Decreased IL-8 and increased IL-10 levels are two important reasons forimmunosuppression after homologous blood transfusion , whereas autologous blood transfusion can alleviate this while increasing the TNF - level , which also has potential to improve anti-tumor immunity in the human body .


To observe the improvements of synchronous treatment of bilateral scalp acupuncture and rehabilitation training on activities of daily life in patients with cerebral infarction at acute phase , so as to compare the efficacy differences between scalp acupuncture at bilateral and affected side as well as differences between synchronous and non-synchronous treatment .


Ninety patients of acute-phase cerebral infarction with motor dysfunction were randomly divided into three groups .


The observation group was treated with synchronous treatment of scalp acupuncture at the Dingzhongxian ( middle line of vertex ) , bilateral Dingnieqianxiexian ( anterior oblique line of vertex-temporal ) and bilateral Dingniehouxiexian ( posterior oblique line of vertex-temporal ) and rehabilitation training ; the control group A was treated with synchronous treatment of affected scalp acupuncture at the Dingzhongxian , affected Dingnieqianxiexian and affected Dingniehouxiexian and rehabilitation training ; the control group B was treated with bilateral scalp acupuncture for 4 h , followed by rehabilitation training .


All the patients took the treatment once a day , and 6 days for a course of treatment for total of 4 courses .


The modified Barthel index ( MBI ) , activities of daily living ( ADL ) and Fugl-Meyer motor assessment ( FMA ) were used to perform efficacy assessment before treatment , in the 14th days of treatment and in the 28th days of treatment in three groups .


After treatment , three indices at each time point were superior to those before the treatment in three groups ( all P < 0.01 ) ; the improvements of ADL and FMA in the observation group after 28 days of treatment were superior to those in the control group A and control group B ( all P < 0.05 ) , and the improvement of MBI was superior to that in the control group B ( P < 0.05 ) .


The synchronous treatment of bilateral scalp acupuncture and rehabilitation training could significantly improve the activities of daily life and motor function in patients with cerebral infarction at acute phase , which is superior to scalp acupuncture at affected side and non-synchronous treatment .


Clinical prediction rules can assist clinicians to identify patients with low back pain ( LBP ) who are likely to recover quickly with minimal treatment ; however , there is a paucity of validated instruments to assist with this task .


We performed a pre-planned external validation study to assess the generalizability of a simple 3-item clinical prediction rule developed to estimate the probability of recovery from acute LBP at certain time points .


The accuracy of the rule ( calibration and discrimination ) was determined in a sample of 956 participants enrolled in a randomized controlled trial .


The calibration of the rule was reasonable in the new sample with predictions of recovery typically within 5-10 % of observed recovery .


Discriminative performance of the rule was poor to moderate and similar to that found in the development sample .


The results suggest that the rule can be used to provide accurate information about expected recovery from acute LBP , within the first few weeks of patients presenting to primary care .


Impact analysis to determine if the rule influences clinical behaviours and patient outcomes is required .


Multidrug-resistant organisms ( MDRO ) are the dominant airway pathogens in the intensive care unit ( ICU ) and present a major treatment challenge to intensivists .


Aerosolized antibiotics ( AA ) result in airway concentrations of drug 100-fold greater than the minimal inhibitory concentration of most bacteria including MDRO .


These levels , without systemic toxicity , may eradicate MDRO and reduce the pressure for selection of new resistant organisms .


To determine if AA effectively eradicate MDRO in the intubated patient without promoting new resistance .


In a double-blind placebo-controlled study , critically ill intubated patients were randomized if they exhibited signs of respiratory infection ( purulent secretions and Clinical Pulmonary Infection Score 6 ) .


Using a well-characterized aerosol delivery system , AA or saline placebo was given for 14 days or until extubation .


The responsible clinician determined administration of systemic antibiotics for ventilator-associated pneumonia and any other infection .


AA eradicated 26 of 27 organisms present at randomization compared with 2 of 23 organisms with placebo ( P < 0.0001 ) .


AA eradicated the original resistant organism on culture and Gram stain at end of treatment in 14 out of 16 patients compared with 1 of 11 for placebo ( P < 0.001 ) .


New drug resistance to AA was not seen .


Compared with AA , resistance to systemic antibiotics significantly increased in placebo patients ( P = 0.03 ) .


Compared with placebo , AA significantly reduced Clinical Pulmonary Infection Score ( mean SEM , 9.3 2.7 to 5.3 2.6 vs. 8.0 23 to 8.6 2.10 ; P = 0.0008 ) .


In chronically intubated critically ill patients , AA successfully eradicated existing MDRO organisms and reduced the pressure from systemic agents for new respiratory resistance .


Clinical trial registered with www.clinicaltrials.gov ( NCT 01878643 ) .


To explore the feasibility and cost effectiveness of screening and delivery of a brief intervention for hazardous drinking employees .


A pilot randomised controlled trial of a brief intervention delivered by an Occupational Health nurse versus no delivery of brief intervention ( control group ) conducted in a Local Authority Council ( LCA ) in the United Kingdom .


Changes in quality of life and economic indicators were measured by the EQ-5D .


627 employees were screened of whom 163 ( 26.01 % ) fulfilled the inclusion criteria with a total of 57 ( 35 % ) agreeing to participate .


No significant differences were found between the groups for baseline demographics or levels/patterns of alcohol consumption .


A statistically significant effect was found in the mean AUDIT scores over time ( F = 8.96 , p = 0.004 ) but not for group ( F = 0.017 , p = 0.896 ) , and no significant interaction was found ( F = 0.148 , p = 0.702 ) .


The cost of each intervention was calculated at 12.48 , the difference in service costs was calculated at 344.50 per person ; that is there was a net saving of health and other care costs in the intervention group compared to the control group .


The QALYs fell in both intervention and control groups , the difference -0.002 - ( -0.010 ) yields a net advantage of the intervention of 0.008 QALYs .


The main results from this pilot study suggest that alcohol brief interventions delivered in the workplace may offer the potential to reduce alcohol-related harm and save public sector resources .


A fully powered multi-centre trial is warranted to contribute to the current evidence base and explore further the potential of alcohol brief interventions in the workplace .


In a full trial the recruitment method may need to be re-considered .


We investigated the safety , tolerability , pharmacokinetics and pharmacodynamics of evacetrapib .


Healthy volunteers received multiple daily doses of evacetrapib ( 10-600mg ) administered for up to 15 days in a placebo-controlled study .


Mean peak plasma concentrations of evacetrapib occurred at 4-6h and terminal half-life ranged 24-44h .


Steady state was achieved at approximately 10 days ; all subjects had undetectable levels of evacetrapib 3 weeks after their last dose .


The trough inhibition of cholesteryl ester transfer protein ( CETP ) activity was 65 and 84 % at 100 and 300mg , respectively .


At the highest dose ( 600mg ) , evacetrapib significantly inhibited CETP activity ( 91 % ) , increased HDL-C ( 87 % ) and apo AI ( 42 % ) , and decreased LDL-C ( 29 % ) and apo B ( 26 % ) relative to placebo .


For the highest dose tested , levels of evacetrapib , CETP activity , CETP mass , HDL-C and LDL-C returned to levels at or near baseline after a 2-week washout period .


Evacetrapib at the highest dose tested did not produce any significant effect on 24-h ambulatory systolic or diastolic blood pressure .


Multiple doses of evacetrapib potently inhibited CETP activity , leading to substantial elevations in HDL-C and lowering of LDL-C .


Evacetrapib was devoid of clinically relevant effects on blood pressure and mineralocorticoid levels .


Clinical decision support ( CDS ) for primary care has been shown to improve delivery of preventive services .


However , there is little evidence for efficiency of physicians due to CDS assistance .


In this article , we report a pilot study for measuring the impact of CDS on the time spent by physicians for deciding on preventive services and chronic disease management .


We randomly selected 30 patients from a primary care practice , and assigned them to 10 physicians .


The physicians were requested to perform chart review to decide on preventive services and chronic disease management for the assigned patients .


The patients assignment was done in a randomized crossover design , such that each patient received 2 sets of recommendations-one from a physician with CDS assistance and the other from a different physician without CDS assistance .


We compared the physician recommendations made using CDS assistance , with the recommendations made without CDS assistance .


The physicians required an average of 1 minute 44 seconds , when they were they had access to the decision support system and 5 minutes when they were unassisted .


Hence the CDS assistance resulted in an estimated saving of 3 minutes 16 seconds ( 65 % ) of the physicians ' time , which was statistically significant ( P < .0001 ) .


There was no statistically significant difference in the number of recommendations .


Our findings suggest that CDS assistance significantly reduced the time spent by physicians for deciding on preventive services and chronic disease management .


The result needs to be confirmed by performing similar studies at other institutions .


Tenofovir alafenamide ( formerly GS-7340 ) is a new oral prodrug of tenofovir , a nucleotide analogue that inhibits HIV-1 reverse transcription .


Unlike the currently marketed tenofovir prodrug , tenofovir disoproxil fumarate , tenofovir alafenamide is stable in plasma and then rapidly converted into tenofovir once inside cells .


The pharmacokinetics , safety and antiviral activity of 40 or 120 mg of tenofovir alafenamide compared with 300 mg of tenofovir disoproxil fumarate when administered as monotherapy once daily for 14 days in HIV-1-infected , treatment-naive subjects was studied .


Administration of 40 mg of tenofovir alafenamide for 14 days resulted in lower tenofovir Cmax ( 13 versus 207 ng/mL ) and lower systemic exposures ( AUC0-t , 383 versus 1810 ngh/mL ) compared with subjects who received tenofovir disoproxil fumarate .


There were higher intracellular tenofovir concentrations within peripheral blood mononuclear cells with both 40 mg of tenofovir alafenamide ( 8.2 M ) and 120 mg of tenofovir alafenamide ( 16.9 M ) compared with 300 mg of tenofovir disoproxil fumarate ( 0.9 M ) .


The most commonly observed adverse events were headache , nausea and flatulence , which occurred similarly across the three groups .


After 14 days , the mean changes in HIV-1 RNA were -0.94 logcopies/mL for the tenofovir disoproxil fumarate group , -1.57 log copies/mL for the 40 mg of tenofovir alafenamide group and -1.71 log copies/mL for the 120 mg of tenofovir alafenamide group .


The mean first-phase HIV-1 RNA decay slopes were -0.36 , -0.63 and -0.64 for the tenofovir disoproxil fumarate group , the 40 mg of tenofovir alafenamide group and the 120 mg of tenofovir alafenamide group , respectively .


No resistance mutations to either tenofovir alafenamide or tenofovir disoproxil fumarate were detected .


Tenofovir alafenamide , a new once-daily oral prodrug of tenofovir , showed more potent anti-HIV-1 activity and higher intracellular tenofovir levels compared with tenofovir disoproxil fumarate , while maintaining lower plasma tenofovir exposure at 40 mg with good tolerability over 14 days of monotherapy .


To verify the incidence of facetary and low back pain after a controlled medial branch anesthetic block in a three-month follow-up and to verify the correlation between the positive results and the demographic variables .


Patients with chronic lumbar pain underwent a sham blockade ( with a saline injection ) and then a controlled medial branch block .


Their symptoms were evaluated before and after the sham injection and after the real controlled medial branch block ; the symptoms were reevaluated after one day and one week , as well as after one , two and three months using the visual analog scale .


We searched for an association between the positive results and the demographic characteristics of the patients .


A total of 104 controlled medial branch blocks were performed and 54 patients ( 52 % ) demonstrated > 50 % improvements in pain after the blockade .


After three months , lumbar pain returned in only 18 individuals , with visual analogue scale scores > 4 .


Therefore , these patients were diagnosed with chronic facet low back pain .


The three-months of follow-up after the controlled medial branch block excluded 36 patients ( 67 % ) with false positive results .


The results of the controlled medial branch block were not correlated to sex , age , pain duration or work disability but were correlated with patient age ( p < 0.05 ) .


Patient diagnosis with a controlled medial branch block proved to be effective but was not associated with any demographic variables .


A three-month follow-up is required to avoid a high number of false positives .


To investigate the prevalence of malnutrition in patients with inflammatory bowel disease ( IBD ) by subjective global assessment ( SGA ) and the effects of oral nutritional support on the clinical parameters , consumption of energy , macronutrients and fiber intake in the Study and Control groups , prospectively .


A total of 38 ( 28 Male ; 10 Female ) hospitalized patients with moderate or severe IBD ( 13 with Crohn 's disease ( CD ) ; 25 with Ulcerative colitis ( UC ) ) were included .


At stage 1 , the disease severity , clinical symptoms and , signs , food consumption and nutritional status by using subjective global assessment ( SGA ) were recorded .


At stage 2 , the patients were blindly randomized into a Study Group and Controls .


In the Study Group , a standard enteral product was added into the regulated hospital diets , but for the Controls , deficits were regulated by only hospital diets for 3 weeks .


the independent variables were the group , the disease and its activity , age , Body body mass index ( BMI ) , weight loss history , the hospitalization period ; the dependent variables were SGA , bowel movements , change in nutritional status , disease severity , clinical findings , and also consumption of macronutrients .


Prevalance of malnutrition ( SGA-B or SGA-C ) for all the patients was 92.1 % at the beginning and 71.1 % at the end of study .


Improvements in disease activity score for the patients with UC were statistically significant in both the Study Group and the Controls ( p = 0.006 for the Study Group and p = 0.001 for the Controls , respectively ) .


Macronutrients , total and water soluble fiber consumption levels improved , with statistically significant differences for all the groups .


The prevalence of malnutrition is a major problem in patients with IBD .


Not only the regulation of hospital food , but also enteral nutritional support , improved their levels of malnutrition , as well as their energy , macronutrients , and fiber consumption , and SGA is an easy method for nutritional monitoring .


Stroke can result in death and long-term disability .


Fast and high-quality care can reduce the impact of stroke , but UK national audit data has demonstrated variability in compliance with recommended processes of care .


Though quality improvement collaboratives ( QICs ) are widely used , whether a QIC could improve reliability of stroke care was unknown .


Twenty-four NHS hospitals in the Northwest of England were randomly allocated to participate either in Stroke 90:10 , a QIC based on the Breakthrough Series ( BTS ) model , or to a control group giving normal care .


The QIC focused on nine processes of quality care for stroke already used in the national stroke audit .


The nine processes were grouped into two distinct care bundles : one relating to early hours care and one relating to rehabilitation following stroke .


Using an interrupted time series design and difference-in-difference analysis , we aimed to determine whether hospitals participating in the QIC improved more than the control group on bundle compliance .


Data were available from nine interventions ( 3,533 patients ) and nine control hospitals ( 3,059 patients ) .


Hospitals in the QIC showed a modest improvement from baseline in the odds of average compliance equivalent to a relative improvement of 10.9 % ( 95 % CI 1.3 % , 20.6 % ) in the Early Hours Bundle and 11.2 % ( 95 % CI 1.4 % , 21.5 % ) in the Rehabilitation Bundle .


Secondary analysis suggested that some specific processes were more sensitive to an intervention effect .


Some aspects of stroke care improved during the QIC , but the effects of the QIC were modest and further improvement is needed .


The extent to which a BTS QIC can improve quality of stroke care remains uncertain .


Some aspects of care may respond better to collaboratives than others .


ISRCTN13893902 .


Tirofiban and eptifibatide are both small-molecule , competitive glycoprotein IIb/IIIa receptor inhibitors ( GPIs ) that are guideline-supported for upstream therapy in acute coronary syndromes ( ACS ) .


This study sought to compare the efficacy and safety of tirofiban and eptifibatide in patients with ACS .


Within the ACUITY trial , 4,323 patients with moderate - and high-risk ACS received upstream , adjunctive GPI ( tirofiban or eptifibatide ) in addition to an antithrombin .


Primary outcomes included 30-day rates of composite major adverse cardiac events ( MACE ) , major bleeding ( not related to coronary artery bypass grafting ) , and composite net adverse clinical events ( NACE ) .


The outcomes were compared based on the upstream GPI administered .


There were significant differences in the baseline characteristics of patients treated with tirofiban vs eptifibatide , particularly related to country/region .


In unadjusted analyses , treatment with upstream tirofiban vs eptifibatide was associated with similar rates of major bleeding ( 5.8 % vs 6.5 % , P = .39 ) and nonsignificantly lower rates of MACE ( 6.1 % vs 7.6 % , P = .06 ) and NACE ( 10.6 % vs 12.6 % , P = .06 ) .


After propensity-based multivariable adjustment , there were no significant differences between tirofiban and eptifibatide with respect to 30-day major bleeding , MACE , or NACE .


Among more than 4,000 patients with moderate - and high-risk ACS treated with upstream GPI as part of an early invasive management strategy , the use of tirofiban and eptifibatide resulted in similar clinical outcomes .


These data suggest equivalence of these 2 agents for upstream use , while highlighting some of the difficulties of nonrandomized comparative effectiveness analyses , specifically the difficulty in addressing geographic differences in the use of nonrandomized treatments .


There has been no comparison of detectability of small lung cancer between general and medical LCD monitors or no comparison of detectability of small lung cancer between solid and part-solid nodules .


To compare the detectabilities of T1a lung cancer on chest radiographs on three LCD monitor types : 2-megapixel ( MP ) for general purpose ( General ) , 2-MP for medical purpose ( Medical ) , and 3-MP-Medical .


Radiographs from forty patients with T1aN0M0 primary lung cancer ( 27 solid nodules , 13 part-solid nodules ) and 60 patients with no abnormalities on both chest X-ray and computed tomography ( CT ) were consecutively collected .


Five readers assessed 100 cases for each monitor .


The observations were analyzed using receiver operating characteristic ( ROC ) analysis .


A jackknife method was used for statistical analysis .


A P value of < 0.05 was considered significant .


The average AUC for all T1a lung cancer nodule detection using the 2-MP-General , 2-MP-Medical , and 3-MP-Medical LCD monitors were 0.86 , 0.89 , and 0.89 , respectively ; there were no significant differences among them .


The average AUC for part-solid nodule detection using a 2-MP-General , 2-MP-Medical , and 3-MP-Medical LCD monitors were 0.77 , 0.86 , and 0.89 , respectively .


There were significant differences between the 2-MP-General and 2-MP-Medical LCD monitors ( P = 0.043 ) and between the 2-MP-General and 3-MP-Medical LCD monitors ( P = 0.027 ) .


There was no significant difference between the 2-MP-Medical and 3-MP-Medical LCD monitors .


The average AUC for solid nodule detection using a 2-MP-General , 2-MP-Medical , and 3-MP-Medical LCD monitors were 0.90 , 0.90 , and 0.88 , respectively ; there were no significant differences among them .


The mean AUC values for all and part-solid nodules of the low-experienced readers were significantly lower than those of the high-experienced readers with the 2 M-GP color LCD monitor ( P < 0.05 ) .


Detectability of part-solid nodules using a general-purpose LCD monitor was significantly lower than those using medical-purpose LCD monitors .


To test whether community mobilization adds effectiveness to conventional dengue control .


Pragmatic open label parallel group cluster randomized controlled trial .


Those assessing the outcomes and analyzing the data were blinded to group assignment .


Centralized computerized randomization after the baseline study allocated half the sites to intervention , stratified by country , evidence of recent dengue virus infection in children aged 3-9 , and vector indices .


Random sample of communities in Managua , capital of Nicaragua , and three coastal regions in Guerrero State in the south of Mexico .


Residents in a random sample of census enumeration areas across both countries : 75 intervention and 75 control clusters ( about 140 households each ) were randomized and analyzed ( 60 clusters in Nicaragua and 90 in Mexico ) , including 85,182 residents in 18,838 households .


A community mobilization protocol began with community discussion of baseline results .


Each intervention cluster adapted the basic intervention-chemical-free prevention of mosquito reproduction-to its own circumstances .


All clusters continued the government run dengue control program .


Primary outcomes per protocol were self reported cases of dengue , serological evidence of recent dengue virus infection , and conventional entomological indices ( house index : households with larvae or pupae/households examined ; container index : containers with larvae or pupae/containers examined ; Breteau index : containers with larvae or pupae/households examined ; and pupae per person : pupae found/number of residents ) .


Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use .


With cluster as the unit of analysis , serological evidence from intervention sites showed a lower risk of infection with dengue virus in children ( relative risk reduction 29.5 % , 95 % confidence interval 3.8 % to 55.3 % ) , fewer reports of dengue illness ( 24.7 % , 1.8 % to 51.2 % ) , fewer houses with larvae or pupae among houses visited ( house index ) ( 44.1 % , 13.6 % to 74.7 % ) , fewer containers with larvae or pupae among containers examined ( container index ) ( 36.7 % , 24.5 % to 44.8 % ) , fewer containers with larvae or pupae among houses visited ( Breteau index ) ( 35.1 % , 16.7 % to 55.5 % ) , and fewer pupae per person ( 51.7 % , 36.2 % to 76.1 % ) .


The numbers needed to treat were 30 ( 95 % confidence interval 20 to 59 ) for a lower risk of infection in children , 71 ( 48 to 143 ) for fewer reports of dengue illness , 17 ( 14 to 20 ) for the house index , 37 ( 35 to 67 ) for the container index , 10 ( 6 to 29 ) for the Breteau index , and 12 ( 7 to 31 ) for fewer pupae per person .


Secondary per protocol analysis showed no serological evidence of a protective effect of temephos .


Evidence based community mobilization can add effectiveness to dengue vector control .


Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement .


ISRCTN27581154 .


Traditionally , the therapeutic effect of antidepressants is thought to take several weeks .


However , several studies found evidence of early drug response occurring within the first 2weeks of antidepressant treatment and that this early onset response may predict eventual treatment outcome .


This study aims to investigate the predictive value of early improvement in the course of treatment with imipramine or venlafaxine in an inpatient population with severe major depression .


A post hoc analysis was conducted after pooling data from two almost identical trials .


The study included 149 patients with DSM-IV diagnosis major depression and a baseline score 17 on the 17-item Hamilton Rating Scale for Depression ( HAM-D ) .


Patients were randomized for double-blind treatment with either antidepressant .


Early improvement ( 25 % reduction on HAM-D score ) was evaluated after 2weeks and response ( 50 % reduction on HAM-D score ) after 6weeks of acute treatment .


Of 64 patients achieving early improvement , 38 ( 59 % ) became responders , whereas of 85 patients not achieving early improvement , only 23 ( 27 % ) became responders .


There was a significant difference in time to response between patients achieving early improvement and patients not achieving early improvement .


Early improvement is a modest sensitive predictor for eventual response .


In the present study , although the sensitivity of early improvement was modest , based on the severity of clinical symptoms , a clinician treating a patient with severe major depression may seriously consider changing the treatment at an earlier stage than is presently customary .


Our objective was to investigate the actual incidence and clinical determinants of cough leading to discontinuation of ACE-inhibitors .


Cough is the most frequent reason to stop ACE-inhibitor treatment .


We studied 27,492 ACE-inhibitor nave patients randomized to the ACE-inhibitor perindopril or placebo using individual data of 3 clinical trials .


Multivariate logistic regression analysis was used to study the incidence of cough in relation to baseline clinical characteristics including racial background .


In 27,492 patients with cardiovascular disease , 1076 patients discontinued ACE-inhibitor perindopril due to cough ( 3.9 % ) , 703 patients during run-in period of 4 weeks and 373 patients during a mean four years of follow-up .


Significant determinants of cough were female gender ( OR 1.92 95 % CI 1.68-2 .18 ) , age above 65 years ( OR 1.53 95 % CI 1.35-1 .73 ) , and concomitant use of lipid-lowering agents ( OR 1.37 ; 95 % CI 1.18-1 .59 ) .


A simple clinical risk score composed of these 3 predictors of cough mounted to an odds ratio of 4.4 ( 95 % CI 3.1-5 .4 ) in the subjects with highest score ( i.e. all determinants present ) .


Racial background was not related to a differential incidence of cough in patients of Caucasian or Asian descendent ( OR 1.11 95 % CI 0.92-1 .39 ) .


This large combined analysis of randomized clinical trials in 27,492 patients showed an overall lower incidence of cough leading to discontinuation of ACE-inhibitors ( 3.9 % ) as compared to literature .


Clinical determinants of such cough are older age , female gender and concomitant use of lipid-lowering agents .


In contrast , racial differences were not related to the incidence of cough .


The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM ( Drug-Eluting-Balloon-Evaluation-for-Lower-Limb - mUltilevel-treatMent ) randomized trial .


From September 2010 to March 2011 , 50 patients were randomized between drug eluting balloon ( DEB , N. = 25 ) and conventional angioplasty balloon ( PTA , N. = 25 ) .


Patients were symptomatic for claudication and critical limb ischemia , with de novo stenosis or occlusion in the femoropopliteal ( SFA ) and infrapopliteal ( BTK ) region .


Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group .


One hundred and twenty-two lesions were treated : 92 ( 75.4 % ) SFA , 30 ( 24.6 % ) BTK .


Twenty ( 40 % ) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions .


Late lumen loss ( LLL ) was 0.640.9 mm in DEB group vs. 1.810.1 mm in the control group ( P = 0.01 ) .


In non-stented segment LLL was 0.630.9 mm ( DEB ) vs. 1.700.6 mm ( PTA ) , P < 0.01 .


In the stent subgroup was LLL 0.650.2 mm ( DEB ) vs. 1.910.3 mm ( PTA ) , P < 0.01 .


In the femoropopliteal region the overall LLL was 0.610.8 mm for DEB vs. 1.840.3 mm for PTA ( P = 0.02 ) .


BTK the overall LLL was 0.660.9 mm ( DEB ) vs. 1.690.5 mm ( PTA ) ( P = 0.03 ) .


The overall TLR was 12.2 % for DEB and 35.3 % for PTA ( P < 0.05 ) .


Amputation rate was 4 % ( DEB ) vs. 12 % ( PTA ) , P = 0.36 .


Thrombosis was 4 % ( DEB ) vs. 8 % ( PTA ) , P0 .05 .


Major adverse events 24 % ( DEB ) vs. 60 % ( PTA ) , P < 0.05 .


ABI improved more in the DEB group : 0.810.3 vs. 0.680.13 ( P = 0.02 ) .


Fontaine stage increased ( from II b to I ) 80 % DEB vs. 56 % PTA ( P < 0.05 ) .


Results confirm and reinforce initial 6-month outcomes .


In.Pact DEB balloons can be considered efficient to reduce restenosis rate .


The aim of this study was to evaluate the effects of perioperative psychological and music interventions in elderly patients undergoing elective surgery on anxiety , post-operative pain , and changes in heart rate variability ( HRV ) to ascertain if perioperative psychological and music interventions can affect overall anxiety levels .


Fourty elderly patients undergoing elective surgery were randomized to two groups ; one group received psychological and music intervention , and the other was the control .


The intervention group underwent psychological intervention and listening to music for 30 min before surgery .


The mean change in HRV as determined by low frequency ( LF ) power measurements .


After the intervention , the ratio of mean LF to high frequency ( HF ) power decreased significantly in the intervention group compared to before the intervention ( p < 0.05 ) .


In the control group , mean LF measurements and the ratio of LF : HF did not change significantly .


In the intervention group , mean HF power was significantly higher after the procedure than before ( p < 0.01 ) .


Moreover , the mean self-rating anxiety score of the intervention group decreased after the procedure compared to before ( p < 0.05 ) .


The mean visual analogue score of the intervention group 6 hours after surgery was significantly lower than that of the control group ( p < 0.01 ) .


Perioperative psychological and music interventions can reduce anxiety and postoperative pain in elderly patients .


The primary aim of the present study was to evaluate the short - and longer-term effects of a cycle training on children 's cycling skills .


A second aim of the study was to examine the effects of a cycle training , with and without parental involvement , on levels of cycling to school and on parental attitudes towards cycling .


Three participating schools were randomly assigned to the `` intervention '' ( 25 children ) , the `` intervention plus parent '' ( 34 children ) or `` control '' condition ( 35 children ) .


A cycle training ( four sessions of 45 min ) took place only in the intervention schools .


Parents in the `` intervention plus parent '' condition were asked to assist their child in completing weekly homework tasks .


Children 's cycling skills were assessed , using a practical cycling test .


All participating children also received a short parental questionnaire on cycling behavior and parental attitudes towards cycling .


Assessments took place at baseline , within 1 week after the last session and at 5-months follow-up .


Repeated measure analyses were conducted to evaluate the effects of the cycle training .


Children 's total cycling skill score increased significantly more from pre to post and from pre to 5-months follow-up in the intervention group than in the control group .


On walking with the bicycle ( F = 1.6 ) , cycling in a straight line ( F = 2.6 ) , cycling a slalom ( F = 1.9 ) , cycling over obstacles ( F = 2.1 ) , cycling on a sloping surface ( F = 1.7 ) and dismounting the bicycle ( F = 2.0 ) , the cycle training had no effect .


For all other cycling skills , significant improvements were observed on short - and longer-term .


No significant intervention effects were found on children 's cycling to school levels ( F = 1.9 ) and parental attitudes towards cycling .


The cycle training course was effective in improving children 's cycling skills and the improvements were maintained 5 months later .


However , the cycle training course was not effective in increasing children 's cycling to school levels .


This study aims to investigate the influence of dietary education in patients with gout on a stable dose of urate-lowering therapy ( ULT ) .


Males and females aged > 18 years with a history of gout , receiving an appropriate and stable dose of ULT , were recruited from two tertiary hospitals and randomised into two groups .


The control group received basic advice regarding the importance of compliance with therapy and the benefit of weight loss .


The intervention group received comprehensive dietary advice based on the British Society of Rheumatology Guidelines .


Both groups received education at baseline and 3 months .


Serum urate was measured at baseline , 3 months and 6 months , and a questionnaire was completed at baseline and at 6 months .


The primary outcome of the study was to compare the change in serum urate between groups .


Thirty patients were recruited into the study .


There was no difference in serum urate between the control and intervention group at 6 months ( 0.29 mmol/L vs 0.29 mmol/L at baseline and 0.27 mmol/L vs 0.30 mmol/L at 6 months ) .


The intervention group showed a statistically significant improvement in knowledge ( 8/13 in control group at baseline to 9/13 at 6 months vs 8/13 in intervention group at baseline to 12/13 at 6 months , P < 0.05 ) and self-reported dietary modification ( 1 in control vs 7 in intervention P < 0.05 ) at 6 months .


This randomised controlled trial shows that in patients on ULT , providing education on diet does not lead to any clinically significant difference in serum urate at 6 months .


Prevention of atherosclerotic cardiovascular diseases is an important public health priority in Japan due to an aging population .


To determine whether daily , low-dose aspirin reduces the incidence of cardiovascular events in older Japanese patients with multiple atherosclerotic risk factors .


The Japanese Primary Prevention Project ( JPPP ) was a multicenter , open-label , randomized , parallel-group trial .


Patients ( N = 14,464 ) were aged 60 to 85 years , presenting with hypertension , dyslipidemia , or diabetes mellitus recruited by primary care physicians at 1007 clinics in Japan between March 2005 and June 2007 , and were followed up for up to 6.5 years , with last follow-up in May 2012 .


A multidisciplinary expert panel ( blinded to treatment assignments ) adjudicated study outcomes .


Patients were randomized 1:1 to enteric-coated aspirin 100 mg/d or no aspirin in addition to ongoing medications .


Composite primary outcome was death from cardiovascular causes ( myocardial infarction , stroke , and other cardiovascular causes ) , nonfatal stroke ( ischemic or hemorrhagic , including undefined cerebrovascular events ) , and nonfatal myocardial infarction .


Secondary outcomes included individual end points .


The study was terminated early by the data monitoring committee after a median follow-up of 5.02 years ( interquartile range , 4.55-5 .33 ) based on likely futility .


In both the aspirin and no aspirin groups , 56 fatal events occurred .


Patients with an occurrence of nonfatal stroke totaled 114 in the aspirin group and 108 in the no aspirin group ; of nonfatal myocardial infarction , 20 in the aspirin group and 38 in the no aspirin group ; of undefined cerebrovascular events , 3 in the aspirin group and 5 in the no aspirin group .


The 5-year cumulative primary outcome event rate was not significantly different between the groups ( 2.77 % [ 95 % CI , 2.40 % -3.20 % ] for aspirin vs 2.96 % [ 95 % CI , 2.58 % -3.40 % ] for no aspirin ; hazard ratio [ HR ] , 0.94 [ 95 % CI , 0.77-1 .15 ] ; P = .54 ) .


Aspirin significantly reduced incidence of nonfatal myocardial infarction ( 0.30 [ 95 % CI , 0.19-0 .47 ] for aspirin vs 0.58 [ 95 % CI , 0.42-0 .81 ] for no aspirin ; HR , 0.53 [ 95 % CI , 0.31-0 .91 ] ; P = .02 ) and transient ischemic attack ( 0.26 [ 95 % CI , 0.16-0 .42 ] for aspirin vs 0.49 [ 95 % CI , 0.35-0 .69 ] for no aspirin ; HR , 0.57 [ 95 % CI , 0.32-0 .99 ] ; P = .04 ) , and significantly increased the risk of extracranial hemorrhage requiring transfusion or hospitalization ( 0.86 [ 95 % CI , 0.67-1 .11 ] for aspirin vs 0.51 [ 95 % CI , 0.37-0 .72 ] for no aspirin ; HR , 1.85 [ 95 % CI , 1.22-2 .81 ] ; P = .004 ) .


Once-daily , low-dose aspirin did not significantly reduce the risk of the composite outcome of cardiovascular death , nonfatal stroke , and nonfatal myocardial infarction among Japanese patients 60 years or older with atherosclerotic risk factors .


clinicaltrials.gov Identifier : NCT00225849 .


Insecticide-treated nets ( ITNs ) have proven instrumental in the successful reduction of malaria incidence in holoendemic regions during the past decade .


As distribution of ITNs throughout sub-Saharan Africa ( SSA ) is being scaled up , maintaining maximal levels of coverage will be necessary to sustain current gains .


The effectiveness of mass distribution of ITNs , requires careful analysis of successes and failures if impacts are to be sustained over the long term .


Mass distribution of ITNs to a rural Kenyan community along Lake Victoria was performed in early 2011 .


Surveyors collected data on ITN use both before and one year following this distribution .


At both times , household representatives were asked to provide a complete accounting of ITNs within the dwelling , the location of each net , and the ages and genders of each person who slept under that net the previous night .


Other data on household material possessions , education levels and occupations were recorded .


Information on malaria preventative factors such as ceiling nets and indoor residual spraying was noted .


Basic information on malaria knowledge and health-seeking behaviours was also collected .


Patterns of ITN use before and one year following net distribution were compared using spatial and multi-variable statistical methods .


Associations of ITN use with various individual , household , demographic and malaria related factors were tested using logistic regression .


After infancy ( < 1 year ) , ITN use sharply declined until the late teenage years then began to rise again , plateauing at 30 years of age .


Males were less likely to use ITNs than females .


Prior to distribution , socio-economic factors such as parental education and occupation were associated with ITN use .


Following distribution , ITN use was similar across social groups .


Household factors such as availability of nets and sleeping arrangements still reduced consistent net use , however .


Comprehensive , direct-to-household , mass distribution of ITNs was effective in rapidly scaling up coverage , with use being maintained at a high level at least one year following the intervention .


Free distribution of ITNs through direct-to-household distribution method can eliminate important constraints in determining consistent ITN use , thus enhancing the sustainability of effective intervention campaigns .


Randomised control trials ( RCTs ) do not always reflect real-life outcomes for glucose-lowering drugs .


In this work we compared RCT and real-life data on the efficacy of the dipeptidyl peptidase-IV ( DPP-4 ) inhibitor vildagliptin or sulfonylureas when added to metformin .


Data were pooled from five RCTs examining vildagliptin ( n = 2,788 ) and sulfonylureas ( glimepiride [ n = 1,259 ] or gliclazide [ n = 433 ] ) , added to metformin .


For real-life conditions , data were extracted from an observational study examining vildagliptin ( n = 7,002 ) or sulfonylureas ( n = 3,702 ) , added to metformin monotherapy .


Linear regression analyses were performed between the baseline HbA1c and the change in HbA1c ( HbA1c ) after 24 weeks .


Baseline HbA1c correlated to HbA1c ( r ( 2 ) = 0.36 , slope = -0.54 [ 95 % CI -0.55 , -0.53 ; p < 0.0001 ] ) for both treatments .


With sulfonylureas , the slope of the correlation was steeper in the observational study than in RCTs ( interaction coefficient = -0.327 , p < 0.001 ) , whereas for vildagliptin , the slope was virtually identical in the observational study and the RCTs ( interaction coefficient = 0.024 , p = 0.175 ) .


For any given baseline HbA1c , HbA1c with sulfonylureas was smaller in real life than in RCTs , whereas HbA1c with vildagliptin was the same .


When comparing RCT to real-life data , the decrease in HbA1c from baseline with sulfonylurea treatment is smaller in real life than in RCTs , whereas the reduction with vildagliptin is essentially the same , suggesting that the full power of treatment is retained in real life for vildagliptin but not for sulfonylureas , possibly due to fear of hypoglycaemia .


Chronic kidney disease ( CKD ) is associated with inflammation .


The effects of atorvastatin on biomarkers of inflammation were assessed in CKD patients in the LORD trial .


117 patients with serum creatinine > 120 mol/L were randomized to receive atorvastatin 10 mg/day ( 56 ) or placebo ( 61 ) and followed for a mean of 2.5 years .


33 individuals with normal kidney function were controls .


Outcomes included comparison of changes in pentraxin-3 ( PTX3 ) , TNF - , CRP , IL-6 , IL-8 , and IL-10 between atorvastatin and placebo-treated patients .


At baseline , compared with controls , CKD patients had increased PTX3 ( mean , 1.08 vs. 0.58 ng/mL ; p < 0.001 ) , CRP ( 4.9 vs. 1.5 mg/L ; p < 0.001 ) , IL-8 ( 6.00 vs. 4.58 pg/mL ; p = 0.001 ) , IL-10 ( 59.0 vs. 17.6 pg/mL ; p = 0.007 ) , and TNF - ( 18.0 vs. 5.6 ng/mL ; p < 0.001 ) .


In patients with raised baseline plasma IL-6 / 8/10 and/or PTX3 the eGFR decline during the trial was significantly less in those treated with atorvastatin compared to placebo ( mean change , -3.36 ; vs. + 1.25 mL/min/1 .73 m2/year ; difference , 4.61 95 % CI 0.98 - 8.25 ; p = 0.002 ) , whilst those without raised inflammatory biomarkers showed no difference .


Placebo treated patients with raised TNF - levels had no eGFR decline ( p > 0.90 ) , whereas in atorvastatin-treated patients eGFR declined ( p = 0.05 ) .


CKD patients with inflammation treated with atorvastatin had significantly less eGFR decline .


Larger studies using statin therapy , specifically enrolling CKD patients with inflammation , may be worthwhile exploring .


To study the effect of metformin on metabolic parameters , body weight ( BW ) , and waist circumference ( WC ) in patients with abdominal obesity ( AO ) .


The results of using metformin 2000 mg daily for 3 months in 46 patients with AO .


The comparison group consisted of 50 people .


BW , WC , and blood pressure ( BP ) were measured ; lipid profile parameters and blood insulin concentrations were determined ; and Homeostasis Model Assessment ( HOMA ) estimates were calculated .


Metabolic syndrome ( MS ) and AO were judged by the 2005 International Diabetes Federation ( IDF ) criteria .


The study and comparison groups showed were reductions in BW by 4.2 and 1.7 kg and in WC by 4.2 and 1.1 cm , respectively .


Metformin used in the patients with AO contributed to a more significant improvement in the lipid profile than in those who received no medication .


A decrease in the HOMA index was observed only in the metformin group .


The effects of the drug were more pronounced in MS and insulin resistance .


The use of metformin in the patients with AO decreased lower BW and HOMA index and improved lipid metabolism even in the absence of MS.


The trial has demonstrated that the people with AO may take metformin could be used in to reduce BW and WC and to treat and prevent MS.


Neoadjuvant chemotherapy with 5-fluorouracil plus cisplatin and subsequent esophagectomy with two - to three-field lymphadenectomy is a standard treatment for patients with clinical stage II/III squamous cell carcinoma ( SCC ) of the esophagus .


This study investigates the prognostic factors for patients who received neoadjuvant chemotherapy .


Of 164 patients assigned to receive neoadjuvant chemotherapy in the JCOG9907 trial , multivariate analyses were performed for 159 and 149 patients to evaluate the preoperative and the combined preoperative and postoperative prognostic factors , respectively .


The multivariate analyses using preoperative factors showed that clinical stage T3 [ vs. cT1-2 ; hazard ratio ( HR ) 3.60 , p = 0.0007 ] and serum albumin ( Alb ) < 4.0 g/dl ( vs. 4.0 g/dl ; HR 2.29 , p = 0.0005 ) were associated with a poor prognosis .


Four independent prognostic factors were identified by multivariate analysis of both preoperative and postoperative factors : pathological curability B ( pB ; R0 with stage IV or pD < pN ) or pC [ microscopic or macroscopic residual tumor ( R1/R2 ) ] [ vs. pA ( R0 ) ; HR 1.93 , p = 0.015 ] , pathological stage N1 ( vs. pN0 ; HR 3.86 , p = 0.0012 ) , cT3 ( vs. cT1-2 ; HR 2.80 , p = 0.0073 ) , and serum Alb < 4.0 g/dl ( vs. 4.0 g/dl ; HR 2.03 , p = 0.0069 ) .


Preoperative cT stage , Alb , and postoperative pathological findings are independent prognostic factors for patients undergoing neoadjuvant chemotherapy for advanced thoracic esophageal SCC .


This analysis may aid in stratification according to individual patient risk .


Insomnia is frequent in schizophrenia and may contribute to cognitive impairment as well as overuse of weight inducing sedative antipsychotics .


We investigated the effects of eszopiclone on sleep and cognition for patients with schizophrenia-related insomnia in a double-blind placebo controlled study , followed by a two-week , single-blind placebo phase .


Thirty-nine clinically stable outpatients with schizophrenia or schizoaffective disorder and insomnia were randomized to either 3mg eszopiclone ( n = 20 ) or placebo ( n = 19 ) .


Primary outcome measure was change in Insomnia Severity Index ( ISI ) over 8 weeks .


Secondary outcome measure was change in MATRICS Consensus Cognitive Battery ( MATRICS ) .


Sleep diaries , psychiatric symptoms , and quality of life were also monitored .


ISI significantly improved more in eszopiclone ( mean = -10.7 , 95 % CI = -13.2 ; -8.2 ) than in placebo ( mean = -6.9 , 95 % CI = -9.5 ; -4.3 ) with a between-group difference of -3.8 ( 95 % CI = -7.5 ; -0.2 ) .


MATRICS score change did not differ between groups .


On further analysis there was a significant improvement in the working memory test , letter-number span component of MATRICS ( mean = 9.89.2 , z = -2.00 , p = 0.045 ) only for subjects with schizophrenia on eszopiclone .


There were improvements in sleep diary items in both groups with no between-group differences .


Psychiatric symptoms remained stable .


Discontinuation rates were similar .


Sleep remained improved during single-blind placebo phase after eszopiclone was stopped , but the working memory improvement in patients with schizophrenia was not durable .


Eszopiclone stands as a safe and effective alternative for the treatment of insomnia in patients with schizophrenia .


Its effects on cognition require further study .


The first large-scale randomised trial ( Immediate Management of the Patient with Rupture : Open Versus Endovascular repair [ IMPROVE ] ) for endovascular repair of ruptured abdominal aortic aneurysm ( rEVAR ) has recently finished recruiting patients .


The aim of this study was to examine the impact on survival after rEVAR when the IMPROVE protocol was initiated in a high volume abdominal aortic aneurysm ( AAA ) centre previously performing rEVAR .


One hundred and sixty-nine patients requiring emergency infrarenal AAA repair from January 2006 to April 2013 were included .


Eighty-four patients were treated before ( 38 rEVAR , 46 open ) and 85 ( 31 rEVAR , 54 open ) were treated during the trial period .


A retrospective analysis was performed .


Before the trial , there was a significant survival benefit for rEVAR over open repair ( 90-day mortality 13 % vs. 30 % , p = .04 , difference remained significant up to 2 years postoperatively ) .


This survival benefit was lost after starting randomisation ( 90-day mortality 35 % vs. 33 % , p = .93 ) .


There was an increase in overall 30-day mortality from 15 % to 31 % ( p = .02 ) , while there was no change for open repair ( p = .438 ) .


There was a significant decrease in general anaesthetic use ( p = .002 ) for patients treated during the trial .


Randomised patients had shorter hospital and intensive treatment unit stays ( p = .006 and p = .03 respectively ) .


The change in survival seen during the IMROVE trial highlights the need for randomised rather than cohort data to eliminate selection bias .


These results from a single centre reinforce those recently reported in IMPROVE .


To assess the efficacy of ketoprofen vs intravaginal misoprostol for pain relief during outpatient hysteroscopy .


Prospective , randomized , single-blind , placebo-controlled clinical trial ( Canadian Task Force classification I ) .


Tertiary medical center .


One hundred fifty women referred for hysteroscopy between January and October 2013 .


Women were randomized to receive vaginal misoprostol , 400 g , with 100 mL of 5 % intravenous glucose ( misoprostol arm ) ; intravenous ketoprofen , 50 mg/mL , in 100 mL 5 % glucose with intravaginal placebo ( ketoprofen arm ) ; or vaginal placebo tablets , 100 mL 5 % intravenous glucose ( placebo arm ) before outpatient hysteroscopy .


A visual analog scale ( VAS ) was used for 1-dimensional pain assessment .


Patients were asked to mark a VAS score before , during , and at 5 and 15 minutes after the procedure .


Median VAS scores during and directly after the anesthesia-free hysteroscopy were significantly lower in the misoprostol group than in the ketoprofen ( p = .02 ) or placebo ( p = .006 ) groups .


There were no statistical differences between the 3 arms in median VAS score assessed at 15 minutes after the procedure ( p = .16 ) .


There were no differences in procedure time between groups ( p = .16 ) .


When administrated 4 hours before the procedure , 400 g vaginal misoprostol seems to reduce the pain during and immediately after hysteroscopy .


The effect does not depend on patient age , hormone status , parity , or type of outpatient hysteroscopy ( operative or diagnostic ) .


The aim of this study was to evaluate the effectiveness of oral n-acetyl cysteine , as a potential nephroprotective agent , in preventing and/or attenuating amphotericin B-induced electrolytes imbalances .


During a one year period , patients were to receive conventional amphotericin b for any indication for at least one week and were randomly allocated to receive either placebo or 600 mg oral n-acetyl cysteine twice daily during the treatment course of amphotericin b. Demographic and clinical data of the study population were gathered .


Different aspects of amphotericin b nephrotoxicity including decrease of glomerular filtration rate , hypokalemia , hypomagnesemia , renal magnesium and potassium wasting were assessed .


Each patient was monitored for any adverse reaction to n-acetyl cysteine .


Sixteen and 14 patients in the n-acetyl cysteine and placebo groups completed the study , 3incidences of hypokalemia ( 75 % versus 70 % ; P = 0.724 ) and hypomagnesemia ( 30 % versus 20 % ; P = 0.468 ) did not differ significantly between placebo and NAC groups , respectively .


Although the rate of AmB nephrotoxicity was higher in the placebo than in the NAC group ( 60 % versus 40 % ) , this difference was not statistically significant ( P = 0.209 ) even after adjusting for probable associated factors of amphotericin b nephrotoxicity ( P = 0.206 ) .


The incidence as well as time of onset of electrolyte abnormalities also did not differ significantly between placebo and n-acetyl cysteine groups .


About 44 % of n-acetyl cysteine recipients experienced new onset nausea and a mild unpleasant taste during the study .


Oral n-acetyl cysteine during the amphotericin B treatment course was not significantly effective in preventing or mitigating different features of its nephrotoxicity including decrease of glomerular filtration rate , hypokalemia , hypomagnesemia , and renal potassium as well as magnesium wasting .


To determine whether regional anticoagulation of continuous renal replacement therapy circuits using citrate and calcium prolongs circuit life and/or affects circulating cytokine levels compared with regional anticoagulation using heparin and protamine .


Multicenter , parallel group randomized controlled trial .


Seven ICUs in Australia and New Zealand .


Critically ill adults requiring continuous renal replacement therapy .


Patients were randomized to receive one of two methods of regional circuit anticoagulation : citrate and calcium or heparin and protamine .


The primary outcome was functional circuit life measured in hours , assessed using repeated events survival analysis .


In addition , we measured changes in interleukin-6 , interleukin-8 , and interleukin-10 blood levels .


We randomized 212 subjects who were treated with 857 continuous renal replacement therapy circuits ( median 2 circuits per patient [ interquartile range , 1-6 ] , 390 in citrate group vs 467 in heparin group ) .


The groups were well matched for baseline characteristics .


Patients receiving regional continuous renal replacement therapy anticoagulation with heparin and protamine were more likely to experience circuit clotting than those receiving citrate and calcium ( hazard ratio , 2.03 [ 1.36-3 .03 ] ; p < 0.0005 ; 857 circuits ) .


The median lifespan of the first study circuit in each patient was 39.2 hours ( 95 % CI , 32.1-48 .0 hr ) in the citrate and calcium group versus 22.8 hours ( 95 % CI , 13.3-34 .0 hr ) in the heparin and protamine group ( log rank p = 0.0037 , 204 circuits ) .


Circuit anticoagulation with citrate and calcium had similar effects on cytokine levels compared with heparin and protamine anticoagulation .


There were more adverse events in the group assigned to heparin and protamine anticoagulation ( 11 vs 2 ; p = 0.011 ) .


Regional citrate and calcium anticoagulation prolongs continuous renal replacement therapy circuit life compared with regional heparin and protamine anticoagulation , does not affect cytokine levels , and is associated with fewer adverse events .


The objective of our study is to determine the relative efficacy of the 2 reduction maneuvers , hyperpronation ( HP ) and supination-flexion ( SF ) , in pulled elbow ( PE ) .


We conducted a randomized , prospective study of 2 reduction maneuvers in 115 patients with PE and a mean age of 2 years and 3 months .


Patients were randomly divided into 2 groups : group A , with 65 children ( 56.52 % ) who underwent HP ; and group B , with 50 children ( 43.47 % ) who underwent SF .


In 97.39 % of the children , reduction was achieved by manipulation .


Reduction was achieved at first attempt ( using either maneuver ) in 101 of 115 patients ( 87.82 % ) , with 93.84 % success for HP and 80 % for SF ( P = 0.0243 ) .


Most patients in whom our first attempts failed ( 85.71 % ) had undergone prior manipulation : 100 % of treatment failures from group A ; and 80 % of failures from group B. Most ( 95.04 % ) patients in whom our first attempts succeeded had not undergone prior manipulation : 93.44 % from group A ; and 97.5 % from group B.


A significant relationship was found when comparing those who had undergone prior manipulation from group A ( P = 0.0001 ) and group B ( P = 0.000000072 ) .


Although both SF and HP are effective for reduction of PE , a higher first-attempt success rate was achieved by HP , and this should therefore be the first maneuver used .


In recurring cases , it would seem appropriate to teach the child 's parents the HP maneuver as the most effective and easiest to do .


The Interventional Management of Stroke ( IMS ) - III trial randomized patients with acute ischemic stroke to intravenous tissue-type plasminogen activator ( tPA ) plus endovascular therapy versus intravenous tPA therapy alone within 3 hours from symptom onset .


A predefined secondary hypothesis was that subjects with significant early ischemic change on the baseline scan would not respond to endovascular therapy .


The primary outcome was 90-day modified Rankin Scale score 0 to 2 .


The baseline and follow-up computed tomographic ( CT ) scan images were reviewed centrally and blinded to any clinical information .


We assessed whether the baseline Alberta Stroke Program Early CT Score ( ASPECTS ) predicted outcome and interacted with study treatment .


We analyzed subgroups defined by time from onset to intravenous tPA initiation and baseline occlusion status at a prespecified = 0.01 .


Baseline demographic and clinical characteristics of 656 randomized patients were similar between subjects with a baseline ASPECTS 8 to 10 ( 58 % of the study sample ) versus 0 to 7 .


Subjects with ASPECTS 8 to 10 were almost twice as likely ( relative risk , 1.8 ; 99 % confidence interval , 1.4-2 .4 ) to achieve a favorable outcome .


There was insufficient evidence of a treatment-by-ASPECTS interaction .


In those treated with onset to intravenous tPA < 120 minutes , in CT angiography-proven internal carotid artery or middle cerebral artery occlusion , and in both , results were similar .


The probability of achieving recanalization ( arterial occlusion lesion , 2-3 ) of the primary arterial occlusive lesion ( relative risk , 1.3 ; 99 % confidence interval , 1.0-1 .8 ) or achieving thrombolysis in cerebral ischemia score 2b/3 reperfusion ( relative risk 2.0 ; 99 % confidence interval , 1.2-3 .2 ) was higher among subjects with higher ASPECTS .


ASPECTS is a strong predictor of outcome and a predictor of reperfusion .


ASPECTS did not identify a subpopulation of subjects that particularly benefitted from endovascular therapy immediately after routine intravenous tPA .


http://www.clinicaltrials.gov .


Unique identifier : NCT00359424 .


Proton pump inhibitors ( PPIs ) are a major breakthrough in the medical management of gastroesophageal reflux disease ( GERD ) .


In several patients with non erosive reflux disease symptoms ( NERD ) the response to PPIs is partial or limited and symptoms relief needs the administration of additional medications .


The aim of this study was to evaluate the effect of a new medical device , based on an oral fixed combination of hyaluronic acid and chondroitin-sulphate ( HA+CS ) , in a bioadhesive carrier , in adults with symptoms of non erosive gastroesophageal reflux and with a low response to PPIs .


Twenty patients who had experienced heartburn and/or acid regurgitation for at least 3 days during a 7 day run-in period , without endoscopic mucosal breaks , were randomized in a double blind crossover study to receive four daily doses of a fixed oral combination of HA+CS and placebo for 14 days .


Relief of cardinal symptoms of GERD was evaluated at the end of each period .


A significant greater Sum of Symptoms Intensity Difference , compared to placebo , was observed after HA+CS treatment ( -2.7 vs 0.5 - p < 0.01 ) , being both heartburn ( -1.6 vs 0.5 - p < 0.03 ) and acid regurgitation ( -1.1 vs 0.1 - p < 0.03 ) significantly improved by the medical device .


A speed of action 30 min was significantly more frequently reported by patients during HA+CS administration than with placebo ( 60 % vs 30 % - p = 0.05 ) .


Total disappearance of symptoms was observed in 50 % of the patients compared to 10 % during placebo administration ( p = 0.01 between group comparison ) .


A fixed combination of HA+CS has demonstrated to be effective in gastroesophageal reflux control , with a rapid onset of action .


Insomnia is a distressing and often persisting consequence of cancer .


Although cognitive behavioral therapy for insomnia ( CBT-I ) is the treatment of choice in the general population , the use of CBT-I in patients with cancer is complicated , because it can result in transient but substantial increases in daytime sleepiness .


In this study , we evaluated whether CBT-I , in combination with the wakefulness-promoting agent armodafinil ( A ) , results in better insomnia treatment outcomes in cancer survivors than CBT-I alone .


We report on a randomized trial of 96 cancer survivors ( mean age , 56 years ; female , 87.5 % ; breast cancer , 68 % ) .


The primary analyses examined whether one of the 7-week intervention conditions ( ie , CBT-I , A , or both ) , when compared with a placebo capsule ( P ) group , produced significantly greater clinical gains .


Insomnia was assessed by the Insomnia Severity Index and sleep quality by the Pittsburgh Sleep Quality Inventory .


All patients received sleep hygiene instructions .


Analyses controlling for baseline differences showed that both the CBT-I plus A ( P = .001 ) and CBT-I plus P ( P = .010 ) groups had significantly greater reductions in insomnia severity postintervention than the P group , with effect sizes of 1.31 and 1.02 , respectively .


Similar improvements were seen for sleep quality .


Gains on both measures persisted 3 months later .


CBT-I plus A was not significantly different from CBT-I plus P ( P = .421 ) , and A alone was not significantly different from P alone ( P = .584 ) .


CBT-I results in significant and durable improvements in insomnia and sleep quality .


A did not significantly improve the efficacy of CBT-I or independently affect insomnia or sleep quality .


As airway management specialists , thoracic surgeons should be familiar with percutaneous dilatational tracheostomy .


To optimize the learning curve , we propose a home-made pig model obtained from a slaughterhouse for training residents in the technical aspects of performing percutaneous dilatational tracheostomy .


The satisfaction of the residents ' training experience using this model was compared with that using a standard manikin model .


Fifty residents participated in the present study .


At the end of the session , each participant completed a questionnaire assessing the pig model and the manikin by assigning a score ( ranging from 1 to 4 ) to five specific characteristics including ( i ) reality of skin turgor ; ( ii ) landmark recognition ; ( iii ) feasibility of the procedure ; ( iv ) reality of the model and ( v ) preference of each model .


The differences between models were statistically analysed .


Forty-five participants completed the study .


The pig model , compared with the manikin model , presented a higher value regarding the reality of skin turgor ( 1.7 0.5 vs 0.4 0.8 ; respectively , P < 0.0001 ) ; landmark recognition ( 3.8 0.5 vs 2.0 0.5 ; respectively ; P < 0.0001 ) and reality of the model ( 3.0 0.8 vs 1.3 1.0 ; respectively ; P < 0.0001 ) .


No difference was found regarding the feasibility of the procedure ( 3.7 0.6 vs 3.5 0.5 ; respectively , P = 0.1 ) .


The pig model was preferred to the manikin ( 3.2 0.7 vs 1.6 1.0 ; respectively , P < 0.0001 ) .


Our pig model allowed residents to develop the skills required for successful percutaneous dilatational tracheostomy .


In particular , they developed confidence with certain manoeuvres such as needle and guide-wire placement , dilatation of the trachea and insertion of a cannula , before attempting the procedure on a live patient .


Stress has been associated with high-calorie , low-nutrient food intake ( HCLN ) and emotion-driven eating ( EDE ) .


However , effects on healthy food intake remain unknown .


This study examined two facets of stress ( self-efficacy , perceived helplessness ) and food consumption , mediated by EDE .


Cross-sectional data from fourth-graders ( n = 978 ; 52 % female , 28 % Hispanic ) in an obesity intervention used self-report to assess self-efficacy , helplessness , EDE , fruit/vegetable ( FV ) intake , and high-calorie/low-nutrient ( HCLN ) food .


Higher stress self-efficacy was associated with higher FV intake , = .354 , p < 0.001 , and stress perceived helplessness had an indirect effect on HCLN intake through emotion-driven eating , indirect effect = .094 , p < 0.001 ; ( 2 ) ( 347 ) = 659.930 , p < 0.001 , CFI = 0.940 , TLI = 0.930 , RMSEA = 0.030 , p = 1.00 , adjusting for gender , ethnicity , BMI z-score , and program group .


Stress self-efficacy may be more important for healthy food intake and perceived helplessness may indicate emotion-driven eating and unhealthy snack food intake .


Obesity prevention programs may consider teaching stress management techniques to avoid emotion-driven eating .


Preliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder ( ASD ) .


We sought to examine the feasibility of a novel , Internet-based clinical trial design to evaluate the efficacy of this supplement .


E-mail invitations were sent to parents of children aged 5 to 8 years enrolled in the Interactive Autism Network .


All study procedures , including screening , informed consent , and collection of outcome measures took place over the Internet .


The primary outcome measures were parent - and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist ( ABC-H ) .


During the 6-week recruitment period , 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks .


Outcome assessments were obtained from all 57 participants and 57 teachers , and the study was completed in 3 months .


Children in the omega-3 fatty acid group had a greater reduction in hyperactivity ( -5.3 points ) compared to the placebo group ( -2.6 points ) , but the difference was not statistically significant ( 1.9-point greater improvement in the omega-3 group , 95 % CI = -2.2 to 5.2 ) .


Adverse events were rare and not associated with omega-3 fatty acids .


Participant feedback was positive .


Internet-based , randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials .


A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids .


Clinical trial registration information-Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder ; http://clinicaltrials.gov; NCT01694667 .


Concurrent treatment with temozolomide and radiotherapy followed by maintenance temozolomide is the standard of care for patients with newly diagnosed glioblastoma .


Bevacizumab , a humanized monoclonal antibody against vascular endothelial growth factor A , is currently approved for recurrent glioblastoma .


Whether the addition of bevacizumab would improve survival among patients with newly diagnosed glioblastoma is not known .


In this randomized , double-blind , placebo-controlled trial , we treated adults who had centrally confirmed glioblastoma with radiotherapy ( 60 Gy ) and daily temozolomide .


Treatment with bevacizumab or placebo began during week 4 of radiotherapy and was continued for up to 12 cycles of maintenance chemotherapy .


At disease progression , the assigned treatment was revealed , and bevacizumab therapy could be initiated or continued .


The trial was designed to detect a 25 % reduction in the risk of death and a 30 % reduction in the risk of progression or death , the two coprimary end points , with the addition of bevacizumab .


A total of 978 patients were registered , and 637 underwent randomization .


There was no significant difference in the duration of overall survival between the bevacizumab group and the placebo group ( median , 15.7 and 16.1 months , respectively ; hazard ratio for death in the bevacizumab group , 1.13 ) .


Progression-free survival was longer in the bevacizumab group ( 10.7 months vs. 7.3 months ; hazard ratio for progression or death , 0.79 ) .


There were modest increases in rates of hypertension , thromboembolic events , intestinal perforation , and neutropenia in the bevacizumab group .


Over time , an increased symptom burden , a worse quality of life , and a decline in neurocognitive function were more frequent in the bevacizumab group .


First-line use of bevacizumab did not improve overall survival in patients with newly diagnosed glioblastoma .


Progression-free survival was prolonged but did not reach the prespecified improvement target .


( Funded by the National Cancer Institute ; ClinicalTrials.gov number , NCT00884741 . )


The most effective and efficient model for providing organized stroke care remains uncertain .


This study aimed to compare the effect of two models in a randomized controlled trial .


Patients with acute stroke were randomized on day one of admission to combined , co-located acute/rehabilitation stroke care or traditionally separated acute/rehabilitation stroke care .


Outcomes measured at baseline and 90 days postdischarge included functional independence measure , length of hospital stay , and functional independence measure efficiency ( change in functional independence measure score total length of hospital stay ) .


Among 41 patients randomized , 20 were allocated co-located acute/rehabilitation stroke care and 21 traditionally separated acute/rehabilitation stroke care .


Baseline measurements showed no significant difference .


There was no significant difference in functional independence measure scores between the two groups at discharge and again at 90 days postdischarge ( co-located acute/rehabilitation stroke care : 103.6 22.2 vs. traditionally separated acute/rehabilitation stroke care : 99.5 27.7 ; P = 0.77 at discharge ; co-located acute/rehabilitation stroke care : 109.5 21.7 vs. traditionally separated acute/rehabilitation stroke care : 104.4 27.9 ; P = 0.8875 at 90 days post-discharge ) .


Total length of hospital stay was 5.28 days less in co-located acute/rehabilitation stroke care compared with traditionally separated acute/rehabilitation stroke care ( 24.15 3.18 vs. 29.42 4.5 , P = 0.35 ) .


There was significant improvement in functional independence measure efficiency score among participants assigned to co-located acute/rehabilitation stroke care compared with traditionally separated acute/rehabilitation stroke care ( co-located acute/rehabilitation stroke care : median 1.60 , interquartile range : 0.87-2 .81 ; traditionally separated acute/rehabilitation stroke care : median 0.82 , interquartile range : 0.27-1 .57 , P = 0.0393 ) .


Linear regression analysis revealed a high inverse correlation ( R ( 2 ) = 0.89 ) between functional independence measure efficiency and time spent in the acute stroke unit .


This proof-of-concept study has shown that co-located acute/rehabilitation stroke care was just as effective as traditionally separated acute/rehabilitation stroke care as reflected in functional independence measure scores , but significantly more efficient as shown in greater functional independence measure efficiency .


Co-located acute/rehabilitation stroke care has potential for significantly improved hospital bed utilization with no patient disadvantage .


Observational evidence suggests that the use of a genotype-guided dosing algorithm may increase the effectiveness and safety of acenocoumarol and phenprocoumon therapy .


We conducted two single-blind , randomized trials comparing a genotype-guided dosing algorithm that included clinical variables and genotyping for CYP2C9 and VKORC1 with a dosing algorithm that included only clinical variables , for the initiation of acenocoumarol or phenprocoumon treatment in patients with atrial fibrillation or venous thromboembolism .


The primary outcome was the percentage of time in the target range for the international normalized ratio ( INR ; target range , 2.0 to 3.0 ) in the 12-week period after the initiation of therapy .


Owing to low enrollment , the two trials were combined for analysis .


The primary outcome was assessed in patients who remained in the trial for at least 10 weeks .


A total of 548 patients were enrolled ( 273 patients in the genotype-guided group and 275 in the control group ) .


The follow-up was at least 10 weeks for 239 patients in the genotype-guided group and 245 in the control group .


The percentage of time in the therapeutic INR range was 61.6 % for patients receiving genotype-guided dosing and 60.2 % for those receiving clinically guided dosing ( P = 0.52 ) .


There were no significant differences between the two groups for several secondary outcomes .


The percentage of time in the therapeutic range during the first 4 weeks after the initiation of treatment in the two groups was 52.8 % and 47.5 % ( P = 0.02 ) , respectively .


There were no significant differences with respect to the incidence of bleeding or thromboembolic events .


Genotype-guided dosing of acenocoumarol or phenprocoumon did not improve the percentage of time in the therapeutic INR range during the 12 weeks after the initiation of therapy .


( Funded by the European Commission Seventh Framework Programme and others ; EU-PACT ClinicalTrials.gov numbers , NCT01119261 and NCT01119274 . )


To determine whether providing additional information to the standard consent process , in the form of a multimedia module ( MM ) , improves patient knowledge about operative laparoscopy without increasing anxiety .


Randomized controlled trial ( Canadian Task Force classification I ) .


Two outpatient gynecologic clinics , one in a private hospital and the other in a public teaching hospital .


Forty-one women aged 19 to 51 years ( median , 35.6 years ) requiring operative laparoscopy for investigation and treatment of pelvic pain .


Following the standard informed consent process , patients were randomized to watch the MM ( intervention group , n = 21 ) or not ( control group , n = 20 ) .


The surgeon was blinded to the group assignments .


All patients completed a knowledge questionnaire and the Spielberger short-form State-Trait Anxiety Inventory .


Six weeks after recruitment , patients completed the knowledge questionnaire and the State-Trait Anxiety Inventory a second time to assess knowledge retention and anxiety scores .


Patient knowledge of operative laparoscopy , anxiety level , and acceptance of the MM were recorded .


The MM intervention group demonstrated superior knowledge scores .


Mean ( SE ) score in the MM group was 11.3 ( 0.49 ) , and in the control group was 7.9 ( 0.50 ) ( p < .001 ) ( maximum score , 14 ) .


This did not translate into improved knowledge scores 6 weeks later ; the score in the MM group was 8.4 ( 0.53 ) vs. 7.8 ( 0.50 ) in the control group ( p = .44 ) .


There was no difference in anxiety levels between the groups at intervention or after 6 weeks .


Overall , patients found the MM acceptable , and 18 women ( 86 % ) in the intervention group and 12 ( 60 % ) in the control group stated they would prefer this style of informed consent in the future .


Use of an MM enhances the informed consent process by improving patient knowledge , in the short term , without increasing anxiety .


Recently , an increased scientific interest was focused on mild approaches for ovarian stimulation in clinical practice .


Milder stimulation aims to develop safer and more patient-friendly protocols which are more physiological , less drug use , less expensive and the risks of treatment are highly minimized .


To investigate the efficacy and safety of a mild ovarian stimulation protocol in patients at high risk of developing ovarian hyperstimulation syndrome ( OHSS ) , compared to conventional long down-regulation protocol .


This a prospective , open , randomized study , included 349 infertile patients considered at high risk of developing OHSS , undergoing in vitro fertilization treatment in two private assisted reproduction centers .


The patients were randomized into two groups : group A ( n = 148 ) had a mild/minimal stimulation protocol of recombinant FSH ( rFSH ) combined with GnRH antagonist .


Group B ( n = 201 ) ( control group ) had a standard long protocol of rFSH combined with GnRH agonist .


There was no significant difference observed between the two groups regarding the mean number of oocytes retrieved per patient , mature metaphase II oocytes , fertilization rate , and embryo cleavage rate .


Significantly higher implantation rate ( 21.5 vs 14.5 % ) ( p < 0.05 ) , pregnancy rate ( 37.7 vs 23.4 % ) ( p < 0.05 ) , and delivery rate ( 32.8 vs 20.1 % ) ( p < 0.05 ) were observed in favor of groups A compared to group B. Lower proportion of patients ( 4.7 % ) , though not statistically significant , has developed OHSS in group A compared to group B ( 8.4 % ) .


Our study shows that mild stimulation regimen is highly effective for ovarian stimulation of patients who have experienced OHSS complication without increasing the risk of OHSS .


Vessel-sealing devices ( VSDs ) are widely used for various surgical procedures , including thoracoscopic surgery , but very few reports have compared their safety and usefulness with human thoracoscopic lobectomy procedures not employing VSDs .


Primary lung cancer patients for whom a thoracoscopic lobectomy involving mediastinal lymph node dissection was planned in our department from April 2011 to March 2013 were recruited for the study .


Patients were randomly allocated to a control group ( n = 14 ) or a VSD group ( n = 44 ) , which comprised three sub-groups , namely EnSeal ( n = 17 ) , LigaSure ( n = 15 ) and Harmonic ( n = 12 ) .


The control group comprised patients undergoing surgery solely with ligation and conventional electrocautery .


EnSeal , LigaSure and Harmonic were chosen because they are the three most popular disposable VSDs used in Japan .


In the VSD groups , the proximal side of pulmonary artery stumps ( 7 mm diameter ) were ligated and then treated with respective devices .


Primary end-points were burst pressure of the pulmonary artery stump ( measured using resected specimens ) , operative time , intraoperative blood loss , instances of endostapler use , intraoperative surgeon stress ( assessed by visual analogue scale ) and postoperative drainage volume and duration .


As a secondary objective , the individual VSD groups were also compared with each other .


The burst pressure of ligation-treated pulmonary artery stumps was higher than that of VSD-treated stumps ( P < 0.0001 ) .


The burst pressure of < 5-mm-wide VSD-treated stumps was higher than that of 5-mm-wide stumps ( P = 0.0421 ) .


However , the burst pressure for all groups and all vessel diameters was sufficient to withstand the physiological pulmonary artery pressure .


The VSD group demonstrated reduced intraoperative blood loss ( P = 0.0241 ) , surgeon stress ( P = 0.0002 ) , postoperative drainage volume ( P = 0.0358 ) and shortened postoperative drainage duration ( P = 0.0449 ) .


Operative time and the instances of endostapler use did not significantly differ .


Comparison between each of the VSD groups revealed no significant differences .


None of the patients experienced serious perioperative complications or died because of surgery .


VSD is simple and safe to use in thoracoscopic lobectomy involving mediastinal lymph node dissection for primary lung cancer .


Furthermore , none of the VSDs used in this study presented any observable differences in quality that could lead to clinical problems .


Hypertension is associated with dyslipidemia .


Thiazides adversely affect serum lipid levels in hypertensives .


There is currently a dearth of information on benefits of aerobic exercise training on serum lipid levels in individuals on thiazides and this study aimed at bridging this gap in knowledge .


This randomized-controlled trial involved 120 newly-diagnosed adults with essential hypertension ( 65 years ) .


They were treated with 50 mg of hydrochlorothiazide + 5 mg of hydrochloride amiloride and 5 or 10 mg of amlodipine for 4-6 weeks before they were randomly assigned into exercise group ( EG ) and control croup ( CG ) .


Only EG underwent 12-week aerobic dance training at 50-70 % of heart rate reserve three times per week .


Low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol , triglyceride and total cholesterol were measured and recorded at baseline and post-study .


Eighty-eight ( 45 in EG and 43 in CG ) of 120 participants randomly assigned to groups completed the study .


Systolic ( p = 0.370 ) and diastolic ( p = 0.771 ) blood pressures ( BP ) were similar between the two groups at baseline .


Systolic ( p < 0.001 ) and diastolic ( p < 0.001 ) BPs reduced significantly in exercise and control groups .


LDL-C ( from 120.10 33.41 to 110.50 31.68 mg/dl ; p = 0.037 ) and triglyceride ( from 117.49 45.12 to 100.63 35.42 mg/dl ; p = 0.002 ) decreased in EG post-study but no significant between-group differences were observed .


Although , LDL-C and triglyceride are reduced after aerobic dance training , they were not any more than without it .


Aerobic dance training has favorable effects on LDL-C , triglyceride , and systolic and diastolic BP in individuals with hypertension on a thiazide .


This randomized , double-blind study was designed to assess the effect of perioperative remifentanil with controlled hypotension on intraoperative bleeding , postoperative edema , and ecchymosis .


Fifty-two patients undergoing rhinoplasty were divided into 2 groups .


The remifentanil group received 1 g kg ( -1 ) intravenously as a bolus before induction of anesthesia , 0.5 to 1 g kg ( -1 ) h ( -1 ) by continuous intravenous infusion during the operation .


After anesthesia induction with propofol ( 2-3 mg kg ( -1 ) ) and fentanyl ( 1-15 g kg ( -1 ) ) , muscle relaxation was achieved with rocuronium ( 0.45-0 .90 mg kg ( -1 ) ) .


Mean arterial pressure was maintained at 50 to 60 mm Hg in controlled hypotensive anesthesia achieved using remifentanil infusion .


Perioperative hemodynamics and bleeding ; early postoperative pain and agitation scale ; postoperative first , third , and seventh day edema ; and ecchymosis were evaluated .


Edema and ecchymosis were evaluated using graded scale from 0 to 4 .


Remifentanil reduced mean arterial pressure during the entire operative period and the first 30 minutes postoperatively ( P < 0.05 for these comparisons ) .


Intraoperative bleeding also decreased ( P < 0.001 ) .


There was a significant decrease in edema in both upper and lower eyelid edema on the first and third days in the remifentanil group , although this difference was not detected on the seventh day ( P ( 1upper ) = 0.000 , P ( 1lower ) = 0.000 , P ( 3upper ) = 0.008 , and P ( 3lower ) = 0.002 ) .


Ecchymosis decreased significantly in both upper and lower eyelids on the first , third , and seventh days in the remifentanil group ( P ( 1upper ) = 0.000 , P ( 3upper ) = 0.000 , P ( 3upper ) = 0.002 , P ( 3lower ) = 0.002 , P ( 7upper ) = 0.049 , and P ( 7lower ) = 0.038 ) .


There were no differences in postoperative pain and agitation between 2 groups .


Remifentanil with controlled hypotension may reduce edema and ecchymosis of the upper and lower eyelids , by reducing mean arterial pressure and amount of bleeding in rhinoplasty .


To compare the effectiveness of a single LipiFlow ( ) treatment with combined lid warming and massage in patients with meibomian gland dysfunction ( MGD ) .


In this prospective , randomized , crossover , observer-masked clinical trial , subjects were randomized to receive either a single 12-min LipiFlow-LipiFlow Thermal Pulsation ( LTP ) system treatment or to perform combined twice-daily lid warming and massage for 3 months .


All subjects were examined before , and 1 and 3 months after initiation of treatments .


Investigated parameters included subjective symptoms , lipid layer thickness , meibomian gland assessment , tear break-up time , tear osmolarity , corneal and conjunctival staining , Schirmer test values , and tear meniscus height .


A total of 31 subjects completed the 3-month follow-up .


At 1 and 3 months , patients in the LipiFlow treatment group had a significant reduction in Ocular Surface Disease Index ( OSDI ) scores compared with those in the lid-margin hygiene group .


Both treatments produced a significant improvement in expressible meibomian glands compared to the baseline parameters , but no significant difference was noted between the two groups .


The other investigated objective parameters did not show a significant difference .


Results of our study show that a single LipiFlow treatment is as least as effective as a 3-month , twice-daily lid margin hygiene regimen for MGD .


However , the present study was observer-masked only , and therefore a placebo effect may have confounded any improvements in subjective symptoms and other parameters in both groups .


To compare prospectively the surgical outcomes of different surgery procedures for convergence insufficiency ( CI ) - type intermittent exotropia ( IXT ) in children .


Forty-five children with CI-type IXT were included in this prospective surgical study with 6 months follow-up .


According to the different surgical procedures , all children were randomly divided into three groups : the unilateral medial rectus resection ( UMR ) group ( 15 cases ) , the bilateral medial rectus resections ( BMR ) group ( 14 cases ) and the improved unilateral recession-resection ( R&R ) group ( 16 cases ) .


In the UMR and BMR groups , the medial rectus resection ( s ) were based on the distance exodeviation .


In the R&R group , UMR was based on the near exodeviation while lateral rectus recession was based on the distance exodeviation .


A successful surgical alignment was defined as the distant deviation in the primary gaze to be between 10 prism dioptres ( PD ) of exophoria/tropia and 5 PD of esophoria/tropia .


The success rate , the preoperative and postoperative deviations at distance and near and near-distance differences among groups were compared .


At the last follow-up of 6 months , the success rate in the R&R ( 87.5 % ) group was significantly higher than those in the UMR ( 13.3 % ) and BMR ( 42.9 % ) groups ( p = 0.000 and 0.008 ) ; the mean exodeviations at distance and near in the R&R group were significantly different from those in the UMR and BMR groups ( p = 0.000 and 0.001 ) ; there were no significant differences in the mean near-distance differences between the R&R group and the other two groups ( p > 0.05 ) .


The improved R&R procedure in which medial rectus resection based on the near deviation with lateral rectus recession based on the distant deviation has a better alignment than the UMR and BMR surgeries for the treatment of children with CI-type IXT .


All the UMR , BMR and improved R&R surgery can reduce near-distance differences in children with CI-type IXT .


The use of biodegradable-polymer drug-eluting stents has been shown to provide favorable results when compared with durable polymer drug-eluting stents and long-term follow up data have recently shown significant reductions in terms of very late stent thrombosis .


Aim of the present study was to assess the safety and efficacy profile of a novel biodegradable polymer DES , the Yukon Choice Flex sirolimus-eluting stent .


We report here the one-year clinical outcomes associated with the use of the Yukon Choice Flex sirolimus-eluting stent in an all-comers patient population .


The present stent represents a further refinement of the stent platform tested in the ISAR TEST 3 and 4 randomized clinical trials .


A total of 778 consecutive patients undergoing implantation of this stent were enrolled in the present observational study and prospectively followed for one year .


The use of the Yukon Choice Flex stent in a patient population with complex coronary lesion morphology was associated with optimal immediate angiographic results .


At one year follow up the rates of death , myocardial infarction , definite stent thrombosis and ischemia-driven target lesion revascularization were respectively 2.4 % , 1.9 % , 0.3 % and 11.3 % .


The use of the sirolimus-eluting biodegradable polymer Yukon Choice Flex stent in an all-comers population of patients with complex coronary artery disease is associated with a favorable safety and efficacy profile up to one year follow up .


To evaluate the literacy level of patients with glaucoma in a tertiary care teaching centre compared with a rural community centre and to assess comprehension of and preference for educational material written at different reading levels .


Prospective , randomized , double-blinded study .


Patients with glaucoma presenting for routine examination or referral at a tertiary care academic centre in southwestern Ontario and a single general ophthalmology clinic located in a moderately sized suburban community in Ontario , Canada , were invited to participate in this study .


Patients aged 19 to 90 with sufficient visual acuity to read the pamphlets were recruited .


Eligible and consenting participants underwent a validated literacy study , and their literacy levels were classified as adequate , barely adequate , marginal , or inadequate .


They were then randomized to receive educational pamphlets written at either a grade 5 ( intervention group ) or grade 10 ( control group ) reading level .


Comprehension of and preference for the material were determined by analysis of cloze testing and a feedback questionnaire .


Of 199 participants , 179 were included in the analysis .


The literacy testing found that 35 % of patients in the community practice and 30 % in the tertiary care academic centre had `` marginal '' or `` inadequate '' literacy skills , but there was no significant difference between sites ( p = 0.77 ) .


Comprehension of the educational material was higher in the intervention group versus the control group ( p = 0.0057 ) , with a mean cloze score of 57.9 % in the intervention group and 48.3 % in the control group .


The intervention group spent significantly less time reading the pamphlets ( p < 0.0001 ) , with an average of 2.52 minutes compared with 4.51 minutes .


The feedback survey indicated that patients found the pamphlet with the lower reading level easier to read ( p = 0.02 ) , which was reflected in their comments as well .


In both academic and community practice settings , about 30 % of patients with glaucoma have marginal or inadequate literacy skills .


However , regardless of practice , all patients better comprehend , and were more receptive to , educational material written at grade 5 reading level with illustrations , regardless of initial literacy level .


Patients are classically at risk of delayed cerebral ischemia ( DCI ) after aneurysmal subarachnoid hemorrhage .


We validated a grading scale-the VASOGRADE-for prediction of DCI .


We used data of 3 phase II randomized clinical trials and a single hospital series to assess the relationship between the VASOGRADE and DCI .


The VASOGRADE derived from previously published risk charts and consists of 3 categories : VASOGRADE-Green ( modified Fisher scale 1 or 2 and World Federation of Neurosurgical Societies scale [ WFNS ] 1 or 2 ) ; VASOGRADE-Yellow ( modified Fisher 3 or 4 and WFNS 1-3 ) ; and VASOGRADE-Red ( WFNS 4 or 5 , irrespective of modified Fisher grade ) .


The relation between the VASOGRADE and DCI was assessed by logistic regression models .


The predictive accuracy of the VASOGRADE was assessed by receiver operating characteristics curve and calibration plots .


In a cohort of 746 patients , the VASOGRADE significantly predicted DCI ( P < 0.001 ) .


The VASOGRADE-Yellow had a tendency for increased risk for DCI ( odds ratio [ OR ] , 1.31 ; 95 % CI , 0.77-2 .23 ) when compared with VASOGRADE-Green ; those with VASOGRADE-Red had a 3-fold higher risk of DCI ( OR , 3.19 ; 95 % CI , 2.07-4 .50 ) .


Studies were not a significant confounding factor between the VASOGRADE and DCI .


The VASOGRADE had an adequate discrimination for prediction of DCI ( area under the receiver operating characteristics curve = 0.63 ) and good calibration .


The VASOGRADE results validated previously published risk charts in a large and diverse sample of subarachnoid hemorrhage patients , which allows DCI risk stratification on presentation after subarachnoid hemorrhage .


It could help to select patients at high risk of DCI , as well as standardize treatment protocols and research studies .


To determine the effect of suppression of vascular endothelial growth factor ( VEGF ) by monthly injection of ranibizumab on posterior retinal nonperfusion ( RNP ) in patients with diabetic macular edema ( DME ) .


Unplanned retrospective analysis of prospectively collected data from 2 randomized , sham injection-controlled , double-masked , multicenter clinical trials .


Six hundred sixty-six patients with DME .


An independent reading center measured the area of RNP on fluorescein angiograms obtained in the phase 3 RISE and RIDE trials .


The percentage of patients with no posterior RNP .


The percentage of patients with no posterior RNP decreased in the sham group between baseline and month 24 , but remained relatively stable in the 2 ranibizumab groups .


After month 24 , the sham group crossed over to receive monthly injections of ranibizumab 0.5 mg , and the differences between the sham and ranibizumab groups were reduced .


The percentage of patients who showed an increase in posterior RNP from baseline increased over time in all 3 groups , but at a faster rate in the sham group , resulting in statistically significant differences at every time point between months 3 ( 9.6 % vs. 18.5 % ; P = 0.016 ) and 24 ( 16.1 % vs. 37.6 % ; P < 0.0001 ) for ranibizumab 0.5 mg versus sham and from months 6 ( 12.3 % vs. 23.0 % ; P = 0.013 ) through 24 ( 15.0 % vs. 37.6 % ; P < 0.0001 ) for ranibizumab 0.3 mg .


Initiation of ranibizumab in the sham group at month 24 was followed by reduction in the percentage of patients with an increase in posterior RNP from baseline at months 30 and 36 , whereas the 2 ranibizumab groups continued their gradual rise .


Just as high VEGF levels contribute to progression of retinal nonperfusion in retinal vein occlusion , the same is true in patients with DME , suggesting that regardless of the underlying disease process , high levels of VEGF can cause closure of retinal vessels .


However , our data also suggest that VEGF-induced worsening of retinal perfusion in DME is superimposed on another cause of more gradually worsening perfusion , possibly glucotoxicity .


Thus , monthly injections of ranibizumab can slow , but not completely prevent , retinal capillary closure in patients with DME .


To assess the efficacy of combined use of scorpion antivenom ( SAV ) with prazosin , compared with prazosin alone in children with Mesobuthus tamulus scorpion envenomation .


Randomised controlled trial .


A tertiary care hospital in south India .


50 children with definite history and/or systemic manifestations of scorpion envenomation were recruited from the paediatric emergency or outpatient department from February 2012 to July 2013 .


The children were randomised into two groups .


In 25 children , SAV was administrated as a slow intravenous bolus combined with prazosin ( group A ) .


Others received prazosin alone ( group B ) .


Results were analysed by Student t test and ( 2 ) test .


Time required for resolution of autonomic symptoms , total dose of prazosin , adverse events .


Children in group A recovered earlier than those in group B ( mean difference 9.1 h , 95 % CI 6.0 to 12.2 ) .


23 children ( 92 % ) in group A were clear of autonomic symptoms within 10h , compared with 10 children ( 40 % ) in group B ( mean difference 52 % , 95 % CI 29 % to 75 % ) .


The proportion of children deteriorating to clinical grade 3 or 4 was 8 % in group A as against 44 % in group B ( p < 0.01 ) .


The mean dose of prazosin required was 54g/kg versus 130.8 g/kg in group A and B , respectively ( p < 0.01 ) .


SAV was not associated with severe adverse reactions .


Usage of SAV led to faster recovery and reduced the incidence of myocardial dysfunction .


Combined therapy with SAV and prazosin is beneficial for children with M tamulus scorpion envenomation .


CTRI/2013/09 / 004002 ( Clinical Trials Registry of India ) .


Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome .


There are , however , only three published randomized trials on the effect of feedback on the treatment of eating disorders , showing inconclusive results , and there are no randomized trials on the effect of feedback in group therapy .


Accordingly the current randomized clinical trial , initiated in September 2012 at the outpatient clinic for eating disorders at Stolpegaard Psychotherapy Centre , aims to investigate the impact of continuous feedback on attendance and outcome in group psychotherapy .


The hypothesis is that continuous feedback to both patient and therapist on treatment progress and alliance will increase attendance and treatment outcome .


The trial is set up using a randomized design with a minimum of 128 patients allocated to either an experimental or control group at a ratio of 1:1 .


The experimental group will receive standard treatment ( systemic and narrative group psychotherapy ) with feedback intervention , whereas the control group will receive standard treatment only .