To evaluate the occurrence of reflux from the great saphenous vein by color Doppler ultrasonography in subjects undergoing treatment of insufficiency of the saphenofemoral junction by simple ligation or ligation with section of the saphenous arch .


We performed 60 operations ( in 45 subjects ) of varicose insufficiency of the saphenofemoral junction ( SFJ ) , belonging to the CEAP clinical classification of 2-5 , who were randomly divided into two groups .


A group called C , with ligature and section of the saphenous arch , and a group called L , with simple ligation of the saphenous vein and no sectioning of its arch .


We then investigated the occurrence of reflux from the great saphenous vein in groups C and L through postoperative color Doppler ultrasonography at intervals of six months to one year .


Of the 60 members submitted to the approach of the saphenous arch , 57 were evaluated by postoperative doppler ultrasound , since two subjects ( three limbs ) did not return and were excluded from the study .


The mean age was 54 years , with 93 % females and predominance of CEAP classification 2 in 60.5 % .


Of the 57 operations for the treatment of reflux of the saphenous arch , 43.9 % had reflux postoperatively ,14.1 % in group C and 29.8 % in group L ( p < 0,05 ) .


The relative risk of reflux of the saphenous arch in group L was 2.03 times higher compared with group C.


the section of the arch of the great saphenous vein causes less postoperative reflux than simple ligation in treatment of insufficiency of the great saphenous vein .


To examine the measurement differences in sleep and EEG arousal statistics between the American Academy of Sleep Medicine ( AASM ) recommended EEG montage ( F4-M1 , C4-M1 , O2-M1 ) and acceptable EEG montage ( Fz-Cz , C4-M1 , Oz-Cz ) .


Prospective , blinded , randomized comparison .


Australian clinical sleep laboratory in a tertiary hospital .


50 consecutive patients undertaking polysomnography ( PSG ) for the clinical suspicion of sleep disordered breathing .


N/A .


Patient EEGs were recorded using both the AASM recommended and acceptable EEG montages during the PSG .


Two scorers were used to examine the difference in PSG statistics using the two EEG montages .


The scorers analyzed the 50 studies using the two EEG montages .


Ten of the studies were scored twice for each montage by each scorer to calculate intra-scorer and inter-scorer agreement .


No statistically significant differences were observed between the PSG statistics of the recommended and acceptable EEG montages .


The recommended EEG montage had greater inter-scorer agreement but no difference in intra-scorer agreement .


This study demonstrates that the two EEG montages endorsed by the AASM Manual produce similar sleep and EEG arousal statistics .


It is recommended that treatments that include clarithromycin should be avoided in eradication of Helicobacter pylori ( HP ) in cases where clarithromycin resistance is higher than 20 % .


We aimed to compare levofloxacin - and moxifloxacin-based triple therapies with standard treatment and with each other in eradication of helicobacter pylori as first-line therapy .


Patients were randomized prospectively as three groups .


There were 102 patients in the levofloxacin group , 101 patients in the moxifloxacin group , and 103 patients in the standard treatment group .


The patients received levofloxacin 500 mg daily , amoxicillin 1 g b.i.d. and lansoprazole 30 mg b.i.d. for ten days ( LAL ) in the levofloxacin group ; moxifloxacin 400 mg daily , amoxicillin 1 g b.i.d. and lansoprazole 30 mg b.i.d. ( MAL ) in the moxifloxacin group ; and clarithromycin 500 mg b.i.d. , amoxicillin 1 g b.i.d. and lansoprazole 30 mg b.i.d. ( CAL ) in the standard treatment group .


At post-treatment week 6 , HP was checked by using stool antigen test .


In the eradication of Helicobacter pylori , the success rate as determined by per protocol ( PP ) analysis was 92 % in the LAL group , 91.8 % in the MAL group , and 82.4 % in the CAL group .


A statistically significant difference was found in the LAL and MAL groups compared to the CAL group ( p < 0.05 ) .


There was no difference between the LAL and MAL groups .


It was determined that levofloxacin - and moxifloxacin-based triple therapies were more effective than the standard treatment in first-line setting in the eradication of Helicobacter pylori .


In addition , no difference was found between levofloxacin - and moxifloxacin-based triple therapies .


Currently observed high efficacy may be evaluated in treatment .


Although quinolon resistance is not considered a major problem , it appears to be a factor that may reduce treatment success over a period of time .


Bone tunnel enlargement after anterior cruciate ligament ( ACL ) reconstruction is well documented in the literature .


The cause of this tunnel enlargement is unclear , but is thought to be multifactorial , with mechanical and biological factors playing a role .


The aim of this prospective study was to evaluate how the different techniques may affect the bone tunnel enlargement and clinical outcome .


Forty-five consecutive patients undergoing ACL reconstruction with autologous doubled semitendinosus and gracilis tendons entered this study .


They were randomly assigned to enter group A ( In-Out technique , with cortical fixation and Interference screw ) and group B ( Out-In technique , metal cortical fixation on the femour and tibia ) .


At a mean follow-up of 10 months , all the patients underwent CT scan exam to evaluate the post-operative diameters of both femoral and they underwent tibial tunnels clinical examination after 24 months .


The mean femoral tunnel diameter increased significantly from 9.050.3 mm to 10.012.3 mm in group A and from 9.040.8 mm to 9.31.12 mm in group B.


The mean increase in femoral tunnel diameters observed in group A was significantly higher than that observed in group B ( p < 0.05 ) The mean tibial tunnel diameter increased significantly from 9.030.04 mm to 10.682.5 mm in group A and from 9.040.03 mm to 10.0.78 mm in group B.


The mean increase in tibial tunnel diameters observed in group A was significantly higher than that observed in group B ( p < 0.05 ) .


No clinical differences were found between two groups and no correlations between clinical and radiological results were found in any patients of both groups .


Results of the study suggest that different mechanical fixation devices could influence tunnel widening .


The lower stiffness of the fixation devices is probably responsible of the tunnel widening through the fixation devices 's micromotions in the femoral and tibial tunnels .


Laboratory skills training is now required for general surgery residents .


The optimal method of teaching vascular anastomosis ( VA ) is not well defined .


Teaching VA skills one-on-one with a faculty instructor will result in a more rapid accumulation of skills than teaching in a large group setting .


Residents were shown an instructional video on how to perform a VA using a standardized model ( cadaver saphenous vein and porcine aorta ) .


Each resident then performed a baseline VA. .


Sixteen first - and second-year surgical residents were then randomized to 2 VA teaching sessions that consisted of either 1 ) group teaching ( GT , 8 residents in a room with 1 faculty instructor circulating ) or 2 ) one-on-one teaching ( 1-on-1 , faculty member focused on individual resident ) .


After each of these sessions , residents performed a standardized VA. .


The anastomoses were video recorded .


Performance was evaluated using a standardized scoring system by a separate expert who viewed the video recordings in a blinded fashion .


Outcome measures included total errors , total time , global rating scale , and an anastomosis-specific end-product evaluation ( leak and passage of coronary dilator ) .


Overall , significant decreases in total errors ( 21 to 15 , P = 0.001 ) and time to complete anastomoses ( 42 to 38 min , P = 0.02 ) and an increase in global rating scales ( 7 to 11 , P = 0.003 ) were noted in both groups from baseline after 2 VA teaching session .


The 1-on-1 group demonstrated significantly greater improvement in terms of reduced anastomotic time ( 30 vs. 42 min , P = 0.007 ) and in reduction of errors ( 13 vs. 19 errors , P = 0.09 ) than the GT group .


The high-fidelity VA model is a useful tool for junior general surgery residents .


Both GT and 1-on-1 groups demonstrated significant improvement in total errors and time after only 2 sessions .


Greater improvement was noted using the 1-on-1 model .


Preincisional analgesia is an antinociceptive treatment that prevents altered central excitability from high-intensity noxious stimuli .


To determine the analgesic efficacy of preoperative infiltration with bupivacaine for reduction mammaplasty , a randomized , double-blind , placebo-controlled trial was designed .


Women with mammary hypertrophy were allocated randomly to one of two study groups .


Patients in group I received preincision infiltration with bupivacaine into each breast after general anesthesia .


Group II patients received similar injections of saline injection alone after general anesthesia .


Visual analogue pain score , verbal pain score , and short-form McGill Pain Questionnaire scores were higher in group II patients until 22 hours after surgery ( p < 0.008 ) .


Patients in the saline group had higher intravenous meperidine consumption for 22 hours postoperatively and solicited opioids before the patients in the bupivacaine group ( p < 0.001 ) .


The difference between groups was statistically significant .


Preincisional infiltration with bupivacaine results in reduced pain and lower postoperative opioid requirements in the early postoperative phase of pain following breast reduction .


Therapeutic , I.


This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D 1000 IU daily vs strontium ranelate 2 g daily for correcting vitamin D insufficiency in osteoporosis .


A 6-month international , randomized , double-blind , parallel-group , phase 3 study .


A total of 518 men and postmenopausal women aged 50 years with primary osteoporosis ( T-score -2.5 s.d. ) and serum 25-hydroxyvitamin D ( 25 ( OH ) D ) > 22.5 nmol/l were included .


Patients were allocated to strontium ranelate 2 g/vitamin D 1000 IU daily ( n = 413 ) or strontium ranelate 2 g daily ( n = 105 ) .


The participants received calcium 1 g daily .


The primary endpoint was serum 25 ( OH ) D at last post-baseline evaluation during 3 months .


Both groups were comparable at baseline .


Mean baseline of 25 ( OH ) D was 44.1 14.6 nmol/l .


After 3 months , the percentage of patients with 25 ( OH ) D 50 nmol/l was higher with strontium ranelate/vitamin D vs strontium ranelate ( 84 vs 44 % , P < 0.001 ; adjusted between-group odds ratio = 6.7 ; 95 % CI , 4.2-10 .9 ) .


The efficacy of the fixed-dose combination on 25 ( OH ) D was maintained at 6 months ( 86 vs 40 % , P < 0.001 ) .


Mean 25 ( OH ) D was 65.1 and 49.5 nmol/l , respectively , after 3 months and 66.9 and 45.4 nmol/l after 6 months .


Physical performance improved in both groups .


Falls were 17 and 20 % in the strontium ranelate/vitamin D and strontium ranelate groups respectively .


Parathyroid hormone levels were inversely correlated with 25 ( OH ) D. No clinically relevant differences in safety were observed .


This study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D 1000 IU for correction of vitamin D insufficiency in osteoporotic patients .


CBP501 , a synthetic duodecapeptide , increases cisplatin influx into tumor cells through an interaction with calmodulin enhancing cisplatin cytotoxicity , and effects cell cycle progression by abrogating DNA repair at the G2 checkpoint .


In phase I clinical trials of CBP501 alone or in combination with cisplatin , the most common toxicity was infusion-related urticaria .


Activity of CBP501 plus cisplatin was observed in patients with ovarian cancer and mesothelioma , including some patients previously treated with cisplatin .


Chemotherapy nave patients with unresectable MPM were stratified by histology and performance status , and randomized 2:1 to pemetrexed/cisplatin plus CBP501 25mg/m ( 2 ) IV ( Arm A ) or pemetrexed/cisplatin alone ( Arm B ) .


The primary endpoint was progression free survival ( PFS ) at 4 months .


65 patients were randomized , and 63 were treated .


Patient characteristics in the two arms were balanced .


Based on independent radiology review of the treated population , 25/40 patients ( 63 % ) in Arm A and 9/23 ( 39 % ) in Arm B had PFS4mo ; the median PFS was 5.1 mo ( 95 % CI , 3.9 , 6.5 ) vs 3.4 mo ( 2.5 , 6.7 ) .


Median OS was 13.3 mo ( 9.2 , 16.3 ) in Arm A and 12.8 ( 6.5 , 16.1 ) in Arm B. Adverse events were not different than expected from standard chemotherapy , and comparable in the two arms , aside from infusion reactions which occurred in 70 % of patients treated with CBP501 .


While this randomized phase II trial met its primary endpoint of PFS at 4 months , other parameters such as response rate and overall survival suggest that the addition of CBP501 does not improve the efficacy of standard chemotherapy for MPM .


The home food environment is an important setting for the development of dietary patterns in childhood .


Interventions that support parents to modify the home food environment for their children , however , may also improve parent diet .


The purpose of this study was to assess the impact of a telephone-based intervention targeting the home food environment of preschool children on the fruit and vegetable consumption of parents .


In 2010 , 394 parents of 3-5 year-old children from 30 preschools in the Hunter region of Australia were recruited to this cluster randomised controlled trial and were randomly assigned to an intervention or control group .


Intervention group parents received four weekly 30-minute telephone calls and written resources .


The scripted calls focused on ; fruit and vegetable availability and accessibility , parental role-modelling , and supportive home food routines .


Two items from the Australian National Nutrition Survey were used to assess the average number of serves of fruit and vegetables consumed each day by parents at baseline , and 2 - , 6 - , 12 - , and 18-months later , using generalised estimating equations ( adjusted for baseline values and clustering by preschool ) and an intention-to-treat-approach .


At each follow-up , vegetable consumption among intervention parents significantly exceeded that of controls .


At 2-months the difference was 0.71 serves ( 95 % CI : 0.58-0 .85 , p < 0.0001 ) , and at 18-months the difference was 0.36 serves ( 95 % CI : 0.10-0 .61 , p = 0.0067 ) .


Fruit consumption among intervention parents was found to significantly exceed consumption of control parents at the 2 -,12 - and 18-month follow-up , with the difference at 2-months being 0.26 serves ( 95 % CI : 0.12-0 .40 , p = 0.0003 ) , and 0.26 serves maintained at 18-months , ( 95 % CI : 0.10-0 .43 , p = 0.0015 ) .


A four-contact telephone-based intervention that focuses on changing characteristics of preschoolers ' home food environment can increase parents ' fruit and vegetable consumption .


( ANZCTR12609000820202 ) .


We previously demonstrated that 48 % of patients with pain at sites of previously irradiated bone metastases benefit from reirradiation .


It is unknown whether alleviating pain also improves patient perception of quality of life ( QOL ) .


We used the database of a randomized trial comparing radiation treatment dose fractionation schedules to evaluate whether response , determined using the International Consensus Endpoint ( ICE ) and Brief Pain Inventory pain score ( BPI-PS ) , is associated with patient perception of benefit , as measured using the European Organisation for Resesarch and Treatment of Cancer ( EORTC ) Quality of Life Questionnaire Core 30 ( QLQ-C30 ) and functional interference scale of the BPI ( BPI-FI ) .


Evaluable patients completed baseline and 2-month follow-up assessments .


Among 850 randomly assigned patients , 528 were evaluable for response using the ICE and 605 using the BPI-PS .


Using the ICE , 253 patients experienced a response and 275 did not .


Responding patients had superior scores on all items of the BPI-FI ( ie , general activity , mood , walking ability , normal work , relations with other people , sleep , and enjoyment of life ) and improved QOL , as determined by scores on the EORTC QLQ-C30 scales of physical , role , emotional and social functioning , global QOL , fatigue , pain , and appetite .


Similar results were obtained using the BPI-PS ; observed improvements were typically of lesser magnitude .


Patients responding to reirradiation of painful bone metastases experience superior QOL scores and less functional interference associated with pain .


Patients should be offered re-treatment for painful bone metastases in the hope of reducing pain severity as well as improving QOL and pain interference .


To evaluate wrinkle improvement and safety of a novel cosmetic dissolving microneedle patches loaded with two active compounds with different hydrophilicities , namely ascorbic acid and retinyl retinoate .


Clinical studies were performed on 24 Korean women for 12 weeks .


Patients in group A were treated with retinyl retinoate-loaded dissolving microneedle patches on the left eye crow 's feet area , and patients in group B were treated with ascorbic acidloaded patches on the right eye crow 's feet area twice daily .


Wrinkle improvement was evaluated by skin Visiometer SV 600 .


Both the retinyl retinoate - and ascorbic acid-loaded dissolving microneedle patches demonstrated statistically significant differences in all Visiometer R-values ( P < 0.05 ) .


In particular , highly significant differences were shown at R1 ( skin roughness ) and R5 ( arithmetic average roughness ) ( P < 0.001 ) .


Also , there were no side effects such as allergies or irritant contact dermatitis .


Retinyl retinoate and ascorbic acid were successfully loaded into dissolving microneedles and used to produce novel cosmetic patches .


These novel patches can be used efficiently in cosmetics given their patient usability , safety and effectiveness in wrinkle improvement .


To determine whether fitness-center attendance established with the provision of weekly monetary incentives persisted after the discontinuation , or decreased frequency , of incentives .


One hundred seventeen first-year college students participated during the 2011-2012 academic year .


A randomized controlled trial with control , discontinued-incentive , and continued-incentive conditions was conducted .


During fall semester , students in incentive conditions received weekly monetary payments for meeting fitness-center attendance goals .


During spring semester , discontinued-incentive condition participants no longer received incentives , whereas continued-incentive condition participants received payments on a variable-interval schedule .


ID-card attendance records tracked fitness-center attendance .


Goal completion decreased from 63 % in the incentive groups during the fall semester to 3 % in the discontinued-incentive condition , and 39 % in the continued-incentive condition during the spring semester .


There was not a significant interaction between condition and body mass index change , F ( 6 , 332 ) = 0.67 , p = .68 .


Incentive discontinuation resulted in students no longer meeting fitness-center attendance goals .


A variable-interval reward schedule better maintained attendance .


Statins have a beneficial effect on bone mineral density ( BMD ) and lean mass in some studies of HIV-uninfected adults ; however , this has never been investigated in the setting of HIV infection .


HIV-infected individuals on stable antiretroviral therapy with a low-density lipoprotein cholesterol level of 130 mg/dl or less and evidence of heightened immune activation or inflammation were randomized to rosuvastatin 10 mg daily or placebo for 96 weeks .


This was a prespecified interim analysis at 48 weeks .


Between-group and within-group differences were compared ; multivariable regression models were constructed .


Seventy-two individuals were randomized to statin therapy and 75 to placebo .


Modest 48-week relative increases in trochanter BMD [ 0.9 % ; 95 % confidence interval ( 95 % CI ) -0.9 to 0.6 ] and total hip BMD ( 0.6 % ; 95 % CI 0.0-1 .1 ) in the statin arm were significantly greater than placebo ( P < 0.05 ) .


The relationship between statin use and total hip BMD change was robust to adjustment of age , sex , race and smoking status ( P = 0.02 ) and strengthened by inclusion of baseline ( P = 0.01 ) and week 48 change in soluble tumour necrosis factor - receptor ( sTNFR ) -1 ( P = 0.009 ) .


Relative increases in total body , trunk and limb fat were similar between statin and placebo arms ( P0 .58 ) .


Although a significant gain in leg lean mass was seen in the statin arm , this was not significantly different compared with placebo ( P = 0.36 ) .


The improvements seen in total hip BMD after 48 weeks of rosuvastatin therapy support further potential benefits of statin therapy in HIV , beyond a reduction of cardiovascular risk .


Mobilization-Observation-Behavior-Intensity-Dementia-2 ( MOBID-2 ) pain scale is a staff-administered pain tool for patients with dementia .


This study explores MOBID-2 's test-retest reliability , measurement error and responsiveness to change .


Analyses are based upon data from a cluster randomized trial including 352 patients with advanced dementia from 18 Norwegian nursing homes .


Test-retest reliability between baseline and week 2 ( n = 163 ) , and weeks 2 and 4 ( n = 159 ) was examined in patients not expected to change ( controls ) , using intraclass correlation coefficient ( ICC2 .1 ) , standard error of measurement ( SEM ) and smallest detectable change ( SDC ) .


Responsiveness was examined by testing six priori-formulated hypotheses about the association between change scores on MOBID-2 and other outcome measures .


ICCs of the total MOBID-2 scores were 0.81 ( 0-2 weeks ) and 0.85 ( 2-4 weeks ) .


SEM and SDC were 1.9 and 3.1 ( 0-2 weeks ) and 1.4 and 2.3 ( 2-4 weeks ) , respectively .


Five out of six hypotheses were confirmed : MOBID-2 discriminated ( p < 0.001 ) between change in patients with and without a stepwise protocol for treatment of pain ( SPTP ) .


Moderate association ( r = 0.35 ) was demonstrated with Cohen-Mansfield Agitation Inventory , and no association with Mini-Mental State Examination , Functional Assessment Staging and Activity of Daily Living .


Expected associations between change scores of MOBID-2 and Neuropsychiatric Inventory - Nursing Home version were not confirmed .


The SEM and SDC in connection with the MOBID-2 pain scale indicate that the instrument is responsive to a decrease in pain after a SPTP .


Satisfactory test-retest reliability across test periods was demonstrated .


Change scores 3 on total and subscales are clinically relevant and are beyond measurement error .


To test whether a brief mindfulness meditation training intervention buffers self-reported psychological and neuroendocrine responses to the Trier Social Stress Test ( TSST ) in young adult volunteers .


A second objective evaluates whether pre-existing levels of dispositional mindfulness moderate the effects of brief mindfulness meditation training on stress reactivity .


Sixty-six ( N = 66 ) participants were randomly assigned to either a brief 3-day ( 25-min per day ) mindfulness meditation training or an analytic cognitive training control program .


All participants completed a standardized laboratory social-evaluative stress challenge task ( the TSST ) following the third mindfulness meditation or cognitive training session .


Measures of psychological ( stress perceptions ) and biological ( salivary cortisol , blood pressure ) stress reactivity were collected during the social evaluative stress-challenge session .


Brief mindfulness meditation training reduced self-reported psychological stress reactivity but increased salivary cortisol reactivity to the TSST , relative to the cognitive training comparison program .


Participants who were low in pre-existing levels of dispositional mindfulness and then received mindfulness meditation training had the greatest cortisol reactivity to the TSST .


No significant main or interactive effects were observed for systolic or diastolic blood pressure reactivity to the TSST .


The present study provides an initial indication that brief mindfulness meditation training buffers self-reported psychological stress reactivity , but also increases cortisol reactivity to social evaluative stress .


This pattern may indicate that initially brief mindfulness meditation training fosters greater active coping efforts , resulting in reduced psychological stress appraisals and greater cortisol reactivity during social evaluative stressors .


Palmar-plantar erythrodysesthesia ( PPE ) is a common chemotherapy and anti-VEGF multi-kinase inhibitor class-related toxicity that often results in debilitating skin changes and often limits the use of active anti-cancer regimens .


Mechanistic and anecdotal clinical evidence suggested that topical application of sildenafil cream may help reduce the severity of PPE .


Therefore , we conducted a randomized , double-blind , placebo-controlled pilot study to evaluate the feasibility , safety and efficacy of topical sildenafil cream for the treatment of PPE .


Eligible subjects were required to have grade 1-3 PPE associated with either capecitabine or sunitinib .


Subjects were randomized to receive 1 % topical sildenafil cream to the left extremities or right extremities and placebo cream on the opposite extremity .


Two times per day , 0.5 mL of cream was applied to each affected hand/foot .


The primary endpoint was improvement in PPE grading at any point on study .


Clinical assessments were evaluated by NCI-CTC 4.0 grading and patient self-reported pain .


Ten subjects were enrolled , nine were evaluable for safety and efficacy .


Five of nine subjects reported some improvement in foot pain and three of eight subjects for hand pain improvement .


One of these subjects noted specific improvement in tactile function .


No treatment-related toxicities were observed .


In this limited , single-center study , topical cream containing 1 % sildenafil is feasible to administer , is well-tolerated , and may mitigate PPE-related symptoms due to anti-cancer therapeutic agents .


Further validation is necessary .


We set out to compare emergency medicine residents ' intubating times and success rates for direct laryngoscopy ( DL ) , GlideScope-assisted intubation ( GS ) , and the Supraglottic Airway Laryngopharyngeal Tube ( SALT ) airway with and without biohazard gear .


Each resident passed through 2 sets of 3 testing stations ( DL , GS , SALT ) in succession , intubating Laerdal mannequin heads with the 3 modalities after randomization to start with or without biohazard gear .


Thirty-seven residents participated , and 27 were male ( 73 % ) ; 14 ( 37.8 % ) had prior experience intubating in biohazard suits .


There was a statistically significant difference in those who had prior intubation experience between DL ( 37 , 100 % ) , GS ( 32 , 86.5 % ) , and SALT ( 12 , 32.4 % ) ( P < .001 ) and in median time to intubation ( 48 seconds , no suit ; 57 seconds , with suits ) ( P = .03 ) .


There was no statistically significant difference between the overall times to intubate for the 3 devices .


First-pass success was highest for DL ( 91.2 % , no suit ; 83.7 % , suit ) followed by GS ( 89 % , no suit ; 78.3 % , suit ) and SALT ( 51 % , no suit ; 67.6 % , suit ) .


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


Use of biohazard suits extends time to successful intubation .


There was no difference in time to intubation for the 3 devices , but first-pass success was highest for DL ( with or without biohazard gear ) .


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


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


Randomized trial .


Sixteen North American medical and surgical ICUs .


Four hundred thirty critically ill , mechanically ventilated adults .


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


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


Delirium screening occurred daily ; positive screening was defined as an Intensive Care Delirium Screening Checklist score of 4 or more at any time .


Delirium was diagnosed in 226 of 420 assessed patients ( 53.8 % ) .


Coma was identified in 32.7 % of delirious compared with 22.7 % of nondelirious patients ( p = 0.03 ) .


The median time to onset of delirium was 3.5 days ( interquartile range , 2-7 ) , and the median duration of delirium was 2 days ( interquartile range , 1-4 ) .


Delirious patients were more likely to be male ( 61.1 % vs 46.6 % ; p = 0.005 ) , have a surgical/trauma diagnosis ( 21.2 % vs 11.0 % ; p = 0.030 ) , and history of tobacco ( 31.5 % vs 16.2 % ; p = 0.002 ) or alcohol use ( 34.6 % vs 20.9 % ; p = 0.009 ) .


Patients with positive delirium screening had longer duration of ventilation ( 13 vs 7 d ; p < 0.001 ) , ICU stay ( 12 vs 8 d ; p < 0.0001 ) , and hospital stay ( 24 vs 15 d ; p < 0.0001 ) .


Delirious patients were more likely to be physically restrained ( 86.3 % vs 76.7 % ; p = 0.014 ) and undergo tracheostomy ( 34.6 % vs 15.5 % ; p < 0.0001 ) .


Antecedent factors independently associated with delirium onset were restraint use ( hazard ratio , 1.87 ; 95 % CI , 1.33-2 .63 ; p = 0.0003 ) , antipsychotic administration ( hazard ratio , 1.67 ; 95 % CI , 1.005-2 .767 ; p = 0.047 ) , and midazolam dose ( hazard ratio , 0.998 ; 95 % CI , 0.997-1 .0 ; p = 0.049 ) .


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


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


Physical restraint was most strongly associated with delirium .


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


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


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


In this randomised , parallel-group , comparator-controlled , single-blind phase 3 trial , we assessed the efficacy of a new fluid protocol based on the left ventricular end-diastolic pressure for the prevention of contrast-induced acute kidney injury in patients undergoing cardiac catheterisation .


The primary outcome was the occurrence of contrast-induced acute kidney injury , which was defined as a greater than 25 % or greater than 05 mg/dL increase in serum creatinine concentration .


Between Oct 10 , 2010 , and July 17 , 2012 , 396 patients aged 18 years or older undergoing cardiac catheterisation with an estimated glomerular filtration rate of 60 mL/min per 173 m ( 2 ) or less and one or more of several risk factors ( diabetes mellitus , history of congestive heart failure , hypertension , or age older than 75 years ) were randomly allocated in a 1:1 ratio to left ventricular end-diastolic pressure-guided volume expansion ( n = 196 ) or the control group ( n = 200 ) who received a standard fluid administration protocol .


Four computer-generated concealed randomisation schedules , each with permuted block sizes of 4 , were used for randomisation , and participants were allocated to the next sequential randomisation number by sealed opaque envelopes .


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


Both groups received intravenous 09 % sodium chloride at 3 mL/kg for 1 h before cardiac catheterisation .


Analyses were by intention to treat .


Adverse events were assessed at 30 days and 6 months and all such events were classified by staff who were masked to treatment assignment .


This trial is registered with ClinicalTrials.gov , number NCT01218828 .


Contrast-induced acute kidney injury occurred less frequently in patients in the left ventricular end-diastolic pressure-guided group ( 67 % [ 12/178 ] ) than in the control group ( 163 % [ 28/172 ] ; relative risk 041 , 95 % CI 022-079 ; p = 0005 ) .


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


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


Kaiser Permanente Southern California regional research committee grant .


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


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


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


Sixty patients were randomly divided into two groups ( 30 cases/group ) : group A using the tourniquet throughout the surgical procedure , and group B using the tourniquet starting from the cementation to the completion of the procedure .


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


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


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


The limb circumference at 10 cm above the superior patellar pole or below the inferior patellar pole and the pain score in group B were significantly decreased compared with that in group A at any time point .


Range of motion in group B was significantly increased at three and 5 days postoperatively in comparison to that in group A.


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


Level I ( Therapeutic ) .


NCT02102581 .


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


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


Fifty-five consecutive male obese patients underwent ultrasound evaluation and metabolic and anthropometric parameters determination at baseline and after 3 weeks of a very low-calorie diet ( VLCD ) therapy .


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


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


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


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


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


Antiplatelet drugs are recommended for patients with acute noncardioembolic stroke .


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


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


Altogether 574 patients with acute ( 2days ) large-artery atherosclerosis stroke were randomly assigned to receive either combined clopidogrel and aspirin or aspirin alone .


Platelet aggregation and platelet-leukocyte aggregation studies were performed at days 1 and 30 .


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


Safety endpoints were hemorrhagic episodes and death .


The prevalence of neurologic deterioration and recurrent ischemic stroke were lower in patients in the combination therapy group than in those of the monotherapy group ( 3.52 % versus 9.78 % and 1.76 % versus 6.29 % , respectively ) .


At day 30 of treatment , the platelet aggregations and platelet-leukocyte aggregates were lower in patients who were treated with clopidogrel and aspirin than in patients given aspirin alone ( P < .001 ) .


For patients with acute large-artery atherosclerosis stroke , treatment with clopidogrel and aspirin for 1month provided significantly greater inhibition of platelet activity than aspirin alone .


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


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


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


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


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


A total of 144 patients with cervical radiculopathy will be randomly allocated to either of the two interventions .


The interventions will be delivered by experienced physiotherapists and last 14 weeks .


The primary outcome variable is neck - and arm pain intensity measured with a Visual Analogue Scale accompanied with secondary outcome measures of impairments and subjective health measurements collected before intervention and at 3 , 6 , 12 and 24 months after base-line assessment .


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


ClinicalTrials.gov identifier : NCT01831271 .


This study is a European multicentre , randomised , double-blind , placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer 's disease ( AD ) in a phase III study that will run for a period of 82weeks with a treatment period of 78weeks .


Adult patients , males and females over 50years with mild-to-moderate AD as defined by the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer 's disease and Related Disorders Association ( NINCDS-ADRDA ) criteria , will be included in the study .


It aims to recruit a total of 500 patients with AD ; 250 in the nilvadipine group and 250 in the placebo group .


Participants will be randomised to receive nilvadipine , an 8mg overencapsulated , sustained release capsule , or a matching overencapsulated placebo ( sugar pill ) for a period of 78weeks of treatment .


The primary efficacy outcome measure in this study is the change in cognitive function as assessed by the Alzheimer 's disease Assessment Scale ( ADAS-Cog 12 ) from baseline to the end of treatment duration ( 78weeks ) .


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


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


The study and all subsequent amendments have received ethical approval within each participating country according to national regulations .


Each participant will provide written consent to participate in the study .


All participants will remain anonymised throughout and the results of the study will be published in an international peer-reviewed journal .


EUDRACT Reference Number : 2012-002764-27 .


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


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


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


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


Sixteen patients with chronic unilateral stroke were recruited .


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


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


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


The results for the BBT ( p = 0.013 ) , total scores ( p = 0.031 ) , grasping subscales ( p = 0.036 ) of ARAT , and FIM transfer scores ( p = 0.013 ) presented significantly large effects in favor of the MG+MT group .


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


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


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


Chemokines , such as CXCL1 and CXCL8 , play an important role in neutrophilic inflammation in the lung through the activation of CXCR2 and small molecule antagonists of these receptors have now been developed .


We investigated the effect of AZD8309 , a CXCR2 antagonist , compared with placebo on LPS-induced inflammation measured in sputum of healthy volunteers .


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


AZD8309 ( 300 mg ) or placebo was dosed twice daily orally for 3 days prior to challenge with inhaled LPS and induced sputum was collected 6 h later .


Treatment with AZD8309 showed a mean 77 % reduction in total sputum cells ( p < 0.001 ) and 79 % reduction in sputum neutrophils ( p < 0.05 ) compared with placebo after LPS challenge .


There was also a reduction in neutrophil elastase activity ( p < 0.05 ) and CXCL1 ( p < 0.05 ) and trends for reductions in sputum macrophages ( 47 % ) , leukotriene B4 ( 39 % ) and CXCL8 ( 52 % ) .


AZD8309 inhibited LPS-induced inflammation measured in induced sputum of normal volunteers , indicating that this treatment may be useful in the treatment of neutrophilic diseases of the airways , such as COPD , severe asthma and cystic fibrosis .


NCT00860821 .


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


In this waitlist controlled clinical trial in Western Australia , adolescents ( n = 69 , 71 % female , mean age 14.1 ( SD 1.6 ) years ) and parents completed an 8-week intervention followed by 12 months of telephone and text message support .


Assessments were completed at baseline , before beginning the intervention , immediately following the intervention , and at 3 - , 6 - , and 12 - months follow-up .


The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit , vegetables and junk food assessed by 3-day food records .


During the intensive 8-week intervention sedentary time decreased by -5.1 min/day/month ( 95 % CI : -11.0 , 0.8 ) which was significantly greater than the rate of change during the waitlist period ( p = .014 ) .


Moderate physical activity increased by 1.8 min/day/month ( 95 % CI : -0.04 , 3.6 ) during the intervention period , which was significantly greater than the rate of change during the waitlist period ( p = .041 ) .


Fruit consumption increased during the intervention period ( monthly incidence rate ratio ( IRR ) 1.3 , 95 % CI : 1.10 , 1.56 ) and junk food consumption decreased ( monthly IRR 0.8 , 95 % CI : 0.74 , 0.94 ) and these changes were different to those seen during the waitlist period ( p = .004 and p = .020 respectively ) .


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


Australia and New Zealand Clinical Trials Registry ACTRN12611001187932 .


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


Optimum glycaemic control in patients with type 2 diabetes is important to minimise the risk of microvascular and macrovascular complications and to slow the progression of CKD .


We assessed the efficacy and safety of empagliflozin as an add-on treatment in patients with type 2 diabetes and CKD .


We did a phase 3 , randomised , double-blind , parallel-group , placebo-controlled trial at 127 centres in 15 countries .


Patients with HbA1c of 7 % or greater to 10 % or less were eligible for inclusion .


Patients with stage 2 CKD ( estimated glomerular filtration rate [ eGFR ] 60 to < 90 mL/min per 173 m ( 2 ) ; n = 290 ) were randomly assigned ( 1:1:1 ) to receive empagliflozin 10 mg or 25 mg or placebo once daily for 52 weeks .


Patients with stage 3 CKD ( eGFR 30 to < 60 mL/min per 173 m ( 2 ) ; n = 374 ) were randomly assigned ( 1:1 ) to receive empagliflozin 25 mg or placebo for 52 weeks .


Randomisation was done with a computer-generated random sequence and stratified by renal impairment , HbA1c , and background antidiabetes medication .


Treatment assignment was masked from patients and investigators .


The primary endpoint was change from baseline in HbA1c at week 24 by ANCOVA in the full analysis set .


This study is registered with ClinicalTrials.gov , number NCT01164501 .


In patients with stage 2 CKD , adjusted mean treatment differences versus placebo in changes from baseline in HbA1c at week 24 were -052 % ( 95 % CI -072 to -032 ) for empagliflozin 10 mg and -068 % ( -088 to -049 ) for empagliflozin 25 mg ( both p < 00001 ) .


In patients with stage 3 CKD , adjusted mean treatment difference versus placebo in change from baseline in HbA1c at week 24 was -042 % ( -056 to -028 ) for empagliflozin 25 mg ( p < 00001 ) .


In patients with stage 2 CKD , adverse events were reported over 52 weeks by 83 patients ( 87 % ) on placebo ( 15 severe [ 16 % ] and 11 serious [ 12 % ] ) , 86 ( 88 % ) on empagliflozin 10 mg ( six severe [ 6 % ] and six serious [ 6 % ] ) and 78 ( 80 % ) on empagliflozin 25 mg ( eight severe [ 8 % ] and seven serious [ 7 % ] ) .


In patients with stage 3 CKD , adverse events were reported over 52 weeks by 156 patients ( 83 % ) on placebo ( 15 severe [ 8 % ] and 23 serious [ 12 % ] ) and 156 ( 83 % ) on empagliflozin 25 mg ( 18 severe [ 10 % ] and 22 serious [ 12 % ] ) .


In patients with type 2 diabetes and stage 2 or 3 CKD , empagliflozin reduced HbA1c and was well tolerated .


However , our findings might not be applicable to the general population of patients with type 2 diabetes and renal impairment .


Boehringer Ingelheim , Eli Lilly .


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


RA patients maintaining DAS28-CRP ( Disease Activity Score of 28 joints with C-reactive protein ) scores < 2.6 for 6 months with IFX were randomized either to receive addition of bucillamine ( BUC ) to MTX ( BUC + MTX group ; n = 24 ) or not ( MTX group ; n = 31 ) upon discontinuing IFX .


The primary endpoint was the flare rate within 2 years of IFX discontinuation .


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


Seventeen patients ( 63.0 % ) experienced flares in the MTX group , which was significantly reduced in the BUC + MTX group ( 31.8 % ; p = 0.045 ) .


Further , the flare rates differed significantly between remission and non-remission by a Boolean definition upon IFX discontinuation in the MTX group ( 40.0 % vs. 91.7 % , respectively ; p = 0.014 ) , but they were comparable in the BUC + MTX group .


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


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


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


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


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


Treatments with regular recommended therapeutic doses were administered .


The effects of antihistaminic drugs on mood , daytime sleepiness , dream anxiety , and sleep quality were assessed on the first day and 1 month after .


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


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


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


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


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


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


Daytime sleepiness was significantly predicted by rupadatine and pheniramine treatment .


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


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


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


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


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


Sixty women were treated for 12 weeks with isoflavone vaginal gel 4 % ( 1g/day ) and a placebo gel .


After 4 and 12 weeks , the vaginal atrophy symptoms were classified at none , mild , moderate and severe and the vaginal cytology were taken to determine the maturation value .


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


Microbiopsies in vaginal fornix were performed before the treatment and after 12 weeks of treatment .


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


The vaginal pH in the isoflavone group was 7.1 at baseline and 5.4 after 12 weeks , whereas in the placebo group there was no significant change .


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


The percentage of estrogen receptor positive cells in vaginal epithelium for the Isoflavone Group ranged from 58.5 % at the beginning of treatment to 82.6 % after 12 weeks .


These results were superior to placebo gel .


Glycine max ( L. ) Merr .


at 4 % vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms , maturation values , vaginal pH , morphology and expression of estrogen receptors in vaginal epithelium .


Isoflavones proved good treatment options for relief of vulvovaginal atrophy .


Breastfeeding has several advantages for both mother and child .


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


Dietary intake during the initial complementary feeding period from 5 to 6 months was collected on mother-infant pairs who had unlimited access to lactation consultants along with those mother-infant pairs who received routine care at the well-baby clinics .


The total duration of breastfeeding in each study population was also recorded , and total breastfeeding durations of infants receiving complementary foods from 4 months and those exclusively breastfed for 6 months in each of the two study populations were compared .


Higher proportion of infants of mothers with unlimited access to lactation consultants were fed vegetable and vegetable pures ( p = 0.05 ) and more than one food type ( p = 0.05 ) at 5 months .


Furthermore , a lower percentage of them had three meals per day at 6 months ( p = 0.001 ) compared with those receiving routine care at the well-baby clinics .


Infants exclusively breastfed for 6 months all had similar duration of total breastfeeding .


Mother-infant pairs with unlimited access to lactation consultant had slower introduction of complementary foods at the initial complementary feeding period , according to number of infant 's meals at 6 months of age .


Furthermore , those exclusively breastfed for 6 months had more prolonged breastfeeding compared with mothers who began complementary feeding at 4 months regardless of exposure to lactation consultants .


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


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


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


Adult outpatients with chronic and/or recurrent MDD were randomly assigned in 1:1:1 ratio to 28 weeks of single-blind , placebo-controlled antidepressant treatment with ( 1 ) escitalopram + placebo , ( 2 ) bupropion-sustained-release + escitalopram , or ( 3 ) venlafaxine-extended-release + mirtazapine .


We compared baseline characteristics , tolerability , and treatment outcomes at 12 and 28 weeks for patients with and without pre-treatment insomnia .


Of the 665 evaluable patients , the majority ( 88.3 % ) reported significant pre-treatment insomnia .


Those with pre-treatment insomnia were more likely to be female ( 69.3 % vs. 57.7 % ) and African-American ( 29.1 % vs. 11.8 % ) .


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


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


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


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


Phe508del is the most common CFTR mutation .


We conducted two phase 3 , randomized , double-blind , placebo-controlled studies that were designed to assess the effects of lumacaftor ( VX-809 ) , a CFTR corrector , in combination with ivacaftor ( VX-770 ) , a CFTR potentiator , in patients 12 years of age or older who had cystic fibrosis and were homozygous for the Phe508del CFTR mutation .


In both studies , patients were randomly assigned to receive either lumacaftor ( 600 mg once daily or 400 mg every 12 hours ) in combination with ivacaftor ( 250 mg every 12 hours ) or matched placebo for 24 weeks .


The primary end point was the absolute change from baseline in the percentage of predicted forced expiratory volume in 1 second ( FEV1 ) at week 24 .


A total of 1108 patients underwent randomization and received study drug .


The mean baseline FEV1 was 61 % of the predicted value .


In both studies , there were significant improvements in the primary end point in both lumacaftor-ivacaftor dose groups ; the difference between active treatment and placebo with respect to the mean absolute improvement in the percentage of predicted FEV1 ranged from 2.6 to 4.0 percentage points ( P < 0.001 ) , which corresponded to a mean relative treatment difference of 4.3 to 6.7 % ( P < 0.001 ) .


Pooled analyses showed that the rate of pulmonary exacerbations was 30 to 39 % lower in the lumacaftor-ivacaftor groups than in the placebo group ; the rate of events leading to hospitalization or the use of intravenous antibiotics was lower in the lumacaftor-ivacaftor groups as well .


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


The rate of discontinuation due to an adverse event was 4.2 % among patients who received lumacaftor-ivacaftor versus 1.6 % among those who received placebo .


These data show that lumacaftor in combination with ivacaftor provided a benefit for patients with cystic fibrosis homozygous for the Phe508del CFTR mutation .


( Funded by Vertex Pharmaceuticals and others ; TRAFFIC and TRANSPORT ClinicalTrials.gov numbers , NCT01807923 and NCT01807949 . )


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


This prospective randomised study was conducted in 59 patients who underwent implantation of different targets of monofocal intraocular lens for each eye at Konkuk University Medical Center between November 2009 and August 2012 .


The following were examined before bilateral cataract surgery and 2months after the surgery : refractive error , binocular uncorrected distance visual acuity ( UCDVA ) , uncorrected near visual acuity ( UCNVA ) , best corrected visual acuity ( BCVA ) and stereopsis .


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


The conventional monovision group and the crossed monovision group were composed of 28 and 31 patients , respectively .


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


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


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


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


KCT0001065 .


The efficacy of pharmacotherapy for smoking cessation is well documented .


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


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


We evaluated self-reported and biochemically verified 7-day prevalence smoking abstinence rates at 12 and 26 weeks post-hospitalization .


Patients ( n = 164 ) were randomized into one of three counseling-based treatment groups : NRT for 30 days ( NRT ; n = 41 ) , a 90-min hypnotherapy session ( H ; n = 39 ) , and NRT with hypnotherapy ( HNRT ; n = 37 ) .


Treatment groups were compared to a `` self-quit '' group of 35 patients who refused intervention .


Hypnotherapy patients were more likely than NRT patients to be nonsmokers at 12 weeks ( 43.9 % vs. 28.2 % ; p = 0.14 ) and 26 weeks after hospitalization ( 36.6 % vs. 18.0 % ; p = 0.06 ) .


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


There was no difference in smoking abstinence rates at 26 weeks between `` self quit '' and participants in any of the treatment groups .


In multivariable regression analysis adjusting for diagnosis and demographic characteristics , H and HNRT were over three times more likely than NRT participants to abstain at 26-weeks post-discharge ( RR = 3.6 ; p = 0.03 and RR = 3.2 ; p = 0.04 , respectively ) .


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


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


Thirty-one educators and 4 children from each of their classrooms ( N = 121 ) were randomly assigned to an experimental group ( 21 hr of in-service workshops plus 5 coaching sessions ) and a comparison group ( workshops alone ) .


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


All educators were video-recorded during a 15-min craft/writing activity with a small group of preschoolers at pretest and posttest .


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


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


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


Varenicline , a partial agonist at 42 nicotinic receptors ( nAChRs ) aids smoking cessation by reducing craving .


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


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


A double-blind , placebo-controlled study investigating the effect of varenicline 1 mg ( or matched placebo ) in satiated and abstinent smokers .


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


Smoking enhanced RVIP accuracy and latency to respond .


Varenicline did not alter RVIP performance , nor the effect of smoking , suggesting that these effects were unrelated to 42 nAChRs .


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


Varenicline partially mimicked this effect of smoking but also reduced the smoking-induced increase , indicating a role for 42 nAChRs .


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


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


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


Varenicline improved response speed in both satiated and abstinent smokers .


Some aspects of inhibitory control may be mediated by 42-related mechanisms and blockade of smoking-induced disinhibition may contribute towards the action of varenicline as an aid to smoking cessation .


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


In this prospective , interventional case series , 30 toric , aspheric Bi-Flex T toric IOLs ( Medicontur Medical Engineering Ltd. , Inc. , Zsmbk , Hungary ) were implanted in 20 consecutive patients with topographic corneal astigmatism between 1.50 and 4.00 diopters ( D ) and evaluated within the first year after implantation .


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


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


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


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


At 12 months postoperatively , a reduction of the refractive astigmatism from 1.930.90 D ( range : 0.50 to 4.00 D ) to 0.280.61 D ( range : 0.00 to 1.50 D ) could be found , with patients achieving a mean UDVA of 0.060.16 logMAR ( range : -0.18 to 0.40 logMAR ; Snellen 20/20 ) .


Intraoperative to 12-month postoperative comparison of IOL axis alignment showed low levels of rotation ( 0.22.41 ; range : +4 to -5 ) .


Vector analysis showed target induced astigmatism of 0.60 D @ 180 , surgically induced astigmatism of 0.80 D @ 177 , correction index of 1.020.25 , and a difference vector of 0.30 D @ 82 .


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


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


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


The intervention group accessed RAP-eL over 4 weeks .


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


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


Retention was evaluated in a cohort study 8 weeks after the RCT .


Eighty physiotherapists were randomized into the intervention and 79 into the control groups .


Fifty-six and 48 , respectively , provided baseline data .


Significant between-group differences were observed for change in confidence in knowledge ( mean difference 8.51 ; 95 % confidence interval [ 95 % CI ] 6.29 , 10.73 ; effect size 1.62 ) and skills ( mean difference 7.26 ; 95 % CI 5.1 , 9.4 ; effect size 1.54 ) , with the intervention group performing better .


Satisfaction in ability to manage RA , 4 of the 6 clinical statements , and responses to vignettes demonstrated significant improvement in the intervention group .


Although 8-week scores showed declines in most outcomes , their clinical significance remains uncertain .


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


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


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


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


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


Prior to the main trial , a run-in of up to 12 weeks was permitted to facilitate physiotherapists to become confident in delivering the new service .


Outcomes collected from the run-in and main trial were length of telephone calls within the PhysioDirect service and patients ' physical function ( SF-36v2 questionnaire ) and Measure Yourself Medical Outcome Profile v2 collected at baseline and six months .


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


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


Mean PhysioDirect call times ( minutes ) were higher in the run-in ( 31 ( SD : 12.6 ) ) than in the main trial ( 25 ( SD : 11.6 ) ) .


Each physiotherapist needed to answer 42 ( 95 % CI : 20,56 ) calls for their mean call time to stabilise at 25 minutes per call ; this took a minimum of seven weeks .


For patients ' physical function , PhysioDirect was equally clinically effective as usual care during both the run-in ( 0.17 ( 95 % CI : -0.91,1.24 ) ) and main trial ( -0.01 ( 95 % CI : -0.80,0.79 ) ) .


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


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


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


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


Current Controlled Trials , ISRCTN55666618 .


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


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


We enrolled PPI-nave stented patients treated with standard clopidogrel and aspirin therapy for at least six months ( n = 100 ) .


The patients were randomly assigned to receive either cilostazol at a dose of 100mg twice daily ( CILO group ) or clopidogrel at a dose of 75mg daily ( CLPD group ) in addition to lansoprazole ( 30mg daily ) .


The platelet aggregation ( PA ) determined using light transmittance aggregometry and the platelet reactivity index ( PRI ) obtained using a vasodilator-stimulated phosphoprotein phosphorylation assay were measured before randomization and at the 14-day follow-up visit .


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


At follow-up , the CLPD group showed similar values of PRI as the CILO group ( 66.914.0 % vs. 63.114.1 % ; mean difference : 3.9 % ; 95 % confidence interval of difference : -1.7 % to 9.4 % ; p = 0.174 ) .


However , the 6g/mL collagen - and 0.5 mg/mL arachidonic acid-induced PA values in the CLPD group were higher than those observed in the CILO group ( mean differences : 9.8 % to 11.1 % ; all p values 0.001 ) .


CYP2C19 loss-of-function allele carriage was the major contributing factor associated with the PRI level in the absence of lansoprazole treatment ( with a gene-dose effect ) ; this association was not observed in the subjects receiving lansoprazole co-administration in the CLPD group .


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


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


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


A quasi-experimental design ( n = 91 ) was used to examine arousal status ( self-reported and physiological indices ) and response to manipulated arousal ( i.e. induced psychosocial stress/activation ; reduced activation/relaxation ) between persons who acknowledged prior MHI and persons with no-MHI .


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


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


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


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


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


To investigate the efficacy of various formulations of chlorhexidine 0.2 % ( CHX ) in terms of plaque and gingival bleeding control compared to each other and to saline rinse ( CTRL ) over a 35-day rinsing period .


Seventy subjects were randomly allocated to one of 4 groups rinsing twice daily for 35 days .


The different groups used CHX 0.2 % rinse with alcohol ( CHX1 ) and without alcohol ( CHX2 ) , with an antidiscolouration system ( CHX3 ) or saline rinse ( CTRL ) .


Clinical examinations to evaluate full-mouth plaque scores ( FMPS ) and periodontal parameters were performed at baseline , 7 , 21 and 35 days .


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


At 35 days , CTRL showed the highest levels of plaque .


The mean changes in FMPS from baseline were 69.8 % 6.8 for CHX1 , 57.5 % 9.8 for CHX2 , 43.7 % 9.8 for CHX3 and 25.8 % 7.7 for CTRL .


Statistically significant differences were demonstrated between CHX1 and CHX3 ( p = 0.02 ) , CHX2 vs CHX3 ( p 0.05 ) and CHX1/CHX2 vs CHX3 ( p < 0.05 ) .


In contrast , CHX3 appeared more effective in reducing inflammatory indexes .


TD increased over time in 60 % to 70 % of participants , although lighter staining was found in the CHX3 group .


Greater FMPS reduction was observed in participants with staining vs without staining ( 26.0 % 12.3 , p = 0.04 ) .


Conventional CHX appeared more effective in terms of plaque reduction .


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


Staining was associated with lower plaque levels .


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


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


For this review , data from two randomized , double-blind trials were analyzed in respect to the onset and persistence of effects on several measures of psychopathology ( as measured by the Positive and Negative Syndrome Scale [ PANSS ] ) after treatment with LAI paliperidone palmitate ( PP ) ( NCT00590577 and NCT00589914 ) .


Symptom reductions from baseline with PP were significant by day 4 for all five PANSS factors in both studies .


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


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


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


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


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


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


Thirty one patients with subacromial impingement syndrome were randomly assigned to low-level laser therapy group ( n = 16 ) and ultrasound therapy group ( n = 15 ) .


Study participants received 10 treatment sessions of low-level laser therapy or ultrasound therapy over a period of two-consecutive weeks ( five days per week ) .


Outcome measures ( visual analogue pain scale , Shoulder Pain and Disability Index - SPADI - , patient 's satisfactory level and sleep interference score ) were assessed before treatment and at the 1st and 3rd months after treatment .


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


Mean reduction in VAS pain , SPADI disability and sleep interference scores from baseline to after 1 month , and 3 months of treatment was statistically significant in both groups ( P < 0.05 ) .


However , there was no significant difference in the mean change in VAS pain , SPADI disability and sleep interference scores between the two groups ( P > 0.05 ) .


The mean level of patient satisfaction in group 1 at the first and third months after treatment was 72.45 23.45 mm and 71.50 16.54 mm , respectively .


The mean level of patient satisfaction in group 2 at the first and third months after treatment was 70.38 21.52 mm and 72.09 13.42 mm , respectively .


There was no significant difference in the mean level of patient satisfaction between the two groups ( p > 0.05 ) .


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


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


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


Treatment has been unified in the middle of 1980 in the Czech Republic .


In 2002-2007 children and adolescents with acute lymphoblastic leukemia were treated in an international randomized trial ALL-IC BFM 2002 in the Czech Republic .


291 patients aged 1-18 years were enrolled ; infants below 1 year entered a separate trial .


Patients were stratified into three risk groups according to their age , initial leukocyte count , prednisone response , presence of fusion genes BCR/ABL or MLL/AF4 , bone marrow D +15 and remission status D +33 .


The whole therapy took 24 months .


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


The median follow-up was 8.7 years .


Complete remission was achieved in 97.9 % patients , 1 % died in remission .


11 % of children relapsed , 1.7 % with CNS involvement .


Six children ( 2.1 % ) developed secondary malignancy .


Event free survival ( EFS ) 8 years from diagnosis was 83.5 % , overall survival ( OS ) 91.4 % .


EFS and OS of the risk groups were : standard risk : 89.4 % ; 98.1 % ; intermediate risk : 82.6 % ; 89.6 % ; high risk : 68.8 % ; 78.1 % .


Male sex and age above 10 years were adverse prognostic factors .


In comparison with the previous trial ALL-BFM 95 , significant improvement was achieved .


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


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


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


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


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


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


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


Statistically significant improvement in self-efficacy was noted between treatment ( n = 8 ) and control ( n = 7 ) groups at mid treatment series ( t = 2.32 ; p < 0.02 ) , post treatment series ( t = 1.81 ; p < 0.05 ) and at four week follow up ( t = 2.24 ; p < 0.02 ) .


At the eight week follow up self-efficacy scores had decreased and there was no statistically significant difference between groups ( t = 0.87 ; p < 0.2 ) .


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


The increase in self-efficacy after 4 weeks of treatment suggests that positive response occurs more rapidly that was previously demonstrated .


The improvement in self-efficacy endured 4 weeks after the end of the treatment series , which suggests that massage therapy may have longer term effects on self-efficacy that were not previously noted .


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


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


Since the issuance and enforcement of the new Anti-Drug law in 2008 , the community has become the primary site for drug rehabilitation .


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


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


A total of 848 individuals participated ( response rate 83.7 % ) .


Respondents initially were asked a set of questions about their knowledge about dug dependence , and then were randomly assigned to 1 of 4 vignette conditions .


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


Poor knowledge of drug dependence was common .


Negative attitudes towards drug dependent people were widespread .


Most respondents believed that drug dependence was caused by the person 's own weak will ( 82.0 % ) and own hedonistic lifestyle ( 81.3 % ) , and should be punished as illegal behavior ( 80.4 % ) .


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


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


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


TAS-114 is a first-in-class oral deoxyuridine triphosphatase ( dUTPase ) inhibitor , which acts as a modulator of the pyrimidine nucleotide metabolic pathway .


This was a first-in-human , phase 1 study that investigated the pharmacokinetics ( PK ) and safety of single-agent TAS-114 when it was given at single and multiple doses .


For the single-dose cohort ( n = 25 ) , healthy male volunteers received a single dose of TAS-114 at 6 , 18 , 60 , 150 , and 300 mg .


The magnitude of dihydropyrimidine dehydrogenase ( DPD ) inhibition and the food effect on TAS-114 PK were also investigated .


For the multiple-dose cohort ( n = 10 ) , subjects received TAS-114 for 14 days consecutively .


In the dose-escalating single-dose cohort , the disposition of TAS-114 followed linear kinetics .


The elimination half-life was approximately 2 h.


The urine excretion rate and food effect were minimal .


A significant increase in uracil Cmax was observed at administered doses of 150 mg or higher of TAS-114 , suggesting that significant inhibition of DPD occurred at these doses .


No apparent CYP3A4 auto-induction was observed in the multiple-dose cohort .


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


TAS-114 has shown both a favorable safety and pharmacokinetic profile after single and repeated doses .


TAS-114 was considered to possess a moderate DPD inhibitory effect .


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


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


Twelve schools in New York were randomly assigned to receive the school garden intervention ( n = 6 ) or to the waitlist control group that later received gardens ( n = 6 ) .


PA was measured by self-report survey ( Girls Health Enrichment Multi-site Study Activity Questionnaire ) ( N = 227 ) and accelerometry ( N = 124 , 8 schools ) at baseline ( Fall 2011 ) and follow-up ( Spring 2012 , Fall 2012 , Spring 2013 ) .


Direct observation ( N = 117 , 4 schools ) was employed to compare indoor ( classroom ) and outdoor ( garden ) PA. .


Analysis was by general linear mixed models .


Survey data indicate garden intervention children 's reports of usual sedentary activity decreased from pre-garden baseline to post-garden more than the control group children 's ( = -.19 , p = .001 ) .


Accelerometry data reveal that during the school day , children in the garden intervention showed a greater increase in percent of time spent in moderate and moderate-to-vigorous PA from baseline to follow-up than the control group children ( = +.58 , p = .010 ; = +1.0 , p = .044 ) .


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


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


clinicaltrials.gov # NCT02148315 .


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


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


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


The primary outcome was all-cause mortality at 1 year .


Among 657 patients enrolled in PARTNER who underwent treatment , there were 275 patients with diabetes ( 145transcatheter , 130 surgical ) .


There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality ( p = 0.048 ) .


Among diabetic patients , all-cause mortality at 1 year was 18.0 % in the transcatheter group and 27.4 % in the surgical group ( hazard ratio : 0.60 [ 95 % confidence interval : 0.36 to 0.99 ] ; p = 0.04 ) .


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


In contrast , among nondiabetic patients , there was no significant difference in all-cause mortality at 1 year ( p = 0.48 ) .


Among diabetic patients , the 1-year rates of stroke were similar between treatment groups ( 3.5 % transcatheter vs. 3.5 % surgery ; p = 0.88 ) , but the rate of renal failure requiring dialysis > 30 days was lower in the transcatheter group ( 0 % vs. 6.1 % ; p = 0.003 ) .


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


( The PARTNER Trial : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .


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


Minimal evidence is available for determining optimal exposure time .


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


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


Fourteen male professional first team super league rugby players were exposed to 1 , 2 , and 3 minutes of WBC at -135 C. Testing took place the day after a competitive league fixture , each exposure separated by seven days .


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


Significant reductions ( p < 0.05 ) in deoxyhaemoglobin for gastrocnemius and vastus lateralis were found .


In vastus lateralis significant reductions ( p < 0.05 ) in oxyhaemoglobin and tissue oxygenation index ( p < 0.05 ) were demonstrated .


Significant reductions ( p < 0.05 ) in skin temperature were recorded .


No significant changes were recorded in core temperature .


Significant reductions ( p < 0.05 ) in thermal sensation and comfort were recorded .


Three brief exposures to WBC separated by 1 week are not sufficient to induce physiological changes in IL-6 or core temperature .


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


We conclude that a 2 minute WBC exposure was the optimum exposure length at temperatures of -135 C and could be applied as the basis for future studies .


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


A total of 40 patients were equally and randomly assigned to elective VFN excision using suspension laryngoscopy under intubation with propofol and remifentanil alone ( Group A ) or with supplementary cisatracurium ( Group B ) .


Intubation time was significantly longer in Group A than in Group B ( 300.0 30.0 s vs. 265.2 38.7 s , P = 0.003 ) .


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


Both groups showed favorable cardiopulmonary safety profiles .


Post-anesthesia recovery was significantly more rapid in Group A than in Group B , in terms of times to spontaneous breathing return ( 7.2 1.4 min vs. 10.9 1.6 min , P < 0.001 ) , consciousness return ( 7.4 1.5 min vs. 12.3 1.8 min , P < 0.001 ) , removal of tracheal intubation ( 8.1 1.5 min vs. 13.2 1.7 min , P < 0.001 ) and operating room discharge ( 12.7 1.4 min vs. 22.1 1.3 min , P < 0.001 ) .


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


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


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


Using Department of Veteran Affairs ( VA ) administrative data from October 2001 to September 2007 , we examined a cohort of patients 65 years old and older , who were hospitalized with pneumonia , in 150 VA acute care hospitals .


The cohort was randomly split into derivation and validation samples , and then logistic regression models were used to identify and validate predictors of all-cause rehospitalization within 30 days .


Of the 45,134 subjects , 13 % were rehospitalized within 30 days .


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


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


The C statistics for the derivation and validation models were 0.615 and 0.613 , respectively .


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


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


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


Thirteen persons with PPH were recruited and studied on 2 randomized days ( control , intervention ) .


On both study days , participants ingested 200 mL of water containing 50 g glucose , followed by ambulatory BP and HR monitoring 6 minutely for 60 minutes , then 15 minutely until 120 minutes .


On the intervention day , participants walked at their usual pace for 30 m every 30 minutes for 120 minutes .


On the control day , significant falls in systolic blood pressure ( SBP ) ( P < .005 ) and diastolic blood pressure ( DBP ) ( P = .016 ) were demonstrated between t = 0-120 minutes .


On the intervention day , over the same period , there was no significant fall in SBP ( P = .520 ) , however , DBP still fell significantly ( P = .045 ) .


There was a statistically significant difference ( P = .005 ) for the area under the curve for the change in SBP from baseline for the study days but not DBP ( P = .716 ) .


There was no significant change in HR ( control : P = .854 ; intervention , P = .168 ) nor between the area under the curve ( P = .798 ) for the change in HR from baseline for the study days .


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


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


We assessed whether catheter instillation of 200 U onabotulinumtoxinA formulated with liposomes is safe and effective for the treatment of overactive bladder .


This 2-center , double-blind , randomized , placebo controlled study enrolled patients with overactive bladder inadequately managed with antimuscarinics .


Patients were assigned to intravesical instillation of lipo-botulinum toxin ( 31 ) or normal saline ( 31 ) .


The primary end point was the mean change inmicturition events per 3 days at 4 weeks after treatment .


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


At 4 weeks after treatment lipo-botulinum toxin instillation was associated with a statistically significant decrease in micturition events per 3 days ( -4.64 for lipo-botulinum toxin vs -0.19 for placebo , p = 0.0252 ) .


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


However , lipo-botulinum toxin instillation was associated with a statistically significant decrease in urgency severity scores compared to placebo ( p = 0.0181 ) .


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


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


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


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


Postoperative analgesia is important in patients undergoing open abdominal surgery .


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