The purpose of this study was to refine a commercial car driving simulation for occupational research .


As the effects of ethanol on driving behavior are well established , we choose alcohol as a test compound to investigate the performance of subjects during simulation .


We programmed a night driving scenario consisting of monotonous highway and a rural road on a Foerst F@-P driving simulator .


Twenty healthy men , @-@ years , participated in a pilot study .


Subjects were screened for simulator sickness , followed by training on the simulator one hour in total .


Experiments were performed in the morning on a separate day .


Participants were randomized into either an alcoholized or a control group .


All subjects drove two courses consisting of highway and rural road and were sober for the first course .


During a @ h break the ethanol group drank an alcoholic beverage to yield @ % blood alcohol concentration ( BAC ) .


Generalized linear mixed models were used to analyze the influence of alcohol on driving performance .


Among others , independent variables were Simulator Sickness Questionnaire scores and subjective sleepiness .


Subjects did not experience simulator sickness during the experiments .


Mean BAC before the second test drive was @ % in the mildly intoxicated group .


There was no clear-cut difference in the number of crashes between @ groups .


BAC of @ % would deteriorate mean braking reaction time by @ ms ( SE = @ , p < @ ) .


Ethanol slightly impaired the tracking in the right-hand curves ( p = @ ) .


Braking reaction time improved by @ ms ( SE = @ , p < @ ) for the second test drive , indicating a learning effect .


In sum , a clear ethanol effect was observed in the driving simulation .


This simulation seems suitable for occupational research and produces little simulator sickness .


Controlling for possible learning effects is recommended in driving simulation studies .


To determine the prognostic value of outer retinal tubulation ( ORT ) in the enlargement amount of geographic atrophy ( GA ) in eyes with age-related macular degeneration ( AMD ) .


Cohort study .


One hundred eight fellow untreated eyes of @ patients with GA resulting from AMD enrolled in the MAHALO study ( clinicaltrials.gov identifier , NCT@ ) who completely satisfied the study term and had gradable spectral-domain optical coherence tomography ( OCT ) images obtained at both baseline and month @ visits .


The MAHALO study enrolled @ subjects into a phase @b/@ multicenter , randomized , single-masked , sham-injection controlled clinical trial of the safety , tolerability , and evidence of activity of lampalizumab in patients with GA associated with AMD .


Spectral-domain optical coherence tomography images were obtained at multiple time points in both eyes , although only the baseline and month @ data of the fellow ( nonstudy ) eyes were considered in this exploratory analysis .


The Cirrus HD-OCT review software was used for automatic segmentation and measurement of GA areas , with manual correction of segmentation errors by certified OCT graders .


Baseline OCT images also were assessed for the presence of ORT .


The enlargement amount of GA in eyes with ORT was compared with that of eyes without ORT .


Comparison of the enlargement amount of GA in eyes with and without ORT .


Twenty-four of these @ eyes demonstrated evidence of ORT .


The amount of enlargement of GA in eyes with ORT was significantly slower than that of eyes without ORT ( @ vs. @ ; P = @ ) .


This difference remained significant when considering subgroups with unifocal or multifocal GA lesions , because eyes with ORT in both subgroups had a slower enlargement amount of GA than eyes without ORT ( @ vs. @ -LSB- P = @ -RSB- , in eyes with multifocal GA lesions ; and @ vs. @ -LSB- P = @ -RSB- , in eyes with unifocal GA lesions ) .


In eyes with ORT , GA lesions seem to enlarge at a significantly slower rate than those of eyes without ORT .


The presence of ORT may need to be accounted for in longitudinal studies of GA. .


To compare the efficacy and safety of ranibizumab @ mg , guided by visual acuity ( VA ) stabilization or disease activity criteria , versus verteporfin photodynamic therapy ( vPDT ) in patients with visual impairment due to myopic choroidal neovascularization ( CNV ) .


Phase III , @-month , randomized , double-masked , multicenter , active-controlled study .


Patients ( N = @ ) with visual impairment due to myopic CNV .


Patients were randomized to receive ranibizumab on day @ , month @ , and thereafter as needed guided by VA stabilization criteria ( group I , n = @ ) ; ranibizumab on day @ and thereafter as needed guided by disease activity criteria ( group II , n = @ ) ; or vPDT on day @ and disease activity treated with ranibizumab or vPDT at investigators ' discretion from month @ ( group III , n = @ ) .


Mean average best-corrected visual acuity ( BCVA ) change from baseline to month @ through months @ ( primary ) and @ , mean BCVA change and safety over @ months .


Ranibizumab treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month @ through month @ ( group I : +@ , group II : +@ vs. group III : +@ Early Treatment Diabetic Retinopathy Study -LSB- ETDRS -RSB- letters ; both P < @ ) .


Ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month @ through month @ ( group II : +@ vs. group I : +@ ETDRS letters ; P < @ ) .


Mean BCVA change from baseline to month @ was +@ ( group I ) , +@ ( group II ) , and +@ ETDRS letters ( group III ) .


At month @ , @ % to @ % of patients showed resolution of myopic CNV leakage .


Patients received a median of @ ( group I ) and @ ( groups II and III ) ranibizumab injections over @ months .


No deaths or cases of endophthalmitis and myocardial infarction occurred .


Ranibizumab treatment , irrespective of retreatment criteria , provided superior BCVA gains versus vPDT up to month @ .


Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month @ .


Over @ months , individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well tolerated in patients with myopic CNV .


Widespread psoriasis has great effects on life .


Effective and rapid response in the treatment is needed .


So this study was done to compare the efficacy of combined narrowband ultraviolet-B ( NBUVB ) plus methotrexate ( MTX ) versus each one alone in the treatment of psoriasis .


A total of @ patients with widespread plaque-type psoriasis were enrolled , but only @ patients completed the study .


They were divided into three groups randomly , group MN ( @ ) received NBUVB plus MTX , group N ( @ ) received NBUVB alone , and group M ( @ ) received MTX only .


End point of treatment ( clearance ) was @ % reduction in Psoriasis Area and Severity Index ( PASI ) Score or up to six months , whichever was earlier ; follow-up was done for one year .


The mean number of weeks required for achieving clearance was @ @ weeks in group MN , @ @ weeks in group N , and @ @ weeks in group M ( P < @ ) .


The mean number of phototherapy sessions was @ @ sessions in group MN , and @ @ sessions in group N ( P < @ ) .


The mean total cumulative dose of NBUVB for achieving clearance was @ @ J/cm ( @ ) in group MN , compared with @ @ J/cm ( @ ) in group N ( P < @ ) , while the mean total cumulative dose of MTX was @ @ mg in group MN compared with @ @ mg in group M ( P < @ ) .


Combination of NBUVB plus MTX provided rapid improvement with less cumulative doses of both therapies compared with each one alone in the treatment of psoriasis .


A number of investigative strategies exist for the diagnosis of coronary heart disease ( CHD ) .


Despite the widespread availability of noninvasive imaging , invasive angiography is commonly used early in the diagnostic pathway .


Consequently , approximately @ % of angiograms reveal no evidence of obstructive coronary disease .


Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk .


There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance .


CE-MARC @ is a prospective , multicenter , @-arm parallel group , randomized controlled trial of patients with suspected CHD ( pretest likelihood @ % -@ % ) requiring further investigation .


A total of @,@ patients will be randomized on a @:@:@ basis to receive @-T cardiovascular magnetic resonance-guided care , single-photon emission computed tomography-guided care ( according to American College of Cardiology/American Heart Association appropriate-use criteria ) , or National Institute for Health and Care Excellence guidelines-based management .


The primary ( efficacy ) end point is the occurrence of unnecessary angiography as defined by a normal ( > @ ) invasive fractional flow reserve .


Safety of each strategy will be assessed by @-year major adverse cardiovascular event rates .


Cost-effectiveness and health-related quality-of-life measures will be performed .


The CE-MARC @ trial will provide comparative efficacy and safety evidence for @ different strategies of investigating patients with suspected CHD , with the intension of reducing unnecessary invasive angiography rates .


Evaluation of these management strategies has the potential to improve patient care , health-related quality of life , and the cost-effectiveness of CHD investigation .


To determine if an abnormal CA-@ level in a menopausal female without ovarian cancer is associated with an increase in mortality .


The Prostate , Lung , Colorectal , and Ovarian Cancer Screening Randomized Controlled ( PLCO ) Trial is a large multicenter prospective trial conducted by the National Cancer Institute ( NCI ) .


Over @,@ healthy women aged @-@ were randomized to a screening arm versus a usual medical care arm to evaluate the efficacy of screening in reducing mortality due to ovarian cancer .


Women in the screening arm underwent annual screening for ovarian cancer with transvaginal ultrasound and CA-@ levels .


There were @,@ patients without ovarian cancer that had at least one CA-@ level drawn ; @ ( @ % ) had at least one abnormal level .


The current study compares mortality in patients that had one or more abnormal CA-@ levels without ovarian cancer versus those with all normal levels .


Patients with one or more abnormal CA-@ levels , without ovarian cancer , had a significantly higher mortality than patients with all normal CA-@ levels in the PLCO screening trial ( p < @ ) .


This increased risk extended throughout the follow-up period .


Analysis of cause of death listed on the death certificate showed an excess mortality attributable to lung cancer , digestive disease , and endocrine , nutritional , and metabolic disease .


Menopausal females with an elevated CA-@ and without ovarian cancer are exposed to an increased risk of premature mortality .


Cariprazine is an orally active and potent D@ and D@ partial agonist with preferential binding to D@ receptors in development for the treatment of schizophrenia and bipolar mania .


This study ( NCT@ ) evaluated the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia .


This study was a multinational , double-blind , randomized , placebo - and active-controlled , fixed-dose trial .


Patients were randomized to receive placebo , cariprazine @ mg/d , cariprazine @ mg/d , cariprazine @ mg/d , or risperidone @ mg/d ( for assay sensitivity ) for @ weeks of double-blind treatment and @ weeks of safety follow-up .


Primary and secondary efficacy parameters were change from baseline to Week @ in Positive and Negative Syndrome Scale ( PANSS ) total and Global Impressions-Severity of Illness ( CGI-S ) scores , respectively .


Safety parameters included adverse events ( AEs ) , vital signs , laboratory measures , and extrapyramidal symptom ( EPS ) scales .


Of @ randomized patients , @ % completed the study .


PANSS total score improvement at Week @ was statistically significant versus placebo for cariprazine @ mg/d , @ mg/d , and @ mg/d ( least squares mean difference -LSB- LSMD -RSB- : -@ , -@ , -@ , respectively ; p < @ ; LOCF ) and risperidone ( -@ , p < @ ; LOCF ) ; significant improvement on CGI-S was demonstrated for all active treatments ( p < @ ) .


The most frequent cariprazine AEs ( @ % and at least twice the rate of the placebo group ) were insomnia , extrapyramidal disorder , akathisia , sedation , nausea , dizziness , and constipation .


Mean changes in metabolic parameters were small and similar between groups .


The results of this study support the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia .


Limited data exists regarding the relationship between left ventricular systolic dysfunction ( LVSD ) and heart failure ( HF ) symptoms and embolic risk among patients with atrial fibrillation .


Participants in the Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events ( ACTIVE ) trials with HF , but not randomized to oral anticoagulation , were categorized as having preserved versus reduced ejection fraction .


If reduced , LVSD was classified as mild , moderate , or severe .


Symptoms were quantified using New York Heart Association class.The primary outcome was a composite of stroke , transient ischemic attack , and systemic embolism .


There were @ antiplatelet-treated patients with HF at baseline .


Of these patients , @ ( @ % ) had HF with preserved ejection fraction and @ ( @ % ) had HF with reduced ejection fraction .


During @ years of mean follow-up , first occurrence of stroke , transient ischemic attack , or systemic embolism occurred in @ patients.The strongest independent predictors of embolic events were age @ years ( hazard ratio @ ; confidence interval , @-@ @ ) , prior stroke or transient ischemic attack ( hazard ratio @ ; @ % confidence interval , @-@ @ ) , and female sex ( hazard ratio @ ; confidence interval , @-@ @ ) .


However , ejection fraction < @ , degree of LVSD , and New York Heart Association class did not predict embolic events .


Patients with HF with preserved ejection fraction exhibited similar risk of embolic events as those with HR with reduced ejection fraction : @ % versus @ % per @ person-years ( hazard ration @ ; @ % confidence interval , @-@ @ ) .


Risk of embolic events was similar across categories of LVSD ( P for trend = @ ) and New York Heart Association class ( P for trend = @ ) .


Among HF patients in ACTIVE , neither the presence of LVSD or degree of symptom severity influenced risk of embolic events .


We previously have shown that buttonhole needling is associated with a reduction in hematoma and postulated that buttonhole needling may increase long-term survival of an arteriovenous fistula ( AVF ) .


The purpose of this study was to evaluate AVF survival and complications in buttonhole versus standard needling .


Long-term follow up of a randomized controlled trial in which participants were randomly assigned to standard or buttonhole needling and followed up until the AVF was abandoned or the study end date .


@ long-term hemodialysis patients in Calgary , Alberta .


Buttonhole needling with median time of exposure to the intervention of @ ( IQR , @-@ @ ) months .


Patients were prospectively followed up for study outcomes .


Median follow-up times were @ ( IQR , @-@ @ ) and @ ( IQR , @-@ @ ) months for standard and buttonhole needling , respectively ( P = @ ) .


The primary outcome was median access survival in months .


Other outcomes included assisted and unassisted patency rates , rates of surgical and radiologic interventions , and time to abandonment ( months ) of buttonhole .


Baseline characteristics were similar .


The primary outcome , median access survival , was similar inboth groups : @ ( IQR , @-@ @ ) and @ ( IQR , @-@ @ ) months for standard and buttonhole needling , respectively ( P = @ ) .


There were @ ( @ % ) and @ ( @ % ) thromboses with standard and buttonhole needling , respectively ( P = @ ) .


Median fistulogram rates were similar between techniques ( P = @ with intention-to-treat analysis ) .


Most patients ( @ of @ ) abandoned buttonhole needling by a median of @ ( IQR , @-@ @ ) months .


Median time to first infection for buttonhole needling was @ ( IQR , @-@ @ ) months .


There were no infections in standard needling of AVFs .


Findings are limited to patients needled by multiple hemodialysis nurses and not applicable to self-needlers .


AVFs with buttonhole needling did not have improved survival .


The lack of survival benefit and higher risk of infection should be noted when promoting buttonhole needling .


The Age-Related Eye Disease Study ( AREDS ) formulation for the treatment of age-related macular degeneration ( AMD ) contains vitamin C , vitamin E , beta carotene , and zinc with copper .


The Age-Related Eye Disease Study @ ( AREDS@ ) assessed the value of substituting lutein/zeaxanthin in the AREDS formulation because of the demonstrated risk for lung cancer from beta carotene in smokers and former smokers and because lutein and zeaxanthin are important components in the retina .


To further examine the effect of lutein/zeaxanthin supplementation on progression to late AMD .


The Age-Related Eye Disease Study @ is a multicenter , double-masked randomized trial of @ participants , aged @ to @ years , at risk for developing late AMD ; @ % of patients had bilateral large drusen and @ % had large drusen and late AMD in @ eye .


In addition to taking the original or a variation of the AREDS supplement , participants were randomly assigned in a factorial design to @ of the following @ groups : placebo ; lutein/zeaxanthin , @ mg/@ mg ; omega-@ long-chain polyunsaturated fatty @ acids , @ g ; or the combination .


S Documented development of late AMD by central , masked grading of annual retinal photographs or by treatment history .


RESULTS In exploratory analysis of lutein/zeaxanthin vs no lutein/zeaxanthin , the hazard ratio of the development of late AMD was @ ( @ % CI , @-@ @ ; P = @ ) .


Exploratory analyses of direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of @ ( @ % CI , @-@ @ ; P = @ ) for development of late AMD , @ ( @ % CI , @-@ @ ; P = @ ) for development of neovascular AMD , and @ ( @ % CI , @-@ @ ; P = @ ) for development of central geographic atrophy .


In analyses restricted to eyes with bilateral large drusen at baseline , the direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of @ ( @ % CI , @-@ @ ; P = @ ) for progression to late AMD , @ ( @ % CI , @-@ @ ; P = @ ) for neovascular AMD , and @ ( @ % CI , @-@ @ ; P = @ ) for central geographic atrophy .


The totality of evidence on beneficial and adverse effects from AREDS@ and other studies suggests that lutein/zeaxanthin could be more appropriate than beta carotene in the AREDS-type supplements .


QVA@ is a dual bronchodilator , containing a fixed-dose combination of the long-acting @-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium , for the treatment of chronic obstructive pulmonary disease ( COPD ) .


Here we assess the potential of QVA@ ( @/@ g ) at @-fold the therapeutic dose for causing cardiac pharmacodynamic ( PD ) effects .


This double-blind , randomized study estimated the time-matched largest heart rate ( HR ) change and average HR change ( over @ hours ) from baseline for QVA@ vs. placebo in healthy subjects .


Similar analyses were done for QVA@ vs. indacaterol @ g , glycopyrronium @ g , and salmeterol @ g.


The time-matched and average change from baseline in QT interval corrected for HR using Fridericia 's formula ( QTcF ) , effects on serum potassium and blood glucose , pharmacokinetic ( PK ) parameters , and safety were also assessed .


Of @ subjects randomized , @ completed the study .


QVA@ , when compared with placebo , showed the time-matched largest mean increase and decrease in HR of @ bpm and -@ bpm , respectively , and average HR change from baseline of @ bpm .


QVA@ showed no tachycardic potential compared with indacaterol and no relevant tachycardic effect compared with glycopyrronium .


No consistent differences were seen in the time-matched largest mean change and average change from baseline in QTcF for QVA@ vs. other treatments .


There were no relevant effects of QVA@ on serum potassium and blood glucose .


There was no apparent PK/PD relationship between the observed exposures to indacaterol and glycopyrronium in QVA@ on HR and QTcF .


There were no deaths or serious adverse events .


Overall , short-term administration of QVA@ showed a good cardiovascular safety and tolerability profile in healthy subjects .


To observe the effects of navel-warming therapy on clinical efficacy in patients with yang-deficiency tympanites based on regular treatment of western medication .


One hundred and twenty cases of yang-deficiency tympanites were randomly divided into a navel-warming therapy group and a western medication group , sixty cases in each one .


The regular treatment of western medicine was applied in the western medication group , including oral administration of antiviral drug and diuretics as well as intravenous drip of hepatic protector .


Based on western medicine treatment , the navel-warming therapy was applied in the navel-warming group .


A medical cake was laid on Shenque ( CV @ ) , and then a medical cylinder was placed above the medical cake and ignited .


The treatment was given once daily .


One month was considered as a treatment session in both groups and totally one session was required .


The TCM symptom score , B-ultrasound ascites and temporary use of diuretics before and after treatment were observed in both groups ; also the efficacy was evaluated .


The total effective rate was @ % ( @/@ ) in the navel-warming therapy group , which was superior to @ % ( @/@ ) in the western medication group ( P < @ ) .


After the treatment , the TCM symptom score and ascites were improved in both groups ( all P < @ ) , which was more significant in the navel-warming therapy group ( all P < @ ) .


The temporary use of diuretics was statistically different between the two groups ( P < @ ) , indicating the navel-warming therapy group could obviously reduce or stop the use of diuretics .


Based on regular treatment of western medication , the navel-warming therapy could significantly improve therapeutic efficacy , effectively relieve clinical symptoms and ease ascites .


The purpose of this study was to identify gene polymorphisms of interleukin-@ ( IL-@ ) -@ A/C and -@ G/C specific to patients with oral cancer susceptibility and clinicopathological status .


A total of @,@ participants , including @ healthy people and @ patients with oral cancer , were recruited for this study .


Allelic discrimination of -@ A/C ( rs@ ) and -@ G/C ( rs@ ) polymorphisms of the IL-@ gene was assessed by a real-time PCR with the TaqMan assay .


There was no significant association between IL-@ -@ A/C polymorphism and oral cancer risk .


However , among alcohol consumers , people with A/A homozygotes of IL-@ -@ A/C polymorphism had a @-fold ( @ % CI = @-@ @ ; p = @ ) increased risk of developing oral cancer compared with those with C/C homozygotes .


The participants with G/C heterozygotes of IL-@ -@ polymorphism had a @-fold ( @ % CI : @-@ @ ; p = @ ) increased risk of developing oral cancer compared with those with G/G wild type homozygotes .


Both sets of statistics were determined after adjusting for confounding factors .


Among people who had exposure to oral cancer-related environmental risk factors such as areca , alcohol , and tobacco consumption , the adjusted odd ratios and @ % confidence intervals were increased to a @-fold ( @ % CI = @-@ @ ; p = @ ) , @ ( @ % CI = @-@ @ ; p = @ ) and a @-fold ( @ % CI = @-@ @ ; p = @ ) risk of developing oral cancer .


However , patients with G/C alleles of IL-@ -@ were correlated with a lower clinical stage ( AOR = @ ; @ % CI = @-@ @ ; p = @ ) , smaller tumor size ( AOR = @ ; @ % CI = @-@ @ ; p = @ ) , and non-lymph node metastasis ( AOR = @ ; @ % CI = @-@ @ ; p = @ ) .


IL-@ -@ G/C gene polymorphism may be a factor that increases the susceptibility to oral cancer , as well as a protective factor for oral cancer progression .


The interactions of gene to oral cancer-related environmental risk factors have a synergetic effect that can further enhance oral cancer development .


Exact mechanism of causation of chronic kidney disease of unknown etiology ( CKDu ) in Sri Lanka is not described to date , despite the identification of possible multiple risk factors .


Questions have been raised as to why only some are affected while others remain intact , though they are inhabitants of the same locality .


Comparative studies were carried out , assessing urinary @ microglobulin ( @m ) and the dietary patterns of CKDu patients and age sex matched non-CKDu subjects .


Urinary @m levels of spot urine samples were analyzed using the Enzyme-linked Immunosorbent assay ( ELISA ) and dietary patterns were studied using twenty four hour dietary recalls and frequency consumption of foods of animal origin performed on three occasions at six months intervals within a period of one and half years .


The mean urinary @m level of CKDu patients from Medawachchiya was significantly ( p < @ ) higher when compared with that of the non-CKDu subjects .


The mean urinary @m level of the non-CKDu subjects was within the reference limits for spot urine samples ( @ - @ g/mL ) .


White raw rice was the staple diet of both CKDu patients and non-CKDu subjects and the level of consumption was almost the same .


The consumption of fresh water fish products of CKDu patients under high ( @ , @ % ) , moderate ( @ , @ % ) , low ( @ , @ % ) and less ( @ , @ % ) categories did not show significant variations ( p > @ ) compared to non-CKDu subjects .


Staple food in diet and the consumption pattern of CKDu patients from Medawachchiya were similar to that of non-CKDu subjects from the same area despite their urinary @m concentration being significantly higher .


To assess efficacy of membrane peeling combined with intravitreal injection of bevacizumab in the treatment of macular epiretinal membrane .


From January , @ to June , @ , @ patients ( @ eyes ) with the diagnosis of macular epiretinal membrane underwent vitreous surgery and membrane peeling .


The patients were randomly divided into intravitreal bevacizumab group ( IVB group ) and non-intravitreal bevacizumab group ( non-IVB group ) .


All the patients underwent standard three-port vitrectomy and peeling of epiretinal membrane , with intravitreal injection of @ mg bevacizumab at the end of operation in IVB group .


The best corrected visual acuity and optical coherence tomography ( OCT ) were examined before and after the treatment .


The patients were followed up for @-@ months ( mean @ months ) .


Macular epiretinal membranes were successfully peeled during operation in all the patients without postoperative intraocular infection or bleeding .


Fifteen eyes received vitrectomy combined with intravitreal injection of bevacizumab , and @ underwent only vitreous operation and membrane peeling .


At the end of the follow up , the visual acuity improved in @ eyes ( @ % ) in IVB group , as compared to @ eyes ( @ % ) in the non-IVB group ( P = @ ) .


Central macular thickness decreased by @ m in IVB group and by @ m in non-IVB group , showing a significant difference between the two groups ( t = @ , P < @ ) .


Vitrectomy and membrane peeling combined with intravitreal injection of bevacizumab can promote the recovery of macular morphology but not visual function , and its clinical use still needs to be tested in a long-term and large-sample randomized controlled study .


Alcohol consumption is common on college campuses and is associated with negative consequences .


Factors associated with availability of alcohol are not completely understood .


To describe how proximity and density of alcohol outlets are associated with any drinking and binge drinking in students at the University of Wisconsin-Madison .


Participants were full-time students enrolled in the Young Adults Eating and Active for Health , a multisite , randomized intervention that assessed a variety of health behaviors .


Geographic information systems were used to calculate proximity and enumerate alcohol outlet densities .


Participants were categorized as `` drinkers '' or `` nondrinkers '' based on self-reported alcohol consumption .


Binge drinking was categorized as `` non-binge drinker , '' `` frequent binge drinker , '' and `` excessive binge drinker . ''


Analysis included regression , t tests , and chi-square tests .


RESULTS .


Among the @ participants , @ ( @ % ) were drinkers .


Among drinkers , @ ( @ % ) were either frequent or excessive binge drinkers .


Drinkers lived closer to an alcohol outlet than non-drinkers ( @ + / - @ vs. @ + / - @ miles , respectively , P = @ ) .


Within a @-mile walking radius , there were @ % more establishments for drinkers ( @ + / - @ compared to @ + / - @ outlets for nondrinkers , P < @ ) .


At distances of @-@ @ and @-@ @ miles , twice as many outlets were available to drinkers ( @ + / - @ and @ + / - @ , respectively ) compared to nondrinkers ( @ + / - @ and @ + / - @ , respectively ) , P < @ .


Proximity and density were hot associated with binge drinking frequency .


Drinkers lived closer to alcohol outlets and had significantly more outlets available at a distance of up to @ mile .


Municipal and college administrators could consider limiting alcohol license distributions in municipalities with high alcohol consumption .


Hyperkalemia is a potentially life-threatening condition predominantly seen in patients treated with renin-angiotensin-aldosterone system ( RAAS ) inhibitors with stage @ or greater chronic kidney disease ( CKD ) who may also have diabetes , heart failure , or both .


To select starting doses for a phase @ study and to evaluate the long-term safety and efficacy of a potassium-binding polymer , patiromer , in outpatients with hyperkalemia .


Phase @ , multicenter , open-label , dose-ranging , randomized clinical trial ( AMETHYST-DN ) , conducted at @ sites in Europe from June @ to June @ evaluating patiromer in @ outpatients with type @ diabetes ( estimated glomerular filtration rate , @ to < @ mL/min/@ @ m@ and serum potassium level > @ mEq/L ) .


All patients received RAAS inhibitors prior to and during study treatment .


Patients were stratified by baseline serum potassium level into mild or moderate hyperkalemia groups and received @ of @ randomized starting doses of patiromer ( @ g -LSB- n = @ -RSB- , @ g -LSB- n = @ -RSB- , or @ g -LSB- n = @ -RSB- twice daily -LSB- mild hyperkalemia -RSB- or @ g -LSB- n = @ -RSB- , @ g -LSB- n = @ -RSB- , or @ g -LSB- n = @ -RSB- twice daily -LSB- moderate hyperkalemia -RSB- ) .


Patiromer was titrated to achieve and maintain serum potassium level @ mEq/L or lower .


The primary efficacy end point was mean change in serum potassium level from baseline to week @ or prior to initiation of dose titration .


The primary safety end point was adverse events through @ weeks .


Secondary efficacy end points included mean change in serum potassium level through @ weeks .


A total of @ patients were randomized .


The least squares mean reduction from baseline in serum potassium level at week @ or time of first dose titration in patients with mild hyperkalemia was @ ( @ % CI , @-@ @ ) mEq/L for the @ g twice daily starting-dose group , @ ( @ % CI , @-@ @ ) mEq/L for the @ g twice daily starting-dose group , and @ ( @ % CI , @-@ @ ) mEq/L for the @ g twice daily starting-dose group .


In those with moderate hyperkalemia , the reduction was @ ( @ % CI , @-@ @ ) mEq/L for the @ g twice daily starting-dose group , @ ( @ % CI , @-@ @ ) mEq/L for the @ g twice daily starting-dose group , and @ ( @ % CI , @-@ @ ) mEq/L for the @ g twice daily starting-dose group ( P < @ for all changes vs baseline by hyperkalemia starting-dose groups within strata ) .


From week @ through week @ , statistically significant mean decreases in serum potassium levels were observed at each monthly point in patients with mild and moderate hyperkalemia .


Over the @ weeks , hypomagnesemia ( @ % ) was the most common treatment-related adverse event , mild to moderate constipation ( @ % ) was the most common gastrointestinal adverse event , and hypokalemia ( < @ mEq/L ) occurred in @ % of patients .


Among patients with hyperkalemia and diabetic kidney disease , patiromer starting doses of @ to @ g twice daily resulted in statistically significant decreases in serum potassium level after @ weeks of treatment , lasting through @ weeks .


Preterm infants are at risk for adverse neurodevelopment .


Furthermore , nutrition may play a key role in supporting neurodevelopment .


The aim of this study was to evaluate whether a nutrient-enriched formula fed to preterm infants after hospital discharge could improve their neurodevelopment at @ months ( term-corrected age ) .


We conducted an observer-blinded , single-center , randomized controlled trial in infants admitted to the Fondazione IRCCS C Granda Ospedale Maggiore Policlinico , University of Milan , Italy between @ and @ .


Inclusion criteria were gestational age < @ weeks and/or birth weight < @ g , and being fed human milk for < @ % of the total milk intake .


Exclusion criteria were congenital malformations or conditions that could interfere with growth or body composition .


Included infants were randomized to receive a standard full-term formula or a nutrient-enriched formula up until @ months of corrected age , using two computer-generated randomization lists ; one appropriate for gestational age ( AGA ) and one for small for gestational age ( SGA ) infants .


We assessed neurodevelopment at @ months of corrected age using the Griffiths Mental Development Scale and related subscales ( locomotor , personal-social , hearing and speech , hand and eye coordination , and performance ) .


Of the @ randomized infants , @ completed the study .


@ AGA and @ SGA infants were fed a nutrient-enriched formula , whereas @ AGA and @ SGA infants were fed a standard full-term formula .


The general quotient at @ months of corrected age was not significantly different between infants randomized to receive a nutrient-enriched formula compared with a standard term formula up until @ months of corrected age ( AGA infants : @ @ vs. @ @ , respectively ; SGA infants : @ @ vs. @ @ , respectively ) .


The scores of related subscales were also similar among groups .


This study found that feeding preterm infants a nutrient-enriched formula after discharge does not affect neurodevelopment at @ months of corrected age , in either AGA or SGA infants , free from major comorbidities .


The primary purpose of this randomized controlled trial ( RCT ) was to evaluate the efficacy of internet-based problem-solving training ( iPST ) for employees in the educational sector ( teachers ) with depressive symptoms .


The results of training were compared to those of a waitlist control group ( WLC ) .


One-hundred and fifty teachers with elevated depressive symptoms ( Center for Epidemiologic Studies Depression Scale , CES-D @ ) were assigned to either the iPST or WLC group .


The iPST consisted of five lessons , including problem-solving and rumination techniques .


Symptoms were assessed before the intervention began and in follow-up assessments after seven weeks , three months , and six months .


The primary outcome was depressive symptom severity ( CES-D ) .


Secondary outcomes included general and work-specific self-efficacy , perceived stress , pathological worries , burnout symptoms , general physical and mental health , and absenteeism .


iPST participants displayed a significantly greater reduction in depressive symptoms after the intervention ( d = @ , @ % CI @-@ @ ) , after three months ( d = @ , @ % CI @-@ @ ) and after six months ( d = @ , @ % CI @-@ @ ) compared to the control group .


The iPST participants also displayed significantly higher improvements in secondary outcomes .


However , workplace absenteeism was not significantly affected .


iPST is effective in reducing symptoms of depression among teachers .


Disseminated on a large scale , iPST could contribute to reducing the burden of stress-related mental health problems among teachers .


Future studies should evaluate iPST approaches for use in other working populations .


Anaemia is a major cardiovascular risk factor in chronic kidney disease ( CKD ) .


Treatment and correction of anaemia leads to improvement of cardiovascular status and quality of life of patients with CKD .


This interventional open labeled randomised controlled study comparing the effect of intravenous and oral iron therapy in improving red cell indices and iron status in anaemic pre-dialysis Chronic Kidney Disease was carried out to determine iron status in anaemic pre-dialysis CKD patients to assess the benefit of parenteral iron supplementation as against empirical oral iron in CKD patients with iron deficiency .


Sixty consecutive pre-dialysis chronic kidney disease patients attending the renal clinic over a six month period were screened .


Forty - one subjects ( @ % ) were found to be anaemic and were subsequently studied .


The ages of the patients ranged between @ and @ years with a mean age of @ years .


The mean serum creatinine and mean creatinine clearance were @ ( @ ) ?


mol/L and @ ( @ ) ml/minute respectively .


The haematocrit concentration was found to correlate inversely with the level of serum creatinine and @ % of the anaemic patients had iron deficiency .


The mean PCV rise in the intravenous iron group was @ ( @ ) % and this was statistically significant ( p = @ ) while the mean PCV difference was @ ( @ ) % in the oral iron group .


Intravenously administered iron alone permitted anaemia correction in about one-third of these patients without any life threatening adverse drug event .


Anaemia is very common in the pre-dialysis CKD population and the prevalence of iron deficiency is high .


Intravenous iron supplementation is an effective and safe treatment for the anaemia in the pre-dialysis CKD patients .


Response to oral iron was poor .


Conventional endotracheal intubation requires laryngoscopy for a direct view of the glottis .


However , laryngoscopy is associated with many potential complications .


The aim of the present study was to compare the efficacy and safety of pyriform sinus localization-assisted blind orotracheal intubation with those of conventional laryngoscopic orotracheal intubation .


A randomized , patient-blind , prospective study of @ patients who underwent various operations was performed .


One hundred patients were assigned to the laryngoscopic intubation group ( laryngoscopy group ) , and @ patients were assigned to the blind intubation group ( blind group ) .


The total intubation success rate in the blind group was similar to that in the laryngoscopy group ( @ % vs. @ % , respectively ; p = @ ) .


Oxygen saturation by pulse oximetry in both groups was maintained at > @ % .


The intubation time was significantly shorter in the blind group than in the laryngoscopy group ( @ s vs. @ s , respectively ; p < @ ) .


Postoperative complication rates were significantly lower in the blind group than in the laryngoscopy group .


Recovery time from these symptoms was significantly shorter in the blind group than in the laryngoscopy group ( p = @ ) .


Pyriform sinus localization-assisted blind orotracheal intubation was shown to be more effective than conventional laryngoscopic orotracheal intubation in terms of success rate , intubation time , and postoperative complication rate .


Moreover , it is less affected by common risk factors ; thus , this method may be more beneficial in patients with difficult airways .


Most published contraceptive continuation rates have scientific limitations and can not be compared ; this is particularly true for dissimilar contraceptives .


This study uses a new approach to determine if high continuation rates of long-acting reversible contraception ( LARC ) and protection from unintended pregnancy are observable in a population not self-selecting to use LARC .


We are conducting a partially randomized patient preference trial ( PRPPT ) to compare continuation rates of short-acting reversible contraception ( SARC ) and LARC .


Only women seeking SARC were invited to participate .


Participants chose to be in the preference cohort ( self-selected method use ) or opted to be randomized to SARC or LARC ; only those in the randomized cohort received free product .


We compared participant characteristics , reasons for not trying LARC previously and the contraceptive choices that were made .


We enrolled @ eligible women ; @ % chose to be in the preference cohort and @ % opted for the randomized trial .


The preference and randomized cohorts were similar on most factors .


However , the randomized cohort was more likely than the preference cohort to be uninsured ( @ % versus @ % , respectively ) and to cite cost as a reason for not trying LARC previously ( @ % versus @ % ) ( p < @ for both comparisons ) .


In the preference cohort , fear of pain/injury/side effects/health risks were the predominant reasons ( cited by over @ % ) for not trying LARC previously ( p < @ in comparison to randomized cohort ) .


Enrollment was successful and the process created different cohorts to compare contraceptive continuation rates and unintended pregnancy in this ongoing trial .


The choices participants made were associated with numerous factors ; lack of insurance was associated with participation in the randomized trial .


This PRPPT will provide new estimates of contraceptive continuation rates , such that any benefits of LARC will be more easily attributable to the technology and not the user .


Combined with measuring level of satisfaction with LARC , the results will help project the potential role and benefits of expanding voluntary use of LARC .


To explore the effect of pectin , a kind of soluble dietary fiber , on colonic transit time ( CTT ) , clinical symptoms and gut microbiota in adults with slow-transit constipation .


A total of @ patients with slow-transit constipation were selected between June @ and December @ .


For this randomized controlled trial , we evaluated the efficacy of pectin on intestinal transit time and other indices of constipation in adults with slow-transit constipation .


They were randomized to receive either pectin or placebo .


Treatment consisted of @-week supplementation with @ g/d pectin ( fiber group ) or maltodextrin ( placebo group ) .


Before and after @-week treatment , CTT , constipation symptoms and fecal bacterial population were compared between groups .


CTT of the fiber group after treatment was lower than those of fiber group before treatment and those in the placebo group ( ( @ @ ) h vs ( @ @ ) , ( @ @ ) h , P < @ ) .


Constipation score of the fiber group after treatment also decreased than those of fiber group before treatment and those in the placebo group ( both P < @ ) .


Bifidobacterium sp .


and Lactobacillus sp .


evidently increased ( lg copies/g :@ @ vs @ @ and @ @ , @ @ vs @ @ and @ @ ; all P < @ ) and total Clostridium sp .


significantly decreased ( @ @ vs @ @ and @ @ , P < @ ) in the fiber group after treatment versus the placebo group .


No significant adverse effects were reported .


Four-week soluble dietary fiber use accelerates colon transit time and alleviates clinical symptoms in patients with slow-transit constipation .


Additionally , supplementary fiber offers protective effects on gut microbiota by increasing the population of healthy microflora .


Recurrence rates of between @ % and @ % have been reported following surgery for chronic subdural hematoma ( CSH ) .


A previous study showed that the treatment with angiotensin converting enzyme ( ACE ) inhibitors decreases the risk of recurrence .


To test the effects of ACE inhibitors on the recurrence CSH and CSH remnant six weeks after surgery , we conducted a prospective double-blinded randomized controlled clinical trial on patients with CSHs from July @ until October @ .


Patients eligible for burr hole surgery for CSH were randomized into either an ACE inhibitor perindopril @mg or placebo treatment daily for three months prior to surgery .


Cerebral CT scans were performed after six weeks , and clinical follow-ups were performed three months after surgery .


Additionally , a retrospective analysis of the data and CT scans from all nonrandomized patients from the same time period was performed .


Forty-seven patients were included in the randomized study .


The patients ' preoperative Glasgow Coma Scale scores were @ .


None of the patients in the randomized group developed a recurrence after surgery .


Measurements of the sizes of the CSH before and six weeks after surgery revealed no difference between the placebo and perindopril-treated groups .


In the retrospective group ( @ patients ) , there was no correlation between the risk of recurrence and ACE inhibitor treatment .


Our data suggest that perindopril does not diminish the size of residual CSHs six weeks after burr hole surgery and that ACE inhibitors do not decrease the risk of CSH recurrence .


Knee osteoarthritis ( OA ) progression has been linked to increased peak external knee adduction moments ( KAMs ) .


Although some trials have attempted to reduce pain and improve function in OA by reducing KAMs with a wedged footwear insole intervention , KAM reduction has not been specifically controlled for in trial designs , potentially explaining the mixed results seen in the literature .


Therefore , the primary purpose of this trial is to identify the effects of reduced KAMs on knee OA pain and function .


Forty-six patients with radiographically confirmed diagnosis medial knee OA will be recruited for this @ month randomized controlled trial .


Recruitment will be from Alberta and surrounding areas .


Eligibility criteria include being between the ages of @ and @ years , have knee OA primarily localized to the medial tibiofemoral compartment , based on the American College of Rheumatology diagnostic criteria and be classified as having a Kellgren-Lawrence grade of @ to @ .


Patients will visit the laboratory at baseline for testing that includes dual x-ray absorptiometry , biomechanical testing , and surveys ( KOOS , PASE activity scale , UCLA activity scale , comfort visual analog scale ) .


At baseline , patients will be randomized to either a wedged insole group to reduce KAMs , or a waitlist control group where no intervention is provided .


The survey tests will be repeated at @ months , and response to wedged insoles over @ months will be evaluated .


This study represents the first step in systematically evaluating the effects of reduced KAMs on knee OA management by using a patient-specific wedged insole prescription procedure rather than providing the same insole to all patients .


The results of this trial will provide indications as to whether reduced KAMs are an effective strategy for knee OA management , and whether a personalized approach to footwear insole prescription is warranted .


To compare the effects on anesthesia recovery between assisted-electroacupuncture fast tracking anesthesia and simple fast tracking anesthesia in patients with minim ally invasive percutaneous nephrolithotomy ( mPCNL ) .


Eighty cases of mPCNL were selected and randomly divided into a treatment group and a control group .


Fentanyl ( @-@ microg/kg ) , sevoflurane ( @ % ) and rocuronium ( @ mg/kg ) were applied to perform anesthesia induction in both groups , and endotracheal inhalation of sevoflurane and intravenous pump injection of remifentanil were adopted to main anesthesia status during the operation .


@ min before anesthesia induction , bilateral Neiguan ( PC @ ) , Neimadian , Hegu ( LI @ ) , Yangxi ( LI @ ) , Zhongji ( CV @ ) , Qichong ( ST @ ) , Zuwuli ( LR @ ) were selected and punctured in the treatment group , and elecctroacupuncture was given after arrival of qi until @ min after the wake-up from anesthesia and withdrawal of endotracheal tube .


The dosage for anesthesia maintenance , recovery time of awareness , extubation time , incidences of nausea , vomiting and chill and irritation of urethral catheters were observed and recorded .


( @ ) The dosages of remifentanil and sevoflurane in the treatment group during the operation were obviously less than those in the control group -LSB- remifentanil : ( @ + / -@ ) micro g/kg h vs ( @ + / -@ ) micro g/kg .


h ; sevoflurane : ( @ + / -@ ) vol % vs ( @ + / -@ ) vol % , both P < @ -RSB- .


( @ ) The recovery time of awareness and extubation time in the treatment group were significantly earlier than those in the control group -LSB- recovery time of awareness : ( @ + / - @ ) min vs ( @ + / - @ ) min , P < @ ; extubation time : ( @ + / -@ ) min vs ( @ + / -@ ) min , P < @ -RSB- .


( @ ) The incidences of nausea , vomiting and chill in the treatment group were significantly less than those in the control group ( all P < @ ) .


( @ ) The irritation of urethral catheters on urethra in the treatment group was significantly less than that in the control group ( P < @ ) .


The assisted-electroacupuncture anesthesia could reduce the dosage of remifentanil and sevoflurane in mPCNL fast tracking anesthesia in urinary surgery , reduce the incidences of nausea , vomiting , chill and irritation of urethral catheters during recovery stage , and prompt recovery of mPCNL patients .


Photocoagulation reduces the incidence of visual loss in diabetic patients with focal macular edema , but it can induce it for Efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema @ weeks after treatment and produces visual improvement in some cases .


Topical ketorolac may reduce the inflammation caused by photocoagulation and improve visual outcome .


To determine the efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema .


An experimental , comparative , prospective , longitudinal study in diabetic patients with focal macular edema was conducted .


Eyes were randomized into two groups of topical treatment for @ weeks after photocoagulation ( A : ketorolac , B : placebo ) .


Best corrected visual acuity before and after treatment was compared in each group ( paired t test ) , and the proportion of eyes with visual improvement was compared between groups ( ( @ ) ) .


The evaluation was repeated after stratifying for initial visual acuity ( @ , < @ ) .


There were @ eyes included .


In group A ( n = @ ) mean visual acuity changed from @ to @ ( p = @ ) , and from @ to @ in group B ( n = @ , p = @ ) ; mean percent change was @ % in group A and @ % in group B ( p = @ ) .


Visual improvement was identified in @ eyes from group A ( @ % ) and @ from group B ( @ % , p = @ , RR @ ) ; the difference only persisted when initial visual acuity was @ ( @ -LSB- @ % -RSB- , group A , @ -LSB- @ % -RSB- , group B , p = @ , RR @ ) .


Topical ketorolac was more effective than placebo to improve best corrected visual acuity in diabetic patients with focal macular edema .


To describe the effectiveness of buccal misoprostol as an adjunct to laminaria for cervical ripening before later second-trimester abortion by dilation and evacuation ( D&E ) .


A randomized , double-blinded , placebo-controlled trial of @ women undergoing D&E between @ and @ weeks of gestation .


Subjects had overnight laminaria and @ mcg buccal misoprostol or placebo @-@ h before the abortion .


We used logarithmic transformation of the primary outcome -- D&E procedure duration -- to achieve a normal distribution .


Mean D&E duration was @ min shorter with misoprostol ( p = @ ) .


The median duration was @ versus @ min in the misoprostol and placebo groups , respectively ( p = @ ) .


Cervical dilation was slightly greater with misoprostol ( median @ mm vs. @ mm , p = @ ) ; however , physicians did not find the misoprostol D&E s easier to complete .


Half of subjects reported severe pain after misoprostol vs. @ % with placebo ( p < @ ) .


Adjuvant buccal misoprostol results in slightly shorter D&E s at the cost of more side effects .


Generalised recalcitrant facial verruca plana responds poorly to current therapeutic options , including cryotherapy , topical drugs and carbon dioxide ( CO@ ) laser .


Case reports and uncontrolled studies suggested that topical photodynamic therapy ( PDT ) is effective choice of treatment free from potential complications associated with invasive therapies .


To investigate the efficacy and safety of PDT with different concentrations of photosensitiser in the treatment of verruca plana .


The two sides of a subject 's face were separately randomized to receive aminolevulinic acid ( ALA ) of @ % , @ % or @ % concentration .


All patients were irradiated with @-nm red light for @ J/cm ( @ ) total dose .


Complete response ( CR ) rate was assessed on Week @ , @ , and @ respectively .


The mean overall clearance rate was @ % , @ % , and @ % on Week @ , @ , and @ , respectively , in the @ treated sides .


The CR rate was lower in the @ % - ALA group than in the @ % - ALA group ( @ % vs. @ % , p < @ ) and @ % - ALA group ( @ % vs. @ % , p < @ ) after @ weeks .


The mean severity of pain measured by visual analogue scale ( VAS ) scoring was @ ( range : @ to @ , depending on the lesion location ) .


The overall recurrence rate was @ % ( @/@ ) on Week @ .


Hyperpigmentation was observed in @ % ( @/@ ) of all treated sides .


On Week @ , @ , and @ , hyperpigmentation was more developed in the @ % - ALA group than in the other two groups ( p < @ ) .


In terms of complete clearance rate , the @ % ALA-PDT group was significantly inferior to the @ % and @ % ALA-PDT groups at each follow-up .


In contrast , the @ % ALA group showed a higher incidence rate of transient hyperpigmentation than the other two groups .


This randomised clinical trial suggests that PDT with ALA of @ % concentration offers better efficacy and safety than @ % or @ % concentration for generalised recalcitrant facial verruca plana .


Vaccination is crucial to the control of equine influenza ( EI ) .


The study was conducted in an effort to lay the groundwork for achieving international harmonisation of regulatory requirements based on scientific evidence of performance of different vaccination regimes .


To evaluate the effectiveness of @ different primary vaccination regimes : vaccination with the minimal intervals permitted by the racing authorities ; vaccination in accordance with the manufacturer 's instructions and vaccination with the longest intervals permitted by the racing authorities .


Randomised , prospective clinical trial .


The @ seronegative unvaccinated horses in this study were subdivided by age and randomly allocated one of the @ vaccination regimes .


All groups were sampled each time a group was vaccinated and @-@ weeks post vaccination .


Horses were vaccinated with a subunit immune stimulating complex-based vaccine ( Equip FT ) .


Antibodies against EI were measured by single radial haemolysis .


Lengthening the vaccination intervals increased the immunity gaps between first ( V@ ) and second ( V@ ) doses , and V@ and third dose ( V@ ) but did not inhibit the response to V@ and V@ .


The response to V@ and V@ was similar irrespective of the regime .


Poor responders to V@ were identified in all age groups included in this study but the greatest number of poor responders was among the yearlings .


The @ - and @-year-old horses responded better to vaccination than the weanlings or yearlings .


Longer vaccination intervals permitted by racing authorities increase the periods of susceptibility to EI but they may facilitate strategic vaccination prior to times of increased risk of exposure to virus .


The study provides the type of evidence-based data necessary to commence meaningful discussion of international harmonisation of EI vaccination requirements .


The manipulation of the composition of foods consumed as between-meal snacks may aid daily energy restriction .


We compared the effects of the consumption of @ energy-matched snack bars on appetite , energy intake ( EI ) , and metabolic and endocrine responses .


In addition , we investigated whether the acute effects of the consumption of snacks were maintained under free-living conditions and whether the habitual daily consumption of the snack over @ d influenced these effects .


Ten lean men -LSB- mean SD age : @ @ y ; body mass index ( in kg/m ( @ ) ) : @ @ -RSB- consumed a whey protein and polydextrose ( PPX ) snack bar or an isoenergetic control snack bar as a midmorning , between-meal snack for @ consecutive days in a double-blind , randomized , crossover design .


The two @-d intervention phases were separated by a @-d washout period .


On the first ( day @ ) and last ( day @ ) days of each intervention phase , appetite , food intake , and blood metabolite and endocrine responses were assessed under laboratory conditions .


Free-living EI was recorded on days @ , @ , and @ of interventions .


Total daily EI was significantly lower when the PPX snack was consumed during experimental days ( @,@ @ compared with @,@ @ kJ ; P < @ ) , and daily EI remained lower when the PPX snack was consumed during the free-living part of the intervention ( @ @ compared with @ @ kJ ; P < @ ) .


The PPX snack was associated with lower glucose and ghrelin and higher glucagon-like peptide @ and peptide tyrosine-tyrosine responses .


The manipulation of the composition of foods consumed as snacks is an effective way to limit subsequent EI .


This trial was registered at clinicaltrials.gov as NCT@ .


To validate the device and investigate the effect of this device on symptoms , quality of life , and pelvic floor muscle strength .


The device was designed to measure vaginal pressure changes using air-pressure balloon and abdominal wall muscle activities using surface electromyography .


To test the accuracy of the device , for vaginal pressure measurement , a Mercury sphygmomanometer was used as a gold standard , and for abdominal wall muscle activity , a standard biofeedback machine was used as a reference device .


A randomized , controlled trial was conducted in sixty-one women with stress urinary incontinence .


They were randomly divided into two groups undergoing PFMT with a single @-minute biofeedback session ( BF + PFMT group ) or without biofeedback ( PFMT group ) .


The pelvic floor muscle strength , abdominal wall muscle activity and incontinence-specific quality of life questionnaire ( I-QOL ) , measurements were evaluated at baseline and at @ - and @-week after treatment .


The accuracy of vaginal probe pressure perineometry was @ % compared to a standard sphygmomanometer .


The device could detect abdominal wall muscles activities at @ milliseconds ( @ Hz ) , @ milliseconds ( @ Hz ) , and @ milliseconds ( @ Hz ) .


After @ and @ weeks of treatment , there were statistically significant intra-group differences in the maximum vaginal squeeze pressure in both groups .


However , the inter-group differences were not demonstrated .


The proportion of women who performed pelvic floor muscle exercise correctly was significantly higher in the BF + PFMT group ( @ % ) compared to the PFMT group ( @ % ) at week @ ( p < @ ) .


The simple pelvic floor muscle strength evaluation device might be helpful in pelvic floor muscle training in a low resource setting .


Left ventricular ( LV ) dysfunction during and after hospitalization for ST-segment elevation myocardial infarction ( STEMI ) is associated with increased mortality .


Whether baseline LV dysfunction impacts STEMI outcomes is not well studied .


Furthermore , whether bivalirudin and paclitaxel-eluting stents ( PES ) are beneficial in patients with LV dysfunction is unknown .


We studied the impact of left ventricular ejection fraction ( LVEF ) on outcomes of patients with STEMI in the HORIZONS-AMI trial .


LVEF was determined in @ ( @ % ) of @ enrolled STEMI patients , who were divided into three groups according to LV function : ( @ ) severely impaired ( LVEF < @ % ) ; ( @ ) moderately impaired ( LVEF @-@ % ) ; and ( @ ) normal ( LVEF @ % ) .


Compared to patients with normal LV function , those with severely impaired LVEF had higher @-year rates of net adverse clinical events ( @ vs. @ % , p < @ ) , major adverse cardiovascular events ( @ vs. @ % , p < @ ) , cardiac death ( @ vs. @ % , p < @ ) , and non-coronary artery bypass graft major bleeding ( @ vs. @ % , p = @ ) , differences which persisted after adjustment for baseline characteristics .


Among patients with LVEF < @ % , treatment with bivalirudin compared to heparin + GPIIb/IIIa inhibitors resulted in reduced @-year mortality ( @ vs. @ % , p = @ ) .


Patients with LVEF < @ % receiving PES rather than bare metal stents had lower rates of @-year ischaemia-driven target lesion revascularization ( @ vs. @ % , p = @ ) and reinfarction ( @ vs. @ % , p = @ ) .


Among patients with STEMI undergoing primary percutaneous coronary intervention , adverse events are markedly increased in those with LVEF < @ % during the index revascularization procedure .


Nevertheless , these high-risk patients experience substantial clinical benefits from bivalirudin and PES .


Increased intracranial pressure ( ICP ) in patients with traumatic brain injury ( TBI ) is associated with a higher mortality rate and poor outcome .


Mannitol and hypertonic saline ( HTS ) have both been used to treat high ICP , but it is unclear which one is more effective .


Here , the authors compare the effect of mannitol versus HTS on lowering the cumulative and daily ICP burdens after severe TBI .


The Brain Trauma Foundation TBI-trac New York State database was used for this retrospective study .


Patients with severe TBI and intracranial hypertension who received only @ type of hyperosmotic agent , mannitol or HTS , were included .


Patients in the @ groups were individually matched for Glasgow Coma Scale score ( GCS ) , pupillary reactivity , craniotomy , occurrence of hypotension on Day @ , and the day of ICP monitor insertion .


Patients with missing or erroneous data were excluded .


Cumulative and daily ICP burdens were used as primary outcome measures .


The cumulative ICP burden was defined as the total number of days with an ICP of > @ mm Hg , expressed as a percentage of the total number of days of ICP monitoring .


The daily ICP burden was calculated as the mean daily duration of an ICP of > @ mm Hg , expressed as the number of hours per day .


The numbers of intensive care unit ( ICU ) days , numbers of days with ICP monitoring , and @-week mortality rates were also compared between the groups .


A @-sample t-test or chi-square test was used to compare independent samples .


The Wilcoxon signed-rank or Cochran-Mantel-Haenszel test was used for comparing matched samples .


A total of @ patients who received only HTS and @ who received only mannitol after severe TBI were identified .


Eight patients in the HTS group were excluded because of erroneous or missing data , and @ other patients did not have matches in the mannitol group .


The remaining @ patients were matched @:@ .


Twenty-four patients received @ % HTS , and @ received @ % HTS as bolus therapy .


All @ patients in the mannitol group received @ % mannitol .


The mean cumulative ICP burden ( @ % -LSB- HTS -RSB- vs @ % -LSB- mannitol -RSB- ; p = @ ) and the mean ( SD ) daily ICP burden ( @ @ hours/day -LSB- HTS -RSB- vs @ @ hours/day -LSB- mannitol -RSB- ; p = @ ) were significantly lower in the HTS group .


The mean ( SD ) number of ICU days was significantly lower in the HTS group than in the mannitol group ( @ @ vs @ @ , respectively ; p = @ ) , whereas there was no difference in the numbers of days of ICP monitoring ( p = @ ) .


There were no significant differences between the cumulative median doses of HTS and mannitol ( p = @ ) .


The @-week mortality rate was lower in the HTS group , but the difference was not statistically significant ( p = @ ) .


HTS given as bolus therapy was more effective than mannitol in lowering the cumulative and daily ICP burdens after severe TBI .


Patients in the HTS group had significantly lower number of ICU days .


The @-week mortality rates were not statistically different between the @ groups .


This prospective , randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine ( TPZ ) to standard cisplatin ( CIS ) chemoradiotherapy in locally advanced cervix cancer .


Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy .


Primary end point was progression-free survival ( PFS ) .


Secondary end points included overall survival ( OS ) and tolerability .


PFS was evaluable in @ of @ patients randomly assigned over @ months , with enrollment ending in September @ .


Because of the lack of TPZ supply , the study did not reach its original target accrual goal .


At median follow-up of @ months , PFS and OS were similar in both arms .


Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were @ % and @ % , respectively ( log-rank P = @ ) .


Three-year OS for the TPZ/CIS/RT and CIS/RT arms were @ % and @ % , respectively ( log-rank P = @ ) .


A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm , with resulting tolerance in both treatment arms .


TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS , although definitive commentary was limited by an inadequate number of events ( progression or death ) .


TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose .


We describe the statistical analysis plan ( SAP ) for the Permissive Hyperthermia through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit ( HEAT ) trial , a @-patient , prospective , randomised , Phase @b , multicentre , double-blind , parallel-groups , placebo-controlled trial of paracetamol administration for the treatment of fever in critically ill patients with known or suspected infection .


The data fields described are those outlined in the study protocol published previously .


We describe the plan for the presentation and comparison of baseline characteristics , process measures and outcomes .


We describe baseline characteristics , and define and categorise trial outcomes according to their assigned importance .


We developed an SAP for the HEAT trial , and produced a mock Consolidated Standards of Reporting Trials diagram and tables .


Our prespecified SAP accords with high-quality standards of internal validity and should minimise future analysis bias .


To examine the effect of an individually tailored , motivationally matched prenatal exercise intervention on gestational diabetes mellitus ( GDM ) and other measures of glucose intolerance among ethnically diverse prenatal care patients at increased risk for GDM .


The Behaviors Affecting Baby and You study randomized eligible women at a mean ( standard deviation ) of @ ( @ ) weeks of gestation to a @-week individually tailored , motivationally matched exercise intervention or a comparison health and wellness intervention .


The goal of the exercise intervention was to achieve the American College of Obstetricians and Gynecologists ' guidelines for physical activity during pregnancy .


Diagnosis of GDM , impaired glucose tolerance , abnormal glucose screen , and screening glucose values ( mg/dL ) were abstracted from medical records .


A sample size of @ women ( @ per group ) was planned to have @ % power to detect reductions in risk of @ % or larger .


From July @ to December @ , a total of @ ( @ % ) women completed the intervention ; n = @ and @ in the exercise and comparison interventions , respectively .


Based on an intention-to-treat analysis , no statistically significant differences between the intervention groups were observed ; the relative odds of GDM in the exercise group was @ ( @ % confidence interval -LSB- CI -RSB- @-@ @ ) as compared with the health and wellness comparison group .


Odds ratios for impaired glucose tolerance and abnormal glucose screen were @ ( @ % CI @-@ @ ) and @ ( @ % CI @-@ @ ) , respectively .


The intervention had no effect on birth outcomes .


In this randomized trial among ethnically diverse pregnant women at increased risk for GDM , we found that a prenatal exercise intervention implemented in the second trimester did not result in a statistically significant reduction in relative odds for GDM , impaired glucose tolerance , or abnormal glucose screen .


Prospective , multicenter , randomized , and controlled Investigational Device Exemption clinical trial .


To compare the clinical safety and effectiveness of the selectively constrained SECURE-C ( Globus Medical , Audubon , PA ) Cervical Artificial Disc to anterior cervical discectomy and fusion ( ACDF ) .


Cervical total disc replacement has been developed as an alternative to ACDF by allowing segmental motion .


Current cervical total disc replacement designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulating designs with various means of fixation .


A total of @ patients from @ investigational sites were prospectively enrolled in the study .


Patients were randomized , treated surgically , and evaluated postoperatively at @ weeks , @ months , @ months , @ months , and @ months .


Clinical outcomes include overall success , visual analogue scale pain ( right arm , left arm , and neck ) , neck disability index , neurological status , Short Form @ ( SF-@ ) Health Status Survey questionnaires , range of motion , and adverse events .


Bayesian statistical methods were used to analyze the outcomes .


Overall success results demonstrated statistical superiority of the randomized SECURE-C group compared with the randomized ACDF group at @ months , with a posterior probability of @ % using the protocol-specified criteria and @ % using Food and Drug Administration-defined criteria .


At @ months postoperatively , SECURE-C demonstrated clinically significant improvement in pain and function in terms of neck disability index , visual analogue scale , and @-Item Short Form Health Survey .


At @ months , the percentage of patients experiencing secondary surgical interventions at the index level was statistically lower for the SECURE-C group ( @ % ) than the ACDF group ( @ % ) .


At @ months , @ % of as-treated SECURE-C patients were range-of-motion successes .


Satisfaction was high among SECURE-C patients .


The selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as the standard of care , an anterior cervical discectomy and fusion .


SECURE-C is statistically superior in terms of overall success , index-level subsequent surgical procedures , and patient satisfaction , making it an attractive surgical option for patients with symptomatic cervical disc disease .


Alirocumab , a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type @ ( PCSK@ ) , has been shown to reduce low-density lipoprotein ( LDL ) cholesterol levels in patients who are receiving statin therapy .


Larger and longer-term studies are needed to establish safety and efficacy .


We conducted a randomized trial involving @ patients at high risk for cardiovascular events who had LDL cholesterol levels of @ mg per deciliter ( @ mmol per liter ) or more and were receiving treatment with statins at the maximum tolerated dose ( the highest dose associated with an acceptable side-effect profile ) , with or without other lipid-lowering therapy .


Patients were randomly assigned in a @:@ ratio to receive alirocumab ( @ mg ) or placebo as a @-ml subcutaneous injection every @ weeks for @ weeks .


The primary efficacy end point was the percentage change in calculated LDL cholesterol level from baseline to week @ .


At week @ , the difference between the alirocumab and placebo groups in the mean percentage change from baseline in calculated LDL cholesterol level was -@ percentage points ( P < @ ) ; the treatment effect remained consistent over a period of @ weeks .


The alirocumab group , as compared with the placebo group , had higher rates of injection-site reactions ( @ % vs. @ % ) , myalgia ( @ % vs. @ % ) , neurocognitive events ( @ % vs. @ % ) , and ophthalmologic events ( @ % vs. @ % ) .


In a post hoc analysis , the rate of major adverse cardiovascular events ( death from coronary heart disease , nonfatal myocardial infarction , fatal or nonfatal ischemic stroke , or unstable angina requiring hospitalization ) was lower with alirocumab than with placebo ( @ % vs. @ % ; hazard ratio , @ ; @ % confidence interval , @ to @ ; nominal P = @ ) .


Over a period of @ weeks , alirocumab , when added to statin therapy at the maximum tolerated dose , significantly reduced LDL cholesterol levels .


In a post hoc analysis , there was evidence of a reduction in the rate of cardiovascular events with alirocumab .


( Funded by Sanofi and Regeneron Pharmaceuticals ; ODYSSEY LONG TERM ClinicalTrials.gov number , NCT@ . )


The relationship between lower urinary tract symptoms ( LUTS ) and erectile dysfunction ( ED ) has recently received increased attention .


The aim of this study was to evaluate the efficacy of the Alfa-@ association of Serenoa repens , Pinus massoniana Bark Extract ( PMBE ) and Crocus sativus ( IDIProst Gold ) in improvement of patient 's quality of life , when compared with Serenoa repens alone .


All patients with clinical and instrumental diagnosis of LUTS due to Benign Prostatic Hyperplasia ( BPH ) and ED , attending @ Italians Urological Institutions from May to December @ were enrolled in this prospective , multicentre , phase @ study .


Participants were assigned to receive oral capsules of IDIProst Gold ( one capsule q@ h ) or Serenoa repens @ mg ( one capsule q@h ) for @ months .


Clinical and instrumental analyses were carried out at the enrollment and at the end of therapy .


IPSS , IIEF-@ and SF-@ questionnaires have been used .


The main outcome measure was the improvement of quality of life at the end of the whole study period .


@ ( mean age @-@ @ ) men were randomly allocated to IDIProst Gold ( n = @ ) or Serenoa repens ( n = @ ) .


The baseline questionnaire mean scores were @ @ , @ @ , @ @ for IPSS , IIEF-@ and SF-@ , respectively .


At the follow-up examination , statistically significant differences have been reported in terms of IPSS ( @ vs @ ; p < @ ) , IIEF-@ and SF-@ mean scores ( @ vs @ ; @ vs @ ; p < @ ; p < @ ) .


Moreover , statistically significant differences were then reported between the two visits , in terms of IPSS , IIEF-@ and SF-@ scores ( p < @ ; p < @ ; p < @ ) , only in the IDIProst Gold group .


In conclusions , we found that IDIProst Gold significantly improve the quality of life of patients affected by LUTS due to BPH and ED , specifically in terms of sexual function , highlighting that a better sexual quality of life is correlated with an higher overall quality of life regardless of the urinary function .


The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-@ ( GS ) combination chemotherapy in patients with unresectable pancreatic cancer .


Patients were randomly assigned to receive GS ( oral S-@ @mg/m ( @ ) daily on days @-@ every @weeks and gemcitabine @,@ mg/m ( @ ) on days @ and @ ) or gemcitabine ( @,@ mg/m ( @ ) on days @ , @ , and @ every @weeks ) .


The primary endpoint was progression-free survival ( PFS ) .


One hundred and one patients were randomly assigned .


PFS was significantly longer in the GS arm with an estimated hazard ratio ( HR ) of @ ( @ % CI @-@ @ ; P = @ ; median @ vs @ months ) .


Objective response rate ( ORR ) was also better in the GS arm ( @ vs @ % , P = @ ) .


Median survival was @ months for GS and @ months for GEM ( HR @ ; @ % CI @-@ @ ; P = @ ) .


Grade @-@ neutropenia ( @ vs @ % , P = @ ) and thrombocytopenia ( @ vs @ % , P = @ ) were more frequent in the GS arm .


GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer .


Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction , and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal .


The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population .


Persons with serious mental illness and a body mass index ( BMI ) > @ receiving services in three community mental health organizations were recruited and randomly assigned either to the @-month In SHAPE program , which included membership in a public fitness club and weekly meetings with a health promotion coach , or to fitness club membership alone .


The primary outcome measures were weight and cardiorespiratory fitness ( as measured with the @-minute walk test ) , assessed at baseline and at @ , @ , @ , @ , and @ months .


Participants ( N = @ ) were ethnically diverse ( @ % were nonwhite ) , with a mean baseline BMI of @ ( SD = @ ) .


At @ months , the In SHAPE group ( N = @ ) had greater reduction in weight and improved fitness compared with the fitness club membership only group ( N = @ ) .


Primary outcomes were maintained at @ months .


Approximately half of the In SHAPE group ( @ % at @ months and @ % at @ months ) achieved clinically significant cardiovascular risk reduction ( a weight loss @ % or an increase of > @ meters on the @-minute walk test ) .


This is the first replication study confirming the effectiveness of a health coaching intervention in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness .


Allograft safety is contingent on effective sterilization .


However , current sterilization methods have been associated with decreased biomechanical strength and higher failure rates of soft-tissue allografts .


In this study , electron beam ( e-beam ) sterilization was explored as an alternative sterilization method to preserve biomechanical integrity .


We hypothesized that e-beam sterilization would not significantly alter the biomechanical properties of tendon allograft compared with aseptic , nonsterilized controls and gamma-irradiated grafts .


Separate sets of forty fresh-frozen tibialis tendon allografts ( four from each of ten donors ) and forty bisected bone-patellar tendon-bone ( BTB ) allografts ( four from each of ten donors ) were randomly assigned to four study groups .


One group received a @ to @-kGy gamma radiation dose ; two other groups were sterilized with an e-beam at either a high ( @ to @-kGy ) or low ( @ to @-kGy ) dose .


A fourth group served as nonsterilized controls .


Each graft was cyclically loaded to @ N of tension for @ cycles at a frequency of @ Hz , allowed to relax for five minutes , and then tested in tension until failure at a @ % / sec strain rate .


One-way analysis of variance testing was used to identify significant differences .


Tibialis tendons sterilized with both e-beam treatments and with gamma irradiation exhibited values for cyclic tendon elongation , maximum load , maximum displacement , stiffness , maximum stress , maximum strain , and elastic modulus that were not significantly different from those of nonsterilized controls .


BTB allografts sterilized with the high e-beam dose and with gamma irradiation were not significantly different in cyclic tendon elongation , maximum load , maximum displacement , stiffness , maximum stress , maximum strain , and elastic modulus from nonsterilized controls .


BTB allografts sterilized with the e-beam at the lower dose were significantly less stiff than nonsterilized controls ( p = @ ) but did not differ from controls in any other properties .


The difference in stiffness likely resulted from variations in tendon size rather than the treatments , as the elastic moduli of the groups were similar .


The biomechanical properties of tibialis and BTB allografts sterilized with use of an e-beam at a dose range of @ to @ kGy were not different from those of aseptic , nonsterilized controls or gamma-irradiated allografts .


E-beam sterilization can be a viable method to produce safe and biomechanically uncompromised soft-tissue allografts .


Angular stable locking of intramedullary nails has been shown to enhance fixation stability of tibial fractures in biomechanical and animal studies .


The aim of our study was to assess whether use of the angular stable locking system or conventional locking resulted in earlier full weight-bearing with minimum pain for patients with a distal tibial fracture treated with an intramedullary nail .


A prospective multicenter , randomized , patient-blinded trial was conducted with adults who had a distal tibial fracture .


Patients ' fractures were managed with an intramedullary nail locked with either an angular stable locking system or conventional locking screws .


Outcomes were evaluated at six weeks , twelve weeks , six months , and one year after surgery .


Time to full weight-bearing with minimum pain was calculated with use of daily entries from patient diaries .


Secondary outcomes included pain at the fracture site under load , quality of life , gait analysis , mobility , radiographic findings , and adverse events .


One hundred and forty-two patients were randomly allocated to two treatment groups : seventy-five to the group receiving intramedullary nailing with the angular stable locking system and sixty-seven to the group receiving conventional intramedullary nailing .


No clinically important differences were found for either the primary or secondary outcome parameters between the groups during the entire follow-up period .


Use of an angular stable locking system with intramedullary nailing did not improve the outcome compared with conventional locking screws in the treatment of distal tibial fractures .


Ridge preservation protocols reduce crestal remodeling after tooth extraction .


There is insufficient evidence on bone grafting in combination with platelet-rich plasma ( PRP ) or recombinant human platelet-derived growth factor ( rhPDGF-BB ) .


The aim of this study is to evaluate healing of grafted and nongrafted sockets and the effect of PRP and rhPDGF-BB on early remodeling .


Forty-one patients whose treatment plan included extraction of anterior or premolar teeth were randomized into four groups .


Group @ : collagen plug ( control ) .


Group @ : mineralized freeze-dried bone allograft ( FDBA ) / - tricalcium phosphate ( - TCP ) / collagen plug .


Group @ : FDBA / - TCP/PRP/collagen plug .


Group @ : FDBA / - TCP/rhPDGF-BB/collagen plug .


At @ weeks , a core was harvested from the center of @ sockets .


Histomorphometric analysis took place .


Differences were analyzed using one-way analysis of variance ( ANOVA ) or chi-square tests for continuous and categorical data .


Pairwise comparisons were tested using least squares means .


Spearman correlation coefficients were used to evaluate the relationship of bone growth with potential confounders .


A P value < @ was considered statistically significant .


ANOVA did not indicate statistical significance in age , gender , smoking , ethnicity , or race distribution .


Significant differences in tissue distribution were identified between groups and between different thirds of harvested core .


More new bone and amorphous organic matrix was noted in the control group .


In sites where bone graft was combined with growth factors , the amount of residual particles was less than in sites where bone graft was used alone .


Inclusion of bone replacement graft suppressed new bone formation during early healing .


Inclusion of PRP and rhPDGF-BB produced less residual bone graft material , indicating more rapid turnover of bone graft .


All treatment modalities achieved a significant amount of new vital bone at @ weeks postextraction .


To investigate in this phase @a study ( ZENITH ) the safety , tolerability , and antiviral activity of VX-@ , a selective , non-nucleoside inhibitor of hepatitis C virus ( HCV ) NS@B polymerase , combined with various telaprevir-based regimens for treatment of genotype @ HCV .


In total , @ treatment-naive patients received VX-@ + telaprevir ( ` DUAL ' regimen ; n = @ ) , with ribavirin ( ` TRIPLE ' regimen ; n = @ ) , or with peginterferon + ribavirin ( ` QUAD ' regimen ; n = @ ) for @ weeks .


Patients with detectable HCV RNA at weeks @ and/or @ received peginterferon + ribavirin for @ ( DUAL and TRIPLE ) or @ ( QUAD ) additional weeks .


VX-@ ( @ or @ mg twice daily ) was well tolerated , with an increased rate of gastrointestinal adverse events observed with the higher dose .


Across VX-@ @-mg twice-daily regimens , the QUAD was associated with the highest frequency of grade @/@ adverse events .


The DUAL was discontinued because of high viral breakthrough before week @ .


Sustained virologic response ( SVR ) @ weeks after end of treatment ( SVR@ ) , including patients treated with @ or @ additional weeks of peginterferon + ribavirin , was @ % for TRIPLE ( VX-@ @ mg twice daily ) and @ and @ % for QUAD ( VX-@ @ and @ mg twice daily , respectively ) .


These results provide valuable information regarding the safety , tolerability , and efficacy of telaprevir combined with a non-nucleoside polymerase inhibitor , as dual therapy or with ribavirin without or with peginterferon .


Telaprevir and VX-@ , alone or with ribavirin without or with peginterferon , were generally well tolerated , with improved tolerability without peginterferon .


SVR@ rates achieved with TRIPLE and QUAD regimens containing telaprevir and VX-@ were comparable to those observed with telaprevir-based therapy .


Remote ischemic preconditioning may result in reduction in infarct size during percutaneous coronary intervention ( PCI ) .


It is unclear whether remote ischemic postconditioning ( RIPost ) will reduce the incidence of myocardial injury after PCI , and whether ischemic conditioning of a larger remote organ ( thigh versus arm ) would provide further myocardial protection .


We randomized @ patients presenting with stable or unstable angina ( @ % of patients ) and negative Troponin T at baseline to @ groups : @ groups received RIPost ( induced by ischemia to upper or lower limb ) , and a third was the control group .


RIPost was applied during PCI immediately after stent deployment , by three @-minute cycles of blood pressure cuff inflation to > @ mmHg in the arm or thigh ( @ mmHg in the control ) with @-minute breaks between each cycle .


The primary end-point was the proportion of patients with Troponin T levels > @ULN postprocedure ( at @ or @-@ hours ) , where ULN stands for upper limit of normal .


A total of @ patients were randomized to each group .


There were no differences in baseline characteristics between the @ groups .


The primary outcome occurred in @ % , @ % , and @ % of the arm , thigh , and control groups , respectively ( P = @ ) .


There were no differences in creatine kinase or high sensitivity C-reactive protein levels after PCI or in the incidence of acute kidney injury between the groups .


RIPost during PCI did not reduce the incidence of periprocedural myocardial injury .


Similar effect was obtained when remote ischemia was induced to the upper or lower limb .


The term angiokeratoma refers to a group of unrelated diseases with similar histopathologic features .


Four clinical variants of angiokeratoma have been described .


However , it is not known whether some variants of angiokeratoma are of lymphatic origin , and an immunohistochemical study of lymphatic markers has not been previously performed .


We performed an immunohistochemical study of angiokeratomas using lymphatic markers .


Fifteen cases of angiokeratoma corporis diffusum , @ cases of Fordyce angiokeratoma , @ cases of Mibelli angiokeratoma and @ cases of solitary angiokeratoma were examined by immunohistochemical analysis using CD@ , D@-@ , Prox@ and Wilms ' tumor @ ( WT-@ ) .


The vessels of angiokeratoma corporis diffusum , Fordyce angiokeratoma and solitary angiokeratoma were usually focally positive for D@-@ and positive for Prox@ , whereas the vessels of Mibelli angiokeratoma were negative for D@-@ and positive for Prox@ .


The results suggest lymphatic derivation of angiokeratoma corporis diffusum , Fordyce angiokeratoma and solitary angiokeratoma .


However , the derivation of Mibelli angiokeratoma could not be determined based on the present immunohistochemical results .


The purpose of this research was to replicate a successful intervention to increase physical activity in a different region of the country , and explore genetic and physiological moderators of intervention efficacy drawn from a transdisciplinary theoretical framework .


A randomized controlled trial comparing a print-based physical activity intervention ( COSTRIDE ) to a print-based health and wellness contact control ( HW ) intervention was conducted .


Sedentary participants ( n = @ ) completed assessments at baseline and follow-up assessments at @ , @ , @ , and @months following the initiation of the intervention .


Participants in both conditions significantly increased exercise behavior in the first six months , and then leveled off or decreased physical activity in the second six months of the study .


Those in the COSTRIDE intervention increased significantly more than those in the HW intervention , and were better able to maintain their exercise behavior .


Genetic factors ( BDNF , rs@ ; FTO , rs@ ) , but not selected physiological ( body temperature , blood lactate , systolic blood pressure , plasma norepinephrine , and heart rate ) or subjective ( perceived pain , affect ) responses to physical activity , moderated response to the intervention .


There are underlying genetic factors that influence response to behavioral intervention , and a better understanding of these factors has the potential to influence the development , targeting and tailoring of behavioral interventions to increase physical activity .


Subcuticular closure provides a superior cosmetic result in clean wounds .


The aim of this work was to investigate the safety in terms of postoperative infection and cosmetic effectiveness of subcuticular wound closure after elective colon cancer surgery in clean-contaminated wounds .


Patients who underwent elective resection of colon cancer were randomized to interrupted subcuticular and interrupted transdermal suture groups .


The large bowel was prepared by mechanical washout with polyethylene glycol .


All patients received metronidazole and kanamycin orally and flomoxef sodium once parenterally for antimicrobial prophylaxis .


The primary end point was the incidence of incisional surgical-site infections within @ days after operation .


We assessed noninferiority of subcuticular suture within a margin of @ % .


Analysis was by intent-to-treat .


Secondary objectives include comparison of wound closure time , comfort , and cosmesis of the scar and satisfaction of patients .


This study was registered with UMIN-CTR , UMIN@ .


A total of @ patients were randomized to the two groups .


Incisional surgical-site infection rates were @ % ( @ % confidence interval @-@ @ % ) for both groups .


The relative risk of subcuticular suture was @ ( @-@ @ , one-tail P = @ ) .


Interrupted subcuticular suture was noninferior to interrupted transdermal suture ( P = @ ) .


Throughout @ months after operation , patients expressed a significant preference for the subcuticular suture technique , noting rapid relief from pain , decreased vascularity , and smaller width , although the procedure took twice as long .


Subcuticular suture did not increase the incidence of wound complications in elective colon cancer operation .


Patients preferred a technique of interrupted subcuticular closure , citing better cosmetic results , and less pain .


Life-threatening ear , nose , and throat ( ENT ) emergencies are uncommon but require immediate skilled management .


We investigated if traditional lecture-based teaching can be improved by a simulation and lecture hybrid approach .


A single-blinded , prospective , randomized controlled trial .


Two groups of interns with no previous ENT experience were randomized to one of two training groups : a simulation/lecture hybrid group or a lecture-only control group .


Both groups received @ minutes of training covering the assessment of critically ill patients and four ENT emergency topics .


Both groups received the same initial lecture slides .


The control group received additional slides , and the simulation group received simulated emergency scenario training using basic mannequins .


Following the training , candidates were asked to provide feedback on their perception of training , and they were formally assessed with a standardized one-to-one viva .


Thirty-eight interns were recruited : @ in the control group and @ in the simulation group .


The candidates in the simulation group performed significantly better in all viva situations ( P < @ ) and had better perception of learning ( P < @ ) .


Additionally , the simulation group was more likely to recommend the training to a colleague ( P < @ ) .


We have demonstrated that replacing traditional lecture-based training with a mixture of lectures and emergency scenario simulation is more effective at preparing junior doctors for ENT emergencies , and better met their learning needs .


Implementing this kind of teaching is feasible with a minimum of additional resources or time .


Polycystic ovary syndrome ( PCOS ) is characterized by obesity and insulin resistance ( IR ) , which result in elevated plasminogen activator inhibitor-@ ( PAI-@ ) levels .


We aimed to assess the changes in PAI-@ levels in PCOS during treatment with metformin and during weight loss .


Twenty-three normal weight women with PCOS were given metformin @ mg bid for @ months .


Fifty overweight/obese women with PCOS were prescribed an energy-restricted diet , were instructed to exercise and were randomized to orlistat @ mg tid or sibutramine @ mg qd for @ months .


In normal weight women , treatment with metformin reduced the body mass index ( BMI ) and circulating androgens , improved markers of IR and lowered PAI-@ levels .


In overweight/obese women , sibutramine and orlistat yielded comparable reductions in BMI and markers of IR .


In contrast , the effects on the free androgen index ( FAI ) differed ( p = @ ) : sibutramine reduced the FAI ( p = @ ) , whereas orlistat had no effect .


The effects of sibutramine and orlistat on PAI-@ levels also differed ( p = @ ) : sibutramine reduced PAI-@ levels ( p < @ ) , whereas orlistat had no effect .


Metformin and sibutramine , but not orlistat , reduce PAI-@ levels in PCOS .


The reduction in circulating androgens during metformin and sibutramine treatment might be implicated in this decline .


There are limited data on the extent of blood-brain barrier ( BBB ) compromise in acute intracerebral hemorrhage patients .


We tested the hypotheses that BBB compromise measured with permeability-surface area product ( PS ) is increased in the perihematoma region and predicts perihematoma edema growth in acute intracerebral hemorrhage patients .


Patients were randomized within @ hours of symptom onset to a systolic blood pressure ( SBP ) treatment of < @ ( n = @ ) or < @ mm Hg ( n = @ ) .


Permeability maps were generated using computed tomographic perfusion source data acquired @ hours after randomization , and mean PS was measured in the hematoma , perihematoma , and hemispheric regions .


Hematoma and edema volumes were measured on noncontrast computed tomographic scans obtained at baseline , @ hours and @ hours after randomization .


Patients were randomized at a median ( interquartile range ) time of @ hours ( @ ) from symptom onset .


Treatment groups were balanced with respect to baseline SBP and hematoma volume .


Perihematoma PS ( @ mL/@ mL per minute ) was higher than PS in contralateral regions ( @ mL/@ mL per minute ; P < @ ) .


Relative edema growth ( @-@ hours ) was not predicted by perihematoma PS ( = -@ -LSB- -@ to @ -RSB- ) or SBP change ( = -@ -LSB- -@ to @ -RSB- ) .


SBP was lower in the < @ target group ( @ mm Hg ) than in the < @ group ( @ mm Hg ; P < @ ) .


Perihematoma PS was not different between groups ( @ mL/@ mL per minute for the < @ group , @ mL/@ mL per minute for the < @ group ; P = @ ) .


BBB permeability is focally increased in the hematoma and perihematoma regions of acute intracerebral hemorrhage patients .


BBB compromise does not predict acute perihematoma edema volume or edema growth .


SBP reduction does not affect BBB permeability .


To implement and evaluate an evidence-informed multicomponent strategy to reduce physical restraint use in older adults admitted to acute care medical units .


Stepped-wedge trial .


Four acute care medical units in Calgary , Alberta , over a @-month time period .


Data were collected from individuals aged @ and older present on the study units during monthly restraint audits .


Development of opinion leaders among the nursing leadership , education and training of physicians and unit nurses , and implementation of least restraint rounds .


The primary outcome was rate of restraint use as determined from walk-around audits .


Secondary outcomes included number of physician orders for physical restraints on the electronic medical record and fall reports .


Thirteen percent to @ % of individuals were being restrained on the medical units before the intervention , with the vast majority of restraints being bed rails .


This decreased to @ % to @ % after the intervention .