The intervention crisis resource management group placed monitor leads 24.6 seconds earlier ( p = 0.02 ) , placed an IV 47.1 seconds sooner ( p = 0.04 ) , called for help 50.4 seconds faster ( p = 0.03 ) , and checked for a pulse after noticing a rhythm change 84.9 seconds quicker ( p = 0.01 ) .


There was no statistically significant difference in time to initiation of cardiopulmonary resuscitation ( p = 0.264 ) .


The intervention group had overall crisis resource management performance scores 1.15 points higher ( Ottawa Global Rating Scale [ out of 7 ] ) ( p = 0.02 ) .


Three months later , these differences between the groups persisted .


A 1-hour crisis resource management teaching session improved time to critical initial steps of pediatric resuscitation and crisis resource management performance as measured by the Ottawa Global Rating Scale .


The control group did not develop these crisis resource management skills over 3 months of standard training indicating that obtaining these skills requires specific education .


Larger studies of crisis resource education are required .


Cardiovascular disease and dementia are growing medical and social problems in aging societies .


Appropriate knowledge of cardiovascular disease and cognitive decline risk factors ( RFs ) are critical for global CVR health preventive intervention .


Many epidemiological studies use case definition based on data collected/measured in a single visit , a fact that can overestimate prevalence rates and distant from clinical practice demanding criteria .


Portugal displays an elevated stroke mortality rate .


However , population 's global CV risk characterization is limited , namely , considering traditional/nontraditional RF and new intermediate phenotypes of CV and renal disease .


Association of hemodynamic variables ( pulse wave velocity and central blood pressure ) with global CVR stratification , cognitive performance , and kidney disease are practically inexistent at a dwelling population level .


After reviewing published data , we designed a population-based cohort study to analyze the prevalence of these cardiovascular RFs and intermediate phenotypes , using random sampling of adult dwellers living in 2 adjacent cities .


Strict definition of phenotypes was planned : subjects were observed twice , and several hemodynamic and other biological variables measured at least 3 months apart .


Three thousand thirty-eight subjects were enrolled , and extensive data collection ( including central and peripheral blood pressure , pulse wave velocity ) , sample processing , and biobank edification were carried out .


One thousand forty-seven cognitive evaluations were performed .


Seeking for CV risk reclassification , early identification of subjects at risk , and evidence of early vascular aging and cognitive and renal function decline , using the strict daily clinical practice criteria , will lead to better resource allocation in preventive measures at a population level .


Cow 's milk protein ( CMP ) - specific IgG4 responses and the efficacy of oral desensitization in infants with cow 's milk allergy ( CMA ) warrant more clarification .


To explore whether CMP-specific IgG4 responses develop during infancy and whether regular CM exposure is efficacious for inducing a CMP-specific IgG4 response accompanying CM desensitization in 7 - to 12-month-old infants .


CM-specific IgE and CMP ( - lactalbumin , - lactoglobulin , and casein ) - specific IgG4 levels were measured in 262 CM-sensitized children .


Of these , 31 infants 7 to 12 months old with challenge-proved CMA were randomly assigned to oral desensitization or an elimination diet and evaluated 6 months later .


CMP-specific IgG4 levels in 7 - to 12-month-old infants were higher than in those younger than 6 months but comparable to those in children older than 12 months .


CMP-specific IgG4 levels in 7 - to 12-month-old infants with CMA were significantly lower than in those without CMA .


Fourteen of 16 patients receiving oral desensitization could accept daily doses of 200 mL of CM , whereas all but 3 dropout patients receiving the elimination diet still showed allergic symptoms at the follow-up food challenge .


In patients who became desensitized , CM-specific IgE levels were lower than at baseline , whereas CMP-specific IgG4 levels were significantly increased .


In patients receiving the elimination diet , CM-specific IgE and CMP-specific IgG4 levels remained unchanged .


CMP-specific IgG4 responses did not develop sufficiently in 7 - to 12-month-old infants with CMA .


Oral desensitization in 7 - to 12-month-old infants with CMA was associated with the upregulation of CMP-specific IgG4 responses accompanying the alleviation of CMA symptoms .


Data are needed to guide therapeutic decisions about stopping bisphosphonates after an initial treatment period .


To define significant predictors of fracture and quantify fracture incidence in risk factor-defined subgroups of women who discontinue zoledronic acid ( ZOL ) after 3 years of treatment .


To determine if continuing ZOL reduces fracture risk in subgroups .


This study is based on data from the 3 year extension of HORIZON .


Subjects were in the ZOL arm of the Multicenter HORIZON trial .


One thousand two hundred thirty three women who previously received 3 ZOL treatments during the Core trial .


Randomization to three additional annual ZOL ( Z6 , n = 616 ) or placebo infusions ( Z3P3 , n = 617 ) .


The risk of morphometric vertebral fractures ( MorphVertFx ) and clinical nonvertebral fractures ( NVF ) .


The incidence of MorphVertFx in Z3P3 was predicted by femoral neck ( FN ) t-score -2.5 [ OR 3.3 ( 1.4 , 8.0 ) , p = .008 ] , total hip ( TH ) t-score -2.5 [ OR 4.0 ( 1.8 , 9.0 ) , p = .0007 ] , and incident MorphVertFx during Core [ OR 4.75 ( 1.4 , 16.8 ) , p < .015 ] .


Incidence of NVF was predicted by TH t-score [ for 1 decline , HR 1.7 ( 1.2 , 2.6 ) , p = .008 ] , incident NVF during Core [ HR 2.5 ( 1.2 , 5.3 ) , p = .014 ] , and prevalent vertebral fracture [ HR 3.0 ( 1.4 , 6.3 ) , p = .005 ] .


For MorphVertFx , there were no significant treatment subgroup interactions ; absolute fracture reductions with continued ZOL were greatest in high-risk subgroups .


For NVF , there were no significant treatment reductions overall or in subgroups and no significant interactions .


After 3 years of ZOL , in women who have a TH t-score above -2.5 , no recent incident fracture and no more than one risk factor ( almost 55 % of the population ) , risk for subsequent fracture ( over three additional years ) is low if treatment is discontinued ( for MorphVertFx , average risk 3.2 % and for NVF , average risk 5.8 % ) .


In these patients , discontinuation for up to 3 years is reasonable .


Brief interventions delivered by family physicians to address excessive alcohol use among adult patients are effective .


We conducted a study to determine whether such an intervention would be similarly effective in reducing binge drinking and excessive cannabis use among young people .


We conducted a cluster randomized controlled trial involving 33 family physicians in Switzerland .


Physicians in the intervention group received training in delivering a brief intervention to young people during the consultation in addition to usual care .


Physicians in the control group delivered usual care only .


Consecutive patients aged 15-24 years were recruited from each practice and , before the consultation , completed a confidential questionnaire about their general health and substance use .


Patients were followed up at 3 , 6 and 12 months after the consultation .


The primary outcome measure was self-reported excessive substance use ( 1 episode of binge drinking , or 1 joint of cannabis per week , or both ) in the past 30 days .


Of the 33 participating physicians , 17 were randomly allocated to the intervention group and 16 to the control group .


Of the 594 participating patients , 279 ( 47.0 % ) identified themselves as binge drinkers or excessive cannabis users , or both , at baseline .


Excessive substance use did not differ significantly between patients whose physicians were in the intervention group and those whose physicians were in the control group at any of the follow-up points ( odds ratio [ OR ] and 95 % confidence interval [ CI ] at 3 months : 0.9 [ 0.6-1 .4 ] ; at 6 mo : 1.0 [ 0.6-1 .6 ] ; and at 12 mo : 1.1 [ 0.7-1 .8 ] ) .


The differences between groups were also nonsignificant after we restricted the analysis to patients who reported excessive substance use at baseline ( OR 1.6 , 95 % CI 0.9-2 .8 , at 3 mo ; OR 1.7 , 95 % CI 0.9-3 .2 , at 6 mo ; and OR 1.9 , 95 % CI 0.9-4 .0 , at 12 mo ) .


Training family physicians to use a brief intervention to address excessive substance use among young people was not effective in reducing binge drinking and excessive cannabis use in this patient population .


Australian New Zealand Clinical Trials Registry , no .


ACTRN12608000432314 .


To evaluate a new levonorgestrel-releasing intrauterine system ( LNG-IUS ) called Levosert ( ) for the treatment of heavy menstrual bleeding ( HMB ) in comparison to the reference product Mirena ( ) .


A multicentre , randomised , controlled trial , in non-menopausal women diagnosed with functional HMB ( defined as menstrual blood loss [ MBL ] 80 mL ) randomised to either Levosert ( ) or Mirena ( ) and followed for up to one year .


MBL was evaluated using a validated modified version of the Wyatt pictogram .


A total of 280 women were randomised ( 141 to Levosert ( ) and 139 to Mirena ( ) ) .


During the one-year treatment period , both Levosert ( ) and Mirena ( ) dramatically decreased MBL and increased haemoglobin and ferritin levels .


There were no statistically significant differences between Levosert ( ) and Mirena ( ) regarding any of the parameters evaluated during the study .


Similar bleeding patterns were observed in both groups .


Levosert ( ) was inserted with the same ease as Mirena ( ) .


Both treatments were associated with identical expulsion rates and no perforations occurred in either treatment group .


Levosert ( ) , a new LNG-IUS designed to release the same daily amount of LNG as Mirena ( ) , is highly effective in the treatment of HMB .


No differences were observed between Levosert ( ) and Mirena ( ) regarding all evaluated outcomes , including safety profile .


Cardiopulmonary bypass is still a major cause of lung injury and delay in pulmonary recovery after cardiac surgery .


Although it has been shown that pulsatile flow induced by intra-aortic balloon pumping is beneficial for preserving lung function , it is not clear if the same beneficial effect can be accomplished with pulsatile flow generated in the extracorporeal circuit .


Therefore , we investigated the effect of pulsatile flow , produced by a centrifugal pump , on lung function in elderly patients .


Serial measurements of lung biomarkers Clara cell 16 kD protein , surfactant protein D , and elastase were performed on blood samples from 37 elderly patients ( 75 years ) who underwent elective aortic valve replacement surgery with CPB , either with pulsatile perfusion or continuous perfusion .


Pulmonary function was assessed by postoperative ventilation time , the arterial blood oxygenation ( PaO2/FiO2 ) , the alveolar-arterial oxygen gradient ( Aa-O2 gradient ) and the pulmonary vascular resistance indexed by body surface area ( PVRi ) .


There was no difference in lung function between both groups , as assessed by the postoperative ventilation time , the PaO2/FiO2 ratio , and the Aa-O2 gradient .


The PVRi , however , was significantly lower in the pulsatile perfusion group 15 mins after the administration of protamine ( p < 0.05 ) .


The plasma concentrations of the lung biomarkers increased during surgery and peaked at 1 h ICU , there were however no differences between groups .


Pulsatile flow does not seem beneficial to postoperative lung function in elderly patients .


Moreover , pulsatile flow does not affect lung function on a subclinical level as assessed by lung biomarkers .


The objective of this study was to investigate functional abnormalities of the brain in females with migraine using magnetoencephalography ( MEG ) and a finger-tapping task .


Twenty-nine female patients with migraine ( aged 16-40years ) and age - and gender-matched healthy controls were studied with an MEG system at a sampling rate of 6000Hz .


MEG recordings were performed during an attack in migraineurs with and without aura .


Neuromagnetic brain activation was elicited by a finger-tapping task .


The latency and amplitude of neuromagnetic responses were analyzed with averaged waveforms in the frequency range of 5-100Hz .


The Morlet wavelet and beamformers were used to analyze the spectral and spatial signatures of MEG data from subjects in two frequency ranges of 5-100 and 100-1000Hz .


The latency of motor-evoked magnetic fields evoked by finger movement was significantly prolonged in migraineurs as compared with controls .


Neuromagnetic spectral power in the motor cortex in migraineurs was significantly elevated .


There were significantly higher odds of activation in 5-30 , 100-300 and 500-700Hz frequency ranges in the ipsilateral primary motor cortices and the supplementary motor area in migraineurs as compared with controls .


Neuromagnetic signal abnormalities in this study suggest cortical hyperexcitability in females with migraine during migraine attack , which could be measured and analyzed with MEG signal in a frequency range of 5-1000Hz .


These findings may help to identify neurophysiological biomarkers for studying mechanisms of migraine , and may facilitate to develop new therapeutic strategies for migraine by alterations in cortical excitability .


Among older home health care patients , depression is highly prevalent , is often inadequately treated , and contributes to hospitalization and other poor outcomes .


Feasible and effective interventions are needed to reduce this burden of depression .


To determine whether , among older Medicare Home Health recipients who screen positive for depression , patients of nurses receiving randomization to an intervention have greater improvement in depressive symptoms during 1 year than patients receiving enhanced usual care .


This cluster randomized effectiveness trial conducted at 6 home health care agencies nationwide assigned nurse teams to an intervention ( 12 teams ) or to enhanced usual care ( 9 teams ) .


Between January 13 , 2009 , and December 6 , 2012 , Medicare Home Health patients 65 years and older who screened positive for depression on routine nursing assessments were recruited , underwent assessment , and were followed up at 3 , 6 , and 12 months by research staff blinded to intervention status .


Patients were interviewed at home and by telephone .


Of 502 eligible patients , 306 enrolled in the study .


The Depression Care for Patients at Home ( Depression CAREPATH ) trial requires nurses to manage depression at routine home visits by weekly symptom assessment , medication management , care coordination , education , and goal setting .


Nurses ' training totaled 7 hours ( 4 onsite and 3 via the web ) .


Researchers telephoned intervention team supervisors every other week .


Depression severity , assessed by the 24-item Hamilton Scale for Depression ( HAM-D ) .


The 306 participants were predominantly female ( 69.6 % ) , were racially/ethnically diverse ( 18.0 % black and 16.0 % Hispanic ) , and had a mean ( SD ) age of 76.5 ( 8.0 ) years .


In the full sample , the intervention had no effect ( P = .13 for intervention time interaction ) .


Adjusted HAM-D scores ( Depression CAREPATH vs control ) did not differ at 3 months ( 10.5 vs 11.4 , P = .26 ) or at 6 months ( 9.3 vs 10.5 , P = .12 ) but reached significance at 12 months ( 8.7 vs 10.6 , P = .05 ) .


In the subsample with mild depression ( HAM-D score , < 10 ) , the intervention had no effect ( P = .90 ) , and HAM-D scores did not differ at any follow-up points .


Among 208 participants with a HAM-D score of 10 or higher , the Depression CAREPATH demonstrated effectiveness ( P = .02 ) , with lower HAM-D scores at 3 months ( 14.1 vs 16.1 , P = .04 ) , at 6 months ( 12.0 vs 14.7 , P = .02 ) , and at 12 months ( 11.8 vs 15.7 , P = .005 ) .


Home health care nurses can effectively integrate depression care management into routine practice .


However , the clinical benefit seems to be limited to patients with moderate to severe depression .


clinicaltrials.gov Identifier : NCT01979302 .


In preparing novice anesthesiologists to perform their first ultrasound-guided axillary brachial plexus blockade , we hypothesized that virtual reality simulation-based training offers an additional learning benefit over standard training .


We carried out pilot testing of this hypothesis using a prospective , single blind , randomized controlled trial .


We planned to recruit 20 anesthesiologists who had no experience of performing ultrasound-guided regional anesthesia .


Initial standardized training , reflecting current best available practice was provided to all participating trainees .


Trainees were randomized into one of two groups ; ( i ) to undertake additional simulation-based training or ( ii ) no further training .


On completion of their assigned training , trainees attempted their first ultrasound-guided axillary brachial plexus blockade .


Two experts , blinded to the trainees ' group allocation , assessed the performance of trainees using validated tools .


This study was discontinued following a planned interim analysis , having recruited 10 trainees .


This occurred because it became clear that the functionality of the available simulator was insufficient to meet our training requirements .


There were no statistically significant difference in clinical performance , as assessed using the sum of a Global Rating Score and a checklist score , between simulation-based training [ mean 32.9 ( standard deviation 11.1 ) ] and control trainees [ 31.5 ( 4.2 ) ] ( p = 0.885 ) .


We have described a methodology for assessing the effectiveness of a simulator , during its development , by means of a randomized controlled trial .


We believe that the learning acquired will be useful if performing future trials on learning efficacy associated with simulation based training in procedural skills .


ClinicalTrials.gov identifier : NCT01965314 .


Registered October 17th 2013 .


The aim of this study was to evaluate the clinical efficacy of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma .


Using the randomized controlled clinical research method , 65 patients with nasopharyngeal carcinoma were randomly divided into an experimental group consisting of 32 patients and a control group consisting of 33 patients .


The submandibular glands were averted to the submental region in 32 patients with nasopharyngeal carcinoma before they received conventional radiotherapy ; a lead block was used to shield the submental region during therapy .


Prior to radiotherapy , the function of the submandibular glands was assessed using imaging .


Submandibular gland function was measured using 99mTc radionuclide scanning at 60 months after radiotherapy .


The data in the questionnaire regarding the degree of xerostomia were investigated and saliva secretion was measured at 3 , 6 , 12 , and 60 months after radiotherapy .


In addition , the 5-year survival rate was calculated .


After follow-up for 3 , 6 , and 12 months , the incidence of moderate to severe xerostomia was significantly lower in the experimental group than in the control group .


The average amount of saliva produced by the experimental and control groups was 1.60 g and 0.68 g , respectively ( P < 0.001 ) .


After follow-up for 60 months , the uptake and secretion functions of the submandibular glands in the experimental group were found to be significantly higher than in the control group ( P < 0.001 and P < 0.001 , respectively ) .


The incidence of moderate or severe xerostomia was significantly lower than in the control group ( 15.4 % and 76.9 % , respectively ; P < 0.001 ) .


The 5-year survival rates of the experimental group and the control group were 81.3 % and 78.8 % , respectively , and there was no significant difference between the two groups ( P = 0.806 ) .


After a 5 year follow-up period involving 32 patients who had their submandibular glands transferred for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma , we found that clinical efficacy was good .


This approach could improve the quality of life of nasopharyngeal carcinoma patients after radiotherapy and would not affect long-term treatment efficacy .


To provide a framework for implementation of multicomponent , school-based nutrition interventions .


This article describes the research methods for the Shaping Healthy Choices Program , a model to improve nutrition and health-related knowledge and behaviors among school-aged children .


Longitudinal , pretest/posttest , randomized , controlled intervention .


Four elementary schools in California .


Fourth-grade students at intervention ( n = 252 ) and control ( n = 238 ) schools and their parents and teachers .


Power analyses demonstrate that a minimum of 159 students per group will be needed to achieve sufficient power .


The sample size was determined using the variables of nutrition knowledge , vegetable preference score , and body mass index percentile .


A multicomponent school-based nutrition education intervention over 1 academic year , followed by activities to support sustainability of the program .


Dietary and nutrition knowledge and behavior , critical thinking skills , healthy food preferences and consumption , and physical activity will be measured using a nutrition knowledge questionnaire , a food frequency questionnaire , a vegetable preferences assessment tool , the Test of Basic Science Process Skills , digital photography of plate waste , PolarActive accelerometers , anthropometrics , a parent questionnaire , and the School and Community Actions for Nutrition survey .


Evaluation will include quantitative and qualitative measures .


Quantitative data will use paired t , chi-square , and Mann-Whitney U tests and regression modeling using P = .05 to determine statistical significance .


The performance of glomerular filtration rate ( GFR ) equations incorporating both cystatin C ( CysC ) and serum creatinine ( Creat ) in living kidney donors has not been studied before .


From a population of 3,698 living kidney donors , 257 donors were randomly selected to undergo GFR measurement ( mGFR ) by the plasma disappearance of iohexol .


GFR was estimated with the Modification of Diet in Renal Disease ( MDRD ) equation and the Chronic Kidney Disease Epidemiology Collaboration study eGFR ( CKD-EPI-Creat ) in 257 donors and the two newly developed equations using CysC with and without Creat , eGFR ( CKD-EPI-CysC ) and eGFR ( CKD-EPI-Creat + CysC ) , in 215 donors .


Mean mGFR was 71.811.8 mL/min/1 .73 m.


The eGFR ( MDRD ) exhibited least and only negative bias and the three other models were comparable in terms of bias .


The eGFR ( CKD-EPI-Creat + CysC ) equation was most precise ; r = 0.64 .


Both eGFR ( MDRD ) and eGFR ( CKD-EPI-Creat + CysC ) had high percentage ( 94.4 % and 92.6 % , respectively ) of estimates falling within 30 % of mGFR versus estimates by eGFR ( CKD-EPI-Creat ) and eGFR ( CKD-EPI-CysC ) equations ( 87.2 % and 85.1 % , respectively ) .


The eGFR ( MDRD ) was by far most accurate in identifying those with mGFR less than 60 mL/min/1 .73 m whereas the CKD-EPI models were extremely accurate in classifying those with mGFR greater than or equal to 60 mL/min/1 .73 m.


eGFR ( CKD-EPI-Creat + CysC ) equation provides comparable accuracy to the eGFR ( MDRD ) in overall estimation of mGFR , but with higher precision .


However , eGFR ( CKD-EPI-Creat + CysC ) clearly misses many of those with a post-donation GFR less than 60 mL/min/1 .73 m and therefore eGFR ( MDRD ) is preferable in detecting donors with GFR less than 60 mL/min/1 .73 m.


To compare the clinical efficacy of navigated pattern and conventional slit-lamp pattern panretinal photocoagulation ( PRP ) .


Randomized clinical trial .


Seventy-four eyes with proliferative diabetic retinopathy ( PDR ) in need of PRP were randomly assigned to 1 of 4 groups : PRP conventional pattern 30 ms , 100 ms , navigated pattern 30 ms , 100 ms pulse .


Navigated laser is a fundus camera-based photocoagulator with retinal eye tracking .


Outcome variables included stability of visual acuity , regression or development of neovascularization and need for retreatment sessions and surgical intervention , pain perception , and procedure time .


There was no change in visual acuity between pre - and post-treatment measurements among the study groups .


Short pulse groups in total required 22 procedures compared to 12 procedures in long pulse groups ( P < .05 ) .


A trend toward worse outcome using 30 ms pulse duration treatments is expressed by slightly increased relative risk of 1.3 compared to 100 ms groups .


Only 2 eyes required vitreoretinal surgery for nonclearing vitreous hemorrhage , 1 in each 30 ms group ; insignificantly different between study groups ( P = .98 ) .


The pain score was lower with navigated laser as compared to conventional laser in both 30 ms groups ( P = .1 ) and 100 ms groups , where it reached statistical significance ( P = .02 ) .


Pain experience was significant ( P < .001 ) between navigated 100 ms pattern and conventional single-spot 100 ms treatments .


This study demonstrates better clinical efficacy of 100 ms compared to 30 ms treatments using both conventional and navigated pattern lasers .


The ability to use long-pulse-duration navigated pattern treatments broadens therapeutic options for PRP in proliferative diabetic retinopathy .


The response of Crohn 's disease ( CD ) stricture to endoscopic therapy compared with non-CD stricture is unknown .


Our aim was to compare the short - and long-term outcomes of endoscopic management of those strictures .


All eligible patients with benign non-CD strictures who underwent the endoscopic balloon dilation between January 2002 and September 2013 were included .


Patients with CD strictures were randomly selected with a ratio ( CD versus non-CD strictures ) of 2:1 .


A total of 90 patients were included , including 30 ( 33.3 % ) with non-CD strictures and 60 ( 66.7 % ) with CD strictures .


Patients with CD strictures were younger than those with non-CD strictures at the time of disease diagnosis ( 25.8 11.1 versus 50.5 17.5 ; P < 0.001 ) and at the time of the first dilation ( 43.9 12.4 versus 55.8 13.9 ; P < 0.001 ) .


There were no significant differences in characteristics of strictures and their endoscopic treatments between the CD and non-CD groups , except for the percentage of patients who were ever treated with intralesional corticosteroid injection ( 25.0 % versus 6.7 % , P = 0.046 ) .


Patients in the 2 groups had similar technical success rates ( 94.0 % versus 93.9 % , P = 1.00 ) .


Few patients in CD stricture group required emergency room visits due to obstructive symptoms from recurrence of disease ( 1.7 % versus 16.7 % , P = 0.02 ) .


There were on procedure-related complications in either of the 2 groups .


The efficacy and safety of endoscopic balloon dilation in the treatment of CD and non-CD strictures seemed to be comparable .


We compared the effects of intravenous administration of 6 % hydroxyethyl starch ( maize-derived ) in 0.9 % saline ( Voluven ; Fresenius Kabi , Runcorn , United Kingdom ) and a `` balanced '' preparation of 6 % hydroxyethyl starch ( potato-derived ) [ Plasma Volume Redibag ( PVR ) ; Baxter Healthcare , Thetford , United Kingdom ] on renal blood flow velocity and renal cortical tissue perfusion in humans using magnetic resonance imaging .


Hyperchloremia resulting from 0.9 % saline infusion may adversely affect renal hemodynamics when compared with balanced crystalloids .


This phenomenon has not been studied with colloids .


Twelve healthy adult male subjects received 1-L intravenous infusions of Voluven or PVR over 30 minutes in a randomized , double-blind manner , with crossover studies 7 to 10 days later .


Magnetic resonance imaging proceeded for 60 minutes after commencement of infusion to measure renal artery blood flow velocity and renal cortical perfusion .


Blood was sampled , and weight was recorded at 0 , 30 , 60 , 120 , 180 , and 240 minutes .


Mean peak serum chloride concentrations were 108 and 106 mmol/L , respectively , after Voluven and PVR infusion ( P = 0.032 ) .


Changes in blood volume ( P = 0.867 ) , strong ion difference ( P = 0.219 ) , and mean renal artery flow velocity ( P = 0.319 ) were similar .


However , there was a significant increase in mean renal cortical tissue perfusion after PVR when compared with Voluven ( P = 0.033 ) .


There was no difference in urinary neutrophil gelatinase-associated liopcalin to creatinine ratios after the infusion ( P = 0.164 ) .


There was no difference in the blood volume-expanding properties of the 2 preparations of 6 % hydroxyethyl starch .


The balanced starch produced an increase in renal cortical tissue perfusion , a phenomenon not seen with starch in 0.9 % saline .


The specific attributes of inhaler devices can influence patient use , satisfaction and treatment compliance , and may ultimately impact on clinical outcomes in patients with chronic obstructive pulmonary disease ( COPD ) .


To assess patient preference , satisfaction and critical inhaler technique errors with Genuair ( a multidose inhaler ) and Breezhaler ( a single-dose inhaler ) after 2 weeks of daily use .


Patients with COPD and moderate to severe airflow obstruction were randomised in a cross-over , open-label , multicentre study to consecutive once-daily inhalations of placebo via Genuair and Breezhaler , in addition to current COPD medication .


The primary end point was the proportion of patients who preferred Genuair versus Breezhaler after 2 weeks ( Patient Satisfaction and Preference Questionnaire ) .


Other end points included overall satisfaction and correct use of the inhalers after 2 weeks , and willingness to continue with each device .


Of the 128 patients enrolled , 127 were included in the safety population ( male n = 91 ; mean age 67.6 years ) .


Of the 110 of the 123 patients in the intent-to-treat population who indicated an inhaler preference , statistically significantly more patients preferred Genuair than Breezhaler ( 72.7 vs. 27.3 % ; P < 0.001 ) .


Mean overall satisfaction scores were also greater for Genuair than for Breezhaler ( 5.9 vs. 5.3 , respectively ; P < 0.001 ) .


After 2 weeks , there was no statistically significant difference in the number of patients who made 1 critical inhaler technique error with Breezhaler than with Genuair ( 7.3 vs. 3.3 % , respectively ) .


Patient overall preference and satisfaction was significantly higher with Genuair compared with Breezhaler .


The proportion of patients making critical inhaler technique errors was low with Genuair and Breezhaler .


Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring ( ABPM ) to assess the efficacy of the procedure .


SYMPLICITY HTN-3 ( Renal Denervation in Patients With Uncontrolled Hypertension ) was a prospective , blinded , randomized , sham-controlled trial .


The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization .


Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control .


Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization .


The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure ( SBP ) .


Nondipper to dipper ( nighttime blood pressure [ BP ] 10 % to 20 % lower than daytime BP ) conversion was calculated at 6 months .


The 24-h ambulatory SBP changed-6 .8 15.1 mm Hg in the denervation group and-4 .8 17.3 mm Hg in the sham group : difference of-2 .0 mm Hg ( 95 % confidence interval [ CI ] : -5.0 to 1.1 ; p = 0.98 with a 2 mm Hg superiority margin ) .


The daytime ambulatory SBP change difference between groups was-1 .1 ( 95 % CI : -4.3 to 2.2 ; p = 0.52 ) .


The nocturnal ambulatory SBP change difference between groups was-3 .3 ( 95 CI : -6.7 to 0.1 ; p = 0.06 ) .


Thepercent of nondippers converted to dippers was 21.2 % in the denervation group and 15.0 % in the sham group ( 95 % CI : -3.8 % to 16.2 % ; p = 0.30 ) .


Change in 24-h heart rate was-1 .4 7.4 in the denervation group and-1 .3 7.3 in the sham group ; ( 95 % CI : -1.5 to 1.4 ; p = 0.94 ) .


This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP ineither the 24-h or day and night periods compared with sham ( Renal Denervation in Patients WithUncontrolled Hypertension [ SYMPLICITY HTN-3 ] ; NCT01418261 ) .


Chemotherapy-induced stomatitis is a major side effect of the treatment .


Numerous approaches are described in the literature for the prevention and treatment of this complication .


the aim was assess the effectiveness of Gelclair in patients undergoing hematopoietic stem-cell transplantation in terms of reducing the incidence of stomatitis , stomatitis-pain and the severity of stomatitis


Fifty-seven patients ( 28 control group and 29 experimental group ) used a mouthwash 3 times a day and were evaluated by means of a specially-tailored form containing the following assessment items : stomatitis evaluation scale ( WHO ) , VAS for pain and Likert-Scale for agreement .


61 % of patients presented with stomatitis .


No difference was observed between the two groups with regard to stomatitis grade throughout the observation period .


Painful symptoms were observed in 54 % subjects .


No differences were observed in terms of average pain perception before the use of mouthwashes throughout the period of observation p = 0.06 .


RESULTS showed a pain-relieving effect in the experimental group after using the mouthwash p = 0.04 .


Although Gelclair had no influence on the onset and severity of stomatitis in transplanted patients , a significant benefit was observed in terms of pain control .


Our study suggest the possibility to implementation the use of Gelclair in clinical practice .


However , further multicenter trials are needed to provide stronger evidence on the real usefulness of this product .


To compare laser in situ keratomileusis ( LASIK ) outcomes between 2 wavefront-guided excimer laser systems in the treatment of myopia .


University eye clinic , Palo Alto , California , USA .


Prospective comparative case series .


One eye of patients was treated with the Allegretto Wave Eye-Q system ( small-spot scanning laser ) and the fellow eye with the Visx Star Customvue S4 IR system ( variable-spot scanning laser ) .


Evaluations included measurement of uncorrected visual acuity , corrected visual acuity , and wavefront aberrometry .


One hundred eyes ( 50 patients ) were treated .


The mean preoperative spherical equivalent ( SE ) refraction was -3.89 diopters ( D ) 1.67 ( SD ) and -4.18 1.73 D in the small-spot scanning laser group and variable-spot scanning laser group , respectively .


There were no significant differences in preoperative higher-order aberrations ( HOAs ) between the groups .


Twelve months postoperatively , all eyes in the small-spot scanning laser group and 92 % in the variable-spot scanning laser group were within 0.50 D of the intended correction ( P = .04 ) .


At that time , the small-spot scanning laser group had significantly less spherical aberration ( 0.12 versus 0.15 ) ( P = .04 ) and significantly less mean total higher-order root mean square ( 0.33 m versus 0.40 m ) ( P = .01 ) .


Subjectively , patients reported that the clarity of night and day vision was significantly better in the eye treated with the small-spot scanning laser .


The predictability and self-reported clarity of vision of wavefront-guided LASIK were better with the small-spot scanning laser .


Eyes treated with the small-spot scanning laser had significantly fewer HOAs .


This paper details the research protocol for a study funded by the Australian Research Council .


An integrated approach towards helping young children respond to the significant pressures of ' 360 degree marketing ' on their food choices , levels of active play , and sustainability consciousness via the early childhood curriculum is lacking .


The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children 's knowledge about healthy eating , active play and the sustainability consequences of their toy food and toy selections .


This cluster-randomised trial will be conducted with 300 , 4 to 5 year-old children attending pre-school .


Early childhood educators will develop a curriculum intervention using a pedagogical communication strategy that integrates content knowledge about healthy eating , active play and sustainability consciousness and deliver this to their pre-school class .


Children will be interviewed about their knowledge of healthy eating , active play and the sustainability consequences of their food and toy selections .


Parents will complete an Eating and Physical Activity Questionnaire rating their children 's food preferences , digital media viewing and physical activity habits .


All measures will be administered at baseline , the end of the intervention and 6 months post intervention .


Informed consent will be obtained from all parents and the pre-school classes will be allocated randomly to the intervention or wait-list control group .


This study is the first to utilise an integrated pedagogical communication strategy developed specifically for early childhood educators focusing on children 's healthy eating , active play , and sustainability consciousness .


The significance of the early childhood period , for young children 's learning about healthy eating , active play and sustainability , is now unquestioned .


The specific teaching and learning practices used by early childhood educators , as part of the intervention program , will incorporate a sociocultural perspective on learning ; this perspective emphasises building on the play interests of children , that are experienced within the family and home context , as a basis for curriculum provision .


Australian New Zealand Clinical Trials Registry ACTRN12614000363684 : Date registered : 07/04/2014 .


Routine symptom and health-related quality of life ( HRQOL ) assessments can engage patients , give provider feedback , and improve doctor/patient communication .


We compared the impact of a technology-assisted symptom monitoring system versus usual care on HRQOL and doctor/patient communication in early-stage prostate cancer ( PCa ) survivors .


Men ( N = 94 ) were on average 62-years old , mostly African American ( AA ; 61.7 % ) , and 10-19 months post-treatment .


They were randomized to symptom monitoring plus feedback ( SM + F ; n = 49 ) or usual care ( UC ; n = 45 ) .


SM+F participants completed a 12-item telephoneassisted monitoring intervention .


All participants completed a baseline and 2 follow-up interviews .


Among the SM+F participants , perceptions of the monitoring system were positive : 97.1 % endorsed it as easy/very easy to use and 85 % felt all patients could benefit from it .


At baseline , men reported favorable general and cancer-specific HRQOL and doctor/patient communication , but poorer urinary and sexual function .


Although there was no overall impact of the intervention , post hoc exploratory analyses indicated that among AA men , those who received SM+F improved relative to UC on doctor/patient communication ( P < .05 ) , general HRQOL ( P < .06 ) , and sexual function ( P < .05 ) .


Variability in survivor follow-up care , limited access to eligible participants , and minimal physician training in the use of reports likely decreased physician investment .


Overall , PCa survivors were receptive to this monitoring system .


Exploratory analyses suggest that this technology-assisted monitoring system may be of particular benefit to African American men .


Additional studies with larger samples , more intervention time-points , and increased physician training are needed to strengthen the intervention 's impact .


Recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) applied on an absorbable collagen sponge improves open tibial fracture-healing as an adjunct to unreamed intramedullary nail fixation .


We evaluated rhBMP-2 and a new , injectable calcium phosphate matrix ( CPM ) formulation in acute closed tibial diaphyseal fractures treated with reamed intramedullary nail fixation .


Patients were randomized ( 1:2:2:1 ) to receive standard of care , which consisted of definitive fracture fixation within seventy-two hours of injury with a locked intramedullary nail after reaming ; standard of care and injection with 1.0 mg/mL of rhBMP-2 / CPM ; standard of care and injection with 2.0 mg/mL of rhBMP-2 / CPM ; or standard of care and injection with buffer/CPM , to evaluate the activity of the CPM delivery matrix and provide for sponsor and investigator blinding .


The co-primary end points of the study were the effects of rhBMP-2 / CPM on the time to fracture union ( based on blinded assessment of radiographs ) and the time to return to normal function ( based on blinded assessment of the time to full weight-bearing without pain at the fracture site ) compared with standard of care alone .


Three hundred and sixty-nine patients were randomized and included in the intent-to-treat population .


This study was terminated after an interim analysis ( 180 patients with six months of follow-up ) revealed no shortening in the time to fracture union in the active treatment arms compared with the standard of care control ( the SOC group ) .


In the final primary analysis , the median time to radiographic fracture union was not significantly different for the SOC ( 13.1 weeks ) , 1.0-mg / mL rhBMP-2 / CPM ( 13.0 weeks ) , 2.0-mg / mL rhBMP-2 / CPM ( 15.9 weeks ) , or buffer/CPM ( 15.4 weeks ) treatment groups .


The median time to pain-free full weight-bearing was also not significantly different among the SOC ( 13.4 weeks ) , 1.0-mg / mL rhBMP-2 / CPM ( 13.4 weeks ) , 2.0-mg / mL rhBMP-2 / CPM ( 14.3 weeks ) , and buffer/CPM ( 16.4 weeks ) treatment groups .


In patients with closed tibial fractures treated with reamed intramedullary nailing , the time to fracture union and pain-free full weight-bearing were not significantly reduced by rhBMP-2 / CPM compared with standard of care alone .


African health services have shortages of clinical staff .


We showed previously , in a cluster-randomized trial , that a home-based strategy using trained lay-workers is as effective as a clinic-based strategy .


It is not known whether home-based care is suitable for patients with advanced HIV disease .


The trial was conducted in Jinja , Uganda .


One thousand , four hundred and fifty-three adults initiating ART between February 2005 and January 2009 were randomized to receive either home-based care or routine clinic-based care , and followed up for about 3 years .


Trained lay workers , supervised by clinical staff based in a clinic , delivered the home-based care .


In this sub-analysis , we compared survival between the two strategies for those who presented with CD4 cell count less than 50 cells/l and those who presented with higher CD4 cell counts .


We used Kaplan-Meier methods and Poisson regression .


Four hundred and forty four of 1453 ( 31 % ) participants had baseline CD4 cell count less than 50cells/l .


Overall , 110 ( 25 % ) deaths occurred among participants with baseline CD4 cell count less than 50 cells/l and 87 ( 9 % ) in those with higher CD4 cell count .


Among participants with CD4 cell count less than 50 cells/l , mortality rates were similar for the home and facility-based arms ; adjusted mortality rate ratio 0.80 [ 95 % confidence interval ( CI ) 0.53-1 .18 ] compared with 1.22 ( 95 % CI 0.78-1 .89 ) for those who presented with higher CD4 cell count .


HIV home-based care , with lay workers playing a major role in the delivery of care including providing monthly adherence support , leads to similar survival rates as clinic-based care even among patients who present with very low CD4 cell count .


This emphasises the critical role of adherence to antiretroviral therapy .


Approximately 5.6 million South Africans are living with human immunodeficiency virus ( HIV ; UNAIDS , 2010 ) .


Prevalence among Black adolescents and young adults is particularly alarming .


This pilot study of an HIV preventive intervention targeting South African youth contributes to the growing body of research on culturally competent family-based interventions .


A total of 99 parent-child dyads were enrolled in an experimental repeated measures study , using a wait-list control group .


Our 6-session intervention targeted general parenting ( relationship quality , parental monitoring , and involvement ) , gender roles , and parent-youth communication about sex ( content and quality ) .


Parents and youth were assessed at baseline , postintervention , and 6-month follow-up .


Eligibility included being the primary female caregiver of a 10 - to 14-year-old child with whom they spent at least 4 nights a week and being able to participate in English or Xhosa .


Effect sizes with this small sample met or exceeded those of other family-based HIV interventions for youth in the United States and South Africa ( e.g. , Bell et al. , 2008 ; Forehand et al. , 2007 ) .


Parents ' reports at postintervention indicated larger effect sizes for general parenting than youths ' reports indicated .


Parents ' reports showed medium to large effects for all sex communication outcomes at postintervention and the 6-month follow-up .


Youth reports demonstrated small to medium effects for most communication variables and these effects lasted through the 6-month follow-up period .


Intergenerational social networks ( e.g. , families ) hold promise for HIV prevention among South African youth .


A full efficacy trial with longer-term follow-up and attention to maintenance of effects is warranted .


2-Ethyl-3-methylbutyl-carbamate ( EMC ) and 2-isopropylpentyl-carbamate ( IPC ) are among the most potent anticonvulsant carbamate derivatives of valproic acid .


EMC and IPC are chiral compounds .


Consequently , the aim of the current study was to comparatively evaluate the pharmacokinetic ( PK ) and pharmacodynamic ( PD anticonvulsant activity ) profile of EMC and IPC individual enantiomers .


The anticonvulsant activity of EMC and IPC individual enantiomers was evaluated in several anticonvulsant rodent models including maximal electroshock ( MES ) , 6 Hz psychomotor , subcutaneous ( pentylenetetrazole ) ( scMet ) , and the pilocarpine-induced and soman-induced status epilepticus ( SE ) .


The PK-PD relationship of EMC and IPC individual enantiomers was evaluated following intraperitoneal administration ( 50 mg/kg ) to rats .


Induction of neural tube defects ( NTDs ) was evaluated in a mouse strain that was highly susceptible to teratogen-induced NTDs .


In mice and rats , ( 2S ) - EMC exhibited anticonvulsant activity similar to that of racemic EMC in the MES and scMet tests , whereas in the 6 Hz test , racemic EMC was more potent than its two individual enantiomers .


Racemic EMC exhibited a potent activity in the soman-induced SE model when administered 5 and 20 min after seizure onset with median effective dose ( ED50 ) values of 33 and 48 mg/kg , respectively .


( 2R ) - IPC and ( 2S ) - IPC exhibited ED50 values similar to those of racemic IPC in the mouse and rat MES and scMet models .


( 2R ) - IPC had similar ED50 values on the 6 Hz tests .


Racemic IPC had an ED50 value of 107 mg/kg in the pilocarpine-induced SE model when given 30 min after seizure onset .


Racemic EMC and IPC and their enantiomers had similar clearance ( 3.8-5 .5 L/h/kg ) and short half-life ( < 1 h ) .


EMC and its enantiomers did not cause NTDs at doses 3-10 times higher than their anticonvulsant ED50 values .


EMC and IPC did not exhibit enantioselective PK , a fact that may contribute to their nonenantioselective activity in any of the anticonvulsant models .


The nonsignificant difference between racemic EMC and racemic IPC and their enantiomers , suggests that their wide spectrum of anticonvulsant activity is likely to be caused by multiple mechanisms of action .


Staged clinical treatment of pediatric obesity is recommended , but untested .


Understanding the lowest intensity stage 's effectiveness is necessary for future research .


This was a randomized controlled trial of children ages 4 to < 9 years .


Participants were recruited after routine evaluations at a primary care pediatric clinic revealed a BMI 85th percentile .


The intervention was patterned after the `` Prevention plus , Stage 1 '' treatment recommended by an expert committee .


Groups were compared for changes , over a 3-month time period , in BMI z-score and parental reports of behavioral issues related to childhood obesity using intent-to-treat ( ITT ) analysis .


Seventy-two ( 30 % of eligible ) children were enrolled and 64 were remeasured at 3-month follow-up .


ITT analysis revealed that both groups improved mean BMI z-score [ adjusted change -0.07 , control , and -0.04 , intervention ; 95 % confidence interval ( CI ) of difference = -0.14 -0.20 ] .


Over half of the children in each group improved their BMI z-score ( adjusted proportion decreasing = 55 % in control vs. 72 % in intervention ; 95 % CI of difference = -0.07 -0.42 ) .


The intervention group improved comparatively to the control group on numerous behavioral indicators .


Implementation of the lowest intensity stage of current recommendations is feasible and possibly of benefit toward lifestyle changes .


Results of this study can be used by future clinical researchers designing protocols to test the full multi-staged approach for the treatment of pediatric overweight and obesity in primary care clinical settings .


Tenofovir disoproxil fumarate can cause renal and bone toxic effects related to high plasma tenofovir concentrations .


Tenofovir alafenamide is a novel tenofovir prodrug with a 90 % reduction in plasma tenofovir concentrations .


Tenofovir alafenamide-containing regimens can have improved renal and bone safety compared with tenofovir disoproxil fumarate-containing regimens .


In these two controlled , double-blind phase 3 studies , we recruited treatment-naive HIV-infected patients with an estimated creatinine clearance of 50 mL per min or higher from 178 outpatient centres in 16 countries .


Patients were randomly assigned ( 1:1 ) to receive once-daily oral tablets containing 150 mg elvitegravir , 150 mg cobicistat , 200 mg emtricitabine , and 10 mg tenofovir alafenamide ( E/C/F / tenofovir alafenamide ) or 300 mg tenofovir disoproxil fumarate ( E/C/F / tenofovir disoproxil fumarate ) with matching placebo .


Randomisation was done by a computer-generated allocation sequence ( block size 4 ) and was stratified by HIV-1 RNA , CD4 count , and region ( USA or ex-USA ) .


Investigators , patients , study staff , and those assessing outcomes were masked to treatment group .


All participants who received one dose of study drug were included in the primary intention-to-treat efficacy and safety analyses .


The main outcomes were the proportion of patients with plasma HIV-1 RNA less than 50 copies per mL at week 48 as defined by the the US Food and Drug Adminstration ( FDA ) snapshot algorithm ( pre-specified non-inferiority margin of 12 % ) and pre-specified renal and bone endpoints at 48 weeks .


These studies are registered with ClinicalTrials.gov , numbers NCT01780506 and NCT01797445 .


We recruited patients from Jan 22 , 2013 , to Nov 4 , 2013 ( 2175 screened and 1744 randomly assigned ) , and gave treatment to 1733 patients ( 866 given E/C/F / tenofovir alafenamide and 867 given E/C/F / tenofovir disoproxil fumarate ) .


E/C/F / tenofovir alafenamide was non-inferior to E/C/F / tenofovir disoproxil fumarate , with 800 ( 92 % ) of 866 patients in the tenofovir alafenamide group and 784 ( 90 % ) of 867 patients in the tenofovir disoproxil fumarate group having plasma HIV-1 RNA less than 50 copies per mL ( adjusted difference 20 % , 95 % CI -07 to 47 ) .


Patients given E/C/F / tenofovir alafenamide had significantly smaller mean serum creatinine increases than those given E/C/F / tenofovir disoproxil fumarate ( 008 vs 012 mg/dL ; p < 00001 ) , significantly less proteinuria ( median % change -3 vs 20 ; p < 00001 ) , and a significantly smaller decrease in bone mineral density at spine ( mean % change -130 vs -286 ; p < 00001 ) and hip ( -066 vs -295 ; p < 00001 ) at 48 weeks .


Through 48 weeks , more than 90 % of patients given E/C/F / tenofovir alafenamide or E/C/F / tenofovir disoproxil fumarate had virological success .


Renal and bone effects were significantly reduced in patients given E/C/F / tenofovir alafenamide .


Although these studies do not have the power to assess clinical safety events such as renal failure and fractures , our data suggest that E/C/F / tenofovir alafenamide will have a favourable long-term renal and bone safety profile .


Gilead Sciences .


Family functioning impairment is widely reported in the eating disorders literature , yet few studies have examined the role of family functioning in treatment for adolescent anorexia nervosa ( AN ) .


This study examined family functioning in two treatments for adolescent AN from multiple family members ' perspectives .


Participants were 121 adolescents with AN ages 12-18 from a randomized-controlled trial comparing family-based treatment ( FBT ) to individual adolescent-focused therapy ( AFT ) .


Multiple clinical characteristics were assessed at baseline .


Family functioning from the perspective of the adolescent and both parents was assessed at baseline and after 1 year of treatment .


Full remission from AN was defined as achieving both weight restoration and normalized eating disorder psychopathology .


In general , families dealing with AN reported some baseline impairment in family functioning , but average ratings were only slightly elevated compared to published impaired functioning cutoffs .


Adolescents ' perspectives on family functioning were the most impaired and were generally associated with poorer psychosocial functioning and greater clinical severity .


Regardless of initial level of family functioning , improvements in several family functioning domains were uniquely related to full remission at the end of treatment in both FBT and AFT .


However , FBT had a more positive impact on several specific aspects of family functioning compared to AFT .


Families seeking treatment for adolescent AN report some difficulties in family functioning , with adolescents reporting the greatest impairment .


Although FBT may be effective in improving some specific aspects of family dynamics , remission from AN was associated with improved family dynamics , regardless of treatment type .


To evaluate the effects of subarachnoid propofol administration ( SPA ) on analgesia , sedation , ataxia , cardiopulmonary , blood gas variables , and its application in ovariectomy in Jennies .


Prospective , randomized , clinical trial .


Adult Jennies ( n = 20 ; 100-120kg ; 5-7 years old ) .


In study 1 , 5 Jennies had SPA ( n = 5 ; group 1 ) through Tuohy catheter , and another 5 control Jennies had normal saline subarachnoid administration ( n = 5 ; group 2 ) .


In study 2 , 10 Jennies had SPA and ovariectomy ( n = 10 ; group 3 ) .


In groups 1 and 3 analgesia , sedation and ataxia scores , cardiopulmonary and blood gas variables were recorded at different intervals before and after PSA .


In group 2 , only cardiopulmonary and blood gas variables were recorded .


SPA produced pronounced analgesia , mild sedation and minimal ataxia .


Heart rate ( HR ) , respiratory rate ( RR ) , pulse rate ( PR ) , rectal temperature ( RT ) , arterial blood pH , PaO2 , and PaCO2 were not significantly different from base line values after subarachnoid administration of either propofol or normal saline .


SPA was found to be useful , efficient and feasible procedure for ovariectomy through standing flank laparotomy in Jennies .


The aim of this study was to determine the minimum effective volume ( MEV ) of combined lidocaine 1.0 % - bupivacaine 0.25 % with epinephrine 5 g/mL in 90 % of patients ( MEV90 ) for ultrasound-guided subparaneural popliteal sciatic nerve block .


All subjects received an ultrasound-guided subparaneural popliteal sciatic nerve block ( at the neural bifurcation ) with combined lidocaine 1.0 % - bupivacaine 0.25 % and epinephrine 5 g/mL .


Using an out-of-plane technique , a 17-gauge , 8-cm Tuohy needle was advanced until its tip was positioned between the tibial and peroneal nerves inside the paraneural sheath .


Volume assignment was carried out using a biased coin design , up-and-down sequential method , where the volume of local anesthetic administered to each patient depended on the response of the previous one .


In case of failure , the next subject received a higher volume ( defined as the previous volume with an increment of 3.0 mL ) .


If the previous patient had a successful block , the next subject was randomized to a lower volume ( defined as the previous volume with a decrement of 3.0 mL ) , with a probability of b = 0.11 , or the same volume , with a probability of 1 - b = 0.89 .


Using a composite scale encompassing sensory and motor block , success was defined , at 30 minutes , as a minimal score of 6 points ( out of 8 points ) .


The 6-point score was intended to mirror successful postoperative analgesia .


Patients undergoing surgery of the leg , ankle , or foot were prospectively enrolled until 45 successful blocks were obtained .


Fifty-two patients were recruited for this study .


Using isotonic regression and bootstrap confidence interval , the MEV90 of combined lidocaine 1.0 % - bupivacaine 0.25 % with epinephrine 5 g/mL was estimated to be 13.3 mL ( 95 % confidence interval , 10.2-16 .4 mL ) .


For ultrasound-guided subparaneural ( analgesic ) popliteal sciatic nerve block , the MEV90 of combined lidocaine 1.0 % - bupivacaine 0.25 % with epinephrine 5 g/mL is 13.3 mL ( 95 % confidence interval , 10.2-16 .4 mL ) .


Thrombotic microangiopathy ( TMA ) is a complication that developed in some patients receiving 12 Gy total body irradiation ( TBI ) in addition to lymphodepleting preparative chemotherapy prior to infusion of autologous tumor-infiltrating lymphocytes ( TIL ) with high-dose aldesleukin ( IL-2 ) .


This article describes the incidence , presentation , and course of radiation-associated TMA .


The data for patients with metastatic melanoma who received ACT with TIL plus aldesleukin following myeloablative chemotherapy and 12-Gy TBI was examined , in order to look at patient characteristics and the natural history of TMA .


The median time to presentation was approximately 8 months after completing TBI .


The estimated cumulative incidence of TMA was 31.2 % ( median follow-up of 24 months ) .


Noninvasive criteria for diagnosis included newly elevated creatinine levels , new-onset hypertension , new-onset anemia , microscopic hematuria , thrombocytopenia , low haptoglobin , and elevated lactate dehydrogenase values .


Once diagnosed , patients were managed with control of their hypertension with multiple agents and supportive red blood cell transfusions .


TMA typically stabilized or improved and no patient progressed to dialysis .


TMA was associated with a higher probability of an antitumor response .


TMA occurs in approximately a third of patients treated with a lymphodepleting preparative chemotherapy regimen with TBI prior to autologous T cell therapy .


The disease has a variable natural history , however , no patient developed end-stage renal failure .


Successful management with supportive care and aggressive hypertension control is vital to the safe application of a systemic therapy that has shown curative potential for patients with disseminated melanoma .


The present study compared the effect of bupivacaine and bupivacaine + sufentanil on hemodynamic parameters and characteristics of spinal anesthesia in elderly patients undergoing transurethral resection of the prostate ( TURP ) under spinal anesthesia .


The study included 40 American Society of Anesthesiologists ( ASA ) I-III patients scheduled to undergo TURP .


Patients were blindly and randomly divided into two groups .


Group B ( n = 20 ) received 10 mg of intrathecal bupivacaine and group BS ( n = 20 ) received 7.5 mg of bupivacaine + 5 g of sufentanil .


Sensory and motor block characteristics , hemodynamic changes , side effects , and time to first analgesic requirement were recorded .


No differences in mean arterial pressure or heart rate , time for sensory blockade to reach the T10 level , and maximum sensory level were observed between the two groups .


The time to first analgesic request was longer in group BS ( P < 0.05 ) .


Motor block was significantly higher in group B ( P < 0.05 ) .


In terms of side effects , no statistically significant differences occurred between the groups .


Similar hemodynamic stability and sufficient level of sensory blockade were provided by bupivacaine and bupivacaine + sufentanil used for spinal anesthesia in patients undergoing TUR .


Due to the fact that less motor block was observed and the time to first analgesic request was longer , the combination of bupivacaine + sufentanil might be appropriate for patients undergoing TUR .


This study aimed to assess acute and chronic effects of right ventricular mid-septum ( RVS ) versus right ventricular apex ( RVA ) pacing on left ventricular ( LV ) mechanical dyssynchrony using phase analysis of gated single photon emission computed tomography myocardial perfusion imaging ( MPI ) .


Thirty-nine patients with complete atrioventricular ( AV ) block , who were indicated for permanent pacing , were recruited and randomized to receive RVA ( n = 20 ) or RVS ( n = 19 ) pacing .


All patients underwent MPI at 1 week and 6 months after pacemaker implantation .


LV dyssynchrony and cardiac function were assessed by MPI and compared between the two groups .


There were no significant differences in baseline characteristics between the RVS and RVA groups .


The paced QRS duration was significantly longer in the RVA group than in the RVS group .


LV dyssynchrony parameters were not significantly different between the groups at the 1-week follow-up , but they were significantly smaller in the RVS group than in the RVA group at the 6-month follow-up .


LV dyssynchrony parameters significantly decreased in the RVS group from the 1-week follow-up to the 6-month follow-up , but were unchanged in the RVA group .


No differences in LV function parameters were observed between the groups at the 1-week and 6-month follow-ups .


RVS pacing produces better electrical and mechanical synchrony than RVA pacing for patients with complete AV block .


Polyneuropathy , organomegaly , endocrinopathy , M-protein and skin changes ( POEMS ) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor ( VEGF ) .


Recently , the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma .


However , no randomised clinical trial has been performed because of the rarity and severity of the disease .


The Japanese POEMS syndrome with Thalidomide ( J-POST ) Trial is a phase II/III multicentre , double-blinded , randomised , controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome , with an additional 48-week open-label safety study .


Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at 12 tertiary neurology centres in Japan .


Patients who satisfy the eligibility criteria are randomised ( 1:1 ) to receive thalidomide ( 100-300mg daily ) plus dexamethasone ( 12mg/m ( 2 ) on days 1-4 of a 28-day cycle ) or placebo plus dexamethasone .


Both treatments were administered for 24weeks ( six cycles ; randomised comparative study period ) .


Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study ( long-term safety period ) .


The primary end point of the study is the reduction rate of serum VEGF levels at 24weeks .


The protocol was approved by the Institutional Review Board of each hospital .


The trial was notified and registered at the Pharmaceutical and Medical Devices Agency , Japan ( No. 22-1716 ) .


The J-POST Trial is currently ongoing and is due to finish in August 2015 .


The findings of this trial will be disseminated through peer-reviewed publications and conference presentations and will also be disseminated to participants .


UMIN000004179 and JMA-IIA00046 .


Remote ischemic preconditioning ( RIPC ) may confer the protection in critical organs .


The authors hypothesized that limb RIPC would reduce lung injury in patients undergoing pulmonary resection .


In a randomized , prospective , parallel , controlled trial , 216 patients undergoing elective thoracic pulmonary resection under one-lung ventilation with propofol-remifentanil anesthesia were randomized 1:1 to receive either limb RIPC or conventional lung resection ( control ) .


Three cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff served as RIPC stimulus .


The primary outcome was PaO2/FIO2 .


Secondary outcomes included other pulmonary variables , the incidence of in-hospital complications , markers of oxidative stress , and inflammatory response .


Limb RIPC significantly increased PaO2/FIO2 compared with control at 30 and 60 min after one-lung ventilation , 30 min after re-expansion , and 6 h after operation ( 238 52 vs. 192 67 , P = 0.03 ; 223 66 vs. 184 64 , P = 0.01 ; 385 61 vs. 320 79 , P = 0.003 ; 388 52 vs. 317 46 , P = 0.001 , respectively ) .


In comparison with control , it also significantly reduced serum levels of interleukin-6 and tumor necrosis factor - at 6 , 12 , 24 , and 48 h after operation and malondialdehyde levels at 60 min after one-lung ventilation and 30 min after re-expansion ( all P < 0.01 ) .


The incidence of acute lung injury and the length of postoperative hospital stay were markedly reduced by limb RIPC compared with control ( all P < 0.05 ) .


Limb RIPC attenuates acute lung injury via improving intraoperative pulmonary oxygenation in patients without severe pulmonary disease after lung resection under propofol-remifentanil anesthesia .


To test our hypothesis that initiating therapy with a combination of agents known to improve insulin secretion and insulin sensitivity in subjects with new-onset diabetes would produce greater , more durable reduction in glycated haemoglobin ( HbA1c ) levels , while avoiding hypoglycaemia and weight gain , compared with sequential addition of agents that lower plasma glucose but do not correct established pathophysiological abnormalities .


Drug-nave , recently diagnosed subjects with type 2 diabetes mellitus ( T2DM ) were randomized in an open-fashion design in a single-centre study to metformin/pioglitazone/exenatide ( triple therapy ; n = 106 ) or an escalating dose of metformin followed by sequential addition of sulfonylurea and glargine insulin ( conventional therapy ; n = 115 ) to maintain HbA1c levels at < 6.5 % for 2years .


Participants receiving triple therapy experienced a significantly greater reduction in HbA1c level than those receiving conventional therapy ( 5.95 vs. 6.50 % ; p < 0.001 ) .


Despite lower HbA1c values , participants receiving triple therapy experienced a 7.5-fold lower rate of hypoglycaemia compared with participants receiving conventional therapy .


Participants receiving triple therapy experienced a mean weight loss of 1.2 kg versus a mean weight gain of 4.1 kg ( p < 0.01 ) in those receiving conventional therapy .


The results of this exploratory study show that combination therapy with metformin/pioglitazone/exenatide in patients with newly diagnosed T2DM is more effective and results in fewer hypoglycaemic events than sequential add-on therapy with metformin , sulfonylurea and then basal insulin .


A surgical glove will protect surgeons and patients only if the glove 's integrity remains intact .


However , several studies have demonstrated that undetected micro-perforations of surgical gloves are common .


Because of the possibility of surgical glove puncture , an antimicrobial surgical glove was developed .


The aim of this laboratory based experimental study was to assess the antibacterial efficacy of the interior chlorhexidine-gluconate ( CHG ) - coat of an antimicrobial synthetic polyisoprene surgical glove by using a standardized microbiological challenge .


Sixteen healthy adult participants donned one antimicrobial surgical glove and one non-antimicrobial surgical glove randomly allocated to their dominant and non-dominant hand following a crossover design .


During a 2-h wear time , participants performed standardized finger and hand movements .


Thereafter , the interior surface of excised fingers of the removed gloves was challenged with 8.00 log10 cfu/mLS .


aureus ( ATCC 6538 ) or K. pneumoniae ( ATCC 4352 ) , respectively .


The main outcome measure was the viable mean log10 cfu counts of the two glove groups after 5min contact with the interior glove 's surface .


When comparing an antimicrobial glove against an untreated reference glove after 2-h simulated use wear-time , a mean reduction factor of 6.24 log10 ( S. aureus ) and 6.22 log10 ( K. pneumoniae ) was achieved after 5min contact .


These results demonstrate that wearing antibacterial gloves on hands does not negatively impact their antibacterial activity after 2-h of wear .


This may have a potential benefit for patient safety in case of glove puncture during surgical procedures .


To explore the influence of rosa roxburghii tratt preparation on immune function of arseniasis patients caused by burning coal .


According to the diagnosis standard for endemic arseniasis ( WS/T 211-2001 ) , 62 cases of arseniasis patients who resided in endemic arseniasis area in Guizhou province were selected and divided stratified randomly into two groups : rosa roxburghii tratt juice treatment group and superoxide dismutase ( SOD ) - enriched rosa roxburghii tratt juice treatment group , with 31 patients in each group.Each patient took 120 ml/d rosa roxburghii tratt preparation or SOD-enriched rosa roxburghii tratt orally for one month .


Another 30 healthy residents from a neighbour township 12 km away where arsenic was not prevalent were selected as controls .


A 2 ml blood and 50 ml urine samples were collected from individuals and the urine arsenic contents , peripheral blood T-lymphocyte subsets ( CD3 ( + ) , CD4 ( + ) , CD8 ( + ) T cell ) , serum immunoglobulin ( IgG , IgM , IgA ) and complement ( C3 , C4 ) were detected .


The differences between more than two groups on above indicators were compared .


The correlations between urinary arsenic and immune parameters were analyzed .


Among the rosa roxburghii tratt juice group , SOD-enriched rosa roxburghii tratt juice before intervention group and the control group , the levels of urine arsenic were ( 76.55 23.02 ) , ( 72.60 25.91 ) and ( 26.33 11.30 ) g/g Cr respectively and IgG were ( 11.31 1.68 ) , ( 11.35 1.94 ) and ( 9.23 1.75 ) g/L respectively .


The differences were statistically significant ( F values were 82.01 , 13.82 , both P values < 0.05 ) .


After intervention with rosa roxburghii tratt preparation , the levels of urine arsenic were ( 53.21 16.51 ) and ( 51.72 17.70 ) g/g Cr , both decreased than before intervention ( t values were 5.80 and 3.78 , both P values < 0.05 ) .


The levels of CD3 ( + ) were ( 44.47 7.14 ) % , ( 43.44 6.61 ) % and ( 70.78 5.26 ) % , CD4 ( + ) were ( 29.87 5.67 ) % , ( 29.42 5.87 ) % and ( 46.08 5.87 ) % , CD4 ( + ) / CD8 ( + ) were ( 1.25 0.42 ) , ( 1.22 0.39 ) and ( 1.79 0.26 ) and C4 were ( 0.13 0.08 ) , ( 0.13 0.09 ) and ( 0.20 0.11 ) g/L respectively among the two treatment group before intervention and the control group .


The differences were significant ( F values were 178.04 , 76.71 , 23.13 and 5.26 , all P values < 0.05 ) .


After intervention , the levels of CD3 ( + ) were ( 59.73 7.38 ) % and ( 66.31 7.57 ) % , CD4 ( + ) were ( 34.00 7.97 ) % and ( 39.11 5.81 ) % , CD4 ( + ) / CD8 ( + ) were ( 1.41 0.37 ) and ( 1.58 0.26 ) , all increased than before intervention ( t values were 12.47 , 25.18 , 5.41 , 10.47 , 3.22 and 5.05 , all P values < 0.05 ) .


The levels of urine arsenic and CD3 ( + ) , CD4 ( + ) , CD4 ( + ) / CD8 ( + ) , C4 were inversely correlated correlation , while positive correlation existed between the level of urine arsenic and IgG ( r values were -0.68 , -0.56 , -0.51 , -0.43 and 0.36 , all P values < 0.01 ) .


The level of urinary arsenic level is closely related to immune function suppression in arseniasis patients caused by burning coal , rosa roxburghii tratt preparation can effectively improve immune function of arseniasis patients .


Oral mucositis is one of the common complications of cancer chemotherapy and about 40 % of the patients who take chemotherapy protocols , experience this irritating problem .


The purpose of this study was to draw comparison between the therapeutic effects of our treatment modalities ( topical steroid , honey , honey plus coffee ) in patients suffering from oral mucositis .


This was a double blinded randomised clinical trial of a total of 75 eligible adult participants which they randomly fell into three treatment groups .


For all the participants a syrup-like solution was prepared .


Each 600 grams of the product consisted of `` 20 eight-mg Betamethasone solution ampoules '' in the Steroid ( S ) group , `` 300 grams of honey plus 20 grams of instant coffee '' in the Honey plus Coffee ( HC ) group , and `` 300 grams of honey '' for the Honey ( H ) group .


The participants were told to sip 10 ml of the prescribed product , and then swallow it every three hours for one week .


Severity of lesions was clinically evaluated before the treatment and also one week after the initiation of the intervention .


This study adhered to the principles of the Declaration of Helsinki and guidelines of Good Clinical Practice .


This study showed that all three treatment regimens reduce the severity of lesions .


The best reduction in severity was achieved in HC group .


H group and S group took the second and third places .


In other words , honey plus coffee regimen was the most effective modality for the treatment of oral mucositis .


Oral mucositis can be successfully treated by a combination of honey and coffee as an alternative medicine in a short time .


Further investigations are warranted in this field .


Iranian Registry of Clinical Trials IRCT : 201104074737N3 , ( 9 May 2011 ) .


The purpose of this study was to investigate if the levonorgestrel-impregnated intrauterine device ( LNG-IUS , Mirena ( ) ) is safe and effective as therapy for low-risk and medium-risk endometrial hyperplasia compared with oral medroxyprogesterone ( MPA ) .


A multicentre randomised trial .


Norway .


In all , 170 women aged 30-70years with low - or medium-risk endometrial hyperplasia who met inclusion criteria .


Patients were randomly assigned to one of three treatment arms : LNG-IUS ; oral MPA 10mg administered for 10days per cycle , or continuous oral MPA 10mg daily , for 6months .


The primary outcome measure was normalisation or persisting hyperplasia .


After 6months all three treatment regimens showed significant effect when the outcome was evaluated as therapy response or not ( P < 0.001 ) .


Responses were obtained for all the women in the LNG-IUS group ( 53/53 , 95 % CI 0.93-1 .0 ) and for 96 % of the women in the continuous oral group ( 46/48 , 95 % CI 0.86-0 .99 ) .


Only 69 % of the women in the cyclic oral group were responders ( 36/52 , 95 % CI 0.55-0 .81 ) .


Adverse effects were relatively common with minimal differences between therapy groups .


In the first trial of its kind , women treated with the LNG-IUS showed histologically normal endometrium after 6months of therapy for endometrial hyperplasia .


Cyclical progestogens are found to be less effective compared with continuous oral therapy and LNG-IUS and should not be used for this purpose .


n-3 polyunsaturated fatty acids reduce insulin resistance , lipogenesis , and inflammation , which are features of nonalcoholic steatohepatitis ( NASH ) .


Ethyl-eicosapentanoic acid ( EPA-E ) is a synthetic polyunsaturated fatty acid that reduces hypertriglyceridemia .


We report the final results of a phase 2b multicenter , prospective , double-blind , randomized , placebo-controlled trial of EPA-E for NASH .


Our study , performed at 37 sites in North America , included subjects with NASH and nonalcoholic fatty liver disease ( NAFLD ) activity scores 4 , with minimum scores of 1 for steatosis and inflammation , along with either ballooning or at least stage 1a fibrosis .


A total of 243 subjects were randomly assigned to groups given placebo ( n = 75 ) , low-dosage EPA-E ( 1800 mg/d ; n = 82 ) , or high-dosage EPA-E ( 2700 mg/d ; n = 86 ) for 12 months .


Subjects were examined at 4-week intervals for 3 months , 6-week intervals for the next 3 months , and every 3 months thereafter , until 1 month after the last dose was taken .


Liver biopsies were collected 2 weeks after the last dose of EPA-E or placebo .


The primary efficacy end point was NAFLD activity score 3 , without worsening of fibrosis ; or a decrease in NAFLD activity score by 2 with contribution from > 1 parameter , without worsening of fibrosis , 1 year after the last dose of EPA-E or placebo was given .


Similar proportions of subjects in each group met the primary end point ( 40 % , 37 % , and 35.9 % for placebo , low-dosage , and high-dosage EPA-E , respectively ) .


EPA-E had no significant effects on steatosis , inflammation , ballooning , or fibrosis scores .


There were no significant effects on levels of liver enzymes , insulin resistance , adiponectin , keratin 18 , high-sensitivity C-reactive protein , or hyaluronic acid .


High-dosage EPA-E reduced levels of triglyceride ( -6.5 mg/dL vs an increase of 12 mg/dL in the placebo group ; P = .03 ) .


There were no treatment-related serious adverse events .


In a phase 2 trial , EPA-E had no significant effect on the histologic features of NASH .


EPA-E reduced subjects ' levels of triglyceride compared with placebo , without any increase in serious adverse events .


Clinicaltrials.gov Number : 01154985 .


Various preparations of botulinum toxin type A ( BTX-A ) are used to reduces glabellar ( frown ) lines .


However , dose-related safety and efficacy of intramuscular injections of a widely used , locally produced BTX-A in China has not been established .


Assessment of dose-dependent safety and efficacy of Chinese botulinum toxin type A ( Hengli BTX-A [ HBTX-A ] ) intramuscular injections on glabellar lines .


Four hundred eighty-eight BTX-A-naive participants were included in the double-blind trial and randomly divided into placebo ( n = 122 ) , low-dose ( n = 183 ) , and high-dose ( n = 183 ) treatment groups for injection with saline solution , 10 units and 20 units of HBTX-A , respectively , at 4 sites in the corrugator muscle and 1 site in the procerus muscle .


Outcomes were recorded before treatment and after 7 , 30 , 60 , and 120 days , including glabellar line severity at maximum contraction and relaxation .


Significantly greater improvement was observed in both HBTX-A groups in comparison with the placebo group ( p < .05 ) .


Better efficacy was obtained in the high-dose treatment group .


More participants developed adverse events after treatment with HBTX-A doses , than with the placebo ( p < .05 ) .


Twenty-unit HBTX-A provided optimal improvement in glabellar lines , and its use might minimize injection frequency while maintaining acceptable safety .


While energy devices are ubiquitous in the operating room , they remain poorly understood and can result in significant complications .


The purpose of this study was to estimate the extent to which adding a novel bench-top component improves learning of SAGES ' Fundamental Use of Surgical Energy ( FUSE ) electrosurgery curriculum among surgical trainees .


Surgical residents participated in a 1-h didactic electrosurgery ( ES ) course , based on the FUSE curriculum .


They were then randomized to one of two groups : an unstructured hands-on session where trainees used ES devices ( control group ) or a goal-directed hands-on training session ( Sim group ) .


Pre - and post-curriculum ( immediate and at 3 months ) assessments included knowledge of ES ( multiple-choice examination ) , self-perceived competence for each of the 35 course objectives ( questionnaire ) , and self-perceived comfort with performance of seven tasks related to safe use of ES .


Data expressed as median [ interquartile range ] , * p < 0.05 .


56 ( 29 control ; 27 Sim ) surgical trainees completed the curriculum and assessments .


Baseline characteristics , including pre-curriculum exam and questionnaire scores , were similar .


Total score on the exam improved from 46 % [ 40 ; 54 ] to 84 % [ 77 ; 91 ] * for the entire cohort , with higher immediate post-curriculum scores in the Sim group compared to controls ( 89 % [ 83 ; 94 ] vs. 83 % [ 71 ; 86 ] * ) .


At 3 months , performance on the exam declined in both groups , but remained higher in the Sim group ( 77 % [ 69 ; 90 ] vs 60 % [ 51 ; 80 ] * ) .


Participants in both groups reported feeling greater comfort and competence post-curriculum ( immediate and at 3 months ) compared to baseline .


This improvement was greater in the Sim group with a higher proportion feeling `` Very Comfortable '' or `` Fully Competent '' ( Sim : 3/7 tasks and 28/35 objectives ; control : 0/7 tasks and 10/35 objectives ) .


A FUSE-based curriculum improved surgical trainees ' knowledge and comfort in the safe use of electrosurgical devices .


The addition of a structured interactive bench-top simulation component further improved learning and retention at 3 months .


To evaluate the efficacy and safety of USL255 , Qudexy ( ) XR ( topiramate ) extended-release capsules , as an adjunctive treatment for refractory partial-onset seizures ( POS ) in adults taking one to three concomitant antiepileptic drugs .


In this global phase III study ( PREVAIL ; NCT01142193 ) , 249 adults with POS were randomized 1:1 to once-daily USL255 ( 200 mg/day ) or placebo .


The primary and key secondary efficacy endpoints were median percent reduction in weekly POS frequency and responder rate ( proportion of patients with 50 % reduction in seizure frequency ) .


Seizure freedom was also assessed .


Safety ( adverse events , clinical and laboratory findings ) , as well as treatment effects on quality of life ( QOLIE-31-P ) and clinical global impression of change ( CGI-C ) , were evaluated .


Across the entire 11-week treatment phase , USL255 significantly reduced the median percent seizure frequency and significantly improved responder rate compared with placebo .


Efficacy over placebo was observed early in treatment , in patients with highly refractory POS , and in those with the most debilitating seizure types ( i.e. , complex partial , partial secondarily generalized ) .


USL255 was safe and generally well tolerated with a low incidence of neurocognitive adverse events .


USL255 was associated with significant clinical improvement without adversely affecting quality of life .


The PREVAIL phase III clinical study demonstrated that once-daily USL255 ( 200 mg/day ) significantly improved seizure control and was safe and generally well tolerated with few neurocognitive side effects .


Hypertension is one of the most common chronic diseases .


Hypertensive patients who intend to control blood pressure need professional medical assistance .


Auricular acupressure is a patient-dependent task , wherein a person does not have to rely on a healthcare professional to self-perform the task .


To evaluate the effects of auricular acupressure on heart rate variability ( HRV ) and quality of life ( QoL ) in patients with hypertension .


A randomized controlled trial with permuted block randomization was used .


In total , 150 participants from a medical teaching hospital were randomly assigned to the experimental group that received auricular acupressure for 10 weeks , and the control group that received only routine care of equal duration .


Outcomes were assessed through HRV parameters , heart rate , blood pressure , and QoL before and after the auricular acupressure intervention .


After the adjustment of disease duration and mental health , a significant difference existed between the two groups in body pain ( p = .03 ) and mental health ( p = .002 ) of QoL , but not in HRV parameters , heart rate , blood pressure , and overall QoL ( p > .05 ) .


Acupressure can be applied at the acupoints of shenmen , sympathesis , kidney , liver , heart , and subcortex to improve physical pain and mental health of QoL for hypertensive patients .


Auricular acupressure is acceptable and feasible although it does not support physiological benefits .


Further studies are warranted to assure the effects of using auricular acupressure as an adjunctive care for patients with hypertension .


The treatment of adhesive capsulitis ( AC ) is a well-known , complicated , and long process .


Recent studies have shown that pulsed radiofrequency ( PRF ) lesioning of the suprascapular nerve ( SSN ) using a fluoroscopy - or computed tomography-guided technique can alleviate shoulder pain .


However , there are no studies of PRF lesioning of the SSN in patients with AC using ultrasound-guided ( UG ) techniques , except for 2 case reports .


In this study , we compared the effect of physical therapy alone with physical therapy and PRF lesioning of the SSN using a UG technique .


Sixty patients with AC were included in the study .


Patients were randomized into the following 2 groups : the intervention group containing patients who received 12 weeks of physical therapy after 1 treatment of PRF lesioning of the SSN , and the control group containing patients who received 12 weeks of physical therapy alone .


All outcome measurements including visual analog scale ( VAS ) , shoulder pain and disability index , and passive range of motion ( PROM ) were performed at 1 , 4 , 8 , and 12 weeks after treatment .


Forty-two patients ( 21 patients in each group ) completed the study .


The intervention group had a notably shorter time to onset of significant pain relief ( 6.1 3.4 vs 28.1 9.2 days ; P < 0.001 ) and noticeable reduction of VAS score at week 1 ( 40 % vs 4.7 % ) than the control group ( P < 0.001 ) .


All measured variables in the intervention group and most variables in the control group showed significant improvement from the baseline ( P < 0.05 ) .


A comparison of the 2 groups indicated significantly greater improvement in the intervention group at all times in VAS and shoulder pain and disability index scores ( all P < 0.05 ) , and for most gain of PROM ( P < 0.05 ) .


There were no serious adverse effects or complications in either group .


This study indicates that the application of PRF lesioning of the SSN using a UG technique combined with physical therapy provided better and faster relief from pain , reduced disability , and improved PROM when compared with physical therapy alone in patients with AC , an effect that persisted for at least 12 weeks .


To analyse the influence of serving method on compliance and consumption of nutritional supplement drinks in older adults with cognitive impairment .


Oral nutritional supplement drinks have positive benefits on increasing nutritional status in undernourished older people leading to weight gain .


However , consumption of these drinks is low and therefore limits their effectiveness .


This study was a non-blind randomized control trial where participants either consumed nutritional supplement drinks in a glass/beaker or consumed them through a straw inserted directly into the container .


Participants with long-standing cognitive impairment were recruited from nursing homes ( n = 31 ) and hospitals ( n = 14 ) .


Participants were randomized to serving method .


Nursing and care staff were instructed to give the supplement drinks three times per day on alternate days over a week by the allocated serving method .


The researcher weighed the amount of supplement drink remaining after consumption .


Data were collected over 12 months in 2011-2012 .


Forty-five people participated in this study , mean age 867 ( sd 75 ) years .


After randomization , there was no significant difference between the baseline characteristics of the two groups .


Participants randomized to consume nutritional drinks from a glass/beaker drank statistically significantly more than those who consumed them via a straw inserted directly into the container .


However , supplements allocated to be given in a glass/beaker were more frequently omitted .


Nutritional supplement drinks should be given to people with dementia who are able to feed themselves in a glass or a beaker if staffing resources allow ( NIHR CSP ref 31101 ) .


To evaluate the efficacy of a 2-week administration of a 0.1 % chlorhexidine mouthwash in the short-term treatment of chronic periodontitis patients and the impact of this product when administered twice by pocket irrigation .


Sixty patients were enrolled in a single-centre , placebo-controlled , randomized study with the blind allocation of product to two parallel groups .


Clinical assessments were performed , and samples from six selected subgingival sites were collected for microbial analysis by culture at baseline , D15 and D56 .


Three of the six sites were randomly selected and were treated by subgingival irrigation with the same 0.1 % chlorhexidine product at D0 and D7 .


A subsequent statistical analysis was performed using the paired Student 's t-test and Wilcoxon rank sum test for within-group analyses ; analysis of variance and the Kruskall-Wallis test were used for between-group analyses .


Two-week treatment with a 0.1 % chlorhexidine mouthwash slightly reduced the gingival inflammation associated with periodontitis .


We observed a significant decrease in Gram-negative , facultative anaerobes and micro-aerophiles , and a significant increase in Gram-positive cocci .


No increase in the treatment effect was demonstrated by irrigation of the periodontal pockets .


The 0.1 % chlorhexidine mouthwash showed limited beneficial effects in the treatment of periodontitis patients .


The EUROACTION PLUS trial measured the effectiveness of a nurse-led preventive cardiology programme ( EUROACTION ) offering intensive smoking cessation PLUS optional varenicline for persistent high CVD risk smokers to reduce overall cardiovascular risk compared with usual care ( UC ) in general practice ( GP ) .


A parallel group randomized controlled trial in 20 GP in Italy , Netherlands , Spain , and UK .


Six hundred and ninety-six current smokers , ( 137 vascular disease and 559 high total CVD risk ) , were randomized 350 to EUROACTION PLUS ( EA + ) and 346 to UC .


Specially , trained nurses offered the EUROACTION preventive cardiology programme addressing smoking cessation , diet , physical activity , and risk factor management to reduce overall cardiovascular risk .


The primary endpoint was 7 day point prevalence of self-reported abstinence ( validated breath carbon monoxide < 10 p.p.m. ) at 16 weeks .


Secondary outcomes included dietary habits , physical activity , weight , blood pressure ( BP ) , lipid , and glucose management .


One hundred and seventy-seven ( 51 % ) EA + patients ( 91 % opted to use varenicline ) were abstinent vs. 63 ( 19 % ) in UC ; OR 4.52 ( 95 % CI : 3.20-6 .39 ) .


The Mediterranean diet score of 9 in 149 ( 52 % ) EA + patients vs. 97 ( 37 % ) in UC ; OR 1.84 ( 95 % CI : 1.31-2 .59 ) .


Physical activity target achieved in 46 ( 16 % ) EA + patients vs. 19 ( 7 % ) in UC ; OR 2.48 ( 95 % CI : 1.41-4 .36 ) .


Target BP ( < 140/90 mm Hg ) achieved in 150 ( 52 % ) EA + patients vs. 112 ( 43 % ) in UC , OR 1.47 ( 95 % CI : 1.05-2 .06 ) with no difference in antihypertensive drugs .


There were no differences in management of cholesterol or glucose .


The EUROACTION preventive cardiology programme in high CVD risk smokers using optional varenicline substantially increased smoking abstinence over 16 weeks and also reduced overall cardiovascular risk compared with UC .


REC reference : 09/H0402/85 ; EudraCT number : 2009-012451-18 ; http://www.controlled-trials.com/ISRCTN22073647 , 12 February 2014 , date last accessed .


Effectiveness of advanced technologies for diabetes management may differ depending on national healthcare models or population characteristics .


In the setting of a cross-national trial , we aimed to compare efficacy of sensor-augmented pump ( SAP ) therapy in the United States ( US ) and Canada .


In the clinical trial Sensor-Augmented Pump Therapy for A1C Reduction ( STAR 3 ) , 329 adults with type 1 diabetes were randomly allocated to either SAP or glargine-based multiple daily injection ( MDI ) therapy at 26 US sites ( n = 271 ) and 4 Canadian sites ( n = 58 ) .


A bootstrap analysis was performed to confirm significant differences in baseline characteristics .


For the primary analysis , we compared the baseline to 1-year change in glycated hemoglobin ( A1C ) between Canadian and US subjects .


At baseline , compared with US subjects , Canadian subjects were more likely to be students ( 19 % vs. 7 % , p < 0.01 ) and to consume alcohol ( 91 % vs. 63 % , p < 0.01 ) .


Although Canadian subjects had greater A1C reductions from baseline compared with US subjects ( p = 0.02 ) , the incremental benefit of SAP was similar in the US ( SAP compared with MDI,-0 .93 % 0.73 % vs.-0 .31 % 0.81 % , p < 0.001 ) and Canada ( -1.14 % 0.72 % vs.-0 .67 % 0.71 % , p < 0.001 ) .


Mean sensor use was significantly higher in Canada than in the US ( 79 % vs. 68 % of the time , p < 0.001 ) .


Despite differences in baseline characteristics and sensor adherence , SAP efficacy was similar between US and Canadian participants .


As long as the intervention is administered with a similar level of expertise as was conducted in the trial , it is likely to be applicable in diverse clinical practice settings .


To evaluate the effect of intravitreal ciliary neurotrophic factor ( CNTF ) implant on mean macular thickness ( MMT ) in eyes with retinitis pigmentosa using high-resolution Fourier domain optical coherence tomography imaging .


A cohort of 8 patients ( CNTF-3 : n = 5 ; CNTF-4 : n = 3 ) enrolled in Neurotech sponsored Phase 2 clinical trial underwent Fourier domain optical coherence tomography imaging .


A 3 % change in MMT from baseline or fellow eye was considered as a measurable change .


Two patients enrolled in the CNTF-3 study received low-dose implant .


At 18 months , a change in MMT from -4.47 m to 6 m from baseline was noted .


Six patients received high-dose implant ( CNTF-3 : n = 3 ; CNTF-4 : n = 3 ) .


In CNTF-3 group , 1 eye showed an increase in MMT by 19.25 m ( +7.6 % ) from baseline at 18 months .


In CNTF-4 group , 1 eye had an increase in MMT of 27.08 m ( +11 % ) from baseline at 30 months ; second eye had increase in MMT of 31.36 m ( +12 % ) from contralateral eye .


Amongst these 3 responsive high-dose implant eyes , overall thickening of the retina could not be attributed to any specific retinal layer .


A heterogeneous dose-dependent response on MMT was noted in eyes treated using intravitreal CNTF implant for retinitis pigmentosa .


We recommend corroboration of our findings with Neurotech sponsored clinical trial results .


To assess the effect of initiating insulin treatment on quality of life of patients with type 2 diabetes ( T2DM ) in the 60-week All-to-Target trial ( NCT00384085 ) .


Patient-reported outcomes from a phase IV , multicentre , randomised , open-label , parallel-group study were analysed .


Participants were randomised to : insulin glargine with up to one insulin glulisine injection ( G + 1 ) ; insulin glargine with stepwise addition of up to three insulin glulisine injections ( G + 3 ) ; or twice-daily premixed 70/30 insulin protamine-aspart/aspart ( PM-2 ) .


Patient-reported outcome questionnaires were administered at weeks 0 , 6 , 12 , 24 , 36 , 48 and 60 .


There were no between-group differences in the Psychosocial Adjustment to Illness State-Self Report ( PAIS-SR ) or in the EuroQoL Group Five-Dimension Self-Report Index Questionnaire ( EQ-5D ) from baseline to week 60 ; however , PAIS-SR scores improved significantly over this period in the G + 3 group ( p = 0.0016 ) and EQ-5D scores worsened significantly in the PM-2 group ( p = 0.02 ) .


Hypoglycemia Fear Survey Behaviour and Worry subscales worsened significantly for all groups , with greater deterioration being observed in the PM-2 group than in the G + 1 group ( Behaviour , p = 0.0050 ; Worry , p = 0.0017 ) and G + 3 groups ( Behaviour , p = 0.0105 ; Worry , p = 0.0016 ) .


Total scores on the Diabetes Quality of Life ( DQoL ) questionnaire improved more in the G + 3 group than in the PM-2 group over the study period ( p = 0.0284 ) , with all groups showing a significant improvement in DQoL score over time .


Insulin glargine-based regimens showed advantages over premixed insulin in a number of patient-reported outcome measures .


The potential impact on fear of hypoglycaemia may be of particular relevance when addressing the major barriers to early insulin treatment .


This study examined the effects of atomoxetine ( ATX ) and OROS methylphenidate ( MPH ) on laboratory measures of inhibitory control and attention in youth with attention-deficit/hyperactivity disorder ( ADHD ) .