ASAQ ( 58.4 % ) than in the AL arm ( 46.1 % ) at day 28 but these trends were similar after correction with PCR data ( ASAQ ( 89.7 % ) and AL ( 89.8 % ) ) .


New infections started to appear after day 14 , first in the AL and then in the ASAQ arm but at day 42 day of follow-up we observed no difference in the occurrence of recrudescent infection .


Despite a lower cure rate than those reported in efficacy studies in which the treatment administration was directly observed , both AL and ASAQ can still be used for the treatment of uncomplicated malaria in Burkina Faso .


Social factors may be of importance causally and act as maintenance factors in patients with anorexia nervosa .


Oxytocin is a neuromodulatory hormone involved in social emotional processing associated with attentional processes .


This study aimed to examine the impact of oxytocin on attentional processes to social faces representing anger , disgust , and happiness in patients with anorexia nervosa .


A double-blind , placebo-controlled within-subject crossover design was used .


Intranasal oxytocin or placebo followed by a visual probe detection task with faces depicting anger , disgust , and happiness was administered to 64 female subjects : 31 patients with anorexia nervosa and 33 control students .


Attentional bias to the disgust stimuli was observed in both groups under the placebo condition .


The attentional bias to disgust was reduced under the oxytocin condition ( a moderate effect in the patient group ) .


Avoidance of angry faces was observed in the patient group under the placebo condition and vigilance was observed in the healthy comparison group ; both of these information processing responses were moderated by oxytocin producing an increase in vigilance in the patients .


Happy/smiling faces did not elicit an attentional response in controls or the patients under either the placebo or oxytocin conditions .


Oxytocin attenuated attentional vigilance to disgust in patients with anorexia nervosa and healthy controls .


On the other hand , oxytocin changed the response to angry faces from avoidance to vigilance in patients but reduced vigilance to anger in healthy controls .


We conclude that patients with anorexia nervosa appear to use different strategies/circuits to emotionally process anger from their healthy counterparts .


The examination of cough reflex sensitivity through inhalational challenge can be utilized to demonstrate pharmacological end points .


Here we compare the effect of butamirate , dextromethorphan and placebo on capsaicin-induced cough in healthy volunteers .


In this randomized , placebo-controlled , six way crossover study the effect of dextromethrophan 30mg , four doses of butamirate and placebo was evaluated on incremental capsaicin challenges performed at baseline and 2 , 4 , 6 , 8 , 12 and 24h following dosing .


The primary end point was the area under the curve ( AUC ( 0,12 h ) ) of log10 C5 from pre-dose to 12h after dosing .


Plasma butamirate metabolites were analyzed to evaluate pharmacokinetic and pharmacodynamic relationships .


Thirty-four subjects ( 13 males , median age 25 years ) completed the study .


Cough sensitivity decreased from baseline in all arms of the study .


Dextromethorphan was superior to placebo ( P = 0.01 ) but butamirate failed to show significant activity with maximum attenuation at the 45mg dose .


There was no apparent relationship between pharmacokinetic and pharmacodynamic parameters for butamirate .


We have demonstrated for the first time that dextromethorphan attenuates capsaicin challenge confirming its broad activity on the cough reflex .


The lack of efficacy of butamirate could be due to formulation issues at higher doses .


A variety of apheresis instruments are now available on the market for double dose plateletpheresis .


We compared three apheresis devices ( Fenwal Amicus , Fresenius COM.TEC and Trima Accel ) with regard to processing time , platelet ( PLT ) yield , collection efficiency ( CE ) and collection rate ( CR ) .


The single-needle or double-needle double plateletpheresis procedures of the three instruments were compared in a retrospective , randomized study in 135 donors .


In the pre-apheresis setting , 45 double plateletpheresis procedures performed with each instrument revealed no significant differences in donor 's age , sex , weight , hemoglobin , white blood cell and PLT count between three groups .


The blood volume processed to reach a target PLT yield of610 ( 11 ) was higher in the COM.TEC compared with the Amicus and Trima ( 4394 vs. 3780 and 3340ml , respectively ; p < 0.001 ) .


Also there was a significantly higher median volume of ACD used in collections on the COM.TEC compared with the Amicus and Trima ( 426 vs. 387 and 329ml , respectively ; p < 0.001 ) .


There was a significantly higher median time needed for the procedures on the COM.TEC compared with the Amicus and Trima ( 66 vs. 62 and 63min , respectively ; p = 0.024 ) .


The CE was significantly higher with the Trima compared with the Amicus and COM.TEC ( 83.5717.19 vs. 66.713.47 and 58.795.14 % , respectively ; p < 0.001 ) .


Also , there was a significantly higher product volume on the Trima compared with the Amicus and COM.TEC ( 395.56 vs. 363.11 and 386.4 ml , respectively ; p = 0.008 ) .


Additionally , the CR was significantly lower with the COM.TEC compared with the Amicus and Trima ( 0.0920.011 vs. 0.0990.013 and 0.0970.013 plt10 ( 11 ) / min , respectively ; p = 0.039 ) .


There was no significant differences in PLT yield between the three groups ( p = 0.636 ) .


Trima single-needle device collected double dose platelets more efficiently than Amicus and COM.TEC double-needle devices .


Blood volume processed , ACD-A volume , and median separation time was significantly higher with the COM.TEC .


Also , the CR was significantly lower with the COM.TEC .


To investigate clinical outcomes of coronary intervention using a biolimus-eluting stent ( BES ) compared with a sirolimus-eluting stent ( SES ) in patients with acute myocardial infarction ( AMI ) in the Limus Eluted from A Durable versus ERodable Stent ( LEADERS ) coating trial at the final 5-year follow-up .


The LEADERS trial is a multicentre all-comer study , where patients ( n = 1707 ) were randomised to percutaneous intervention with either BES containing biodegradable polymer or SES containing durable polymer .


Out of 1707 patients enrolled in this trial , 573 patients had percutaneous coronary intervention for AMI ( BES = 280 , SES = 293 ) and were included in the current analysis .


Patient-oriented composite endpoint ( POCE , including all death , all myocardial infarction ( MI ) and all revascularisations ) , major adverse cardiac events ( MACE , including cardiac death , MI and clinically indicated target vessel revascularisation ) and stent thrombosis were assessed at 5-year follow-up .


The baseline clinical , angiographic and procedural characteristics were well matched between BES and SES groups .


In all patients with AMI , coronary intervention with a BES , compared with SES , significantly reduced POCE ( 28.9 % vs 42.3 % ; relative risk ( RR ) 0.61 , 95 % CI 0.47 to 0.82 , p = 0.001 ) at 5-year follow-up .


There was also a reduction in MACE rate in the BES group ( 18.2 % vs 25.9 % ; RR 0.67 , 95 % CI 0.47 to 0.95 , p = 0.025 ) ; however , there was no difference in cardiac death and stent thrombosis .


In patients with ST-elevation MI ( STEMI ) , coronary intervention with BES significantly reduced POCE ( 24.4 % vs 39.3 % ; RR 0.55 , 95 % CI 0.36 to 0.85 , p = 0.006 ) , MACE ( 12.6 % vs 25.0 % ; RR 0.47 , 95 % CI 0.26 to 0.83 , p = 0.008 ) and cardiac death ( 3.0 % vs 11.4 % ; RR 0.25 , 95 % CI 0.08 to 0.75 , p = 0.007 ) , along with a trend towards reduction in definite stent thrombosis ( 3.7 % vs 8.6 % ; RR 0.41 , 95 % CI 0.15 to 1.18 , p = 0.088 ) , compared with SES .


BES , compared with SES , significantly improved safety and efficacy outcomes in patients with AMI , especially those with STEMI , at 5-year follow-up .


NCT 00389220 .


The need for a fundoplication during repair of paraesophageal hiatal hernias ( PEH ) remains unclear .


Prevention of gastroesophageal reflux represents a trade-off against the risk of fundoplication-related side effects .


The aim of this trial was to compare laparoscopic mesh-augmented hiatoplasty with simple cardiophrenicopexy ( LMAH-C ) with laparoscopic mesh-augmented hiatoplasty with fundoplication ( LMAH-F ) in patients with PEH .


The study was designed as a patient - and assessor-blinded randomized controlled pilot trial , registration number : DRKS00004492 ( www.germanctr.de / ) .


Patients with symptomatic PEH were eligible and assigned by central randomization to LMAH-C or LMAH-F .


Endpoints were postoperative gastroesophageal reflux , complications , and quality of life 12 months postoperatively .


Forty patients ( 9 male , 31 female ) were randomized .


Patients were well matched for baseline characteristics .


At 3 months , the DeMeester score was higher after LMAH-C compared with LMAH-F ( 40.9 39.9 vs. 9.6 17 ; p = 0.048 ) .


At 12 months , the reflux syndrome score was higher after LMAH-C compared with LMAH-F ( 1.9 1.2 vs. 1.1 0.4 ; p = 0.020 ) .


In 53 % of LMAH-C patients and 17 % of LMAH-F patients , postoperative esophagitis was present ( p = 0.026 ) .


Values of dysphagia ( 2.1 1.6 vs 1.9 1.4 ; p = 0.737 ) , gas bloating ( 2.6 1.4 vs 2.8 1.4 ; p = 0.782 ) , and quality of life ( 116.0 16.2 vs 115.9 15.8 ; p = 0.992 ) were similar .


Relevant postoperative complications occurred in 4 ( 10 % ) patients and did not differ between the groups .


Laparoscopic repair of PEH should be combined with a fundoplication to avoid postoperative gastroesophageal reflux and resulting esophagitis .


Fundoplication-related side effects do not appear to be clinically relevant .


Multicenter randomized trials are required to confirm these findings .


This study examined parental factors associated with outcomes of youth in the Treatment Options for type 2 Diabetes in Adolescents and Youth ( TODAY ) clinical trial .


Of 699 youth with type 2 diabetes in the TODAY cohort , 623 ( 89.1 % ) had a parent participate and provide data at baseline , including weight , HbA1c , blood pressure , symptoms of depression , binge eating ( BE ) , and medical history .


Youth were followed 2-6 .5 years .


Data were analyzed using regression models and survival curve methods .


Parental diabetes ( 43.6 % of parents ) was associated with higher baseline HbA1c ( P < 0.0001 ) and failure of youths to maintain glycemic control on study treatment ( 53.6 % vs. 38.2 % failure rate among those without a diabetic parent , P = 0.0002 ) .


Parental hypertension ( 40.6 % of parents ) was associated with hypertension in youth during TODAY ( 40.4 % vs. 27.4 % of youth with and without parental hypertension had hypertension , P = 0.0008 ) and with higher youth baseline BMI z scores ( P = 0.0038 ) .


Parents had a mean baseline BMI of 33.6 kg/m ( 2 ) .


Parental obesity ( BMI > 30 kg/m ( 2 ) ) was associated with higher baseline BMI z scores in the youth ( P < 0.0001 ) .


Depressive symptoms in parents ( 20.6 % of parents ) were related to youth depressive symptoms at baseline only ( P = 0.0430 ) ; subclinical BE in parents was related to the presence of subclinical BE ( P = 0.0354 ) and depressive symptoms ( P = 0.0326 ) in youth throughout the study period .


Parental diabetes and hypertension were associated with lack of glycemic control , hypertension , and higher BMI z scores in youth .


Further research is needed to better understand and address parental biological and behavioral factors to improve youth health outcomes .


To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve ( AGV ) ( New World Medical , Cucamonga , CA ) and the Baerveldt 101-350 Glaucoma Implant ( BGI ) ( Abbott Medical Optics , Abbott Park , IL ) for the treatment of refractory glaucoma .


Multicenter , randomized , controlled clinical trial .


A total of 276 patients , including 143 in the AGV group and 133 in the BGI group .


Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure ( IOP ) of 18 mmHg in whom glaucoma drainage implant ( GDI ) surgery was planned were randomized to implantation of an AGV or a BGI .


Surgical failure , IOP , visual acuity ( VA ) , use of glaucoma medications , and complications .


At 5 years , IOP ( mean standard deviation [ SD ] ) was 14.74.4 mmHg in the AGV group and 12.74.5 mmHg in the BGI group ( P = 0.015 ) .


The number of glaucoma medications in use at 5 years ( mean SD ) was 2.21.4 in the AGV group and 1.81.5 in the BGI group ( P = 0.28 ) .


The cumulative probability of failure during 5 years of follow-up was 44.7 % in the AGV group and 39.4 % in the BGI group ( P = 0.65 ) .


The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group ( 80 % of AGV failures ) and 25 in the BGI group ( 53 % of BGI failures ; P = 0.003 ) .


Eleven eyes in the AGV group ( 20 % of AGV failures ) experienced persistent hypotony , explantation of implant , or loss of light perception compared with 22 eyes ( 47 % of failures ) in the BGI group .


Change in logarithm of the minimum angle of resolution VA ( mean SD ) at 5 years was 0.420.99 in the AGV group and 0.430.84 in the BGI group ( P = 0.97 ) .


Similar rates of surgical success were observed with both implants at 5 years .


The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV , but the BGI was associated with twice as many failures because of safety issues .


Elective cholecystectomy for symptomatic gall stone disease carries low risk of postoperative infective complications .


Yet the routine use of prophylactic antibiotic is in vogue in many centres .


The aim of this study was to find out the efficacy of antibiotic prophylaxis in preventing postoperative infective complications in low risk elective laparoscopic cholecystectomy patients .


Randomised controlled trial was carried out in our hospital from 1st Nov 2009 to 15th Oct 2011 .


A total of 350 patients were included in the study and were divided into Group A ( n = 177 ) .


and Group B ( n = 173 ) .


Group A was given single dose of injection Celfuroxime 1.5 gm as prophylactic antibiotic at the time of induction of anaesthesia , and Group B was not given any antibiotic .


In both groups , age , sex , duration of surgery , American Society of Anesthesiologists classification , duration of surgery and length of hospital stay were recorded .


Patients were followed-up weekly for 4 weeks and rates of superficial surgical site infections as well as intra-abdominal infections were recorded .


There were no significant differences in both groups in terms of age , sex , duration of surgery , length of hospital stay .


Eight ( 4.5 % ) cases of superficial surgical site infection were noted in Group A and 7 ( 4.0 % ) in Group B which was insignificant statistically ( p > 0.05 ) .


In low risk patients antibiotic prophylaxis does not seem to affect the incidence of postoperative infective complications in elective laparoscopic cholecystectomy .


The use of prophylactic antibiotics should be reserved for high risk patients undergoing laparoscopic cholecystectomy .


Myocardial perfusion SPECT ( MPS ) is one of the frequently used methods for quantification of perfusion defects in patients with known or suspected coronary artery disease .


This article describes open access software for automated quantification in MPS of stress-induced ischemia and infarction and provides phantom and in vivo validation .


A total of 492 patients with known or suspected coronary artery disease underwent both stress and rest MPS .


The proposed perfusion analysis algorithm ( Segment ) was trained in 140 patients and validated in the remaining 352 patients using visual scoring in MPS by an expert reader as reference standard .


Furthermore , validation was performed with simulated perfusion defects in an anthropomorphic computer model .


Total perfusion deficit ( TPD , range 0-100 ) , including both extent and severity of the perfusion defect , was used as the global measurement of the perfusion defects .


Mean bias SD between TPD by Segment and the simulated TPD was 3.6 3.8 ( R ( 2 ) = 0.92 ) .


Mean bias SD between TPD by Segment and the visual scoring in the patients was 1.2 2.9 ( R ( 2 ) = 0.64 ) for stress-induced ischemia and -0.3 3.1 ( R ( 2 ) = 0.86 ) for infarction .


The proposed algorithm can detect and quantify perfusion defects in MPS with good agreement to expert readers and to simulated values in a computer phantom .


Pentoxifylline , a nonselective phosphodiesterase inhibitor , shows vasodilator effects in certain vascular beds and reduces blood viscosity .


We have previously shown that under states of vasoconstriction an interaction between circulating erythrocytes and leukocytes may play a role in the control of blood flow .


The reason for this observation is not entirely clear but may be related to a mechanical interaction between red and white blood cells .


In the present study we hypothesized that pentoxifylline may alter this interaction during oxygen-induced vasoconstriction .


24 healthy male subjects participated in this double masked , randomized , placebo-controlled 2 way cross over trial .


In order to increase white blood cell count ( WBC ) count , 300 g of G-CSF was administered intravenously .


Vasoconstriction of retinal vessels was induced by oxygen inhalation .


400mg of pentoxifylline or placebo was infused at two different study days .


White blood cell flux was assessed with the blue-field entoptic technique .


Vessel calibers were measured with a dynamic vessel analyzer ( DVA ) and red blood cell velocity ( RBCV ) was determined with laser Doppler velocimetry ( LDV ) .


Retinal blood flow was calculated based on retinal vessel diameters and RBCV .


Administration of G-CSF induced a significant increase in WBC , both in the placebo and the pentoxifylline group ( p < 0.01 for both groups ) .


Retinal vessel diameter , RBCV , calculated retinal blood flow and white blood cell flow were not altered by administration of pentoxifylline .


Hyperoxia induced a pronounced decrease in retinal blood flow parameters .


No difference was observed between groups during oxygen breathing in vessel diameters ( p = 0.54 ) , RBCV ( p = 0.34 ) , calculated retinal blood flow ( p = 0.3 ) and white blood cell flow ( p = 0.26 ) .


Our data indicate that short time administration of pentoxifylline does not alter the oxygen-induced effect on ocular blood flow parameters during leukocytosis .


Whether long-term treatment could improve retinal blood flow under states of vasoconstriction remains to be investigated .


Randomized clinical trials ( RCTs ) suggest benefits for the transradial approach to percutaneous coronary intervention ( PCI ) for ST-elevation myocardial infarction ( STEMI ) .


However , transradial PCI may delay reperfusion , leading to its avoidance .


We sought to quantify the delay in reperfusion from transradial PCI ( `` transradial delay '' ) that would need to be introduced to offset the potential mortality benefit of transradial PCI , compared with transfemoral , observed in RCTs .


We developed a decision-analytic model to compare transfemoral and transradial PCI in STEMI .


Thirty-day mortality rates were estimated by pooling STEMI patients from 2 RCTs comparing transfemoral and transradial PCI .


We projected the impact of transradial delay using estimates of the increase in mortality associated with door-to-balloon time delays .


Sensitivity analyses were performed to understand the impact of uncertainty in assumptions .


In the base case , a transradial delay of 83.0 minutes was needed to offset the mortality benefit of transradial PCI .


When the mortality benefit of transradial PCI was one-quarter that observed in RCTs , the delay associated with equivalent mortality was 20.9 minutes .


In probabilistic sensitivity analyses , transradial PCI was preferred over transfemoral PCI in 97.5 % of simulations when transradial delay was 30 minutes and in 79.0 % of simulations when delay was 60 minutes .


A substantial transradial delay is required to eliminate even a fraction of the mortality benefit observed with transradial PCI in RCTs .


Results were robust to changing multiple assumptions and have implications for operators reluctant to transition to transradial PCI in STEMI because of concern for delaying reperfusion .


Heart rate ( HR ) plays an important role in the assessment of stress during therapeutic hypothermia ( TH ) for neonatal encephalopathy ; we aimed to quantify the effect on HR of endotracheal ( ET ) intubation and drugs given to facilitate it .


If atropine premedication independently increased HR , the main indicator of effective sedation , we hypothesised that increased sedation would have been given .


Thirty-two , term , neonates recruited into a randomised pilot study comparing TH and TH combined with 50 % Xenon inhalation were studied .


Indications for ET intubation included : resuscitation at delivery , clinical need and elective re-intubation with a cuffed ET tube if randomised to Xenon .


Standard intubation drugs comprised one or more of intravenous morphine , atropine , and suxamethonium .


Local cooling guidelines were followed including morphine infusion for sedation .


At postnatal hours five to eight atropine increased HR in a linear regression model ( p < 0.01 ) .


All other independent variables were excluded .


Where more than one dose of atropine was given total morphine sedation given up to 8h into the treatment period was significantly higher ( p < 0.01 ) .


We have shown that atropine premedication for ET intubation significantly increased HR , the main indicator of effective sedation and total morphine dose for sedation during early TH was increased where more than one dose of atropine was given .


Bradycardia was not reported in any neonate , even without atropine premedication .


We suggest that the use of atropine as part of standard premedication for ET intubation of term neonates undergoing TH should be reconsidered .


Narrowband UV-B ( NB-UV-B ) phototherapy is used extensively to treat vitiligo .


Afamelanotide , an analogue of - melanocyte-stimulating hormone , is known to induce tanning of the skin .


To evaluate the efficacy and safety of combination therapy for generalized vitiligo consisting of afamelanotide implant and NB-UV-B phototherapy .


This study was performed in 2 academic outpatient dermatology centers and 1 private dermatology practice .


We enrolled men and women 18 years or older with Fitzpatrick skin phototypes ( SPTs ) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15 % to 50 % of total body surface area .


Vitiligo was stable or slowly progressive for 3 months .


Patients were randomized to combination therapy ( n = 28 ) vs NB-UV-B monotherapy ( n = 27 ) .


After 1 month of NB-UV-B phototherapy , 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued ; the other group continued to receive NB-UV-B monotherapy .


Narrowband UV-B monotherapy vs combined NB-UV-B phototherapy and afamelanotide .


Response on the Vitiligo Area Scoring Index and Vitiligo European Task Force scoring system .


Response in the combination therapy group was superior to that in the NB-UV-B monotherapy group ( P < .05 ) at day 56 .


For the face and upper extremities , a significantly higher percentage of patients in the combination therapy group achieved repigmentation , and at earlier times ( face , 41.0 vs 61.0 days [ P = .001 ] ; upper extremities , 46.0 vs 69.0 days [ P = .003 ] ) .


In the combination therapy group , repigmentation was 48.64 % ( 95 % CI , 39.49 % -57.80 % ) at day 168 vs 33.26 % ( 95 % CI , 24.18 % -42.33 % ) in the NB-UV-B monotherapy group .


Notable adverse events included erythema in both groups and minor infections and nausea in the combination therapy group .


Comparison between Fitzpatrick SPTs showed patients with SPTs IV to VI in the combination therapy group had improvement in the Vitiligo Area Scoring Index at days 56 and 84 ( P < .05 ) ; no significant difference was noted in patients with SPT III .


A combination of afamelanotide implant and NB-UV-B phototherapy resulted in clinically apparent , statistically significant superior and faster repigmentation compared with NB-UV-B monotherapy .


The response was more noticeable in patients with SPTs IV to VI .


clinicaltrials.gov Identifier : NCT01430195 .


Cough is an extremely common problem in pediatrics , mostly triggered and perpetuated by inflammatory processes or mechanical irritation leading to viscous mucous production and increased sensitivity of the cough receptors .


Protecting the mucosa might be very useful in limiting the contact with micro-organisms and irritants thus decreasing the inflammation and mucus production .


Natural molecular complexes can act as a mechanical barrier limiting cough stimuli with a non pharmacological approach but with an indirect anti-inflammatory action .


Aim of the study was to assess the efficacy of a medical device containing natural functional components in the treatment of cough persisting more than 7 days .


In this randomized , parallel groups , double-blind vs. placebo study , children with cough persisting more than 7 days were enrolled .


The clinical efficacy of the study product was assessed evaluating changes in day - and night-time cough scores after 4 and 8 days ( t4 and t8 ) of product administration .


In the inter-group analysis , in the study product group compared with the placebo group , a significant difference ( t4 study treatment vs. t4 placebo , p = 0.03 ) was observed at t4 in night-time cough score.Considering the intra-group analysis , only the study product group registered a significant improvement from t0 to t4 in both day-time ( t0 vs. t4 , p = 0.04 ) and night-time ( t0 vs. t4 , p = 0.003 ) cough scores.A significant difference , considering the study product , was also found in the following intra-group analyses : day-time scores at t4 vs. t8 ( p = 0.01 ) and at t0 vs. t8 ( p = 0.001 ) ; night-time scores at t4 vs. t8 ( p = 0.05 ) , and at t0 vs. t8 ( p = 0.005 ) .


Considering a subgroup of patients with higher cough ( 3 ) scores , 92.9 % of them in the study product group improved at t0 vs. t4 day-time .


Grintuss pediatric syrup showed to possess an interesting profile of efficacy and safety in the treatment of cough persisting more than 7 days .


Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases , such as less perioperative blood loss and faster patient recovery .


It also maintains similar results with regard to tumor resection margins and oncological long-term survival .


In gastric cancer the role of laparoscopic surgery remains unclear .


Current recommended treatment for gastric cancer consists of radical resection of the stomach , with a free margin of 5 to 6 cm from the tumor , combined with a lymphadenectomy .


The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care .


Therefore , it is imperative that a novel surgical technique , such as minimally invasive total gastrectomy , should be non-inferior with regard to radicality of surgery and lymph node yield .


The Surgical Techniques , Open versus Minimally invasive gastrectomy After CHemotherapy ( STOMACH ) study is a randomized , clinical multicenter trial .


All adult patients with primary carcinoma of the stomach , in which the tumor is considered surgically resectable ( T1-3 , N0-1 , M0 ) after neo-adjuvant chemotherapy , are eligible for inclusion and randomization .


The primary endpoint is quality of oncological resection , measured by radicality of surgery and number of retrieved lymph nodes .


The pathologist is blinded towards patient allocation .


Secondary outcomes include patient-reported outcomes measures ( PROMs ) regarding quality of life , postoperative complications and cost-effectiveness .


Based on a non-inferiority model for lymph node yield , with an average lymph node yield of 20 , a non-inferiority margin of -4 and a 90 % power to detect non-inferiority , a total of 168 patients are to be included .


The STOMACH trial is a prospective , multicenter , parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy : the conventional ` open ' approach or minimally invasive total gastrectomy .


This trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .


This study aims to investigate the role of fast-track surgery in preventing the development of postoperative delirium and other complications in elderly patients with colorectal carcinoma .


A total of 240 elderly patients with colorectal carcinoma ( aged 70years ) undergoing open colorectal surgery was randomly assigned into two groups , in which the patients were managed perioperatively either with traditional or fast-track approaches .


The length of hospital stay ( LOS ) and time to pass flatus were compared .


The incidence of postoperative delirium and other complications were evaluated .


Serum interleukin-6 ( IL-6 ) levels were determined before and after surgery .


The LOS was significantly shorter in the fast-track surgery ( FTS ) group than that in the traditional group .


The recovery of bowel movement ( as indicated by the time to pass flatus ) was faster in the FTS group .


The postoperative complications including pulmonary infection , urinary infection and heart failure were significantly less frequent in the FTS group .


Notably , the incidence of postoperative delirium was significantly lower in patients with the fast track therapy ( 4/117 , 3.4 % ) than with the traditional therapy ( 15/116 , 12.9 % ; p = 0.008 ) .


The serum IL-6 levels on postoperative days 1 , 2 , and 3 in patients with the fast-track therapy were significantly lower than those with the traditional therapy ( p < 0.001 ) .


Compared to traditional perioperative management , fast-track surgery decreases the LOS , facilitates the recovery of bowel movement , and reduces occurrence of postoperative delirium and other complications in elderly patients with colorectal carcinoma .


The lower incidence of delirium is at least partly attributable to the reduced systemic inflammatory response mediated by IL-6 .


We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect .


We completed a randomized controlled community trial among adults aged 65 and older in ( 1 ) 10 control communities receiving no special resources or guidance on fall prevention , ( 2 ) 5 standard support communities receiving modest funding to implement Stepping On , and ( 3 ) 5 enhanced support communities receiving funding and technical support .


The primary outcome was hospital inpatient and emergency department discharges for falls , examined with Poisson regression .


Compared with control communities , standard and enhanced support communities showed significantly higher community-wide reductions ( 9 % and 8 % , respectively ) in fall injuries from baseline ( 2007-2008 ) to follow-up ( 2010-2011 ) .


No significant difference was found between enhanced and standard support communities .


Population-based fall prevention interventions can be effective when implemented in community settings .


More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice .


There is little evidence on the efficacy of glucocorticoid transnasal nebulization therapy in patients witheosinophilic chronic rhinosinusitis with nasal polyps ( CRSwNP ) .


We sought to evaluate the immunologic and remodeling effects of budesonide transnasal nebulization in patients with eosinophilic CRSwNP .


Sixty patients with eosinophilic CRSwNP were randomized to receive budesonide or placebo treatment for 14days by means of transnasal nebulization in a double-blind manner .


Endoscopic polyp size scores ( maximum = 6 points , Kennedy score ) and visual analog scale scores for nasal symptoms were assessed before and after treatment .


Similarly , polyp samples were evaluated for inflammatory cytokines , matrix metalloproteinases ( MMPs ) , and tissue inhibitors of metalloproteinases ( TIMPs ) by using an immunoassay ; collagen by using histochemistry ; eosinophils by using hematoxylin and eosin stain ; and T-cell subsets by using flow cytometry .


Budesonide transnasal nebulization significantly reduced polyp size compared with placebo ( mean difference between groups , -0.73 units ; 95 % CI , -1.15 to -0.32 units ; P = .002 ) and improved symptoms .


Polyp IL-5 and eotaxin expression decreased significantly , whereas TGF - and IL-10 expression increased .


Expression of IFN - and IL-17 was not altered .


Budesonide transnasal nebulization consistently reduced eosinophil infiltration and TH2 cell frequency and increased natural regulatory T-cell and type 1 regulatory T-cell frequencies .


Indices of remodeling , including albumin , MMP-2 , MMP-7 , MMP-8 , and MMP-9 , were significantly decreased , whereas collagen deposition and TIMP-1 , TIMP-2 , and TIMP-4 levels were significantly increased .


Budesonide transnasal nebulization did not suppress the hypothalamic-pituitary-adrenal axis or cause any serious side effects .


Short-term budesonide transnasal nebulization is an effective and safe treatment option in patients with eosinophilic CRSwNP , achieving clinical improvement by regulating remodeling , cytokine expression , and T-cell subset distribution .


To report 5-year results from a previously reported trial evaluating intravitreal 0.5 mg ranibizumab with prompt versus deferred ( for 24 weeks ) focal/grid laser treatment for diabetic macular edema ( DME ) .


Multicenter , randomized clinical trial .


Among participants from the trial with 3 years of follow-up who subsequently consented to a 2-year extension and survived through 5 years , 124 ( 97 % ) and 111 ( 92 % ) completed the 5-year visit in the prompt and deferred groups , respectively .


Random assignment to ranibizumab every 4 weeks until no longer improving ( with resumption if worsening ) and prompt or deferred ( 24 weeks ) focal/grid laser treatment .


Best-corrected visual acuity at the 5-year visit .


The mean change in visual acuity letter score from baseline to the 5-year visit was +7.2 letters in the prompt laser group compared with +9.8 letters in the deferred laser group ( mean difference,-2 .6 letters ; 95 % confidence interval,-5 .5 to +0.4 letters ; P = 0.09 ) .


At the 5-year visit in the prompt versus deferred laser groups , there was vision loss of 10 letters in 9 % versus 8 % , an improvement of 10 letters in 46 % versus 58 % , and an improvement of 15 letters in 27 % versus 38 % of participants , respectively .


From baseline to 5 years , 56 % of participants in the deferred group did not receive laser .


The median number of injections was 13 versus 17 in the prompt and deferral groups , including 54 % and 45 % receiving no injections during year 4 and 62 % and 52 % receiving no injections during year 5 , respectively .


Five-year results suggest focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better than deferring laser treatment for 24 weeks in eyes with DME involving the central macula with vision impairment .


Although more than half of eyes in which laser treatment is deferred may avoid laser for at least 5 years , such eyes may require more injections to achieve these results when following this protocol .


Most eyes treated with ranibizumab and either prompt or deferred laser maintain vision gains obtained by the first year through 5 years with little additional treatment after 3 years .


Postoperative pulmonary complications ( PPCs ) are the most commonly reported complications after esophagectomy .


The aim of this study was to examine the effect and feasibility of preoperative inspiratory muscle training-high intensity ( IMT-HI ) , and IMT-endurance ( IMT-E ) on the incidence of PPCs in patients following esophagectomy for esophageal cancer ( EC ) .


A single-blind , randomized , clinical pilot study was conducted between 2009 and 2012 .


Forty-five participants were assigned to either IMT-HI or IMT-E .


Effectiveness was assessed by analyzing PPCs , length of hospital stay ( LOS ) , duration of mechanical ventilation , stay on the intensive care unit , and number of reintubations .


Maximal inspiratory pressure and lung function changes were recorded pre - and post-training .


Feasibility was assessed by IMT-related adverse events , training compliance , and patients ' satisfaction .


Thirty-nine patients could be analyzed , 20 patients in the IMT-HI arm and 19 patients in the IMT-E arm .


The incidence of PPCs differed significantly between groups and was almost three times lower for the IMT-HI group ( 4 vs. 11 patients ; p = 0.015 ) .


Other differences in favor of the IMT-HI group were LOS ( 13.5 vs. 18 days ; p = 0.010 ) and number of reintubations ( 0 vs. 4 patients ; p = 0.030 ) .


Both interventions proved to be equally feasible .


Preoperative IMT-HI showed to be a promising , effective , and feasible intervention to reduce PPCs in EC patients undergoing esophagectomy .


Further research with a larger sample size is recommended .


Increased oxidative stress , inflammation , and malnutrition are present in hemodialysis patients and these factors exacerbate cardiovascular comorbidities .


Vitamin E and alpha-lipoic acid ( ALA ) may have a protective role against cardiovascular disease risk factors via anti-oxidative and anti-inflammatory properties .


The aim of this study was to evaluate the effect of ALA and vitamin E administration ( alone or combined ) on hemodialysis-induced stress oxidation , inflammation , and malnutrition .


In a randomized placebo-controlled trial , we examined the effects of 2-month supplementation by vitamin E and ALA ( alone or combined ) on biomarkers of lipid peroxidation ( malondialdehyde ) , inflammation ( high-sensitivity C-Reactive protein and interleukin-6 ) , and malnutrition ( Subjective Global Assessment and body mass index ) in 85 hemodialysis patients receiving ALA ( 600 mg ) , vitamin E ( 400 IU ) , ALA and vitamin E , and placebo .


After supplementation , no significant changes were observed in malondialdehyde level ; however , there was a decrease in the ALA and vitamin E group during the period of the study .


Also , a nonsignificant decrease was seen in the high-sensitivity C-Reactive protein concentration of the interventional groups .


Supplementation of vitamin E with and without ALA significantly reduced interleukin-6 concentration .


A significant improvement was observed in malnutrition status of all groups .


Vitamin E and ALA supplementation , especially their combination , might improve inflammation and malnutrition status , which suggest it as a potential preventive strategy against CVD among end-stage renal disease patients .


To investigate the effect of dexmedetomidine on T helper 1 ( Th1 ) and T helper 2 ( Th2 ) cytokines and their ratio during and after surgery .


Single-blinded , randomized , placebo-controlled clinical comparison study .


Academic medical center .


46 adult , ASA physical status 1 and 2 patients scheduled for laparoscopic cholecystectomy .


Patients were randomized to two groups : the dexmedetomidine group ( n = 23 ) , in which dexmedetomidine was infused with a 1.0 g/kg loading dose followed by infusion of 0.5 g/kg/h ; or the saline group ( n = 23 ) .


Interferon-gamma ( IFN-gamma ) and interleukin-4 ( IL-4 ) as Th1 and Th2 cytokines , respectively , were quantified three times : after induction of anesthesia ( T0 ) , at the end of peritoneal closure ( T1 ) , and 60 minutes after surgery ( T2 ) .


The IFN-gamma/IL -4 ratio was then calculated .


The dexmedetomidine group displayed higher levels of IFN-gamma at T1 and T2 ( 42.30 pg/dL vs 6.91 pg/dL at T1 [ P = 0.025 ] ; 40.51 pg/dL vs 8.29 pg/dL at T2 [ P = 0.030 ] ) than the saline group .


The dexmedetomidine group was also associated with higher ratios of IFN-gamma/IL -4 ( 1.22 vs 0.32 , respectively , at T1 [ P = 0.012 ] ; 1.53 vs 0.13 , respectively , at T2 [ P = 0.012 ] ) .


Dexmedetomidine plays an immunomodulatory role , shifting the Th1/Th2 cytokine balance toward Th1 in patients with surgical and anesthetic stress .


Animal studies report photodynamic therapy ( PDT ) to improve healing of excisional wounds ; the mechanism is uncertain and equivalent human studies are lacking .


To explore the impact of methyl aminolaevulinate ( MAL ) - PDT on clinical and microscopic parameters of human cutaneous excisional wound healing , examining potential modulation through production of transforming growth factor ( TGF ) - isoforms .


In 27 healthy older men ( 60-77 years ) , a 4-mm punch biopsy wound was created in skin of the upper inner arm and treated with MAL-PDT three times over 5 days .


An identical control wound to the contralateral arm was untreated and both wounds left to heal by secondary intention .


Wounds were re-excised during the inflammatory phase ( 7 days , n = 10 ) , matrix remodelling ( 3 weeks , n = 8 ) and cosmetic outcome/dermal structure ( 9 months , n = 9 ) .


Production of TGF-1 , TGF-3 and matrix metalloproteinases ( MMPs ) was assessed by immunohistochemistry alongside microscopic measurement of wound size/area and clinical assessment of wound appearance .


MAL-PDT delayed re-epithelialization at 7 days , associated with increased inflammation .


However , 3 weeks postwounding , treated wounds were smaller with higher production of MMP-1 ( P = 001 ) , MMP-9 ( P = 004 ) and TGF-3 ( P = 003 ) .


TGF-1 was lower than control at 7 days and higher at 3 weeks ( both P = 003 ) .


At 9 months , MAL-PDT-treated wounds showed greater , more ordered deposition of collagen I , collagen III and elastin ( all P < 005 ) .


MAL-PDT increases MMP-1 , MMP-9 and TGF-3 production during matrix remodelling , ultimately producing scars with improved dermal matrix architecture .


Injections of human placental extract , which is known to play a role in skin regulation , have long been used for the treatment of skin wrinkles and non-healing wounds .


Porcine placental extract ( PPE ) , an oral supplement , was recently developed for this purpose .


The aim of this study was to assess whether PPE has a positive effect on the improvement of fine wrinkles below the eye in climacteric women .


We first non-invasively measured wrinkle widths with a skin analyzer in a cross-section of 185 healthy adult Japanese women .


Next , 44 climacteric women with mild or few climacteric symptoms were enrolled into an open-label , randomized , controlled study of the effect of PPE on wrinkle widths .


A retrospective comparison of wrinkle widths in 123 climacteric women with climacteric symptoms with or without PPE treatment was also performed .


Wrinkle widths below the eye in women 30 years of age were significantly higher than in women 20-29 years of age .


Treatment with three capsules of PPE per day was significantly ( p < 0.05 ) effective in reducing wrinkle widths at 24 weeks compared with control subjects .


Retrospective analysis showed that subjects treated with three ( p < 0.05 ) and six ( p < 0.01 ) capsules of PPE per day observed a significant reduction in wrinkle widths compared with untreated subjects .


Oral PPE treatment is a possible option for improving the appearance of fine wrinkles below the eye in climacteric women .


It is recommended to vaccinate pregnant women against influenza .


A possible impact on the immune expression of the fetus has never been studied .


We aim to study the immune signature in the upper airways and the incidence of infections in neonates born to mothers receiving Influenza A ( H1N1 ) pnd09 vaccination during pregnancy .


One hundred and fifty-six women from the unselected Copenhagen Prospective Study on Asthma in Childhood ( COPSAC2010 ) received Influenza A ( H1N1 ) pnd09-vaccination during the 2009 pandemic .


Fifty-one mothers received the vaccine during pregnancy and 105 after pregnancy ; 332 neonates of nonvaccinated mothers were included as secondary controls .


Nasal mucosal lining fluid was sampled in 488 neonates and assessed for interleukin ( IL ) -12 p70 , IP-10 , interferon-gamma ( IFN ) - , tumor necrosis factor-alpha ( TNF ) - , MIP-1 , MCP-1 , MCP-4 , IL-4 , IL-5 , IL-13 , eotaxin-1 , eotaxin-3 , TARC , MDC , IL-17 , IL-1 , IL-8 , transforming growth factor beta ( TGF ) -1 , IL-10 and IL-2 .


Infections were monitored the first year of life by daily diary cards and clinical controls .


Neonates of mothers vaccinated during pregnancy had significant up-regulation of TGF-1 [ ratio = 1.52 ( 1.22-1 .90 ) , P = 0.0002 ] , and corresponding down-regulation ( P < 0.05 ) of IL-12p70 , IFN - , IL-5 , eotaxin-1 , TARC , MDC , IL-8 in comparison to those vaccinated after pregnancy .


The lag-time from vaccination during pregnancy to assessment of the immune signature showed significant and positive association to up-regulation of TGF-1 levels ( P = 0.0003 ) and significant negative association to other mediators .


The study was not powered to study differences in the incidence of infections in early infancy which did not differ between the study groups .


Influenza A ( H1N1 ) pnd09 vaccination during pregnancy up-regulates TGF-1 and down-regulates key mediators of the protective immunity .


Although glucocorticoids are widely used in the treatment of patients with early rheumatoid arthritis , the best dosage of glucocorticoids with regards to efficacy and safety is not known.The aim of the study ` Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis ' ( CORRA ) is to compare two standard glucocorticoid starting dosages and the non-use of glucocorticoids in the treatment of patients with early active rheumatoid arthritis on the background of the established ` anchor ' therapy with methotrexate .


CORRA is an investigator-initiated , randomized , multicenter , double-blind , placebo-controlled trial with two treatment arms , starting with 60 mg or 10 mg prednisolone per day , tapered down to 5 mg prednisolone within eight weeks , and one placebo arm , each arm comprising 150 patients .


The duration of the intervention is 12 weeks .


In parallel , all patients will be treated with methotrexate ( usual dosage 15 mg/week ) .


The primary efficacy endpoint is the progression of radiographic joint damage after one year compared to baseline .


Important secondary endpoints are the percentage of patients in remission , patient global assessment of disease activity , and changes of functional capacity .


Safety monitoring is performed.The statistical analysis is performed in three hierarchical steps .


The first step is an analysis of covariance ( = 0.05 ) to compare the group with the initial prednisolone dosage of 60 mg and the placebo group .


In case of a statistically significant result , the comparison of the group starting with 10 mg prednisolone with the placebo group will be performed as a second step ( = 0.05 ) .