The primary end-point was Hb change between baseline and the evaluation period ( weeks @-@ ) , with a non-inferiority margin of -@ g/dL .


Three hundred and fifty-five subjects received @ dose of DA .


Mean ( @ % confidence interval -LSB- CI -RSB- ) change in Hb between baseline and the evaluation period was @ ( @-@ @ ) g/dL for the Q@W group and @ ( @-@ @ ) g/dL for the QM group , the mean ( @ % CI ) difference in Hb change being -@ ( -@ to @ ) g/dL .


Most subjects ( @ % Q@W ; @ % QM ) achieved a Hb level @ g/dL and @ g/dL increase in Hb from baseline .


Mean DA ( SD ) weekly equivalent doses over the evaluation period were @ ( @ ) and @ ( @ ) g/kg per week for the Q@W and QM groups , respectively .


Safety profiles were similar between groups .


In subjects with CKD-ND , QM dosing was non-inferior to Q@W dosing for anaemia correction and had a similar safety profile .


To compare the effect of semi-recumbent and sitting positions on gas exchange , respiratory mechanics and hemodynamics in patients weaning from mechanical ventilation .


Upright positions are encouraged during rehabilitation of the critically ill but there effects have not been well described .


A prospective , randomized , cross-over trial was conducted .


Subjects were passively mobilized from supine into a seated position ( out of bed ) and from supine to a semi-recumbent position ( > @ backrest elevation in bed ) .


Arterial blood gas ( PaO@/FiO@ , PaO@ , SaO@ , PaCO@ and A-a gradient ) , respiratory mechanics ( VE , VT , RR , Cdyn , RR/VT ) and hemodynamic measurements ( HR , MABP ) were collected in supine and at @min and @min after re-positioning .


Thirty-four intubated and ventilated subjects were enrolled .


The angle of backrest inclination in sitting ( @ ) was greater than gained with semi-recumbent positioning ( @ , p < @ ) .


There were no clinically important changes in arterial blood gas , respiratory mechanic or hemodynamic values due to either position .


Neither position resulted in significant changes in respiratory and hemodynamic parameters .


Both positions can be applied safely in patients being weaned from ventilation .


To explore the optimal timing of tirofiban early treatment in ST-segment elevated acute myocardial infarction ( STEMI ) undergoing elective percutaneous coronary intervention ( PCI ) .


A total of @ consecutive STEMI patients were enrolled in the study .


They were randomly assigned to the tirofiban early treatment group with tirofiban administrated routinely at @ hours prior to angiography or the control group with tirofiban provisional administrated during or after angiography .


Thrombolysis in myocardial infarction ( TIMI ) flow , creatine kinase MB isoenzyme ( CK-MB ) levels , acute thrombus events , efficacy and safety endpoints at Day @ , Day @ , @ months and @ year ( efficacy endpoints : death , myocardial infarction , target vessel revascularization and ischemic stroke ; safety endpoints : bleeding and thrombocytopenia ) were observed and compared between the two groups .


A total of @ STEMI patients underwent elective PCI with @ patients in each group and the baseline characteristics were balanced between the two groups .


Tirofiban was administered ( @ @ ) hours earlier in the tirofiban early treatment group than the control group .


No statistical difference was observed between the two groups in TIMI flow before -LSB- grade @ : @ ( @ % ) vs @ ( @ % ) , grade @ : @ ( @ % ) vs @ ( @ % ) -RSB- and after PCI -LSB- grade @ : @ ( @ % ) vs @ ( @ % ) -RSB- .


No difference was shown between the two groups in CK-MB levels before PCI -LSB- ( @ @ ) U/L vs ( @ @ ) U/L , P > @ -RSB- ; and the increase of CK-MB @-@ hours after PCI -LSB- ( @ @ ) U/L vs ( @ @ ) U/L , P > @ -RSB- .


The incidence of acute thrombus events was similar ( @ % vs @ % , P > @ ) .


No statistical difference was observed between the two groups in the efficacy endpoints at Day @ ( @ % vs @ % , P > @ ) , Day @ ( @ % vs @ % , P > @ ) , @ months ( @ % vs @ % , P > @ ) and @ year ( @ % vs @ % , P > @ ) .


Similar incidence was shown in the slight bleeding ( @ % vs @ % , P > @ ) and the slight thrombocytopenia ( @ % vs @ % , P > @ ) , while no severe to moderate bleeding or severe thrombocytopenia happened in both groups .


Tirofiban early treatment is not better than the tirofiban bailout treatment during or after PCI in STEMI patients undergoing elective PCI .


Trail registration ChiCTR-TRC-@ .


To investigate whether Sudarshan Kriya and related practices ( SK&P ) can lead to increased global assessment of functioning ( GAF ) and increased feeling of wellness in male prisoners with a non psychotic psychiatric disorder .


This is a six month parallel randomized controlled study with sample size of @ male prisoners .


Participants meeting inclusion and exclusion criteria were assigned to a study or control group by simple random allocation in which random allocation sequence was generated using a random number table .


Each individual study participant was involved in a daily program of SK&P for six weeks .


Each individual control participant was instructed to sit in an armchair with his eyes closed and gentle attention to their breath for duration of six weeks .


To be included in this study , a participant must be a male prisoner diagnosed to be suffering from a psychiatric disorder ( except psychosis and bipolar affective disorder -LSB- BPAD -RSB- ) by ICD-@ ( DCR ) criteria with age between @ and @ years .


Majority of subjects were unemployed married individuals , educated until undermatric level and not having occupational skills of more than an unskilled labor level .


Practicing SK&P for six weeks led to improvement in meanSD score of study participants in GAF , anxiety ( ANX ) , depressed mood ( DEP ) , positive well being ( PWB ) , general health ( GH ) , self control ( SC ) , vitality ( VT ) and total positive general well being ( PGWB ) .


Change in meanSD score of study participants when compared with control participants was statistically significant in terms of GAF , ANX , DEP , PWB , GH and PGWB .


Increase in SC and VT scores was statistically insignificant when compared with control participants .


Practicing SK&P helps in improving GAF , PWB , GH and total PGWB of an individual .


SK&P also causes significant reduction in anxiety and depression levels .


Effect of SK&P on SC and VT is insignificant .


The immune checkpoint inhibitor ipilimumab is the standard-of-care treatment for patients with advanced melanoma .


Pembrolizumab inhibits the programmed cell death @ ( PD-@ ) immune checkpoint and has antitumor activity in patients with advanced melanoma .


In this randomized , controlled , phase @ study , we assigned @ patients with advanced melanoma in a @:@:@ ratio to receive pembrolizumab ( at a dose of @ mg per kilogram of body weight ) every @ weeks or every @ weeks or four doses of ipilimumab ( at @ mg per kilogram ) every @ weeks .


Primary end points were progression-free and overall survival .


The estimated @-month progression-free-survival rates were @ % for pembrolizumab every @ weeks , @ % for pembrolizumab every @ weeks , and @ % for ipilimumab ( hazard ratio for disease progression , @ ; P < @ for both pembrolizumab regimens versus ipilimumab ; @ % confidence intervals -LSB- CIs -RSB- , @ to @ and @ to @ , respectively ) .


Estimated @-month survival rates were @ % , @ % , and @ % , respectively ( hazard ratio for death for pembrolizumab every @ weeks , @ ; @ % CI , @ to @ ; P = @ ; hazard ratio for pembrolizumab every @ weeks , @ ; @ % CI , @ to @ ; P = @ ) .


The response rate was improved with pembrolizumab administered every @ weeks ( @ % ) and every @ weeks ( @ % ) , as compared with ipilimumab ( @ % ) ( P < @ for both comparisons ) .


Responses were ongoing in @ % , @ % , and @ % of patients , respectively , after a median follow-up of @ months .


Efficacy was similar in the two pembrolizumab groups .


Rates of treatment-related adverse events of grade @ to @ severity were lower in the pembrolizumab groups ( @ % and @ % ) than in the ipilimumab group ( @ % ) .


The anti-PD-@ antibody pembrolizumab prolonged progression-free survival and overall survival and had less high-grade toxicity than did ipilimumab in patients with advanced melanoma .


( Funded by Merck Sharp & Dohme ; KEYNOTE-@ ClinicalTrials.gov number , NCT@ . )


The aim of this study was to evaluate the effectiveness of specially processed cereal ( SPC ) as a suitable adjunctive treatment for Meniere 's disease .


We performed a randomized double-blinded , placebo-controlled , crossover study in a tertiary referral center of patients who had a diagnosis of Meniere 's disease based on the guidelines of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery ( AAO-HNS ) .


The main outcome measure was the AAO-HNS Functional Level Scale ( FLS ) .


Thirty-nine patients completed the study without any reported complications .


The mean pretreatment FLS score for the entire study cohort was @ ( median , @ ; range , @ to @ ) .


The overall FLS score improved significantly ( p < @ ) , to @ ( median , @ ) , after SPC treatment .


No patients showed worsening on the FLS during SPC or placebo treatment .


Of the @ patients , @ showed improvement on the FLS , and no change was observed in the remaining @ .


The median improvement on the FLS in these @ patients was @ points ( mean , @ ; range , @ to @ ) .


The mean FLS score after placebo cereal treatment was not significantly different from baseline ( p = @ ) , but was significantly higher than that after SPC treatment ( mean , @ ; p < @ ) .


The marginal difference observed between the baseline FLS score and the placebo FLS score was due to the fact that @ patients reported @-point improvements on the FLS after placebo treatment .


Nevertheless , significantly fewer patients improved on placebo than on SPC ( p < @ ) .


Treatment with SPC appears to be well tolerated by most patients ( @ % ) without any complications .


More than half ( @ % ) of the study cohort reported subjective improvement in functional level .


This study sought to randomly compare cerebral protection with ANGIOGUARD ( Cordis Corporation , Bridgewater , New Jersey ) with Mo.Ma ( Invatec/Medtronic Vascular Inc , Santa Rosa , California ) during carotid artery stenting ( CAS ) , using diffusion-weighted magnetic resonance imaging ( DW-MRI ) to detect new ischemic cerebral lesions .


The number , size , and location of lesions were analyzed .


The choice of the type of cerebral protection during CAS is controversial .


From July @ to July @ , @ patients undergoing CAS were randomized to ANGIOGUARD or Mo.Ma , distributed by chance , @ patients for each group .


All patients underwent DW-MRI before and after CAS .


An independent neuroradiologist blinded to the cerebral protection used analyzed the images .


Univariate and multivariate logistic models were fitted to analyze new ischemic lesions .


Alternatively , a propensity score approach was used to reduce the bias due to differences between the groups .


For the number of lesions , we used Poisson regression models .


New ischemic lesions seen on DW-MRI were present in @ % of the ANGIOGUARD group versus @ % of the Mo.Ma cohort ( p = @ ) .


The number of ischemic cerebral lesions per patient , when present , was significantly lower in the Mo.Ma group ( a median of @ lesions per patient vs. a median of @ in the ANGIOGUARD , p < @ ) .


Most lesions were small ( < @ mm ) and localized in the ipsilateral territory .


One patient in the ANGIOGUARD group had a minor stroke during CAS ( @ % ) .


New ischemic lesions seen on DW-MRI were present in both groups in > @ % , but the number of lesions per patient was greater in the ANGIOGUARD group .


No death or disabling stroke occurred during at least @ year of follow-up in both cohorts .


This double-blind randomized controlled trial assessed the effect of subgingival ozone ( O@ , gaseous ozone , HealOzone MK II , KaVo ) and/or hydrogen peroxide ( H@O@ ) on the development of peri-implant mucositis .


Twenty subjects ( mean age , @ @ years ) with @ implants ( @ implants each ) were recruited .


First , a @-week pretrial phase took place to achieve healthy gingiva .


Subsequently , partial gum shields were constructed for the experimental area ( around the @ implants ) ; subjects were asked to refrain from brushing in that area by wearing the gum shield .


The following treatments were randomly applied ( for @ seconds ) to implant sites on days @ , @ , and @ : ( @ ) air ( O@ ) and saline ( @ % NaCl ) ( control group ) , ( @ ) O@ and H@O@ ( @ % ) , ( @ ) O@ and saline , and ( @ ) O@ and H@O@ .


Plaque , gingival , and bleeding indices were recorded on days @ , @ , @ , and @ .


Significant differences were seen among the treatments ( P < @ ) in plaque ( F = @ ) , modified gingival ( F = @ ) , and bleeding ( F = @ ) indices .


O@ + saline and O@ + H@O@ produced optimum gingival health scores and were equally effective and the most effective in controlling bleeding ( mean score = @ ) , while O@ + saline was the least effective ( mean score = @ ) .


Ozone showed great potential for management of peri-implant mucositis .


Cardiogenic shock ( CS ) complicating acute myocardial infarction ( AMI ) is associated with high mortality .


Previous studies regarding gender-specific differences in CS are conflicting and there are insufficient data for the presence of gender-associated differences in the contemporary percutaneous coronary intervention era .


Aim of this study was therefore to investigate gender-specific differences in a large cohort of AMI patients with CS undergoing contemporary treatment .


In the randomized Intra-aortic Balloon Pump in Cardiogenic Shock II ( IABP-SHOCK II ) trial , @ patients with CS complicating AMI undergoing early revascularization were assigned to therapy with or without intra-aortic balloon pump .


We compared sex-specific differences in these patients with regard to baseline and procedural characteristics as well as short - and long-term clinical outcome .


Of @ patients @ ( @ % ) were female .


Women were significantly older than men and had a significantly lower systolic and diastolic blood pressure at presentation ( p < @ for all ) .


Diabetes mellitus and hypertension were more frequent in women , whereas smoking was more frequent in men ( p < @ for all ) .


Women showed a higher mortality within the first day after randomization ( p = @ ) .


However , after multivariable adjustment this numerical difference was no longer statistically significant .


No gender-related differences in clinical outcome were observed after @ , @ and @ months of follow-up .


In this large-scale multicenter study in patients with CS complicating AMI , women had a worse-risk profile in comparison to men .


No significant gender-related differences in treatment as well as short - and long-term outcome were observed .


Performing rigorously designed clinical trials in device-based treatments is challenging .


Continuous positive airway pressure ( CPAP ) is the most effective device-based treatment for obstructive sleep apnoea .


We performed a randomised crossover trial of CPAP versus placebo therapy and did not disclose the presence of placebo .


We assessed rates of staff unblinding , the likelihood of patient unblinding and obtained patient perceptions on lack of full disclosure .


All patients ( n = @ ) underwent a semi-structured exit interview .


Prior to full disclosure patients were asked questions to ascertain whether they suspected one therapy was ineffective .


The use of placebo was then disclosed and additional questions were administered to indicate the likelihood of unblinding had full disclosure occurred during consent .


Staff unblinding was determined by means of a questionnaire that was completed after each patient encounter .


While the lack of full disclosure prevented patient unblinding during the trial , patients revealed a clear preference for active CPAP .


After disclosing the presence of placebo , @ % ( n = @ ) felt they would have been unblinded had they known at the start of the trial .


Only one patient described unease about the lack of full disclosure .


Staff thought they were unblinded in @ % ( n = @/@ ) of encounters .


They correctly identified the treatment device in @ % of cases ( n = @/@ , p < @ ) .


Successful patient blinding was achieved , however this was probably reliant on the lack of full disclosure .


Staff unblinding occurred and highlights the difficulty with investigator blinding in device-based trials .


Ethical challenges in this type of study are likely to compromise research feasibility .


Closer clinical supervision has been increasingly promoted to improve patient care .


However , the continuous bedside presence of supervisors may threaten the model of progressive independence traditionally associated with effective clinical training .


Studies have shown favourable effects of closer supervision on trainees ' learning , but have not paid specific attention to the learning processes involved .


We conducted a simulation-based study to explore the learning opportunities created during simulated resuscitation scenarios under different levels of supervision .


Fifty-three residents completed a supervised scenario .


Residents were randomised to one of three levels of supervision : telephone ( distant ) ; in-person after telephone consultation ( immediately available ) , and in-person from the beginning of the simulation ( direct ) .


These interactions were converted into @ pages of transcripts for analysis .


We performed an inductive thematic analysis followed by a deductive analysis using situated learning theory as a theoretical framework .


Learning opportunities created during simulated scenarios were identified as belonging to either of two categories , incidental and engineered opportunities .


The themes resulting from this framework contributed to our understanding of trainees ' contributions to patient care , supervisors ' influences on patient care , and trainee-supervisor interactions .


All forms of supervision offered trainees incidental opportunities for practice , although the nature of these contributions could be affected by the bedside presence of supervisors .


Supervisors ' involvement in patient care by telephone and in person was associated with a shift of responsibility for patient care , but represented , respectively , engineered and incidental opportunities for observation .


In-person supervisor-trainee interactions added value to observation and created additional opportunities for incidental feedback and engineered practice .


The shift of responsibility for patient care occurred during both direct and distant supervision , and did not necessarily translate into a lack of opportunities for trainee participation and practice .


To evaluate the effect of muscovite in preventing small bowel injury induced by nonsteroidal anti-inflammatory drugs ( NSAIDs ) .


We recruited and screened thirty-two healthy volunteers who were randomly allocated equally into two groups : an NSAID control group , who received @ mg slow-release diclofenac , twice daily for @ d ; and an NSAID-muscovite group , who received @ g of muscovite in addition to the @ mg of slow-release diclofenac , twice daily for @ d. For gastroprotection , both groups were administered @ mg/d of the proton pump inhibitor omeprazole .


All eligible subjects underwent video capsule endoscopy ( CE ) prior to and @ d after treatment .


Thirty subjects ( NSAID-muscovite group , n = @ ; NSAID control group , n = @ ) finally completed the whole trail .


At the baseline CE examination , no statistically significant differences between the two groups have been observed .


However , after @ d of drug treatment , a significant difference was observed in the percentage of subjects with mucosal breaks when comparing the NSAID-muscovite group with the NSAID control group .


While @ % ( @/@ ) of subjects in the NSAID control group had at least one mucosal break , co-administration of muscovite in the NSAID-muscovite group reduced the rate to @ % ( @/@ ) ( P = @ ) .


Moreover , higher number of mucosal breaks was found in the NSAID control group vs that in the NSAID-muscovite group ( P < @ ) .


Muscovite co-therapy reduced the incidence of small intestinal injury after @ d of diclofenac administration .


Bursectomy , a traditional operative procedure to remove the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon , has been performed for serosa-positive gastric cancer in Japan and Eastern Asia .


We conducted a multicenter , randomized , controlled trial to demonstrate the noninferiority of the omission of bursectomy .


Between July @ and January @ , @ patients with cT@-@ gastric adenocarcinoma were randomized intraoperatively to D@ gastrectomy with or without bursectomy .


The primary endpoint was overall survival ( OS ) .


We provide the results of the final analysis of the complete @-year follow-up data .


After the median follow-up of @ months , @-year OS was @ % for the bursectomy group and @ % for the nonbursectomy group ( @-sided P = @ for superiority ; @-sided P = @ for noninferiority ) .


The hazard ratio for death in the nonbursectomy group was @ ( @ % CI , @-@ @ ) .


The @-year recurrence-free survivals were @ % and @ % in the bursectomy and nonbursectomy groups , respectively ( @-sided P = @ for superiority ; @-sided P = @ for noninferiority ) .


Cox multivariate analysis revealed that bursectomy was an independent prognostic factor of good OS ( P = @ ) .


Subgroup analysis showed a trend toward improved survival after bursectomy for tumors in the middle or lower third of the stomach and for pathologically serosa-positive tumors .


The final analysis could not demonstrate the noninferiority of the omission of bursectomy .


Bursectomy should not be abandoned as a futile procedure .


To assess the comparative efficacy and safety of pregabalin and levetiracetam for the reduction of seizure frequency in patients with partial seizures .


This was a randomized , double-blind , flexible-dose , parallel-group noninferiority study of pregabalin and levetiracetam ( randomized @:@ ) as adjunctive treatment in adult patients with refractory partial seizures .


The study included a @-week baseline phase , @-week dose-escalation phase , and @-week maintenance phase .


The primary endpoint was the proportion of patients with a @ % reduction in @-day seizure rate during the @-week maintenance phase , as compared with baseline .


Noninferiority of pregabalin was declared if the lower limit of the @ % confidence interval ( CI ) for the difference in responder rates was greater than the prespecified noninferiority margin of -@ % .


A key secondary endpoint was the percent change from baseline in @-day seizure rate during the dose-escalation and maintenance phases .


Five hundred nine patients were randomized to pregabalin ( n = @ ) or levetiracetam ( n = @ ) and @ ( @ pregabalin , @ levetiracetam ) completed the maintenance phase .


With both pregabalin and levetiracetam , the proportion of patients with a @ % reduction in @-day seizure rate was @ ( difference between groups -LSB- @ % CI -RSB- , @ -LSB- -@ to @ -RSB- ) .


Because the lower bound of the @ % CI was greater than the prespecified noninferiority margin of -@ % , pregabalin was not inferior to levetiracetam .


There was no significant difference between pregabalin and levetiracetam in the percent change in @-day seizure rate ( median difference -LSB- @ % CI -RSB- , @ -LSB- -@ to @ -RSB- , p = @ ) .


In a post hoc analysis , the proportion of patients who were seizure-free for the maintenance phase was lower with pregabalin ( @ % ) than with levetiracetam ( @ % ) , p = @ .


Safety profiles were similar and consistent with prior trials .


These results indicate that pregabalin is noninferior , and has a similar tolerability , to levetiracetam as adjunctive therapy in reducing seizure frequency in patients with partial seizures .


Nicorandil , an ATP sensitive potassium channel opener , may reduce the incidence of microvascular dysfunction after percutaneous coronary intervention ( PCI ) by dilating coronary resistance vessels .


The aim of the study was evaluation of the impact of the administration of intravenous nicorandil on measuring the index of microcirculatory resistance ( IMR ) in PCI to patients with stable angina pectoris ( SAP ) .


Intravascular ultrasound ( IVUS ) , fractional flow reserve ( FFR ) , IMR and blood examination ( CK-MB ) , cardiac troponin I ( cTnI ) immediately post-PCI ( and @ hours later ) were performed in @ consecutive patients with SAP undergoing PCI .


FFR and IMR were measured simultaneously with a single coronary pressure wire .


IMR was defined as Pd/coronary flow ( or Pd * mean transit time ) at peak hyperaemia .


Patients were randomised to the control ( n = @ ) , or nicorandil group ( n = @ ) .


In the nicorandil group , nicorandil was intravenously administered as a @ mg bolus injection just before PCI and as a constant infusion at @ mg/hour for @ hours thereafter .


All volumetric IVUS parameters and FFR were similar between the two groups both pre - and post-PCI .


However , IMR immediately post-PCI and cTnI @ hours post-PCI were significantly higher in the control group compared to the nicorandil group ( IMR : @ vs. @ units , and cTnI : @ vs. @ ng/mL , for control vs. nicorandil ) .


The incidence for cTnI elevation more than fivefold the normal range ( > @ ng/mL ) was significantly larger in the control group than in the nicorandil group ( @ % vs. @ % , p < @ ) .


Additionally , the control group showed a closer correlation between plaque volume reduction during stenting as assessed by volumetric IVUS , and cTnI elevation than the nicorandil group ( r = @ vs. @ , p < @ for control vs. nicorandil ) .


In patients undergoing successful coronary stenting for stable angina , administration of nicorandil is associated with reduced microvascular dysfunction induced by PCI .


Methadone maintenance treatment ( MMT ) patients have an exceedingly high prevalence of tobacco use , and interventions that have been specifically developed for this vulnerable subpopulation have struggled to attain even modest rates of cessation .


A significant barrier has been an inability to initiate a quit attempt early in the treatment process and adherence to treatment .


This study examined the extent to which self-efficacy , medication adherence , and other demographic and smoking variables predicted an early quit day in a sample of MMT smokers ( n = @ ) enrolled in a smoking cessation pharmacotherapy trial .


Using logistic regression , we estimated the association of having an early quit day-@hr without smoking during the first month of treatment .


Only @ % of participants reported a successful early quit day .


The likelihood of an early quit day increased significantly ( odds ratio -LSB- OR -RSB- = @ , @ % CI = @-@ @ , p < @ ) with education level and if a quit attempt was made in the past year ( OR = @ , @ % CI = @-@ @ , p < @ ) .


Compared to the placebo arm , those randomized to either nicotine replacement therapy ( OR = @ , @ % CI = @-@ @ , p < @ ) or varenicline ( OR = @ , @ % CI = @-@ @ ) were significantly more likely to have an early quit day .


The likelihood of an early quit day was also positively associated with adherence to the medication protocol ( OR = @ , @ % CI = @-@ @ ) .


Difficulty in achieving an early quit attempt may help explain the very low cessation rates found in studies of MMT smokers .


Most women with breast cancer who undergo breast-conserving surgery receive whole-breast irradiation .


We examined whether the addition of regional nodal irradiation to whole-breast irradiation improved outcomes .


We randomly assigned women with node-positive or high-risk node-negative breast cancer who were treated with breast-conserving surgery and adjuvant systemic therapy to undergo either whole-breast irradiation plus regional nodal irradiation ( including internal mammary , supraclavicular , and axillary lymph nodes ) ( nodal-irradiation group ) or whole-breast irradiation alone ( control group ) .


The primary outcome was overall survival .


Secondary outcomes were disease-free survival , isolated locoregional disease-free survival , and distant disease-free survival .


Between March @ and February @ , a total of @ women were assigned to the nodal-irradiation group or the control group ( @ women in each group ) .


The median follow-up was @ years .


At the @-year follow-up , there was no significant between-group difference in survival , with a rate of @ % in the nodal-irradiation group and @ % in the control group ( hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


The rates of disease-free survival were @ % in the nodal-irradiation group and @ % in the control group ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


Patients in the nodal-irradiation group had higher rates of grade @ or greater acute pneumonitis ( @ % vs. @ % , P = @ ) and lymphedema ( @ % vs. @ % , P = @ ) .


Among women with node-positive or high-risk node-negative breast cancer , the addition of regional nodal irradiation to whole-breast irradiation did not improve overall survival but reduced the rate of breast-cancer recurrence .


( Funded by the Canadian Cancer Society Research Institute and others ; MA @ ClinicalTrials.gov number , NCT@ . )


Screening for lung cancer with low-dose spiral computed tomography ( LDCT ) has been shown to reduce lung cancer mortality by @ % compared with screening with chest X-ray ( CXR ) in the National Lung Screening Trial , but uncertainty remains concerning the efficacy of LDCT screening in a community setting .


To explore the effect of LDCT screening on lung cancer mortality compared with no screening .


Secondary endpoints included incidence , stage , and resectability rates .


Male smokers of @ + pack-years , aged @ to @ years , underwent a baseline CXR and sputum cytology examination and received five screening rounds with LDCT or a yearly clinical review only in a randomized fashion .


A total of @,@ subjects were enrolled in the LDCT arm and @,@ in the control arm .


Their median age was @ years ( interquartile range , @ ) , and median smoking exposure was @ pack-years .


One hundred four patients ( @ % ) were diagnosed with lung cancer in the screening arm ( @ by CT ) , @ of whom ( @ % ) had stage I disease ; @ control patients ( @ % ) were diagnosed with lung cancer , with @ ( @ % ) being stage I cases .


Lung cancer mortality was @per@ ,@ person-years ( @ % confidence interval , @-@ ) in the LDCT arm versus @per@ ,@ person-years ( @ % CI , @-@ ) in the control arm ( hazard ratio , @ ; @ % confidence interval , @-@ @ ) .


Because of its limited statistical power , the results of the DANTE ( Detection And screening of early lung cancer with Novel imaging TEchnology ) trial do not allow us to make a definitive statement about the efficacy of LDCT screening .


However , they underline the importance of obtaining additional data from randomized trials with intervention-free reference arms before the implementation of population screening .


Migraine headaches are a significant problem for American women with many of them suffering from headaches around the time of their menstrual cycle .


Women taking oral contraceptives in the standard @/@ cycle regimen often suffer from headaches around the time of the hormone free intervals ( HFIs ) as well .


Extended oral contraceptive regimens have been shown to decrease the frequency , but not eliminate these headaches .


This study is a double-blind , randomized , placebo-controlled pilot study of participants with menstrual-related migraines ( MRMs ) who were initiated on extended combined oral contraceptives and given frovatriptan prophylactically during HFIs .


Participants having spontaneous menstrual cycles or taking daily combined oral contraceptives in a @/@ regimen with MRMs were placed on a contraceptive containing levonorgestrel and ethinyl estradiol .


Analyses compared headache scores during pre-study baseline cycles to those in a @-day extended regimen with placebo versus frovatriptan treatments during HFIs .


Daily headache scores decreased ( p = @ ) from @ @ during pre-study cycles to @ @ during extended combined oral contraceptive use .


Frovatriptan blocked the increase in headache score over the placebo during HFIs .


However , following the withdrawal of frovatriptan , headache scores increased ( p > @ ) despite resuming combined oral contraceptive use .


Extended combined oral contraceptive regimen reduces MRM severity .


Frovatriptan prevents headaches during HFIs , but is associated with new headache symptoms when withdrawn .


To compare the anaesthetic , analgesic and cardiorespiratory effects of intramuscular ( IM ) medetomidine and ketamine administered alone or combined with morphine or tramadol , for orchiectomy in cats .


Randomised , blinded , prospective clinical study .


Thirty client-owned cats .


Cats ( n = @ in each group ) received a combination of medetomidine ( @ gkg ( -@ ) ) and ketamine ( @ mg kg ( -@ ) ) alone ( MedK ) ; combined with morphine ( @ mg kg ( -@ ) ) ( MedKM ) , or combined with tramadol ( @ mg kg ( -@ ) ) ( MedKT ) IM .


Time of induction , surgical and recovery events were recorded , and physiological parameters measured and recorded .


Analgesia was evaluated with a visual analogue scale , a composite scoring system and the von Frey mechanical threshold device , every hour from three to eight hours post-drug administration injection .


Data were analyzed with a linear mixed model , Kruskal-Wallis or Chi-square tests ( p < @ ) .


Median ( IQR ) induction and recovery times ( minutes ) were not significantly ( p = @ ) different between groups : @ ( @-@ @ ) , @ ( @-@ @ ) and @ ( @-@ @ ) for induction and @ ( @-@ @ ) , @ ( @-@ @ ) and @ ( @-@ @ ) for recovery , with MedK , MedKT and MedKM , respectively .


Two cats ( MedKM ) required alfaxalone for endotracheal intubation .


In all groups , three or four cats required additional isoflurane for surgery .


Arterial oxygen tension overall ( mean SD : @ @ mmHg ) was low .


Surgery resulted in increased systolic arterial blood pressure ( p < @ ) , haemoglobin saturation ( p < @ ) , respiratory ( p = @ ) and heart rates ( p = @ ) .


Pain scores did not differ significantly between groups .


Von Frey responses decreased over time ; changes over time varied by treatment ( p < @ ) , MedK returning to baseline values more rapidly than MedKM and MedKT .


No cat required rescue analgesics .


All three protocols can provide adequate anaesthesia and analgesia for orchiectomy in cats .


However , rescue intervention to maintain surgical anaesthesia may be required in some cats .


Oxygen supplementation is advised .


The value of frequent Carcino-Embryonic Antigen ( CEA ) measurements and CEA-triggered imaging for detecting recurrent disease in colorectal cancer ( CRC ) patients was investigated in search for an evidence-based follow-up protocol .


This is a randomized-controlled multicenter prospective study using a stepped-wedge cluster design .


From October @ to October @ , surgically treated non-metastasized CRC patients in follow-up were followed in eleven hospitals .


Clusters of hospitals sequentially changed their usual follow-up care into an intensified follow-up schedule consisting of CEA measurements every two months , with imaging in case of two CEA rises .


The primary outcome measures were the proportion of recurrences that could be treated with curative intent , recurrences with definitive curative treatment outcome , and the time to detection of recurrent disease .


@ patients were included ; @ recurrences were detected ( @ % ) .


A higher proportion of recurrences was detected in the intervention protocol compared to the control protocol ( OR = @ ; @ % - CI : @-@ @ ; p = @ ) .


The proportion of recurrences that could be treated with curative intent was higher in the intervention protocol ( OR = @ ; @ % - CI : @-@ @ ; p = @ ) and the proportion of recurrences with definitive curative treatment outcome was also higher ( OR = @ , @ % - CI : @-@ @ , p-value : @ ) .


The time to detection of recurrent disease was significantly shorter in the intensified follow-up protocol ( HR = @ ; @ % - CI : @-@ @ ; p = @ ) .


The CEAwatch protocol detects recurrent disease after colorectal cancer earlier , in a phase that a significantly higher proportion of recurrences can be treated with curative intent .


To monitor the development of graft vascularization after pterygium excision with conjunctival autograft transplantation ( CAT ) using indocyanine green angiography ( ICGA ) and to compare the graft vascularization between @ different fixation techniques ( fibrin glue and sutures ) .


A total of @ eyes of @ patients with primary pterygium were randomly assigned after pterygium excision as having either fibrin glue ( @ eyes ) or Vicryl sutures ( @ eyes ) for CAT .


Anterior segment ICGA findings were evaluated postoperatively at @ , @ , and @ days and the percentages of graft vascularization in both groups were compared using pixel analysis software program .


The mean SD age of patients in the suture and fibrin glue groups was @ @ years and @ @ years , respectively .


There was no statistically significant difference between the groups regarding age , sex , or follow-up ( p < @ for all ) .


Also , the mean intraoperative defect size was not significantly different between the groups , which was measured as @ @ mm@ in the suture group and @ @ mm@ in the fibrin glue group ( p = @ ) .


The mean percentage of vascularized graft area at postoperative day @ and @ was @ @ % and @ @ % in the suture group and @ @ % and @ @ % in the fibrin glue group .


The difference between the groups was statistically significant ( p < @ for both ) .


At postoperative day @ , all grafts were @ % perfused in both groups .


Fibrin glue fixation of conjunctival autografts led to more vascularization in the early postoperative period than suture fixated grafts , which in turn may have significance in terms of graft health and pterygium recurrence .


To explore the effects of parecoxib sodium multimode analgesia on postoperative analgesia in patients undergoing laparoscopic cholecystectomy ( LC ) .


A prospective , double-blind , randomized and placebo-controlled study was conducted on @ patients undergoing elective LC at Department of Endoscopic Surgery , First Affiliated Hospital , Wenzhou Medical College from March @ to June @ .


They were randomized to receive either @ mg parecoxib infusion @ min preoperative and at @ , @ , @ , @ h post-operation ( treatment group ) .


And @ ml normal saline infusion was administered similarly as a placebo ( control group ) .


All patients received ropivacaine infusion at port sites at the end of LC .


The degree of postoperative pain was assessed with visual analog scale ( VAS ) at @ , @ , @ , @ , @ , @ , @ , @ h post-operation respectively .


The consumption of pethidine in the first @ h post-operation was also recorded .


The VAS pain scores at each timepoint were significantly lower in the treatment group than those in the control group ( @ h : @ @ vs @ @ , t = -@ , P = @ ; @ h : @ @ vs @ @ , t = -@ , P = @ ; @ h : @ @ vs @ @ , t = -@ , P = @ ; @ h : @ @ vs @ @ , t = -@ , P = @ ; @ h : @ @ vs @ @ , t = -@ , P = @ ; @ h : @ @ vs @ @ , t = -@ , P = @ ; @ h : @ @ vs @ @ , t = -@ , P = @ ; @ h : @ @ vs @ @ , t = -@ , P = @ ) .


And the amount of pethidine used in the first @h after LC was also less in the treatment group ( @ vs @ mg , ( @ ) = @ , P = @ ) .


The infusion multimode analgesia of parecoxib sodium @ mg provides significant effect of postoperative pain relief after laparoscopic cholecystectomy .


In this study we aimed to assess the feasibility and safety of fast-track surgery ( FTS ) combined with laparoscopy for treating patients with rectal cancer and compare the results with those of the conventional perioperative intervention group .


A total of @ patients with rectal cancer were prospectively randomly assigned to the FTS combined with laparoscopy group and the conventional perioperative intervention plus laparoscopy group from November @ to November @ .


All patients received radical anterior resection with total mesorectal excision .


Their baseline characteristics and the perioperative outcomes were recorded for analyses .


Compared with the conventional perioperative intervention group , the fast-track protocol combined with laparoscopy could shorten the time to the first flatus ( @ h vs @ h , P = @ ) and first defecation ( @ h vs @ h , P = @ ) after operation , accelerate the decrease of white blood cell count ( P < @ ) , inhibit body temperature augmentation ( P < @ ) and reduce postoperative complication rate ( @ % vs @ % , P = @ ) .


In addition , the length of postoperative stay was also shortened ( @ days vs @ days , P = @ ) .


The medical cost of hospitalization was also reduced in the FTS group .


FTS in combination with laparoscopy may accelerate the clinical recovery of patients with rectal cancer after surgery .


Plant-made biotherapeutics are gathering momentum and some plant glycoproteins are allergens .


Glycans with core @-@xylose and @,@ fucose motifs and antennae terminated by mannose residues ( e.g. : MMXF ) are found on several plant allergens and can cross-react with glyco-epitopes from other sources .


To date , reactivity to these cross-reactive determinants has not been associated with clinical symptoms .


We produced VLP vaccines bearing the hemagglutinin ( HA ) of H@ ( A/Indonesia/@ / @ ) or H@ ( A/California/@ / @ ) influenza viruses by transfection of Nicotiana benthamiana .


Subjects enrolled in Phase I/II trials were followed for evidence of allergy/hypersensitivity and development of antibodies against plant glyco-epitopes .


A total of @/@ subjects received either one ( H@ ) or @ doses ( H@ ) of vaccine ( @-@ g of HA/dose ) intramuscularly including @ with pre-existing plant allergies .


Subjects were monitored for @ months .


IgG and IgE to plant glyco-epitopes were measured by ELISA using corn - / egg-derived avidin and bromelain as target antigens .


No subject developed allergic/hypersensitivity symptoms .


Some ( @ % ) developed transient IgG and , in some cases IgE , to plant glyco-epitopes but no subject mounted an IgE response to the MMXF motif .


Antibodies returned to baseline by @ months in most subjects .


VLP vaccines bearing influenza HA glycoproteins can elicit transient IgG and , in some cases , IgE responses that are not associated with either the development or worsening of allergic/hypersensitivity symptoms .


Cognitive training has been shown to improve both cognitive and everyday abilities in older adults ; however , little is known concerning the amount of training needed or the characteristics of those who benefit .


These analyses examined the longitudinal impact of dosage ( number of training sessions ) on the improvement and maintenance of cognitive and everyday function .


ACTIVE is a longitudinal , randomized , single-blind clinical trial evaluating cognitive interventions in older adults ( aged @-@ ) from six states in the United States .


Latent growth curve models indicated that initial training effects were maintained over @ years and amplified by booster sessions .


A single booster session counteracted @ months of age-related processing speed decline .


Cognitive performance improved by @ standard deviations for participants who attended all @ initial sessions and all @ booster sessions compared to randomized participants who attended none .


Implications for the broader application of cognitive training interventions are discussed .


Galectin-@ is a prognostic heart failure biomarker associated with aldosterone-induced myocardial fibrosis ; mineralocorticoid receptor antagonists ( MRAs ) may reduce such fibrosis .


We sought to examine outcomes of patients with heart failure with reduced ejection fraction ( HFrEF ) as a function of galectin-@ and MRA therapy .


A total of @ patients with chronic HFrEF were categorized by baseline galectin-@ and subsequent MRA therapy trends with regard to cardiovascular ( CV ) events , left ventricular remodeling , safety , and quality of life , over a mean of @ months .


Although galectin-@ > @ ng/mL was associated with doubling in adjusted risk for CV events , regardless of MRA treatment , there was no difference in CV event rates with regard to MRA use patterns , independent of galectin-@ concentrations .


Specifically , in patients with elevated galectin-@ treated with intensified MRA therapy , a significant difference was not detected in CV event rates ( P = @ ) or the cumulative number of such events ( P = @ ) .


Adjusted analysis revealed no difference in time to first CV event if MRA was added/intensified in those with elevated galectin-@ ( hazard ratio @ , @ % CI @-@ @ , P = @ ) ; similarly , cumulative MRA dose was not a specific predictor of benefit .


In those with elevated galectin-@ , MRA therapy did not affect left ventricular remodeling indices or quality of life at follow-up ; these patients had the highest rates of treatment-related adverse events with intensified MRA use .


Regardless of MRA use , elevated galectin-@ was associated with more significant renal dysfunction .


Among patients with chronic HFrEF and elevated galectin-@ concentrations , we found no specific benefit from addition or intensification of MRA therapy .


To observe the curative effect of acupuncture at hour-prescriptive points , a method of midnight-noon ebb-flow , to treat female adult abdominal obesity with spleen deficiency and exuberant dampness .


Seventy-two patients with adult abdominal obesity with spleen deficiency and exuberant dampness were randomly divided into a treatment group and a control group with @ patients in each group .


Patients in the treatment group were treated with acupuncture at hour-prescriptive points from @ to @ AM every day on the principle of taking points along channels in time .


Patients in the control group were treated with acupuncture at any time beyond @ to @ AM .


Patients in both groups were treated for three courses of treatment .


The total effective rate was @ % in the treatment group and @ % in the control group .


The total curative effect in the treatment group was significantly better than that in the control group in reducing body weight , body mass index , waistline , obesity level , and clinical symptoms ( P < @ ) .


After treatment , t-test was used on two independent samples to analyze the ratio of waistline to hipline and hipline .


A value of @ < P < @ expressed a weaker outcome and similar curative effect between the two groups in reducing ratio of waistline to hipline and hipline of patients .


This value indicates that the treatment group has no obvious superiority to that of the control group for curative effect .


Because it was superior in reducing waistline and body weight of female adult patients suffering from abdominal obesity with spleen deficiency and exuberant dampness , acupuncture at hour-prescriptive points , a method of midnight-noon ebb-flow , is an effective method to treat obesity .


To evaluate how an intervention , which combined hand washing promotion aimed at @-year-olds with provision of free soap , affected illnesses among the children and their families and children 's school absenteeism .


We monitored illnesses , including diarrhoea and acute respiratory infections ( ARIs ) , school absences and soap consumption for @ weeks in @ low-income communities in Mumbai , India ( @ communities per arm ) .


Outcomes from @ intervention households ( containing @ @-year-olds and @ subjects in total ) and @ control households ( containing @ @-year-olds and @ subjects ) were modelled using negative binomial regression .


Intervention group @-year-olds had fewer episodes of diarrhoea ( -@ % , @ % confidence intervals -LSB- CI -RSB- = -@ % , -@ % ) , ARIs ( -@ % , @ % CI = -@ % , -@ % ) , school absences due to illnesses ( -@ % , @ % CI = -@ % , -@ % ) and eye infections ( -@ % , @ % CI = -@ % , -@ % ) .


Further , there were fewer episodes of diarrhoea and ARIs in the intervention group for ` whole families ' ( -@ % , @ % CI = -@ % , -@ % ; and -@ % , @ % CI = -@ % , -@ % , respectively ) , @ - to @-year-olds ( -@ % , @ % CI = -@ % , -@ % ; and -@ % , @ % CI = -@ % , -@ % ) and under @ s ( -@ % , @ % CI = -@ % , -@ % ; and -@ % , @ % CI = -@ % , -@ % ) .


Direct-contact hand washing interventions aimed at younger school-aged children can affect the health of the whole family .


These may be scalable through public-private partnerships and classroom-based campaigns .


Further work is required to understand the conditions under which health benefits are transferred and the mechanisms for transference .


Canine babesiosis due to Babesia canis is an endemic disease in many European countries .


A vaccine is available in some countries , but it does not prevent the infection and just helps in reducing the gravity of clinical signs .


Therefore , the major way to help preventing the disease is by controlling tick infestations on dogs.To assess the preventive efficacy of afoxolaner ( NexGard ) , a new oral anti- flea and tick product , against Babesia canis infected adult Dermacentor reticulatus in an experimentally controlled study .


Sixteen healthy mixed breed adult dogs , negative for Babesia canis antibodies were included in a single centre , randomized , blinded and controlled study to evaluate the impact of treatment with afoxolaner on the transmission of Babesia canis to dogs exposed to Dermacentor reticulatus .


The dogs were randomly allocated into two groups of @ dogs each .


One group remained untreated .


In the other group , dogs were treated orally with a novel formulation of afoxolaner ( NexGard ) on day @ .


All dogs were infested each by @ adult Dermacentor reticulatus ticks ( equal sex ratio ) at days @ , @ , @ and @ .


The Dermacentor reticulatus ticks were confirmed to harbour Babesia canis by Polymerase Chain Reaction ( PCR ) .


The treatment was well tolerated by all dogs without any adverse effects .


Babesia canis was transmitted by D. reticulatus to all untreated control dogs , confirmed following demonstration of hyperthermia , detection of B. canis parasites in blood smears and PCR assay from blood and serology .


These confirmed infected dogs were subsequently treated with imidocarb and diminazene .


The treated dogs remained negative based on all criteria until the last study , Day @ , confirming that the oral treatment of dogs with NexGard prevented transmission of Babesia canis and development of clinical babesiosis for up to @ days .


This is the first demonstration that an oral acaricidal treatment may prevent the transmission of a pathogen despite the need for the tick to attach and start feeding before being killed by the acaricide .


Medical trainees have identified stress as an important contributor to their medical errors in acute care environments .


The objective of this study was to determine if the addition of acute stressors to simulated resuscitation scenarios would impact on residents ' simulated clinical performance .


Fifty-four residents completed a control and a high-stress simulated scenario on separate visits .


Stress measures were collected before and after scenarios .


Two assessors independently evaluated residents ' videotaped performance .


Both control and high-stress scenarios triggered significant stress responses among participants ; however , stress responses were not significantly different between control and high-stress conditions .


No difference in performance was found between control and high-stress conditions ( F value = @ , p = @ ) .


Residents exposed to simulated resuscitation scenarios experienced significant stress responses irrespective of the presence of acute stressors during these scenarios .


This anticipatory stressful response could impact on resident learning and performance and should be further explored .


This prospective , randomized , double-blind study was designed to evaluate the use of intranasally administered dexmedetomidine vs intranasal midazolam as a premedication in children undergoing complete dental rehabilitation .


Seventy-two children of American Society of Anesthesiology classification ( ASA ) physical status ( I & II ) , aged @-@ years , were randomly assigned to one of two equal groups .


Group M received intranasal midazolam ( @ mgkg ( -@ ) ) , and group D received intranasal dexmedetomidine ( @ gkg ( -@ ) ) .


The patients ' sedation status , mask acceptance , and hemodynamic parameters were recorded by an observer until anesthesia induction .


Recovery conditions , postoperative pain , and postoperative agitation were also recorded .


The median onset of sedation was significantly shorter in group M @ ( @-@ ) min than in group D @ ( @-@ ) min ( P = @ ) .


Compared with the children in group M , those in group D were significantly more sedated when they were separated from their parents ( @ % vs @ % , respectively ) ( P = @ ) .


Satisfactory compliance with mask application was @ % in group M vs @ % in group D ( P = @ ) .


The incidences of postoperative agitation and shivering were significantly lower in Group D compared with group M. Thirteen children ( @ % ) in group M , showed signs of nasal irritation with teary eyes , and none of these signs was seen in the children in group D ( P = @ ) .


There were no incidences of bradycardia , hypotension , in either of the groups during study observation .


Intranasal dexmedetomidine ( @ gkg ( -@ ) ) is an effective and safe alternative for premedication in children ; it resulted in superior sedation in comparison to @ mgkg ( -@ ) intranasal midazolam .


However , it has relatively prolonged onset of action .


To examine the effectiveness , acceptability and sustainability of interventions to reduce vitamin B@ ( B@ ) deficiency in South Asian women before conception .


A @-month randomised controlled trial conducted in Auckland , New Zealand .


Participants ( @ South Asian women , @-@ years old ) were stratified by dietary practices , then randomised to three treatment groups : B@ Supplement ( oral cyanocobalamin @g/day ) ( n = @ ) , Placebo ( n = @ ) , or B@ Dietary Advice ( n = @ ) .


Primary outcome measures were changes in B@ biomarkers ( serum B@ and holotranscobalamin ( holoTC ) ) at @ months .


Dietary B@ intake was estimated from a B@ food-specific frequency questionnaire ( B@FFQ ) .


Intention-to-treat analysis was applied using ` last observation carried forward ' method .


Changes in B@ biomarkers by treatment were compared using analysis of variance .


Pearson 's correlations tested relationships between dietary B@ intake and B@ biomarkers .


At baseline , @ % of women tested as insufficient or deficient in serum B@ ( < @pmol/l ) and @ % as insufficient or deficient in holoTC ( < @pmol/l ) .


B@ status was moderately correlated with dietary B@ intake ( r = @ , @ % confidence interval ( CI ) ( @-@ @ ) ) and @ % of women reported insufficient dietary intake ( < @ g/day ) .


B@ Supplement was the only treatment group to record a significant increase in B@ biomarkers over @ months : serum B@ by @ % ( @ % CI ( @-@ % ) ) and holoTC by @ % ( @-@ % ) .


The prevalence of B@ insufficiency among Auckland South Asian women is high and moderately correlated with inadequate intake of foods that contain B@ .


Cyanocobalamin supplementation ( @g/day ) was associated with improved B@ biomarkers , with a potential to improve preconception B@ status in South Asian women .


To compare the results of combined non-penetrating deep sclerectomy with phacoemulsification ( Phaco-NPDS ) to those of non-penetrating deep sclerectomy ( NPDS ) alone .


Fifty-two eyes with cataract and primary open angle glaucoma ( POAG ) or pseudoexfoliative glaucoma ( PXG ) were randomly assigned to either Phaco-NPDS or NPDS .


Follow-up was performed at regular intervals for up to @ months .


Complete success was defined as intraocular pressure ( IOP ) < @mmHg without medication and qualified success was defined as IOP < @mmHg with medication .


Mean IOP in the Phaco-NPDS group decreased from @ mmHg to @ mmHg and in the NPDS group from @ @ to @ mmHg @ months after surgery .


The decreases of IOP in the postoperative period were statistically significant in both groups ( p < @ ) .


There was no significant IOP difference between Phaco-NPDS and NPDS patients postoperatively ( p > @ ) .


The mean number of glaucoma medications decreased from @ to @ and from @ to @ in the Phaco-NPDS and NPDS groups , respectively .


The decreases in the mean number of the anti-glaucoma medications at the end of the postoperative , @-month follow-up period were found to be statistically significant for both Phaco-NPDS and NPDS groups ( p < @ ) .


Mean BCVA increased significantly in both groups .


However , the visual outcome was significantly better for the Phaco-NPDS group ( p < @ ) .


The complete and qualified success rates were @ % and @ % for Phaco-NPDS patients and @ % and @ % for NPDS patients , respectively ( p > @ ) .


Phaco-NPDS surgery achieved excellent IOP control , while also providing immediate visual recovery .


The success rate was similar to that of the NPDS procedure alone .


It is advisable to consider Phaco-NPDS as a primary surgery for patients with coexisting cataract and open angle glaucoma , including PXG .


Depression is a major public health problem that affects both individuals and society .


Previous studies report that university teachers are particularly susceptible to high levels of occupational stress and depressive symptoms .


The aims of this study were to explore the association between occupational stress and depressive symptoms in a group of university teachers , and assess the mediating role of psychological capital between these variables .


A cross-sectional study was performed between November @ and January @ .


Teachers from six universities were randomly sampled in Shenyang .


The Center for Epidemiologic Studies Depression Scale , effort-reward imbalance scale , and psychological capital questionnaire ( PCQ-@ ) , as well as questions about demographic and working factors , were administered in questionnaires distributed to @,@ university teachers .


Completed questionnaires were received from @,@ participants .


Hierarchical linear regression analysis was used to examine the mediating role of psychological capital .


In the present study , @ % ( @ % CI ( Confidence Intervals ) : @ % to @ % ) of university teachers had a CES-D score equal to or above the cut-off of @ .


Both effort-reward ratio ( ERR ) and scores of over-commitment were positively associated with depressive symptoms , whereas psychological capital was negatively associated with depressive symptoms among university teachers .


Psychological capital partially mediated the relationship between occupational stress and depressive symptoms .


Among Chinese university teachers , occupational stress may be a risk factor for depressive symptoms , whereas psychological capital might be protective against depressive symptoms .


Our results suggest that college administrators could support the development of psychological capital in their staff to alleviate depressive symptoms .


To examine the associations between amyloid - brain deposition and physical activity ( PA ) in elderly adults without dementia and to investigate whether the association has a dose-response relationship .


Cross-sectional study .


French community-dwelling people .


Elderly adults with normal or mildly impaired cognition ( mean age @ @ ; @ % female ) with available information on current self-reported PA and amyloid - brain deposition measured using positron emission tomography ( PET ) using the PET-ligand florbetapir F @ ( n = @ ) .


A standardized uptake value ratio ( SUVR ) was obtained for each subject .


Participants were divided according to amyloid plaque cortical retention defined according to a SUVR cutoff of @ ( SUVR + vs SUVR - ) .


Bivariate and multivariate analyses showed that PA was not significantly associated with SUVR .


SUVR + and SUVR - participants did not differ in terms of volume ( continuous PA variables ) and levels ( categorical PA variables ) of PA. .


PA was not correlated with SUVR in apolipoprotein E @ carriers or noncarriers .


PA was not associated with cognitive function .


Although PA protects against dementia , there is no solid evidence that this protection involves a reduction in amyloid - brain deposition .


Further studies are needed to determine whether PA ( ideally measured at several time-points using objective measures ) is involved in the pathophysiology of Alzheimer 's disease .


Forearm blood pressures have been suggested as an alternative site to measure blood pressures when the upper arm is unavailable .


However there is little evidence utilising clinical populations to support this substitution .


To determine agreement between blood pressures measured in the left upper arm and forearm using a singular oscillometric non-invasive device in adult Emergency Department patients .


The secondary objective was to explore the relationship of blood pressure differences with age , sex , ethnicity , smoking history and obesity .


Single centre comparison study .


Adult Emergency Department , Tertiary Trauma Centre .


Forty-four participants who met inclusion/exclusion criteria selected sequentially from the Emergency Department arrival board .


A random assignment of order of measurement for left upper arm and forearm blood pressures was utilised .


Participants were eligible if they were aged @ years or older , had been assigned an Australasian Triage Scale code of @ , @ , @ , or @ , were able to consent , and able to have blood pressures measured on their left arm whilst lying at a @ angle .


The Bland-Altman method of statistical analysis was used , with the level of agreement for clinical acceptability for the systolic , diastolic and mean arterial pressure defined as @ mmHg .


The forearm measure overestimated systolic ( mean difference @ mmHg , @ % limits of agreement @ mmHg ) , diastolic ( mean difference @ mmHg , @ % limits of agreement @ mmHg ) , and mean arterial pressures ( mean difference @ mmHg , @ % limits of agreement @ mmHg ) .


The systolic measure was not significantly different from zero .


Evidence of better agreement was found with upper arm/forearm systolic measures below @ mmHg compared to systolic measures above @ mmHg using the Levene 's test ( p = @ , F-statistic = @ ) .


Blood pressure disparity was not associated with participant characteristics .


Forearm measures can not routinely replace upper arm measures for blood pressure measurement .


If the clinical picture requires use of forearm blood pressure , the potential variance from an upper arm measure is @ mmHg for systolic pressure , although the variability may be close to @ mmHg if the systolic blood pressure is below @ mmHg .


This study compared the effects of a @-week program of low-volume high-intensity interval training ( HIT ) with the effects of higher-volume moderate-intensity continuous training ( CT ) on cardiopulmonary and vascular functions in postmenopausal women .


Twenty-two postmenopausal women were randomly assigned to undertake six HIT ( n = @ ) or CT ( n = @ ) sessions for @ weeks .


HIT sessions consisted of ten @-minute intervals of cycling exercise at @ % of peak power output separated by @ minute of active recovery .


CT sessions involved @ minutes of continuous cycling at @ % of peak power output .


Variables assessed at baseline and @ weeks included cardiopulmonary function ( ventilatory threshold , peak oxygen uptake ) , macrovascular endothelial function ( flow-mediated dilation of the brachial artery ) , and microvascular function ( reactive hyperemia and local thermal hyperemia of forearm skin ) .


Eighteen participants completed the study ( HIT , @ ; CT , @ ) .


Adherence to the exercise programs was excellent , with @ of @ sessions completed .


Despite substantially lower total time commitment ( @ vs. @ h ) and training volume ( @ vs. @,@ kJ ) for HIT versus CT , increases from baseline in peak oxygen uptake achieved significance ( P = @ ) for the HIT group only ( = @ mL kg min ; P for interaction = @ ) .


Improvements in exercise test duration were observed in both groups ( HIT , @ % ; CT , @ % ; P for interaction = @ ) .


There were no significant changes in macrovascular or microvascular function in either group .


The findings suggest that low-volume HIT is feasible and can lead to rapid improvements in cardiopulmonary function in postmenopausal women .


Breast cancer surgery with axillary lymphadenectomy may be associated with prolonged stay of the drain in the axilla due to high wound output , which may require further treatments and prolong the length of stay , impairing quality of life .


No definitive data are available concerning how to prevent this complication .


Our aim was to assess the efficacy of a new low-thrombin fibrin glue in reducing the serous output from the axillary surgical wound in patients undergoing axillary node dissection for breast cancer , and its long-term effects on lymphedema .


Sixty patients undergoing surgery between September @ and June @ were enrolled .


Thirty patients received Artiss ( Baxter , UK ) fibrin glue plus drainage , and @ drainage alone .


A multivariate analysis was performed to identify predictors of seroma , and subgroup analyses were performed .


Lymphedema was assessed @ months after surgery .


Patients who received fibrin glue had reduced serum output collected in the drain after surgery ( @ @ vs @ @ ml p < @ ) and shorter length of postoperative hospital stay ( p = @ ) .


Incidence of seroma at @-week follow-up did not differ between groups .


At multivariate analysis , BMI @ kg/m ( @ ) was the only independent predictor of seroma formation ( OR = @ , @ % CI @-@ @ ; p = @ ) .


Overweight patients receiving Artiss had fewer seroma at @-week follow-up compared with control overweight patients ( @ % vs @ % , p = @ ) .


No differences were observed in lymphedema between groups ( @ % vs @ % , p > @ ) .


Low-thrombin fibrin glue reduced the amount of fluid produced in the axilla after breast surgery .


Overweight patients may be the ideal candidates for this treatment .


Such sealant did not increase the rates of lymphedema .


Ecological intervention programs are recommended to prevent overweight and obesity in children .


The National Institute of Public Health ( INSP ) in Mexico implemented a successful ecological intervention program to promote healthy lifestyle behaviors in school age children .


This study assessed the integration of ecological principles and Social Cognitive Theory ( SCT ) constructs in this effective school-based obesity prevention program implemented in @ elementary schools in Mexico City .


Two coders applied the Intervention Analysis Procedure ( IAP ) to `` map '' the program 's integration of ecological principles .


A checklist gauged the use of SCT theory in program activities .


Thirty-two distinct intervention strategies were implemented in one setting ( i.e. , school ) to engage four different target-groups ( students , parents , school representatives , government ) across two domains ( Nutrition and Physical Activity ) .


Overall , @ % of the strategies targeted the school infrastructure and/or personnel ; @ % of strategies targeted a key political actor , the Public Education Secretariat while fewer strategies targeted parents ( @ % ) and children ( @ % ) .


More strategies were implemented in the Nutrition domain ( @ % ) than Physical Activity ( @ % ) .


The most frequently used SCT construct within both intervention domains was Reciprocal Determinism ( e.g. , where changes to the environment influence changes in behavior and these behavioral changes influence further changes to the environment ) ; no significant differences were observed in the use of SCT constructs across domains .


Findings provide insight into a promising combination of strategies and theoretical constructs that can be used to implement a school-based obesity prevention program .


Strategies emphasized school-level infrastructure/personnel change and strong political engagement and were most commonly underpinned by Reciprocal Determinism for both Nutrition and Physical Activity .


Intradialytic hypotension ( IDH ) is the most common complication of hemodialysis ( HD ) , and it plays a significant role in the morbidity and mortality associated with maintenance HD .


This was a placebo-controlled , parallel-group study evaluating efficacy and safety of droxidopa in improving intradialytic blood pressure ( BP ) responses in @ adults with end-stage renal disease ( ESRD ) and prone to IDH .


Following screening and baseline periods , patients received @ mg or @ mg droxidopa , or placebo , orally @ hour before HD for @ weeks .


Primary outcome endpoint was the change between baseline and last @ treatment weeks in average mean arterial pressure ( MAP ) during HD .


Also assessed were changes from baseline in systolic BP ( SBP ) and diastolic BP ( DBP ) during and after HD ; number of hypotension-induced interventions and symptoms ; and adverse events .


Increase in droxidopa intra-HD MAP were not significantly different from placebo , although droxidopa groups showed significant improvements in mean SBP after HD of +@ @ mm Hg ( @-mg ) and +@ @ ( @-mg ) compared with -@ @ mm Hg in placebo , and the drop seen in mean nadir SBP pre - to intra-HD was also reduced .


Changes in mean DBP pre - and post-HD , changes in mean nadir SBP post-HD , or intra-HD SBP were not significant over the treatment period .


HD terminations decreased @-fold in the @-mg group and @-fold in the @-mg group , whereas the number of discontinuations stayed unchanged in the placebo group .


Overall , treatment with @-mg or @-mg droxidopa was well tolerated in this population .


These data suggest that droxidopa may have a role in reducing IDH complications in patients with ESRD on chronic HD .


The efficacy and safety of subcutaneous tocilizumab ( TCZ-SC ) versus subcutaneous placebo ( PBO-SC ) was evaluated in patients with rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs in the BREVACTA study .


Patients ( n = @ ) were randomized @:@ to receive TCZ-SC @ mg every other week or PBO-SC every other week for @ weeks ; @ % previously received anti-tumor necrosis factor treatment .


Escape therapy with TCZ-SC @ mg weekly was offered from week @ for inadequate response .


The primary end point was the American College of Rheumatology @ % improvement ( ACR@ ) response at week @ .


The key secondary outcomes were radiographic progression and safety .


TCZ-SC was superior to PBO-SC for ACR@ response at week @ ( @ % versus @ % ; P < @ ) .


All secondary end points showed TCZ-SC to be superior to PBO-SC , including ACR@ and ACR@ response ( @ % and @ % for TCZ-SC , respectively , and @ % and @ % for PBO-SC , respectively ; P < @ for both ) and Disease Activity Score in @ joints ( DAS@ ) remission ( DAS@ < @ ; @ % versus @ % -LSB- P < @ -RSB- ) .


The mean change in modified Sharp/van der Heijde score was significantly lower in the TCZ-SC group than the PBO-SC group ( @ versus @ ; P = @ ) .


Adverse events ( AEs ) and serious AEs ( SAEs ) were comparable between the TCZ-SC and PBO-SC groups ; @ % and @ % of patients had at least @ SAE , respectively , and infection was the most common SAE in @ % and @ % of patients , respectively .


More injection site reactions occurred with TCZ-SC than PBO-SC ( @ % versus @ % ) .


No anaphylaxis or serious hypersensitivity reactions occurred .


There were @ deaths in the TCZ-SC group and @ in the PBO-SC group .


TCZ-SC every other week had significantly greater efficacy , including ACR end points and inhibition of joint damage , compared with PBO-SC .


TCZ-SC was well tolerated and its safety profile was comparable with that of previous intravenous TCZ studies .


Impaired nitric oxide synthesis has been implicated as one of the underlying causes of diabetic painful neuropathy ( DPN ) .


Hence , effects of a cutaneous , nitric oxide releasing patch ( NitroSense Derma Protect ) were evaluated in subjects with DPN .


Fifty diabetics were randomised to active/placebo arms after a @ wk wash-out period .


Patients received @ mg patches ( each patch releases around @ nmol/cm@/min of nitric oxide ) for @ hrs , every other day during a @ wks period , or indistinguishable placebo patches .


The extent of pain was recorded at start , at each visit and following completion of the study .


Changes in pain from baseline were measured using the @ point lickert scale ( PLS ) , visual analogue scale ( VAS ) , short form mcgill , pain questionnaire ( SF-MPQ ) , present pain intensity ( PPI ) scale .


Subjects treated with patch experienced a statistically significant reduction in pain from baseline when compared to placebo ( PLS scale ; p = @ ) .


Defining responders as subjects with a > @ % reduction in PLS score from baseline , the number needed to treat ( NNT ) was calculated as @ .


A significant post-treatment decrease ( p = @ ) in vibration perception threshold ( VPT ) for left foot after active treatment was observed .


Present results highlight utility of NitroSense Derma Protect as controllable nitric oxide source for patients with DPN .


Exercise-induced adaptations of the human atria remain understudied , particularly early in the training process .


We examined the effects of short-term high-intensity interval training ( HIT ) and continuous moderate-intensity training ( CMT ) on left atrial ( LA ) systolic and diastolic function , relative to left ventricular ( LV ) function in young , healthy men , by speckle tracking echocardiography ( STE ) .


Fourteen untrained men ( mean age = @ @ years ) were randomized to HIT or CMT , and assessed before and after six training sessions over a @-day period .


HIT included @-@ intervals of cycling for @ s at @-@ % of maximal aerobic power ( VOMAX ) , interspersed by @ s of cycling at @ % VOMAX .


CMT consisted of @-@ min of cycling at @ % VOMAX .


VOMAX increased following HIT and CMT by @ and @ % , respectively ( p < @ ) .


Calculated plasma volume expanded @ % following HIT and @ % following CMT ( p < @ ) .


Resting LV volumes and ejection fraction were unaltered following training .


Peak atrial longitudinal strain increased following HIT ( @ @ % -@ @ % , p < @ ) and CMT ( @ @ % -@ @ % , p < @ ) .


Atrial systolic strain rate increased following HIT ( @ @ % / s-@ @ @ % / s , p < @ ) and CMT ( @ @ % / s-@ @ @ % / s , p < @ ) .


LA function assessed by STE improves rapidly during short-term intensive exercise training .


To compare the effects of three methods of values clarification ( VCM ) : balance sheet ; rating and ranking ; and a discrete choice experiment ( DCE ) on decision-making about colorectal cancer ( CRC ) screening among adults in the US and Australia .


Using online panels managed by a survey research organization in the US and Australia , we recruited adults ages @-@ at average risk for CRC for an online survey .


Those eligible were randomized to one of the three VCM tasks .


CRC screening options were described in terms of five key attributes : reduction in risk of CRC incidence and mortality ; nature of the screening test ; screening frequency ; complications from screening ; and chance of requiring a colonoscopy ( as initial or follow-up testing ) .


Main outcomes included self-reported most important attribute and unlabeled screening test preference by VCM and by country , assessed after the VCM .


A total of @ participants were enrolled ; @ % were Australian ; mean age was @ ; @ % were white ; @ % had a @-year college degree ; @ % had household incomes less than $ @,@ USD per year ; @ % were up to date with CRC screening .


Most important attribute differed across VCM groups : the rating and ranking group was more likely to choose risk reduction as most important attribute ( @ % ) than the balance sheet group ( @ % ) or DCE ( @ % ) , p < @ ; most important attribute did not vary by country ( p = @ ) .


The fecal occult blood test ( FOBT ) - like test was the most frequently preferred test overall ( @ % ) .


Unlabeled test choice did not differ meaningfully by VCM .


Australians were more likely to prefer the FOBT ( AU @ % vs. US @ % , OR @ , @ % CI @ , @ ) .


Few participants favored no screening ( US : @ % , AU : @ % ) .


Screening test attribute importance varied by VCM , but not by country .


FOBT was more commonly preferred by Australians than by Americans , but test preferences were heterogeneous in both countries .


Given the ubiquity of worrying as a consuming and distressing activity at both clinical and sub-clinical levels , it is important to develop theory-driven procedures that address worrying and allow worriers to manage this activity .


This paper describes the development and testing of a psychoeducation procedure based on mood-as-input hypothesis , which is a transdiagnostic model that describes a proximal mechanism for perseverative worrying .


The study used nonclinical participants meeting IAPT criteria indicating GAD symptomatology .


In @ sessions , participants in experimental groups received psychoeducation about the basic principles of the mood-as-input hypothesis and received guidance on how to identify and change worry-relevant goal-directed decision rules and negative moods .


Participants in the psychoeducation conditions were compared with participants in a befriending control group .


Psychoeducation about the model significantly reduced PSWQ scores at follow-up compared with the befriending control condition ( a between-groups large effect size , Cohen 's d = @ ) , and the homework tasks undertaken by the psychoeducation groups raised mood and reduced worry immediately .


At follow up @ % of participants in the psychoeducation groups were below the recommended cut-off for identifying GAD symptomatology compared with @ % of participants in the control condition .


This study was conducted on a small sample , high-worry student population , without a formal diagnosis .


This brief , low-intensity procedure is potentially adaptable to online or self-help procedures , and can be integrated into fuller cognitive therapy packages .


We evaluated the immunogenicity , efficacy , and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence .


This @-site , @ week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks @ to @ .


We measured urine cocaine metabolites thrice weekly as the main outcome .


The @ subjects ( @ % male , @ % African-American , mean age @ years ) had smoked cocaine on average for @ days monthly at baseline .


We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of @ g/mL ( high IgG ) , which was attained by @ % of the @ vaccine subjects receiving five vaccinations .


Almost @-times fewer high than low IgG subjects dropped out ( @ % vs @ % ) .


Although for the full @ weeks cocaine positive urine rates showed no significant difference between the three groups ( placebo , high , low IgG ) , after week @ , more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial ( @ % vs @ % ) , and the high IgG group had the most cocaine-free urines for the last @ weeks of treatment ( OR = @ ) , but neither were significant .


Injection site reactions of induration and tenderness differed between placebo and active vaccine , and the @ serious adverse events did not lead to treatment related withdrawals , or deaths .


The vaccine was safe , but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence .


There is strong evidence of the efficacy of family psychosocial interventions for schizophrenia , but evidence of the role played by the attitudes of relatives in the therapeutic process is lacking .


To study the effect of a family intervention on family attitudes and to analyse their mediating role in the therapeutic process @ patients with schizophrenia and their key relatives undergoing a trial on the efficacy of a family psychosocial intervention were studied by means of the Affective Style Coding System , the Scale of Empathy , and the Relational Control Coding System .


Specific statistical methods were used to determine the nature of the relationship of the relatives ' attitudes to the outcome of family intervention .


Family psychosocial intervention was associated with a reduction in relatives ' guilt induction and dominance and an improvement in empathy .


Empathy and lack of dominance were identified as independent mediators of the effect of family psychosocial intervention .


The change in empathy and dominance during the first @months of the intervention predicted the outcome in the following @months .


Relatives ' empathy and lack of dominance are mediators of the beneficial effect of family psychosocial intervention on patient 's outcome .


Cognitive-behavioral ( CB ) interventions improve outcomes for many pediatric health conditions , but little is known about which mechanisms mediate these outcomes .


The goal of this study was to identify whether changes in targeted process variables from baseline to @ week posttreatment mediate improvement in outcomes in a randomized controlled trial of a brief CB intervention for idiopathic childhood abdominal pain .


Two hundred children with persistent functional abdominal pain and their parents were randomly assigned to @ of @ conditions : a @-session social learning and CB treatment ( N = @ ) , or a @-session educational intervention controlling for time and attention ( N = @ ) .


Outcomes were assessed at @ - , @ - , and @-month follow-ups .


The intervention focused on altering parental responses to pain and on increasing adaptive cognitions and coping strategies related to pain in both parents and children .


Multiple mediation analyses were applied to examine the extent to which the effects of the social learning and CB treatment condition on child gastrointestinal ( GI ) symptom severity and pain as reported by children and their parents were mediated by changes in targeted cognitive process variables and parents ' solicitous responses to their child 's pain symptoms .


Reductions in parents ' perceived threat regarding their child 's pain mediated reductions in both parent-reported and child-reported GI symptom severity and pain .


Reductions in children 's catastrophic cognitions mediated reductions in child-reported GI symptom severity but no other outcomes .


Reductions in parental solicitousness did not mediate outcomes .


Results suggest that reductions in reports of children 's pain and GI symptoms after a social learning and CB intervention were mediated at least in part by decreasing maladaptive parent and child cognitions .


To assess the nasal functions , nasal resistance , and olfactory function in middle turbinate surgery .


Randomized controlled trial .


This prospective controlled study was carried out on patients who underwent laminectomy for aeration of the middle turbinate .


Patients participating in the study were divided into two groups-group @ : medial laminectomy ( n = @ ) and group @ : lateral laminectomy ( n = @ ) .


Patients underwent the preoperative visual analogue score , sinonasal outcome test-@ ( SNOT-@ ) , peak nasal inspiratory flowmeter , and Connecticut Chemosensory Clinical Research Center smell test .


All patients were reevaluated @ months after the operation .


The study group comprised @ consecutive patients .


The mean age of the patients was @ , with a range of @ to @ years .


A total of @ % ( n = @ ) had medial and @ % ( n = @ ) had lateral laminectomy .


Bilateral turbinate intervention was performed in @ % ( n = @ ) , whereas unilateral middle turbinate intervention was performed in @ % ( n = @ ) .


Overall , both groups showed strong significant improvement over time in visual analogue scale results , SNOT-@ scores , peak flowmeter results , and olfactory function between preoperative and postoperative scores ( P < @ ) .


There was no significant difference between the groups for all parameters ( P > @ ) .


This study revealed that medial laminectomy for aeration of the middle turbinate was as effective as lateral laminectomy .


@b .


Laryngoscope , @:@ -@ , @ .


Gabapentin enacarbil ( GEn ) is a prodrug of gabapentin and is approved in the United States in adults for the management of postherpetic neuralgia and in the United States and Japan for the treatment of moderate-to-severe primary restless legs syndrome .


This study examined the lack of effect of GEn on cardiac repolarization in accordance with International Conference on Harmonisation E@ guidance .


This was a randomized , double-blind , double-dummy , placebo - and active - controlled , crossover study in healthy adults ( age range , @-@ years ) .


Study participants received the following in randomized order with a minimum @-day washout period between treatments : placebo at @ hours and GEn @ mg at @ hours ( GEn @ mg group ) , placebo at @ hours and GEn @ mg at @ hours ( GEn @ mg group ) , placebo at @ and @ hours ( placebo group ) , moxifloxacin @ mg ( active control group ) at @ hours , and placebo at @ hours ( moxifloxacin group ) .


Dose offsetting permitted moxifloxacin to be administered in the fasted state and GEn to be administered in the fed state .


Assessments included continuous ECG monitoring , pharmacokinetic parameters , and safety and tolerability profiles .


The primary end point was the change from baseline in the Fridericia corrected QT interval , at each time point , for the GEn @ mg and placebo groups .


Of @ adults enrolled ( mean -LSB- SD -RSB- age , @ -LSB- @ -RSB- years ; @ % women ) , @ adults ( @ % ) completed the study .


Forty-nine adults received GEn @ mg , @ received GEn @ mg , @ received placebo , and @ received moxifloxacin .


The highest estimated ( upper limit of the @ % CI ) model-adjusted difference in mean change from baseline in the Fridericia corrected QT interval between GEn and placebo was @ ( @ ) msec for @ mg and @ ( @ ) msec for @ mg .


Assay sensitivity was confirmed with moxifloxacin @ mg .


The geometric mean ( % CV ) Cmax ( between-subject coefficient of variation ) was @ ( @ ) g/mL for GEn @ mg , @ ( @ ) g/mL for GEn @ mg , and @ ( @ ) g/mL for moxifloxacin @ mg .


The most frequently reported adverse events with GEn @ mg were dizziness ( @ % ) , feeling drunk ( @ % ) , nausea ( @ % ) , headache ( @ % ) , and vomiting ( @ % ) .


Single doses of GEn , up to @ mg , had no effect on cardiac repolarization in this thorough-QT study and are unlikely to cause clinically relevant QT prolongation in clinical use .


Assay sensitivity was confirmed with moxifloxacin as an active control .


ClinicalTrials.gov identifier : NCT@ .


Coronary vasodilator dysfunction has been reported after drug-eluting stent ( DES ) implantation .


Recent ESC guidelines suggest that transthoracic echocardiography ( TTE ) may be considered for assessment of coronary flow reserve ( CFR ) and microvascular disease in patients with stable angina , but its reliability has not been tested in patients with DES .


We sought to assess the agreement between TTE ( CFRTTE ) and invasive thermodilution-derived CFR ( CFRThermodilution ) as well as their association with index of microcirculatory resistance ( IMR ) in mid-term follow-up after percutaneous coronary intervention for acute coronary syndrome .


CFRTTE and CFRThermodilution were assessed @ months after DES implantation in the left anterior descending artery in @ patients .


Patients with haemodynamically significant epicardial stenosis ( fractional flow reserve < @ ) were excluded .


Correlation between the two methods was good ( r = @ , P < @ ) , but CFRThermodilution ( mean SD ) tended to be higher ( @ @ vs. @ @ ; mean difference @ , @ % confidence interval -@ to @ ) .


In Bland-Altman analysis , there was a trend towards a greater difference in the range of higher invasive values .


Nevertheless , TTE was successful in discriminating moderately impaired CFR ( @ ) ( P = @ ) and severely impaired CFR ( @ ) ( P < @ ) when compared with an invasive method .


No association between either CFR measurements vs. IMR measurement was detected , suggesting that in addition to microcirculatory function , CFR also accounts for epicardial vasodilator function in the absence of haemodynamically significant stenosis .


TTE is a feasible and reliable method for the assessment of CFR and vasodilator dysfunction after DES implantation .


Values obtained with this method successfully find abnormal CFR confirmed with the invasive thermodilution method .


Daily intake of @ mg of BNO @ for @ days is an effective treatment in acute viral rhinosinusitis .


The pooled efficacy data of two similar randomized placebo-controlled clinical trials were analyzed .


Safety was evaluated on the basis of the individual trials .


The efficacy analysis was based on @ patients .


Treatment was performed orally with either @ @ mg BNO @ ( n = @ ) or @ placebo ( n = @ ) for @ days .


In both trials patients underwent five visits to the investigational sites .


Symptoms were evaluated according to the EPOS @ guideline .


Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit .


Efficacy was evaluated by the investigator as the mean major symptom score ( MSS ) at the end of treatment ( visit @ , day @ ) .


Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire ( SNOT-@ GAV ) .


MSS improved during the treatment period by a mean of @ @ score points to @ @ for BNO @ and of @ @ to @ @ for placebo .


Differences between treatment groups at end of therapy ( @ @ score points ; p < @ ) and patient-assessed quality of life ( p = @ ) were statistically significant in favor of BNO @ .


Rectal cancer continues to be devastating malignancy worldwide .


Sphincter preservation is the need of the hour .


Distal anastomosis is more prone to leaks .


Proximal diversion in form of ileostomy may be used to protect distal anastomosis .


To compare two groups of low anterior resection with and without diversion ileostomy in rectal cancer patients .


A prospective , hospital based study of @ rectal carcinoma patients were taken for the study .


Inclusion criteria was operable rectal cancer @-@ cm from anal verge .


Patients were randomized into two groups .


Group - A ( @ patient ) patients with low anterior resection with ileostomy ( LAR with ileostomy ) ; Group - B ( @ patients ) patients with low anterior resection without ileostomy ( LAR without ileostomy ) .


Quality of life was assessed by scoring done by self designed method .


A total score of @-@ given for various parameters .


Skin excoriation was the commonest complication .


Stomal retraction and stomal obstruction was seen in @ patient each ( @ % ) .


Hypokalemia was the commonest electrolyte imbalance present in ileostomy group .


Anastomotic leak was present in @ % of Group A and @ % of Group B patients .


Mean time of closure of ileostomy was @ @ weeks .


LAR with ileostomy has certain advantages over LAR without ileostomy in terms of anastomotic leak , postoperative ileus , resumption of diet , wound infection , small bowel obstruction and in terms mortality and recurrence .


However stoma related complications were main disadvantage in LAR with ileostomy .


Currently few evidence based interventions are available for the prevention of PTSD within the first weeks after trauma .


Increased risk for PTSD development is associated with dysregulated fear and stress responses prior to and shortly after trauma , as well as with a lack of perceived social support early after trauma .


Oxytocin is a potent regulator of these processes .


Therefore , we propose that oxytocin may be important in reducing adverse consequences of trauma .


The ` BONDS ' study is conducted in order to assess the efficacy of an early intervention with intranasal oxytocin for the prevention of PTSD .


In this multicenter double-blind randomized placebo-controlled trial we will recruit @ Emergency Department patients at increased risk of PTSD .


Trauma-exposed patients are screened for increased PTSD risk with questionnaires assessing peri-traumatic distress and acute PTSD symptoms within @ days after trauma .


Baseline PTSD symptom severity scores and neuroendocrine and psychophysiological measures will be collected within @ days after trauma .


Participants will be randomized to @ days of intranasal oxytocin ( @ IU ) or placebo twice a day .


Follow-up measurements at @ , @ and @ months post-trauma are collected to assess PTSD symptom severity ( the primary outcome measure ) .


Other measures of symptoms of psychopathology , and neuroendocrine and psychophysiological disorders are secondary outcome measures .


We hypothesize that intranasal oxytocin administered early after trauma is an effective pharmacological strategy to prevent PTSD in individuals at increased risk , which is both safe and easily applicable .


Interindividual and contextual factors that may influence the effects of oxytocin treatment will be considered in the analysis of the results .


To evaluate whether the transillumination method increased the probability of appropriate tracheal tube ( TT ) placement compared with the main-stem method .


Prospective , randomized , controlled study .


Operating room , university hospital .


Eighty children < @ years old scheduled for elective surgery undergoing general anesthesia .


Trachlight was used for the transillumination method .


After intubation , patients were randomly assigned to @ of @ groups : ( @ ) deliberate bronchial intubation with subsequent withdrawal of the TT to @ cm above the carina ( main-stem group ) or ( @ ) transmitted visual signal from a bright light at the TT tip on the skin at the suprasternal notch after inserting the Trachlight into the TT ( transillumination group ) .


The TT tip position was assessed by chest radiograph after the procedure .


Appropriate TT placement was defined when the TT tip was located between the sternoclavicular junction and @ cm above the carina .


Appropriate TT placement was found in @ ( @ % ) of @ patients in the transillumination group and @ ( @ % ) of @ in the main-stem group .


The transillumination method had higher rate of appropriate TT placement than the main-stem method ( P = @ ; risk ratio , @ ; @ % confidence interval , @-@ @ ) .


Seven patients ( @ % ) had proximal TT placement , and @ ( @ % ) had distal TT placement in the transillumination group .


In the main-stem group , @ patients ( @ % ) had proximal TT placement , and @ ( @ % ) had distal TT placement .


The transillumination method was reliable for appropriate TT placement in small children < @ years old undergoing general anesthesia , although the transillumination method was not found to be better compared with the main-stem method .


Myocardial blood flow ( MBF ) quantification with dynamic SPECT could lead to widespread utilization of MBF imaging in clinical practice with little cost increase over current standard SPECT myocardial perfusion imaging .


This work evaluates the feasibility and operator-dependent variability of MBF and flow reserve measurements with ( @m ) Tc-sestamibi ( MIBI ) dynamic SPECT imaging using a standard dual-head SPECT camera .


Twenty-eight patients underwent dipyridamole-stress and rest imaging with dynamic SPECT/CT acquisition .


Quantitative images were iteratively reconstructed with all physical corrections and then myocardial and arterial blood regions of interest ( ROI ) were defined semi-automatically .


A compartmental model was fitted to these ROI-sampled time-activity-curves , and flow-dependent MIBI extraction correction was applied to derive regional MBF values .


Myocardial flow reserve ( MFR ) was estimated as stress/rest MBF ratio .


MBF and MFR in low and high risk populations were evaluated for ability to detect disease .


Images were each processed twice ( @ days apart ) by one expert and one novice operator to evaluate intra - and inter-operator variability of MBF and MFR measurement in the three coronary artery vascular territories .


Mean rest flow , stress flow , and MFR values were @ , @ mLminute ( -@ ) g ( -@ ) , and @ , respectively .


For stress/rest MFR , the inter-operator reproducibility was r ( @ ) = @ with RPC = @ .


Stress MBF and MFR were significantly reduced ( P < @ ) in high risk ( n = @ ) vs low risk populations ( n = @ ) , indicating ability to detect disease .


For expert and novice operators very good intra-operator correlations of r ( @ ) = @ and @ ( n = @ , P < @ ) were observed for combined rest and stress regional flow values .


Bland-Altman reproducibility coefficients ( RPC ) were @ and @ mLminute ( -@ ) g ( -@ ) for the expert and novice operators , respectively ( P < @ ) .


Inter-operator correlation was r ( @ ) = @ and Bland-Altman RPC = @ mLminute ( -@ ) g ( -@ ) ( n = @ ) .


MBF and reserve measurements using ( @m ) Tc-sestamibi on a traditional , two-headed camera with fast rotation and with quantitative dynamic SPECT appears to be feasible , warranting further investigation .


Cognitive impairment is an enduring and functionally relevant feature of early-onset schizophrenia ( EOS ) .


Cognitive remediation therapy ( CRT ) improves cognition and functional outcome in adults with schizophrenia , although data in adolescents with EOS remain scarce .


The purpose of this study is to examine the efficacy of CRT in improving cognition and functional outcomes in a sample of symptomatically stable but cognitively disabled adolescents with EOS .


We performed a randomized , controlled trial of individually delivered CRT plus treatment-as-usual compared with treatment-as-usual ( TAU ) .


Fifty adolescents with EOS were randomly assigned to receive CRT ( n = @ ) or TAU ( n = @ ) and were included in an intention-to-treat analysis .


Clinical symptoms and cognitive and functional performance were assessed before and after treatment in both groups and after @ months in the CRT group .