For the bone mineral density secondary outcomes , total hip bone mineral density increased more in the teriparatide to denosumab group ( 66 % [ 95 % CI 53-79 ] ) than in the denosumab to teriparatide group ( 28 % [ 13-42 ] , p = 00002 ) , but had the greatest increase in the combination to denosumab group ( 86 % [ 71-100 ] ; p = 00446 vs the teriparatide to denosumab group , p < 00001 vs the denosumab to teriparatide group ) .


Similarly , femoral neck bone mineral density increased more in the teriparatide to denosumab group ( 83 % [ 95 % CI 61-105 ] ) and the combination to denosumab group ( 91 % [ 61-120 ] ) than in the denosumab to teriparatide group ( 49 % [ 22-75 ] ; p = 00447 for teriparatide to denosumab vs denosumab to teriparatide , p = 00336 for combination to denosumab vs denosumab to teriparatide ) .


Differences between the combination to denosumab group and the teriparatide to denosumab group did not differ significantly ( p = 067 ) .


After 48 months , radius bone mineral density was unchanged in the teriparatide to denosumab group ( 00 % [ 95 % CI -13 to 14 ] ) , whereas it decreased by -18 % ( -50 to 13 ) in the denosumab to teriparatide group , and increased by 28 % ( 12-44 ) in the combination to denosumab group ( p = 00075 for the teriparatide to denosumab group vs the combination to denosumab group ; p = 00099 for the denosumab to teriparatide group vs the combination to denosumab group ) .


One participant in the denosumab to teriparatide group had nephrolithiasis , classified as being possibly related to treatment .


In postmenopausal osteoporotic women switching from teriparatide to denosumab , bone mineral density continued to increase , whereas switching from denosumab to teriparatide results in progressive or transient bone loss .


These results should be considered when choosing the initial and subsequent management of postmenopausal osteoporotic patients .


Amgen , Eli Lilly , and National Institutes of Health .


Previous evaluations of the SunSmart Program have supported the link between a written sun protection policy and improved sun protection behaviours in New South Wales ( NSW ) primary schools .


However these evaluations have relied on self-reported data and research suggests that direct observations are required to better represent schools ' usual sun protective practices .


Data will be collected in the summer months of 2014 , 2015 , and 2016 as part of an 18-month cluster-controlled trial in NSW primary schools ( n = 20 ) .


Researchers will conduct three direct observations to record students ' hat use and teachers ' use of sun protective measures during recess and lunch periods in each school .


Researchers will also record the volume of sunscreen that the Year 6 classes in each school utilise over the term .


At the conclusion of baseline data collection , five schools will be randomised into an intervention group that will work with researchers to develop a policy-driven intervention to improve sun safety behaviour in NSW primary schools .


An initial review of relevant Australian and New Zealand literature suggests that provision of policy support is likely to improve school sun protection practices ; however there is no suggested model for this support .


This will be the first objective analysis of sun safe behaviours leading to a policy-driven intervention conducted in Australian primary schools since the 1990s , and will inform the future direction of sun safety in our schools .


Australian and New Zealand Clinical Trials Register ACTRN12614000926639 Registered 28 ( th ) August 2014 .


Phosphatidylcholine is a key component of the mucosal barrier .


Treatment with modified release phosphatidylcholine aims to improve the impaired barrier function .


The primary objective is to evaluate the efficacy of LT-02 , a newly designed modified release phosphatidylcholine formula , in a multicenter setting .


This is a double-blinded , randomized , placebo-controlled , superiority study conducted in 24 ambulatory referral centers in Germany , Lithuania , and Romania .


A total of 156 patients with an inadequate response to mesalazine , a disease activity score ( Simple Clinical Colitis Activity Index ( SCCAI ) ) of 5 , and bloody diarrhea underwent treatment with 0 , 0.8 , 1.6 , or 3.2 g LT-02 .


The primary end point was defined a priori as changes in SCCAI from baseline to the end of treatment .


The primary statistical model was a general linear least-squares model .


The study was funded by the sponsor Lipid Therapeutics , Heidelberg , Germany , and registered at http://clinicaltrials.gov/show/NCT01011322 .


Baseline characteristics and dropouts were well balanced between all groups .


The primary analyses revealed an SCCAI drop of 33.3 % in the placebo group ( from 9.0 to 6.0 points ) compared with 44.3 % in the 0.8 g LT-02 ( from 8.8 to 4.9 , P > 0.05 ) and 40.7 % in the 1.6 g groups ( from 8.6 to 5.1 , P > 0.05 ) .


The 3.2 g group improved 51.7 % from 8.5 to 4.1 ( P = 0.030 in comparison with placebo ) .


The remission rate was 15 % ( 6/40 ) in the placebo group compared with 31.4 % ( 11/35 ) in the highest LT-02 dose group ( P = 0.089 ) .


Mucosal healing was achieved in 32.5 % of placebo patients compared with 47.4 % of LT-02 patients ( P = 0.098 ) ; the rates for histologic remission were 20 % compared with 40.5 % , respectively ( P = 0.016 ) .


There were 17 ( 48.6 % ) treatment-emergent adverse events in the highest dose group ( and 0 serious adverse events ( SAEs ) ) compared with 22 ( 55 % ) in the placebo group ( 4 SAEs ) .


The primary end point analysis showed a statistically significant improvement in disease activity during LT-02 treatment in comparison with placebo .


The drug was found to be very safe .


To evaluate an individually tailored oral health educational programme on patient-reported outcome compared with a standard oral health educational programme , assess change over time and determine minimal important differences ( MID ) in change scores for two different oral health related quality of life ( OHRQoL ) instrument after non-surgical periodontal treatment ( NSPT ) .


In a randomized controlled trial evaluating two educational programmes , patients ( n = 87 ) with chronic periodontitis completed a questionnaire at baseline and after 12 months .


OHRQoL was assessed with the General Oral Health Assessment Index ( GOHAI ) and the UK oral health-related quality-of-life measure ( OHQoL-UK ) .


In addition , patients ' global rating of oral health and socio-demographic variables were recorded .


The MID was estimated with anchor-based and distributions-based methods .


There were no differences between the two educational groups .


The OHRQoL was significantly improved after treatment .


The MID was approximately five for OHQoL-UK with a moderate ES , and three for GOHAI with a Small ES , and 46-50 % of the patients showed improvements beyond the MID .


Both oral health educational groups reported higher scores in OHRQoL after NSPT resulting in more positive well-being ( OHQoL-UK ) and less frequent oral problems ( GOHAI ) .


OHQoL-UK gave a greater effect size and mean change scores but both instruments were associated with the participants ' self-rated change in oral health .


The changes were meaningful for the patients supported by the estimated MID .


Streamlining the triage process is the key in improving emergency department ( ED ) workflow .


Our objective was to determine if parents of pediatric ED patients in , low-literacy , inner-city hospital , who used the audio-assisted bilingual ( English/Spanish ) self-triage kiosk , were able to enter their child 's medical history data using a touch screen panel with greater speed and accuracy than routine nurse-initiated triage .


Parent/child dyads visiting the pediatric ED for nonurgent conditions ( February to April 2012 ) were randomized prospectively to self-triage kiosk group ( n = 200 ) and standard nurse triage group ( n = 200 ) .


Both groups underwent routine nurse-initiated triage that included verbal elicitation of basic medical history and manual entry into patients ' electronic medical records .


The kiosk user was a parent in 88.5 % of the cases , a patient ( range , 11-17 years ) in 9.5 % of the cases , and a proxy user ( sibling or friend ) in 2 % of the cases .


Language choice for kiosk use was equally distributed ( English vs Spanish , 50.5 % vs 49.5 % ) .


The mean ( SD ) time to enter medical history data by the kiosk group was significantly shorter than the standard nurse triage group ( 94.38 [ 38.61 ] vs 126.72 [ 62.61 ] seconds ; P < 0.001 ) .


Significant inverse relationship was observed between parent education level and kiosk usage time ( r = -0.26 ; P < 0.001 ) .


The mean inaccuracies were significantly lower for kiosk group ( P < 0.05 ) in areas of medical , medication and immunization histories , and total discrepancy score .


Kiosk triage enabled users to enter basic medical triage history data quickly and accurately in an ED setting with future potential for its wider use in improving ED workflow efficiency .


To observe the long-term effects of hydroxychloroquine treatment on blood lipids and left ventricular function of systemic lupus erythematosus ( SLE ) patients .


A total of 72 SLE patients were randomly divided into 2 groups of hydroxychloroquine treatment ( n = 36 ) and non-hydroxychloroquine ( n = 36 ) .


The serum level of lipids , left ventricular end-diastolic diameter ( LVEDD ) , left ventricular end-systolic diameter ( LVESD ) , interventricular septum thickness ( IVST ) , left ventricular posterior wall thickness ( LVPWT ) , fractional shortening rate ( FS ) , left ventricular ejection fraction ( LVEF ) and E/A ratio were measured before , 6 month , 12 month and 2 years after treatment .


After long-term use of hydroxychloroquine , there were statistically differences in the levels of total cholesterol ( TC ) , triglyceride ( TG ) , low-density lipoprotein ( LDL ) and high-density lipoprotein ( HDL ) .


And LVEDD , LVWPT and E/A were statistically different ( P < 0.05 ) before and after hydroxychloroquine dosing .


The long-term use of hydroxychloroquine may improve lipid metabolism and left ventricular function in SLE patients .


The incidence of chronic diseases , including diabetes mellitus ( DM ) , heart failure ( HF ) and chronic obstructive pulmonary disease ( COPD ) is on the rise .


The existing health care system must evolve to meet the growing needs of patients with these chronic diseases and reduce the strain on both acute care and hospital-based health care resources .


Paramedics are an allied health care resource consisting of highly-trained practitioners who are comfortable working independently and in collaboration with other resources in the out-of-hospital setting .


Expanding the paramedic 's scope of practice to include community-based care may decrease the utilization of acute care and hospital-based health care resources by patients with chronic disease .


This will be a pragmatic , randomized controlled trial comparing a community paramedic intervention to standard of care for patients with one of three chronic diseases .


The objective of the trial is to determine whether community paramedics conducting regular home visits , including health assessments and evidence-based treatments , in partnership with primary care physicians and other community based resources , will decrease the rate of hospitalization and emergency department use for patients with DM , HF and COPD .


The primary outcome measure will be the rate of hospitalization at one year .


Secondary outcomes will include measures of health system utilization , overall health status , and cost-effectiveness of the intervention over the same time period .


Outcome measures will be assessed using both Poisson regression and negative binomial regression analyses to assess the primary outcome .


The results of this study will be used to inform decisions around the implementation of community paramedic programs .


If successful in preventing hospitalizations , it has the ability to be scaled up to other regions , both nationally and internationally .


The methods described in this paper will serve as a basis for future work related to this study .


ClinicalTrials.gov : NCT02034045 .


Date : 9 January 2014 .


To evaluate the relationship of physical activity ( PA ) and sedentary behaviour with gestational weight gain ( GWG ) and birth weight .


Combined data from two prospective studies : ( 1 ) nulliparous pregnant women without BMI restrictions and ( 2 ) overweight and obese pregnant women at risk for gestational diabetes .


Daily PA and sedentary behaviour were measured with an accelerometer around 15 and at 32-35 weeks of gestation .


The association between time spent in moderate-to-vigorous PA ( MVPA ) and in sedentary activities with GWG and birth weight was determined .


Main outcome measures were GWG between 15 and 32 weeks of gestation , average GWG per week , and birth weight .


We studied 111 women .


Early in pregnancy , 32 % of women spent 30 minutes/day in at least moderate PA versus 12 % in late pregnancy .


No significant associations were found between time spent in MVPA or sedentary behaviour with GWG or birth weight .


We found no relation between MVPA and sedentary behaviour with GWG or birth weight .


The small percentage of women meeting the recommended levels of PA indicates the need to inform and support pregnant women to maintain regular PA , as there seems to be no adverse effect on birth weight and maintaining PA increases overall health .


To study whether demographic and smoking-related characteristics are associated with participation ( reach ) in a smoking cessation trial and subsequent use ( uptake ) of two specific smoking interventions ( Internet-based program and proactive telephone counseling ) .


We used data from a four-arm randomized smoking cessation trial ( 2011 ) .


Participants ( n = 1,809 ) were recruited among 9,924 smokers who previously participated in two health surveys in Denmark ( 2007-2008 and 2010 ) .


Interventions were as follows : ( 1 ) an Internet-based smoking cessation program , ( 2 ) proactive telephone counseling , ( 3 ) reactive telephone counseling and ( 4 ) a self-help booklet .


Reach ( defined as the proportion accepting to participate in the trial of those invited ) was highest among persons aged 40-59 years , women , heavy smokers and persons with long education .


Among trial participants , uptake ( defined as any use of the specific intervention at 1-month follow-up ) was 69 % for the Internet-based program , 74 % and 9 % for proactive and reactive telephone counseling , respectively , and 84 % for the self-help booklet .


Young age was associated with the uptake of the Internet-based program , and short education was associated with using proactive telephone counseling .


Internet-based interventions and proactive telephone counseling appeal to different age and educational groups .


Further , offering similar intervention content by a proactive and a reactive approach can be associated with different intervention uptake .


Supraglottic airway devices are increasingly used as an option to tracheal intubation for elective procedures of varying complexity .


The aim of this study was to prospectively evaluate the clinical use of the laryngeal mask airway Supreme ( ) ( LMAS ) in patients undergoing elective breast surgery and compare it with endotracheal tube ( ETT ) .


Sixty patients undergoing breast procedures under general anesthesia were randomly divided into two groups according to the device used ( LMAS or ETT ) .


Time of insertion , number of insertion attempts , hemodynamic response to insertion , presence of blood on the device used ; and incidence of sore throat , dysphagia , nausea and vomiting were assessed postoperatively .


There was no difference between groups regarding time of insertion , number of attempts for successful insertion , and presence of blood on the device .


Heart rate and blood pressure after insertion were higher in ETT group .


Incidence of sore throat and dysphagia was also higher in ETT group after two hours in the postoperative period .


There was no difference regarding incidence and severity of complications evaluated after six hours postoperatively .


The use of the LMAS technique to access airway during general anesthesia for elective breast surgery is as safe and effective as tracheal intubation , with the advantage of promoting smaller hemodynamic response during its management and lower incidence of sore throat and dysphagia in the first hours after surgery .


In light of the increasing rate of dengue infections throughout the world despite vector-control measures , several dengue vaccine candidates are in development .


In a phase 3 efficacy trial of a tetravalent dengue vaccine in five Latin American countries where dengue is endemic , we randomly assigned healthy children between the ages of 9 and 16 years in a 2:1 ratio to receive three injections of recombinant , live , attenuated , tetravalent dengue vaccine ( CYD-TDV ) or placebo at months 0 , 6 , and 12 under blinded conditions .


The children were then followed for 25 months .


The primary outcome was vaccine efficacy against symptomatic , virologically confirmed dengue ( VCD ) , regardless of disease severity or serotype , occurring more than 28 days after the third injection .


A total of 20,869 healthy children received either vaccine or placebo .


At baseline , 79.4 % of an immunogenicity subgroup of 1944 children had seropositive status for one or more dengue serotypes .


In the per-protocol population , there were 176 VCD cases ( with 11,793 person-years at risk ) in the vaccine group and 221 VCD cases ( with 5809 person-years at risk ) in the control group , for a vaccine efficacy of 60.8 % ( 95 % confidence interval [ CI ] , 52.0 to 68.0 ) .


In the intention-to-treat population ( those who received at least one injection ) , vaccine efficacy was 64.7 % ( 95 % CI , 58.7 to 69.8 ) .


Serotype-specific vaccine efficacy was 50.3 % for serotype 1 , 42.3 % for serotype 2 , 74.0 % for serotype 3 , and 77.7 % for serotype 4 .


Among the severe VCD cases , 1 of 12 was in the vaccine group , for an intention-to-treat vaccine efficacy of 95.5 % .


Vaccine efficacy against hospitalization for dengue was 80.3 % .


The safety profile for the CYD-TDV vaccine was similar to that for placebo , with no marked difference in rates of adverse events .


The CYD-TDV dengue vaccine was efficacious against VCD and severe VCD and led to fewer hospitalizations for VCD in five Latin American countries where dengue is endemic .


( Funded by Sanofi Pasteur ; ClinicalTrials.gov number , NCT01374516 . )


This study aims to evaluate the feasibility of intraoperative composite target-controlled infusion ( TCI ) anesthesia application using remifentanil hydrochloride with etomidate in patients with severe burns , as monitored by Narcotrend .


A total of 40 patients with severe burns with eschar excisions and skin grafts were randomly and equally grouped into the etomidate ( E ) and the propofol groups ( P ) .


Anesthesia was induced and maintained by a remifentanil hydrochloride TCI combined with etomidate or propofol .


The depth of anesthesia and other relevant indicators were recorded through intraoperative electroencephalogram monitoring using a Narcotrend monitor .


No statistically significant differences were observed between the drug withdrawal times , eye opening requirements , or orientation recoveries of the two groups ( P > 0.05 ) .


The cortisol and aldosterone levels in group E were significantly lower than those in group P 24h post operation ( P < 0.05 ) .


No significant differences between the number of operations , hospitalization duration , mean arterial pressure , heart rate , and postoperative adverse reaction incidence of the two groups were observed at each time point ( P > 0.05 ) .


The application of a composite remifentanil hydrochloride combined with etomidate TCI is feasible for the early eschar excision in patients with severe burns .


Uric acid ( UA ) could act as a natural peroxynitrite scavenger with antioxidant properties .


It has been proposed that hyperuricemia might protect against multiple sclerosis ( MS ) .


Patients with relapsing-remitting MS starting treatment with interferon beta-1a 44 g sc 3/week were randomly assigned to receive either inosine 3 g/day or placebo in a double-blind manner .


Follow-up was 12 months .


Outcome measures were adverse events and UA laboratory results .


Secondary end point was clinical and radiological activity of MS. Relapse rates , percentage of patients without relapses , and progression to secondary MS ( SPMS ) were assessed .


Thirty six patients were included .


Two patients in the inosine group showed UA serum level above 10 mg/ml , and symptoms derived from renal colic not leading to hospital admission .


Ten additional patients had asymptomatic hyperuricemia ( > 7 mg ) .


Efficacy parameters ( clinical and radiological ) were similar between groups .


No patient progressed to SPMS CONCLUSIONS : Inosine administration was associated with hyperuricemia and renal colic with no additional effect on MS. We can not conclude inosine is a safe and well-tolerated drug .


Doses of around 2 g/day may be more appropriate for future trials .


This study aimed to compare the efficacy of a peel-off facial mask based on polyvinyl alcohol ( PVA ) with an oil-in-water ( o/w ) emulsion and the effect of a soybean extract fermented by Bifidobacterium animale incorporated in those formulations ( 5 % w/w ) .


The formulations were submitted to randomized clinical studies in volunteers to evaluate the measurement effects as ( a ) tensor by Cutometer , ( b ) moisturizing by Corneometer and transepidermal water loss ( TEWL ) by Tewameter .


These effects were determined in a short-term study ( 3 h ) in a controlled-temperature room .


The tensor effect and TEWL values indicated no significant difference between the use of facial mask and emulsion .


On the other hand , the moisturizing effect of the facial mask on the stratum corneum was more significant than that of the emulsion according to Corneometer measurements .


Biometric cutaneous evaluation of peel-off facial masks ( short-term study ) showed that the masks promoted moisturizing effect of the stratum corneum more effectively than the oil-in-water emulsions .


Thus , the facial masks were more efficient than emulsions in relation to moisturizing effects , but this efficiency is not related to the presence of fermented soybean extract .


The results indicated that peel-off facial masks increase skin hydration in a process related to the occlusive effect .


The possibility and likelihood of a postoperative medical complication after spine surgery undoubtedly play a major role in the decision making of the surgeon and patient alike .


Although prior study has determined relative risk and odds ratio values to quantify risk factors , these values may be difficult to translate to the patient during counseling of surgical options .


Ideally , a model that predicts absolute risk of medical complication , rather than relative risk or odds ratio values , would greatly enhance the discussion of safety of spine surgery .


To date , there is no risk stratification model that specifically predicts the risk of medical complication .


The purpose of this study was to create and validate a predictive model for the risk of medical complication during and after spine surgery .


Statistical analysis using a prospective surgical spine registry that recorded extensive demographic , surgical , and complication data .


Outcomes examined are medical complications that were specifically defined a priori .


This analysis is a continuation of statistical analysis of our previously published report .


Using a prospectively collected surgical registry of more than 1,476 patients with extensive demographic , comorbidity , surgical , and complication detail recorded for 2 years after surgery , we previously identified several risk factor for medical complications .


Using the beta coefficients from those log binomial regression analyses , we created a model to predict the occurrence of medical complication after spine surgery .


We split our data into two subsets for internal and cross-validation of our model .


We created two predictive models : one predicting the occurrence of any medical complication and the other predicting the occurrence of a major medical complication .


The final predictive model for any medical complications had a receiver operator curve characteristic of 0.76 , considered to be a fair measure .


The final predictive model for any major medical complications had receiver operator curve characteristic of 0.81 , considered to be a good measure .


The final model has been uploaded for use on SpineSage.com .


We present a validated model for predicting medical complications after spine surgery .


The value in this model is that it gives the user an absolute percent likelihood of complication after spine surgery based on the patient 's comorbidity profile and invasiveness of surgery .


Patients are far more likely to understand an absolute percentage , rather than relative risk and confidence interval values .


A model such as this is of paramount importance in counseling patients and enhancing the safety of spine surgery .


In addition , a tool such as this can be of great use particularly as health care trends toward pay-for-performance , quality metrics , and risk adjustment .


To facilitate the use of this model , we have created a website ( SpineSage.com ) where users can enter in patient data to determine likelihood of medical complications after spine surgery .


To determine whether a single trial of interferential current therapy ( ICT ) can immediately alleviate spasticity and improve balance and gait performance in patients with chronic stroke .


Randomized , placebo-controlled clinical trial .


Inpatient rehabilitation in a local center .


A total of 42 adult patients with chronic stroke with plantar flexor spasticity of the lower limb .


The ICT group received a single 60-minute ICT stimulation of the gastrocnemius in conjunction with air-pump massage .


In the placebo-ICT group , electrodes were placed and air-pump massage performed without electrical stimulation .


After a single ICT application , spasticity was measured immediately using the Modified Ashworth Scale ( MAS ) , and balance and functional gait performance were assessed using the following clinical tools : Functional Reach Test ( FRT ) , Berg Balance Scale ( BBS ) , Timed Up and Go Test ( TUG ) , and 10-m Walk Test ( 10MWT ) .


Gastrocnemius spasticity significantly decreased in the ICT group than in the placebo-ICT group ( MAS : ICT vs placebo-ICT : 1.550.76 vs 0.400.50 ) .


The ICT group showed significantly greater improvement in balance and gait abilities than the placebo-ICT group ( FRT : 2.621.21 vs 0.611.34 , BBS : 1.751.52 vs 0.400.88 , TUG : 6.076.11 vs 1.682.39 , 10MWT : 7.027.02 vs 1.963.13 ) .


Spasticity correlated significantly with balance and gait abilities ( P < 0.05 ) .


A single trial of ICT is a useful intervention for immediately improving spasticity , balance , and gait abilities in chronic stroke patients , but not for long-term effects .


Further study on the effects of repeated ICT is needed .


Pretreatment with intravenous 40 mg or 0.5 mg/kg lidocaine with venous occlusion is recommended to prevent pain following injection of lipid emulsion propofol .


This approach is not sufficient to prevent pain from the injection of microemulsion propofol .


The present study investigated whether a higher dose of lidocaine pretreatment with venous occlusion would be more effective for reducing pain following injection of microemulsion propofol compared with 40 mg lidocaine .


Patients undergoing elective surgery were randomly assigned to one of three groups : pretreatment with 40 mg ( group L40 ) , 60 mg ( group L60 ) or 80 mg ( group L80 ) lidocaine intravenously with venous occlusion , followed by injection with microemulsion propofol 1 min later .


Pain was assessed on a four-point scale ( severe , moderate , mild , none ) based on physical responses to the injection .


A total of 68 patients were included in the final analysis .


Pain severity and incidence were significantly lower in patients in group L60 and L80 compared with patients in group L40 .


There were no statistically significant differences in pain incidence or severity between group L60 and group L80 .


Pretreatment with 60 mg lidocaine intravenously with venous occlusion may be the most effective minimum dose for reducing injection pain following microemulsion propofol administration for induction of anaesthesia .


Depressive symptoms are common among adults with diabetes .


Depression and social support may influence diabetes self-management .


This study aimed to examine change in depressive symptoms and the role of depression and support on clinical and dietary outcomes among Latinos with type 2 diabetes participating in a diabetes self-management intervention .


Participants ( N = 252 ) were randomized to the intervention or usual care .


Mixed effects models were used to examine interaction effects between intervention status and depressive symptoms ( Centers for Epidemiologic Studies Depression ( CES-D ) score ) and support for diabetes self-management behaviors at baseline .


Outcomes were measured at baseline and 4 and 12months and included dietary quality , physical activity , depressive symptoms , and hemoglobin A1c levels .


Intervention participants had lower CES-D scores at follow-up than control participants .


An interaction effect between intervention status and CES-D scores predicted diet quality .


Latinos with depressive symptoms may derive the greatest benefits from diabetes self-management interventions .


Additional research on support during diabetes self-management interventions is warranted .


To assess the long-term ( up to 6 months ) safety profile of a 3-month regimen of NeuroAiD for acute ischemic stroke .


A total of 190 patients with acute ischemic stroke were identified for eligibility in a randomized , double-blind , placebo-controlled clinical trial , of which 150 patients allocated to either receiving NeuroAiD ( 80 cases ) or placebo ( 70 cases ) were analyzed after dropouts due to absence of baseline data , early death , or noncompliance .


Both groups received treatment for three months and followed up for another three months after the completion of the treatment .


Occurrence of clinical adverse events and laboratory parameters were assessed at 1 month , 3 months ( while under treatment ) and 6 months ( 3 months after the completion of treatment ) .


Statistical comparisons between groups were performed using chi-square test or t-test whenever appropriate .


The two groups had comparable baseline characteristics .


Mild nausea was more commonly reported in patients taking NeuroAid compared with placebo ( P = 0.01 ) , of which 9 out of 10 were observed only during the first month of treatment .


However , none of the adverse events reported were considered severe or required discontinuation of the study drug .


There was no significant change observed in mean arterial blood pressure , haemoglobin , renal and liver laboratory parameters during treatment with NeuroAid and up to 3 months after completion of a 3-month regimen .


NeuroAiD is safe and does not affect hematologic , hepatic , and renal functions during and long after completion of treatment .


The pre-drinking mood state has been indicated to be an important factor in the mood effects of alcohol .


However , for moderate alcohol consumption there are no controlled studies showing this association .


Also , the mood effects of consuming alcohol combined with food are largely unknown .


The aim of this study was to investigate the effects of moderate alcohol combined with a meal on ambiance-induced mood states .


Furthermore effects on autonomic nervous system activity were measured to explore physiological mechanisms that may be involved in changes of mood state .


In a crossover design 28 women ( age 18-45 y , BMI 18.5-27 kg/m2 ) were randomly allocated to 4 conditions in which they received 3 glasses of sparkling white wine ( 30 g alcohol ) or alcohol-free sparkling white wine while having dinner in a room with either a pleasant or unpleasant created ambiance .


Subjects filled out questionnaires ( B-BAES , POMS and postprandial wellness questionnaire ) at different times .


Skin conductance and heart rate variability were measured continuously .


Moderate alcohol consumption increased happiness scores in the unpleasant , but not in the pleasant ambiance .


Alcohol consumption increased happiness and stimulation feelings within 1 hour and increased sedative feelings and sleepiness for 2.5 hour .


Skin conductance was increased after alcohol within 1 hour and was related to happiness and stimulation scores .


Heart rate variability was decreased after alcohol for 2 hours and was related to mental alertness .


Mood inductions and autonomic nervous system parameters may be useful to evaluate mood changes by nutritional interventions .


Moderate alcohol consumption elevates happiness scores in an unpleasant ambiance .


However , drinking alcohol during a pleasant mood results in an equally positive mood state .


Clinicaltrials.gov NCT01426022 .


Remotely monitored patients may be at risk for a delayed response to critical arrhythmias if the telemetry watchers who monitor them are subject to an excessive patient load .


There are no guidelines or studies regarding the appropriate number of patients that a single watcher may safely and effectively monitor .


Our objective was to determine the impact of increasing the number of patients monitored on response time to simulated cardiac arrest .


Randomized trial .


Laboratory-based experiment .


Forty-two remote telemetry technicians and nurses from cardiac units .


Number of patients monitored in a simulation of cardiac telemetry monitoring work .


We carried out a study to compare response times to ventricular fibrillation across five patient loads : 16 , 24 , 32 , 40 , and 48 patients .


The simulation replicated the work of telemetry watchers using a combination of real recorded patient electrocardiogram signals and a simulated patient experiencing ventricular fibrillation .


Study participants were assigned to one of the five patient loads and completed a 4-hour monitoring session , during which they performed tasks-including event documentation and phone calls to report events-similar to real monitoring work .


When the simulated patient sustained ventricular fibrillation , the time required to report this arrhythmia was recorded .


As patient loads increased , there was a statistically significant increase in response times to the ventricular fibrillation .


In addition , frequency of failure to meet a response time goal of less than 20 seconds was significantly higher in the 48-patient condition than in all other conditions .


Task performance decreased as patient load increased .


As participants monitored more patients in a laboratory setting , their performance with respect to recognizing critical and noncritical events declined .


This study has implications for the design of remote telemetry work and other patient monitoring tasks in critical and intermediate care units .


We conducted a nested randomised trial to evaluate the effect of an educational DVD , providing information about healthy food choices and exercise during pregnancy , on diet and physical activity , among pregnant women who were overweight or obese .


We conducted a nested randomised trial within the context of the LIMIT randomised trial .


Women were eligible with a singleton pregnancy between 10 and 20weeks gestation , and body mass index at the time of their first antenatal appointment of 25kg/m ( 2 ) .


All women who were randomised to the Lifestyle Advice Group of the LIMIT trial received a series of consultations with both research dieticians and research assistants , in addition to standard written dietary and exercise materials ( Standard Materials Group ) .


Women randomised to the DVD Group received the same consultations and written materials , and additionally received an educational DVD ( DVD Group ) .


The primary study outcome was the Healthy Eating Index .


Other study outcomes included physical activity , and gestational weight gain .


Women completed a qualitative evaluation of all the materials provided .


1,108 women in the LIMIT Lifestyle Advice Group participated in the nested trial , with 543 women randomised to the DVD Group , and 565 women to the Standard Materials Group .


Women who received the DVD compared with those who did not , had a higher mean Healthy Eating Index at 36weeks gestation ( 73.6 vs 72.3 ; adjusted mean difference 1.2 ; 95 % CI 0.2 to 2.3 ; p = 0.02 ) , but not at 28weeks gestation ( 73.2 vs 73.5 ; adjusted mean difference -0.1 ; 95 % CI -1.1 to 0.9 ; p = 0.82 ) .


There were no statistically significant differences in physical activity or total gestational weight gain .


While most women evaluated the materials positively , frequency of utilisation was poor .


Ongoing attention to the delivery of information is required , particularly with the increased use and availability of digital and multi-media interactive technologies .


Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 .


This study sought to investigate whether the beneficial impact of high-dose rosuvastatin against contrast-induced acute kidney injury ( CI-AKI ) in acute coronary syndrome ( ACS ) patients varied in relation to baseline high-sensitivity C-reactive protein ( hs-CRP ) levels .


High-dose rosuvastatin administered on admission has been shown to prevent CI-AKI and improve short - and mid-term clinical outcome in ACS patients .


All 504 statin-nave ACS patients enrolled in the PRATO-ACS ( Protective Effect of Rosuvastatin and Antiplatelet Therapy on Contrast-Induced Acute Kidney Injury and Myocardial Damage in ACS Patients ) study were stratified into baseline hs-CRP tertiles : < 2.7 mg/l , 2.7 to < 7.5 mg/l , and 7.5 mg/l .


The primary endpoint was CI-AKI occurrence ( creatinine 0.5 mg/dl or 25 % above baseline within 72 h ) .


Logistic regression models were used to evaluate the relationship between hs-CRP levels and effects of rosuvastatin .


Patients with higher baseline hs-CRP values presented a significantly higher incidence of CI-AKI ( 5.4 % , 8.7 % , and 18.3 % in the first , second , and third tertiles , respectively ; p = 0.0001 ) .


The beneficial effect of rosuvastatin was markedly significant in the third hs-CRP tertile ( odds ratio : 0.20 ; 95 % confidence interval : 0.07 to 0.54 ; p = 0.002 ) .


Statin-treated patients in the third tertile presented a significantly lower rate of adverse events at 30 days ( 7.2 % vs. 17.4 % , p = 0.043 ) with a trend toward better outcome at 6 months ( 6.02 % vs. 13.04 % , p = 0.12 ) .


High-dose rosuvastatin administered on admission appears to exert more effective kidney protection in ACS subjects with higher baseline hs-CRP levels resulting in better short - and mid-term clinical outcome .


( Protective Effect of Rosuvastatin and Antiplatelet Therapy on Contrast-Induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention [ PRATO-ACS ] ; NCT01185938 ) .


Patients with melanoma that progresses on ipilimumab and , if BRAF ( V600 ) mutant-positive , a BRAF or MEK inhibitor or both , have few treatment options .


We assessed the efficacy and safety of two pembrolizumab doses versus investigator-choice chemotherapy in patients with ipilimumab-refractory melanoma .


We carried out a randomised phase 2 trial of patients aged 18 years or older from 73 hospitals , clinics , and academic medical centres in 12 countries who had confirmed progressive disease within 24 weeks after two or more ipilimumab doses and , if BRAF ( V600 ) mutant-positive , previous treatment with a BRAF or MEK inhibitor or both .


Patients had to have resolution of all ipilimumab-related adverse events to grade 0-1 and prednisone 10 mg/day or less for at least 2 weeks , an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 , and at least one measurable lesion to be eligible .


Using a centralised interactive voice response system , we randomly assigned ( 1:1:1 ) patients in a block size of six to receive intravenous pembrolizumab 2 mg/kg or 10 mg/kg every 3 weeks or investigator-choice chemotherapy ( paclitaxel plus carboplatin , paclitaxel , carboplatin , dacarbazine , or oral temozolomide ) .


Randomisation was stratified by ECOG performance status , lactate dehydrogenase concentration , and BRAF ( V600 ) mutation status .


Individual treatment assignment between pembrolizumab and chemotherapy was open label , but investigators and patients were masked to assignment of the dose of pembrolizumab .


We present the primary endpoint at the prespecified second interim analysis of progression-free survival in the intention-to-treat population .


This study is registered with ClinicalTrials.gov , number NCT01704287 .


The study is closed to enrolment but continues to follow up and treat patients .


Between Nov 30 , 2012 , and Nov 13 , 2013 , we enrolled 540 patients : 180 patients were randomly assigned to receive pembrolizumab 2 mg/kg , 181 to receive pembrolizumab 10 mg/kg , and 179 to receive chemotherapy .


Based on 410 progression-free survival events , progression-free survival was improved in patients assigned to pembrolizumab 2 mg/kg ( HR 057 , 95 % CI 045-073 ; p < 00001 ) and those assigned to pembrolizumab 10 mg/kg ( 050 , 039-064 ; p < 00001 ) compared with those assigned to chemotherapy .


6-month progression-free survival was 34 % ( 95 % CI 27-41 ) in the pembrolizumab 2 mg/kg group , 38 % ( 31-45 ) in the 10 mg/kg group , and 16 % ( 10-22 ) in the chemotherapy group .


Treatment-related grade 3-4 adverse events occurred in 20 ( 11 % ) patients in the pembrolizumab 2 mg/kg group , 25 ( 14 % ) in the pembrolizumab 10 mg/kg group , and 45 ( 26 % ) in the chemotherapy group .


The most common treatment-related grade 3-4 adverse event in the pembrolizumab groups was fatigue ( two [ 1 % ] of 178 patients in the 2 mg/kg group and one [ < 1 % ] of 179 patients in the 10 mg/kg group , compared with eight [ 5 % ] of 171 in the chemotherapy group ) .


Other treatment-related grade 3-4 adverse events include generalised oedema and myalgia ( each in two [ 1 % ] patients ) in those given pembrolizumab 2 mg/kg ; hypopituitarism , colitis , diarrhoea , decreased appetite , hyponatremia , and pneumonitis ( each in two [ 1 % ] ) in those given pembrolizumab 10 mg/kg ; and anaemia ( nine [ 5 % ] ) , fatigue ( eight [ 5 % ] ) , neutropenia ( six [ 4 % ] ) , and leucopenia ( six [ 4 % ] ) in those assigned to chemotherapy .


These findings establish pembrolizumab as a new standard of care for the treatment of ipilimumab-refractory melanoma .


Merck Sharp & Dohme .


Febuxostat is a selective inhibitor of xanthine oxidase , which is used to manage hyperuricemia in patients with gout .


The objective of the study was to compare the pharmacokinetics of two different strength of febuxostat formulations ( 80 mg and 40 mg ) .


A randomized , single-dose , open-label , two-period , two-sequence crossover study with a 7-day washout period was conducted in 30 healthy male subjects .


Participants received either reference ( 1 80 mg ) or test ( 2 40 mg ) formulations during the first period and the alternative formulation during the second period .


Plasma samples for the drug analysis were collected up to 24 hours after treatment .


All pharmacokinetic parameters were comparable between the two formulations The observed mean Cmax , AUC ( last ) , and AUC ( ) values for the reference formulation were 3,670 ng/mL , 12,086 ng x h/mL , and 12,880 ng x h/mL , respectively .


Corresponding values for the test formulation were 4,108 ng/mL , 12,689 ng x h/mL , and 13,278 ng x h/mL , respectively .


The geometric mean ratios ( 90 % CI ) between the two formulations were 1.1273 ( 1.0286 - 1.2355 ) for Cmax , 1.054 ( 1.0115 - 1.0980 ) for AUC ( last ) , and 1.0395 ( 0.9959 - 1.0851 ) for AUC ( ) .


The changes of serum uric acid at 24 hours after reference and test formations were comparable ( -1.36 mg/dL for reference and -1.37 mg/dL for test ; p = 0.892 ) .


The results of the present study indicated that the reference and test formulations have comparable pharmacokinetics and that these two formulations meet the regulatory criteria for bioequivalence .


In addition , the reduction of serum UA levels in the reference formulation was similar to that of the test formulation after a single dose .


The aim of this study was to determine whether massage therapy can be used as an adjunct intervention to induce sleep in infants born preterm .


Thirty infants born at a minimum of 28 weeks gestational age , who were at the time of the study between 32 and 48 weeks adjusted gestational age , were randomly assigned to receive massage therapy on 1 day and not receive massage on an alternate day .


The Motionlogger Micro Sleep Watch Actigraph recorded lower extremity activity on the morning of each day .


No significant difference was found between groups for sleep efficiency ( P = .13 ) during the time period evaluated .


Groups differed significantly during the time period after the massage ended with more infants sleeping on the nonmassage day ( = 4.9802 , P = .026 ) .


Massage is well tolerated in infants born preterm and infants do not fall asleep faster after massage than without massage .


Circulating levels of cardiac troponin I ( cTnI ) after ST-segment elevation myocardial infarction ( STEMI ) are associated with infarct size and chronic left ventricular dysfunction , but the relation to clinical end points and biochemical measures of global cardiac function remains less well defined .


One thousand sixty-six patients receiving primary percutaneous coronary intervention ( PCI ) in the PROTECTION AMI trial were studied in a post hoc analysis .


Cardiac troponin I was measured at several time points during the index hospitalization , and patients were followed up for 3 months before reassessment including N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) and left ventricular ejection fraction ( LVEF ) measurements .


The median ( quartile 1-3 ) cTnI levels were 0.4 ( 0.1-0 .4 ) g/L at admission , 33.1 ( 12.8-72 .1 ) g/L after 16 to 24 hours , and 9.1 ( 3.9-17 .5 ) g/L after 70 to 80 hours .


In adjusted models , all post-PCI single points , peak , and area under curve were found to be independently associated with clinical events , NT-proBNP > 118 pmol/L , or LVEF < 40 % ( P for all < .001 ) .


When cTnI was added to a baseline risk model for prediction of clinical events , the C statistic improved from 0.779 to 0.846 ( 16-24 hours ) and 0.859 ( 70-80 hours ) .


Quantified by integrated discrimination improvement , the addition of cTnI significantly augmented prediction ability ( relative integrated discrimination improvement 44 % -154 % ; P for all .001 ) .


Consistent improvements in discrimination of NT-proBNP > 118 pmol/L and LVEF < 40 % were observed .


Cardiac troponin I measured after primary PCI for STEMI is independently associated with clinical outcomes and cardiac function through 3-month follow-up .


These results suggest that cTnI levels are a useful risk stratification tool in STEMI patients .


Published studies of triptans in acute migraine have shown relatively disappointing 2-hour pain-free rates , ranging from 18 % to 58 % , with 2 - to 24-hour sustained pain-free rates from 17 % to 25 % .


A major flaw in the design of previous studies may have contributed to disappointing results : many subjects are not truly episodic in the nature of their headaches-they discount days with mild headache and ignore days with migraine-related neck pain .


Believing that neck pain is integrally related to migraine , we sought to ascertain whether early treatment with sumatriptan 85/naproxen sodium 500 ( sumatriptan/naproxen ) in truly episodic migraineurs is more robust than results when neck pain has not been considered .


Successfully screened adult migraineurs who returned baseline diaries showing 2 to 7 migraine attacks monthly and < 15 headache and/or neck pain days/month received blister packs containing 3 sumatriptan/naproxen/1 placebo for treatment of 4 migraines .


Instructions were to treat within the first 30 minutes of mild headache or neck discomfort-but only if the preceding day was completely free of both headache and neck pain .


In our study , 63.9 % of patient attacks treated with sumatriptan/naproxen achieved 2-hour pain freedom compared with 33.3 % of those with placebo ( P < 0.001 ) .


Sustained pain freedom ( 2-24 hours ) was achieved in 69.1 % of sumatriptan/naproxen-treated attacks , compared with 23.3 % with placebo ( P < 0.01 ) .


More subjects using sumatriptan/naproxen achieved sustained pain freedom ( than 2-hour pain freedom ) , due to 6 time points when the subject was sleeping/napping 2-hours post dose ( 5 sumatriptan/naproxen , 1 placebo ) , yet attested to no discomfort between 2 and 24 hours post dose .


Had the attacks been scored as pain-free at 2 hours , the 2-hour pain-free and sustained pain-free rates with sumatriptan/naproxen would have been identical at 69.1 % ( vs 36.7 % with placebo ) .


With truly episodic migraineurs , pain freedom was significant as soon as 15 minutes following treatment with sumatriptan/naproxen ( 5.2 % vs 0 % with placebo ; P < 0.01 ) .


Our study results support a fundamental re-evaluation of the role of neck pain in migraine .


Endobronchial valve ( EBV ) therapy is an innovative treatment that has been shown to be safe and effective in selected subgroups of patients with severe emphysema .


The objective of our study was to assess the cost-effectiveness of EBV therapy compared to the medical management of patients with high heterogeneity , complete fissures and lobar exclusion in the context of the German health-care system .


Clinical data from a subset of VENT ( Endobronchial Valve for Emphysema Palliation Trial ) provided information about clinical events , health-related quality of life , and disease staging for 12 months .


This information was subsequently used to project long-term disease progression , mortality , and health resource utilization .


We computed the 5 - and 10-year incremental cost-effectiveness ratio ( ICER ) in euros per quality-adjusted life year ( QALY ) .


Costs and effects were discounted at 3 % per year .


EBV therapy led to clinically meaningful disease restaging at 12 months ( 37.8 % of the cohort improved staging , compared to 0 % in the controls ) .


Over 5 years , EBV therapy was projected to increase survival from 66.4 to 70.7 % , and to add 0.22 QALYs .


Costs were estimated to increase by EUR 10,299 , resulting in an ICER of EUR 46,322 per QALY .


Over 10 years , 0.41 QALYs were gained at an additional cost of EUR 10,425 , yielding an ICER of EUR 25,142 per QALY .


Our model-based analysis suggests that EBV therapy leads to clinically meaningful changes in disease staging and progression when compared to medical management , with resulting gains in unadjusted and quality-adjusted life expectancy .


Our results indicate that EBV therapy is cost-effective in the German health-care system .


Burns remain disproportionately prevalent in developing countries .


This study aims to describe the epidemiology of burns in Sierra Leone to serve as a baseline for future programs .


A cluster randomized , cross-sectional , countrywide survey was conducted in 2012 in Sierra Leone .


With a standardized questionnaire demographics and deaths during the previous 12 months of household members were assessed with the household representative .


Thereafter , 2 randomly selected household members were interviewed , elucidating whether participants had ever had a burn in six body regions and determining burn mechanisms and patterns of health care seeking behavior .


This study included 1843 households and 3645 individuals .


3.98 % ( 145/3645 ) of individuals reported at least one burn-injury .


The highest proportions of burns were reported in the age groups 0-4 years old ( 23/426 , 5.4 % ) and 5-14 years old ( 37/887 , 4.17 % ) .


The majority of burns ( 129/145 , 89.0 % ) were caused by a hot liquid/object and the upper , extremities were the most commonly burned body regions , with 36 % ( 53/145 ) of cases .


21 % ( 30/145 ) of individuals with burns sought care from a traditional healer .


Burns are highly prevalent in Sierra Leone .


Further research and resources should be allocated to the care and prevention of thermal injuries .


We investigated whether micronutrients given acutely following the Christchurch earthquakes continued to confer benefit 1 year following the treatment .


Sixty-four adults from the original 91 participants experiencing heightened anxiety or stress 2-3 months following the 22nd February 2011 earthquake and who had been randomized to receive three different doses of micronutrients completed on-line questionnaires assessing mood , anxiety , stress , and symptoms associated with post-traumatic stress disorder 1 year after completing the initial study .


Twenty-one out of 29 nonrandomized controls who did not receive the treatment also completed the questionnaires .


Both the treated and control groups experienced significant improvement in psychological functioning compared with end-of-trial .


However , treated participants had better long-term outcomes on most measures compared with controls ( ES = 0.69-1 .31 ) .


Those who stayed on micronutrients through to follow-up or stopped all treatment reported better psychological functioning than those who switched to other treatments including medications .


About 10 % of the sample continued to have post-traumatic stress disorder symptoms .


Disaster survivors improve psychologically over time regardless of receiving intervention ; however , those taking micronutrients during the acute phase following a disaster show better outcomes , identifying micronutrients as a viable treatment for acute stress following a natural disaster with maintenance of benefits 1 year later .


ACTRN 12611000460909


To investigate an infusion of propofol for anesthesia in comparison to tiletamine-zolazepam anesthesia , evaluating physiological variables and recovery in squirrel monkeys .


Prospective non-blinded randomized study .


Eight healthy squirrel monkeys ( Saimiri sciureus ) , aged 3years and weighing 0.340-0 .695 kg .


Premedication was intramuscular midazolam ( 0.5 mg ) and meperidine ( 4mg ) .


Anesthesia was induced with intravenous ( IV ) propofol ( 4mgkg ( -1 ) minute ( -1 ) ) and maintained with propofol starting at 0.4 mgkg ( -1 ) minute ( -1 ) ( PRO , n = 4 ) or IV tiletamine-zolazepam ( 5mgkg ( -1 ) ) and maintained with supplementary doses of TZ ( TZ , n = 4 ) .


Cardiopulmonary variables were measured continuously .


Arterial blood gases and lactate concentration were measured at the end of anesthesia .


Quality and times of recovery were determined .


Repeatedly measured data for significant differences were tested between groups with t-test and within groups by anova .


Median time for induction of anesthesia in PRO was 180seconds .


Mean maintenance infusion rate of propofol was 0.430.05 mgkg ( -1 ) minute ( -1 ) , varying during the 1hour period .


One monkey died after administration of TZ ; others required 1 , 4 , or 8 supplemental doses .


Cardiopulmonary variables were similar between groups , but hypotension was recorded .


Recovery times to ventral recumbency in PRO ( 3217minutes ) and TZ ( 8411minutes ) and normal ambulation in PRO ( 5822minutes ) and TZ ( 358109minutes ) were significantly different ( p < 0.05 ) .


Recovery quality was superior in PRO , with less ataxia and fewer unsuccessful attempts to stand .


Lactate concentration was not different between treatments .


Cardiopulmonary variables were similar between protocols , aside from the higher incidence of hypotension in PRO , indicating that further studies with a larger number of animals are required .


Compared to tiletamine-zolazepam , propofol anesthesia provided faster and superior anesthetic recovery in these animals .


The objectives of this study were to evaluate the effects of medication education and behavioral intervention on Chinese patients with epilepsy and to compare the difference between them .


A total of 109 patients with epilepsy who did not to take their antiepileptic drugs ( AEDs ) more than once were randomly assigned to two intervention groups : the medication education group ( group I ) and the medication education with behavioral intervention group ( group II ) .


Group I was initially provided with medication education in the form of oral education and written materials , and this education was reinforced by monthly calls from the pharmacist over the next six months .


The behavioral intervention provided to group II consisted of a modified medication schedule which was based on cue-dose training therapy .


The outcomes that were evaluated both in the beginning and in the end of the study included adherence , which was measured using the four-item Morisky Medication Adherence Scale ( MMAS-4 ) , the number of seizures , knowledge of AEDs , and the number of patients who missed a dose of their AEDs .


Differences within and between the groups were analyzed .


After intervention , the adherence and knowledge of AEDs increased greatly in all patients , and the number of patients who had seizures or missed AEDs decreased .


However , no significant differences were observed between groups I and II .


The observed changes were ( group I vs group II , p value ) increased adherence : 62.3 % vs 64.3 % , 0.827 ; increased knowledge of AEDs : 88.7 % vs 80.4 % , 0.231 ; and improved seizure control : 64.2 % vs 64.3 % , 0.988 .


In addition , the percentage of patients who forgot to take their AEDs decreased to 45.0 % from more than 70 % , and 44.9 % of these patients took the missed AEDs as soon as they remembered .


These findings clearly demonstrate that medication education and reinforced telephone calls from pharmacists can help to increase adherence to AEDs , the knowledge of patients regarding AEDs , and seizure control .


However , the inclusion of a behavioral strategy that was easy to administer and use in this program did not lead to any significant effects on improving adherence .


The results indicate that pharmacists can play an important role in improving the effects of medication regimens , but further research is required to identify strategies for improving adherence to behavioral theory .


To compare between the effects of cold and warm ischemia on the risk of deterioration of renal insufficiency in patients with T1 renal tumor managed by partial nephrectomy .


This prospective randomized study was performed on 120 patients with chronic kidney disease , all having T1 renal tumors .


Renal function was estimated by estimated glomerular filtration rate ( eGFR ) , using the Modification of Diet in Renal Disease formula .


Patients were randomly divided into 2 groups : in group A , warm ischemia was used , and in group B , cold ischemia was used .


All patients were treated by open partial nephrectomy .


Patients were followed up for 2years .


The primary outcome of the study was eGFR at 2years .


Secondary outcomes were tumor recurrence , loss of follow-up , or patient death .


Mean age of patients was 60.7 5.3 years .


Associated chronic disease ( diabetes and/or hypertension ) was present in 93 patients .


Worsening of renal insufficiency occurred within 1month of surgery in 38 patients ( 27 in group A and 11 in group B ) .


At 3months follow-up , 21 of these 38 patients returned to their baseline eGFR .


Warm ischemia rendered patients more prone to a decrease in eGFR after partial nephrectomy , with relative risk of 1.34 and 2 times at 3months and 2years of follow-up , respectively .


Warm ischemia increases the risk of deterioration of renal functions in patients with renal insufficiency undergoing open partial nephrectomy for renal tumors .


Impaired nitric oxide-mediated pulmonary vascular tone is commonly found in heart failure with reduced ejection fraction ( HFrEF ) , and is associated with derangement of left ventricular ( LV ) hemodynamics and decreased exercise capacity , which may be reversed by PDE5 inhibitor .


This study investigated the effects of a new , long-acting PDE5 inhibitor on LV hemodynamics and exercise capacity in HFrEF .


Patients with chronic HFrEF on optimal medical therapy for > 30 days before enrollment were randomly assigned to placebo or udenafil at a dose of 50mg 2x/day for the first 4 weeks followed by 100mg 2x/day for the next 8 weeks .


All patients underwent cardiopulmonary exercise echocardiography before and after the 12-week treatment .


Improvement of subjective functional capacity was more frequently reported in the udenafil group ( P = 0.002 ) .


Also , a higher increase in peak VO2 ( peak VO2 , 21.6 % ( 6.9 ~ 106.4 % ) vs 1.9 % ( -15.7 ~ 21.0 % ) in the placebo group , P = 0.04 ) and a larger decrease in ventilatory efficiency were observed in the udenafil group ( -6.4 9.7 vs 1.9 12.1 in the placebo group , P = 0.03 ) .


Regarding LV systolic function , the extent of increment in LV ejection fraction was significantly greater in the udenafil group ( 6.6 6.4 % vs 2.3 4.8 % in the placebo group , P = 0.02 ) .


In the udenafil group , an echocardiographic surrogate of LV filling pressure was more prominently decreased ( P = 0.006 ) along with a significant reverse remodeling of left atrial volume index ( 57 25mL at baseline to 44 23 at 12th week , P = 0.04 ) and a progressive fall in B-type natriuretic peptide level ( 589 679pg/mL at baseline to 220 225pg/mL at 12th week , P < 0.001 ) , indicating LV diastolic function improvement .


Udenafil was well tolerated without excess of adverse events compared to placebo .


Udenafil improves LV systolic/diastolic functions and exercise capacity in conjunction with established conventional pharmacotherapy , without significant adverse events in HFrEF .


Two studies assessing ticagrelor pharmacokinetics , pharmacodynamics , and tolerability in healthy Japanese and Caucasian volunteers .


Single-ascending dose ( SAD ) study : Japanese ( n = 20 ) and Caucasians ( n = 20 ) received single doses of ticagrelor ( 50 , 100 , 200 , 300 , 400 , and 600 mg ) or placebo .


Multiple-ascending dose ( MAD ) study : Japanese ( n = 36 ) and Caucasians ( n = 36 ) received single doses of 100 mg or 300 mg ticagrelor ( day 1 ) , twice-daily 100 mg or 300 mg ticagrelor , or placebo ( days 4 9 ) , and single doses of 100 mg or 300 mg ticagrelor ( day 10 ) .


Exposure to ticagrelor and its active metabolite , AR-C124910XX , was generally higher in Japanese vs. Caucasians .


In the SAD study , area under the plasma concentration-time curve ( AUC ) values were 33 % ( ticagrelor ) and 55 % ( AR-C124910XX ) greater in Japanese vs. Caucasians following 600 mg ticagrelor .


In the MAD study , AUC values of ticagrelor and AR-C124910XX following multiple doses of ticagrelor 100 mg and 300 mg were statistically significantly greater ( 33 - 48 % ) in Japanese vs. Caucasians .


In both groups , mean peak inhibition of platelet aggregation was > 86 % after single doses ( > = 100 mg ticagrelor ) and > 84 % after multiple doses .


Bleeding times were > = 60 minutes in more Japanese than Caucasians with multiple dosing of 100 mg and 300 mg ticagrelor Adverse events were similar between groups ( mild-to-moderate intensity ) .


The pharmacokinetics and tolerability of ticagrelor were broadly similar in Japanese and Caucasians , although exposure was slightly greater in Japanese volunteers .


Ticagrelor was generally well tolerated .


The use of procinticos in the critical patient with nutrition enteral , they have as aim reduce the increase of the gastric residue ( RG ) .


We evaluate his efficiency in the improvement of the intake enteral and on the reduction in the incident gastrointestinal complications ( CGI ) and pneumonia , in critical patients , with neurological injury Aims : To evaluate the effects in the administration metoclopramide ( MCG ) , during the first five days with enteral nutrition , versus control ( GC ) , on the volume of administered diet , gastrointestinal complications and the incidence of mechanical ventilation associated pneumonia ( NAVM ) , in neuro-critically patients ( NC ) of traumatic and vascular aetiology .


Prospective , closed-label , randomized study performed in an intensive Care Unit .


Methords : 150 adult neuro-critical patients ( NC ) were admitted of consecutive form and 109 were randomly and two groups 58 MCG y 51 GC .


The primary outcomes was the nutritional : the volume of administered diet ( VAD ) ; mean efficacious volume ( MEV ) measured in three consecutive periods of time ; the gastrointestinal complications ( GIC ) , and the rate of partial and definitive suspension of the diet .


Infecction : incidence of ventilator associated pneumonia NAVM ; and of secondary outcomes were : the duration of mechanical ventilation , length of ICU and hospital stay , and incidence the serious sequelae , and 30 days mortality .


Differences were not observed in the severity variables between groups on admission .


A significant increase was observed in the global values and in the first five days of ( p < 0.03 ) of the VEM in the group of MCG .


The values of the global VDA and during three phases of study , the number CGI , the rate of partial and definitive suspensions of the diet , and number of NAVM , were similar in both not significant groups .


Neither differences were observed in the overall analysis secondary variables .


The metoclopramida in the NC , it is not effective in the decrease of the CGI , in the doses and time of treatment reflected in the study .


Whereas in the U.S. and Canada the Individual Placement and Support ( IPS ) model has proven to be highly effective in enhancing employment perspectives for persons with severe mental illnesses , the evidence base is less abundant in countries with a different socioeconomic climate .


The aim of this study was to examine the effectiveness of IPS in the Dutch socioeconomic context .


A multisite randomized controlled trial was performed following 151 persons with severe mental illnesses expressing an explicit wish for regular employment , comparing IPS with traditional vocational rehabilitation ( TVR ) .


Primary outcome was the proportion of persons who were competitively employed over a period of 30 months .


Secondary outcomes were self-reported quality of life , self-esteem and mental health .


Additionally , the impact of being engaged in competitive employment on these secondary outcomes was examined .


In 30 months , 44 % of IPS participants found competitive work , compared with 25 % of participants supported by TVR .


No direct effect of IPS on mental health , self-esteem or quality of life was found .


Being competitively employed before follow-up measurements was significantly associated with an increase in mental health , self-esteem and quality of life .


This study strongly confirms that IPS is an effective method in helping people with severe mental illnesses find competitive work also in countries characterized by a relatively protective socioeconomic climate putting up unintended barriers to employment .


The implementation of IPS on a larger scale seems warranted , and new studies are needed on the mechanisms through which IPS works .


The incidence of venous thromboembolism in children has increased significantly over the past 20 years .


Over the same period of time , there was an increase in the prevalence of obesity in the pediatric population .


Obesity is a known risk factor for VTE in adults , but little information is available in children .


This study evaluates the relation between obesity and VTE using a retrospective , case-control design , comparing the body mass index ( BMI ) of patients admitted with a diagnosis of VTE versus patients admitted with other diagnoses , at a single institution , between 2007 and 2011 .


We studied 48 inpatients diagnosed with deep venous thrombosis or pulmonary embolism and a control group of 274 age and gender matched patients admitted with other diagnoses .


We found obese patients ( BMI > 95th percentile ) to have significantly higher risk of VTE ( odds ratio 2.1 , with 95 % CI 1.1-4 .2 ) than patients of normal weight ( BMI < 85th percentile ) .


Overweight patients ( BMI 85th-95th percentile ) did not demonstrate a significant change in risk .


Most of the VTE patients were adolescents and the majority of them had other identifiable risk factors for thrombosis .


This study establishes a correlation between obesity and VTE in a group of hospitalized children , showing a risk for VTE in obese children similar to the one described in much larger adult cohorts .


To evaluate the feasibility of low radiation exposure and low contrast medium volume for coronary CT angiography with High - pitch spiral acquisition mode of dual source CT. .


135 patients whose BMI < 23 kg/m and heart rates < 65 bpm selected from 291 patients diagnosed of suspected CHD at our institution from September 2013 to February 2014 were randomly divided into 3 groups before CCTA , and there were 45 patients in each group .


80 kV , Iodixanol ( 320 mgI/ml ) and sinogram affirmed iterative reconstruction ( SAFIRE ) were used in A group .


80 kV , Iopamidol ( 370 mgI/ml ) and SAFIRE were used in B group .


100 kV , Iodixanol and filtered back projection ( FBP ) were used in C group .


Two radiologists assessed image quality with 5-piont scale subjectively and double-blind .


Independent-Sample Test was used to analyze statistical significance of image quality including signal to noise ratio ( SNR ) and contrast to noise ratio ( CNR ) between A and B group or between A and C group .


At the same time , Contrast medium dose statistical significance between A and B group and mean effective Radiation dose ( ED ) statistical significance between A and C were analyzed by the same way .


There were no significant difference of image quality including SNR and CNR of aortic root ( AO ) , left main coronary artery ( LM ) , left anterior descending artery ( LAD ) , circumflex coronary artery ( CX ) and right coronary artery ( RCA ) Between A and B group ( P = non-significant for all comparison ) , whereas Iodine in taken of A group decreased 14 % ( 17 600 mg vs 20 350 mg ) .


There were no significant difference of image quality including SNR and CNR of AO , LM , LAD , CX and RCA Between A and C group ( P = non-significant for all comparison ) , whereas mean ED of A group decreased 50 % ( 0.41 0.05 mSv vs 0.79 0.15 mSv ) .


The double low dose application which use High-pitch spiral mode , 80 kV , SAFIRE , and Iodixanol ( 320 mgI/ml ) can be used in those patients whose BMI < 23 kg/m and heart rates < 65 bpm to reduce the burden of radiation and contrast medium significantly , without compromising the image quality .


The Fundamentals of Laparoscopic Surgery ( FLS ) trainer is currently the standard for training and evaluating basic laparoscopic skills .


However , its manual scoring system is time-consuming and subjective .


The Virtual Basic Laparoscopic Skill Trainer ( VBLaST ) is the virtual version of the FLS trainer which allows automatic and real time assessment of skill performance , as well as force feedback .


In this study , the VBLaST pattern cutting ( VBLaST-PC ) and ligating loop ( VBLaST-LL ) tasks were evaluated as part of a validation study .


We hypothesized that performance would be similar on the FLS and VBLaST trainers , and that subjects with more experience would perform better than those with less experience on both trainers .


Fifty-five subjects with varying surgical experience were recruited at the Learning Center during the 2013 SAGES annual meeting and were divided into two groups : experts ( PGY 5 , surgical fellows and surgical attendings ) and novices ( PGY 1-4 ) .


They were asked to perform the PC or the ligating loop task on the FLS and the VBLaST trainers .


Their performance scores for each trainer were calculated and compared .


There were no significant differences between the FLS and VBLaST scores for either the PC or the ligating loop task .


Experts ' scores were significantly higher than the scores for novices on both trainers .


This study showed that the subjects ' performance on the VBLaST trainer was similar to the FLS performance for both tasks .


Both the VBLaST-PC and the VBLaST-LL tasks permitted discrimination between the novice and expert groups .


Although concurrent and discriminant validity has been established , further studies to establish convergent and predictive validity are needed .


Once validated as a training system for laparoscopic skills , the system is expected to overcome the current limitations of the FLS trainer .


Patients with major depressive disorder ( MDD ) often suffer from impaired declarative , episodic and working memory .


Further , MDD is associated with alterations in the noradrenergic system .


There is evidence that presynaptic 2 receptors that inhibit release of noradrenaline are upregulated in MDD .


Results from our recent study demonstrated that increasing noradrenergic activity by blocking the 2 receptor with yohimbine leads to stronger memory consolidation in MDD patients .


In the current study , we further examined the role of noradrenaline on memory in MDD by administering clonidine that activates presynaptic 2 receptors and thereby globally suppresses the noradrenergic output .


In a placebo-controlled , within-subject crossover design , 20 patients with MDD and 20 healthy controls received either 0.15 mg of clonidine or placebo orally before memory testing .


A word list paradigm ( memory consolidation ) , an autobiographical memory test ( retrieval ) and a working memory test were applied .


Salivary alpha-amylase and blood pressure were measured .


Across groups , clonidine decreased blood pressure and alpha-amylase .


Clonidine impaired memory consolidation ( word list learning ) in depressed patients and controls .


Memory retrieval and working memory were not affected by clonidine .


Reducing noradrenergic activity had a specific effect on memory consolidation in patients with MDD and healthy controls .


The underlying mechanisms need further scrutiny .


Enterovirus 71 ( EV71 ) is a major cause of hand , foot , and mouth disease in children and may be fatal .


A vaccine against EV71 is needed .


We conducted a randomized , double-blind , placebo-controlled phase 3 trial involving healthy children 6 to 71 months of age in Guangxi Zhuang Autonomous Region , China .


Two doses of an inactivated EV71 vaccine or placebo were administered intramuscularly , with a 4-week interval between doses , and children were monitored for up to 11 months .


The primary end point was protection against hand , foot , and mouth disease caused by EV71 .


A total of 12,000 children were randomly assigned to receive vaccine or placebo .


Serum neutralizing antibodies were assessed in 549 children who received the vaccine .


The seroconversion rate was 100 % 4 weeks after the two vaccinations , with a geometric mean titer of 170.6 .


Over the course of two epidemic seasons , the vaccine efficacy was 97.4 % ( 95 % confidence interval [ CI ] , 92.9 to 99.0 ) according to the intention-to-treat analysis and 97.3 % ( 95 % CI , 92.6 to 99.0 ) according to the per-protocol analysis .


Adverse events , such as fever ( which occurred in 41.6 % of the participants who received vaccine vs. 35.2 % of those who received placebo ) , were significantly more common in the week after vaccination among children who received the vaccine than among those who received placebo .


The inactivated EV71 vaccine elicited EV71-specific immune responses and protection against EV71-associated hand , foot , and mouth disease .


( Funded by the National Basic Research Program and others ; ClinicalTrials.gov number , NCT01569581 . )


Olfactory dysfunction is deemed to be a significant contributor to poor quality of life in chronic rhinosinusitis ( CRS ) .


To assess and to compare the effectiveness of three modalities of corticosteroids administration in patients with CRS .


A prospective randomized controlled study


Thirty patients with CRS were randomized in three groups depending on the route of corticosteroids administration : 16 days by oral route ( Medrol ( Pfizer , Belgique ) , 32 mg/8 days -16 mg/4 days-8 mg/4 days ) ; nasal spray ( Rhinocort ( AstraZeneca , Belgique ) , 2 2 64 g/nostril ) ; or sonic nebulization ( Pulmicort ( AstraZeneca , Belgique ) , 2 1 mg/4 mL ) ( Sonic nebulizer , AOHBOX-NL11SN , DTF , France ) .


Olfactory function was assessed using orthonasal threshold discrimination identification and retronasal psychophysical olfactory tests ( RNT ) before and after the treatment .


Same intranasal modalities were previously tested for in vitro airways scintigraphic deposition .


In vitro differences in drug deposition pattern between both intranasal modalities were demonstrated .


Threshold discrimination identification and RNT were similar between three groups at baseline .


Threshold discrimination identification improved by 5.5 , 5.8 , and -1.1 for sonic nebulization , oral , and nasal spray groups , respectively ( P = 0.010 ) .


This improvement was clinically relevant for oral and nebulized administration .


It was similar between oral and nebulized administration but significantly higher than nasal spray administration .


Retronasal psychophysical olfactory tests improved similarly for the three groups ( P = 0.231 ) CONCLUSION : Effectiveness of sonic nebulized and oral administration is demonstrated on orthonasal olfactory .


The clinical benefit is better than with nasal spray .


Patients with moderately to severely active ulcerative colitis occasionally do not respond to or lose initial response to maintenance dosing of anti-TNF therapy .


To report the efficacy of escalation from every other week ( EOW ) to weekly adalimumab dosing in patients from the clinical trial ULTRA 2 ( NCT00408629 ) , by week 8 response ( i.e. response after adalimumab induction therapy ) .


Week 52 remission , response , and mucosal healing rates were assessed in ULTRA 2 adalimumab-randomised patients who escalated to weekly dosing .


Patients were stratified by week 8 response per partial Mayo score .


Kaplan-Meier and logistic regression analyses estimated time to weekly dosing and defined predictors of escalation to weekly dosing , respectively .


Adverse events were reported for patients receiving open-label adalimumab .


The rate of escalation to weekly dosing was 16.3 % ( 20/123 ) for week 8 responders and 38.4 % ( 48/125 ) for week 8 nonresponders .


Week 52 remission , response and mucosal healing rates with weekly dosing were 20 % , 45 % , and 45 % for week 8 responders and 2.1 % , 25 % and 29.2 % for nonresponders , respectively ( NRI ) .


The median time to weekly dosing was 288days for week 8 nonresponders and not estimable for responders .


Prior anti-TNF use was a significant predictor of escalation to weekly dosing .


Treatment-emergent adverse event rates were similar for patients receiving open-label EOW or weekly adalimumab .


Escalation to weekly adalimumab dosing demonstrated clinical benefits for patients who lost response to therapy and may be beneficial for patients not initially responding to induction therapy .


No new safety risks were identified with weekly dosing .


Implementation intentions are effective for enhancing physical activity , but it is unknown how well these effects extend to older adults and/or are modified by cognitive variables .


Our objective is to examine ( 1 ) the efficacy of an implementation intentions intervention for physical activity in older adult women and ( 2 ) to examine the moderating effects of executive function .


Participants ( N = 75 , M age = 73.72 ) completed measures of executive function and were randomly assigned to weekly implementation intentions for physical activity ( experimental condition ) , implementation intentions for an unrelated behavior ( control condition ) , or no treatment .


Baseline activity was measured by accelerometer and self-report ; follow-up activity was measured by weekly self-report .


Findings indicated a significant treatment effect for the experimental condition and a treatment by executive function interaction .


Specifically , participants with relatively stronger executive function benefited most from the experimental intervention .


Implementation intentions are effective for enhancing physical activity among older adult women , and the effects may be especially pronounced for those with relatively stronger executive function .


Vitamin D ( D ) status is reported to correlate negatively with insulin production and insulin sensitivity in patients with type 2 diabetes mellitus ( T2DM ) .


However , few placebo-controlled intervention data are available .


We aimed to assess the effect of large doses of parenteral D3 on glycosylated haemoglobin ( HbA ( c ) ) and estimates of insulin action ( homeostasis model assessment insulin resistance : HOMA-IR ) in patients with stable T2DM .


We performed a prospective , randomised , double-blind , placebo-controlled pilot study at a single university care setting in Switzerland .


Fifty-five patients of both genders with T2DM of more than 10 years were enrolled and randomised to either 300,000 IU D or placebo , intramuscularly .


The primary endpoint was the intergroup difference in HbA ( c ) levels .


Secondary endpoints were : changes in insulin sensitivity , albuminuria , calcium/phosphate metabolism , activity of the renin-aldosterone axis and changes in 24-hour ambulatory blood pressure values .


After 6 months of D supply , there was a significant intergroup difference in the change in HbA ( c ) levels ( relative change [ mean standard deviation ] +2.9 % 1.5 % in the D group vs +6.9 % 2.1 % the in placebo group , p = 0.041 ) as HOMA-IR decreased by 12.8 % 5.6 % in the D group and increased by 10 % 5.4 % in the placebo group ( intergroup difference , p = 0.032 ) .


Twenty-four-hour urinary albumin excretion decreased in the D group from 200 41 to 126 39 , p = 0.021 ) .


There was no significant intergroup difference for the other secondary endpoints .


D improved insulin sensitivity ( based on HOMA-IR ) and affected the course of HbA ( c ) positively compared with placebo in patients with T2DM .


To investigate the effect of atorvastatin on exercise tolerance in patients with diastolic dysfunction and exercise-induced hypertension .


A randomized , double-blind , placebo-controlled prospective study was performed .


Sixty patients with diastolic dysfunction ( mitral flow velocity E/A < 1 ) and exercise-induced hypertension ( SBP > 200 mm Hg ) treated with atorvastatin ( 20 mg q.d ) or placebo for 1 year .


Cardiopulmonary exercise test and exercise blood pressure measurement were performed .


Plasma B-natriuretic peptide ( BNP ) concentration at rest and at peak exercise , plasma high sensitive-C reaction protein ( hs-CRP ) and endothelin ( ET ) concentration were determined at baseline and after treatment .


After treatment by atorvastatin , the resting SBP , pulse pressure , the peak exercise SBP and BNP were significantly decreased ; and the exercise time , metabolic equivalent , maximal oxygen uptake and anaerobic threshold were increased .


All of these parameters had significant differences with baseline levels ( P < 0.05 ) and the rest pulse pressure , the peak exercise SBP and BNP , and the exercise time had significant differences compared with placebo treatment ( P < 0.05 ) .


Plasma concentrations of hs-CRP and ET were markedly reduced by atorvastatin treatment compared with baseline and placebo ( P < 0.05 ) .


No difference in above parameters was found before and after placebo treatment ( P > 0.05 ) .


In patients with diastolic dysfunction at rest and exercise-induced hypertension , atorvastatin can effectively reduce plasma hs-CRP and ET level , lower blood pressure and peak exercise SBP , decrease peak exercise plasma BNP concentration , and ultimately improve exercise tolerance .


The inequity of randomising participants to control groups in randomised controlled trials ( RCTs ) is often considered inappropriate , especially for research trials that include vulnerable populations such as Indigenous peoples .


The Aboriginal and Torres Strait Islander Women 's Fitness Program conducted a trial that randomly assigned participants to ` active ' and ` waitlisted ' groups .


This paper reports on participant views of the randomisation protocol .


A pragmatic RCT was conducted in an urban setting to assess the effectiveness of the 12-week Aboriginal and Torres Strait Islander Women 's Fitness Program on metabolic health outcomes and waist circumference .


Qualitative interviews were conducted at follow-up , one of the objectives was to explore participant perspectives on the research protocol , including participant randomisation to ` Active ' and ` Waitlisted ' groups .


A total of 49 interviews were conducted ( 26 Active and 23 Waitlisted participants ) .


Two key factors influenced participant views on the protocol : 1 ) group assignment ; and 2 ) how well they understood the research design , including the justification for randomisation .


` Active ' participants were concerned about the inequity of the randomisation process but overall supported the study protocol .


Although most Waitlisted participants were disappointed about having to wait 12-months for the program , some participants derived motivation from being waitlisted , whilst others lost motivation .


Well-informed participants were more likely to express both support for the randomisation process and an understanding of the research benefits than participants not attending an information session prior to registration .


Participants were more accepting of the research protocol if it was clearly explained to them , if they understood the randomisation process and felt the randomisation was justified in terms of the potential for the results to benefit other Aboriginal and Torres Strait Islander women .


Our study suggests that the time and resources required to adequately explain the research protocol in research trials should not be undervalued .


Australian New Zealand Clinical Trials Registry ( ACTRN12610000224022 ) .


The authors studied the interaction between sevoflurane and remifentanil on bispectral index ( BIS ) , state entropy ( SE ) , response entropy ( RE ) , Composite Variability Index , and Surgical Pleth Index , by using a response surface methodology .


The authors also studied the influence of stimulation on this interaction .


Forty patients received combined concentrations of remifentanil ( 0 to 12 ng/ml ) and sevoflurane ( 0.5 to 3.5 vol % ) according to a crisscross design ( 160 concentration pairs ) .


During pseudo-steady-state anesthesia , the pharmacodynamic measures were obtained before and after a series of noxious and nonnoxious stimulations .


For the `` prestimulation '' and `` poststimulation '' BIS , SE , RE , Composite Variability Index , and Surgical Pleth Index , interaction models were applied to find the best fit , by using NONMEM 7.2.0 .


( Icon Development Solutions , Hanover , MD ) .


The authors found an additive interaction between sevoflurane and remifentanil on BIS , SE , and RE .


For Composite Variability Index , a moderate synergism was found .


The comparison of pre - and poststimulation data revealed a shift of C50SEVO for BIS , SE , and RE , with a consistent increase of 0.3 vol % .


The Surgical Pleth Index data did not result in plausible parameter estimates , neither before nor after stimulation .


By combining pre - and poststimulation data , interaction models for BIS , SE , and RE demonstrate a consistent influence of `` stimulation '' on the pharmacodynamic relationship between sevoflurane and remifentanil .


Significant population variability exists for Composite Variability Index and Surgical Pleth Index .


Abdominal aortic aneurysm ( AAA ) is thought to develop as a result of inflammatory processes in the aortic wall .


In particular , mast cells are believed to play a central role .


The AORTA trial was undertaken to investigate whether the mast cell inhibitor , pemirolast , could retard the growth of medium-sized AAAs .


In preclinical and clinical trials , pemirolast has been shown to inhibit antigen-induced allergic reactions .


Inclusion criteria for the trial were patients with an AAA of 39-49mm in diameter on ultrasound imaging .


Among exclusion criteria were previous aortic surgery , diabetes mellitus , and severe concomitant disease with a life expectancy of less than 2years .


Included patients were treated with 10 , 25 or 40mg pemirolast , or matching placebo for 52weeks .


The primary endpoint was change in aortic diameter as measured from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall in systole .


All ultrasound scans were read in a central imaging laboratory .


Some 326 patients ( mean age 708years ; 880 per cent men ) were included in the trial .


The overall mean growth rate was 242mm during the 12-month study .


There was no statistically significant difference in growth between patients receiving placebo and those in the three dose groups of pemirolast .


Similarly , there were no differences in adverse events .


Treatment with pemirolast did not retard the growth of medium-sized AAAs .


NCT01354184 ( https://www.clinicaltrials.gov ) .


Little is known about how U.S. physicians political affiliations , specialties , or sense of social responsibility relate to their reactions to health care reform legislation .


To assess U.S. physicians impressions about the direction of U.S. health care under the Affordable Care Act ( ACA ) , whether that legislation will make reimbursement more or less fair , and examine how those judgments relate to political affiliation and perceived social responsibility .


A cross-sectional , mailed , self-reported survey .


Simple random sample of 3,897 U.S.physicians .


Views on the ACA in general , reimbursement under the ACA in particular , and perceived social responsibility .


Among 2,556 physicians who responded ( RR2 : 65 % ) , approximately two out of five ( 41 % ) believed that the ACA will turn U.S. health care in the right direction and make physician reimbursement less fair ( 44 % ) .


Seventy-two percent of physicians endorsed a general professional obligation to address societal health policy issues , 65 % agreed that every physician is professionally obligated to care for the uninsured or underinsured , and half ( 55 % ) were willing to accept limits on coverage for expensive drugs and procedures for the sake of expanding access to basic health care .


In multivariable analyses , liberals and independents were both substantially more likely to endorse the ACA ( OR 33.0 [ 95 % CI , 23.646.2 ] ; OR 5.0 [ 95 % CI , 3.76.8 ] , respectively ) , as were physicians reporting a salary ( OR 1.7 [ 95 % CI , 1.22.5 ] ) or salary plus bonus ( OR 1.4 [ 95 % CI , 1.11.9 ) compensation type .


In the same multivariate models , those who agreed that addressing societal health policy issues are within the scope of their professional obligations ( OR 1.5 [ 95 % CI , 1.02.0 ] ) , who believe physicians are professionally obligated to care for the uninsured / under-insured ( OR 1.7 [ 95 % CI ,1.32.4 ] ) , and who agreed with limiting coverage for expensive drugs and procedures to expand insurance coverage ( OR 2.3 [ 95 % CI , 1.83.0 ] ) , were all significantly more likely to endorse the ACA .


Surgeons and procedural specialists were less likely to endorse it ( OR 0.5 [ 95 % CI , 0.40.7 ] , OR 0.6 [ 95 % CI , 0.50.9 ] , respectively ) .


Significant subsets of U.S. physicians express concerns about the direction of U.S. health care under recent health care reform legislation .


Those opinions appear intertwined with political affiliation , type of medical specialty , as well as perceived social responsibility .


To evaluate the influence of different alveolar bone heights on fracture resistance and pattern of post and core restored maxillary premolars .


Forty-eight maxillary premolars were randomly divided into 6 groups ( 8 teeth in each group ) for different alveolar bone heights and different post and core materials .


Group A : fiber post and core and normal alveolar bone height .


Group B : Ni-Cr cast post and core and normal alveolar bone height .


Group C : fiber post and core with 2 mm alveolar bone height reduction .


Group D : Ni-Cr cast post and core with 2 mm alveolar bone height reduction .


Group E : fiber post and core with 4 mm alveolar bone height reduction .


Group F : Ni-Cr cast post and core with 4 mm alveolar bone height reduction .


All of the teeth were restored with Ni-Cr cast crowns .


Fracture resistances were tested and the failure modes were examined .


The mean fracture resistances were ( 762.49 84.91 ) N for group A , ( 794.26 72.61 ) N for group B , ( 517.69 80.30 ) N for group C , ( 543.50 62.88 ) N for group D , ( 219.91 43.20 ) N for group E , and ( 196.16 41.08 ) N for group F.


The ratios of favorable fractures were 100.0 % for group A , 37.5 % for group B , 75.0 % for group C , 12.5 % for group D , 50.0 % for group E , and 0 for group F.


The alveolar bone height has a significant impact on fracture resistance and modes of post and core restored maxillary premolars .


With the reduction of alveolar bone height , the fracture decreases and the fracture mode tends to be unfavorable .


Computed tomography ( CT ) is used to assess for fracture after knee trauma , but identification of ligamentous injuries may also be beneficial .


Our purpose is to assess the potential of dual-energy computed tomography ( DECT ) for the detection of complete anterior cruciate ligament ( ACL ) disruption .


Sixteen patients with unilateral traumatic ACL disruption ( average of 58 days following trauma ) confirmed by MRI , and 11 control patients without trauma , underwent DECT of both knees .


For each knee , axial , sagittal , and oblique sagittal images ( with DECT bone removal , single-energy ( SE ) bone removal , and DECT tendon-specific color mapping ) were reconstructed .


Four musculoskeletal radiologists randomly evaluated the 324 DECT reconstructed series ( 54 knees with 6 displays ) separately , to assess for ACL disruption using a five-point scale ( 1 = definitely not torn , to 5 = definitely torn ) .


ROC analysis was used to compare performance across readers and displays .


Sagittal oblique displays ( mixed kV soft tissue , SE bone removal , and DECT bone removal ) demonstrated higher areas under the curve for ACL disruption ( AUC = 0.95 , 0.93 and 0.95 respectively ) without significant differences in performance between readers ( p > 0.23 ) .


Inter-reader agreement was also better for these display methods ( ICC range 0.62-0 .69 ) compared with other techniques ( ICC range 0.41-0 .57 ) .


Mean sensitivity for ACL disruption was worst for DECT tendon-specific color map and axial images ( 24 % and 63 % respectively ) .


DECT knee images with oblique sagittal reconstructions using either mixedkV or bone removal displays ( either DECT or SE ) depict ACL disruption in the subacute or chronic setting with reliable identification by musculoskeletal radiologists .


A treatment-as-usual randomized wait-list controlled trial was conducted to investigate the feasibility and impact of an online synchronous Mindfulness-Based Cancer Recovery ( MBCR ) group program for underserved distressed cancer survivors .


Sixty-two men and women exhibiting moderate to high distress within 3 years of completing primary cancer treatment without access to in-person MBCR were randomized to either immediate online MBCR ( n = 30 ) or to wait for the next available program ( n = 32 ) .


Participants completed questionnaires preintervention and postintervention or wait period online .


Program evaluations were completed after MBCR .


Feasibility was tracked through monitoring eligibility and participation through the protocol .


Intent-to-treat mixed-model analyses for repeated measures were conducted .


Feasibility targets for recruitment and retention were achieved , and participants were satisfied and would recommend online MBCR .


There were significant improvements and moderate Cohen d effect sizes in the online MBCR group relative to controls after MBCR for total scores of mood disturbance ( d = 0.44 , p = .049 ) , stress symptoms ( d = 0.49 , p = .021 ) , spirituality ( d = 0.37 , p = .040 ) , and mindfully acting with awareness ( d = 0.50 , p = .026 ) .


Main effects of time were observed for posttraumatic growth and remaining mindfulness facets .


Results provide evidence for the feasibility and efficacy of an online adaptation of MBCR for the reduction of mood disturbance and stress symptoms , as well as an increase in spirituality and mindfully acting with awareness compared with a treatment-as-usual wait-list .


Future study using larger active control RCT designs is warranted .


Clinical Trials.gov : NCT01476891 .


Lemongrass oil ( LG ) has been reported as being effective against bacteria embedded within the biofilm .


The aims of this study were to investigate antimicrobial activity against common odourigenic micro-organisms , the safety and efficacy of LG mouthrinse on oral malodour in healthy volunteers .


Antimicrobial activity of LG mouthrinse was examined against common odourigenic micro-organisms using broth microdilution assay and the disc diffusion method .


A randomised double-blind clinical study was performed in 20 healthy volunteers .


Volatile sulphur compounds ( VSCs ) level was measured using a Halimeter on day 0 and day 8 in each volunteer .


The results showed that LG mouthrinse was effective against Aggregatibacter actinomycetemcomitans ATCC43718 and Porphyromonas gingivalis W50 but less effective against Streptococcus mutans ATCC 25175 .


In addition , the mouthrinse significantly reduced VSCs on day 8 .