First-pass success was highest for DL ( @ % , no suit ; @ % , suit ) followed by GS ( @ % , no suit ; @ % , suit ) and SALT ( @ % , no suit ; @ % , suit ) .


A minority of participants had prior experience intubating in biohazard suits .


Use of biohazard suits extends time to successful intubation .


There was no difference in time to intubation for the @ devices , but first-pass success was highest for DL ( with or without biohazard gear ) .


Delirium is common during critical illness and associated with adverse outcomes .


We compared characteristics and outcomes of delirious and nondelirious patients enrolled in a multicenter trial comparing protocolized sedation with protocolized sedation plus daily sedation interruption .


Randomized trial .


Sixteen North American medical and surgical ICUs .


Four hundred thirty critically ill , mechanically ventilated adults .


All patients had hourly titration of opioid and benzodiazepine infusions using a validated sedation scale .


For patients in the interruption group , infusions were resumed , if indicated , at half of previous doses .


Delirium screening occurred daily ; positive screening was defined as an Intensive Care Delirium Screening Checklist score of @ or more at any time .


Delirium was diagnosed in @ of @ assessed patients ( @ % ) .


Coma was identified in @ % of delirious compared with @ % of nondelirious patients ( p = @ ) .


The median time to onset of delirium was @ days ( interquartile range , @-@ ) , and the median duration of delirium was @ days ( interquartile range , @-@ ) .


Delirious patients were more likely to be male ( @ % vs @ % ; p = @ ) , have a surgical/trauma diagnosis ( @ % vs @ % ; p = @ ) , and history of tobacco ( @ % vs @ % ; p = @ ) or alcohol use ( @ % vs @ % ; p = @ ) .


Patients with positive delirium screening had longer duration of ventilation ( @ vs @ d ; p < @ ) , ICU stay ( @ vs @ d ; p < @ ) , and hospital stay ( @ vs @ d ; p < @ ) .


Delirious patients were more likely to be physically restrained ( @ % vs @ % ; p = @ ) and undergo tracheostomy ( @ % vs @ % ; p < @ ) .


Antecedent factors independently associated with delirium onset were restraint use ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) , antipsychotic administration ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) , and midazolam dose ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) .


There was no difference in delirium prevalence or duration between the interruption and control groups .


In mechanically ventilated adults , delirium was common and associated with longer duration of ventilation and hospitalization .


Physical restraint was most strongly associated with delirium .


The administration of intravenous fluid remains the cornerstone treatment for the prevention of contrast-induced acute kidney injury .


However , no well-defined protocols exist to guide fluid administration in this treatment .


We aimed to establish the efficacy of a new fluid protocol to prevent contrast-induced acute kidney injury .


In this randomised , parallel-group , comparator-controlled , single-blind phase @ trial , we assessed the efficacy of a new fluid protocol based on the left ventricular end-diastolic pressure for the prevention of contrast-induced acute kidney injury in patients undergoing cardiac catheterisation .


The primary outcome was the occurrence of contrast-induced acute kidney injury , which was defined as a greater than @ % or greater than @ mg/dL increase in serum creatinine concentration .


Between Oct @ , @ , and July @ , @ , @ patients aged @ years or older undergoing cardiac catheterisation with an estimated glomerular filtration rate of @ mL/min per @ m ( @ ) or less and one or more of several risk factors ( diabetes mellitus , history of congestive heart failure , hypertension , or age older than @ years ) were randomly allocated in a @:@ ratio to left ventricular end-diastolic pressure-guided volume expansion ( n = @ ) or the control group ( n = @ ) who received a standard fluid administration protocol .


Four computer-generated concealed randomisation schedules , each with permuted block sizes of @ , were used for randomisation , and participants were allocated to the next sequential randomisation number by sealed opaque envelopes .


Patients and laboratory personnel were masked to treatment assignment , but the physicians who did the procedures were not masked .


Both groups received intravenous @ % sodium chloride at @ mL/kg for @ h before cardiac catheterisation .


Analyses were by intention to treat .


Adverse events were assessed at @ days and @ months and all such events were classified by staff who were masked to treatment assignment .


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


Contrast-induced acute kidney injury occurred less frequently in patients in the left ventricular end-diastolic pressure-guided group ( @ % -LSB- @/@ -RSB- ) than in the control group ( @ % -LSB- @/@ -RSB- ; relative risk @ , @ % CI @-@ ; p = @ ) .


Hydration treatment was terminated prematurely because of shortness of breath in three patients in each group .


Left ventricular end-diastolic pressure-guided fluid administration seems to be safe and effective in preventing contrast-induced acute kidney injury in patients undergoing cardiac catheterisation .


Total knee arthroplasty ( TKA ) is commonly performed using a tourniquet .


However , some studies have reported that several complications were associated with the use of a tourniquet in TKA .


In this study we investigate whether the limited use of a tourniquet in TKA would reduce complications and facilitate postoperative recovery .


Sixty patients were randomly divided into two groups ( @ cases/group ) : group A using the tourniquet throughout the surgical procedure , and group B using the tourniquet starting from the cementation to the completion of the procedure .


Operation time , total measured blood loss , and incidence of complications were all recorded .


There was no significant difference in operation time , total measured blood loss , and hemoglobin concentration between the two groups .


Incidence of postoperative complications in group B was significantly decreased in comparison to that in group A.


The limb circumference at @ cm above the superior patellar pole or below the inferior patellar pole and the pain score in group B were significantly decreased compared with that in group A at any time point .


Range of motion in group B was significantly increased at three and @ days postoperatively in comparison to that in group A.


The limited use of a tourniquet in TKA provides the benefit of decreased limb swelling and knee joint pain while not compromising the operation time or blood loss and recovery .


Level I ( Therapeutic ) .


The relation between visceral fat accumulation and development of cardiovascular and metabolic disorders has been demonstrated .


The aim of this study was to determine the relationship between a new ultrasound visceral fat thickness ( VFT ) measurement and clinical and anthropometric data in a consecutive series of obese patients .


Fifty-five consecutive male obese patients underwent ultrasound evaluation and metabolic and anthropometric parameters determination at baseline and after @ weeks of a very low-calorie diet ( VLCD ) therapy .


The new ultrasound measurement , the thickness of the fat between the aorta and the superior mesenteric artery ( AMFT ) , was determined along with the maximum thickness of preperitoneal fat and the global VFT .


AMFT showed a better correlation than VFT and preperitoneal fat with all anthropometric and metabolic parameters , both at baseline and after VLCD regimen .


At baseline , patients in the middle and high AMFT and VFT tertiles had a significantly higher prevalence of metabolic diseases with respect to AMFT and VFT low tertile patients , whereas after VLCD period , AMFT only showed significant difference within tertiles .


The odds ratios for the various metabolic diseases were higher in the middle and high AMFT tertiles than those in the middle and high VFT tertiles , remaining significant after adjustment for age , body mass index and VLCD regimen only in the middle and high AMFT tertiles .


The ultrasonographic AMFT evaluation is strongly correlated to the presence of metabolic syndrome and could be a valuable tool to predict metabolic diseases and associated cardiovascular risks in men .


Antiplatelet drugs are recommended for patients with acute noncardioembolic stroke .


However , few randomized clinical trials have investigated the safety and efficacy of dual antiplatelet therapy for these patients .


The aim of this study was to evaluate the effects of treatment with clopidogrel and aspirin ( combination therapy ) and aspirin alone ( monotherapy ) on neurologic deterioration , platelet activation , and other short-term outcomes in patients with acute large-artery atherosclerosis stroke .


Altogether @ patients with acute ( @days ) large-artery atherosclerosis stroke were randomly assigned to receive either combined clopidogrel and aspirin or aspirin alone .


Platelet aggregation and platelet-leukocyte aggregation studies were performed at days @ and @ .


Primary outcomes including recurrent ischemic stroke , neurologic deterioration , periphery vascular events , and myocardial infarction were monitored .


Safety endpoints were hemorrhagic episodes and death .


The prevalence of neurologic deterioration and recurrent ischemic stroke were lower in patients in the combination therapy group than in those of the monotherapy group ( @ % versus @ % and @ % versus @ % , respectively ) .


At day @ of treatment , the platelet aggregations and platelet-leukocyte aggregates were lower in patients who were treated with clopidogrel and aspirin than in patients given aspirin alone ( P < @ ) .


For patients with acute large-artery atherosclerosis stroke , treatment with clopidogrel and aspirin for @month provided significantly greater inhibition of platelet activity than aspirin alone .


Thus , dual therapy can be safer and more effective in reducing ischemic stroke recurrence and neurologic deterioration .


Patients with cervical radiculopathy often have neck - and arm pain , neurological changes , activity limitations and difficulties in returning to work .


Most patients are not candidates for surgery but are often treated with different conservative approaches and may be sick-listed for long periods .


The purpose of the current study is to compare the effectiveness of neck-specific training versus prescribed physical activity .


The current protocol is a two armed intervention randomised clinical trial comparing the outcomes of patients receiving neck specific training or prescribed physical activity .


A total of @ patients with cervical radiculopathy will be randomly allocated to either of the two interventions .


The interventions will be delivered by experienced physiotherapists and last @ weeks .


The primary outcome variable is neck - and arm pain intensity measured with a Visual Analogue Scale accompanied with secondary outcome measures of impairments and subjective health measurements collected before intervention and at @ , @ , @ and @ months after base-line assessment .


We anticipate that the results of this study will provide evidence to support recommendations as to the effectiveness of conservative interventions for patients with cervical radiculopathy .


This study is a European multicentre , randomised , double-blind , placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer 's disease ( AD ) in a phase III study that will run for a period of @weeks with a treatment period of @weeks .


Adult patients , males and females over @years with mild-to-moderate AD as defined by the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer 's disease and Related Disorders Association ( NINCDS-ADRDA ) criteria , will be included in the study .


It aims to recruit a total of @ patients with AD ; @ in the nilvadipine group and @ in the placebo group .


Participants will be randomised to receive nilvadipine , an @mg overencapsulated , sustained release capsule , or a matching overencapsulated placebo ( sugar pill ) for a period of @weeks of treatment .


The primary efficacy outcome measure in this study is the change in cognitive function as assessed by the Alzheimer 's disease Assessment Scale ( ADAS-Cog @ ) from baseline to the end of treatment duration ( @weeks ) .


There are two key secondary outcome measures , the Clinical Dementia Rating Scale Sum of Boxes ( CDR-sb ) and the Disability Assessment for Dementia ( DAD ) .


If a statistically significant effect is seen in the primary outcome , CDR-sb will be considered to be a coprimary end point and only the DAD will contribute to the secondary outcome analysis .


Mirror therapy ( MT ) has been recommended as a simple , inexpensive approach to treat motor dysfunction .


The use of a mesh glove ( MG ) was suggested to normalize muscle tone that ameliorates motor impairment .


Combining two efficient treatment protocols might maximize the benefits from training .


This study investigated the effects of MT combined with MG ( MG+MT ) versus MT alone on motor performance and daily function after stroke .


Sixteen patients with chronic unilateral stroke were recruited .


A randomized two-group pretest and posttest design was used to randomly assign participants to MG+MT or MT groups .


MT involves repetitive bimanual , symmetrical movement practice in which the individual moves the affected limb as much as she/he could while watching the reflective illusion of the unaffected limb 's movements from a mirror .


The MG+MT group wore a MG on the affected hand during the MT. The Modified Ashworth scale of muscle spasticity ( MAS ) , Action Research Arm Test ( ARAT ) , Box and Block Test ( BBT ) , and Functional Independence Measure ( FIM ) were administered to evaluate spasticity , and motor and daily function .


The results for the BBT ( p = @ ) , total scores ( p = @ ) , grasping subscales ( p = @ ) of ARAT , and FIM transfer scores ( p = @ ) presented significantly large effects in favor of the MG+MT group .


Combining MG with MT significantly improves manual dexterity , grasping , and transfer performance .


Adding the MG component into the MT likely increased the richness of sensory input and improved the movement performance more than MT alone .


Inhaled lipopolysaccharide ( LPS ) induces a dose-dependent , acute neutrophilic response in the airways of healthy volunteers that can be quantified in induced sputum .


Chemokines , such as CXCL@ and CXCL@ , play an important role in neutrophilic inflammation in the lung through the activation of CXCR@ and small molecule antagonists of these receptors have now been developed .


We investigated the effect of AZD@ , a CXCR@ antagonist , compared with placebo on LPS-induced inflammation measured in sputum of healthy volunteers .


Twenty healthy subjects were randomized in a double-blind placebo-controlled , cross-over study .


AZD@ ( @ mg ) or placebo was dosed twice daily orally for @ days prior to challenge with inhaled LPS and induced sputum was collected @ h later .


Treatment with AZD@ showed a mean @ % reduction in total sputum cells ( p < @ ) and @ % reduction in sputum neutrophils ( p < @ ) compared with placebo after LPS challenge .


There was also a reduction in neutrophil elastase activity ( p < @ ) and CXCL@ ( p < @ ) and trends for reductions in sputum macrophages ( @ % ) , leukotriene B@ ( @ % ) and CXCL@ ( @ % ) .


AZD@ inhibited LPS-induced inflammation measured in induced sputum of normal volunteers , indicating that this treatment may be useful in the treatment of neutrophilic diseases of the airways , such as COPD , severe asthma and cystic fibrosis .


To determine the effects of participation in Curtin University 's Activity , Food and Attitudes Program ( CAFAP ) , a community-based , family-centered behavioural intervention , on the physical activity , sedentary time , and healthy eating behaviours of overweight and obese adolescents .


In this waitlist controlled clinical trial in Western Australia , adolescents ( n = @ , @ % female , mean age @ ( SD @ ) years ) and parents completed an @-week intervention followed by @ months of telephone and text message support .


Assessments were completed at baseline , before beginning the intervention , immediately following the intervention , and at @ - , @ - , and @ - months follow-up .


The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit , vegetables and junk food assessed by @-day food records .


During the intensive @-week intervention sedentary time decreased by -@ min/day/month ( @ % CI : -@ , @ ) which was significantly greater than the rate of change during the waitlist period ( p = @ ) .


Moderate physical activity increased by @ min/day/month ( @ % CI : -@ , @ ) during the intervention period , which was significantly greater than the rate of change during the waitlist period ( p = @ ) .


Fruit consumption increased during the intervention period ( monthly incidence rate ratio ( IRR ) @ , @ % CI : @ , @ ) and junk food consumption decreased ( monthly IRR @ , @ % CI : @ , @ ) and these changes were different to those seen during the waitlist period ( p = @ and p = @ respectively ) .


Participating in CAFAP appeared to have a positive influence on the physical activity , sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention .


Diabetes is a leading cause of chronic kidney disease ( CKD ) worldwide .


Optimum glycaemic control in patients with type @ diabetes is important to minimise the risk of microvascular and macrovascular complications and to slow the progression of CKD .


We assessed the efficacy and safety of empagliflozin as an add-on treatment in patients with type @ diabetes and CKD .


We did a phase @ , randomised , double-blind , parallel-group , placebo-controlled trial at @ centres in @ countries .


Patients with HbA@c of @ % or greater to @ % or less were eligible for inclusion .


Patients with stage @ CKD ( estimated glomerular filtration rate -LSB- eGFR -RSB- @ to < @ mL/min per @ m ( @ ) ; n = @ ) were randomly assigned ( @:@:@ ) to receive empagliflozin @ mg or @ mg or placebo once daily for @ weeks .


Patients with stage @ CKD ( eGFR @ to < @ mL/min per @ m ( @ ) ; n = @ ) were randomly assigned ( @:@ ) to receive empagliflozin @ mg or placebo for @ weeks .


Randomisation was done with a computer-generated random sequence and stratified by renal impairment , HbA@c , and background antidiabetes medication .


Treatment assignment was masked from patients and investigators .


The primary endpoint was change from baseline in HbA@c at week @ by ANCOVA in the full analysis set .


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


In patients with stage @ CKD , adjusted mean treatment differences versus placebo in changes from baseline in HbA@c at week @ were -@ % ( @ % CI -@ to -@ ) for empagliflozin @ mg and -@ % ( -@ to -@ ) for empagliflozin @ mg ( both p < @ ) .


In patients with stage @ CKD , adjusted mean treatment difference versus placebo in change from baseline in HbA@c at week @ was -@ % ( -@ to -@ ) for empagliflozin @ mg ( p < @ ) .


In patients with stage @ CKD , adverse events were reported over @ weeks by @ patients ( @ % ) on placebo ( @ severe -LSB- @ % -RSB- and @ serious -LSB- @ % -RSB- ) , @ ( @ % ) on empagliflozin @ mg ( six severe -LSB- @ % -RSB- and six serious -LSB- @ % -RSB- ) and @ ( @ % ) on empagliflozin @ mg ( eight severe -LSB- @ % -RSB- and seven serious -LSB- @ % -RSB- ) .


In patients with stage @ CKD , adverse events were reported over @ weeks by @ patients ( @ % ) on placebo ( @ severe -LSB- @ % -RSB- and @ serious -LSB- @ % -RSB- ) and @ ( @ % ) on empagliflozin @ mg ( @ severe -LSB- @ % -RSB- and @ serious -LSB- @ % -RSB- ) .


In patients with type @ diabetes and stage @ or @ CKD , empagliflozin reduced HbA@c and was well tolerated .


However , our findings might not be applicable to the general population of patients with type @ diabetes and renal impairment .


We examined whether the addition of another conventional disease-modifying anti-rheumatic drugs ( DMARDs ) to methotrexate ( MTX ) upon infliximab ( IFX ) discontinuation in well-controlled rheumatoid arthritis ( RA ) patients could suppress subsequent disease flare .


RA patients maintaining DAS@-CRP ( Disease Activity Score of @ joints with C-reactive protein ) scores < @ for @ months with IFX were randomized either to receive addition of bucillamine ( BUC ) to MTX ( BUC + MTX group ; n = @ ) or not ( MTX group ; n = @ ) upon discontinuing IFX .


The primary endpoint was the flare rate within @ years of IFX discontinuation .


Six patients discontinuing MTX during the study were excluded from analyses .


Seventeen patients ( @ % ) experienced flares in the MTX group , which was significantly reduced in the BUC + MTX group ( @ % ; p = @ ) .


Further , the flare rates differed significantly between remission and non-remission by a Boolean definition upon IFX discontinuation in the MTX group ( @ % vs. @ % , respectively ; p = @ ) , but they were comparable in the BUC + MTX group .


BUC treatment was interrupted in seven patients due to rash , proteinuria and incompliance .


DMARDs combination therapy may be a better treatment strategy than MTX monotherapy for maintaining RA control after successful discontinuation of biological agents .


There are limited comparative studies on classic and new-generation antihistamines that affect sleep quality and mood .


The purpose of this study was to determine and compare the effects of classic and new-generation antihistamines on sleep quality , daytime sleepiness , dream anxiety , and mood .


Ninety-two patients with chronic pruritus completed study in the dermatology outpatient clinic .


Treatments with regular recommended therapeutic doses were administered .


The effects of antihistaminic drugs on mood , daytime sleepiness , dream anxiety , and sleep quality were assessed on the first day and @ month after .


Outpatients who received cetirizine and hydroxyzine treatments reported higher scores on the depression , anxiety , and fatigue sub-scales than those who received desloratadine , levocetirizine , and rupatadine .


Pheniramine and rupatadine were found to be associated with daytime sleepiness and better sleep quality .


UKU side effects scale scores were significantly elevated among outpatients receiving pheniramine .


Classic antihistamines increased daytime sleepiness and decreased the sleep quality scores .


New-generation antihistamines reduced sleep latency and dream anxiety , and increased daytime sleepiness and sleep quality .


Both antihistamines , significantly increased daytime sleepiness and nocturnal sleep quality .


Daytime sleepiness was significantly predicted by rupadatine and pheniramine treatment .


Cetirizine and hydroxyzine , seem to have negative influences on mood states .


Given the extensive use of antihistamines in clinical settings , these results should be more elaborately examined in further studies .


Evaluate the effects of vaginal administration of isoflavones derived from Glycine max ( L. ) Merr .


as a treatment option for vaginal atrophy , on the morphology and expression of estrogen receptors in vaginal epithelium of postmenopausal women .


The double-blind , randomized , placebo-controlled , clinical trial .


Sixty women were treated for @ weeks with isoflavone vaginal gel @ % ( @g/day ) and a placebo gel .


After @ and @ weeks , the vaginal atrophy symptoms were classified at none , mild , moderate and severe and the vaginal cytology were taken to determine the maturation value .


Vaginal pH was measured at the beginning and end of therapy .


Microbiopsies in vaginal fornix were performed before the treatment and after @ weeks of treatment .


Isoflavone vaginal gel was effective for relief of vaginal dryness and dyspareunia symptons and an increase in the intermediate and superficial cells was noted .


The vaginal pH in the isoflavone group was @ at baseline and @ after @ weeks , whereas in the placebo group there was no significant change .


A significant increase in thickness after treatment was detected in the Isoflavone Group .


The percentage of estrogen receptor positive cells in vaginal epithelium for the Isoflavone Group ranged from @ % at the beginning of treatment to @ % after @ weeks .


These results were superior to placebo gel .


Glycine max ( L. ) Merr .


at @ % vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms , maturation values , vaginal pH , morphology and expression of estrogen receptors in vaginal epithelium .


Isoflavones proved good treatment options for relief of vulvovaginal atrophy .


Breastfeeding has several advantages for both mother and child .


Lactation consultants may promote prolonged breastfeeding , but little is known about their impact on the initiation of complementary feeding .


Dietary intake during the initial complementary feeding period from @ to @ months was collected on mother-infant pairs who had unlimited access to lactation consultants along with those mother-infant pairs who received routine care at the well-baby clinics .


The total duration of breastfeeding in each study population was also recorded , and total breastfeeding durations of infants receiving complementary foods from @ months and those exclusively breastfed for @ months in each of the two study populations were compared .


Higher proportion of infants of mothers with unlimited access to lactation consultants were fed vegetable and vegetable pures ( p = @ ) and more than one food type ( p = @ ) at @ months .


Furthermore , a lower percentage of them had three meals per day at @ months ( p = @ ) compared with those receiving routine care at the well-baby clinics .


Infants exclusively breastfed for @ months all had similar duration of total breastfeeding .


Mother-infant pairs with unlimited access to lactation consultant had slower introduction of complementary foods at the initial complementary feeding period , according to number of infant 's meals at @ months of age .


Furthermore , those exclusively breastfed for @ months had more prolonged breastfeeding compared with mothers who began complementary feeding at @ months regardless of exposure to lactation consultants .


Most patients with major depressive disorder ( MDD ) report clinically significant sleep problems .


Pre-treatment insomnia has been associated with poorer treatment outcomes in some antidepressant trials , leading to suggestions that combined treatment regimens may be more successful in this subgroup .


This study investigated this question using data from the CO-MED trial .


Adult outpatients with chronic and/or recurrent MDD were randomly assigned in @:@:@ ratio to @ weeks of single-blind , placebo-controlled antidepressant treatment with ( @ ) escitalopram + placebo , ( @ ) bupropion-sustained-release + escitalopram , or ( @ ) venlafaxine-extended-release + mirtazapine .


We compared baseline characteristics , tolerability , and treatment outcomes at @ and @ weeks for patients with and without pre-treatment insomnia .


Of the @ evaluable patients , the majority ( @ % ) reported significant pre-treatment insomnia .


Those with pre-treatment insomnia were more likely to be female ( @ % vs. @ % ) and African-American ( @ % vs. @ % ) .


Those with pre-treatment insomnia symptoms reported higher rates of concurrent anxiety disorders , lower rates of alcohol and substance use disorders , and greater impairment in psychosocial functioning .


The two groups did not differ in either tolerability or treatment outcomes among the three antidepressant treatments .


Insomnia symptoms , while common in patients with chronic/recurrent MDD were not predictive of response , remission , or tolerability with either single or combined antidepressant medications .


Cystic fibrosis is a life-limiting disease that is caused by defective or deficient cystic fibrosis transmembrane conductance regulator ( CFTR ) protein activity .


Phe@del is the most common CFTR mutation .


We conducted two phase @ , randomized , double-blind , placebo-controlled studies that were designed to assess the effects of lumacaftor ( VX-@ ) , a CFTR corrector , in combination with ivacaftor ( VX-@ ) , a CFTR potentiator , in patients @ years of age or older who had cystic fibrosis and were homozygous for the Phe@del CFTR mutation .


In both studies , patients were randomly assigned to receive either lumacaftor ( @ mg once daily or @ mg every @ hours ) in combination with ivacaftor ( @ mg every @ hours ) or matched placebo for @ weeks .


The primary end point was the absolute change from baseline in the percentage of predicted forced expiratory volume in @ second ( FEV@ ) at week @ .


A total of @ patients underwent randomization and received study drug .


The mean baseline FEV@ was @ % of the predicted value .


In both studies , there were significant improvements in the primary end point in both lumacaftor-ivacaftor dose groups ; the difference between active treatment and placebo with respect to the mean absolute improvement in the percentage of predicted FEV@ ranged from @ to @ percentage points ( P < @ ) , which corresponded to a mean relative treatment difference of @ to @ % ( P < @ ) .


Pooled analyses showed that the rate of pulmonary exacerbations was @ to @ % lower in the lumacaftor-ivacaftor groups than in the placebo group ; the rate of events leading to hospitalization or the use of intravenous antibiotics was lower in the lumacaftor-ivacaftor groups as well .


The incidence of adverse events was generally similar in the lumacaftor-ivacaftor and placebo groups .


The rate of discontinuation due to an adverse event was @ % among patients who received lumacaftor-ivacaftor versus @ % among those who received placebo .


These data show that lumacaftor in combination with ivacaftor provided a benefit for patients with cystic fibrosis homozygous for the Phe@del CFTR mutation .


( Funded by Vertex Pharmaceuticals and others ; TRAFFIC and TRANSPORT ClinicalTrials.gov numbers , NCT@ and NCT@ . )


To compare the visual performances and patient satisfactions of conventional monovision , which corrects the dominant eye for distance vision , and crossed monovision , which corrects the non-dominant eye for distance vision in patients with pseudophakia .


This prospective randomised study was conducted in @ patients who underwent implantation of different targets of monofocal intraocular lens for each eye at Konkuk University Medical Center between November @ and August @ .


The following were examined before bilateral cataract surgery and @months after the surgery : refractive error , binocular uncorrected distance visual acuity ( UCDVA ) , uncorrected near visual acuity ( UCNVA ) , best corrected visual acuity ( BCVA ) and stereopsis .


Questionnaires to evaluate postoperative spectacle dependence and patient satisfaction were completed by all patients .


The conventional monovision group and the crossed monovision group were composed of @ and @ patients , respectively .


There were no significant differences in postoperative UCDVA , UCNVA , BCVA and stereopsis between the two groups .


In addition , patient satisfaction with near and distant vision and spectacle dependence were not significantly different in the two groups .


The clinical results of the crossed monovision were not significantly different from the results of conventional monovision .


Therefore , crossed monovision can also be a valuable option for correcting postoperative presbyopia in patients considering bilateral cataract surgery .


The efficacy of pharmacotherapy for smoking cessation is well documented .


However , due to relapse rates and side effects , hypnotherapy is gaining attention as an alternative treatment option .


The aim of this one-center randomized study was to compare the efficacy of hypnotherapy alone , as well as hypnotherapy with nicotine replacement therapy ( NRT ) , to conventional NRT in patients hospitalized with a cardiac or pulmonary illness .


We evaluated self-reported and biochemically verified @-day prevalence smoking abstinence rates at @ and @ weeks post-hospitalization .


Patients ( n = @ ) were randomized into one of three counseling-based treatment groups : NRT for @ days ( NRT ; n = @ ) , a @-min hypnotherapy session ( H ; n = @ ) , and NRT with hypnotherapy ( HNRT ; n = @ ) .


Treatment groups were compared to a `` self-quit '' group of @ patients who refused intervention .


Hypnotherapy patients were more likely than NRT patients to be nonsmokers at @ weeks ( @ % vs. @ % ; p = @ ) and @ weeks after hospitalization ( @ % vs. @ % ; p = @ ) .


Smoking abstinence rates in the HNRT group were similar to the H group .


There was no difference in smoking abstinence rates at @ weeks between `` self quit '' and participants in any of the treatment groups .


In multivariable regression analysis adjusting for diagnosis and demographic characteristics , H and HNRT were over three times more likely than NRT participants to abstain at @-weeks post-discharge ( RR = @ ; p = @ and RR = @ ; p = @ , respectively ) .


Hypnotherapy is more effective than NRT in improving smoking abstinence in patients hospitalized for a smoking-related illness , and could be an asset to post-discharge smoking cessation programs .


The current study investigated the effects of coaching as part of an emergent literacy professional development program to increase early childhood educators ' use of verbal references to print and phonological awareness during interactions with children .


Thirty-one educators and @ children from each of their classrooms ( N = @ ) were randomly assigned to an experimental group ( @ hr of in-service workshops plus @ coaching sessions ) and a comparison group ( workshops alone ) .


The in-service workshops included instruction on how to talk about print and phonological awareness during a post-story craft/writing activity .


All educators were video-recorded during a @-min craft/writing activity with a small group of preschoolers at pretest and posttest .


All videotapes were transcribed and coded for verbal references to print and phonological awareness by the educators and children .


Although at posttest , there were no significant group differences in the educators ' or the children 's references to print as measured by rate per minute , both the educators and the children in the experimental group used a significantly higher rate per minute of references to phonological awareness relative to the comparison group .


Professional development that included coaching with a speech-language pathologist enabled educators and children to engage in more phonological awareness talk during this activity .


Varenicline , a partial agonist at @ nicotinic receptors ( nAChRs ) aids smoking cessation by reducing craving .


Successful quitting may be associated with greater inhibitory control but the effectiveness of varenicline in this regard is unknown .


This study aimed to investigate the effect of varenicline on aspects of inhibitory control in smokers .


A double-blind , placebo-controlled study investigating the effect of varenicline @ mg ( or matched placebo ) in satiated and abstinent smokers .


Tests included Rapid Visual Information Processing ( RVIP ) , Stop-Signal ( SS ) , Prospective Memory ( PM ) and the Cambridge Gambling Task ( CGT ) .


Smoking enhanced RVIP accuracy and latency to respond .


Varenicline did not alter RVIP performance , nor the effect of smoking , suggesting that these effects were unrelated to @ nAChRs .


Smoking increased the number of errors during SS and increased the stop latency , indicating that smoking decreased inhibitory control .


Varenicline partially mimicked this effect of smoking but also reduced the smoking-induced increase , indicating a role for @ nAChRs .


Likewise , smoking increased the number of points bet following a win during CGT and varenicline blocked this effect .


There was no effect of smoking or varenicline on PM target detection per se .


However , smoking protected the target detection rate in the ongoing task when a concurrent intention was introduced .


Varenicline improved response speed in both satiated and abstinent smokers .


Some aspects of inhibitory control may be mediated by @-related mechanisms and blockade of smoking-induced disinhibition may contribute towards the action of varenicline as an aid to smoking cessation .


To evaluate vector analysis , rotational stability , and refractive and visual outcome of a new toric intraocular lens ( IOL ) for correction of preexisting corneal astigmatism during routine cataract surgery .


In this prospective , interventional case series , @ toric , aspheric Bi-Flex T toric IOLs ( Medicontur Medical Engineering Ltd. , Inc. , Zsmbk , Hungary ) were implanted in @ consecutive patients with topographic corneal astigmatism between @ and @ diopters ( D ) and evaluated within the first year after implantation .


Appropriate IOL-toric alignment was facilitated by combined imaging/eye tracking technology .


Postoperative evaluation included refraction and uncorrected and corrected distance visual acuities ( UDVA , CDVA ) .


For each visit , photodocumentation in retroillumination was performed to evaluate toric alignment and potential toric IOL rotation .


Vector analysis of refractive astigmatism was performed using the Alpins method .


At @ months postoperatively , a reduction of the refractive astigmatism from @ D ( range : @ to @ D ) to @ D ( range : @ to @ D ) could be found , with patients achieving a mean UDVA of @ logMAR ( range : -@ to @ logMAR ; Snellen @/@ ) .


Intraoperative to @-month postoperative comparison of IOL axis alignment showed low levels of rotation ( @ ; range : +@ to -@ ) .


Vector analysis showed target induced astigmatism of @ D @ @ , surgically induced astigmatism of @ D @ @ , correction index of @ , and a difference vector of @ D @ @ .


Implantation of the new Bi-Flex T IOL was a safe , stable , and effective method to correct preexisting regular corneal astigmatism during cataract surgery .


To examine the effectiveness of a physiotherapy-specific , web-based e-learning platform , `` RAP-el , '' in best-practice management of rheumatoid arthritis ( RA ) using a single-blind , randomized controlled trial ( RCT ) and prospective cohort study .


Australian-registered physiotherapists were electronically randomized into intervention and control groups .


The intervention group accessed RAP-eL over @ weeks .


Change in self-reported confidence in knowledge and skills was compared between groups at the end of the RCT using linear regression conditioned for baseline scores by a blinded assessor , using intent-to-treat analysis .


Secondary outcomes included physiotherapists ' satisfaction with RA management and responses to RA-relevant clinical statements and practice-relevant vignettes .


Retention was evaluated in a cohort study @ weeks after the RCT .


Eighty physiotherapists were randomized into the intervention and @ into the control groups .


Fifty-six and @ , respectively , provided baseline data .


Significant between-group differences were observed for change in confidence in knowledge ( mean difference @ ; @ % confidence interval -LSB- @ % CI -RSB- @ , @ ; effect size @ ) and skills ( mean difference @ ; @ % CI @ , @ ; effect size @ ) , with the intervention group performing better .


Satisfaction in ability to manage RA , @ of the @ clinical statements , and responses to vignettes demonstrated significant improvement in the intervention group .


Although @-week scores showed declines in most outcomes , their clinical significance remains uncertain .


RAP-eL can improve self-reported confidence , likely practice behaviors and satisfaction in physiotherapists ' ability to manage people with RA , and improve their clinical knowledge in several areas of best-practice RA management in the short term .


Most randomised clinical trials ( RCTs ) testing a new health service do not allow a run-in period of consolidation before evaluating the new approach .


Consequently , health professionals involved may feel insufficiently familiar or confident , or that new processes or systems that are integral to the service are insufficiently embedded in routine care prior to definitive evaluation in a RCT .


This study aimed to determine the optimal run-in period for a new physiotherapy-led telephone assessment and treatment service known as PhysioDirect and whether a run-in was needed prior to evaluating outcomes in an RCT .


The PhysioDirect trial assessed whether PhysioDirect was as effective as usual care .


Prior to the main trial , a run-in of up to @ weeks was permitted to facilitate physiotherapists to become confident in delivering the new service .


Outcomes collected from the run-in and main trial were length of telephone calls within the PhysioDirect service and patients ' physical function ( SF-@v@ questionnaire ) and Measure Yourself Medical Outcome Profile v@ collected at baseline and six months .


Joinpoint regression determined how long it had taken call times to stabilise .


Analysis of covariance determined whether patients ' physical function at six months changed from the run-in to the main trial .


Mean PhysioDirect call times ( minutes ) were higher in the run-in ( @ ( SD : @ ) ) than in the main trial ( @ ( SD : @ ) ) .


Each physiotherapist needed to answer @ ( @ % CI : @,@ ) calls for their mean call time to stabilise at @ minutes per call ; this took a minimum of seven weeks .


For patients ' physical function , PhysioDirect was equally clinically effective as usual care during both the run-in ( @ ( @ % CI : -@,@ ) ) and main trial ( -@ ( @ % CI : -@,@ ) ) .


A run-in was not needed in a large trial testing PhysioDirect services in terms of patient outcomes .


A learning curve was evident in the process measure of telephone call length .


This decreased during the run-in and stabilised prior to commencement of the main trial .


Future trials should build in a run-in if it is anticipated that learning would have an effect on patient outcome .


Proton pump inhibitor ( PPI ) therapy has been shown to attenuate the antiplatelet effects of clopidogrel .


The aim of this study was to compare the antiplatelet effects of cilostazol versus clopidogrel in patients co-administered a PPI .


We enrolled PPI-nave stented patients treated with standard clopidogrel and aspirin therapy for at least six months ( n = @ ) .


The patients were randomly assigned to receive either cilostazol at a dose of @mg twice daily ( CILO group ) or clopidogrel at a dose of @mg daily ( CLPD group ) in addition to lansoprazole ( @mg daily ) .


The platelet aggregation ( PA ) determined using light transmittance aggregometry and the platelet reactivity index ( PRI ) obtained using a vasodilator-stimulated phosphoprotein phosphorylation assay were measured before randomization and at the @-day follow-up visit .


The primary endpoint was the PRI value at follow-up .


At follow-up , the CLPD group showed similar values of PRI as the CILO group ( @ % vs. @ % ; mean difference : @ % ; @ % confidence interval of difference : -@ % to @ % ; p = @ ) .


However , the @g/mL collagen - and @ mg/mL arachidonic acid-induced PA values in the CLPD group were higher than those observed in the CILO group ( mean differences : @ % to @ % ; all p values @ ) .


CYP@C@ loss-of-function allele carriage was the major contributing factor associated with the PRI level in the absence of lansoprazole treatment ( with a gene-dose effect ) ; this association was not observed in the subjects receiving lansoprazole co-administration in the CLPD group .


During lansoprazole co-administration , cilostazol treatment achieves a more favorable platelet function profile than clopidogrel therapy .


The use of combination treatment with cilostazol and aspirin deserves further attention with respect to the management of stable stented patients requiring PPI co-administration .


This study examined the potential emotional sequelae following self-reported mild head injury ( MHI ; e.g. ` altered state of consciousness ' -LSB- ASC -RSB- ) in university students with a particular focus on arousal status and responsivity to experimental manipulation of arousal .


A quasi-experimental design ( n = @ ) was used to examine arousal status ( self-reported and physiological indices ) and response to manipulated arousal ( i.e. induced psychosocial stress/activation ; reduced activation/relaxation ) between persons who acknowledged prior MHI and persons with no-MHI .


University students who self-reported MHI were physiologically under-aroused and less responsive to stressors ( both laboratory and environmental ) compared to their no-MHI cohort .


Those with reported loss of consciousness demonstrated the most attenuated emotional arousal responses ( i.e. flattened electrodermal responsivity ) relative to those with only a reported ASC , followed by those with no-MHI .


The under-arousal in traumatic brain injury has been hypothesized to be associated with ventromedial prefrontal cortex disruption .


This under-arousal may be mirrored in persons who self-report experiencing subtle head trauma .


Students who reported MHI may be less able to physiologically respond and/or cognitively appraise stressful experiences as compared to their no-MHI cohort ; and experience subtle persistent consequences despite the subtle nature of the reported head trauma .


To investigate the efficacy of various formulations of chlorhexidine @ % ( CHX ) in terms of plaque and gingival bleeding control compared to each other and to saline rinse ( CTRL ) over a @-day rinsing period .


Seventy subjects were randomly allocated to one of @ groups rinsing twice daily for @ days .


The different groups used CHX @ % rinse with alcohol ( CHX@ ) and without alcohol ( CHX@ ) , with an antidiscolouration system ( CHX@ ) or saline rinse ( CTRL ) .


Clinical examinations to evaluate full-mouth plaque scores ( FMPS ) and periodontal parameters were performed at baseline , @ , @ and @ days .


Tooth discolouration ( TD ) was measured at each time point using digital photographs and spectrophotometric analysis .


At @ days , CTRL showed the highest levels of plaque .


The mean changes in FMPS from baseline were @ % @ for CHX@ , @ % @ for CHX@ , @ % @ for CHX@ and @ % @ for CTRL .


Statistically significant differences were demonstrated between CHX@ and CHX@ ( p = @ ) , CHX@ vs CHX@ ( p @ ) and CHX@/CHX@ vs CHX@ ( p < @ ) .


In contrast , CHX@ appeared more effective in reducing inflammatory indexes .


TD increased over time in @ % to @ % of participants , although lighter staining was found in the CHX@ group .


Greater FMPS reduction was observed in participants with staining vs without staining ( @ % @ , p = @ ) .


Conventional CHX appeared more effective in terms of plaque reduction .


Interestingly , the newest formulation showed a higher control of gingival inflammation .


Staining was associated with lower plaque levels .


Several long-acting injectable ( LAI ) second-generation antipsychotics are now available for the management of schizophrenia .


As patients with schizophrenia frequently present with diverse and challenging symptoms , it is important to understand the effects of antipsychotics in treating these different symptom subgroups and the timing of these responses .


For this review , data from two randomized , double-blind trials were analyzed in respect to the onset and persistence of effects on several measures of psychopathology ( as measured by the Positive and Negative Syndrome Scale -LSB- PANSS -RSB- ) after treatment with LAI paliperidone palmitate ( PP ) ( NCT@ and NCT@ ) .


Symptom reductions from baseline with PP were significant by day @ for all five PANSS factors in both studies .


Some effects may have been driven by the presence or absence of a placebo response .


A significant effect for PP versus placebo was observed for all major symptom domains for one or more doses of PP during the first month of treatment .


Once established , most ( but not all ) significant responses persisted to the end point .


Similar improvements were observed in PANSS scores with PP and oral risperidone .


Dose-dependent trends were observed for the effect of PP on positive , negative and uncontrolled hostility/excitement symptoms .


The aim of this study was to compare the effectiveness of low-level laser therapy and ultrasound therapy in the treatment of subacromial impingement syndrome .


Thirty one patients with subacromial impingement syndrome were randomly assigned to low-level laser therapy group ( n = @ ) and ultrasound therapy group ( n = @ ) .


Study participants received @ treatment sessions of low-level laser therapy or ultrasound therapy over a period of two-consecutive weeks ( five days per week ) .


Outcome measures ( visual analogue pain scale , Shoulder Pain and Disability Index - SPADI - , patient 's satisfactory level and sleep interference score ) were assessed before treatment and at the @st and @rd months after treatment .


All patients were analyzed by the intent-to-treat principle .


Mean reduction in VAS pain , SPADI disability and sleep interference scores from baseline to after @ month , and @ months of treatment was statistically significant in both groups ( P < @ ) .


However , there was no significant difference in the mean change in VAS pain , SPADI disability and sleep interference scores between the two groups ( P > @ ) .


The mean level of patient satisfaction in group @ at the first and third months after treatment was @ @ mm and @ @ mm , respectively .


There was no significant difference in the mean level of patient satisfaction between the two groups ( p > @ ) .


The results suggest that efficacy of both treatments were comparable to each other in regarding reducing pain severity and functional disability in patients with subacromial impingement syndrome .


Based on our findings , we conclude that low-level laser therapy may be considered as an effective alternative to ultrasound based therapy in patients with subacromial impingement syndrome especially ultrasound based therapy is contraindicated .


Acute lymphoblastic leukemia ( ALL ) is the most frequent childhood malignancy .


Treatment has been unified in the middle of @ in the Czech Republic .


In @-@ children and adolescents with acute lymphoblastic leukemia were treated in an international randomized trial ALL-IC BFM @ in the Czech Republic .


@ patients aged @-@ years were enrolled ; infants below @ year entered a separate trial .


Patients were stratified into three risk groups according to their age , initial leukocyte count , prednisone response , presence of fusion genes BCR/ABL or MLL/AF@ , bone marrow D +@ and remission status D +@ .


The whole therapy took @ months .


Randomized late intensification compared standard BFM therapy with extended , usually more intensive experimental treatment .


The median follow-up was @ years .


Complete remission was achieved in @ % patients , @ % died in remission .


@ % of children relapsed , @ % with CNS involvement .


Six children ( @ % ) developed secondary malignancy .


Event free survival ( EFS ) @ years from diagnosis was @ % , overall survival ( OS ) @ % .


EFS and OS of the risk groups were : standard risk : @ % ; @ % ; intermediate risk : @ % ; @ % ; high risk : @ % ; @ % .


Male sex and age above @ years were adverse prognostic factors .


In comparison with the previous trial ALL-BFM @ , significant improvement was achieved .


This research was conducted to examine changes in self self-efficacy , ( the perception/belief that one can competently cope with a challenging situation ) in multiple sclerosis clients following a series of massage therapy treatments .


This small practical trial investigated the effects of a pragmatic treatment protocol using a prospective randomized pretest posttest waitlist control design .


Self-Efficacy scores were obtained before the first treatment , mid-treatment series , after the last treatment in the series , four weeks after the final treatment and again eight weeks after the final treatment had been received .


The intervention involved a series of weekly one hour therapeutic massage treatments conducted over eight weeks and a subsequent eight week follow up period .


All treatments were delivered by supervised student therapists in the final term of their two year massage therapy program .


Self-Efficacy -LSB- SE -RSB- was the outcome for the study , measured using the Multiple Sclerosis Self-Efficacy survey -LSB- MSSE -RSB- .


Descriptive statistics for SE scores were assessed and inferential analysis involved the testing of between group differences at each of the measurement points noted above .


Statistically significant improvement in self-efficacy was noted between treatment ( n = @ ) and control ( n = @ ) groups at mid treatment series ( t = @ ; p < @ ) , post treatment series ( t = @ ; p < @ ) and at four week follow up ( t = @ ; p < @ ) .


At the eight week follow up self-efficacy scores had decreased and there was no statistically significant difference between groups ( t = @ ; p < @ ) .


Study results support previous findings indicating that massage therapy increases the self-efficacy of clients with multiple sclerosis , potentially resulting in a better overall adjustment to the disease and an improvement in psycho-emotional state .


The increase in self-efficacy after @ weeks of treatment suggests that positive response occurs more rapidly that was previously demonstrated .


The improvement in self-efficacy endured @ weeks after the end of the treatment series , which suggests that massage therapy may have longer term effects on self-efficacy that were not previously noted .


Lack of inter group difference at the eight week follow up reinforces the notion that on-going treatment is required in order to maintain the positive changes observed .


Drug abuse remains a serious problem in China , and has become a major threat to public health and social security .


Since the issuance and enforcement of the new Anti-Drug law in @ , the community has become the primary site for drug rehabilitation .


However , the attitudes of members in community toward the people with drug use disorders are unclear .


A random sample of household respondents was studied in two communities in Hunan province in China .


A total of @ individuals participated ( response rate @ % ) .


Respondents initially were asked a set of questions about their knowledge about dug dependence , and then were randomly assigned to @ of @ vignette conditions .


Three vignettes described different type of drug dependence meeting diagnostic criteria , and the fourth depicted a `` normal person . ''


Poor knowledge of drug dependence was common .


Negative attitudes towards drug dependent people were widespread .


Most respondents believed that drug dependence was caused by the person 's own weak will ( @ % ) and own hedonistic lifestyle ( @ % ) , and should be punished as illegal behavior ( @ % ) .


The vast majority labeled the person with drug dependence as an addict , rated them as having undesirable characteristics , and expressed a strong desire for social distance .


There were few socio-demographic predictors of both poor knowledge and negative attitudes .


A community-based rehabilitation program in China should take into account the widespread stigmatization of people with drug dependence .


TAS-@ is a first-in-class oral deoxyuridine triphosphatase ( dUTPase ) inhibitor , which acts as a modulator of the pyrimidine nucleotide metabolic pathway .


This was a first-in-human , phase @ study that investigated the pharmacokinetics ( PK ) and safety of single-agent TAS-@ when it was given at single and multiple doses .


For the single-dose cohort ( n = @ ) , healthy male volunteers received a single dose of TAS-@ at @ , @ , @ , @ , and @ mg .


The magnitude of dihydropyrimidine dehydrogenase ( DPD ) inhibition and the food effect on TAS-@ PK were also investigated .


For the multiple-dose cohort ( n = @ ) , subjects received TAS-@ for @ days consecutively .


In the dose-escalating single-dose cohort , the disposition of TAS-@ followed linear kinetics .


The elimination half-life was approximately @ h.


The urine excretion rate and food effect were minimal .


A significant increase in uracil Cmax was observed at administered doses of @ mg or higher of TAS-@ , suggesting that significant inhibition of DPD occurred at these doses .


No apparent CYP@A@ auto-induction was observed in the multiple-dose cohort .


No significant safety concerns at these dose levels were noted after single and multiple dosing .


TAS-@ has shown both a favorable safety and pharmacokinetic profile after single and repeated doses .


TAS-@ was considered to possess a moderate DPD inhibitory effect .


These findings will facilitate clinical studies of the combination chemotherapies in cancer patients and may reduce the safety risk in the frail cancer patients .


This study examines effects of a school garden intervention on elementary school children 's physical activity ( PA ) .


Twelve schools in New York were randomly assigned to receive the school garden intervention ( n = @ ) or to the waitlist control group that later received gardens ( n = @ ) .


PA was measured by self-report survey ( Girls Health Enrichment Multi-site Study Activity Questionnaire ) ( N = @ ) and accelerometry ( N = @ , @ schools ) at baseline ( Fall @ ) and follow-up ( Spring @ , Fall @ , Spring @ ) .


Direct observation ( N = @ , @ schools ) was employed to compare indoor ( classroom ) and outdoor ( garden ) PA. .


Analysis was by general linear mixed models .


Survey data indicate garden intervention children 's reports of usual sedentary activity decreased from pre-garden baseline to post-garden more than the control group children 's ( = -@ , p = @ ) .


Accelerometry data reveal that during the school day , children in the garden intervention showed a greater increase in percent of time spent in moderate and moderate-to-vigorous PA from baseline to follow-up than the control group children ( = +@ , p = @ ; = +@ , p = @ ) .


Direct observation within-group comparison of children at schools with gardens revealed that children move more and sit less during an outdoor garden-based lesson than during an indoor , classroom-based lesson .


School gardens show some promise to promote children 's PA. .


The goal of this study was to determine whether a less-invasive approach to aortic valve replacement ( AVR ) improves clinical outcomes in diabetic patients with aortic stenosis ( AS ) .


Diabetes is associated with increased morbidity and mortality after surgical AVR for AS .


Among treated patients with severe symptomatic AS at high risk for surgery in the PARTNER ( Placement of Aortic Transcatheter Valve ) trial , we examined outcomes stratified according to diabetes status of patients randomly assigned to receive transcatheter or surgical AVR .


The primary outcome was all-cause mortality at @ year .


Among @ patients enrolled in PARTNER who underwent treatment , there were @ patients with diabetes ( @transcatheter , @ surgical ) .


There was a significant interaction between diabetes and treatment group for @-year all-cause mortality ( p = @ ) .


Among diabetic patients , all-cause mortality at @ year was @ % in the transcatheter group and @ % in the surgical group ( hazard ratio : @ -LSB- @ % confidence interval : @ to @ -RSB- ; p = @ ) .


Results were consistent among patients treated via transfemoral or transapical routes .


In contrast , among nondiabetic patients , there was no significant difference in all-cause mortality at @ year ( p = @ ) .


Among diabetic patients , the @-year rates of stroke were similar between treatment groups ( @ % transcatheter vs. @ % surgery ; p = @ ) , but the rate of renal failure requiring dialysis > @ days was lower in the transcatheter group ( @ % vs. @ % ; p = @ ) .


Among patients with diabetes and severe symptomatic AS at high risk for surgery , this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit , no increase in stroke , and less renal failure from treatment with transcatheter AVR compared with surgical AVR .


( The PARTNER Trial : Placement of AoRTic TraNscathetER Valve Trial ; NCT@ ) .


Whole body cryotherapy ( WBC ) is the therapeutic application of extreme cold air for a short duration .


Minimal evidence is available for determining optimal exposure time .


To explore whether the length of WBC exposure induces differential changes in inflammatory markers , tissue oxygenation , skin and core temperature , thermal sensation and comfort .


This study was a randomised cross over design with participants acting as their own control .


Fourteen male professional first team super league rugby players were exposed to @ , @ , and @ minutes of WBC at -@ C. Testing took place the day after a competitive league fixture , each exposure separated by seven days .


No significant changes were found in the inflammatory cytokine interleukin six .


Significant reductions ( p < @ ) in deoxyhaemoglobin for gastrocnemius and vastus lateralis were found .


In vastus lateralis significant reductions ( p < @ ) in oxyhaemoglobin and tissue oxygenation index ( p < @ ) were demonstrated .


Significant reductions ( p < @ ) in skin temperature were recorded .


No significant changes were recorded in core temperature .


Significant reductions ( p < @ ) in thermal sensation and comfort were recorded .


Three brief exposures to WBC separated by @ week are not sufficient to induce physiological changes in IL-@ or core temperature .


There are however significant changes in tissue oxyhaemoglobin , deoxyhaemoglobin , tissue oxygenation index , skin temperature and thermal sensation .


We conclude that a @ minute WBC exposure was the optimum exposure length at temperatures of -@ C and could be applied as the basis for future studies .


The objective of the following study is to examine the effectiveness and safety of suspension laryngoscopy under intubation with propofol and remifentanil alone for vocal fold nodule ( VFN ) excision .


A total of @ patients were equally and randomly assigned to elective VFN excision using suspension laryngoscopy under intubation with propofol and remifentanil alone ( Group A ) or with supplementary cisatracurium ( Group B ) .


Intubation time was significantly longer in Group A than in Group B ( @ @ s vs. @ @ s , P = @ ) .


The two groups showed similar Cormack-Lehane classifications , intubation conditions and ease of suspension laryngoscopy .


Both groups showed favorable cardiopulmonary safety profiles .


Post-anesthesia recovery was significantly more rapid in Group A than in Group B , in terms of times to spontaneous breathing return ( @ @ min vs. @ @ min , P < @ ) , consciousness return ( @ @ min vs. @ @ min , P < @ ) , removal of tracheal intubation ( @ @ min vs. @ @ min , P < @ ) and operating room discharge ( @ @ min vs. @ @ min , P < @ ) .


Use of propofol and remifentanil alone provides favorable intubation and anesthesia conditions for suspension laryngoscopic VFN excision and accelerates post-anesthesia recovery .


Although some factors associated with rehospitalization after community-acquired pneumonia have been identified , other factors such as medical care utilization and medication usage have not been previously studied .


We investigated novel predictors of rehospitalization in patients admitted with pneumonia .


Using Department of Veteran Affairs ( VA ) administrative data from October @ to September @ , we examined a cohort of patients @ years old and older , who were hospitalized with pneumonia , in @ VA acute care hospitals .


The cohort was randomly split into derivation and validation samples , and then logistic regression models were used to identify and validate predictors of all-cause rehospitalization within @ days .


Of the @,@ subjects , @ % were rehospitalized within @ days .


No significant differences were noted between the derivation and validation cohorts .


Factors associated with readmission included age , marital status , chronic renal disease , prior malignancy , nursing home residence , congestive heart failure , use of oral corticosteroids , number of emergency department visits a year prior , prior admission , number of outpatient clinic visits in a year prior , and length of hospital stay .


The C statistics for the derivation and validation models were @ and @ , respectively .


Factors associated with readmission were largely unrelated to the underlying pneumonia , but were related to demographics , comorbidities , healthcare utilization , and length of stay on index admission .


Exercise has been proposed as a possible treatment for postprandial hypotension ( PPH ) , yet , its use has not been extensively investigated .


This study aimed to determine the effects of intermittent walking on blood pressure ( BP ) and heart rate ( HR ) following ingestion of a glucose drink in older people with PPH .


Thirteen persons with PPH were recruited and studied on @ randomized days ( control , intervention ) .


On both study days , participants ingested @ mL of water containing @ g glucose , followed by ambulatory BP and HR monitoring @ minutely for @ minutes , then @ minutely until @ minutes .


On the intervention day , participants walked at their usual pace for @ m every @ minutes for @ minutes .


On the control day , significant falls in systolic blood pressure ( SBP ) ( P < @ ) and diastolic blood pressure ( DBP ) ( P = @ ) were demonstrated between t = @-@ minutes .


On the intervention day , over the same period , there was no significant fall in SBP ( P = @ ) , however , DBP still fell significantly ( P = @ ) .


There was a statistically significant difference ( P = @ ) for the area under the curve for the change in SBP from baseline for the study days but not DBP ( P = @ ) .


There was no significant change in HR ( control : P = @ ; intervention , P = @ ) nor between the area under the curve ( P = @ ) for the change in HR from baseline for the study days .


This study suggests that in older people with PPH , intermittent walking at a usual pace attenuates the fall in SBP after ingestion of a glucose drink .


Cystoscopic intradetrusor injection of botulinum toxin has helped patients with refractory overactive bladder but with the increased risks of urinary tract infection and urinary retention .


We assessed whether catheter instillation of @ U onabotulinumtoxinA formulated with liposomes is safe and effective for the treatment of overactive bladder .


This @-center , double-blind , randomized , placebo controlled study enrolled patients with overactive bladder inadequately managed with antimuscarinics .


Patients were assigned to intravesical instillation of lipo-botulinum toxin ( @ ) or normal saline ( @ ) .


The primary end point was the mean change inmicturition events per @ days at @ weeks after treatment .


Additional end points included mean changes in urgency events , frequency and urinary urge incontinence , as well as changes in overactive bladder symptom scores and urgency severity scores .


At @ weeks after treatment lipo-botulinum toxin instillation was associated with a statistically significant decrease in micturition events per @ days ( -@ for lipo-botulinum toxin vs -@ for placebo , p = @ ) .


Lipo-botulinum toxin instillation was also associated with a statistically significant decrease inurinary urgency events with respectto baseline but not placebo .


However , lipo-botulinum toxin instillation was associated with a statistically significant decrease in urgency severity scores compared to placebo ( p = @ ) .


These observed benefits of lipo-botulinum toxin instillation were not accompanied by an increased risk of urinary retention .


The effects of lipo-botulinum toxin onurinary urge incontinence were inconclusive .


A single intravesical instillation of lipo-botulinum toxin was associated with decreases in overactive bladder symptoms without side effects .


Intravesical instillation of liposomal botulinum toxin may be a promising approach to treat refractory overactive bladder .


Postoperative analgesia is important in patients undergoing open abdominal surgery .


We prospectively compared the efficacy of ropivacaine and that of levobupivacaine for postoperative epidural analgesia in patients undergoing gynecological open abdominal surgery .


Fifty-two ASA @-@ patients scheduled for gynecological open abdominal surgery under combined general and epidural anesthesia were enrolled and randomized into two groups .


In ropivacaine group ( n = @ ) the patients received @ % ropivacaine and fentanyl @ microg x ml ( -@ ) for postoperative epidural analgesia .


In levobupivacaine group ( n = @ ) the patients received @ % levobupivacaine and fentanyl @ microg ml ( -@ ) .


Visual analogue scale ( resting pain and pain on mobilization ) , the amount of rescue analgesics and epidural anesthesia related adverse events such as hypotension , nausea and vomiting were observed for @ hours after surgery .


There were no differences in visual analogue scale at all intervals between the two groups .


In levobupivacaine group the patients used less amounts of rescue analgesics than ropivacaine group ( P = @ ) .


There were no differences in the incidences of postoperative hypotension , nausea and vomiting between the two groups .


Both @ % ropivacaine and levobupivacaine similarly provide appropriate postoperative epidural analgesia for patients undergoing gynecological open abdominal surgery .


To determine the benefit of multifactorial treatment on microvascular complications among people with type @ diabetes detected by screening .


This study was a multicenter cluster randomized controlled trial in primary care with randomization at the practice level .


In four centers in Denmark ; Cambridge , U.K. ; the Netherlands ; and Leicester , U.K. , @ general practices participated in the trial .


Eligible for follow-up were @,@ of the @,@ people with diabetes detected by screening included in the original trial .


Biomedical data on nephropathy were collected in @,@ ( @ % ) participants , retinal photos in @,@ ( @ % ) , and questionnaire data on peripheral neuropathy in @,@ ( @ % ) .


The prespecified microvascular end points were analyzed by intention to treat .


Results from the four centers were pooled using fixed-effects meta-analysis .


Five years after diagnosis , any kind of albuminuria was present in @ % of participants in the intensive treatment ( IT ) group and in @ % in the routine care ( RC ) group ( odds ratio @ -LSB- @ % CI @-@ @ -RSB- ) .


Retinopathy was present in @ % of the IT group and @ % of the RC group ( @ -LSB- @-@ @ -RSB- ) , and severe retinopathy was present in one patient in the IT group and seven in the RC group .


Neuropathy was present in @ % and @ % ( @ -LSB- @-@ @ -RSB- ) , respectively .


Estimated glomerular filtration rate increased between baseline and follow-up in both groups ( @ and @ mL/min , respectively ) .


Compared with RC , an intervention to promote target-driven , intensive management of patients with type @ diabetes detected by screening was not associated with significant reductions in the frequency of microvascular events at @ years .


To determine the feasibility , acceptability and safety of using acupuncture to treat arm lymphoedema in women following treatment for breast cancer .


We conducted a randomised controlled trial of acupuncture compared with treatment as usual .


Twenty women with stable unilateral intransient lymphoedema present for at least @months were recruited from Sydney , Australia .


The women received @ acupuncture treatments administered to body and arm points on the non-lymphoedematous limb over @weeks , twice weekly for @weeks then once weekly for @weeks .


Outcome measures included an assessment of interest to participate in the trial , identification of successful recruitment strategies , the appropriateness of eligibility criteria and compliance with treatment attendance .


Clinical outcomes were assessed at baseline and @weeks and included extracellular fluid , lymphoedema symptoms , well-being and safety .


Acupuncture was an acceptable intervention in women with upper limb lymphoedema .


Compliance with the treatment protocol was high , with nine women completing all @ treatments .


Outcome forms were completed by @ women at @weeks .


No major adverse occurrences , as defined by the study protocol , were reported from the acupuncture group although one woman found the needling uncomfortable , and no study participant experienced an increase in swelling of > @ % .


There was no change in extracellular fluid or any patient-reported outcome measurement .


Lymphoedema is a persistent symptom experienced by women recovering from breast cancer .


Our study suggests that acupuncture may stabilise symptoms and no major safety concerns were identified , so further research is needed .


Inhaled corticosteroids , known to be effective as a maintenance medication in chronic asthma , have also been suggested as a therapy for acute asthma when given at high doses .


A double-blind , randomized , placebo-controlled trial was conducted in children aged @ to @ years with moderate or severe acute asthma , as determined based on a clinical score of @ to @ points , where @ is the most severe .


We compared the addition of budesonide @,@ g vs placebo to standard acute asthma treatment , which included salbutamol , ipratropium bromide , and a single dose of prednisolone @ mg/kg given at the beginning of therapy .


The primary outcome was hospital admission rate within @ h.


A total of @ ED visits by children with moderate or severe acute asthma were evaluated .


Seventy-five cases out of @ ( @ % ) in the budesonide group vs @ of @ ( @ % ) in the placebo group were admitted ( OR , @ ; @ % CI , @-@ @ ; P = @ ) .


However , among cases with high baseline clinical score ( @ ) , significantly fewer children were admitted in the budesonide group ( @ of @ -LSB- @ % -RSB- ) than in the placebo group ( @ of @ -LSB- @ % -RSB- ; OR , @ ; @ % CI , @-@ @ ; P = @ ) .


The addition of budesonide nebulization did not decrease the admission rate of children with acute asthma overall .


However , it may decrease the admission rate of children with severe acute asthma .


Although hepatitis A virus ( HAV ) and hepatitis B virus ( HBV ) infections are vaccine-preventable diseases , few homeless parolees coming out of prisons and jails have received the hepatitis A and B vaccination series .


The study focused on completion of the HAV and HBV vaccine series among homeless men on parole .


The efficacy of three levels of peer coaching ( PC ) and nurse-delivered interventions was compared at @-month follow-up : ( a ) intensive peer coaching and nurse case management ( PC-NCM ) ; ( b ) intensive PC intervention condition , with minimal nurse involvement ; and ( c ) usual care ( UC ) intervention condition , which included minimal PC and nurse involvement .


Furthermore , we assessed predictors of vaccine completion among this targeted sample .


A randomized control trial was conducted with @ recently paroled men to assess the impact of the three intervention conditions ( PC-NCM vs. PC vs. UC ) on reducing drug use and recidivism ; of these , @ seronegative , vaccine-eligible subjects were included in this analysis of completion of the Twinrix HAV/HBV vaccine .


Logistic regression was added to assess predictors of completion of the HAV/HBV vaccine series and chi-square analysis to compare completion rates across the three levels of intervention .


Vaccine completion rate for the intervention conditions were @ % ( PC-NCM ) , @ % ( PC ) , and @ % ( UC ; p = @ ) .


Predictors of vaccine noncompletion included being Asian and Pacific Islander , experiencing high levels of hostility , positive social support , reporting a history of injection drug use , being released early from California prisons , and being admitted for psychiatric illness .


Predictors of vaccine series completion included reporting having six or more friends , recent cocaine use , and staying in drug treatment for at least @ days .


Findings allow greater understanding of factors affecting vaccination completion in order to design more effective programs among the high-risk population of men recently released from prison and on parole .


Our study indicates a prototype blood-based variant Creutzfeldt-Jakob disease ( vCJD ) assay has sufficient sensitivity and specificity to justify a large study comparing vCJD prevalence in the United Kingdom with a bovine spongiform encephalopathy-unexposed population .


In a clinical diagnostic capacity , the assay 's likelihood ratios dramatically change an individual 's pretest disease odds to posttest probabilities and can confirm vCJD infection .


To determine the diagnostic accuracy of a prototype blood test for vCJD and hence its suitability for clinical use and for screening prion-exposed populations .


Retrospective , cross-sectional diagnostic study of blood samples from national blood collection and prion disease centers in the United States and United Kingdom .


Anonymized samples were representative of the US blood donor population ( n = @ ) , healthy UK donors ( n = @ ) , patients with nonprion neurodegenerative diseases ( n = @ ) , patients in whom a prion disease diagnosis was likely ( n = @ ) , and patients with confirmed vCJD ( n = @ ) .


Presence of vCJD infection determined by a prototype test ( now in clinical diagnostic use ) that captures , enriches , and detects disease-associated prion protein from whole blood using stainless steel powder .


The assay 's specificity among the presumed negative American donor samples was @ % ( @ % CI , @ % -@ % ) and was confirmed in a healthy UK cohort ( @ % specificity ; @ % CI , @ % -@ % ) .


Of potentially cross-reactive blood samples from patients with nonprion neurodegenerative diseases , no samples tested positive ( @ % specificity ; @ % CI , @ % -@ % ) .


Among National Prion Clinic referrals in whom a prion disease diagnosis was likely , @ patients with sporadic CJD tested positive ( @ % specificity ; @ % CI , @ % -@ % ) .


Finally , we reconfirmed but could not refine our previous sensitivity estimate in a small blind panel of samples from unaffected individuals and patients with vCJD ( @ % sensitivity ; @ % CI , @ % -@ % ) .


In conjunction with the assay 's established high sensitivity ( @ % ; @ % CI , @ % -@ % ) , the extremely high specificity supports using the assay to screen for vCJD infection in prion-exposed populations .


Additionally , the lack of cross-reactivity and false positives in a range of nonprion neurodegenerative diseases supports the use of the assay in patient diagnosis .


Tadalafil once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia consistently shows statistically significant I-PSS improvements .


However , physicians and patients wish to know whether tadalafil provides rapid , clinically meaningful improvement in lower urinary tract symptoms .


In this post hoc analysis we integrated results from @ placebo controlled studies to determine the duration of tadalafil once daily required to achieve clinically meaningful improvement .


We performed post hoc analysis of data integrated from @ double-blind studies of tadalafil @ mg and placebo once daily in @ and @ men , respectively , @ years old or older with total I-PSS @ or greater .


Two clinically meaningful improvement categories were assessed , including @ ) @-point or greater baseline to end point total I-PSS improvement and @ ) @ % or greater baseline to end point total I-PSS improvement .


I-PSS was assessed at weeks @ , @ and @ in all studies , week @ in @ and week @ in @ .


Results in men treated with tadalafil who showed clinically meaningful improvement ( responders ) were further examined to determine the earliest time to clinically meaningful improvement .


Of @ tadalafil treated patients @ ( @ % ) and @ ( @ % ) demonstrated category @ and @ clinically meaningful improvement , respectively , at the study end point .


Of @ category @ responders with week @ assessments @ ( @ % ) achieved clinically meaningful improvement by week @ and @ of the total of @ category @ responders ( @ % ) showed it by week @ .


Of the @ category @ responders with week @ assessments @ ( @ % ) achieved clinically meaningful improvement by week @ while @ of the @ category @ responders ( @ % ) did so by week @ .


Tadalafil @ mg once daily led to clinically meaningful improvement in approximately two-thirds of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia .


More than half of this group of tadalafil treated responders achieved clinically meaningful improvement after @ week of therapy and more than @ % did so within @ weeks .


Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care .


While previous interventions for spatial neglect have targeted patients ' overt spatial deficits ( e.g. , reduced contralesional visual scanning ) , far fewer have directly targeted patients ' non-spatial deficits ( e.g. , sustained attention deficits ) .


Considering that non-spatial deficits have shown to be highly predictive of long-term disability , we developed a novel computer based training program that targets both sustained ( tonic ) and moment-to-moment ( phasic ) aspects of non-spatial attention ( Tonic and Phasic Alertness Training , TAPAT ) .


Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients .


The purpose of the current trial ( referred to as the REmediation of SPatial Neglect or RESPONSE trial ) is to compare TAPAT to an active control training condition , include a larger sample of patients , and assess both cognitive and functional outcomes .


We will employ a multi-site , longitudinal , blinded randomized controlled trial ( RCT ) design with a target sample of @ patients with spatial neglect .


Patients will either perform , at their home , the experimental TAPAT training program or an active control computer games condition for thirty minutes/day , five days a week , over three months .


Patients will be assessed on a battery of cognitive and functional outcomes on three occasions : a ) immediately before training , b ) within forty-eight hours post completion of total training , and c ) after a three-month no-contact period post completion of total training , to assess the longevity of potential training effects .


The strengths of this protocol are that it tests an innovative , in-home administered treatment that targets a fundamental deficit in neglect , employs highly sensitive computer-based assessments of cognition as well as functional outcomes , and incorporates a large sample size ( relative to other neglect treatment studies ) in an RCT design .


To observe the clinical efficacy of acupuncture combined with auricular point sticking for menstrual headache and to discuss its mechanism .


Eighty-five patients with menstrual headache were randomly divided into an observation group ( @ cases ) and a control group ( @ cases ) .


The observation group was treated with body acupuncture combined with auricular point sticking and the control group was treated with flunarizine hydrochloride capsules orally .


The treatments of @ menstrual cycles were required .


The clinical efficacy was observed in the two groups .


The content of serum prostaglandin F@ , ( PGF@ ) and plasma arginine vasopressin ( AVP ) in the menstrual periods of some patients randomly selected in the two groups was tested before and after treatment and was compared with that of @ cases in a normal group .


Results The total effective rate was @ % ( @/@ ) in the observation group which was obviously superior to @ % ( @/@ ) in the control group ( P < @ ) .


Before treatment , the content of serum PGF@ and plasma AVP of patients in the two groups was higher than that in the normal group ( all P < @ ) .


After treatment , the content of serum PGF@ and plasma AVP was lower than that before treatment in the two groups ( P < @ , P < @ ) .


The content of serum PGF@ in the observation group was decreased significantly compared with that in the control group ( P < @ ) and returned to the level of the normal group .


Body acupuncture combined with auricular point sticking achieves positive efficacy for menstrual headache and its mechanism could be related to regulating the abnormal levels of serum PGF@ and plasma AVP .


It was the aim of this study to compare the efficacy of ozone therapy and drug treatment in patients with painful temporomandibular joint ( TMJ ) disorder ( TMD ) .


A total of @ patients with TMD were enrolled ; @ were treated with bio-oxidative therapy and @ with a ketoprofen tablet thiocolchicoside capsule @ @ for @ days .


Maximum voluntary interincisal mouth opening ( MMO ) was measured in millimeters using a scale and recorded during the pre - and posttreatment periods .


The patients evaluated their subjective pain using a visual analogue scale ( VAS ) .


Data were analyzed using the Mann-Whitney U test , the Kolmogorov-Smirnov test , and the independent t test .


The mean MMO of the group that received ozone therapy during the pretreatment period was @ @ mm , and it immediately increased to @ @ mm after @ week of ozone therapy , which was statistically significant ( p = @ ) .


For those who received medication , the mean MMO during the pretreatment period was @ mm , and at the end of @ week it was @ mm .


In the ozone group , @ % of patients showed a gradual decrease in their VAS pain scores compared to pretreatment values ( @ @ to @ @ ) .


In the medication group , @ % of patients showed a significant decrease in VAS pain scores during the follow-up period ( @ @ to @ @ ) .


This study showed that bio-oxidative therapy was a more effective treatment than medication therapy for relieving TMJ pain .


Previous studies have demonstrated pronounced reduction of REM sleep on the first nights following major surgery which may influence pain , analgesic use , and recovery .


This placebo-controlled , randomized , double-blind study set out to evaluate the effect of zolpidem on sleep architecture in an elderly population undergoing fast-track total hip and knee arthroplasty ( THA/TKA ) with length of stay < @ days .


Twenty patients ( @ years ) undergoing THA or TKA in a standardized setup with spinal anesthesia and multimodal opioid-sparing postoperative analgesia were included .


Polysomnography measures were performed for @ nights , @ night at home prior to surgery and on the first night after surgery , when the patient received placebo or zolpidem @ mg .


Analgesic use , pain levels , and subjective measures of fatigue and sleep quality were recorded .


Analysis of sleep data was performed according to the American Academy of Sleep Medicine manual .


Objective sleep data did not show a significant difference between groups in any of the sleep stages .


However , subjective data on sleep quality and fatigue showed significantly less fatigue and better sleep quality in the zolpidem group ( p < @ ) , and reduced objectively recorded number of arousals ( p = @ ) .


Levels of pain and opioid use were similar in the @ groups .


Our objective data did not support the primary hypothesis that one night 's treatment with zolpidem would significantly improve sleep architecture following major surgery , although there was improved feeling of sleep quality and fatigue associated with fewer postoperative arousals .


This study aimed to assess the effects of sampling interval ( SI ) of computed tomographic ( CT ) perfusion acquisitions on CT perfusion values in normal liver and liver metastases from neuroendocrine tumors .


Computed tomographic perfusion in @ patients with neuroendocrine liver metastases was analyzed using distributed-parameter modeling to yield tissue blood flow , blood volume , mean transit time , permeability , and hepatic arterial fraction for tumor and normal liver .


Computed tomographic perfusion values for the reference SI of @ s ( SI@ @ ) were compared with those of SI data sets of @ second , @ seconds , @ seconds , and @ seconds using mixed-effects model analyses .


Increases in SI beyond @ second were associated with significant and increasing departures of CT perfusion parameters from the reference values at SI@ @ ( P @ ) .


Computed tomographic perfusion values deviated from the reference with increasing uncertainty with increasing SIs .


Findings for normal liver were concordant .


Increasing SIs beyond @ second yield significantly different CT perfusion parameter values compared with the reference values at SI@ @ .


Guanfacine extended - release ( GXR ) is approved for the treatment of attention-deficit/hyperactivity disorder in children and adolescents .


As part of the clinical development of GXR , and to further explore the effect of guanfacine on QT intervals , a thorough QT study of guanfacine was conducted ( ClinicalTrials .


gov identifier : NCT@ ) .


In this double-blind , @-period , crossover trial , healthy adults ( n = @ ) received immediaterelease guanfacine ( at therapeutic ( @ mg ) and supra-therapeutic ( @ mg ) doses ) , placebo , and @ mg moxifloxacin ( positive control ) in @ of @ randomly assigned sequences .


Continuous @-lead electrocardiograms were extracted , and guanfacine plasma concentrations were assessed pre-dose and at intervals up to @ hours post-dose .


QT intervals were corrected using @ methods : subject-specific ( QTcNi ) and Fridericia ( QTcF ) .


Time-matched analyses examined the largest , baseline-adjusted , drug-placebo difference in QTc intervals .


In the QTcNi analysis , the largest @-sided @ % upper confidence bound ( UCB ) through hour @ was @ ms ( @ hours postdose ) .


For the @-hour QTcF analysis , the largest @-sided @ % UCB was @ ms ( @ hours post-supratherapeutic dose ) , representing the only @-sided @ % UCB > @ ms. Following the supra-therapeutic dose , maximum guanfacine plasma concentration was attained at @ hours ( median ) post-dose .


Assay sensitivity was confirmed by moxifloxacin results .


Among guanfacine-treated subjects , most treatment-emergent adverse events were mild ( @ % ) ; dry mouth ( @ % ) and dizziness ( @ % ) were most common .


Neither therapeutic nor supra-therapeutic doses of guanfacine prolonged QT interval after adjusting for heart rate using individualized correction , QTcNi , through @ hours postdose .


Guanfacine does not appear to interfere with cardiac repolarization of the form associated with pro-arrhythmic drugs .


Previous studies reported increased white blood cell counts ( WBCCs ) , an inflammatory marker , in hypertension , prehypertension and metabolic syndrome .


Evidence suggests that inflammation precedes blood pressure ( BP ) elevation and may contribute to incident hypertension .


Angiotensin receptor blockers ( ARBs ) may reduce inflammation .


We analyzed WBCC trends in TRial Of Preventing HYpertension ( TROPHY ) to determine if this inflammatory marker predicted incident hypertension in prehypertensive individuals and whether randomized assignment to the ARB candesartan ( @ individuals ) for @ years , lowered WBCC compared with placebo-treated controls ( @ individuals ) .


A new analysis of TROPHY trial data .


In the total population , baseline BMI correlated with WBCC ( r = @ , P < @ ) , neutrophils ( r = @ , P < @ ) and lymphocytes ( r = @ , P < @ ) .


Baseline triglycerides also correlated significantly with inflammatory markers .


Despite a wide range of home BP ( HBP ) values , HBP did not correlate with baseline WBCC counts .


After @ years , candesartan decreased placebo corrected HBP by -@ / -@ mmHg , ( P < @ ) , but WBCC , neutrophil and lymphocyte counts were not different in placebo and in candesartan groups .


Baseline WBCC , neutrophils and lymphocyte counts did not predict incident hypertension in the placebo group .


In TROPHY , candesartan lowered BP but did not alter WBCC .


Baseline WBCC did not predict incident hypertension .


Our findings do not support the hypothesis that inflammation contributes to incident hypertension or that ARB treatment suppresses inflammation .


The significant independent association of WBCC with baseline BMI and triglycerides is consistent with the evidence that obesity and insulin resistance are associated with inflammation .


The findings highlight the importance of effective lifestyle modification in prehypertension to reduce inflammatory cardio-metabolic risk and suppress transition to hypertension .


Sociodemographic differences have been observed in the treatment of extremely premature ( periviable ) neonates , but the source of this variation is not well understood .


We assessed the feasibility of using simulation to test the effect of maternal race and insurance status on shared decision making ( SDM ) in periviable counseling .


We conducted a @ @ factorial simulation experiment in which obstetricians and neonatologists counseled @ consecutive standardized patients diagnosed with ruptured membranes at @ weeks , counterbalancing race ( black/white ) and insurance status using random permutation .


We assessed verisimilitude of the simulation in semistructured debriefing interviews .


We coded physician communication related to resuscitation , mode of delivery , and steroid decisions using a @-point SDM coding framework and then compared communication scores by standardized patient race and insurer using analysis of variance .


Sixteen obstetricians and @ neonatologists participated ; @ % were women , @ % were married , and @ % were parents ; @ % of the physicians rated the simulation as highly realistic .


Overall , SDM scores were relatively high , with means ranging from @ to @ ( of @ ) .


There was a statistically significant interaction between race and insurer for SDM related to steroid use and mode of delivery ( P < @ and P = @ , respectively ) .


Between-group comparison revealed nonsignificant differences ( P = < @ ) between the SDM scores for privately insured black patients versus privately insured white patients , Medicaid-insured white patients versus Medicaid-insured black patients , and privately insured black patients versus Medicaid-insured black patients .


This study confirms that simulation is a feasible method for studying sociodemographic effects on periviable counseling .


Shared decision making may occur differentially based on patients ' sociodemographic characteristics and deserves further study .


Increased left ventricular ( LV ) size is associated with cardiovascular mortality and morbidity .


Once non-contrast cardiac computed tomography ( CT ) is performed for other purposes , information of LV size is readily available .


To determine the association of gated CT-derived LV size with cardiovascular risk factors and coronary artery calcification ( CAC ) and to describe age - and gender-specific normative values in a general population cohort .


LV area was quantified from non-contrast-enhanced CT in axial , end-diastolic images at a mid-ventricular slice in participants of the population-based Heinz Nixdorf Recall Study , free of known cardiovascular disease .


LV index ( LVI ) was calculated by the quotient of LV area and body surface area ( BSA ) .


Crude and adjusted regression analyses were used to determine the association of LVI with risk factors and CAC .


Overall , @ subjects ( age @ @ years , @ % women ) were included in this analysis .


From quantification in end-diastolic phase , men had larger LV index ( @ @ mm ( @ ) / m ( @ ) vs. @ @ mm ( @ ) / m ( @ ) , both P < @ ) .


LVI was strongly correlated systolic blood pressure ( men , PE -LSB- @ % CI -RSB- : @ -LSB- @-@ @ -RSB- mm ( @ ) / @ mmHg ; women , @ -LSB- @-@ @ -RSB- ) , and antihypertensive medication ( men , @ -LSB- @-@ @ -RSB- mm ( @ ) ; women : @ -LSB- @-@ @ -RSB- , all P < @ ) .


Cholesterol levels were associated with LVI in univariate analysis , however , correlations were low ( R ( @ ) @ ) .


In multivariable regression , blood pressure , antihypertensive medication and cholesterol levels , remained associated with LVI ( P < @ ) .


LVI was linked with CAC in unadjusted ( men , increase of CAC + @ by @ % -LSB- @-@ @ -RSB- with increased LVI by @ standard deviation of LVI , P = @ ; women , @ % -LSB- @-@ @ -RSB- , P < @ ) and risk factor adjusted models ( men , @ % -LSB- @-@ @ -RSB- , P = @ ) ; women , @ % -LSB- @-@ @ -RSB- , P = @ ) .


Non-contrast cardiac CT derived LV index is associated with body size and hypertension .


LVI is weakly linked with CAC-score .


Further studies need to evaluate whether assessment of LV dimensions from cardiac CT helps identifying subjects with increased cardiovascular risk .


To compare the outcomes of surgical periodontal therapy with and without initial scaling and root planing .


Twenty-four patients with severe chronic periodontitis were enrolled in this pilot , randomized controlled clinical trial .


Patients were equally allocated into two treatment groups : Control group was treated with scaling and root planing , re-evaluation , followed by Modified Widman Flap surgery and test group received similar surgery without scaling and root planing .


Clinical attachment level , probing depth and bleeding on probing were recorded .


Standardized radiographs were analysed for linear bone change from baseline to @ months .


Wound fluid inflammatory biomarkers were also assessed .


Both groups exhibited statistically significant improvement in clinical attachment level and probing depth at @ and @ months compared to baseline .


A statistically significant difference in probing depth reduction was found between the two groups at @ and @ months in favour of the control group .


No statistically significant differences in biomarkers were detected between the groups .


Combined scaling and root planing and surgery yielded greater probing depth reduction as compared to periodontal surgery without initial scaling and root planing .