There were no significant differences in lifestyle behaviors and determinants of these behaviors between the intervention and control group after @ or @ months .


The sensitivity analyses showed effect modification for gender in sedentary behavior at work at @-month follow-up , although the main analyses did not .


This study did not show an effect of a worksite mindfulness-based multi-component intervention on lifestyle behaviors and behavioral determinants after @ and @ months .


The effectiveness of a worksite mindfulness-based multi-component intervention as a health promotion intervention for all workers could not be established .


Intralesional antigen therapy has been used in the treatment of anogenital warts ( AGWs ) , but it has not been compared with existing therapies .


Evidence of its efficacy is not strong .


To compare the efficacy and safety of intralesional Mycobacterium w ( Mw ) vaccine with that of imiquimod , @ % , cream in the treatment of AGWs , as well as changes in human papillomavirus ( HPV ) -@ and HPV-@ viral loads .


A double-blind randomized clinical trial was conducted in New Delhi , India , between February @ and July @ and included a @-month follow-up .


Of @ patients with AGWs who were screened , @ were randomized .


Patients received either imiquimod , @ % , cream and an intralesional vehicle ( imiquimod group : @ patients ) or vehicle cream and intralesional Mw vaccine ( Mw group : @ patients ) .


The primary end point was complete clinical remission of visible AGWs .


Secondary measures included the percentage of reduction in the surface area of AGWs and viral load for HPV-@ and HPV-@ .


Viral load was measured by real-time quantitative polymerase chain reaction .


In the intention-to-treat analysis , @ % ( n = @ ) of the patients in the imiquimod group and @ % ( n = @ ) of those in the Mw group had complete resolution ( P = @ ) .


Eighteen HPV genotypes , including high-risk genotypes , were detected , with no significant differences between the treatment groups ( all P > @ ) .


There was a significant decline in the mean viral loads of HPV-@ ( from @ to @ copies/mg of tissue ; P = @ ) and HPV-@ ( from @ to @ copies/mg of tissue ; P = @ ) after treatment in the Mw group but only in the viral load of HPV-@ ( from @ to @ copies/mg of tissue ; P = @ ) in the imiquimod group .


There was no recurrence of AGWs in patients with complete clearance at the @-month follow-up and no serious adverse events .


Imiquimod , @ % , and the Mw vaccine were equally effective in achieving clinical and virologic clearance for HPV-@ .


A significant decline in the HPV-@ viral load was achieved only with the Mw vaccine .


Efficacy and safety of intralesional Mw vaccine is comparable to that of imiquimod , @ % , in treatment of AGWs .


The present study investigated whether cilostazol can eliminate adverse smoking outcome after percutaneous coronary intervention ( PCI ) .


A total of @ patients with successful drug-eluting stent ( DES ) implantation were randomly assigned to dual antiplatelet therapy ( DAT ; aspirin and clopidogrel , n = @ ) or to triple antiplatelet therapy ( TAT ; DAT with cilostazol , n = @ ) .


The effect of smoking on @-year major adverse cardio/cerebrovascular events ( MACCE ) in both the TAT and DAT groups was evaluated .


Total MACCE were not significantly different between the @ anti-platelet regimens ( @ % in TAT vs. @ % in DAT groups , P = @ ) , but the adverse effects of smoking on clinical outcome were different between DAT vs. TAT .


Current smokers had a higher prevalence of MACCE than non-smokers in the DAT group ( @ % vs. @ % , P = @ ) .


In the TAT group , however , the adverse effect of smoking was abolished ( @ % vs. @ % , P = @ ) .


Regarding the effects of smoking on the antiplatelet effects of DAT or TAT , post-treatment platelet reactivity ( in P@Y@ reaction units ; PRU ) in current smokers was not significantly lower than that in non-smokers in the DAT group , whereas , in the TAT group , it was significantly lower than that of non-smokers ( @ vs. @ PRU , P = @ ) .


Adverse clinical effects of smoking may be eliminated by the addition of cilostazol to DAT after DES implantation .


This may be due to the stimulation of cilostazol 's antiplatelet effects by smoking .


The purpose of this study was to test the comparative effectiveness of three variations of an online-based health promotion program for improving health and employment outcomes in a sample of Vocational Rehabilitation consumers .


A total of @ VR consumers participated in a randomized trial of three health promotion variations and provided baseline , @ - , @ - , and @-month data .


Data were analyzed using repeated measures ANOVA .


The three health promotion variations included ( a ) FACTSHEETS-a series of four electronic factsheets ; ( b ) HPE-an online interactive health promotion website that included health behavior content and tailored action planning , and ( c ) HPE + MI-the online health promotion website plus two @-minute calls with a trained motivational interviewer .


Contrary to expectations , evidence did not support between-group differences based on intervention intensity .


In fact , the Factsheet , HPE , and HPE + MI participants all experienced significant reductions in secondary conditions , F ( @ , @ ) = @ , p < @ , HRQoL symptom days , F ( @ , @ ) = @ , p = @ ; and significant improvements in healthy lifestyle behaviors , F ( @ , @ ) = @ , p = @ over the @-month study period .


Although this study did not include a control group , a control group from another study with a similar population did not experience similar outcomes .


People with disabilities experience significantly higher rates of secondary health conditions and lower employment rates than people without disabilities .


The combination of these factors signifies the need for health promotion programming outside the work setting .


Muscle glycogen has been well established as the primary metabolic energy substrate during physical exercise of moderate - to high-intensity and has accordingly been implicated as a limiting factor when such activity is sustained for a prolonged duration .


However , the role of this substrate during repeated exercise after limited recovery is less clear , with ongoing debate regarding how recovery processes can best be supported via nutritional intervention .


The aim of this project is to examine the causes of fatigue during repeated exercise bouts via manipulation of glycogen availability through nutritional intervention , thus simultaneously informing aspects of the optimal feeding strategy for recovery from prolonged exercise .


The project involves two phases with each involving two treatment arms administered in a repeated measures design .


For each treatment , participants will be required to exercise to the point of volitional exhaustion on a motorised treadmill at @ % of previously determined maximal oxygen uptake , before a four hour recovery period in which participants will be prescribed solutions providing @ grams of sucrose per kilogram of body mass per hour of recovery ( g.kg-@ .


h-@ ) relative to either a lower rate of sucrose ingestion ( that is , @ g.kg-@ .


h-@ ; Phase I ) or a moderate dose ( that is , @ g.kg-@ .


h-@ ) rendered isocaloric via the addition of @ g.kg-@ .


h-@ whey protein hydrolysate ( Phase II ) ; the latter administered in a double blind manner as part of a randomised and counterbalanced design .


Muscle biopsies will be sampled at the beginning and end of recovery for determination of muscle glycogen resynthesis rates , with further biopsies taken following a second bout of exhaustive exercise to determine differences in substrate availability relative to the initial sample taken following the first exercise bout .


Phase I will inform whether a dose-response relationship exists between carbohydrate ingestion rate and muscle glycogen availability and/or the subsequent capacity for physical exercise .


Phase II will determine whether such effects are dependent on glycogen availability per se or energy intake , potentially via protein mediated mechanisms .


Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis .


We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis , with respect to overall long-term morbidity and mortality .


We did a multicentre , parallel-group , randomised , open-label trial in @ teaching hospitals and eight academic hospitals in Belgium , Italy , and the Netherlands ( the Ladies trial ) .


The Ladies trial is split into two groups : the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann 's procedure with sigmoidectomy plus primary anastomosis .


The DIVA section of this trial is still underway but here we report the results of the LOLA section .


Patients with purulent perforated diverticulitis were enrolled for LOLA , excluding patients with faecal peritonitis , aged older than @ years , with high-dose steroid use ( @ mg daily ) , and haemodynamic instability .


Patients were randomly assigned ( @:@:@ ; stratified by age -LSB- < @ years vs @ years -RSB- ) using secure online computer randomisation to laparoscopic lavage , Hartmann 's procedure , or primary anastomosis in a parallel design after diagnostic laparoscopy .


Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal , according to local protocols .


The primary endpoint was a composite endpoint of major morbidity and mortality within @ months .


This trial is registered with ClinicalTrials.gov , number NCT@ .


Between July @ , @ , and Feb @ , @ , @ patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group .


Two patients were excluded for protocol violations .


The primary endpoint occurred in @ ( @ % ) of @ patients in the lavage group and @ ( @ % ) of @ patients in the sigmoidectomy group ( odds ratio @ , @ % CI @-@ , p = @ ) .


By @ months , four patients had died after lavage and six patients had died after sigmoidectomy ( p = @ ) .


Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis .


To compare the laser spot quality between the conventional slit lamp pattern laser ( PASCAL ) and the navigated pattern laser ( NAVILAS ) for panretinal photocoagulation ( PRP ) .


Prospective randomized interventional trial of @ eyes ( @ patients ) with high-risk proliferative diabetic retinopathy .


Eyes underwent PRP using @-ms pulse duration with either PASCAL ( @ eyes ) or NAVILAS laser ( @ eyes ) , or @-ms pulse duration with either PASCAL ( @ eyes ) or NAVILAS laser ( @ eyes ) .


Fundus color images of all quadrants were taken @ minutes after treatment .


Laser burn size ( major and minor diameter and area ) and ellipticity ( ratio of minor to major axis ) were analyzed across the retina .


Treatment time and pain were compared between both groups .


The burn size variation in navigated laser @ ms , @ ms , and conventional pattern @ ms and single-spot @ ms laser was @ % , @ % , @ % , and @ % , respectively .


The variation of the laser burn area near the arcade for NAVILAS and for PASCAL was @ % and @ % , respectively ( P < @ ) .


Closer to the equator , burns from the NAVILAS showed even smaller variation of @ % compared with @ % with PASCAL ( P < @ ) .


Laser spots from PASCAL exhibited an increasing elliptical shape toward the periphery , whereas NAVILAS laser spots tended to be more uniform all over the retina .


Average treatment duration and pain experience was less with navigated laser compared with pattern laser ( P @ ) .


Navigated laser treatment achieves more uniform laser burns with less pain during shorter treatment duration in comparison with conventional pattern laser .


In patients with chronic tension-type headache ( CTTH ) changes in pressure pain in the cervical region are associated with peripheral or central sensitization .


It is hypothesized that an increase of isometric strength of neck flexors would lead to a decrease of pressure pain in CTTH , as an expression of reduced peripheral or central sensitization


In this study we aimed to analyze the correlation between change in isometric strength of the neck flexors and change in pressure pain scores ( PPS ) in patients with CTTH .


Comparative analysis of data from previous study .


Primary healthcare center .


Data from @ patients with CTTH who underwent a manual therapy program including isometric strength training of the neck flexors were analyzed at @ and @ weeks post-treatment .


PPS were measured as a total of pain scores on a numeric rating scale ( score @ to @ ) on application of a pressure stimulus of @kg/cm at @ cervical - and suboccipital muscles .


Isometric strength of the neck flexors was measured in seconds .


Correlations were computed between changes in PPS and isometric neck flexor strength .


Isometric strength of neck flexors scored significantly different compared to baseline measurement ( mean @ seconds , sd :@ ) , and increased with a mean difference of @ seconds ( @ % CI : @ to @ ) at @ weeks and @ seconds ( @ % CI : @ to @ ) at @ weeks .


Similarly , compared to PPS baseline measurement ( @ points , sd :@ ) , mean difference in PPS was significantly decreased at @ and @ weeks : -@ points ( @ % CI : -@ to -@ ) and -@ points ( @ % CI : -@ to -@ ) .


There is a negative correlation between changes in PPS and changes in isometric strength of neck flexors which is weak at @ weeks ( r = -@ , P = @ ) and moderate at @ weeks ( r = -@ , P < @ ) .


Correlational analysis .


Decrease in PPS correlates with increases in isometric strength of neck flexors in patients with CTTH in short - and long-term .


Patients with ischemic left ventricular dysfunction have higher operative risk with coronary artery bypass graft surgery ( CABG ) .


However , those whose early risk is surpassed by subsequent survival benefit have not been identified .


This study sought to examine the impact of anatomic variables associated with poor prognosis on the effect of CABG in ischemic cardiomyopathy .


All @,@ patients in the STICH ( Surgical Treatment of IsChemic Heart failure ) surgical revascularization trial were included .


Patients had coronary artery disease ( CAD ) and ejection fraction ( EF ) of @ % and were randomized to receive CABG plus medical therapy or optimal medical therapy ( OMT ) alone .


This study focused on @ prognostic factors : presence of @-vessel CAD , EF below the median ( @ % ) , and end-systolic volume index ( ESVI ) above the median ( @ ml/m ( @ ) ) .


Patients were categorized as having @ to @ or @ to @ of these factors .


Patients with @ to @ prognostic factors ( n = @ ) had reduced mortality with CABG compared with those who received OMT ( hazard ratio -LSB- HR -RSB- : @ ; @ % confidence interval -LSB- CI -RSB- : @ to @ ; p = @ ) ; CABG had no such effect in patients with @ to @ factor ( HR : @ ; @ % CI : @ to @ ; p = @ ) .


There was a significant interaction between the number of factors and the effect of CABG on mortality ( p = @ ) .


Although @-day risk with CABG was higher , a net beneficial effect of CABG relative to OMT was observed at > @ years in patients with @ to @ factors ( HR : @ ; @ % CI : @ to @ ; p < @ ) but not in those with @ to @ factor ( HR : @ ; @ % CI : @ to @ ; p = @ ) .


Patients with more advanced ischemic cardiomyopathy receive greater benefit from CABG .


This supports the indication for surgical revascularization in patients with more extensive CAD and worse myocardial dysfunction and remodeling .


( Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease -LSB- STICH -RSB- ; NCT@ ) .


Hypertension and overweight are prevalent problems in type @ diabetic patients .


The purpose of this study was to assess the effects of long term regular aerobic exercise training on blood pressure ( BP ) as well as body mass index ( BMI ) in type @ diabetes mellitus ( T@DM ) .


In a randomized , controlled trial , @ patients with T@DM aged @-@ years were randomly divided in two groups ( @ subjects in exercise group and @ subjects in control group ) .


Supervised exercise program was performed three times per week for @ years .


Finally , @ patients who completed the optimal sessions , entered in statistical analysis .


Systolic and diastolic blood pressure ( SBP , DBP ) had no significant changes in control group ( respectively @ to @ and @ to @ ) .


These changes were statistically significant in the exercise group ( respectively @ to @ and @ to @ ; P < @ ) .


Furthermore , the BMI of exercise group reduced significantly ( @ to @ ; P < @ ) in comparison with control group that showed a significant increase in terms of this variable ( @ to @ ; P < @ ) .


The present study suggests that long term aerobic exercise has positive effects on systolic and diastolic blood pressure as well as heart rate of T@DM patients .


We observed significant differences in levels of BMI in two groups after intervention .


Intermittent preventive treatment in pregnancy ( IPTp ) with sulfadoxine-pyrimethamine ( SP ) is recommended by WHO to prevent malaria in African pregnant women .


The spread of SP parasite resistance has raised concerns regarding long-term use for IPT .


Mefloquine ( MQ ) is the most promising of available alternatives to SP based on safety profile , long half-life , and high efficacy in Africa .


We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women .


A total of @,@ pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin , Gabon , Mozambique , and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens .


The study arms were : ( @ ) SP , ( @ ) single dose MQ ( @ mg/kg ) , and ( @ ) split-dose MQ in the context of long lasting insecticide treated nets .


There was no difference on low birth weight prevalence ( primary study outcome ) between groups ( @/@ ,@ -LSB- @ % -RSB- ) for MQ group and @/@ ,@ ( @ % ) for SP group ; risk ratio -LSB- RR -RSB- , @ ( @ % CI @-@ @ ; p = @ in the ITT analysis ) .


Women receiving MQ had reduced risks of parasitemia ( @/@ ,@ -LSB- @ % -RSB- in the SP group and @/@ ,@ -LSB- @ % -RSB- in the MQ group ; RR , @ -LSB- @ % CI @-@ @ -RSB- ; p = @ ) and anemia at delivery ( @/@ ,@ -LSB- @ % -RSB- in the SP group and @,@ / @ -LSB- @ % -RSB- in the MQ group ; RR , @ -LSB- @ % CI @-@ @ -RSB- ; p = @ ) , and reduced incidence of clinical malaria ( @/@ @ malaria episodes person/year -LSB- PYAR -RSB- in the SP group and @/@ ,@ episodes PYAR in the MQ group ; RR , @ -LSB- @ % CI @-@ @ -RSB- ; p = @ ) and all-cause outpatient attendances during pregnancy ( @/@ @ outpatients visits PYAR in the SP group and @,@ / @,@ visits PYAR in the MQ group ; RR , @ -LSB- @-@ @ -RSB- ; p = @ ) .


There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups .


Tolerability was poorer in the two MQ groups compared to SP .


The most frequently reported related adverse events were dizziness ( ranging from @ % to @ % after dose @ ; and @ % to @ % after dose @ ) and vomiting ( @ % to @ % , after dose @ and @ % to @ % after dose @ ) with similar proportions in the full and split MQ arms .


The open-label design is a limitation of the study that affects mainly the safety assessment .


Women taking MQ IPTp ( @ mg/kg ) in the context of long lasting insecticide treated nets had similar prevalence rates of low birth weight as those taking SP IPTp .


MQ recipients had less clinical malaria than SP recipients , and the pregnancy outcomes and safety profile were similar .


MQ had poorer tolerability even when splitting the dose over two days .


These results do not support a change in the current IPTp policy .


We studied whether suppressed secretion of the orexigenic peptide ghrelin might be involved in the anorexigenic effects of nicotine .


Fifty healthy non-smokers chewed gums containing @mg nicotine , or no nicotine in a double-blind randomised crossover design in two independent studies .


Plasma nonacylated ghrelin was not significantly affected by nicotine after @ and @min .


Increased blood pressure and decreased appetite ratings confirmed a biological nicotine effect .


These results do not support a key role of peripheral ghrelin secretion in weight changes related to smoking or smoking cessation , but do not rule out that central nervous system ghrelin is involved .


External thermal support is critical for preterm or ill infants due to altered thermoregulation .


Incubators are the gold standard for long-term support and have been adopted successfully in many countries .


Alternatives such as radiant warmers , blankets and others are often used as standard of care ( SoC ) in resource-limited settings when infants are otherwise not in Kangaroo Mother Care ( KMC ) .


In this pilot study , we evaluate the feasibility of a conductive thermal mattress ( CTM ) using phase change materials as a low-cost warmer .


We conducted a prospective multicentre open-label randomised controlled trial to determine non-inferiority of this CTM to SoC warming practices in low birthweight infants .


The primary outcome was maintenance of axillary temperature .


We equally randomised @ infants to CTM or SoC .


The latter cohort continued to receive warmth by radiant warmers ( n = @ ) , blankets ( n = @ ) , warmed cradles ( n = @ ) or KMC ( n = @ ) before , during and subsequent to the study .


CTM was deemed non-inferior since warmed babies had higher axillary temperature compared with SoC ( mean increase @ C SEM ; p < @ ) .


Post hoc comparison to radiant warmers alone showed that CTM led to a higher axillary temperature ( mean increase by @ C SEM ; p < @ ) .


Short-term use of CTM compared with radiant warmers and other modes of warming is non-inferior to SoC and efficacious in maintaining body temperature .


No adverse effects were reported .


An extended multinational trial , preferably one that demonstrates longer-term thermoregulation , is warranted .


Schizophrenia is one of the most serious forms of mental illness among people being treated in psychiatric clinics in developing and developed countries .


Providing care for people diagnosed with schizophrenia can be stressful for their caregivers .


Psycho-educational interventions may improve patients ' and primary caregivers ' knowledge of schizophrenia and impact positively on patients ' physical and psychological outcomes and primary caregivers ' burden of care and quality of life .


Studies thus far have shown that these interventions may improve patients ' and caregivers ' outcomes , but the quality of included randomized controlled trials ( RCTs ) is poor and it is difficult to draw firm conclusions as to the effectiveness of such interventions on patients and primary caregivers ' outcomes , hence the current study .


A randomized controlled trial in four outpatient mental health clinics in Jordan comparing psycho-educational interventions in the form of six booklets every fortnight , with treatment as usual in people diagnosed with schizophrenia and their primary caregivers .


The primary outcome for participants is knowledge of Schizophrenia ; secondary outcomes for patients are positive and negative symptoms of schizophrenia and relapse rate , while secondary outcomes for primary caregivers are burden of care and quality of life .


All measures are assessed at baseline , immediately post-intervention and at three months follow-up .


This randomized control trial , conducted in Jordan among people living with schizophrenia and their primary caregivers , will assess the effect of psycho-educational interventions on knowledge of Schizophrenia , patients ' positive and negative symptoms and quality of life , and caregivers ' burden of care .


Exercise has been shown to improve clinical measures of strength , balance and mobility , and in some cases , has improved symptoms of tremor and rigidity in people with Parkinson 's disease ( PD ) .


However , to date , no research has examined whether improvements in trunk control can remedy deficits in dynamic postural stability in this population .


The proposed randomised controlled trial aims to establish whether a @-week exercise programme aimed at improving dynamic postural stability in people with PD ; ( @ ) is more effective than education ; ( @ ) is more effective when training frequency is increased ; and ( @ ) provides greater long-term benefits than education .


Forty-five community-dwelling individuals diagnosed with idiopathic PD with a falls history will be recruited .


Participants will complete baseline assessments including tests of cognition , vision , disease severity , fear of falling , mobility and quality of life .


Additionally , participants will complete a series of standing balance tasks to evaluate static postural stability , while dynamic postural control will be measured during walking using head and trunk-mounted three-dimensional accelerometers .


Following baseline testing , participants will be randomly-assigned to one of three intervention groups , who will receive either exercise once per week , exercise @ days/week , or education .


Participants will repeat the same battery of tests conducted at baseline after the @-week intervention and again following a further @-week sustainability period .


This study has the potential to show that low-intensity and progressive trunk exercises can provide a non-invasive and effective means for maintaining or improving postural stability for people with PD .


Importantly , if the programme is noted to be effective , it could be easily performed by patients within their home environment or under the guidance of available allied health professionals .


To compare the results of transperitoneal laparoscopic vs retroperitoneoscopic simple nephrectomy for benign renal diseases in a prospective randomized design .


In this study between January @ and August @ , @ patients underwent transperitoneal laparoscopic nephrectomy and @ retroperitoneoscopic nephrectomy after randomization .


The @ groups were compared for the visual pain score on the first and second postoperative days as the primary end point of the study .


Complications were recorded and graded using Dindo-modified Clavien classification of surgical complications .


Secondary objectives were to compare each of the operative techniques in terms of duration of surgery , complication rates , and postoperative convalescence .


Statistical analysis was performed with SPSS version @ with P < @ considered statistically significant .


The difference in the visual pain score ( @ vs @ on day @ ; @ vs @ on day @ ) and the tramadol requirements ( @ vs @ mg ) were statistically significant and more in the transperitoneal laparoscopic nephrectomy .


The hospital stay and convalescence were significantly lower in retroperitoneoscopic group .


Three patients in transperitoneal laparoscopic nephrectomy group and @ patients in retroperitoneoscopic group required conversion .


Mean time to normal activities wassignificantly less in retroperitoneal laparoscopic nephrectomy group ( @ vs @ days ; P = @ ) .


Although both transperitoneal laparoscopic and retroperitoneoscopic simple nephrectomy are feasible options for nonfunctioning kidneys due to benign renal diseases in adults , retroperitoneal laparoscopic nephrectomy is associated with significantly less pain , less analgesic requirement , shorter hospital stay , and short convalescence as compared with transperitoneal laparoscopic approach .


Breathlessness is common in advanced cancer .


The Breathlessness Intervention Service ( BIS ) is a multi-disciplinary complex intervention theoretically underpinned by a palliative care approach , utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease .


We sought to establish whether BIS was more effective , and cost-effective , for patients with advanced cancer and their carers than standard care .


A single-centre Phase III fast-track single-blind mixed-method randomised controlled trial ( RCT ) of BIS versus standard care was conducted .


Participants were randomised to one of two groups ( randomly permuted blocks ) .


A total of @ patients referred to BIS were randomised ( intervention arm n = @ ; control arm n = @ received BIS after a two-week wait ) ; @ completed to the key outcome measurement .


The primary outcome measure was a @ to @ numerical rating scale for patient distress due to breathlessness at two-weeks .


Secondary outcomes were evaluated using the Chronic Respiratory Questionnaire , Hospital Anxiety and Depression Scale , Client Services Receipt Inventory , EQ-@D and topic-guided interviews .


BIS reduced patient distress due to breathlessness ( primary outcome : -@ ; @ % CI -@ to -@ ; P = @ ) significantly more than the control group ; @ % of respondents reported a positive impact ( @/@ ) .


BIS reduced fear and worry , and increased confidence in managing breathlessness .


Patients and carers consistently identified specific and repeatable aspects of the BIS model and interventions that helped .


How interventions were delivered was important .


BIS legitimised breathlessness and increased knowledge whilst making patients and carers feel ` not alone ' .


BIS had a @ % likelihood of better outcomes in terms of reduced distress due to breathlessness at lower health/social care costs than standard care ( @ % with informal care costs included ) .


BIS appears to be more effective and cost-effective in advanced cancer than standard care .


To evaluate the efficacy and tolerability of armodafinil in patients with excessive sleepiness following mild or moderate closed traumatic brain injury ( TBI ) .


Randomized , placebo-controlled , double-blind trial followed by open-label extension .


@ US centers .


Adults with closed TBI ( N = @ ) , Glasgow Coma Scale score > @ at time of injury ; baseline Epworth Sleepiness Scale ( ESS ) @ ; sleep latency < @ minutes on multiple sleep latency test ( MSLT ) ; and Clinical Global Impression-Severity of Illness ( CGI-S ) score @ for excessive sleepiness .


Patients received armodafinil ( @ , @ , or @ mg/day ) or placebo for @ weeks followed by an optional @-month open-label extension .


Outcomes included MSLT , ESS , Clinical Global Impression-Change ( CGI-C ) , TBI-Work Instability Scale ( TBI-WIS ) , CGI-S , and tolerability .


The study was terminated early due to low enrollment .


Patients receiving @ mg armodafinil showed significant improvement in sleep latency from baseline to final visit versus placebo ( +@ minutes vs. +@ minutes ; p = @ ) .


CGI-C ratings were much / very much improved in approximately @ % of patients receiving @ and @ mg armodafinil , compared to @ % on placebo .


ESS and TBI-WIS scores were not significantly different between groups .


In the open-label extension ( N = @ ) , patients demonstrated gradual improvement in ESS , TBI-WIS , and CGI-S scores up to @ weeks post-baseline .


Armodafinil was generally well tolerated , with headache the most common adverse event in both double-blind and open-label portions .


Armodafinil @ mg significantly improved sleep latency in patients with excessive sleepiness associated with mild or moderate TBI .


Efficacy and tolerability of armodafinil were sustained throughout the open-label extension .


Is it possible to reach performance equality between boys and girls in a science class ?


Given the stereotypes targeting their groups in scientific domains , diagnostic contexts generally lower girls ' performance and non-diagnostic contexts may harm boys ' performance .


The present study tested the effectiveness of a mastery-oriented assessment , allowing both boys and girls to perform at an optimal level in a science class .


Participants were @ boys and @ girls ( all high-school students ) .


Participants attended a science lesson while expecting a performance-oriented assessment ( i.e. , an assessment designed to compare and select students ) , a mastery-oriented assessment ( i.e. , an assessment designed to help students in their learning ) , or no assessment of this lesson .


In the mastery-oriented assessment condition , both boys and girls performed at a similarly high level , whereas the performance-oriented assessment condition reduced girls ' performance and the no-assessment condition reduced boys ' performance .


One way to increase girls ' performance on a science test without harming boys ' performance is to present assessment as a tool for improving mastery rather than as a tool for comparing performances .


Traumatic brain injury ( TBI ) is a major public health problem recently , however , no intervention showing convincing efficacy .


Therapeutic hypothermia with a relatively long duration ( more than @ h ) , as a promising treatment measure , might improve the patient outcome following severe TBI .


The LTH-@ trial is a prospective , nationwide multicenter , randomized , controlled clinical trial to examine the efficacy and safety of long-term mild hypothermia in adult patients after severe traumatic brain injury .


A total of @ consecutive patients will be recruited from @ large neurosurgical centers in China .


The eligible patient will be randomized to receive either long-term mild hypothermia ( @-@ C ) for @ days , or normothermia ( @-@ C ) .


Additionally , a standardized management protocol will be used in all patients .


The primary end point is the neurological outcome @ months post-injury on the Glasgow Outcome Scale .


The secondary outcomes include GOS score at one month post-injury , mortality during six months after injury , length of ICU and hospital stay , intracranial pressure control and Glasgow Coma Scale score during the hospital stay and frequency of complications during the six-month follow-up period .


Long-term hypothermia is recommended by most recent studies and its efficacy urgently needs to be established in randomized controlled settings .


The LTH-@ trial , together with other ongoing studies , will present more evidence for optimal use of hypothermia in severe TBI patients .


RESTORE was a randomized , partially placebo-controlled exploratory study evaluating multiple sclerosis ( MS ) disease activity during a @-week interruption of natalizumab .


Eligible patients were relapse-free through the prior year on natalizumab and had no gadolinium-enhancing lesions on screening brain MRI .


Patients were randomized @:@:@ to continue natalizumab , to switch to placebo , or to receive alternative immunomodulatory therapy ( other therapies : IM interferon -@ a -LSB- IM IFN -- @a -RSB- , glatiramer acetate -LSB- GA -RSB- , or methylprednisolone -LSB- MP -RSB- ) .


During the @-week randomized treatment period , patients underwent clinical and MRI assessments every @ weeks .


Patients ( n = @ ) were randomized to natalizumab ( n = @ ) , placebo ( n = @ ) , or other therapies ( n = @ : IM IFN -- @a , n = @ ; GA , n = @ ; MP , n = @ ) .


Of @ patients evaluable for efficacy , @ ( @ % ) had MRI disease activity recurrence : @/@ ( @ % ) natalizumab , @/@ ( @ % ) placebo , @/@ ( @ % ) IM IFN -- @a , @/@ ( @ % ) GA , and @/@ ( @ % ) MP .


Relapse occurred in @ % of natalizumab patients and in @ % -@ % of patients in the other treatment arms .


MRI disease activity recurred starting at @ weeks ( n = @ at week @ ) while relapses were reported as early as @-@ weeks ( n = @ in weeks @-@ ) after the last natalizumab dose .


Overall , @/@ patients ( @ % ) , all in placebo or other-therapies groups , restarted natalizumab early because of disease activity .


MRI and clinical disease activity recurred in some patients during natalizumab interruption , despite use of other therapies .


This study provides Class II evidence that for patients with MS taking natalizumab who are relapse-free for @ year , stopping natalizumab increases the risk of MS relapse or MRI disease activity as compared with continuing natalizumab .


The efficacy of botulinum neurotoxin type A after prolonged storage at room temperature is currently unknown .


This randomized , double-blinded , split-face study investigated the impact of postreconstitution @C storage for @ week on the clinical efficacy of incobotulinumtoxinA in the treatment of lateral canthus lines .


Twenty-one participants with at least mild to moderate crow 's feet at maximum contraction on the Crow 's Feet Grading Scale ( CFGS ) underwent injection to each lateral canthus area with @ U of freshly reconstituted and room temperature-stored product and followed for @ months .


Responders were defined as those demonstrating at least a @-point improvement on their CFGS score .


At each visit ( @ weeks and @ , @ , @ , and @ months ) , there was no statistical difference in the rate of responders between the fresh and the stored products .


In addition , the percentage of responders displaying a @-point versus a @-point improvement and response longevity did not statistically differ between both products for the entire @-month study duration .


Prolonged storage of incobotulinumtoxinA at room temperature does not appear to significantly alter its efficacy or longevity in the treatment of dynamic lateral canthus lines .


The aim of this study was to evaluate the safety and tolerability of sitagliptin @ mg/day in elderly patients with type @ diabetes .


A post hoc pooled analysis of @ randomized , double-blind , parallel group clinical studies with results available as of @ December @ .


Multicenter , international clinical trials .


Patients with type @ diabetes aged @ years or older .


Patients were randomized to sitagliptin @ mg/day ( n = @,@ ) or a comparator ( n = @,@ ) for @ weeks to @ years .


In each study , investigators reported serious and non-serious adverse events that occurred during the study , and serious adverse events occurring within @ days following the last dose of study drug .


This analysis used patient-level data from each study to assess the exposure-adjusted incidence rates of specific adverse events that occurred following initiation of study drug .


Summary measures of adverse events overall were similar between the sitagliptin and non-exposed ( active comparator or placebo ) groups , except for higher incidences of deaths and drug-related adverse events in the non-exposed group .


Incidence rates of specific adverse events were generally similar between the two groups , with the exception of hypoglycemia .


A lower incidence rate of hypoglycemia was observed in the sitagliptin group compared with the non-exposed group -LSB- @ vs. @ per @ patient-years ; difference -@ ( @ % CI -@ to -@ -RSB- ) , primarily due to greater use of sulfonylureas in the non-exposed group .


In this pooled safety analysis of elderly patients with type @ diabetes , treatment with sitagliptin @ mg/day was generally well tolerated for up to @ years .


nab-Paclitaxel ( nab-P ) is approved , in the United States , in combination with carboplatin for the first-line treatment of advanced non-small-cell lung cancer , based on a randomized phase @ trial of nab-P plus carboplatin ( nab-P/C ) versus solvent-based paclitaxel plus carboplatin ( sb-P/C ) .


This trial revealed a higher overall response rate ( @ % versus @ % ; p = @ ) and longer , but not statistically significant , overall and progression-free survival for nab-P/C versus sb-P/C .


In addition , nab-P/C demonstrated lower rates of grade @ or higher peripheral neuropathy , myalgia , arthralgia , and neutropenia but higher rates of anemia and thrombocytopenia .


This report analyzes patient and physician assessment of symptoms within this trial .


Patients completed the taxane subscale of the Functional Assessment of Cancer Therapy questionnaire , which focuses on taxane toxicity , including peripheral neuropathy and neurotoxicity .


Mean baseline scores and changes from baseline are reported .


Physicians also graded the severity of neuropathy at each patient visit using National Cancer Institute Common Toxicity Criteria .


Patients receiving nab-P/C reported significantly less worsening of peripheral neuropathy ( p < @ ) , pain ( p < @ ) , and hearing loss ( p = @ ) .


Patient-reported edema was similar between the two treatment arms .


In agreement with patient-reported symptoms , the results of a per-treatment cycle physician assessment of peripheral neuropathy also favored nab-P/C over sb-P/C ( p < @ ) .


In this trial of patients receiving first-line treatment for advanced non-small-cell lung cancer , nab-P/C was associated with statistically and clinically significant reductions in patient-reported neuropathy , neuropathic pain in the hands and feet , and hearing loss compared with sb-P/C .


Inhaled long-acting beta@ agonists used alone and in combination with an inhaled corticosteroid reduce the risk of exacerbations in patients with stable COPD .


However , the relative efficacy of these agents in preventing recurrent exacerbations in those recovering from an initial episode is not known .


This study compared the rate of COPD exacerbations over the @ weeks after an initial exacerbation in patients receiving the combination of fluticasone propionate and salmeterol ( FP/SAL ) or SAL alone .


Patients ( n = @ ) aged @ years were randomized to either twice-daily inhaled FP/SAL @/@ g or SAL @ g. Primary , and secondary , endpoints were rates of recurrent severe , and moderate/severe , exacerbations of COPD .


Lung function , health outcomes and levels of biomarkers of systemic inflammation were also assessed .


There was no statistically significant treatment difference in rates of recurrent severe exacerbations ( treatment ratio @ -LSB- @ % CI : @ , @ -RSB- ) and moderate/severe exacerbations ( @ -LSB- @ , @ -RSB- ) between FP/SAL and SAL in the intent-to-treat population .


Pre-dose morning FEV@ change from baseline was greater ( @ L -LSB- @ , @ -RSB- ) with FP/SAL than SAL .


No treatment difference was seen for other endpoints including patient-reported health outcomes and biomarker levels for the full cohort .


No significant treatment difference between FP/SAL and SAL was seen in COPD exacerbation recurrence for the complete cohort .


Treatment benefit with FP/SAL over SAL ( treatment ratio @ -LSB- @ , @ -RSB- ) was seen in patients having FEV@ % and prior exposure to ICS .


No unexpected safety issues were identified with either treatment .


Patients with the most severe COPD may be more refractory to treatment .


To evaluate the efficacy of internal application of Qigui Mixture ( QM ) and external application of Qigui Huoxue Lotion ( QHL ) in treating type @ diabetic peripheral neuropathy ( DNP ) patients of qi-yin deficiency complicated phlegm-dampness blocking collaterals syndrome ( QYD-PDBCS ) , and to primarily discuss its mechanism .


Totally @ DPN patients of QYD-PDBCS were randomly assigned to the treatment group ( @ cases ) and the control group ( @ cases ) .


All patients received routine comprehensive therapy .


Patients in the control group took Mecobalamine Tablet , @ microg each time , @ times per day .


Patients in the treatment group additionally took QM , @ mL per day , twice daily .


Besides , they had foot bath in QHL @ - @ min every evening for @ months .


The efficacy was assessed by Chinese medical symptom integrals and Toronto clinical scoring system ( TCSS ) before treatment , @ and @ months after treatment .


The nerve conduction velocity was determined ; the serum levels of total antioxidant capacity ( T - AOC ) , malondialdehyde ( MDA ) , and superoxide dismutase ( SOD ) were detected @ and @ months after treatment .


The total effective rates of Chinese medical symptom integrals and TCSS score were obviously higher in the treatment group than in the control group ( P < @ ) .


The nerve conduction velocity was significantly improved in the treatment group , when compared with before treatment ( P < @ ) .


There was statistical difference in the nerve conduction velocity difference of right median nerve motor branch , bilateral tibial nerve motor branches , bilateral common peroneal nerve motor branches , bilateral ulnar nerve sensory branches , and left tibial nerve sensory branch ( P < @ ) .


Compared with before treatment , serum levels of T-AOC and SOD significantly increased , and the level of MDA decreased significantly in the treatment group after @ and @ months of treatment ( P < @ ) .


But only the SOD level increased significantly in the control group ( P < @ ) .


There was no statistical difference in increased T-AOC level between the two groups after @ months of treatment ( P > @ ) , but there was statistical difference in increased SOD level and decreased MDA level ( P < @ ) .


There was statistical difference in increased T-AOC and SOD levels and decreased MDA level between the two groups after @ months of treatment ( P < @ ) .


No adverse reaction occurred during the therapeutic course .


The internal application of QM and external application of QHL combined with Mecobalamine in treating DPN was safe and effective , with more significant efficacy than using Mecobalamine alone .


Its mechanism might be associated with resistance to oxidative stress .


To compare the effectiveness and costs of telephone-only approach to in-person plus telephone for delivering an evidence-based , coordinated care management program for dementia .


We randomized @ patient-caregiver dyads from an underserved predominantly Latino community to two arms that shared a care management protocol but implemented in different formats : in-person visits at home and/or in the community plus telephone and mail , versus telephone and mail only .


We compared between-arm caregiver burden and care-recipient problem behaviors ( primary outcomes ) and patient-caregiver dyad retention , care quality , health care utilization , and costs ( secondary outcomes ) at @ - and @-months follow-up .


Care quality improved substantially over time in both arms .


Caregiver burden , care-recipient problem behaviors , retention , and health care utilization did not differ across arms but the in-person program cost more to deliver .


Dementia care quality improved regardless of how care management was delivered ; large differences in effectiveness or cost offsets were not detected .


Elevated circulating levels of the protein galectin-@ , a mediator of fibrogenesis , have previously been associated with adverse outcomes in heart failure ( HF ) patients and appear to modify response to certain pharmacologic therapies .


This study investigated the relationship between galectin-@ level and clinical outcomes in HF patients randomized to implantable cardioverter defibrillator ( ICD-only ) or cardiac resynchronization therapy ( CRT-D ) .


Plasma galectin-@ concentrations were measured in @ New York Heart Association functional class I/II patients participating in the MADIT-CRT trial .


A heterogeneity of response was detected between pre-implantation galectin-@ and randomization group ( CRT-D or ICD-only ) on the primary MADIT-CRT trial end point of nonfatal HF event or death ( P = @ ) .


Among patients with baseline galectin-@ levels in the top quartile of the distribution , CRT-D was associated with a @ % reduction in risk of the primary end point ( hazard ratio -LSB- HR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) , whereas among patients with lower baseline galectin-@ values CRT-D was associated with a @ % decrease in risk ( HR @ , @ % CI .


Baseline galectin-@ level also was observed to be an independent predictor of the primary end point ( multivariable adjusted HR per log unit increase : @ ; @ % CI @-@ @ ; P = @ ) .


Elevated galectin-@ was found to be an independent predictor of adverse HF outcome in patients with mildly symptomatic HF .


A significant interaction of device randomization group with pre-implantation galectin-@ level was detected , with HF patients with the highest baseline galectin-@ levels deriving a disproportionately larger benefit from CRT-D .


Although mitral regurgitation ( MR ) results in left ventricular ( LV ) volume overload , right ventricular ( RV ) function may also be impaired .


We investigated the influence of short-term beta-blockade on RV function in patients with moderate-severe MR.


Twenty-six patients were randomised in a cross-over design to receive two weeks of beta-blockade or placebo .


Echocardiography was performed at baseline and at the end of the treatment periods .


Measurements included : RV ejection fraction ( RVEF ) tricuspid annular motion and Tei index .


No differences in mean RVEF ( @ @ v @ @ % , p = @ ) , tricuspid annular motion ( @ @ v @ @ cm/s , p = @ ) , or median Tei index ( @ ( @ , @ ) v @ ( @ , @ ) , p = @ ) were observed between placebo and metoprolol , despite significantly longer cardiac time intervals .


Tei index under both conditions was significantly reduced .


Short-term treatment with a beta-blocker did not influence RV function in these patients .


Interestingly , the RV Tei index was high suggesting significant RV dysfunction despite normal RVEF .


A parallel-group randomized controlled trial ( RCT ) was conducted to evaluate the effect of combining the interscalene brachial plexus block ( IBPB ) with Intravenous-inhalation combined anesthesia to isolated Intravenous-inhalation anesthesia in the upper extremity fractures surgery of elderly patients .


One hundred elderly patients who underwent upper extremity surgery were randomly assigned to received isolated Intravenous-inhalation combined anesthesia ( group CI , n = @ ) and IBPB associated with Intravenous-inhalation combined anesthesia ( group NB , n = @ ) .


Associated side effects , recovery time after operation , as well as the dose of intraoperative vasoactive agents and auxiliary drugs were noted .


The two groups were not significantly different in gender ( P = @ ) , ages ( P = @ ) and weight ( P = @ ) .


Five patients ( @ % ) in the group NB and @ patients ( @ % ) in the group CI suffered from preoperative hypotension ( P = @ ) .


Besides , lower incidence of other adverse effects such as mental stress , incision pain and hypertension were also found in the group NB ; however , the differences were not statistically significant ( P > @ ) .


The consumption of general anesthetics in the group NB was significantly less than that of the group CI ( propofol , P = @ ; lsoflurane , P < @ ) , and the recovery time of the group NB was significantly shorter than that of the group CI ( P = @ ) .


Combining IBPB with Intravenous-inhalation combined anesthesia in elderly patients hold a greater potential for upper extremity fractures surgery due to its improved clinical effectiveness and fewer side effects .


Chronic heart failure , is increasing due to the aging population and improvements in heart disease detection and management .


The prevalence is estimated at ~ @ % of the French general practice patient population over @ years old .


The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner ( GP ) education in primary care .


A randomised , cluster controlled trial , stratified over @ areas of the Auvergne region in France comparing intervention and control groups .


The inclusion criteria are : patients older than @ years with New York Heart Association ( NYHA ) stage I , II , or III heart failure , with reduced ejection fraction or with preserved ejection fraction .


Heart failure should be confirmed by the patient 's cardiologist according to the European Society of Cardiology guidelines criteria .


The exclusion criteria include : severe cognitive disorders , living in an institution , participating in another clinical trial , having NYHA stage IV heart failure , or a lack of French language skills .


The complex intervention consists of training at the GP practice with an interactive @-day workshop to provide a patient 's education programme .


GPs are trained to perform case management , lifestyle counselling and motivational interviewing , to educate patients on the main topics including clinical alarm signs , physical activity , diet and cardiovascular risk factors .


The patients ' education sessions are scheduled at @ , @ , @ , @ , @ and @ months following the start of the trial .


The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires : the Minnesota Living with Heart Failure Questionnaire and SF-@ .


To detect a difference in the mean quality of life at @ months , we anticipate studying a minimum of @ patients from @ GPs .


This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a @-day GP workshop and patients ' education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure .


This complex intervention tool could be used during initial and further medical training .


Enterocolitis ( EC ) is the most common and serious postoperative complication of Hirschsprung 's disease ( HD ) .


Probiotics potentially play a protective role in maintaining intestinal mucosal integrity .


Based on the beneficial effects of probiotics , we hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung 's disease-associated enterocolitis ( HAEC ) .


We conducted a prospective , multicenter , randomized , and controlled trial to assess whether oral probiotics could decrease the incidence and severity of HAEC .


HD patients were randomly assigned into the control group and probiotic-treated group .


All children in probiotic-treated group were fed with probiotics per day for @weeks .


In next @months , the incidence and severity of HAEC were analyzed .


The peripheral blood T lymphocyte subsets and cytokines , including TNF - , IFN - , IL-@ , and IL-@ , were analyzed by flow cytometry and enzyme immunoassay ( EIA ) .


Compared with the control group , the incidence of HAEC in the probiotic-treated group was significantly diminished .


The severity of EC was also remarkably decreased .


Furthermore , probiotics balanced T lymphocyte subsets .


Moreover , pro-inflammatory cytokines TNF - , IFN - , and IL-@ were significantly decreased and anti-inflammatory cytokine IL-@ was notably increased in probiotic-treated group .


Probiotics not only significantly diminished the incidence but also decreased the severity of HAEC .


Moreover , our study revealed that probiotics decreased pro-inflammatory cytokine and increased anti-inflammatory cytokine and furthermore balanced T lymphocytes ( registered with ClinicalTrials.gov , NCT number : NCT@ ) .


Renal impairment increases the risk of stroke and bleeding in patients with atrial fibrillation .


In the Randomized Evaluation of Long-Term Anticoagulant Therapy ( RELY ) trial , dabigatran , with @ % renal elimination , displayed superiority over warfarin for prevention of stroke and systemic embolism in the @-mg dose and significantly less major bleeding in the @-mg dose in @ @ patients with nonvalvular atrial fibrillation .


This prespecified study investigated these outcomes in relation to renal function .


Glomerular filtration rate was estimated with the Cockcroft-Gault , Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) , and Modification of Diet in Renal Disease ( MDRD ) equations in all randomized patients with available creatinine at baseline ( n = @ @ ) , and cystatin C-based glomerular filtration rate was estimated in a subpopulation with measurements available ( n = @ ) .


A glomerular filtration rate @ , @ to < @ , and < @ mL/min was estimated in @ % , @ % , and @ % and in @ % , @ % , and @ % of patients based on Cockcroft-Gault and CKD-EPI , respectively .


Rates of stroke or systemic embolism , major bleeding , and all-cause mortality increased as renal function decreased .


The rates of stroke or systemic embolism were lower with dabigatran @ mg and similar with @ mg twice daily compared with warfarin , without significant heterogeneity in subgroups defined by renal function ( interaction P > @ for all ) .


For the outcome of major bleeding , there were significant interactions between treatment and renal function according to CKD-EPI and MDRD equations , respectively ( P < @ ) .


The relative reduction in major bleeding with either dabigatran dose compared with warfarin was greater in patients with glomerular filtration rate @ mL/min .


The efficacy of both dosages of dabigatran was consistent with the overall trial irrespective of renal function .


However , with the CKD-EPI and MDRD equations , both dabigatran dosages displayed significantly lower rates of major bleeding in patients with glomerular filtration rate @ mL/min .


To determine the prognostic and predictive value of intrinsic subtyping by using immunohistochemical ( IHC ) biomarkers for ipsilateral breast relapse ( IBR ) in participants in an early breast cancer randomized trial of tamoxifen with or without breast radiotherapy ( RT ) .


IHC analysis of estrogen receptor , progesterone receptor , human epidermal growth factor receptor @ ( HER@ ) , cytokeratin @/@ , epidermal growth factor receptor , and Ki-@ was conducted on @ of @ available blocks .


Patients were classified as luminal A ( n = @ ) , luminal B ( n = @ ) , or high-risk subtype ( luminal HER@ , n = @ ; HER@ enriched , n = @ ; basal like , n = @ ; or triple-negative nonbasal , n = @ ) .


Median follow-up was @ years .


Classification by subtype was prognostic for IBR ( @-year estimates : luminal A , @ % ; luminal B , @ % ; high-risk subtypes , @ % ; P < @ ) .


Luminal subtypes seemed to derive less benefit from RT ( luminal A hazard ratio -LSB- HR -RSB- , @ ; luminal B HR , @ ) than high-risk subtypes ( HR , @ ) ; however , the overall subtype-treatment interaction term was not significant ( P = @ ) .


In an exploratory analysis of women with clinical low-risk ( age older than @ years , T@ , grade @ or @ ) luminal A tumors ( n = @ ) , @-year IBR was @ % versus @ % for the high-risk cohort ( n = @ ; P = @ ) .


Clinical low-risk luminal A patients had a @-year IBR of @ % with tamoxifen versus @ % with tamoxifen plus RT ( P = @ ) .


Multivariable analysis showed that RT ( HR , @ ; P < @ ) , clinical risk group ( HR , @ ; P = @ ) , and luminal A subtype ( HR , @ ; P < @ ) were significantly associated with IBR .


IHC subtyping was prognostic for IBR but was not predictive of benefit from RT. .


Further studies may validate the exploratory finding of a low-risk luminal A group who may be spared breast RT. .


Dry skin reflects a skin barrier defect which can lead to atopic dermatitis .


Little is known about the distinct effects of emollient use in children with dry skin and atopic predisposition .


We investigated the effects of daily application of pressed ice plant juice ( PIPJ ) - based emollients and petrolatum-based emollients .


Children aged @-@ years with dry skin and atopic predisposition were randomized into @ groups : group @ received emollients containing PIPJ and natural lipids , while group @ received petrolatum-based emollients .


Skin condition and biophysical properties of the skin barrier were assessed at inclusion and weeks @ , @ and @ .


Skin condition improved significantly in all children .


Comparing the groups , children treated with emollients containing PIPJ showed significantly higher stratum corneum hydration values and significantly lower transepidermal water loss values at week @ on the forearm and forehead .


A significant decrease in skin pH was noted in group @ on the forearm and forehead ; group @ showed a stable course .


Early intervention with emollients in children with dry skin condition and atopic predisposition may improve their skin condition during daily emollient application .


PIPJ-based formulations may be helpful to maintain skin barrier integrity .


In @ a Cochrane review confirmed that folic acid ( FA ) supplementation prevents the first - and second-time occurrence of neural tube defects ( NTDs ) .


At present some evidence from observational studies supports the hypothesis that FA supplementation can reduce the risk of all congenital malformations ( CMs ) or the risk of a specific and selected group of them , namely cardiac defects and oral clefts .


Furthermore , the effects on the prevention of prematurity , foetal growth retardation and pre-eclampsia are unclear.Although the most common recommendation is to take @ mg/day , the problem of the most appropriate dose of FA is still open.The aim of this project is to assess the effect a higher dose of peri-conceptional FA supplementation on reducing the occurrence of all CMs .


Other aims include the promotion of pre-conceptional counselling , comparing rates of selected CMs , miscarriage , pre-eclampsia , preterm birth , small for gestational age , abruptio placentae .


This project is a joint effort by research groups in Italy and the Netherlands .


Women of childbearing age , who intend to become pregnant within @months are eligible for the studies .


Women are randomly assigned to receive @mg of FA ( treatment in study ) or @ mg of FA ( referent treatment ) daily .


Information on pregnancy outcomes are derived from women-and-physician information.We foresee to analyze the data considering all the adverse outcomes of pregnancy taken together in a global end point ( e.g. : CMs , miscarriage , pre-eclampsia , preterm birth , small for gestational age ) .


A total of about @,@ pregnancies need to be evaluated to detect an absolute reduction of the frequency of @ % .


Since the sample size needed for studying outcomes separately is large , this project also promotes an international prospective meta-analysis .


The rationale of these randomized clinical trials ( RCTs ) is the hypothesis that a higher intake of FA is related to a higher risk reduction of NTDs , other CMs and other adverse pregnancy outcomes .


Our hope is that these trials will act as catalysers , and lead to other large RCTs studying the effects of this supplementation on CMs and other infant and maternal outcomes .


Inflammatory processes , which raise the unsteadiness of brain neuron membrane potentials , might enhance the development of epilepsy .


Inflammation is a substantial indicator of epilepsy risk .


In this study , we evaluated whether chronic osteomyelitis ( COM ) , a chronic inflammatory disease , increases epilepsy risk .


A Taiwanese national insurance claims dataset of more than @ million enrollees was used to select @,@ COM patients and @,@ randomly selected age - and gender-matched controls to investigate epilepsy development over an @-year follow-up period , starting on January @ , @ and ending on December @ , @ .


The epilepsy risk was analyzed using a Cox proportional hazards regression model .


Comorbidities known to elevate epilepsy risk , including diabetes , hypertension , head injury , stroke , and cancer , were commonly noted in the COM cohort , which had considerably higher risk of epilepsy than did the control group .


Comparing only those without comorbidities , COM patients still exhibited higher epilepsy risk than the control group did ( adjusted hazard ratio -LSB- aHR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- : @-@ @ ) .


The younger population exhibited an even greater risk ( age @ years : aHR = @ , @ % CI : @-@ @ ; age @ years : aHR = @ , @ % CI : @-@ @ ) .


This is the first study linking COM to an increased risk in epilepsy development .


The results demonstrated that COM is a significant predictor of epilepsy .


Further study of COM patients , particularly young patients , is recommended to facilitate epilepsy prevention .


Hypertension is poorly controlled .


Team-based care and changes in the process of care have been proposed to address these quality problems .


However , assessing care processes is difficult because they are often confounded even in randomized behavioral studies by unmeasured confounders based on discretion of health care providers .


To evaluate the effects of process measures including number of counseling sessions about lifestyle modification and number of antihypertensive medications on blood pressure change and payer-perspective treatment costs .


Data were obtained from two prospective , cluster randomized controlled clinical trials ( Trial A and B ) implementing physician-pharmacist collaborative interventions compared with usual care over six months in community-based medical offices in the Midwest .


Multivariate linear regression models with both instrumental variable methods and as-treated methods were utilized .


Instruments were indicators for trial and study arms .


Models of blood pressure change and costs included both process measures , demographic variables , and clinical variables .


The analysis included @ subjects .


As-treated methods showed no significant associations between process and outcomes .


The instruments used in the study were insufficient to simultaneously identify distinct process effects .


However , the post-hoc instrumental variable models including one process measure at a time while controlling for the other process demonstrated significant associations between the processes and outcomes with estimates considerably larger than as-treated estimates .


Instrumental variable methods with combined randomized behavioral studies may be useful to evaluate the effects of different care processes .


However , substantial distinct process variation across studies is needed to fully capitalize on this approach .


Instrumental variable methods focusing on individual processes provided larger and stronger outcome relationships than those found using as-treated methods which are subject to confounding .


The pharmacokinetic properties of the immediate-release ( IR ) and the recently developed controlled-release ( CR ) formulation of pregabalin are dose proportional .


Pregabalin IR can be taken with or without food .


This analysis characterizes the effect of food on pregabalin CR .


The objectives of this analysis were : ( @ ) to evaluate the effect of administration time and fat or caloric content of an accompanying meal on the pharmacokinetic properties of a single dose of pregabalin CR ( @mg ) relative to a single dose of pregabalin IR ( @mg ) ; ( @ ) to evaluate the pharmacokinetic properties of a single dose of pregabalin CR administered fasted relative to a single dose of pregabalin CR administered immediately after food ; and ( @ ) to determine the safety and tolerability of single-dose administration of pregabalin CR and IR with and without food .


The effect of food on the pharmacokinetic properties of pregabalin CR was determined in five phase I , open-label , single-dose , crossover studies ( @-@ participants/study ) .


Caloric and fat content of meals were varied and treatments were administered in the morning , at midday , or in the evening .


Blood samples were collected up to @h post-dose .


Pharmacokinetic parameters were estimated from plasma concentration-time data using standard noncompartmental methods .


Adverse events were monitored throughout all studies .


One hundred and twenty-eight healthy participants ( @-@years of age ) received pregabalin .


Peak plasma concentrations ( C max ) were lower for CR than the respective pregabalin IR doses , and time to C max occurred later .


When pregabalin CR was administered with food at midday or in the evening , total exposures -LSB- area under the plasma concentration-time curve from time zero extrapolated to infinite time ( AUC ) -RSB- were equivalent for pregabalin CR and IR formulations regardless of fat or caloric content .


When pregabalin CR was administered with an @-@ ,@ calorie medium-fat breakfast , AUC was equivalent for pregabalin CR and IR .


Bioequivalence criteria for comparison of pregabalin CR after a low - or medium-calorie breakfast relative to pregabalin IR were not met ; however , bioavailability of the pregabalin CR vs. IR formulation was relatively high ( @-@ % ) .


When pregabalin CR was administered fasted , the AUC was @-@ % of the AUC of pregabalin CR administered with food and bioequivalence criteria were not met .


Additionally , the AUC of the pregabalin CR formulation administered fasted was @-@ % of that of pregabalin IR administered fasted and bioequivalence criteria were not met .


Single-dose pregabalin CR and IR were well tolerated in all studies , with no serious or severe adverse events reported .


Time of day of administration and the fat and caloric content of the accompanying meal had minimal overall effect on the pharmacokinetic properties and bioavailability of the pregabalin CR formulation .


There is a high medical need for an interferon-free , all-oral , short-duration therapy for hepatitis C virus ( HCV ) that is highly effective across diverse patient populations , including patients with cirrhosis or previous null response to pegylated interferon ( peginterferon ) plus ribavirin ( PR-null responders ) .


We aimed to assess the efficacy , safety , and effective treatment duration of grazoprevir ( an HCV NS@/@A protease inhibitor ) combined with elbasvir ( an HCV NS@A inhibitor ) with or without ribavirin in patients with HCV genotype @ infection with baseline characteristics of poor response .


The C-WORTHY trial is a randomised , open-label phase @ trial of grazoprevir plus elbasvir with or without ribavirin ; here we report findings for two cohorts of previously untreated patients with cirrhosis ( cohort @ ) and those with previous PR-null response with or without cirrhosis ( cohort @ ) enrolled in part B of the study .


Eligible patients were adults aged @ years or older with chronic HCV genotype @ infection and HCV RNA concentrations of @ IU/mL or higher in peripheral blood .


We randomly assigned patients to receive grazoprevir ( @ mg daily ) and elbasvir ( @ mg daily ) with or without ribavirin for @ or @ weeks .


Randomisation was done centrally with an interactive voice response system ; patients and study investigators were masked to treatment duration up to week @ but not to treatment allocation .


The primary endpoint was the proportion of patients achieving HCV RNA less than @ IU/mL at @ weeks after end of treatment ( SVR@ ) , assessed by COBAS TaqMan version @ .


This study is registered with ClinicalTrials.gov , number NCT@ .


We describe findings for @ patients enrolled in cohort @ ( n = @ ) or cohort @ ( n = @ ) .


In cohort @ , we randomly assigned @ patients to the @-week regimen ( @ with ribavirin and @ with no ribavirin ) and @ to the @-week regimen ( @ with ribavirin and @ with no ribavirin ) ; in cohort @ , we randomly assigned @ patients to the @-week regimen ( @ with ribavirin and @ with no ribavirin ) and @ to the @-week regimen ( @ with ribavirin and @ with no ribavirin .


High SVR@ rates were achieved irrespective of the use of ribavirin or extension of the treatment duration from @ to @ weeks ; SVR@ rates ranged from @ % ( @ % CI @-@ ; @/@ ; cohort @ , @ weeks , ribavirin-containing ) to @ % ( @ % CI @-@ ; @/@ ; cohort @ , @ weeks , ribavirin-containing ) .


Among patients treated for @ weeks with grazoprevir plus elbasvir without ribavirin , @ % ( @ % CI @-@ , @/@ ) of patients in cohort @ and @ % ( @-@ , @/@ ) of patients in cohort @ achieved SVR@ .


Adverse events reported in more than @ % of patients were fatigue ( @ patients , @ % -LSB- @ % CI @-@ -RSB- ) , headache ( @ patients , @ % -LSB- @ % CI @-@ -RSB- ) , and asthenia ( @ patients , @ % -LSB- @ % CI @-@ -RSB- ) .


Treatment with grazoprevir plus elbasvir , both with and without ribavirin and for both @ and @ weeks ' treatment duration , showed high rates of efficacy in previously untreated patients with cirrhosis and previous PR-null responders with and without cirrhosis .


These results support the phase @ development of grazoprevir plus elbasvir .


Suvorexant ( MK-@ ) is an orexin receptor antagonist shown to be efficacious for insomnia over @ months .


We aimed to assess its clinical profile during and after @ year of treatment .


We did a randomised , placebo-controlled , parallel-group trial at @ investigational centres in the Americas , Australia , Europe , and South Africa from December , @ , to August , @ .


Patients aged @ years or older with primary insomnia by DSM-IV-TR criteria were assigned using a computer-generated randomised allocation schedule to receive nightly suvorexant ( @ mg for patients younger than @ years , @ mg for patients aged @ years or older ) or placebo at a @:@ ratio for @ year with a subsequent @-month randomised discontinuation phase in which patients on suvorexant either continued suvorexant or were abruptly switched to placebo while patients on placebo remained on placebo .


Treatment assignment was masked from patients and investigators .


The primary objective was to assess the safety and tolerability of suvorexant for up to @ year .


Secondary objectives were to assess the efficacy of suvorexant for improving patient-reported subjective total sleep time ( sTST ) and time to sleep onset ( sTSO ) over the first month of treatment .


Efficacy endpoints over the first month were assessed with a mixed model with terms for baseline value of the response variable , age , sex , region , treatment , time , and treatment by time interaction .


This trial is registered with ClinicalTrials.gov , number NCT@ .


@ ( @ % ) of @ patients randomly assigned to receive suvorexant and @ ( @ % ) of @ assigned to receive placebo completed the @-year phase .


Over @ year , @ ( @ % ) of @ patients treated with suvorexant experienced any adverse events compared with @ ( @ % ) of @ treated with placebo .


Serious adverse events were recorded in @ patients ( @ % ) who received suvorexant and @ ( @ % ) who received placebo .


The most common adverse event , somnolence , was reported for @ patients ( @ % ) who received suvorexant and seven ( @ % ) who received placebo .


At month @ , suvorexant ( @ patients in the efficacy population ) showed greater efficacy than placebo ( @ in the efficacy population ) in improving sTST ( @ min vs @ min ; difference @ , @ % CI @ to @ ; p < @ ) and sTSO ( -@ min vs -@ min , difference -@ , -@ to -@ ; p = @ ) .


Our findings show that suvorexant was generally safe and well tolerated over @ year of nightly treatment in patients with insomnia , with efficacy noted for subjective measures of sleep onset and maintenance .


Denmark has inferior cancer survival rates compared with many European countries .


The main reason for this is suggested to be late diagnosis at advanced cancer stages .


Cancer diagnostic work-up begins in general practice in @ % of all cancer cases .


Thus , general practitioners ( GPs ) play a key role in the diagnostic process .


The latest Danish Cancer Plan included continuing medical education ( CME ) on early cancer diagnosis in general practice to improve early diagnosis .


This dual aims of this protocol are , first , to describe the conceptualisation , operationalisation and implementation of the CME and , second , to describe the study design and outcomes chosen to evaluate the effects of the CME .


The intervention is a CME in early cancer diagnosis targeting individual GPs .


It was developed by a step-wise approach .


Barriers for early cancer diagnosis at GP level were identified systematically and analysed using the behaviour system involving capability , opportunity and motivation described by Michie et al. .


The study will be designed as a geographical cluster randomised stepped wedge study .


The study population counts @ GPs from @ general practices in the Central Denmark Region , geographically divided into eight clusters .


GPs from each cluster will be invited to a CME meeting at a certain date three weeks apart .


The primary outcomes will be primary care interval and GP referral rate on cancer suspicion .


Data will be obtained from national registries , GP-completed forms on patients referred to cancer fast-track pathways and GP-completed online questionnaires before and after the intervention .


To our knowledge , this will be the first study to measure the effect of a theory-based CME in early cancer diagnosis at three levels : GP knowledge and attitude , GP activity and patient outcomes .


The achieved knowledge will contribute to the understanding of whether and how general practice 's ability to perform cancer diagnosis may be improved .


To observe the clinical effects of early use of neuromuscular blocking agents ( NMBA ) in patients with severe sepsis and acute respiratory distress syndrome ( ARDS ) .


A prospective study was conducted .


@ patients with severe sepsis and ARDS admitted from July @ to September @ to intensive care unit ( ICU ) of Liuzhou People 's Hospital in Guangxi Zhuang Autonomous Region were enrolled and divided into severe ARDS group ( n = @ ) and moderate ARDS group ( n = @ ) according to the Berlin definition of ARDS .


Then patients in each group were randomly divided into treatment group ( n = @ ) and control group ( n = @ ) .


All patients with diagnosis in accordance with the @ international septic shock and severe sepsis treatment guidelines were provided with comprehensive treatment and mechanical ventilation on the basis of analgesia and sedation .


The patients in treatment group were given a loading dose of vecuronium during mechanical ventilation , started with @ mg/kg up to @ mgkg ( -@ ) h ( -@ ) for continuous intravenous infusion for @-@ hours .


The acute physiology and chronic health evaluation II ( APACHEII ) score , sequential organ failure assessment ( SOFA ) , arterial oxygenation index ( PaO@/FiO@ ) , central venous oxygen saturation ( ScvO@ ) , arterial blood lactate ( Lac ) , C-reactive protein ( CRP ) levels of two groups were compared before treatment and @ hours after treatment , and @-day mortality rate was finally compared .


In moderate or severe ARDS group , there were no statistically significant difference in APACHEII score , SOFA score , PaO@/FiO@ , ScvO@ , Lac and CRP before treatment between two groups .


APACHEII score , SOFA score , PaO@/FiO@ , ScvO@ , and Lac @ hours after treatment were significantly improved in severe ARDS group compared with control group ( APACHEII score : @ vs. @ , t = @ , P = @ ; SOFA score : @ vs. @ , t = @ , P = @ ; PaO@/FiO@ : @ mmHg vs. @ mmHg , t = @ , P = @ ; ScvO@ : @ vs. @ , t = @ , P = @ ; Lac : @ mmol/L vs. @ mmol/L , t = @ , P = @ ) , while the value of CRP showed no significant difference ( @ mg/L vs. @ mg/L , t = @ , P = @ ) .


@-day mortality in treatment group was significantly lower than that in control group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , ( @ ) = @ , P = @ -RSB- .


In moderate ARDS group , each of the above clinical parameters were improved in both groups expect for CRP at @ hours after treatment , but the indexes showed no statistically significant difference between two groups ( all P > @ ) .


@-day mortality rate in the treatment group was slightly lower than that in the control group which showed no statistically significant difference -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , ( @ ) = @ , P = @ -RSB- .


The early use of NMBA treatment of patients with severe sepsis and severe ARDS can not only improve the severity but also reduce @-day mortality .


Shivering is the most common complication during the recovery period after general anesthesia , and there is no clear consensus about the best strategy for its prophylactic .


The aim of the study was to evaluate the efficacy of parecoxib in prevention of postoperative shivering .


Eighty patients with American Society of Anesthesiologists physical status I-II , who were scheduled for minor urological surgeries under general anesthesia , were randomly assigned to two groups ( n = @ in each group ) : group P received @ mg of parecoxib by intravenous bolus injection and group S received the same volume of normal saline in the same way just after the induction of anesthesia .


Hemodynamic parameters and body temperatures including tympanic and axillary temperature were monitored .


The occurrence of shivering and pain intensity score were recorded during the recovery period .


Parecoxib significantly reduced the incidence and severity of shivering in comparison with the placebo .


Postoperative shivering was observed in @ patients in group S ( @ % ) , compared with nine in group P ( @ % ) ( P = @ ) .


In addition , pain intensity scores were lower in group P during recovery period ; consequently , less rescue analgesics were required in group P when compared with group S ( P = @ ) .


Regarding the body temperature , it was found that core temperature decreased but peripheral temperature increased significantly in both groups .


There was no significant difference between groups in all time intervals .


Prophylactic administration of parecoxib produces dual effects on antishivering and postoperative analgesia .


This implies that cyclooxygenase @-prostaglandin E@ pathways may be involved in the regulation of shivering .


We previously found that inflammation in benign prostate tissue is associated with an increased odds of prostate cancer , especially higher-grade disease .


Since part of this link may be due to genetics , we evaluated the association between single nucleotide polymorphisms ( SNPs ) in immune response genes and prostate cancer in the placebo arm of the Prostate Cancer Prevention Trial .


We genotyped @ candidate SNPs in IL@ , IL@ , IL@ , IL@ , IL@ , IL@ , IL@ ( p@ ) , IFNG , MSR@ , RNASEL , TLR@ , and TNFA and seven tagSNPs in IL@ in @ prostate cancer cases and @ controls negative for cancer on an end-of-study biopsy .


Cases and controls were non-Hispanic white and frequency matched on age and family history .


We classified cases as lower ( Gleason sum < @ ; N = @ ) and higher ( @-@ ; N = @ ) grade , and used logistic regression to estimate odds ratios ( OR ) and @ % confidence intervals ( CI ) adjusting for age and family history .


The minor allele ( C ) of rs@ in IL@ ( p@ ) was associated with an increased risk of total ( log additive : OR = @ , @ % CI @-@ @ ; P-trend = @ ) and lower-grade ( OR = @ , @ % CI @-@ @ ; P-trend = @ ) prostate cancer .


The minor allele ( A ) of rs@ in IL@ was possibly associated with a decreased risk of higher-grade ( OR = @ , @ % CI @-@ @ ; P-trend = @ ) , but not total disease .


None of the other candidates was associated with risk .


The minor alleles of IL@ tagSNPs rs@ ( A ; OR = @ , @ % CI : @-@ @ ; P-trend = @ ) and rs@ ( C ; OR = @ , @ % CI @-@ @ , P-trend = @ ) were associated with risk ; the latter also with lower - ( P-trend = @ ) and possibly higher - ( P-trend = @ ) grade disease .


These patterns were similar among men with PSA < @ng/ml at biopsy .


Variation in some immune response genes may be associated with prostate cancer risk .


These associations were not fully explained by PSA-associated detection bias .


Our findings generally support the role of inflammation in the etiology of prostate cancer .


The objective of this study is to assess the index of decayed , missing and filled teeth ( DMF-T ) , habit of brushing teeth , and the microbiological agents accumulating on the children 's toothbrushes for @ weeks and response of these agents to disinfection via a chlorhexidine solution , then compare those results with the education and income levels of the children 's parents .


Included in the study were @ children ( @ in the control group and @ in the experiment group - chlorhexidine ) chosen randomly from @ kindergarten children whose ages ranged from @ months to @ months .


The children selected had not taken any antibiotics , antimicotics for three months and dental treatments during this trial .


The distribution of these children to the groups was also done randomly .


After performing a survey for the education , occupation , and income status of the parents , the children were examined and the number of decayed teeth was recorded .


The children were given toothbrushes , toothpaste ( with fluroide ) , and the solutions ( including distilled water and chlorhexidine ) for four weeks under the condition that toothbrushes were returned at the end of each week .


The @ different microbiological agents observed as a result of the assessment of the samples taken in the first week were also included in the assessments of the samples taken over the four-week period .


The decrease in the DMF-T index was found to be meaningful according to the differences in education , income , and occupation status of the parents .


Of all the samples taken from the toothbrushes , the bacteria with the greatest rate of reproduction included Streptococcus mutans , Escherichia Coli , Pseudomonas aeuroginosa , Enterococcus spp , Staphylococcus epidermidis and Candida albicans .


Except for Candida albicans , the other microorganisms taken as samples from the toothbrushes reproduced less overall .


In the group using the solution with chlorhexidine , a meaningful decrease in bacterial reproduction was discovered compared to the control group .


The findings of this study show that the education , occupation , and socioeconomic situations of the parents should be considered when discussing children 's oral and dental health .


Moreover , the study shows that disinfection of toothbrushes in order to prevent reinfection and contamination oral flora with the bacteria again is important in terms of preventive medicine and family-children health .


Although the evidence is mixed , female smokers appear to have more difficulty quitting smoking than male smokers .


Craving , stress , and negative affect have been hypothesized as potential factors underlying gender differences in quit rates .


In the current study , the cue-reactivity paradigm was used to assess craving , stress , and negative affect in response to cues presented in the natural environment of cigarette smokers using ecological momentary assessment .


Seventy-six daily smokers ( @ % female ) responded to photographs ( smoking , stress , and neutral ) presented @ times per day on an iPhone over the course of @ weeks .


Both smoking and stress cues elicited stronger cigarette craving and stress responses compared to neutral cues .


Compared with males , females reported higher levels of post-stress cue craving , stress , and negative affect , but response to smoking cues did not differ by gender .


Findings from this project were largely consistent with results from laboratory-based research and extend previous work by measuring response to cues in the natural environment of cigarette smokers .


This study extends previous cue reactivity ecological momentary assessment research by using a new platform and by measuring response to stress cues outside of the laboratory .


Findings from this project highlight the importance of addressing coping in response to stress cues in clinical settings , especially when working with female smokers .


Fundamentals of Laparoscopic Surgery ( FLS ) certification is required for general surgery .


The recommended practice for learning FLS is to practice tasks one at a time until proficient ( blocked practice ) .


Learning theory suggests that interleaved practice , a method in which tasks are rotated rather than learned one at a time , may result in superior learning .


Residents were randomized into @ of @ groups : blocked practice or interleaved practice .


We compared the performance of residents across groups over @ trials of each of @ FLS tasks ( peg transfer , pattern cut , extracorporeal suture , and intracorporeal suture ) .


Four weeks later , participants returned to the laboratory and completed @ additional trials of each of the @ tasks .


Performance on each of the tasks improved with increased practice .


The interleaved group showed significantly better performance on the peg transfer task ; trends favoring the interleaved group resulted for the other tasks .


Standardized mean differences in favor of the interleaved group were substantial both at the end of practice and at follow-up ( with the exception of the pattern cut ) .


Interleaved practice appears to have advantages over blocked practice in developing and retaining FLS skills .


We encourage others to experiment with the method to confirm our findings .


Bipolar disorder places a significant burden on individuals , caregivers and family , and the broader community .


Current treatments are believed to be more effective against manic symptoms , leaving a shortfall in recovery during the depressive phase of the illness .


The current study draws on recent evidence suggesting that , in addition to increased oxidative load , alterations in mitochondrial function occur in bipolar disorder .


This @-week study aims to explore the potential benefits of N-acetylcysteine ( NAC ) alone or in combination ( CT ) with selected nutraceuticals believed to enhance mitochondrial function .


The study includes adults diagnosed with bipolar disorder currently experiencing an episode of depression .


Participants are asked to take NAC , CT , or placebo in addition to any usual treatments .


A post-discontinuation visit is conducted @ weeks following the treatment phase .


The primary outcome of the study will be mean change on the Montgomery-Asberg Depression Rating Scale .


Secondary outcomes include functioning , substance use , mania ratings , and quality of life .


Blood samples will be collected at baseline and week @ to explore biochemical alterations following treatment .


This study may provide a novel adjunctive treatment for bipolar depression .


Analysis of biological samples may assist in understanding the therapeutic benefits and the underlying etiology of bipolar depression .


Compare auto-adjusting positive airway pressure ( APAP ) treatment with positive airway pressure ( PAP ) titration by polysomnography ( PSG ) followed by CPAP treatment in patients diagnosed with obstructive sleep apnea ( OSA ) by home sleep apnea testing ( HSAT ) .


Prospective randomized treatment study .


Tertiary Veterans Administration Medical Center .


@ patients diagnosed with OSA by HSAT ( apneahypopnea index -LSB- AHI -RSB- @/h ) suitable for APAP treatment .


APAP arm : Treatment with an APAP device , CPAP arm : PSG PAP titration followed by CPAP treatment .


Mean PAP adherence , Epworth sleepiness scale ( ESS ) , Functional Outcomes of Sleep Questionnaire ( FOSQ ) .


The mean ( SD ) age , BMI , and diagnostic AHI ( APAP : @ @ , CPAP : @ @ / h , p = NS ) did not differ between the study arms .


After @ weeks of treatment , @ % of @ patients started on APAP and @ % of @ patients started on CPAP ( @ declined treatment after the titration ) were using PAP , p = NS .


The @ % APAP and level of CPAP were similar ( @ @ , @ @ cm H@O , p = @ ) .


The average nightly PAP use did not differ ( APAP : @ @ , CPAP : @ @ h , p = NS ) .


The improvements in the ESS ( APAP : -@ @ , CPAP : -@ @ , p = NS ) and in the FOSQ ( APAP : @ @ , CPAP : @ @ , p = NS ) were not different .


Following diagnosis of OSA by HSAT , treatment with APAP results in equivalent PAP adherence and improvement in sleepiness compared to a PSG titration and CPAP treatment .


A commentary on this article appears in this issue on page @ .


Repeated courses of intravenous ( IV ) aminoglycosides in cystic fibrosis ( CF ) patients are associated with cumulative nephrotoxicity .


Targeting their delivery through the inhaled route during acute pulmonary exacerbations may also be effective , but without systemic side effects .


Using a randomized crossover trial design , in a pilot study we compared @ days of IV tobramycin with nebulized tobramycin @mg twice a day ( TNS ) in acute respiratory exacerbations in @ CF adults chronically infected with Pseudomonas aeruginosa ( Psa ) .


Patients also received IV colistin in both arms .


Improvement in spirometry was similar between the two groups -LSB- mean change in FEV@ % predicted : IV group @ ( standard deviation @ ) versus TNS group @ ( @ ) , p = @ -RSB- , but there was more suppression of sputum Psa in the TNS group -LSB- mean difference between treatments @ log@ colony-forming units/mL ( CI @ to @ ) , p = @ -RSB- .


IV tobramycin was associated with a greater urinary protein leak -LSB- mean difference between treatments @ mg/@hr ( @ to @ ) , p = @ -RSB- and higher urinary levels of markers of acute renal tubular injury : N-acetylglucosaminidase -LSB- @ IU/mmol ( @ to @ ) , p = @ -RSB- , alanine aminopeptidase -LSB- @ IU/mmol ( @ to @ ) , p = @ -RSB- , and @-microglobulin -LSB- @ g/mmol ( @ to @ ) , p = @ -RSB- than TNS .


Compared with IV tobramycin , TNS treatment prolonged the time to next exacerbation requiring hospitalization ( p < @ ) .


Patient satisfaction was similar with both treatments , and no serious adverse effects were recorded .


TNS is effective in treating acute exacerbations of Psa in CF patients , but with a renal sparing potential compared with the IV preparation .


Laser beam diameter affects the depth of laser penetration .


Q-switched lasers tend to have smaller maximum spot sizes than other dermatologic lasers , making beam diameter a potentially more significant factor in treatment outcomes .


To compare the clinical effect of using the maximum-size treatment beam available for each delivered fluence during laser tattoo removal to a standard @-mm-diameter treatment beam .


Thirteen tattoos were treated in @ subjects using a Q-switched Nd : YAG laser equipped with a treatment beam diameter that was adjustable in @mm increments and a setting that would enable the maximally achievable diameter ( `` MAX-ON '' setting ) with any fluence .


Tattoos were randomly bisected and treated on one side with the MAX-ON setting and on the contralateral side with a standard @-mm-diameter spot ( `` MAX-OFF '' setting ) .


Photographs were taken @ weeks following each treatment and each half-tattoo was evaluated for clearance on a @-point scale by physicians blinded to the treatment conditions .


Tattoo clearance was greater on the side treated with the MAX-ON setting in a statistically significant manner following the @st through @th treatments , with the MAX-OFF treatment site approaching the clearance of the MAX-ON treatment site after the @th and @th treatments .


This high-energy , Q-switched Nd : YAG laser with a continuously variable spot-size safely and effectively removes tattoos , with greater removal when using a larger spot-size .


To investigate the feasibility of delivering titrated oxygen therapy to adults with return of spontaneous circulation ( ROSC ) following out-of-hospital cardiac arrest ( OHCA ) caused by ventricular fibrillation ( VF ) or ventricular tachycardia ( VT ) .


We used a multicentre , randomised , single blind , parallel groups design to compare titrated and standard oxygen therapy in adults resuscitated from VF/VT OHCA .


The intervention commenced in the community following ROSC and was maintained in the emergency department and the Intensive Care Unit .


The primary end point was the median oxygen saturation by pulse oximetry ( SpO@ ) in the pre-hospital period .


@ OHCA patients were screened and @ were randomised .


@ participants were analysed : nine in the standard care group and eight in the titrated oxygen group .


In the pre-hospital period , SpO@ measurements were lower in the titrated oxygen therapy group than the standard care group ( difference in medians @ % ; @ % CI @-@ @ % ) .


Low measured oxygen saturation ( SpO@ < @ % ) occurred in @/@ of patients in the titrated oxygen group and @/@ of patients in the standard care group ( P = @ ) .


Following hospital admission , good separation of oxygen exposure between the groups was achieved without a significant increase in hypoxia events .


The trial was terminated because accumulated data led the Data Safety Monitoring Board and Management Committee to conclude that safe delivery of titrated oxygen therapy in the pre-hospital period was not feasible .


Titration of oxygen in the pre-hospital period following OHCA was not feasible ; it may be feasible to titrate oxygen safely after arrival in hospital .


Recent warnings from Health Canada regarding codeine for children have led to increased use of nonsteroidal anti-inflammatory drugs and morphine for common injuries such as fractures .


Our objective was to determine whether morphine administered orally has superior efficacy to ibuprofen in fracture-related pain .


We used a parallel group , randomized , blinded superiority design .


Children who presented to the emergency department with an uncomplicated extremity fracture were randomly assigned to receive either morphine ( @ mg/kg orally ) or ibuprofen ( @ mg/kg ) for @ hours after discharge .


Our primary outcome was the change in pain score using the Faces Pain Scale - Revised ( FPS-R ) .


Participants were asked to record pain scores immediately before and @ minutes after receiving each dose .


We analyzed data from @ participants in the morphine group and @ participants in the ibuprofen group .


For both morphine and ibuprofen , we found a reduction in pain scores ( mean pre-post difference standard deviation for dose @ : morphine @ @ , ibuprofen @ @ , between-group difference -LSB- -RSB- @ -LSB- @ % confidence interval ( CI ) -@ to @ -RSB- ; dose @ : morphine @ @ , ibuprofen @ @ , @ -LSB- @ % CI -@ to @ -RSB- ; dose @ : morphine @ @ , ibuprofen @ @ , -@ -LSB- @ % CI -@ to @ -RSB- ; and dose @ : morphine @ @ , ibuprofen @ @ , @ -LSB- @ % CI -@ to @ -RSB- ) .


We found no significant differences in the change in pain scores between morphine and ibuprofen between groups at any of the @ time points ( p = @ ) .


Participants in the morphine group had significantly more adverse effects than those in the ibuprofen group ( @ % v. @ % , p < @ ) .


We found no significant difference in analgesic efficacy between orally administered morphine and ibuprofen .


However , morphine was associated with a significantly greater number of adverse effects .


Our results suggest that ibuprofen remains safe and effective for outpatient pain management in children with uncomplicated fractures .


In patients with acute pulmonary embolism , systemic thrombolysis improves right ventricular ( RV ) dilatation , is associated with major bleeding , and is withheld in many patients at risk .