The jump height , as dependent variable , showed a different trend as an effect of the different training protocols , in contrast with the current knowledge .


Manova did not show significant interactions between the two groups for the height of jumps , while significant differences were found for interaction time training ( P < 0.05 ) and for main effect time ( P < 0.001 ) .


After training , the BPT group increased significantly CMJ performance by 11.3 % ( P < 0.05 ) , whereas the BTT group increased by 4.6 % .


Likewise , the BPT group demonstrated a significant greater improvement of jump height than BTT group ( an increase of 15.4 % vs. 7.5 % , P < 0.01 ; respectively ) .


These results suggest that both training protocols proposed in this study improved vertical jump performance .


However , a combination of the two protocols , plyometric training and sport-specific-exercises , could be useful to optimize performance by an easy transition from controlled a-specific to sport-specific performance requirements .


In conclusion , BPT is a safe and effective method of achieving a favourable neuro-muscular performance than BTT in female basketball players .


The objective of this study was to determine the feasibility of telementored instruction in bedside ultrasonography ( US ) using Google Glass .


The authors sought to examine whether first-time US users could obtain adequate parasternal long axis ( PSLA ) views to approximate ejection fraction ( EF ) using Google Glass telementoring .


This was a prospective , randomized , single-blinded study .


Eighteen second-year medical students were randomized into three groups and tasked with obtaining PSLA cardiac imaging .


Group A received real-time telementored education through Google Glass via Google Hangout from a remotely located expert .


Group B received bedside education from the same expert .


Group C represented the control and received no instruction .


Each subject was given 3 minutes to obtain a best PSLA cardiac imaging using a portable GE Vscan .


Image clips obtained by each subject were stored .


A second expert , blinded to instructional mode , evaluated images for adequacy and assigned an image quality rating on a 0 to 10 scale .


Group A was able to obtain adequate images six out of six times ( 100 % ) with a median image quality rating of 7.5 ( interquartile range [ IQR ] = 6 to 10 ) out of 10 .


Group B was also able to obtain adequate views six out of six times ( 100 % ) , with a median image quality rating of 8 ( IQR = 7 to 9 ) .


Group C was able to obtain adequate views one out of six times ( 17 % ) , with a median image quality of 0 ( IQR = 0 to 2 ) .


There were no statistically significant differences between Group A and Group B in the achievement of adequate images for E-point septal separation measurement or in image quality .


In this pilot/feasibility study , novice US users were able to obtain adequate imaging to determine a healthy patient 's EF through telementored education using Google Glass .


These preliminary data suggest telementoring as an adequate means of medical education in bedside US .


This conclusion will need to be validated with larger , more powerful studies including evaluation of pathologic findings and varying body habitus among models .


To compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin suspension formulations ( 500 mg/5 mL AMOXIL , reference formulation and AMOXI-PED , test formulation ) in healthy Brazilian volunteers .


Under fasting condition , 25 volunteers ( 13 males and 12 females ) were included in this randomized , open-label , two-period crossover ( 1-week washout interval ) bioequivalence study .


Blood samples were collected at pre-dose ( 0 hour ) and 0.5 , 1 , 1.33 , 1.66 , 2 , 2.5 , 3 , 4 , 6 , 8 , and 12 hours after drug ingestion .


Pharmacokinetic parameters ( Cmax , tmax , t1/2 , AUC0-tlast , and AUC0 - ) were calculated from plasma concentrations for both formulations in each subject .


Arithmetic mean values of the pharmacokinetic parameters were : Cmax = 12.004 ( 2.824 ) gmL-1 ; tmax = 1.118 ( 0.396 ) h ; t1/2 = 1.226 ( 0.179 ) h ; AUC0-tlast = 29.297 ( 6.007 ) ghmL-1 ; and AUC0 - = 29.299 ( 6.007 ) ghmL-1 for reference formulation and Cmax = 11.456 ( 2.825 ) gmL-1 ; tmax = 1.331 ( 0.509 ) h ; t1/2 = 1.141 ( 0.133 ) h ; AUC0-tlast = 28.672 ( 5.778 ) ghmL-1 ; and AUC0 - = 28.693 ( 5.796 ) ghmL-1 for test formulation .


The confidence intervals ( 90 % CI ) for reference and test formulations were , respectively , 90.74 - 100.46 % for Cmax and 93.62 - 103.61 % for AUC0-t .


Based on the results , both formulations of amoxicillin evaluated in this study were considered bioequivalent according to FDA and ANVISA/Brazil criteria .


Autonomic nervous system dysfunction has been implicated in visceral hypersensitivity .


However , the specific contribution of the parasympathetic nervous system ( PNS ) is unclear .


We aimed to determine whether physiological and pharmacological manipulation of parasympathetic tone influences the development of hypersensitivity in a validated model of acid-induced oesophageal pain .


Prior to , and following , a 30-min distal oesophageal infusion of 0.15 M hydrochloric acid , pain thresholds to electrical stimulation were determined in the proximal non-acid exposed oesophagus in healthy subjects .


Validated sympathetic ( skin conductance response ) and parasympathetic ( cardiac vagal tone ) parameters were measured at baseline and continuously thereafter .


In study 1 , 55 subjects were randomised in a pragmatic blinded crossover design to receive deep breathing or un-paced breathing during acid infusion .


In study 2 , 32 subjects were randomised in a blinded , crossover design to receive intravenous atropine or placebo ( saline ) with deep breathing during acid infusion .


Study 1 : Deep breathing increased cardiac vagal tone ( 2.12.3 vs -0.32.3 , p = 0.0006 ) with concomitant withdrawal of skin conductance response ( -0.64.9 vs 34.8 , p = 0.03 ) in comparison with un-paced breathing .


Deep breathing prevented the development of acid-induced oesophageal hypersensitivity in comparison with sham breathing ( p = 0.0001 ) .


Study 2 : Atropine , in comparison with placebo , blocked the attenuating effect of deep breathing on the development of acid-induced oesophageal hypersensitivity ( p = 0.046 ) .


The development of oesophageal hyperalgesia is prevented by physiologically increasing parasympathetic tone .


This effect is pharmacologically blocked with atropine , providing evidence that the PNS influences the development of oesophageal pain hypersensitivity .


Self-management challenges facing adults with epilepsy include limited understanding of the condition and treatment , associated psychosocial issues , and lack of community integration .


Self-management interventions improve patients ' medical , life role , and emotional management .


Previous interventions , developed from expert opinion , indicated issues with participant engagement/retention , and limited follow-up periods .


PACES in Epilepsy addressed methodologic concerns by utilizing patient needs assessment data ( n = 165 ) to derive self-management content and program features for evaluation via randomized controlled trial ( RCT ) .


Participants were adults with chronic epilepsy ( n = 83 ) , without serious mental illness or substantive intellectual impairment , who were recruited from two epilepsy centers .


Participants were assigned randomly to intervention or treatment-as-usual groups .


Outcomes included the Epilepsy Self-Management Scale ( ESMS ) , Epilepsy Self-Efficacy Scale ( ESES ) , Quality of Life in Epilepsy-31 ( QOLIE-31 ) , Patient Health Questionnaire-9 ( PHQ-9 ) , and the Generalized Anxiety Disorder-7 ( GAD-7 ) , administered at baseline , postintervention ( 8weeks ) , and 6months postintervention .


The intervention was an 8-week group of 6-8 adults co-led by a psychologist and trained peer with epilepsy that met one evening per week at a hospital for 75min .


Topics included medical , psychosocial , cognitive , and self-management aspects of epilepsy , in addition to community integration and optimizing epilepsy-related communication .


The treatment group provided satisfaction ratings regarding program features .


PACES participants ( n = 38 ) improved relative to controls ( n = 40 ) on the ESMS ( p < 0.001 ) and subscales [ Information ( p < 0.001 ) ; Lifestyle ( p < 0.002 ) ] ; ESES ( p < 0.001 ) ; and QOLIE-31 ( p = 0.002 ) .


At 6-month follow up , PACES participants remained improved on the ESMS ( p = 0.004 ) and Information subscale ( p = 0.009 ) ; and Energy/Fatigue ( p = 0.032 ) and Medication Effects ( p = 0.005 ) of the QOLIE-31 .


Attrition in both groups was low ( 8 % in each group ) and all program satisfaction ratings exceeded 4.0 / 5.0 , with leadership ( 4.76 ) , topics ( 4.53 ) , and location ( 4.30 ) as the most highly rated aspects .


A consumer generated epilepsy self-management program appears to be a promising intervention from multiple perspectives , particularly in relation to disability management .


Sublingual immunotherapy ( SLIT ) has been described as a significant intervention in the treatment of allergic rhinitis ( AR ) .


However , factors that may predict treatment outcomes with respect to quality of life ( QoL ) results and mainly the role of olfactory function are still being underestimated .


In this study , we investigated determinants that best predict treatment outcomes for QoL , exploring mainly the role of olfaction .


One hundred forty-five patients following SLIT , 45 placebo-controls , and 48 healthy subjects were studied .


Olfactory function was objectively evaluated using `` Sniffin ' Sticks '' test pre - and post-cessation of SLIT .


Three categories of validated QoL questionnaires were filled out by all subjects : questionnaire specific for olfaction ( Questionnaire of Olfactory Deficits ) , questionnaires for assessing psychology ( Beck Depression Inventory , Zung Depression Scale , State & Trait Anxiety Inventory ) , general Short Form-36 health survey .


Statistically significant improvement of olfactory function by 11.1 % and of all QoL questionnaires results ( all P < .001 ) was observed on final evaluation .


Anosmia , asthma history , and the severity of symptoms-expressed by the Total Symptoms Score-were proven independent determinants of clinically significant improvement in patients ' QoL .


Several factors were found that may predict QoL outcomes in AR patients following SLIT .


To evaluate the effect of peer education on postoperative rehabilitation of patients with laryngeal cancer .


From January 2010 to December 2012 , 240 cases of primary laryngeal cancer were treated with partial or total laryngectomy as well as tracheotomy in the Department of Head and Neck Surgery in Shandong Provincial Hospital .


The patients were randomly divided into experimental group or control group by Stochastic tables law , 120 patients in control group accepted only conventional nursing , 120 patients in experimental group accepted both conventional nursing and peer education .


The difference in the treatment nursing cooperation attitude , postoperative recovery , postoperative symptoms and the incidence of complications between two groups were evaluated by postoperative quality of life ( UW-QOL ) , Eysenck personality questionnaire ( EPQ ) and coping style questionnaire ( CSQ ) score .


The independent sample T-test and test were used for statistical analysis .


The patients of experimental group showed more positive attitude to treatment and care compared to the patients of control group ( = 10.7 , P < 0.01 ) .


Experimental group had less time in postoperative wound healing time , gastric tube indwelling time and postoperative hospital stay than control group , with statistically significant differences ( t = 6.89 , t = 6.36 , t = 6.42 , respectively , P < 0.01 ) ; Incidence of postoperative discomfort symptoms in experimental group was less than that in control group ( P < 0.05 ) .


Total score for quality of life ( UW-QOL ) in experimental group was higher than that in control group ( t = 2.40 , P < 0.05 ) .


The P and N scores of EPQ in experimental group were lower than those in control group ( t = 2.28 , t = 2.60 , P < 0.05 ) , while the E score of EPQ in experimental group was significantly higher than that in control group ( t = 4.50 , P < 0.01 ) , with no significant difference in the L score of EPQ between two groups ( P > 0.05 ) .


scores of factor to solve problem and help factor of CSQ in experimental group were higher than those in control group ( t = 7.05 , t = 7.73 , P < 0.01 ) , and the era factor score of experimental group was lower than that of control group ( t = 2.05 , P < 0.05 ) .


Peer education can help the patients with laryngectomy to maintain good psychological and mental status , to cooperate actively with treatment , to reduce symptoms and complications , and to shorten the length of hospital stay , improving their postoperative rehabilitation and quality of life .


To further resolve the clinical equipoise on the choice of chemical sphincterotomy agent for early symptomatic relief of anal fissure by comparing the effectiveness of 2 % Diltiazem gel with 0.2 % Glyceryl TriNitrate .


The randomized clinical trial was conducted at Aga Khan University Hospital , Karachi , from February 1 , to July 30 , 2008 , and comprised 60 adult patients with anal fissure who were equally randomised to either Diltiazem or Glyceryl TriNitrate after taking informed consent .


The creams were applied locally ; the former twice daily , and the latter three times a day for a period of two weeks .


The rest of the treatment was standard .


Patients were followed up in clinic by the principal investigator at two weeks for primary outcome i.e. self-reported symptomatic relief on Visual Analogue Scale , and secondary outcomes i.e. side effects and the overall cost of treatment .


Of the total , 31 ( 52 % ) patients were males and the overall mean age was 37 + / - 11 years .


Patients , who used Diltiazem reported more symptomatic relief than Glyceryl TriNitrate ( p < 0.01 ) .


Side effects were found more in Glyceryl TriNitrate than Diltiazem ( p < 0.01 ) , and most common side effect in the former group was headache in 12 ( 40 % ) patients .


Cost of the treatment was not significantly different between both treatment arms ( p < 0.28 ) .


Chemical sphincterotomy with topical 2 % Diltiazem gel is an effective first-line treatment for early symptomatic relief of anal fissures , owing to negligible side effects .


Antenatal magnesium sulfate given to pregnant women at imminent risk of very preterm delivery reduces the risk of cerebral palsy in early childhood , although its effects into school age have not been reported from randomized trials .


To determine the association between exposure to antenatal magnesium sulfate and neurological , cognitive , academic , and behavioral outcomes at school age .


The ACTOMgSO4 was a randomized clinical trial conducted in 16 centers in Australia and New Zealand , comparing magnesium sulfate with placebo given to pregnant women ( n = 535 magnesium ; n = 527 placebo ) for whom imminent birth was planned or expected before 30 weeks ' gestation .


Children who survived from the 14 centers who participated in the school-age follow-up ( n = 443 magnesium ; n = 424 placebo ) were invited for an assessment at 6 to 11 years of age between 2005 and 2011 .


Mortality , cerebral palsy , motor function , IQ , basic academic skills , attention and executive function , behavior , growth , and functional outcomes .


Main analyses were imputed for missing data .


Of the 1255 fetuses known to be alive at randomization , the mortality rate to school age was 14 % ( 88/629 ) in the magnesium sulfate group and 18 % ( 110/626 ) in the placebo group ( risk ratio [ RR ] , 0.80 ; 95 % CI , 0.62-1 .03 , P = .08 ) .


Of 867 survivors available for follow-up , outcomes at school age ( corrected age 6-11 years ) were determined for 669 ( 77 % ) .


Comparing the magnesium sulfate and placebo groups revealed no statistically significant difference in proportions with cerebral palsy ( 23/295 [ 8 % ] and 21/314 [ 7 % ] , respectively ; odds ratio [ OR ] , 1.26 ; 95 % CI , 0.84-1 .91 ; P = .27 ) or abnormal motor function ( 80/297 [ 27 % ] and 80/300 [ 27 % ] , respectively ; OR , 1.16 ; 95 % CI , 0.88-1 .52 ; P = .28 ) .


There was also little difference between groups on any of the cognitive , behavioral , growth , or functional outcomes .


Magnesium sulfate given to pregnant women at imminent risk of birth before 30 weeks ' gestation was not associated with neurological , cognitive , behavioral , growth , or functional outcomes in their children at school age , although a mortality advantage can not be excluded .


The lack of long-term benefit requires confirmation in additional studies .


anzctr.org.au Identifier : ACTRN12606000252516 .


The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery , the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis .


Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained .


Patients with severe aortic stenosis who were at increased surgical risk were recruited .


Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve ( transcatheter aortic valve replacement [ TAVR ] group ) or to aortic valve replacement with a surgical bioprosthesis ( surgical group ) .


The 2-year clinical and echocardiographic outcomes were evaluated in these patients .


A total of 797 patients underwent randomization at 45 centers in the United States .


The rate of 2-year all-cause mortality was significantly lower in the TAVR group ( 22.2 % ) than in the surgical group ( 28.6 % ; log-rank test p < 0.05 ) in the as-treated cohort , with an absolute reduction in risk of 6.5 percentage points .


Similar results were foundin the intention-to-treat cohort ( log-rank test p < 0.05 ) .


The rate of 2-year death or major stroke was significantly lower in the TAVR group ( 24.2 % ) than in the surgical group ( 32.5 % ; log-rank test p = 0.01 ) .


In patients with severe aortic stenosis who are at increased surgical risk , the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years .


( Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement ; NCT01240902 ) .


A prospective , randomized study examined the effect of interventional preoperative education and orientation for scoliosis surgery ( PEOSS ) on anxiety levels of patients undergoing posterior spinal fusion ( PSF ) .


Secondary outcomes analyzed were caregiver anxiety , length of stay , morphine equivalent usage , and patient/caregiver satisfaction .


Patients undergoing PSF were randomly distributed into a control group ( N = 39 ) or interventional group ( N = 26 ) .


All subjects and caregivers completed the State ( current ) - Trait ( typical ) Anxiety Inventory ( STAI ) at different intervals : preoperative appointment , preoperative holding area , postoperative orthopaedic unit , and discharge .


At discharge , patients and caregivers completed a satisfaction survey .


Significantly higher state anxiety scores were found compared with baseline at all time intervals in both the control group and PEOSS group .


The PEOSS group had higher state anxiety scores than the control group at the postoperative interval ( P = 0.024 ) .


There were no significant differences in the caregiver state anxiety scores between the groups at any time interval .


Trait anxiety scores for both groups remained stable over time , establishing that the measurement tool accurately reflected baseline anxiety .


No significant differences were found in length of stay or morphine equivalent use .


Patient satisfaction scores were higher in the PEOSS group than in the control group ( P = 0.0005 ) .


PSF was associated with increased anxiety at all time intervals in adolescents in both groups .


In the PEOSS group , PSF was associated with increased anxiety in the immediate postoperative period .


Despite the increase in anxiety , patient satisfaction was higher in the intervention group .


It is likely that patients need age-appropriate information and educational strategies to minimize anxiety during PSF .


Further work is underway to study and develop more effective interventional strategies .


Level I study .


This randomized double-blind study was conducted to evaluate the analgesic efficacy and safety of addition of three different doses of dexmedetomidine in caudal ropivacaine compared with plain ropivacaine for postoperative analgesia in pediatric day care patients .


Eighty children of American Society of Anesthesiologists grade I-II , aged 1-8 years , undergoing lower abdominal and perineal surgery were included .


Children were randomly allocated into four groups .


Group 1 received 0.2 % plain ropivacaine 0.75 mlkg ( -1 ) , while group 2 , 3 , and 4 received dexmedetomidine 0.5 , 1.0 , and 1.5 gkg ( -1 ) , respectively , along with 0.2 % ropivacaine 0.75 mlkg ( -1 ) .


Anesthesia was induced and maintained with sevoflurane and 50 % N2O in oxygen .


Children were observed for postoperative pain , nausea-vomiting , agitation , sedation , and adverse effects .


Rescue analgesia was provided with oral paracetamol .


Postoperative analgesia was significantly prolonged in all dexmedetomidine groups as compared to plain ropivacaine group ( P < 0.001 ) .


All patients in the plain ropivacaine group required rescue analgesia within first 6 postoperative hours , while none in the other three groups .


None of the patients showed delayed anesthetic emergence .


Four patients in the plain ropivacaine group developed agitation , while none in the dexmedetomidine groups .


Patients receiving dexmedetomidine 1.5 gkg ( -1 ) were more sedated as compared to the other groups ( P < 0.01 ) , but it did not delay discharge of the patients .


All three doses of caudal dexmedetomidine appear to be effective for preventing postoperative pain in pediatric day care patients .


Caudal dexmedetomidine used in these doses seems to be safe for day care surgery .


Tofacitinib is an oral Janus kinase ( JAK ) inhibitor for the treatment of rheumatoid arthritis ( RA ) .


The pathways affected by tofacitinib and the effects on gene expression in situ are unknown .


Therefore , tofacitinib effects on synovial pathobiology were investigated .


A randomised , double-blind , phase II serial synovial biopsy study ( A3921073 ; NCT00976599 ) in patients with RA with an inadequate methotrexate response .


Patients on background methotrexate received tofacitinib 10mg twice daily or placebo for 28days .


Synovial biopsies were performed on Days -7 and 28 and analysed by immunoassay or quantitative PCR .


Clinical response was determined by disease activity score and European League Against Rheumatism ( EULAR ) response on Day 28 in A3921073 , and at Month 3 in a long-term extension study ( A3921024 ; NCT00413699 ) .


Tofacitinib exposure led to EULAR moderate to good responses ( 11/14 patients ) , while placebo was ineffective ( 1/14 patients ) on Day 28 .


Tofacitinib treatment significantly reduced synovial mRNA expression of matrix metalloproteinase ( MMP ) -1 and MMP-3 ( p < 0.05 ) and chemokines CCL2 , CXCL10 and CXCL13 ( p < 0.05 ) .


No overall changes were observed in synovial inflammation score or the presence of T cells , B cells or macrophages .


Changes in synovial phosphorylation of signal transducer and activator of transcription 1 ( STAT1 ) and STAT3 strongly correlated with 4-month clinical responses ( p < 0.002 ) .


Tofacitinib significantly decreased plasma CXCL10 ( p < 0.005 ) at Day 28 compared with placebo .


Tofacitinib reduces metalloproteinase and interferon-regulated gene expression in rheumatoid synovium , and clinical improvement correlates with reductions in STAT1 and STAT3 phosphorylation .


JAK1-mediated interferon and interleukin-6 signalling likely play a key role in the synovial response .


NCT00976599 .


Patellar straps or sports tapes are commonly used by athletes with patellar tendinopathy in order to reduce pain and to continue sports participation .


Currently , there is no scientific evidence for the effectiveness of a patellar strap or sports tape in the management of this common injury .


To investigate the effect of the use of a patellar strap and sports tape on pain and sports participation in subjects with patellar tendinopathy .


The study is divided into two parts : a randomised controlled crossover experiment and a randomised controlled trial ( parallel group design ) .


140 patients diagnosed with patellar tendinopathy recruited from sports medical centres and physiotherapist practices .


In the first part of the study , participants serve as their own control by performing three functional tests under four different conditions ( patellar strap , sports tape , placebo tape , and no orthosis ) .


In the second part , participants keep a log for two weeks ( control week and intervention week ) about the pain experienced during and after sports and their level of sports participation .


In the intervention week participants will use the orthosis assigned to them during training and competition .


The amount of pain ( both parts of the study ) and sports participation ( second part only ) will be measured .


To analyse the effects of the orthoses a Linear Mixed Model will be used .


The knowledge gained in this study can be used by practitioners in their advice for athletes with patellar tendinopathy about using patellar strap and sports tape during sports .


A head-to-head comparison was performed between vascular endothelial growth factor blockade and laser for treatment of diabetic macular edema ( DME ) .


Two similarly designed , double-masked , randomized , phase 3 trials , VISTA ( DME ) and VIVID ( DME ) .


We included 872 patients ( eyes ) with type 1 or 2 diabetes mellitus who presented with DME with central involvement .


Eyes received either intravitreal aflibercept injection ( IAI ) 2 mg every 4 weeks ( 2q4 ) , IAI 2 mg every 8 weeks after 5 initial monthly doses ( 2q8 ) , or macular laser photocoagulation .


The primary efficacy endpoint was the change from baseline in best-corrected visual acuity ( BCVA ) in Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters at week 52 .


Secondary efficacy endpoints at week 52 included the proportion of eyes that gained 15 letters from baseline and the mean change from baseline in central retinal thickness as determined by optical coherence tomography .


Mean BCVA gains from baseline to week 52 in the IAI 2q4 and 2q8 groups versus the laser group were 12.5 and 10.7 versus 0.2 letters ( P < 0.0001 ) in VISTA , and 10.5 and 10.7 versus 1.2 letters ( P < 0.0001 ) in VIVID .


The corresponding proportions of eyes gaining 15 letters were 41.6 % and 31.1 % versus 7.8 % ( P < 0.0001 ) in VISTA , and 32.4 % and 33.3 % versus 9.1 % ( P < 0.0001 ) in VIVID .


Similarly , mean reductions in central retinal thickness were 185.9 and 183.1 versus 73.3 m ( P < 0.0001 ) in VISTA , and 195.0 and 192.4 versus 66.2 m ( P < 0.0001 ) in VIVID .


Overall incidences of ocular and nonocular adverse events and serious adverse events , including the Anti-Platelet Trialists ' Collaboration-defined arterial thromboembolic events and vascular deaths , were similar across treatment groups .


At week 52 , IAI demonstrated significant superiority in functional and anatomic endpoints over laser , with similar efficacy in the 2q4 and 2q8 groups despite the extended dosing interval in the 2q8 group .


In general , IAI was well-tolerated .


To determine the effects of food on the pharmacokinetics of sublingual asenapine .


Healthy male volunteers ( n = 26 , age 19-53 years ) randomly received a single sublingual dose of asenapine 5 mg after 10 h fasting ( Treatment A , reference ) , after a high-fat meal ( Treatment B ) and after 10 h fasting with a high-fat meal at 4 h post-dose ( Treatment C ) .


Blood samples were drawn over 72 h to measure asenapine plasma concentrations .


Effects of food intake on asenapine pharmacokinetics were assessed using bioequivalence criteria and evaluated using a compartmental modelling analysis .


Compared with the reference , mean asenapine exposure ( AUC0-last and AUC0 - ) was approximately 20 % lower after intake of a high-fat meal prior to dosing , whereas Cmax decreased by only about 10 % .


When a high-fat meal was taken 4 h post-dose in the fasting state , asenapine concentrations were similar to the reference during the first 4 h post-dose .


After the meal intake , asenapine concentrations decreased quickly for several hours .


Compartmental modelling indicated that a transient 2.5-fold increase in asenapine clearance after eating could explain the asenapine concentration-time profiles for both food regimens .


To our knowledge , this is the first study investigating the effect of food upon the sublingual administration of a drug .


A high-fat meal taken before or 4 h post-dose of sublingual asenapine indirectly caused a transient increase in liver blood flow that resulted in a temporal increase in asenapine clearance .


As the effects on asenapine exposure were small and not clinically relevant , no additional restrictions are required for the timing of food intake in relation to asenapine dosing .


Little is known about how the genetic variation in vitamin D modulating genes influences ultraviolet ( UV ) B-induced 25-hydroxyvitamin D [ 25 ( OH ) D ] concentrations .


In the Food with vitamin D ( VitmaD ) study , we showed that common genetic variants rs10741657 and rs10766197 in 25-hydroxylase ( CYP2R1 ) and rs842999 and rs4588 in vitamin D binding protein ( GC ) predict 25 ( OH ) D concentrations at late summer and after 6-mo consumption of cholecalciferol ( vitamin D ) - fortified bread and milk .


In the current study , called the Vitamin D in genes ( VitDgen ) study , we analyzed associations between the increase in 25 ( OH ) D concentrations after a given dose of artificial UVB irradiation and 25 single nucleotide polymorphisms located in or near genes involved in vitamin D synthesis , transport , activation , or degradation as previously described for the VitmaD study .


Second , we aimed to determine whether the genetic variations in CYP2R1 and GC have similar effects on 25 ( OH ) D concentrations after artificial UVB irradiation and supplementation by vitamin D-fortified bread and milk .


The VitDgen study includes 92 healthy Danes who received 4 whole-body UVB treatments with a total dose of 6 or 7.5 standard erythema doses during a 10-d period in winter .


The VitmaD study included 201 healthy Danish families who were given vitamin D-fortified bread and milk or placebo for 6 mo during the winter .


After UVB treatments , rs10741657 in CYP2R1 and rs4588 in GC predicted UVB-induced 25 ( OH ) D concentrations as previously shown in the VitmaD study .


Compared with noncarriers , carriers of 4 risk alleles of rs10741657 and rs4588 had lowest concentrations and smallest increases in 25 ( OH ) D concentrations after 4 UVB treatments and largest decreases in 25 ( OH ) D concentrations after 6-mo consumption of vitamin D-fortified bread and milk .


Common genetic variants in the CYP2R1 and GC genes modify 25 ( OH ) D concentrations in the same manner after artificial UVB-induced vitamin D and consumption of vitamin D-fortified bread and milk .


We evaluated a low-cost strategy for schools to improve the convenience and appeal of drinking water .


We conducted a group-randomized , controlled trial in 10 Boston , Massachusetts , schools in April through June 2013 to test a cafeteria-based intervention .


Signage promoting water and disposable cups were installed near water sources .


Mixed linear regression models adjusting for clustering evaluated the intervention impact on average student water consumption over 359 lunch periods .


The percentage of students in intervention schools observed drinking water during lunch nearly doubled from baseline to follow-up compared with controls ( + 9.4 % ; P < .001 ) .


The intervention was associated with a 0.58-ounce increase in water intake across all students ( P < .001 ) .


Without cups , children were observed drinking 2.4 ( SE = 0.08 ) ounces of water from fountains ; with cups , 5.2 ( SE = 0.2 ) ounces .


The percentage of intervention students observed with sugar-sweetened beverages declined ( -3.3 % ; P < .005 ) .


The current default of providing water through drinking fountains in cafeterias results in low water consumption .


This study shows that an inexpensive intervention to improve drinking water 's convenience by providing cups can increase student water consumption .


Topical photodynamic therapy ( PDT ) for actinic keratoses ( AK ) is hampered by pain during illumination and inferior efficacy in organ-transplant recipients ( OTR ) .


We assessed ablative fractional laser ( AFL ) - assisted daylight photodynamic therapy ( PDT ) ( AFL-dPDT ) compared with daylight PDT ( dPDT ) , conventional PDT ( cPDT ) and AFL alone ( AFL ) in field treatment of AK in OTR .


In each patient , four areas in the same region were randomized to one treatment with AFL-dPDT , dPDT , cPDT and AFL .


AFL was delivered with a 2940-nm AFL at 23 mJ per pulse , 115 W , two stacks , 50-s pulse-duration , 24 % density .


In dPDT and AFL-dPDT , methyl aminolaevulinate ( MAL ) was applied for 25 h without occlusion during daylight exposure .


For cPDT , MAL was occluded for 3 h followed by red-light ( 630 nm ) irradiation at 37 J cm ( -2 ) .


The primary end-point was complete response ( CR ) 3 months post-treatment .


Sixteen patients with 542 AK ( grades I-III ) in field-cancerized skin of the scalp , chest and extremities were treated during August and September 2012 .


After 3 months , CR ( AK I-III ) rates were 74 % after AFL-dPDT , 46 % after dPDT , 50 % after cPDT and 5 % after AFL ( P < 0001 ) .


CR rates in AFL-dPDT , dPDT and cPDT were also significantly different ( P = 0004 ) .


Median maximal pain scores differed significantly during AFL-dPDT ( 0 ) , dPDT ( 0 ) , AFL ( 0 ) and cPDT ( 5 ) ( P < 0001 ) .


Erythema and crusting were more intense following AFL-dPDT than dPDT and cPDT , but only transient hypopigmentation was observed .


AFL-dPDT is a novel PDT modality that enhances CR with excellent tolerability compared with dPDT and cPDT in difficult-to-treat AK in OTR .


Microprocessor knees have improved the gait and functional abilities of persons with transfemoral amputation .


The Genium prosthetic knee offers an advanced sensor and control system designed to decrease impairment by : allowing greater stance phase flexion , easing transitions between gait phases , and compensating for changes in terrain .


The aim of this study was to determine differences between the knee flexion angle of persons using the Genium knee , the C-Leg knee , and non-amputee controls ; and to evaluate the impact the prostheses on gait and level of impairment of the user .


This study used a randomized experimental crossover of persons with transfemoral amputation using the Genium and C-Leg microprocessor knees ( n = 25 ) , with an observational sample of non-amputee controls ( n = 5 ) .


Gait analysis by 3D motion tracking of subjects ambulating at different speeds on level ground and on 5 and 10 ramps was completed .


Use of the Genium resulted in a significant increase in peak knee flexion for swing ( 5 , p < 0.01 , d = 0.34 ) and stance ( 2 , p < 0.01 , d = 0.19 ) phases relative to C-Leg use .


There was a high degree of variability between subjects , and significant differences still remain between the Genium group and the control group 's knee flexion angles for most speeds and slopes .


The Genium knee generally increases flexion in swing and stance , potentially decreasing the level of impairment for persons with transfemoral amputation .


This study demonstrates functional differences between the C-Leg and Genium knees to help prosthetists determine if the Genium will provide functional benefits to individual patients .


The present study aimed to assess the effects of two different sports training methods - traditional and maturational - on the flexibility of female rhythmic gymnasts at different levels of biological maturation .


The sample consisted of 120 children , randomly divided ( by draw ) into six groups of 20 children ( eight and nine-years old ) : traditional training group ( TG ) ; maturational training group ( MG ) ; and the control group ( CG ) .


These were subdivided into early , normal and late , based on biological maturation assessment by hand/wrist X-ray examination .


Flexibility was evaluated by angle goniometer testing , applying the LABIFIE protocol .


A Lafayette Goniometer Set and Hoorn-Brasil exercise mat were used and the following exercises were performed : external shoulder rotation ( ESR ) and lumbar flexion ( LF ) .


Both the TG and MG participated in twice-weekly , 45-minute rhythmic gymnastics classes over 16 weeks .


The TG used the traditional sports training method while the MG executed sporting activities according to biological maturation .


The CG received no special treatment .


The results showed a significant improvement ( P < 0.001 ) in the subgroups ( late , normal and early ) for both variables ( ESR = 7.54 and LF = 7.51 ) in the eight and nine-year age groups .


Moreover , in relation to division by biological maturity , better results were recorded in the early subgroups .


Thus , it can be inferred that , due to the changes in important physical parameters as a result of maturation , selecting children for physical education should not be based solely on chronological , but primarily on biological maturation .


Gender differences in the prevalence of sleep apnea/hypopnea syndrome may be mediated via male sex hormones .


Our objective was to determine the exact pathway for a testosterone-mediated increased propensity for central sleep apnea via blockade of the 5-reductase pathway of testosterone conversion by finasteride .


Randomization to oral finasteride vs. sham , single-center study .


Sleep research laboratory .


Fourteen healthy young males without sleep apnea .


Hypocapnia was induced via brief nasal noninvasive positive pressure ventilation during stable NREM sleep .


Cessation of mechanical ventilation resulted in hypocapnic central apnea or hypopnea .


The apnea threshold ( AT ) was defined as the end-tidal CO ( P ( ET ) CO ) that demarcated the central apnea closest to the eupneic P ( ET ) CO. .


The CO reserve was defined as the difference in P ( ET ) CO between eupnea and AT .


The apneic threshold and CO reserve were measured at baseline and repeated after at a minimum of 1 month .


Administration of finasteride resulted in decreased serum dihydrotestosterone .


In the finasteride group , the eupneic ventilatory parameters were unchanged ; however , the AT was decreased ( 38.9 0.6 mm Hg vs. 37.7 0.9 mm Hg , P = 0.02 ) and the CO reserve was increased ( -2.5 0.3 mm Hg vs. -3.8 0.5 mm Hg , P = 0.003 ) at follow-up , with a significantly lower hypocapnic ventilatory response , thus indicating increased breathing stability during sleep .


No significant changes were noted in the sham group on follow-up study .


Inhibition of testosterone action via the 5-reductase pathway may be effective in alleviating breathing instability during sleep , presenting an opportunity for novel therapy for central sleep apnea in selected populations .


Alternative drug therapies are needed for the treatment of portal hypertension .


The aim of this randomized study was to evaluate and compare the effects of carvedilol and nebivolol on the hepatic venous pressure gradient ( HVPG ) response in the patients with liver cirrhosis .


In total , 20 cirrhotic patients were randomized into 2 groups and treated with carvedilol ( n = 10 ) or nebivolol ( n = 10 ) .


HVPG was measured at baseline , 60 minutes after the administration of carvedilol ( 25 mg ) or nebivolol ( 5 mg ) , and after 14 days of carvedilol ( 25 mg ) or nebivolol ( 5 mg ) administered daily .


RESULTS .


Carvedilol significantly reduced HVPG from 22.2 mm Hg ( SD , 4.4 ) to 15.2 mm Hg ( SD , 3.7 ) after 60 minutes and to 16.4 mm Hg ( SD , 2.9 ) after 14 days ( P < 0.01 ) .


Nebivolol reduced HVPG from 19.7 mm Hg ( SD , 2.5 ) to 15.7 mm Hg ( SD , 2.6 ) and 16.7 mm Hg ( SD , 3.2 ) , respectively ( P < 0.02 ) .


Carvedilol effectively decreased HVPG in a greater proportion of the patients after an acute probe ( 88 % vs. 57 % ) and after 14 days of the treatment ( 88 % vs. 28 % , P < 0.05 ) in comparison with nebivolol .


Carvedilol and nebivolol reduce HVPG in cirrhotic patients ; however , the effect of carvedilol on the HVPG reduction might be superior to that of nebivolol , especially after 14 days of treatment .


To compare the efficacy and safety of intravitreal aflibercept injection ( IAI ) with macular grid laser photocoagulation for the treatment of macular edema after branch retinal vein occlusion ( BRVO ) .


The VIBRANT study was a double-masked , active-controlled , randomized , phase III trial .


Treatment-nave eyes with macular edema after BRVO were included in the study if the occlusion occurred within 12 months and best-corrected visual acuity ( BCVA ) was between 73 and 24 Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters ( 20/40-20 / 320 Snellen equivalent ) .


Eyes ( 1 eye per patient ) received either IAI 2 mg every 4 weeks ( n = 91 ) from baseline to week 20 or grid laser ( n = 92 ) at baseline with a single grid laser rescue treatment , if needed , from weeks 12 through 20 .


The primary outcome measure was the proportion of eyes that gained 15 ETDRS letters from baseline BCVA at week 24 .


Secondary end points included mean change from baseline BCVA and central retinal thickness ( CRT ) at week 24 .


The proportion of eyes that gained 15 ETDRS letters from baseline at week 24 was 52.7 % in the IAI group compared with 26.7 % in the laser group ( P = 0.0003 ) .


The mean improvement from baseline BCVA at week 24 was 17.0 ETDRS letters in the IAI group and 6.9 ETDRS letters in the laser group ( P < 0.0001 ) .


The mean reduction in CRT from baseline at week 24 was 280.5 m in the IAI group and 128.0 m in the laser group ( P < 0.0001 ) .


Traumatic cataract in an IAI patient was the only ocular serious adverse event ( SAE ) that occurred .


There were no cases of intraocular inflammation or endophthalmitis .


The incidence of nonocular SAEs was 8.8 % in the IAI group and 9.8 % in the laser group .


One Anti-Platelet Trialists ' Collaboration-defined event of nonfatal stroke ( 1.1 % ) and 1 death ( 1.1 % ) due to pneumonia occurred during the 24 weeks of the study , both in patients in the laser group .


Monthly IAI provided significantly greater visual benefit and reduction in CRT at 24 weeks than grid laser photocoagulation in eyes with macular edema after BRVO .


Patients undergoing sleeve gastrectomy experience a significant amount of postoperative gastrointestinal ( GI ) symptoms .


The purpose of our study was to assess the efficacy of omentopexy during laparoscopic sleeve gastrectomy ( LSG ) in reducing postoperative food intolerance and GI symptoms .


Morbidly obese patients undergoing LSG were randomly assigned to have LSG with or without omentopexy from May 2012 to June 2013 .


A total of 60 patients were recruited with 30 patients in each group .


Patients and the symptom scorer were blinded as to the assigned surgery .


All procedures were performed by one of two surgeons utilizing the same surgical technique .


Patients were administered standardized surveys , including the Rhodes Index survey , gastroesophageal reflux disease ( GERD ) impact survey , and Eating Assessment Tool ( EAT ) survey at various time points postoperatively to assess nausea , vomiting , retching , frequency of GI symptoms , and level of distress .


There was no significant difference in patient age , percent decrease in BMI at any time point , or length of hospitalization between the two groups ( P > 0.05 ) .


Furthermore , there was no significant difference in Rhodes Index scores , GERD impact scores , or EAT scores at any time point ( P > 0.05 ) .


Patients in the LSG with omentopexy group required significantly more ondansetron perioperatively ( 16.1 12.9 mg vs. 10.3 10.2 mg , respectively ; P = 0.04 ) ; however , there was no difference in metoclopramide requirement ( P = 0.22 ) .


Surgical morbidity was not significantly different between the two groups ( P > 0.05 ) .


Finally , there was no significant difference in number of postoperative clinic visits , office telephone encounters , total postoperative readmissions , or postoperative readmissions associated with GI symptoms ( P > 0.05 ) .


Omentopexy did not significantly decrease postoperative food intolerance or GI symptoms in morbidly obese patients undergoing LSG .


Other methods of mitigating postoperative intolerance to oral intake and GI symptoms should be investigated .


The rehabilitation program after flexor tendon repair of zone II laceration varies .


We designed a Prospective Randomized Controlled Trial of controlled passive mobilization ( modified Kleinert ) vs. Place and active hold exercises after zone 2-flexor tendon repair by two-strand suture ( Modified kessler ) .


Sixty-four fingers in 54 patients with zone 2 flexor tendon modified Kessler repairs were enrolled in a prospective randomized controlled trial comparing place and active hold exercises to controlled passive mobilization ( modified Kleinert ) .


The primary outcome measure was total active motion eight weeks after repair as measured by an independent and blinded therapist .


Patients treated with place and active hold exercises had significantly greater total active motion ( 146 ) eight weeks after surgery than patients treated with controlled passive mobilization ( 114 ) ( modified Klinert ) .


There were no ruptures in either group .


Place and hold achieves greater motion than controlled passive mobilization after a two-strand repair for zone 2 flexor tendon repairs .


To determine whether directly measured arterial blood pressure differs among anatomic locations and whether arterial blood pressure is influenced by body position .


33 client-owned dogs undergoing anesthesia .


Dogs undergoing anesthetic procedures had 20-gauge catheters placed in both the superficial palmar arch and the contralateral dorsal pedal artery ( group 1 [ n = 20 ] ) or the superficial palmar arch and median sacral artery ( group 2 [ 13 ] ) .


Dogs were positioned in dorsal recumbency , and mean arterial blood pressure ( MAP ) , systolic arterial blood pressure ( SAP ) , and diastolic arterial blood pressure ( DAP ) were recorded for both arteries 4 times ( 2-minute interval between successive measurements ) .


Dogs were positioned in right lateral recumbency , and blood pressure measurements were repeated .


Differences were detected between pressures measured at the 2 arterial sites in both groups .


This was especially true for SAP measurements in group 1 , in which hind limb measurements were a mean of 16.12 mm Hg higher than carpus measurements when dogs were in dorsal recumbency and 14.70 mm Hg higher than carpus measurements when dogs were in lateral recumbency .


Also , there was significant dispersion about the mean for all SAP , DAP , and MAP measurements .


Results suggested that arterial blood pressures may be dependent on anatomic location and body position .


Because this may affect outcomes of studies conducted to validate indirect blood pressure measurement systems , care must be used when developing future studies or interpreting previous results .


This study was designed to identify the optimal dose of an MF59-adjuvanted , monovalent , A/H1N1 influenza vaccine in healthy paediatric subjects .


Subjects aged 3-8 years ( n = 194 ) and 9-17 years ( n = 160 ) were randomized to receive two primary doses of A/H1N1 vaccine containing either 3.75 g antigen with half a standard dose of MF59 adjuvant , 7.5 g antigen with a full dose of MF59 , or ( children 3-8 years only ) , a non-adjuvanted 15 g formulation .


A booster dose of MF59-adjuvanted seasonal influenza vaccine including homologous A/H1N1 strain was given one year after priming .


Immunogenicity was assessed by haemagglutination inhibition ( HI ) and microneutralization assays .


Vaccine safety was assessed throughout the study ( up to 18 months ) .


A single priming dose of either MF59-adjuvanted formulation was sufficient to meet the European licensure criteria for pandemic influenza vaccines ( HI titres 1:40 > 70 % ; seroconversion > 40 % ; and GMR > 2.5 ) .


Two non-adjuvanted vaccine doses were required to meet the same licensure criteria .


After first and second doses , percentage of subjects with HI titres 1:40 were between 97 % and 100 % in the adjuvanted vaccine groups compared with 68 % and 91 % in the non-adjuvanted group , respectively .


Postvaccination seroconversion rates ranged from 91 % to 98 % in adjuvanted groups and were 68 % ( first dose ) and 98 % ( second dose ) in the non-adjuvanted group .


HI titres 1:330 after primary doses were achieved in 69 % to 90 % in adjuvanted groups compared with 41 % in the non-adjuvanted group .


Long-term antibody persistence after priming and a robust antibody response to booster immunization were observed in all vaccination groups .


All A/H1N1 vaccine formulations were generally well tolerated .


No vaccine-related serious adverse events occurred , and no subjects were withdrawn from the study due to an adverse event .


An MF59-adjuvanted influenza vaccine containing 3.75 g of A/H1N1 antigen was well tolerated and sufficiently immunogenic to meet all the European licensure criteria after a single dose in healthy children 3-17 years old .


To evaluate the analgesic potential of the centrally acting analgesics tramadol , morphine and the novel analgesic tapentadol in a pre-clinical research model of acute nociceptive pain , the tail-flick model in dogs .


Prospective part-randomized pre-clinical research trial .


Fifteen male Beagle dogs ( HsdCpb : DOBE ) , aged 12-15 months .


On different occasions separated by at least 1 week , dogs received intravenous ( IV ) administrations of tramadol ( 6.81 , 10.0 mg kg ( -1 ) ) , tapentadol ( 2.15 , 4.64 , 6.81 mg kg ( -1 ) ) or morphine ( 0.464 , 0.681 , 1.0 mg kg ( -1 ) ) with subsequent measurement of tail withdrawal latencies from a thermal stimulus ( for each treatment n = 5 ) .


Blood samples were collected immediately after the pharmacodynamic measurements of tramadol to determine pharmacokinetics and the active metabolite O-demethyltramadol ( M1 ) .


Tapentadol and morphine induced dose-dependent antinociception with ED50-values of 4.3 mg kg ( -1 ) and 0.71 mg kg ( -1 ) , respectively .


In contrast , tramadol did not induce antinociception at any dose tested .


Measurements of the serum levels of tramadol and the M1 metabolite revealed only marginal amounts of the M1 metabolite , which explains the absence of the antinociceptive effect of tramadol in this experimental pain model in dogs .


Different breeds of dogs might not or only poorly respond to treatment with tramadol due to low metabolism of the drug .


Tapentadol and morphine which act directly on - opioid receptors without the need for metabolic activation are demonstrated to induce potent antinociception in the experimental model used and should also provide a reliable pain management in the clinical situation .


The non-opioid mechanisms of tramadol do not provide antinociception in this experimental setting .


This contrasts to many clinical situations described in the literature , where tramadol appears to provide useful analgesia in dogs for post-operative pain relief and in more chronically pain states .


This paper describes a randomized prospective study conducted in 308 patients undergoing caesarean section in spinal anaesthesia at a single hospital between 2010 and 2012 to find a suitable anti-emetic strategy for these patients .


Spinal anesthesia was performed in left prone position , at L3/L4 with hyperbaric 0.5 % Bupivacaine according to a cc/cm body height ratio .


There were no opioids given peri-operatively .


The patients received either no prophylaxis ( Group I ) or tropisetron and metoclopramide ( Group II ) or dimenhydrinate and dexamethasone ( Group III ) , or tropisetron as a single medication ( Group IV ) .


The primary outcome was nausea and/or vomiting ( NV ) in the intraoperative , early ( 0-2 h ) or late ( 2-24 h ) postoperative period .


Multivariate statistical analysis was conducted with a regression analysis and a backward elimination of factors without significant correlation .


All prophylactic agents significantly reduced NV incidence intraoperatively .


Relative risk reduction for NV by prophylaxis was most effective ( 59.5 % ) in Group II ( tropisetron and metoclopramide ) .


In Group III ( dimenhydrinate and dexamethasone ) , NV risk was reduced by 29.9 % and by 28.7 % in Group IV ( tropisetron mono-therapy ) .


The incidence of NV in the early ( 0 ?


2 h ) and the late ( 2 ?


24 h ) postoperative period was low all over ( 7.8 % ) , but the relative risk reduction of NV in the early postoperative period was 54.1 % ( Group IV ) , 45.1 % ( Group III ) , and 34.8 % ( Group II ) , respectively .


In the late postoperative period , there was no significant difference between the 4 groups .


We recommend a prophylactic medication with tropisetron 2 mg and metoclopramide 20 mg for patients during caesarean section .


These agents are safe , reasonably priced , and highly efficient in preventing nausea and vomiting .


To explore whether topical application of atropine gel controls epiphora secondary to submandibular gland ( SMG ) transplantion for severe keratoconjunctivitis sicca .


Eighteen patients with epiphora after SMG transplantation participated in a double-blind , controlled , crossover study .


Patients were treated with topical smear common atropine ( CA ) and modified atropine ( MA ) gels ( intervals 1 day ) .


The control effect of atropine gels was observed for 5 hours .


Tear flow was quantified in resting and stimulated ( after exercise ) states using the Schirmer I test .


With the CA gel , tear flow decreased significantly at 10 , 30 , and 120 minutes .


Average epiphora reduction rates ( AERRs ) were 22.37 % , 18.14 % , and 13.27 % , respectively ( P < .05 ) .


With the MA gel , tear flow decreased significantly from 5 minutes to 5 hours ; AERRs increased from 24.06 % to 42.67 % ( P < .05 ) ; Maximum efficacy was maintained from 15 minutes to 3 hours ( P < .01 ) ; Tear flow gradually increased from 4 to 5 hours but was still lower than that before atropine use ( P < .05 ) .


According to results of the Schirmer I test and AERRs , the control efficacy of the MA gel was significantly better than that of the CA gel ( P < .05 ) .


Topical application of atropine gel could effectively control mild epiphora for patients with SMG transplantation for severe keratoconjunctivitis sicca .


The efficacy of MA gel was much better than that of the CA gel .


Eye drops of aganirsen , an antisense oligonucleotide preventing insulin receptor substrate-1 expression , inhibited corneal neovascularization in a previous dose-finding phase II study .


We aimed to confirm these results in a phase III study and investigated a potential clinical benefit on visual acuity ( VA ) , quality of life ( QoL ) , and need for transplantation .


Multicenter , double-masked , randomized , placebo-controlled phase III study .


Analysis of 69 patients with keratitis-related progressive corneal neovascularization randomized to aganirsen ( 34 patients ) or placebo ( 35 patients ) .


Patients applied aganirsen eye drops ( 86 g/day/eye ) or placebo twice daily for 90 days and were followed up to day 180 .


The primary end point was VA. .


Secondary end points included area of pathologic corneal neovascularization , need for transplantation , risk of graft rejection , and QoL .


Although no significant differences in VA scores between groups were observed , aganirsen significantly reduced the relative corneal neovascularization area after 90 days by 26.20 % ( P = 0.014 ) .


This improvement persisted after 180 days ( 26.67 % , P = 0.012 ) .


Aganirsen tended to lower the transplantation need in the intent-to-treat ( ITT ) population at day 180 ( P = 0.087 ) .


In patients with viral keratitis and central neovascularization , a significant reduction in transplantation need was achieved ( P = 0.048 ) .


No significant differences between groups were observed in the risk of graft rejection .


However , aganirsen tended to decrease this risk in patients with traumatic/viral keratitis ( P = 0.162 ) at day 90 .


The QoL analyses revealed a significant improvement with aganirsen in composite and near activity subscores ( P = 0.039 and 0.026 , respectively ) at day 90 in the per protocol population .


Ocular and treatment-related treatment-emergent adverse events ( TEAEs ) were reported in a lower percentage with aganirsen compared with placebo .


Only 3 serious TEAEs ( 2 with aganirsen and 1 with placebo ) were considered treatment-related .


This first phase III study on a topical inhibitor of corneal angiogenesis showed that aganirsen eye drops significantly inhibited corneal neovascularization in patients with keratitis .


The need for transplantation was significantly reduced in patients with viral keratitis and central neovascularization .


Topical application of aganirsen was safe and well tolerated .


Structural learning theory suggests that experiencing motor task variation enables the central nervous system to extract general rules regarding tasks with a similar structure - rules that can subsequently be applied to novel situations .


Complex minimally invasive surgery ( MIS ) requires different port sites , but switching ports alters the limb movements required to produce the same endpoint control of the surgical instrument .


The purpose of the present study was to determine if structural learning theory can be applied to MIS to inform training methods .


A tablet laptop running bespoke software was placed within a laparoscopic box trainer and connected to a monitor situated at eye level .


Participants ( right-handed , non-surgeons , mean age = 23.2 years ) used a standard laparoscopic grasper to move between locations on the screen .


There were two training groups : the M group ( n = 10 ) who trained using multiple port sites , and the S group ( n = 10 ) who trained using a single port site .


A novel port site was used as a test of generalization .


Performance metrics were a composite of speed and accuracy ( SACF ) and normalized jerk ( NJ ; a measure of movement ` smoothness ' ) .


The M group showed a statistically significant performance advantage over the S group at test , as indexed by improved SACF ( p < 0.05 ) and NJ ( p < 0.05 ) .


This study has demonstrated the potential benefits of incorporating a structural learning approach within MIS training .


This may have practical applications when training junior surgeons and developing surgical simulation devices .


The Randomized Olmesartan and Diabetes Microalbuminuria Prevention ( ROADMAP ) study showed that 40 mg Olmesartan medoxomil ( OM ) versus placebo delayed microalbuminuria onset in patients with type 2 diabetes and normoalbuminuria .


One thousand seven hundred and fifty-eight ROADMAP patients ( placebo arm : 877 ; OM arm : 881 ) participated in the observational follow up ( OFU ) with an average of 3.3 years .


They received standard medical care and micro - and macrovascular events were documented .


During observational follow-up 62.9 % and 60.1 % in the former OM and placebo group , respectively , received treatment with a RAS blocking agent .


During the OFU period the systolic blood pressure ( SBP ) increased to mean values of 135 mm Hg in both groups .


Patients who had developed microalbuminuria during ROADMAP had a higher incidence of cardio - and cerebrovascular events ( OR 1.77 , CI 1.03 to 3.03 , P = 0.039 ) during the OFU period compared with patients in whom this was not the case .


Diabetic retinopathy was significantly reduced in the former OM group ( 8 [ 0.9 % ] versus 23 [ 2.6 % ] , OR : 0.34 , CI 0.15 to 0.78 , P = 0.011 ) and the rate of microalbuminuria was numerically reduced .


Congestive heart failure requiring hospitalization ( 3 [ 0.3 % ] versus 12 [ 1.4 % ] , OR : 0.23 , CI 0.06 to 0.85 , P = 0.027 ) was reduced and there was a trend of reduced cardio - / cerebrovascular events ( OM versus Pb : 73 [ 8.3 % ] versus 86 [ 9.8 % ] patients ) .


Seven ( 0.8 % ) deaths ( including 2 CV events ) were reported in former placebo patients versus 3 ( 0.3 % ) ( non-CV events ) in former OM patients .


Development of microalbuminuria is a valid marker for future CV events .


RAS blockade with Olmesartan might cause sustained reduction ( legacy effect ) of micro - and macrovascular events .


Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care ; however , the intervention is poorly defined and not underpinned by strong evidence .


We aimed to compare the effectiveness of frequent , higher dose , very early mobilisation with usual care after stroke .


We did this parallel-group , single-blind , randomised controlled trial at 56 acute stroke units in five countries .


Patients ( aged 18 years ) with ischaemic or haemorrhagic stroke , first or recurrent , who met physiological criteria were randomly assigned ( 1:1 ) , via a web-based computer generated block randomisation procedure ( block size of six ) , to receive usual stroke-unit care alone or very early mobilisation in addition to usual care .


Treatment with recombinant tissue plasminogen activator was allowed .


Randomisation was stratified by study site and stroke severity .


Patients , outcome assessors , and investigators involved in trial and data management were masked to treatment allocation .


The primary outcome was a favourable outcome 3 months after stroke , defined as a modified Rankin Scale score of 0-2 .


We did analysis on an intention-to-treat basis .


The trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12606000185561 .


Between July 18 , 2006 , and Oct 16 , 2014 , we randomly assigned 2104 patients to receive either very early mobilisation ( n = 1054 ) or usual care ( n = 1050 ) ; 2083 ( 99 % ) patients were included in the 3 month follow-up assessment .


965 ( 92 % ) patients were mobilised within 24 h in the very early mobilisation group compared with 623 ( 59 % ) patients in the usual care group .


Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group ( n = 480 [ 46 % ] vs n = 525 [ 50 % ] ; adjusted odds ratio [ OR ] 073 , 95 % CI 059-090 ; p = 0004 ) .


88 ( 8 % ) patients died in the very early mobilisation group compared with 72 ( 7 % ) patients in the usual care group ( OR 134 , 95 % CI 093-193 , p = 0113 ) .


201 ( 19 % ) patients in the very early mobilisation group and 208 ( 20 % ) of those in the usual care group had a non-fatal serious adverse event , with no reduction in immobility-related complications with very early mobilisation .


First mobilisation took place within 24 h for most patients in this trial .


The higher dose , very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months .


Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide , and our findings should affect clinical practice by refining present guidelines ; however , clinical recommendations should be informed by future analyses of dose-response associations .


National Health and Medical Research Council , Singapore Health , Chest Heart and Stroke Scotland , Northern Ireland Chest Heart and Stroke , UK Stroke Association , National Institute of Health Research .


To assess the short-term efficacy and safety of corneal collagen cross-linking ( CXL ) in preventing the progression of keratoconus ( KCN ) .


This randomized controlled clinical trial enrolled 26 patients diagnosed with bilateral progressive KCN and were eligible for CXL .


In each patient , one eye was randomly selected for treatment , and the contralateral eye served as the control .


The patients underwent CXL with riboflavin drops and ultraviolet radiation in the treated eye .


One year follow-up data are presented .


Postoperatively , patients were assessed for progression of KCN , visual changes , and other findings .


The main outcome measures were maximum simulated keratometry ( K-max ) , best spectacle-corrected visual acuity ( BSCVA ) , and average simulated keratometry .


P < 0.05 was considered as statistically significant .


In the treated eyes , the mean K-max values decreased by 0.22 D at 1-year postoperatively and increased by 0.41 D in the control group .


This difference was statistically significant ( P < 0.001 ) .


BSCVA improved slightly ( a decrease of 0.13 LogMAR ) and decreased slightly in the control group ( a 0.01 LogMAR increase ) .


The difference between groups was statistically significant ( P = 0.014 ) .


There was no decrease in visual acuity attributable to complications of CXL in the treated eyes .


At 1-year , the keratometry in 3 ( 12 % ) treated eyes increased by more than 0.50 D and were considered cases of failed treatment .


Preliminary and 1-year results indicate CXL can halt the progression of KCN in most cases without causing serious complications .


We describe the organization of a prospective , randomized , multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair ( OPAR ) and endovascular popliteal artery aneurysm repair ( EPAR ) of asymptomatic popliteal artery aneurysms ( PAAs ) as an example for how to use the Vascular Quality Initiative ( VQI ) framework .


Given that many centers participate in the VQI , this model can be used to perform multicenters ' prospective trials on very modest budget .


VQI prospectively collects data on many vascular procedures .


These data include many important perioperative , intraoperative , and postoperative details regarding both patients and their procedures .


We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question .


Data will be collected using modified VQI forms within the existing VQI data reporting structure .


We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts .


Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years .


Our primary hypothesis is that major adverse limb event-free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions , improved quality of life , and decreased length of stay .


The budget for this trial is fixed at $ 10,000 / year for the course of the study , and the trial is judged to be feasible because of the functionality of the VQI platform .


Using the existing VQI infrastructure , Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget .


The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates .


Many minimally invasive interventional techniques as well as expectant treatment exist for the management of lower ureteric calculi .


This study was conducted to evaluate th efficacy of tamsulosin as an expulsive pharmacologic therapy for the treatment of distal uretern stone .


This randomized control trial included 100 patients over 18 years of age wit stone Size > or = mm in distal 1/3 of ureter .


Patients were randomly assigned into two groups ( A & B Group A Patients were given Capsule Tamsulosin 0.4 mg , 1 daily up to 4 weeks while group B patients were given placebo , 1 Capsule daily up to 4 weeks .


The primary endpoint was expulsio rate .


A written informed consent was taken from all the patients .


Expulsion time , need for analgesics , need for hospitalization and drug side effects were secondary endpoints .


A total of 49 patients in group A and 48 patients in group B reported back , therefore 97 out of 10 patients were evaluated .


Mean age of the patients was 36.34 years ( range 18-57 years ) .


Mea stone size was 5.78 mm ( range 4-8 mm ) in greatest dimension .


A stone expulsion rate of 85.71 C ( 42 patients ) was noted in group A and 54.20 % ( 26 patients ) in group B. Group A revealed statistically significant advantage in term of stone expulsion rate ( p = 0.032 ) .


Considering expulsio time in days group A showed statistically significant advantage ( p = 0.015 ) .


Regarding age , se ) stone size and stone lateralization ( right/left ) , there was no significant difference between th group A and B. No drug side effects were noted in both the groups .


By usin tamsulosin a higher stone expulsion rates can be achieved in a shorter time .


More randomize control trials are required to establish tamsulosin as a standard medical expulsive treatment fc


Despite improvements in liver surgery over the past decades , hemostasis during hepatic resections remains challenging .


This multicenter randomized study compares the hemostatic effect of a collagen hemostat vs. a carrier-bound fibrin sealant after hepatic resection .


Patients scheduled for elective liver resection were randomized intraoperatively to receive either the collagen hemostat ( COLL ) or the carrier-bound fibrin sealant ( CBFS ) for secondary hemostasis .


The primary endpoint was the proportion of patients with hemostasis after 3 min .


Secondary parameters were the proportions of patients with hemostasis after 5 and 10 min , the total time to hemostasis , and the complication rates during a 3 months follow-up period .


A total of 128 patients were included .


In the COLL group , 53 out of 61 patients ( 86.9 % ) achieved complete hemostasis within 3 min after application of the hemostat compared to 52 out of 65 patients ( 80.0 % ) in the CBFS group .


The 95 % confidence interval for this difference [ -6.0 % , 19.8 % ] does not include the lower noninferiority margin ( -10 % ) .


Thus , the COLL treatment can be regarded as noninferior to the comparator .


The proportions of patients with hemostasis after 3 , 5 , and 10 min were not significantly different between the two study arms .


Postoperative mortality and morbidity were similar in both treatment groups .


The collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate .


Several studies emphasise that arabinoxylan and - glucan have more beneficial effects on glucose metabolism than low-dietary fibre ( DF ) meals .


Less attention has been paid to the effects of concentrated DF compared with whole grain .


We compared the effects of DF and whole grain on glucose , hormone responses and appetite in subjects with the metabolic syndrome ( MetS ) .


Fifteen subjects with MetS participated in this acute , randomised , cross-over intervention study .


The test breads provided 50 g of digestible carbohydrate : wheat bread with concentrated arabinoxylan ( AX ) or - glucan ( BG ) , rye bread with kernels ( RK ) and wheat bread ( WB ) as control .


Blood samples were drawn for 270 min to determine glucose , insulin , glucagon-like peptide-1 , glucose-dependent insulinotropic peptide ( GIP ) and ghrelin .


Appetite score was addressed every 30 min .


Ad libitum energy intake ( EI ) was measured 270 min after test meals .


Compared with WB , BG and RK induced lower initial glycaemic responses ( P < 0.001 ) , whereas AX only reduced the glucose peak value ( P < 0.001 ) .


RK reduced insulin ( P < 0.001 ) and GIP responses ( P < 0.001 ) compared with the other breads .


BG lowered insulin responses more than AX ( P < 0.001 ) .


AX , BG and RK increased satiety feeling ( P < 0.001 ) more than WB , but did not differ significantly in terms of subsequent EI ( P = 0.089 ) .


BG and RK had beneficial impact on the glucose response , whereas AX had only effect on the postprandial glucose peak .


The impact of the AX bread was influenced by higher protein content .


Whether the metabolic effects of the breads are still present to mixed meals remains to be tested .


To evaluate the clinical effect of proton pump inhibitor-based triple therapy combined with Saccharomyces boulardii in the treatment of Helicobacter pylori ( Hp ) infection among children in terms of Hp eradication rate and incidence of adverse events .


A prospective randomised controlled study was conducted on 240 children with a confirmed diagnosis of Hp infection .


These patients were randomized into triple therapy ( n = 120 ) and probiotics groups ( n = 120 ) .


The triple therapy group received amoxicillin [ 40mg / ( kgd ) , Tid ] , clarithromycin [ 15mg / ( kgd ) , Bid ] and omeprazole [ 0.7-0 .8 mg / ( kgd ) , Qd ] , while the probiotics group received Saccharomyces boulardii ( 250mg , Bid ) in addition to triple therapy .


The course of treatment was 14 days in both groups .


The adverse events in subjects were recorded by their parents during treatment .


Hp eradiation was evaluated by ( 13 ) C breath test at 4 weeks after treatment , and the eradication rate and incidence of adverse events were compared between the two groups .


The Hp eradication rates were 75.8 % ( 91/120 ) in the triple therapy group and 85 % ( 102/120 ) in the probiotics group ( P > 0.05 ) .


Compared with the triple therapy group , the probiotics group had nonsignificantly lower incidence of nausea , vomiting , and abdominal pain ( P > 0.05 ) and significantly lower incidence of stomatitis , constipation and diarrhea ( P < 0.05 ) .


Triple therapy combined with Saccharomyces boulardii can not significantly increase Hp eradication rate , but can significantly reduce the incidence of stomatitis , constipation , and diarrhea during treatment .


Little is known about the differences between standard-dose statins effects on glucose level and lipids in Japanese patients with diabetes mellitus ( DM ) .


The 1,049 patients were randomly assigned to either the rosuvastatin group or atorvastatin group .


There were no significant differences between the 2 groups in the effect on non-high-density lipoprotein cholesterol ( non-HDL-C ) and HbA1c at 12 months .


However , physicians tended to switch to more intensive therapy for DM in the atorvastatin group .


Rosuvastatin 5 mg and atorvastatin 10 mg have a similar lowering effect on non-HDL-C , but might be different in terms of adverse effect on glucose levels .


Oral feeding is likely to have an impact on early return of normal bowel function after uncomplicated surgery including cesarean section .


This study compared postoperative outcomes of early versus late oral feeding regimes after cesarean section .


In this clinical trial , 140 pregnant women who underwent elective cesarean section with regional anesthesia were randomized into two feeding groups .


In the early oral and delayed oral feeding groups , liquid diets were commenced 2 and 8 h after surgery , respectively .


Patients able to tolerate the liquid diet were then gradually introduced to the regular diet .


Main clinical outcomes included duration of hospital stay , time to return of normal bowel function and postoperative gastrointestinal complications .


Time to return of bowel movement ( 7.8 2.9 vs 11.7 5 h , P < 0.0001 ) and time to mobilization ( 10.7 7.7 vs 13.5 5.9 h , P = 0.015 ) occurred significantly earlier in the early feeding group .


Early oral feeding reduces the time required for return of normal bowel function .


This is without significant detrimental effects on the incidence of gastrointestinal complications .


Hepatitis C virus ( HCV ) infection is common among prisoners , particularly those with a history of injecting drug use ( IDU ) .


Incarcerated people who inject drugs frequently report high-risk injecting practices both in prison and in the community .


In spite of rising morbidity and mortality , utilisation of HCV-related services in Australia has been persistently low .


This study aimed to describe the incidence , prevalence and correlates of HCV seropositivity in a large cohort of prisoners who have injected drugs , and to identify correlates of receiving confirmation of active infection .


Data-linkage to a State-wide statutory notifiable diseases surveillance system was used to investigate the incidence of notified HCV seropositivity , seroconversion and confirmed HCV infection in a cohort of 735 prisoners with a history of IDU , over 14 years of follow up .


Hepatitis C test results from prison medical records were used to identify correlates of testing positive in prison .


The crude incidence of HCV notification was 5.1 cases per 100 person-years .


By the end of follow up , 55.1 % of the cohort had been the subject of a HCV-related notification , and 47.4 % of those tested in prison were HCV seropositive .


In multivariable analyses , injecting in prison was strongly associated with HCV seropositivity , as was opioid use compared to injection of other drugs .


The rate of reported diagnostic confirmation among those with notified infections was very low , at 6.6 confirmations per 100 seropositive participants per year .


Injecting drugs in prison was strongly associated with HCV seropositivity , highlighting the need for increased provision of services to mitigate the risk of transmission within prisons .


Once identified as seropositive through screening , people with a history of IDU and incarceration may not be promptly receiving diagnostic services , which are necessary if they are to access treatment .


Improving access to HCV-related services will be of particular importance in the coming years , as HCV-related morbidity and mortality is increasing , and next generation therapies are becoming more widely available .


Data comparing the efficacy and safety of combination therapy with peginterferon plus low-dose ribavirin and peginterferon monotherapy in treatment-naive haemodialysis patients with hepatitis C virus genotype 2 ( HCV-2 ) infection are limited .


In this randomised trial , 172 patients received 24weeks of peginterferon alfa-2a 135g/week plus ribavirin 200mg/day ( n = 86 ) or peginterferon alfa-2a 135g/week ( n = 86 ) .


The efficacy and safety endpoints were sustained virological response ( SVR ) rate and adverse event ( AE ) - related withdrawal rate .


Compared with monotherapy , combination therapy had a greater SVR rate ( 74 % vs 44 % , relative risk ( RR ) : 1.68 [ 95 % CI 1.29 to 2.20 ] ; p < 0.001 ) .


The beneficial effect of combination therapy was more pronounced in patients with baseline viral load 800,000 IU/mL than those with baseline viral load < 800,000 IU/mL ( RR : 3.08 [ 95 % CI 1.80 to 5.29 ] vs. RR : 1.11 [ 95 % CI 0.83 to 1.45 ] ; interaction p = 0.001 ) .


Patients receiving combination therapy were more likely to have a haemoglobin level of < 8.5 g/dL ( 70 % vs. 8 % , risk difference ( RD ) : 62 % [ 95 % CI 50 % to 73 % ] ; p < 0.001 ) and required a higher dosage [ mean : 13,417 vs. 6667 IU/week , p = 0.027 ] of epoetin to manage anaemia than those receiving monotherapy .


The AE-related withdrawal rates were 6 % and 3 % in combination therapy and monotherapy groups , respectively ( RD : 2 % [ 95 % CI -4 % to 9 % ] ) .


In treatment-naive haemodialysis patients with HCV-2 infection , combination therapy with peginterferon plus low-dose ribavirin achieved a greater SVR rate than peginterferon monotherapy .


Most haemodialysis patients can tolerate combination therapy .


ClinicalTrial.gov number , NCT00491244 .


The secreted protein acidic and rich in cysteine-like 1 ( SPARCL1 ) is expressed in various normal tissues and many types of cancers .


The function of SPARCL1 and its relationship to a patient 's prognosis have been studied , whereas its relationship to radiation therapy ( RT ) is not known .


Our aim was to investigate the expression of SPARCL1 in rectal cancer patients who participated in a clinical trial of preoperative RT. .


The study included 136 rectal cancer patients who were randomized to undergo preoperative RT and surgery ( n = 63 ) or surgery alone ( n = 73 ) .


The expression levels of SPARCL1 in normal mucosa ( n = 29 ) , primary tumor ( n = 136 ) , and lymph node metastasis ( n = 35 ) were determined by immunohistochemistry .


Tumors with RT had stronger SPARCL1 expression than tumors without RT ( P = .003 ) .


In the RT group , strong SPARCL1 expression was related to better survival than weak expression in patients with stage III tumors , independent of sex , age , differentiation , and margin status ( P = .022 ; RR = 18.128 ; 95 % confidence interval , 1.512-217 .413 ) .


No such relationship was found in the non-RT group ( P = .224 ) .


Further analysis of interactions among SPARCL1 expression , RT , and survival showed statistical significance ( P = .024 ) .


In patients with metastases who received RT , strong SPARCL1 expression was related to better survival compared to weak expression ( P = .041 ) but not in the non-RT group ( P = .569 ) .


SPARCL1 expression increases with RT and is related to better prognosis in rectal cancer patients with RT but not in patients without RT. .


This result may help us to select the patients best suited for preoperative RT. .


Relatively few treatment programs have been developed specifically for smokeless tobacco ( ST ) users who want to quit .


Their results suggest that self-help materials , telephone counseling , and nicotine lozenges are efficacious .


This study provides the first direct examination of the separate and combined effects of telephone counseling and lozenges .


We recruited ST users online ( N = 1067 ) and randomly assigned them to 1 of 3 conditions : ( a ) a lozenge group ( n = 356 ) , who were mailed 4-mg nicotine lozenges ; ( b ) a coach calls group ( n = 354 ) , who were offered 3 coaching phone calls ; or ( c ) a lozenge + coach calls group ( N = 357 ) , who received both lozenges and coaching calls .


Additionally , all participants were mailed self-help materials .


Self-reported tobacco abstinence was assessed at 3 and 6 months after randomization .


Complete-case and intention-to-treat ( ITT ) analyses for all tobacco abstinence were performed at 3 months , 6 months , and both 3 and 6 months ( repeated point prevalence ) .


ITT analyses revealed a highly similar result : the lozenge + coach calls condition was significantly more successful in encouraging tobacco abstinence than either the lozenge group or the coach calls group , which did not differ .


Combining nicotine lozenges and phone counseling significantly increased tobacco abstinence rates compared with either intervention alone , whereas coach calls and lozenges were equivalent .


The study confirms the high tobacco abstinence rates for self-help ST cessation interventions and offers guidance to providing tobacco treatment to ST users .


The authors conducted a randomized , controlled , parallel-arm , superiority study to test the hypothesis that a continuous adductor canal block decreases the time to attain four discharge criteria compared with a continuous femoral nerve block after tricompartment knee arthroplasty .


Subjects undergoing tricompartment knee arthroplasty were randomized using computer-generated lists to either an adductor canal or femoral perineural catheter ( 3-day ropivacaine 0.2 % infusion ) in an unmasked manner .


The primary outcome was the time to attain four criteria : ( 1 ) adequate analgesia ; ( 2 ) intravenous opioids independence ; ( 3 ) ability to stand , walk 3 m , return , and sit down ; and ( 4 ) ambulate 30 m.


Subjects with an adductor canal catheter ( n = 39 ) reached all four criteria in a median of 55h ( interquartile , 42 to 63h ) compared with 61h ( 49 to 69h ) for those with a femoral catheter ( n = 41 ; 95 % CI , -13 to 1h ; P = 0.12 ) .


The percentage of subjects who reached the two mobilization criteria on postoperative days 1 and 2 were 72 and 95 % for those with an adductor canal catheter ( n = 39 ) , but only 27 and 76 % in subjects with a femoral catheter ( n = 41 ; both P < 0.001 ) .


Differences in pain scores at rest and intravenous opioid requirements were minimal , but femoral infusion improved dynamic analgesia ( P = 0.01 to 0.02 ) .


Compared with a continuous femoral nerve block , a continuous adductor canal block did not appreciably decrease the time to overall discharge readiness even though it did decrease the time until adequate mobilization , primarily because both groups experienced similar analgesia and intravenous opioid requirements that -- in most cases -- exceeded the time to mobilization .


To our knowledge , only a few double-blind randomized controlled trials with antipsychotic drugs have been conducted to examine the treatment of methamphetamine-induced psychosis ( MAP ) .


The aims of this study are to compare the antipsychotic and adverse events of quetiapine , an atypical antipsychotic drug , to haloperidol , a standard treatment for primary psychotic disorder , in individuals with MAP .


Eighty individuals with MAP were randomly assigned into two groups , i.e. treatment with quetiapine ( n = 36 ) and haloperidol ( n = 44 ) .


Sixty-eight patients ( 85 % ) completed the study protocol , i.e. treatment with quetiapine at least 100 mg per day or haloperidol at least 2 mg per day orally once a day for 4 weeks .


The doses were increased every 5 days until no psychotic symptom was observed from the Positive and Negative Syndrome Scale ( PANSS ) .


Data were analysed by survival analysis with Cox 's proportional regression analysis , general estimating equations and log-rank tests .


Thirty-two ( 89 % ) subjects from the quetiapine group and 37 subjects ( 84 % ) from the haloperidol group met the remission criteria at the end of the study .


Baseline PANSS total scores of quetiapine and haloperidol groups were 82.4 16.6 and 90.0 18.4 , respectively ( mean SD ; p = 0.06 ) .


The change-from-baseline scores were -47.8 for the quetiapine group and -53.2 for the haloperidol group .


There were no significant differences between the antipsychotic effects ( coefficient value = -2.6 , p = 0.32 , 95 % CI = -7.6 , 2.5 ) and the adverse effects of quetiapine and haloperidol .


Quetiapine may be used as an antipsychotic treatment for MAP with comparable therapeutic effects and adverse events to treatment with classical antipsychotic drugs .


Despite the important role that health professionals have in reducing tobacco use , many have a smoking habit themselves .


The prevalence of smoking is particularly high among nurses .


To test the efficacy , acceptability and feasibility of a motivational interviewing ( MI ) based smoking cessation intervention with nurses .


Two group parallel experimental design with random allocation to groups .


A large teaching hospital in the North of Spain .


Nurses who smoked ( n = 30 ) were randomised into two groups : motivational interviewing based intervention ( n = 15 ) and usual care ( n = 15 ) .


Motivational interviewing based intervention consisted of four individual MI sessions .


Usual care consisted of brief advice .


Variables considered to assess efficacy were biochemically verified smoking cessation , mean cigarettes smoked , stages of change , self-efficacy and depression score .


Variables to assess acceptability and feasibility included participant satisfaction , adherence to MI , and duration of sessions .


Data were collected at : baseline , end of intervention and three months after the end of the intervention .


At three month follow up , compared with the control group , more nurses in the intervention group had quit ( absolute difference 33.3 % ; 95 % confidence interval [ CI ] 2.6-58 .2 ) .


In the nurses who did not quit , there was no significant difference between the intervention and control groups in the number of cigarettes smoked per day , although progress in the stages of change was greater in the intervention group compared to the control group .


Measures of acceptability and feasibility indicated good satisfaction with the intervention , with high levels of attendance and completion .


This study found a beneficial effect of motivational interviewing on nurses ' smoking cessation .


The intervention was acceptable for nurses and a number of aspects were identified that need to be considered prior to conducting a larger scale in order to optimise the intervention .


Using MI might be a novel approach to the problem of health professionals who smoke .


The traditional treatment after closed reduction of distal radius ( DR ) and distal both bone ( DBB ) forearm fractures has been application of a long-arm cast ( LAC ) or a short-arm cast ( SAC ) .


Splinting is another option that avoids the potential complications associated with casting .


The purpose of this study is to evaluate the maintenance of reduction of DR or DBB fractures placed in a double-sugar-tong splint ( DSTS ) compared with a LAC in a pediatric population .


This is an IRB-approved , prospective , randomized trial .


Patients aged 4 to 12 years with DR or DBB fractures treated at a single institution between 2010 and 2012 were enrolled .


After reduction , fractures were placed into either a LAC or a DSTS .


Radiographs were reviewed at initial injury , postreduction , and at set intervals for angulation , displacement , and apposition , as well as cast index and 3-point index .


The DSTS was overwrapped into a cast after week 1 .


The immobilization device was changed to a SAC at week 4 or 6 .


Total duration of immobilization was 6 to 8 weeks .


Seventy-one patients were enrolled with 37 in the LAC and 34 in the DSTS .


Average age was 8.73 years ( range , 4 to 12 ) with 43 being males .


There were 28 isolated DR and 43 DBB fractures .


There were no week-to-week differences between the 2 groups in regards to sagittal alignment , coronal alignment , apposition , or displacement .


Sagittal alignment at immediate postreduction and week 2 showed that the DSTS was slightly better ( average 2.0 vs. 5.0 degrees , respectively , P = 0.04 ) .


For the entire treatment period there was an increased risk of loss of reduction of 10 degrees in the LAC group versus the DSTS group ( 7 patients vs. 2 patients , respectively , P = 0.0001 ) , and of meeting the criteria for remanipulation ( 10 patients vs. 5 patients , respectively , P = 0.01 ) .


At cast removal , there was no difference between groups .


Although there were significant differences between the 2 groups with regards to risk of reduction loss , the DSTS and LAC were comparable in maintenance of reduction at the time of cast removal .


Both the DSTS and LAC are appropriate immobilization devices for these pediatric fractures .


Level II-prospective , comparative study .


Pancreatic ductal adenocarcinoma ( PDAC ) is one of the most common malignant tumours and is still associated with a poor prognosis in advanced disease .


To improve the standard therapy with gemcitabine , we initiated a prospective randomised phase-II trial with gemcitabine ( GEM ) versus gemcitabine plus sunitinib ( SUNGEM ) based on data of in vitro trials and phase-I data for the combination treatment .


The rational of adding sunitinib was its putative antiangiogenic mechanism of action .


A total of 106 eligible patients with locally advanced , unresectable or metastatic PDAC without previous system therapy were randomised to receive GEM at a dosage of 1.000 mg/m ( 2 ) d1 , 8 , 15 q28 versus a combination of SUNGEM at a dosage of GEM 1.000 mg/m ( 2 ) d1 +8 and sunitinib 50mg p.o. d1-14 , q21d .


The primary end-point was progression free survival ( PFS ) , secondary end-points were overall survival ( OS ) , toxicity and overall response rate ( ORR ) .


The confirmatory analysis of PFS was based on the intend-to-treat ( ITT ) population ( N = 106 ) .


The median PFS was 13.3 weeks ( 95 % confidence interval ( 95 % - CI ) : 10.4-18 .1 weeks ) for GEM and 11.6 weeks for SUNGEM ( 95 % - CI : 7.0-18 .0 weeks ; p = 0.78 one-sided log-rank ) .


The ORR was 6.1 % ( 95 % - CI : 0.7-20 .2 % ) for GEM and for 7.1 % ( 95 % - CI : 0.9-23 .5 % ) for SUNGEM ( p = 0.87 ) .


The median time to progression ( TTP ) was 14.0 weeks ( 95 % - CI : 12.4-22 .3 weeks ) for GEM and 18.0 weeks ( 95 % - CI : 11.3-19 .3 weeks ) for SUNGEM ( p = 0.60 ; two-sided log-rank ) .


The median OS was 36.7 weeks ( 95 % - CI : 20.6-49 .0 weeks ) for the GEM arm and 30.4 weeks ( 95 % - CI : 18.1-37 .6 weeks ) for the SUNGEM ( p = 0.78 , one-sided log-rank ) .


In regard to toxicities , suspected SAEs were reported in 53.7 % in the GEM arm and 71.2 % in the SUNGEM arm .


Grade 3 and 4 neutropenia was statistically significantly higher in the SUNGEM arm with 48.1 % versus 27.8 % in the GEM arm ( p = 0.045 , two sided log-rank ) .


The combination SUNGEM was not sufficient superior in locally advanced or metastatic PDAC compared to GEM alone in regard to efficacy but was associated with more toxicity .


DHA is accumulated in the central nervous system ( CNS ) before birth and is involved in early developmental processes , such as neurite outgrowth and gene expression .


To determine whether fetal DHA insufficiency occurs and constrains CNS development in term gestation infants .


A risk reduction model using a randomized prospective study of term gestation single birth healthy infants born to women ( n = 270 ) given a placebo or 400 mg/day DHA from 16 wk gestation to delivery .


Fetal DHA deficiency sufficient to constrain CNS development was assessed based on increased risk that infants in the placebo group would not achieve neurodevelopment scores in the top quartile of all infants in the study .


Infants in the placebo group were at increased risk of lower language development assessed as words understood ( OR 3.22 , CL 1.49-6 .94 , P = 0.002 ) and produced ( OR 2.61 , CL 1.22-5 .58 , P = 0.01 ) at 14 mo , and words understood ( OR 2.77 , CL 1.23-6 .28 , P = 0.03 ) and sentences produced ( OR 2.60 , CL 1.15-5 .89 , P = 0.02 ) at 18 mo using the McArthur Communicative Developmental Inventory ; receptive ( OR 2.23 , CL 1.08-4 .60 , P = 0.02 ) and expressive language ( OR 1.89 , CL 0.94-3 .83 , P = 0.05 ) at 18 mo using the Bayley Scales of Infant Development III ; and visual acuity ( OR 2.69 , CL 1.10-6 .54 , P = 0.03 ) at 2 mo. .


ClinicalTrials.gov NCT00620672 .


Although screening , brief intervention , and referral to treatment ( SBIRT ) has shown promise for alcohol use , relatively little is known about its effectiveness for adult illicit drug use .


This randomized controlled trial assessed the effectiveness of the SBIRT approach for outcomes related to drug use among patients visiting trauma and emergency departments ( EDs ) at two large , urban hospitals .


A total of 700 ED patients who admitted using illegal drugs in the past 30days were recruited , consented , provided baseline measures of substance use and related problems measured with the Addiction Severity Index-Lite ( ASI-Lite ) , and then randomized to the Life Shift SBIRT intervention or to an attention-placebo control group focusing on driving and traffic safety ( Shift Gears ) .


Both groups received a level of motivational intervention matched to their condition and risk level by trained paraprofessional health educators .


Separate measurement technicians conducted face-to-face follow-ups at 6months post-intervention and collected hair samples to confirm reports of abstinence from drug use .


The primary outcome measure of the study was past 30-day drug abstinence at 6months post-intervention , as self-reported on the ASI-Lite .


Of 700 participants , 292 ( 42 % ) completed follow-up .


There were no significant differences in self-reported abstinence ( 12.5 % vs. 12.0 % , p = 0.88 ) for Life Shift and Shift Gears groups , respectively .


When results of hair analyses were applied , the abstinence rate was 7 percent for Life Shift and 2 percent for Shift Gears ( p = .074 ) .


In an analysis in which results were imputed ( n = 694 ) , there was no significant difference in the ASI-Lite drug use composite scores ( Life Shift +0.005 vs. Shift Gears +0.017 , p = 0.12 ) .


In this randomized controlled trial , there was no evidence of effectiveness of SBIRT on the primary drug use outcome .


ClinicalTrials.gov NCT01683227 .


This study aimed to compare the effects of different local anesthetic solutions on postoperative pain of anal surgery in adult patients .


In this randomized double-blind prospective clinical trial , 60 adult patients ( 18 to 60 years old ) with physical status class I and class II that had been brought to a university hospital operating room for fistula anal surgery with spinal anesthesia were selected .


Patients were randomly divided into 4 equal groups according to table of random numbers ( created by Random Allocation Software 1 ) .


Group 1 received 3 mL of normal saline , group 2 , 1 mL of normal saline plus 2 mL of bupivacaine 0.5 % , group 3 , 1 mL of ketamine plus 2 mL of bupivacaine 0.5 % , and group 4 , no infiltration .


Intensity of pain in patients was measured using visual analogue scale ( VAS ) at 0 ( transfer to ward ) , 2 , 6 , 12 , and 24 hours after surgery .


Time interval to administration of drugs and overall dose of drugs were measured in 4 groups .


Mean level of pain was the lowest in group 3 at all occasions with a significant difference , followed by groups 2 , 4 , and lastly 1 ( P < 0.001 ) .


Furthermore , groups 2 and 3 compared to groups 1 and 4 had the least overall dose of analgesics and requested them the latest , with a significant difference ( P < 0.05 ) .