For this study , 263 young people with depressive symptoms were randomized to the Web-based SFBT intervention , PratenOnline , or to a waiting list control condition .


The chat treatment was delivered by trained professionals .


Groups were compared on depressive complaints as measured by the Center for Epidemiologic Studies Depression Scale ( CES-D ) after 9 weeks and 4.5 months .


For the chat group only , changes in depressive symptoms at 7.5 months after baseline were explored .


The experimental SFBT condition ( n = 131 ) showed significantly greater improvement than the waiting list condition ( n = 132 ) in depressive symptoms at 9 weeks and 4.5 months on the CES-D , with a small between group effect size at 9 weeks ( d = 0.18 , 95 % CI -0.10 to 0.47 ) and a large effect size at 4.5 months ( d = 0.79 , 95 % CI 0.45-1 .08 ) .


The percentage of participants showing a reliable and clinically significant change in depression was significantly larger for the SFBT intervention at 4.5 months only ( 28.2 % vs 11.4 % for the waiting list , P < .001 , number needed to treat = 6 ) .


At 7.5 months , the SFBT group showed further improvements .


However , results have to be considered carefully because of high attrition rates .


The Web-based SFBT chat intervention of PratenOnline was more effective than a waiting list control group in reducing depressive symptoms , and effects were larger at follow-up then at post-treatment .


More studies are needed to find out if outcomes will be replicated , especially for those younger than 18 year old .


Netherlands Trial Register : NTR 1696 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1696 ( Archived by WebCite at http://www.webcitation.org/6DspeYWrJ ) .


We investigated predictors for acute and persisting periprocedural ischemic brain lesions among patients with symptomatic carotid stenosis randomized to stenting or endarterectomy in the International Carotid Stenting Study .


We assessed acute lesions on diffusion-weighted imaging 1 to 3 days after treatment in 124 stenting and 107 endarterectomy patients and lesions persisting on fluid-attenuated inversion recovery after 1 month in 86 and 75 patients , respectively .


Stenting patients had more acute ( relative risk , 8.8 ; 95 % confidence interval , 4.4-17 .5 ; P < 0.001 ) and persisting lesions ( relative risk , 4.2 ; 95 % confidence interval , 1.6-11 .1 ; P = 0.005 ) than endarterectomy patients .


Acute lesion count was associated with age ( by trend ) , male sex , and stroke as the qualifying event in stenting ; high systolic blood pressure in endarterectomy ; and white matter disease in both groups .


The rate of conversion from acute to persisting lesions was lower in the stenting group ( relative risk , 0.4 ; 95 % confidence interval , 0.2-0 .8 ; P = 0.007 ) , and was only predicted by acute lesion volume .


Stenting caused more acute and persisting ischemic brain lesions than endarterectomy .


However , the rate of conversion from acute to persisting lesions was lower in the stenting group , most likely attributable to lower acute lesion volumes .


Clinical Trial Registration - URL : www.isrctn.org .


Unique identifier : ISRCTN25337470 .


Compare efficacy of 0.5 % proparacaine eye drops and oral 25 % dextrose in reducing pain during screening for retinopathy of prematurity ( ROP ) .


Double-blinded randomized controlled trial .


Twenty eligible babies were randomized .


Group I received 0.5 % proparacaine eye drops at first ROP screening , while Group II received 25 % dextrose orally .


At second examination , babies received no intervention .


Pain was assessed using Premature Infant Pain Profile ( PIPP ) score .


The mean ( SD ) PIPP during procedure in Group I were 15.5 2.06 and 14 2.4 at first and second screening ( p = 0.259 ) .


The mean ( SD ) PIPP in Group II were 14.2 1.8 and 14.9 2.5 at the first and second screening ( p = 0.428 ) .


Differences were not statistically significant .


The PIPP scores of Group I and Group II at the first screening were also not significantly different ( p = 0.165 ) .


ROP screening causes moderate to severe pain and neither proparacaine nor dextrose is an effective analgesic .


High expression of human equilibrative nucleoside transporter 1 ( hENT1 ) is considered to predict survival in patients treated with adjuvant gemcitabine for pancreatic cancer .


A standard evaluation system for immunohistochemical analysis ( antibody , scoring system ) has not yet been established .


CONKO-001 , a prospective randomised phase III study investigated the role of adjuvant gemcitabine ( gem ) as compared to observation ( obs ) .


Tumour samples of 156 patients were analysed by immunohistochemistry with the rabbit monoclonal antibody SP120 ( Ventana Medical Systems ) for expression of hENT1 .


Kaplan-Meier analyses for median disease-free survival ( DFS ) and overall survival ( OS ) were performed in dependence of hENT1 expression measured analogously to Farrell et al. 2009 and Poplin et al. 2013 .


For the 88 gem and 68 obs patients , median DFS/OS was 12.9 / 22.7 months and 6.2 / 19.1 months .


High hENT1 expression was not associated with improved median DFS ( Farrell : no hENT1 22.2 months , low hENT1 13.7 months , high hENT1 12.1 months , p = 0.248 ; Poplin : low hENT1 13.2 months versus high hENT1 11.5 months , p = 0.5 ) or median OS ( Farrell : no hENT1 21.7 months , low hENT1 24.7 months , high hENT1 19.5 , p = 0.571 ; Poplin : low hENT1 24.4 months versus high hENT1 19.7 months , p = 0.92 ;) in the gem group or in the obs group ( median DFS Farrell : no hENT1 5.1 months , low hENT1 6.2 months , high hENT1 7.5 months , p = 0.375 ; Poplin : low hENT1 6.2 months versus high hENT1 5.9 months , p = 0.83 ; median OS Farrell : no hENT1 20.2 months , low hENT1 17.7 months , high HENT1 19.1 months , p = 0.738 ; Poplin : low hENT1 17.7 months versus high hENT1 20.4 months , p = 0.65 ) measured by the Farrell or Poplin Score .


We can not confirm a predictive role of hENT1 measured by the clone SP120 rabbit antibody in our study population .


Reproducible standard procedures are urgently needed prior to the implementation or exclusion of hENT1 as a predictive biomarker in the treatment of pancreatic cancer .


ISRCTN34802808 .


Hand eczema is a common disease , and continuous preventive skin protection and skin care must be adopted to prevent a chronic course .


Hand eczema is not a uniform disease , and counselling must therefore be individually tailored .


To evaluate the effectiveness of a nurse-led counselling programme , the Healthy Skin Clinic , emphasizing the patient 's self-management , resources , and risks .


Patients ( n = 306 ) referred for diagnostic work-up and treatment of hand eczema were randomized and allocated either to the programme or to usual care .


The primary outcome was clinical disease severity at follow-up .


Secondary outcomes were quality of life , burden of disease , skin protective behaviours , and self-reported medication adherence .


Patients in the intervention group had greater reductions in clinical severity and reported more beneficial behavioural changes at follow-up than those in the usual-care group .


This was especially true of patients who were treated solely with topical corticosteroids and who had a primarily exogenous aetiology of hand eczema .


However , the effect was very dependent on baseline disease severity .


No differences in quality of life or burden of disease were found between the two groups .


A tailored nurse-led programme of skin protection counselling may be recommended as an essential part of hand eczema treatment .


Melasma is a commonly acquired hyperpigmentation symmetrically distributed on the face , neck , and arms .


The skin-lightening properties of Rumex occidentalis make it a therapeutic alternative to the reference standard treatment of hydroquinone ( HQ ) .


This study was conducted to evaluate the safety and efficacy of 3 % R.occidentalis cream versus 4 % HQ cream in the management of epidermal and mixed melasma .


This was a randomized , double-blind , placebo-controlled trial .


Forty-five subjects with epidermal and mixed melasma were recruited to compare 3 % R.occidentalis cream , 4 % HQ cream , and placebo cream applied twice daily for eightweeks .


Changes in pigmentation were measured every twoweeks using the Melasma Area Severity Index ( MASI ) and a mexameter .


Adverse events were noted on every visit .


Patient and investigator global evaluations were performed at the end of the study .


Overall mean MASI and mexameter readings in the three groups decreased from baseline to week 8 .


The greatest decline in score from weeks 2 to 6 was achieved by the HQ group , followed by the R.occidentalis group .


By week 8 , the R.occidentalis group showed a greater meanstandard deviation decline in MASI and mexameter readings from baseline ( MASI : 0.600.86 ; mexameter : 50.5625.63 ) than the HQ group ( MASI : 0.550.62 ; mexameter : 45.8947.83 ) .


The efficacy of R.occidentalis cream and HQ cream were assessed as similarly favorable by both study subjects and investigators .


Rumex occidentalis 3 % cream is a safe and effective skin-lightening agent for melasma and is comparable in efficacy with 4 % HQ cream .


Previous randomised trial data have demonstrated that male circumcision reduces Mycoplasma genitalium prevalence in men .


We assessed whether male circumcision also reduces M genitalium infection in female partners of circumcised men .


HIV-negative men were enrolled and randomised to either male circumcision or control .


Female partners of male trial participants from the intervention ( n = 437 ) and control ( n = 394 ) arms provided interview information and self-collected vaginal swabs that were tested for M genitalium by APTIMA transcription-mediated amplification-based assay .


Prevalence risk ratios ( PRR ) and 95 % CI of M genitalium prevalence in intervention versus control group were estimated using Poisson regression .


Analysis was by intention-to-treat .


An as-treated analysis was conducted to account for study-group crossovers .


Male and female partner enrolment sociodemographic characteristics , sexual behaviours , and symptoms of sexually transmitted infections were similar between study arms .


Female M genitalium prevalence at year 2 was 3.2 % ( 14/437 ) in the intervention arm and 3.6 % ( 14/394 ) in the control arm ( PRR = 0.90 , 95 % CI 0.43 to 1.89 , p = 0.78 ) .


In an as-treated analysis , the prevalence of M genitalium was 3.4 % in female partners of circumcised men and 3.3 % in female partners of uncircumcised men ( PRR = 1.01 , 95 % CI 0.48 to 2.12 , p = 0.97 ) .


Contrary to findings in men , male circumcision did not affect M genitalium infection in female partners .


There is a paucity of evidence documenting the pathogenicity of Dientamoeba fragilis , an intestinal protozoan common in children .


As case reports on successful treatment are numerous , many authors advocate treatment , despite no placebo-controlled trials being available .


Metronidazole is often used for treatment , though eradication rates are relatively low ( 60 % -80 % ) .


In the present study we determined the clinical and microbiological efficacy of metronidazole in Danish children .


In this parallel placebo-controlled double-blinded trial , children aged 3-12 years with > 4 weeks of gastrointestinal symptoms were allocated using block randomization in a 1:1 ratio to a 10-day course of oral metronidazole or placebo .


Primary outcome was change in level of gastrointestinal symptoms , measured on a visual-analog-scale ( VAS ) , and secondary outcome was eradication of D. fragilis infection .


Participants , caregivers , investigators , and sponsor were all blinded to group assignment .


The trial was registered with clinicaltrials.gov ( NCT01314976 ) prior to start .


Of 96 participants , 48 were allocated to the metronidazole and placebo group each .


Mean VAS change from pre - to post-treatment did not differ significantly ( P = .8 ) between the metronidazole ( -1.8 CI , [ -2.5 , -1.1 ] ) and the placebo group ( -1.6 CI , [ -2.3 , -.9 ] ) .


Eradication of D. fragilis was significantly greater in the metronidazole group , although it declined rapidly from 62.5 % 2 weeks after end of treatment to 24.9 % 8 weeks after end of treatment .


These findings do not provide evidence to support routine metronidazole treatment of D. fragilis positive children with chronic gastrointestinal symptoms .


Study funded by Statens Serum Institut .


Trial was registered with clinicaltrials.gov ( NCT01314976 ) .


To examine the efficacy and safety of intramuscular botulinum toxin A ( BoNT-A ) to reduce spasticity and improve comfort and ease of care in nonambulant children with cerebral palsy ( CP ) .


Nonambulant children with CP ( n = 41 ; Gross Motor Function Classification System level IV = 3 , level V = 38 ; mean age 7.1 years , range 2.3-16 years , 66 % male ) were randomly allocated to receive either intramuscular BoNT-A injections ( n = 23 ) or sham procedure ( n = 18 ) combined with therapy .


The analysis used generalized estimating equations with primary outcome the Canadian Occupational Performance Measure ( COPM ) at 4 weeks postintervention and retention of effects at 16 weeks .


Adverse events ( AE ) were collected at 2 , 4 , and 16 weeks by a physician masked to group allocation .


There were significant between group differences favoring the BoNT-A-treated group on COPM performance at 4 weeks ( estimated mean difference 2.2 , 95 % CI 0.8 , 3.5 ; P = .002 ) and for COPM satisfaction ( estimated mean difference 2.2 , 95 % CI 0.5 , 3.9 ; P = .01 ) .


These effects were retained at 16 weeks for COPM satisfaction ( estimated mean difference 1.8 , 95 % CI 0.1 , 3.5 ; P = .04 ) .


There were more mild AE at 4 weeks for the BoNT-A group ( P = .002 ) , however , there were no significant between-group differences in the reporting of moderate and serious AE .


In a double-blind randomized sham-controlled trial , intramuscular BoNT-A and therapy were effective for improving ease of care and comfort for nonambulant children with CP .


There was no increase in moderate and severe AE in the children who had BoNT-A injections compared with the sham group .


To examine whether adding either small , variable financial incentives or optional group sessions improves weight losses in a community-based , Internet behavioral program .


Participants ( N = 268 ) from Shape Up Rhode Island 2012 , a 3-month Web-based community wellness initiative , were randomized to : Shape Up + Internet behavioral program ( SI ) , Shape Up + Internet program + incentives ( SII ) , or Shape Up + Internet program + group sessions ( SIG ) .


At the end of the 3-month program , SII achieved significantly greater weight losses than SI ( SII : 6.4 % [ 5.1-7 .7 ] ; SI : 4.2 % [ 3.0-5 .6 ] ; P = 0.03 ) ; weight losses in SIG were not significantly different from the other two conditions ( SIG : 5.8 % [ 4.5-7 .1 ] , P 's 0.10 ) .


However , at the 12-month no-treatment follow-up visit , both SII and SIG had greater weight losses than SI ( SII : 3.1 % [ 1.8-4 .4 ] ; SIG : 4.5 % [ 3.2-5 .8 ] ; SI : 1.2 % [ -0.1 -2.6 ] ; P 's 0.05 ) .


SII was the most cost-effective approach at both 3 ( SII : $ 34/kg ; SI : $ 34/kg ; SIG : $ 87/kg ) and 12 months ( SII : $ 64/kg ; SI : $ 140/kg ; SIG : $ 113/kg ) .


Modest financial incentives enhance weight losses during a community campaign , and both incentives and optional group meetings improved overall weight loss outcomes during the follow-up period .


However , the use of the financial incentives is the most cost-effective approach .


Sensory and/or motor nerve function impairment as a consequence of neuropathy is often assessed using electroneurophysiological tests .


However , in low-resource countries where the required equipment is rarely available , manual muscle strength testing ( MMST ) and monofilament testing ( MFT ) offer very reliable alternatives .


In six leprosy programmes in four Asian countries , a multi-centre randomised clinical trial ( RCT ) was carried out to assess the effect of corticosteroids on neuropathy in leprosy-affected people .


The sensory and motor nerve function was tested using MMST and MFT , including new test sites for the sural and radial cutaneous nerves ( MFT ) and the posterior tibial and common peroneal nerves ( MMST ) .


The reliability studies of the MMST and MFT tests of the TENLEP ( Treatment of Early Neuropathy in LEProsy ) trials are presented here .


Two assessors in each centre independently used the MFT and MMST in 30 leprosy-affected people .


Reliability is good to very good for MFT in nearly all nerves .


MMST also shows good to very good agreement , with a few exceptions .


Our study confirms that MMST and MFT can be performed reliably , and that the new tests also have acceptable reliability .


To compare the efficacy of slow-release oral morphine ( SROM ) and methadone as maintenance medication for opioid dependence in patients previously treated with methadone .


Prospective , multiple-dose , open label , randomized , non-inferiority , cross-over study over two 11-week periods .


Methadone treatment was switched to SROM with flexible dosing and vice versa according to period and sequence of treatment .


Fourteen out-patient addiction treatment centres in Switzerland and Germany .


Adults with opioid dependence in methadone maintenance programmes ( dose 50mg/day ) for 26 weeks .


The efficacy end-point was the proportion of heroin-positive urine samples per patient and period of treatment .


Each week , two urine samples were collected , randomly selected and analysed for 6-monoacetyl-morphine and 6-acetylcodeine .


Non-inferiority was concluded if the two-sided 95 % confidence interval ( CI ) in the difference of proportions of positive urine samples was below the predefined boundary of 10 % .


One hundred and fifty-seven patients fulfilled criteria to form the per protocol population .


The proportion of heroin-positive urine samples under SROM treatment ( 0.20 ) was non-inferior to the proportion under methadone treatment ( 0.15 ) ( least-squares mean difference 0.05 ; 95 % CI = 0.02 , 0.08 ; P > 0.01 ) .


The 95 % CI fell within the 10 % non-inferiority margin , confirming the non-inferiority of SROM to methadone .


A dose-dependent effect was shown for SROM ( i.e. decreasing proportions of heroin-positive urine samples with increasing SROM doses ) .


Retention in treatment showed no significant differences between treatments ( period 1/period 2 : SROM : 88.7 % / 82.1 % , methadone : 91.1 % / 88.0 % ; period 1 : P = 0.50 , period 2 : P = 0.19 ) .


Overall , safety outcomes were similar between the two groups .


Slow-release oral morphine appears to be at least as effective as methadone in treating people with opioid use disorder .


The interrelationship between the well-being of injecting drug users ( IDUs ) and their family environment has been widely documented .


However , few intervention programs have addressed the needs of both IDUs and their family members .


This study describes a randomized intervention pilot targeting 83 IDUs and 83 of their family members from four communes in Ph Th province , Vietnam .


The IDUs and family members in the intervention condition received multiple group sessions , with the intent to improve psychological well-being and family relationships .


The intervention outcomes ( depressive symptoms and family relations ) were evaluated at baseline , 3-month and 6-month follow-up assessments .


Depressive symptoms and family relations reported by IDUs were found to be correlated to those reported by their family members .


Overall , significant intervention effects on depressive symptoms and family relations were observed for both IDUs and family members .


A similar improvement pattern in family relations emerged for both the IDU and family member samples , although the intervention effect of reducing depressive symptoms was more sustainable for family members at the 6-month assessment when compared to the IDU sample .


The intervention pilot addressed challenges faced by IDUs and their family members and revealed correlated outcomes for the two groups .


Findings suggest a vital need to include family members in future drug prevention and harm reduction intervention efforts .


Postoperative cognitive dysfunction ( POCD ) is well established in adults but has been underinvestigated in children .


As day-case procedures are increasingly common , it is important to establish whether children suffer significant POCD .


Pediatric POCD has been associated with several intravenous and inhalation anesthetics , but isoflurane has not been studied .


As evidence indicates superior recovery after propofol , the study compared POCD after propofol or isoflurane anesthesia .


To compare the effects of propofol versus isoflurane upon children 's POCD .


Fifty-eight children aged 5-14 years were randomized to propofol ( total intravenous anesthesia ) or isoflurane for day-case dental procedures .


Reaction time ( RT ) , verbal and visual memory , psychomotor coordination , and attention were assessed preoperatively , prior to discharge and at 24 h.


Reaction time and psychomotor control were impaired postoperatively in both groups but recovered at 24 h. Delayed verbal recall was significantly impaired only after propofol .


Both groups had significant impairment of visual memory postoperatively and at 24 h , and of recognition memory postoperatively only .


Propofol and isoflurane exert similar adverse effects on RT , psychomotor coordination , and visual memory .


Selective impairment of verbal recall by propofol is consistent with adult evidence of the drug 's effect on retrieval .


The enduring postoperative impairment of memory has implications for instructions to parents and caregivers for the safety and well-being of children in the 24 h after day-case anesthesia with propofol and isoflurane .


Little is known about the impact of an oncological treatment on muscle mass and strength in patients with lung cancer and the impact of a subsequent rehabilitation program .


This study investigates the effect of radical treatment and post-treatment pulmonary rehabilitation on muscle mass and strength in patients with lung cancer and the relationship between muscle mass and strength .


Lung cancer patients , candidate for radical treatment , were randomly ( 2:1 ) allocated after radical treatment to either standard follow up ( CON ) or a 12-week rehabilitation training program ( RT ) .


Muscle mass was estimated by bioelectric impedance and CT-scan .


Muscle strength was estimated by measuring quadriceps force ( QF ) with a hand held dynamometer .


All variables were measured before ( M1 ) and after radical treatment ( M2 ) , and at the earliest 12 weeks after randomization ( M3 ) .


Data are presented as means with standard deviation .


45 lung cancer patients ( age : 65 years ( 9 ) ) participated in the study .


At M2 , both muscle cross sectional area ( MCSA ) and QF were significantly decreased ( p < 0.05 ) .


28 patients were randomized .


13/18 RT and 9/10 CON patients ended the trial .


At M3 , RT-patients improved significantly their MCSA compared to CON-patients ( MCSA : 6 cm ( 2 ) ( 6 ) ( p = 0.003 ) vs. 1cm ( 2 ) ( 11 ) ( p = 0.8 ) ) .


Muscle mass and strength : ( 1 ) are decreased at presentation in a substantial part of lung cancer patients ; ( 2 ) are significantly negatively affected by radical treatment and ( 3 ) completely recover after a 12 week structured rehabilitation program , whereas a further decline was observed in CON-patients .


Negative affective states such as anxiety , depression and stress are significant risk factors for cardiovascular disease , particularly in cardiac and post-cardiac rehabilitation populations.Yoga is a balanced practice of physical exercise , breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function .


It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardiac rehabilitation in further reducing cardiac risk factors as well as improving self-efficacy and post-cardiac rehabilitation adherence to healthy lifestyle behaviours .


This is a parallel arm , multi-centre , randomised controlled trial that will assess the outcomes of post - phase 2 cardiac rehabilitation patients assigned to a yoga intervention in comparison to a no-treatment wait-list control group .


Participants randomised to the yoga group will engage in a 12 week yoga program comprising of two group based sessions and one self-administered home session each week .


Group based sessions will be led by an experienced yoga instructor .


This will involve teaching beginner students a hatha yoga sequence that incorporates asana ( poses and postures ) , pranayama ( breathing control ) and meditation .


The primary outcomes of this study are negative affective states of anxiety , depression and stress assessed using the Depression Anxiety Stress Scale .


Secondary outcomes include measures of quality of life , and cardiovascular and cognitive function .


The cardiovascular outcomes will include blood pressure , heart rate , heart rate variability , pulse wave velocity , carotid intima media thickness measurements , lipid/glucose profiles and C-reactive protein assays .


Assessments will be conducted prior to ( week 0 ) , mid-way through ( week 6 ) and following the intervention period ( week 12 ) as well as at a four week follow-up ( week 16 ) .


This study will determine the effect of yoga practice on negative affective states , cardiovascular and cognitive function in post-phase 2 cardiac rehabilitation patients .


The findings may provide evidence to incorporate yoga into standardised cardiac rehabilitation programs as a practical adjunct to improve the management of psychosocial symptoms associated with cardiovascular events in addition to improving patients ' cognitive and cardiovascular functions .


ACTRN12612000358842 .


The US FDA and the EMA have approved seven agents for the treatment of renal cell carcinoma , primarily based on differences in progression-free survival ( PFS ) .


Because PFS is an arbitrary endpoint we hypothesized that an analysis would demonstrate the growth rate of tumors remained constant at the time of RECIST-defined disease progression .


We previously estimated the growth ( g ) and regression ( d ) rates and the stability of g using data from the Phase III trial comparing sunitinib and interferon .


Sufficient data were available and rate constants statistically valid in 321 of 374 patients randomized to sunitinib .


Median d was 00052 days ( -1 ) ; in 53 patients no tumor growth was recorded .


Median g was 000082 days ( -1 ) and was stable for a median of 275 days on therapy , remaining stable beyond 300 , 600 and 900 days in 122 , 65 and 27 patients , respectively .


A possible increase in g while receiving sunitinib could be discerned in only 18 of 321 patients .


Given a median g of 000082 days ( -1 ) the estimated median time to a second progression were sunitinib continued past RECIST-defined progression was 7.3 months .


At 100 , 200 , and 300 days after starting therapy , an estimated 47 % , 27 % , and 13 % of tumor remains sunitinib sensitive and could explain a RECIST-defined response to a new TKI .


Prolonged stability of g with sunitinib suggests continued sunitinib beyond RECIST-defined progression may provide a beneficial outcome .


Randomized trials in patients whose disease has `` progressed '' on sunitinib are needed to test this hypothesis .


The effectiveness of chest compressions for cardiopulmonary resuscitation ( CPR ) is affected by the rescuer 's position with respect to the patient .


In hospitals , chest compressions are typically performed while standing beside the patient , who is placed on a bed .


To compare the effectiveness of chest compressions , performed on a bed during 2 min of CPR , among three different rescuer positions : standing , on a footstool , or kneeling on the bed .


We performed a crossover randomized simulation trial .


Participants were recruited from among students in the Department of Paramedics from July to August 2011 .


Thirty-eight participants were enrolled , and they performed chest compressions on a mannequin for 2 min in each of the three different positions , with a 1-week interval between each position .


The number of adequate compressions ( depth > 50 mm ) and the mean compression depth were significantly greater in the kneeling and footstool positions than in the standing position , but there was no significant difference between the kneeling and footstool positions .


There were no significant differences in the compression rate , the percentage of correctly released compressions , and the percentage of compressions performed using the correct hand position among the three rescuer positions .


The mean compression depth and the number of adequate compressions were greater for both the kneeling and footstool positions than for the standing position during 2 min of CPR .


We recommend kneeling on a bed or standing on a footstool as the rescuer positions during hospital CPR on a bed .


Plant sterols ( PSs ) lower LDL cholesterol , an established risk factor for coronary artery disease ( CAD ) .


No direct evidence is available supporting a reduced risk of CAD for foods with added PSs .


Endothelial dysfunction is seen as an early indicator of atherosclerotic damage .


This study was primarily designed to investigate the effect of a low-fat spread with added PSs on brachial artery endothelial function as measured by flow-mediated dilation ( FMD ) .


Second , effects on arterial stiffness , blood pressure , serum lipids , and plasma PS concentrations were investigated .


We hypothesized that PSs would not worsen FMD but would rather modestly improve FMD .


This study had a double-blind , randomized , placebo-controlled , parallel design .


After a 4-wk run-in period , 240 hypercholesterolemic but otherwise healthy men and women consumed 20 g/d of low-fat spread without ( control ) or with added PSs ( 3 g/d ) during 12 wk .


Pre - and postintervention , vascular function measurements and blood sampling were performed .


In total , 232 participants completed the study period .


For the primary endpoint FMD , 199 participants were included in the statistical analysis .


PS intake did not affect FMD ( +0.01 percentage points ; 95 % CI : -0.73 , 0.75 ) compared with control .


Measures of arterial stiffness ( pulse wave velocity and augmentation index ) and blood pressure were also not significantly changed compared with control .


After PS intervention , LDL cholesterol significantly decreased on average by 0.26 mmol/L ( 95 % CI : -0.40 , -0.12 ) or 6.7 % compared with control .


Plasma sitosterol and campesterol concentrations significantly increased in the PS group up to on average 11.5 mol/L and 13.9 mol/L ( expressed as geometric means ) , respectively .


The intake of a low-fat spread with added PSs neither improved nor worsened FMD or other vascular function markers in hypercholesterolemic men and women .


As expected , serum LDL cholesterol decreased , whereas plasma PSs increased after PS intake .


This study was registered at clinicaltrials.gov as NCT01803178 .


In two 6-month , double-blind , placebo-controlled studies , rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD .


This post hoc analysis of the long-term open-label extensions ( NCT00594165 ; NCT00599196 ) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine , with or without concomitant levodopa , for up to 6 years .


Open-label rotigotine was titrated to optimal dose ( 16mg/24h ) .


Concomitant levodopa was permitted .


Dyskinesia data , recorded using the Unified Parkinson 's Disease Rating Scale Part IV , were pooled from the two open-label studies .


Of 596 participants who received open-label rotigotine , 299 ( 50 % ) remained at trial closure ; no patient discontinued due to dyskinesia .


In the two studies , median exposure to rotigotine was 1910 days ( 5 years , 3 months ) , and 1564.5 days ( 4 years , 3 months ) .


During up to 6 years of open-label rotigotine , 423/596 ( 71 % ) received levodopa .


Dyskinesias were reported in 115/596 ( 19 % ) participants , 90/115 ( 78 % ) of who developed dyskinesia after levodopa was added ; 25 reported dyskinesia in the absence of levodopa ( includes patients who never received open-label levodopa , and those who reported dyskinesia before starting concomitant levodopa ) .


Dyskinesia severity data were available for 107 of the 115 participants .


In 56/107 ( 52 % ) participants , dyskinesia was considered ` not disabling ' for all occurrences ; the worst-case severity was ` mildly disabling ' for 33/107 ( 31 % ) , and ` moderately ' or ` severely disabling ' for 18/107 ( 17 % ; 3 % of total participants ) .


During treatment with rotigotine in patients with PD for up to 6 years the incidence of dyskinesia was low , and the dyskinesia was generally ` not disabling ' or ` mildly disabling ' .


The aim of the study was to investigate how tailored exercise is experienced by cancer survivors .


Twenty-five breast cancer survivors who were recently treated with systemic adjuvant treatments attended tailored exercise classes as a part of a randomized controlled exercise intervention study ( Breast Cancer and Exercise , BREX ) .


Focus group discussions with a median of four ( range 3-6 ) participants in each group were conducted to capture their individual experiences of their course of illness , taking part in the exercise trial , the personal meaning of tailored exercise classes and the group .


Attending the intervention in which the focus of attention was on physical rehabilitation was highly valued , since the participants experienced both improved physical fitness and improved coping .


Due to altered physical appearance and poor physical fitness , the participants felt that tailored exercise for patients with breast cancer reduced their barrier to start exercising .


Peer support from the group was valued , especially that of sharing experiences , receiving psychological support and gaining a sense of normality .


A sense of mastery over their disease through participating in the intervention , i.e. better psychological functioning and improved mood , was a consequence of better physical fitness and of meeting other breast cancer survivors .


Also participating in the study per se increases a sense of comfort and security with extra medical examinations and follow-up .


Participating in the tailored exercise group for breast cancer survivors helped patients gain a sense of mastery , restoring their self-esteem and constructing a meaning for their cancer experience and its impact on their lives .


We wanted to assess if sertraline treatment ( versus placebo ) or remission of depression at 12 weeks ( versus nonremission ) in Alzheimer patients is associated with improved caregiver well being .


We conducted a randomized , double-blind , placebo-controlled clinical trial of the efficacy and safety of sertraline for the treatment of depression in individuals with Alzheimer disease in five clinical research sites across the United States .


Participants were caregivers of patients enrolled in the Depression in Alzheimer 's Disease Study 2 ( N = 131 ) .


All caregivers received standardized psychosocial support throughout the study .


Caregiver outcome measures included depression ( Beck Depression Inventory ) , distress ( Neuropsychiatric Inventory ) , burden ( Zarit Burden Interview ) , and quality of life ( Medical Outcomes Study Short Form Health Survey ) .


Fifty-nine percent of caregivers were spouses , 63.4 % were women , and 64.1 % were white .


Caregivers of patients in both treatment groups had significant reductions in distress scores over the 24-week study period , but there was not a greater benefit for caregivers of patients taking sertraline .


However , caregivers of patients whose depression was in remission at week 12 had greater declines in distress scores over the 24 weeks than caregivers of patients whose depression did not remit by week12 .


Patient treatment with sertraline was not associated with significantly greater reductions in caregiver distress than placebo treatment .


Distress but not level of depression or burden lessened for all caregivers regardless of remission status and even more so for those who cared for patients whose depression remitted .


Results imply an interrelationship between caregiver distress and patient psychiatric outcomes .


Through experiment on animals and clinical trials to explore the safety and efficacy of hypoglycemic anti-deafness capsules on diabetic patients with deafness .


Total 296 patients with non-insulin dependent diabetes mellitus ( NIDDM ) were randomly divided into two groups .


A treatment group of 164 patients ( 208 ears ) was treated with hypoglycemic anti-deafness capsules based on TCM syndrome differentiation .


A control group of 132 patients ( 184 ears ) was treated with glibenclamide and conventional drug treatment for deafness .


The following were observed : hearing , fasting plasma glucose ( FPG ) , 2 h postprandial plasma glucose ( 2hPG ) , 24 h urine glucose ( 24hUG ) , improvement of main symptoms , platelet function , and changes in superoxide dismutase ( SOD ) and lipid peroxide ( LPO ) levels .


In animal studies , Kunming mice , weighing 18-22 g were used .


Half of the mice were males and half were females .


Wistar rats , weighing 80-120 g were used .


Half of the rats were males and half were females .


Male Wistar rats , weighing 200-220 g , were also used .


Their acute and chronic toxicity was studied .


The hearing improvement was 56.7 % in the treatment group and 26.6 % in the control group .


FPG , 2hPG , and 24hUG were improved significantly ( P < 0.05 , P < 0.01 , P < 0.01 , respectively ) in the treatment group and 2hPG and 24hUG improved significantly in the control group ( P < 0.05 , P < 0.05 ) .


The improvement in 2hPG and 24hUG in the treatment group was significantly greater than that in the control group P < 0.01 ) .


There was no significant difference in FPG between the two groups ( P < 0.05 ) .


Main symptoms in the treatment group were significantly more improved than those in the control group ( P < 0.05 , P < 0.01 ) .


In the treatment group , platelet adhesion and aggregation , SOD , and LPO were all significantly improved from before treatment ( P < 0.05 , P < 0.01 ) .


However , in the control group , except LOP ( P < 0.05 ) , there were no significant differences from before treatment to after ( P < 0.05 ) .


In animal studies , no obvious acute or long-term toxicity was observed from capsule administration .


Through experiment on animals and clinical trials , we can found that hypoglycemic anti-deafness capsules could decrease blood glucose and serum triglycerides of alloxan-induced diabetic rats .


This herbal capsule is effective for safely treating diabetic patients with deafness .


The primary objectives of this study were to evaluate the effect of food on the oral bioavailability and to evaluate the effect of diurnal variation on the pharmacokinetics of linifanib , a novel tyrosine kinase ( TK ) inhibitor selective for vascular endothelial growth factor ( VEGF ) and platelet-derived growth factor ( PDGF ) receptors , in patients with advanced solid tumors .


Adverse events were monitored .


This was a phase 1 , open-label , randomized , crossover study .


Thirty-four patients received dosing regimens to evaluate linifanib pharmacokinetic parameters under fasting and non-fasting conditions and with morning or evening dosing .


Adverse events ( AEs ) were assessed according to National Cancer Institute Common Terminology Criteria for AEs ( Version 3.0 ) .


The administration with food had a negligible effect on the AUC of linifanib , but the Cmax of linifanib was decreased by 40 % compared to the fasting condition .


Evening dosing after a 2-h fast had a negligible effect on AUC ; however , the dose-normalized Cmax of linifanib after evening dosing was 64 % of that after morning dosing following a 10-h fast .


Common Grade 3/4 AEs were fatigue ( 24 % ) , hypertension ( 21 % ) , and palmar-plantar erythrodysaesthesia syndrome ( 15 % ) .


Dosing with food or in the evening has a significant effect on the oral bioavailability of linifanib that should be taken into consideration when designing future clinical studies .


The pattern of adverse advents reported in this study is similar to that seen in other studies of linifanib and other agents in the VEGF/PDGF TK receptor inhibitor class .


To evaluate the efficacy and safety of sarilumab in combination with methotrexate ( MTX ) for the treatment of rheumatoid arthritis ( RA ) .


Adults with moderate-to-severe RA and an inadequate response to MTX were randomized ( 1:1:1 ) to receive sarilumab ( doses of 150 mg or 200 mg ) or placebo every 2 weeks in conjunction with weekly MTX for 52 weeks .


Co-primary end points were the proportion of patients achieving American College of Rheumatology 20 % ( ACR20 ) improvement responses at week 24 , change from baseline in the Health Assessment Questionnaire ( HAQ ) disability index ( DI ) at week 16 , and change from baseline in the modified Sharp/van der Heijde score ( SHS ) of radiographic damage at week 52 .


Baseline characteristics were similar among the groups .


For all 3 co-primary end points , the sarilumab 150 mg and 200 mg groups demonstrated statistically significant improvements as compared with the placebo group ( ACR20 response rate at week 24 , 58.0 % , 66.4 % , and 33.4 % , respectively [ P < 0.0001 ] ; least squares mean change in HAQ DI at week 16 , -0.53 , -0.55 , and -0.29 , respectively [ P < 0.0001 ] ; and mean change in SHS at week 52 , 0.90 , 0.25 , and 2.78 , respectively [ P < 0.0001 ] ) .


The most common treatment-emergent adverse event was infection .


In the sarilumab 150 mg , sarilumab 200 mg , and placebo groups , the incidence of serious infections was 2.6 % , 4.0 % , and 2.3 % , respectively .


Elevations in alanine aminotransferase levels > 3-fold the upper limit of normal occurred in 9.5 % , 8.0 % , and 2.1 % of patients , respectively ; in 24 patients , this led to discontinuation of treatment .


Elevated total cholesterol levels were observed in 36.8 % , 43.0 % , and 18.3 % of patients , respectively .


In patients receiving 150 mg and 200 mg sarilumab , neutrophil counts of 0.5 to < 1.0 10 ( 9 ) / liter were observed in 5.1 % and 7.8 % of patients , respectively , while neutrophil counts of < 0.5 10 ( 9 ) / liter were observed in 0.9 % and 0.7 % of patients , respectively ; none of the patients receiving placebo experienced changes in neutrophil counts .


In RA patients treated with sarilumab ( 150 mg or 200 mg every 2 weeks ) in combination with MTX , both doses provided sustained clinical efficacy , as shown by significant improvements in symptomatic , functional , and radiographic outcomes .


Sarilumab was generally well tolerated .


The adverse events observed in this study were consistent with the effects of interleukin-6 signaling blockade .


To evaluate long-term cure rates and late complication rates after treatment for female stress urinary incontinence ( SUI ) with transobturator tape ( TOT ) procedure and to compare the outcomes of 1st year versus 5th year .


We analyzed 138 women who underwent TOT procedure for pure SUI and mixed urinary incontinence in two institutions during the time period of June 2005-May 2008 retrospectively .


We used two kinds of polypropylene monofilament tapes ( Heine Medizinurethral support system , Germany and I-STOPCL Medical , France ) for the standard outside-in TOT in similar numbers .


All patients were evaluated with pelvic examination including cough stress test and International Consultation on Incontinence Questionnaire-Short Form at 3 and 12 months and annually .


Our primary outcome measures were rates of objective cure , subjective cure , patient satisfaction and failure for long-term follow-up .


The objective cure , subjective cure and patient satisfaction rates of the 126 women at 1 year were 89.6 , 86.5 and 92 % respectively .


During 5-year follow-up , objective cure rate was stable with 87.3 % rate ( p = 0.554 ) , whereas subjective cure and patient satisfaction rates were decreased to 65.9 and 73 % , respectively ( p = 0.001 ) .


Complications are reported according to the Clavien-Dindo classification with Gr I 14.3 % , Gr II 64.3 % , Gr IIIa 7.1 % and Gr IIIb 14.3 % .


TOT procedure is an effective minimal invasive procedure with satisfactory results for female SUI in short term .


Although recovery in SUI symptoms was stable during 5-year follow-up , subjective cure and patient satisfaction rates decreased significantly due to urge urinary incontinence symptoms .


The infiltration of local anaesthetic ( LA ) , ketorolac , and epinephrine has been suggested to be effective for analgesia after total hip arthroplasty ( THA ) .


The part of action of each component of the mixture remains unclear .


We investigated the contribution of infiltration of ropivacaine alone on the morphine consumption during the first 24 h after surgery .


Sixty patients undergoing primary THA were included in this prospective randomized double-blinded placebo-controlled trial , after IRB approval and informed consent .


Surgical and general anaesthetic management were standardized .


At the end of surgery , 80 ml of ropivacaine 0.2 % ( 160 mg ) or saline was infiltrated .


The primary endpoint was morphine consumption 24 h after surgery .


The secondary endpoints were : visual analogue scale scores and opioid side-effects at H2 , H4 , H8 , H12 , H24 , D1 , D2 , D3 , D4 , D5 , rehabilitation programme progress , chronic pain level , analgesic consumption , and surgical result at 3 months and 1 yr after surgery .


The observation period was 1 yr .


Groups were similar for patient characteristic and perioperative characteristics .


The ropivacaine wound infiltration did not reduce morphine consumption at 24 h [ median ( 25th and 75th inter-quartile ) 27 ( 17-37 ) mg in the ropivacaine group vs 24 ( 18-34 ) mg in the placebo group , P = 0.51 ] or its side-effects .


No effect was found on rehabilitation progress or chronic pain after 3 months or 1 yr , but these were not the main endpoints of the study .


Ropivacaine infiltration alone did not reduce morphine consumption at 24 h after operation nor did it improve postoperative rehabilitation .


We assessed the associations of serum , red blood cell membranes ( RBCM ) and dietary long-chain n-3 polyunsaturated fatty acids ( LC-PUFAs ) with neovascular age-related macular degeneration ( AMD ) .


We included 290 patients of the Nutritional AMD Treatment 2 Study ( NAT2 ) with neovascular AMD in one eye and early AMD lesions in the other eye , and 144 normal vision controls without AMD .


Dietary intake of seafood was estimated by food frequency questionnaire .


Eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) composition in serum and RBCM were determined by gas chromatography from 12-hour fasting blood samples and was expressed as percentages of total fatty acids profile .


Logistic regressions estimated associations of neovascular AMD with dietary intake of seafood and circulating n-3 LC-PUFAs .


Dietary oily fish and seafood intake were significantly lower in AMD patients than in controls .


After adjustment for all potential confounders ( age , sex , CFH Y402H , ARMS2 A69S , and ApoE4 polymorphisms , plasma triglycerides , hypertension , hypercholesterolemia , and family history of AMD ) , serum EPA was associated significantly with a lower risk for neovascular AMD ( odds ratio [ OR ] = 0.41 ; 95 % confidence interval [ CI ] , 0.22-0 .77 ; P = 0.005 ) .


Analysis of RBCM revealed that EPA and EPA+DHA were associated significantly with a lower risk for neovascular AMD ( OR = 0.25 ; 95 % CI , 0.13-0 .47 ; P < 0.0001 and OR = 0.52 ; 95 % CI , 0.29-0 .94 ; P = 0.03 , respectively ) .


The RBCM EPA and EPA+DHA , as long-term biomarkers of n-3 dietary PUFA status , were associated strongly with neovascular AMD and may represent an objective marker identifying subjects at high risk for neovascular AMD , who may most benefit from nutritional interventions .


( http://www.controlled-trials.com/isrctn number , ISRCTN98246501 ) .


Rates of varicella have decreased substantially in countries implementing routine varicella vaccination .


Immunisation is possible with monovalent varicella vaccine or a combined measles-mumps-rubella-varicella vaccine ( MMRV ) .


We assessed protection against varicella in naive children administered one dose of varicella vaccine or two doses of MMRV .


This study was done in ten European countries with endemic varicella .


Healthy children aged 12-22 months were randomised ( 3:3:1 ratio , by computer-generated randomisation list , with block size seven ) to receive 42 days apart ( 1 ) two doses of MMRV ( MMRV group ) , or ( 2 ) MMR at dose one and monovalent varicella vaccine at dose two ( MMR+V group ) , or ( 3 ) two doses of MMR ( MMR group ; control ) .


Participants and their parents or guardians , individuals involved in assessment of any outcome , and sponsor staff involved in review or analysis of data were masked to treatment assignment .


The primary efficacy endpoint was occurrence of confirmed varicella ( by detection of varicella zoster virus DNA or epidemiological link ) from 42 days after the second vaccine dose to the end of the first phase of the trial .


Cases were graded for severity .


Efficacy analyses were per protocol .


Safety analyses included all participants who received at least one vaccine dose .


This trial is registered with ClinicalTrials.gov , number NCT00226499 .


Between Sept 1 , 2005 , and May 10 , 2006 , 5803 children ( mean age 142 months , SD 25 ) were vaccinated .


In the efficacy cohort of 5285 children , the mean duration of follow-up in the MMRV group was 36 months ( SD 88 ) , in the MMR+V group was 36 months ( 85 ) and in the MMR group was 35 months ( 89 ) .


Varicella cases were confirmed for 37 participants in the MMRV group ( two moderate to severe ) , 243 in the MMR+V group , and 201 in the MMR group .


Second cases occurred for three participants ( all in the MMR+V group ) .


Varicella cases were moderate to severe for two participants in the MMRV group , 37 in the MMR+V group ( one being a second case that followed a mild first case ) ; and 117 in the MMR group .


Efficacy of two-dose MMRV against all varicella was 949 % ( 975 % CI 924-966 ) , and against moderate to severe varicella was 995 % ( 975-999 ) .


Efficacy of one-dose varicella vaccine against all varicella was 654 % ( 572-721 ) , and against moderate to severe varicella ( post hoc ) was 907 % ( 859-939 ) .


The most common adverse event in all groups was injection-site redness ( up to 25 % of participants ) .


Within 15 days after dose one , 574 % ( 95 % CI 539-609 ) of participants in the MMRV group reported fever of 38C or more , by contrast with 445 % ( 410-481 ) with MMR+V , and 398 % ( 338-461 ) with MMR .


Eight serious adverse events were deemed related to vaccination ( three MMRV , four MMR+V , one MMR ) .


All resolved within the study period .


These results support the implementation of two-dose varicella vaccination on a short course , to ensure optimum protection from all forms of varicella disease .


GlaxoSmithKline Vaccines .


For older adults with type 2 diabetes ( T2DM ) , declines in balance and walking ability are risk factors for falls , and peripheral neuropathy magnifies this risk .


Exercise training may improve balance , gait and reduce the risk of falling .


This study investigated the effects of 12weeks of aerobic exercise training on walking , balance , reaction time and falls risk metrics in older T2DM individuals with/without peripheral neuropathy .


Adults with T2DM , 21 without ( DM ; age 58.71.7 years ) and 16 with neuropathy ( DM-PN ; age 58.91.9 years ) , engaged in either moderate or intense supervised exercise training thrice-weekly for 12weeks .


Pre/post-training assessments included falls risk ( using the physiological profile assessment ) , standing balance , walking ability and hand/foot simple reaction time .


Pre-training , the DM-PN group had higher falls risk , slower ( hand ) reaction times ( 232 vs. 219ms ) , walked at a slower speed ( 108 vs. 113cm/s ) with shorter strides compared to the DM group .


Following training , improvements in hand/foot reaction times and faster walking speed were seen for both groups .


While falls risk was not significantly reduced , the observed changes in gait , reaction time and balance metrics suggest that aerobic exercise of varying intensities is beneficial for improving dynamic postural control in older T2DM adults with/without neuropathy .


The objective of this study was to compare acellular dermal matrix graft ( ADM ) combination with coronally advanced flap ( CAF ) on complete defect coverage , aesthetics and patient satisfaction with CAF alone for multiple recessions with gingival thickness ( GT ) < 0.8 mm .


Forty-eight Miller Class I multiple recessions 3 mm were divided into test ( CAF + ADM ) and control ( CAF ) groups .


At baseline and 12 months , recession height ( RH ) , keratinized tissue height ( KT ) , GT , mean and complete defect coverage were evaluated .


Patient satisfaction , root coverage aesthetic score ( RES ) and the correlation between GT and defect coverage were also assessed .


Baseline RH in CAF + ADM and CAF groups was 3.25 0.34 mm and 3.21 0.26 mm , respectively .


Mean and complete defect coverage were 94.84 % and 83.33 % in test group , 74.99 % and 50.00 % in control group , respectively .


Inter-group differences were found to be statistically significant for RH reduction , attachment gain , KT and GT increase , mean defect coverage and RES in favour of test group ( p < 0.05 ) .


There was a significant positive correlation between GT and mean defect coverage ( p < 0.05 ) .


Coronally advanced flap in association with ADM can be proposed as a valid approach for the treatment of multiple recessions with thin tissue biotype .


The US Food and Drug Administration has said that oral preparations containing benzocaine should only be used in infants under strict medical supervision , due to the rare , but potentially fatal , risk of methemoglobinemia .


This study aimed to determine the analgesic effect of topical application of benzocaine prior to lingual frenotomy in infants with symptomatic tongue-tie .


We hypothesised that the duration of crying immediately following frenotomy with topical benzocaine would be shorter than with no benzocaine .


This randomised controlled study compared the length of crying after lingual frenotomy in term infants who did , or did not , receive topical application of benzocaine to the lingual frenulum prior to the procedure .


We recruited 21 infants to this study .


Crying time was less than one minute in all of the subjects .


The average length of crying in the benzocaine group ( 21.6 13.6 sec ) was longer than the length of crying in the control group ( 13.1 4.0 sec ) , p = 0.103 .


Contrary to our hypothesis , infants who were treated with topical benzocaine did not benefit from topical analgesia in terms of crying time .


The use of benzocaine for analgesia prior to lingual frenotomy in term infants should therefore be discouraged .


Computer-based decision support systems are a promising method for incorporating research evidence into clinical practice .


However , evidence is still scant on how such information technology solutions work in primary healthcare when support is provided across many health problems .


In Finland , we designed a trial where a set of evidence-based , patient-specific reminders was introduced into the local Electronic Patient Record ( EPR ) system .


The aim was to measure the effects of such reminders on patient care .


The hypothesis was that the total number of triggered reminders would decrease in the intervention group compared with the control group , indicating an improvement in patient care .


From July 2009 to October 2010 all the patients of one health center were randomized to an intervention or a control group .


The intervention consisted of patient-specific reminders concerning 59 different health conditions triggered when the healthcare professional ( HCP ) opened and used the EPR .


In the intervention group , the triggered reminders were shown to the HCP ; in the control group , the triggered reminders were not shown .


The primary outcome measure was the change in the number of reminders triggered over 12 months .


We developed a unique data gathering method , the Repeated Study Virtual Health Check ( RSVHC ) , and used Generalized Estimation Equations ( GEE ) for analysing the incidence rate ratio , which is a measure of the relative difference in percentage change in the numbers of reminders triggered in the intervention group and the control group .


In total , 13,588 participants were randomized and included .


Contrary to our expectation , the total number of reminders triggered increased in both the intervention and the control groups .


The primary outcome measure did not show a significant difference between the groups .


However , with the inclusion of patients followed up over only six months , the total number of reminders increased significantly less in the intervention group than in the control group when the confounding factors ( age , gender , number of diagnoses and medications ) were controlled for .


Computerized , tailored reminders in primary care did not decrease during the 12 months of follow-up time after the introduction of a patient-specific decision support system .


ClinicalTrial.gov NCT00915304 .


To compare the safety , efficacy , and complications of percutaneous nephrolithotomy ( PCNL ) in the oblique supine lithotomy position vs the prone position in a randomized comparative study .


The study included 101 and 102 patients in the oblique supine lithotomy position and prone position , respectively .


Inclusion criteria were renal and upper ureteral stones .


Exclusion criteria were uncorrectable bleeding disorders , active urinary tract infection , and pregnancy .


Both the groups were comparable regarding the male/female ratio , stone size , and site .


No significant differences were found in terms of the stone-free rate , blood transfusion rate , and complication rates .


Significant differences were reported in mean hemoglobin loss ( -1.03 and -2.18 g/dL ) , mean operative time ( 86.16 and 111.7 minutes ) , and mean hospital stay ( 49.88 and 81.2 hours ) in the supine and prone positions , respectively , and anesthesiological parameters ( the mean blood pressure decreased by 2 and 14.06 mm Hg , the mean heart rate changed by -0.82 and +13.28 beat/minute , and the peak air way pressure changed by +1.08 cm H2O and +7.56 cm H2O in the supine and prone positions , respectively ) .


PCNL in both positions was equally successful with no significant differences in complications .


PCNL in the oblique supine lithotomy position was superior to PCNL in the prone position regarding operative time , hospital stay , and effects on respiratory and cardiovascular status , making it more comfortable for patients and anesthesiologists .


Morbidly obese patients , patients with cardiologic disorders , and patients with pulmonary obstructive airway disease need further studies to show if they would benefit from these differences .


Additionally , it is more comfortable for the surgeon with little challenges added in the initial puncture .


Sunitinib is a first-line advanced renal cell carcinoma ( RCC ) standard of care .


In a randomized phase II trial comparing sunitinib treatment schedules , separate exploratory biomarker analyses investigated the correlations of efficacy with selected serum , germ line single-nucleotide polymorphism ( SNP ) , or tumor markers .


Advanced RCC patients received first-line sunitinib 50 mg/day on the approved 4-week-on-2-week-off schedule ( n = 146 ) or 37.5 mg/day continuous dosing ( n = 146 ) .


The following correlation analyses were performed : ( 1 ) response evaluation criteria in solid tumors-defined tumor response with serum soluble protein levels via two distinct multiplex ( n < 1,000 ) platforms ; ( 2 ) response and time-to-event outcomes with germ line SNPs in vascular endothelial growth factor ( VEGF ) - A and VEGF receptor ( VEGFR ) 3 genes ; and ( 3 ) response and time-to-event outcomes with tumor immunohistochemistry status for hypoxia-inducible factor 1-alpha ( HIF-1 ) and carbonic anhydrase-IX or tumor Von Hippel-Lindau ( VHL ) gene inactivation status .


Lower baseline angiopoietin-2 ( Ang-2 ) and higher baseline matrix metalloproteinase-2 ( MMP-2 ) levels were identified by both platforms as statistically significantly associated with tumor response .


There were no significant correlations between VEGF-A or VEGFR3 SNPs and outcomes .


Progression-free survival was longer for HIF-1 percent of tumor expression groups 0-2 ( HIF-1 low ) versus 3-4 ( HIF-1 high ; p = 0.034 ) .


There were no significant correlations between outcomes and each VHL inactivation mechanism [ mutation ( 86 % of VHL-inactive patients ) , methylation ( 14 % ) , and large deletion ( 7 % ) ] or mechanisms combined .


Serum Ang-2 and MMP-2 and tumor HIF-1 were identified as relevant baseline biomarkers of sunitinib activity in advanced RCC , warranting further research into their prognostic versus predictive value .


We previously reported a progressive decline in absolute responses of FEV1 and FVC to a near-maximal dose of 2 different short-acting bronchodilators over 4 years .


Since varying host factors and the method of expressing the response may impact the time trend of acute bronchodilator responses , we now examined the potential influence of salient host characteristics on changes in bronchodilator responses over time expressed in different ways .


As part of the 4-year , placebo-controlled Understanding Potential Long-term Impacts on Function with Tiotropium ( UPLIFT ) trial , pre - and post-bronchodilator spirometry was performed at baseline and 1 month and every 6 months thereafter .


Post-bronchodilator values for FEV1 and FVC were analyzed for subjects completing at least the 1 year visit ( Placebo - N = 2463 ; Tiotropium - N = 2579 ) , stratified by GOLD stage , age , gender and smoking status and expressed as absolute , relative ( % ) and % predicted changes from pre-bronchodilator values .


Annual changes in bronchodilator response were estimated using linear mixed effects models .


For all subjects analyzed , FEV1 and FVC bronchodilator responses showed progressive and highly significant ( p < 0.0001 ) declines over 4 years .


Declines were generally larger in patients with severe/very severe than mild/moderate airflow obstruction , in older patients ( 65 yrs ) and in former than continuing smokers .


Acute FEV1 and FVC responses to bronchodilators decline significantly over time in COPD patients , whether expressed as absolute , relative or % predicted changes , potentially impacting on the clinical responses to bronchodilator therapy as well as on the annual rate of decline in post-bronchodilator lung function .


Clinicaltrials.gov number : NCT00144339 .


Fibromyalgia syndrome ( FMS ) is a chronic disorder characterised by widespread musculoskeletal pain , troubled sleep , disturbed mood , and fatigue .


Recently published reviews have demonstrated that it is influenced by various psychological aspects , and antidepressants are now considered the treatment of choice for most patients .


The aim of this randomised controlled trial was to compare the effects of duloxetine and acetyl L-carnitine on pain , depression , anxiety and well-being in FMS patients .


Sixty-five female outpatients with FMS diagnosed by a rheumatologist were recruited between January 2011 and May 2012 , and randomised to receive duloxetine 60 mg/day or acetyl L-carnitine 1500 mg/day ( 500 mg t.i.d. ) .


Drug efficacy and side effects were assessed by the same psychiatrist at baseline , and four and 12 weeks later .


Both drugs led to a general clinical improvement , with positive effects on pain and depressive symptoms ; but neither induced a significant improvement in anxiety .


Both drugs had a positive effect on the physical component of the quality of life , but only duloxetine improved the psychological component .


Although they need to be confirmed by further studies , these preliminary findings confirm the efficacy of duloxetine , and suggest that acetyl L-carnitine is also efficacious in improving depressive symptoms , pain , and the quality of life of FMS patients .


This work aims to explore the safety and efficacy of intracoronary tirofiban administration in patients with serious thrombus burden and ST-elevation myocardial infarction ( STEMI ) undergoing emergency percutaneous coronary intervention ( PCI ) .


A total of 104 patients with serious thrombus burden and acute STEMI were randomly divided into treatment ( intracoronary tirofiban administration , 56 cases ) and control ( 48 cases ) groups .


Comparison of coronary blood flow , ST-segment resolution ( STR ) , duration of hospital stay , 30-day major adverse cardiac events ( MACE ) and complications such as hemorrhage was conducted .


In treatment group , the percentage of thrombolysis in myocardial infarction-3 ( TIMI-3 ) flow in the infarct-related artery ( IRA ) increased ( 89.3 % to 85.4 , p < 0.05 ) , blood flow in the IRA calculated with TIMI frame count method enhanced [ ( 1.68 0.23 ) ml/s to ( 1.42 0.31 ) ml/s , p < 0.05 ] , STR on electrocardiogram ( ECG ) enlarged [ ( 64.3 7.84 ) % to ( 48.6 6.47 ) % , p < 0.05 ) ] and the prevalence of MACE decreased ( 10.7 % to 18.8 % , p < 0.05 ) , all of which were significantly different from those of control group , but no statistical difference in complications was observed between two groups ( p > 0.05 ) .


It was simple , safe and effective to perform intracoronary tirofiban administration in patients with serious thrombus burden and STEMI when undergoing emergency PCI .


To evaluate efficacy and safety of injectable extended-release naltrexone ( XR-NTX , Vivitrol ) , an opioid receptor antagonist , in the treatment of opioid dependence , we carried out a 1-year open-label extension study .


The study followed the initial 6-month randomized , double-blind , PBO-controlled investigation of XR-NTX , used in dose 380 mg , as a treatment for opioid dependence .


The study was conducted at 13 clinical sites in Russia .


The main measurements were monthly urine samples ( efficacy ) and adverse events ( safety ) .


The open-label extension included 114 patients ( 67 continued on XR-NTX and 47 switched from placebo ) .


Overall , 62.3 % ( 95 % CI : 52.7 % , 71.2 % ) of patients completed the extension .


Urine testing revealed that 50.9 % ( 41.5 % , 60.4 % ) were abstinent from opioids at all assessments during the 1-year open-label phase .


Adverse events were reported by 21.1 % of patients .


Elevations in liver function tests occurred in 16.7 % of patients .


No severe adverse events were reported .


The data obtained demonstrate the long-term safety and efficacy of XR-NTX in opioid dependent patients .


Despite considerable research on substance-abuse placement matching , evidence is still inconclusive .


The aims of this exploratory trial are to evaluate ( a ) the effects of following matching guidelines on health-care costs and heavy drinking , and ( b ) factors affecting the implementation of matching guidelines in the treatment of alcohol-dependent patients .


A total of 286 alcohol-dependent patients entering one of four participating detoxification units and having no arrangements for further treatment will be recruited .


During the first week of treatment , all patients will be administered Measurements in the Addictions for Triage and Evaluation ( MATE ) , European Quality of Life-Five Dimensions health status questionnaire ( EQ-5D ) , and the Client Socio -- Demographic and Service Receipt Inventory-European Version ( CSSRI-EU ) .


Patients who are randomly allocated to the intervention group will receive feedback regarding their assessment results , including clear recommendations for subsequent treatment .


Patients of the control group will receive treatment as usual and , if requested , global feedback regarding their assessment results , but no recommendations for subsequent treatment .


At discharge , treatment outcome and referral decisions will be recorded .


Six months after discharge , patients will be administered MATE-Outcome , EQ-5D , and CSSRI-EU during a telephone interview .


This trial will provide evidence on the effects and costs of using placement-matching guidelines based on a standardized assessment with structured feedback in the treatment of alcohol-dependent patients .


A process evaluation will be conducted to facilitate better understanding of the relationship between the use of guidelines , outcomes , and potential mediating variables .


German Clinical Trials Register DRKS00005035 .


Registered 03 June 2013 .


Positron emission tomography ( PET ) after chemotherapy can guide consolidating radiotherapy in advanced-stage Hodgkin lymphoma ( HL ) .


This analysis aims to improve outcome prediction by integrating additional criteria derived by computed tomography ( CT ) .


The analysis set consisted of 739 patients with residues2 .5 cm after chemotherapy from a total of 2,126 patients treated in the HD15 trial ( HD15 for advanced stage Hodgkin 's disease : Quality assurance protocol for reduction of toxicity and the prognostic relevance of fluorodeoxyglucose-positron-emission tomography [ FDG-PET ] in the first-line treatment of advanced-stage Hodgkin 's disease ) performed by the German Hodgkin Study Group .


A central panel performed image analysis and interpretation of CT scans before and after chemotherapy as well as PET scans after chemotherapy .


Prognosis was evaluated by using progression-free survival ( PFS ) ; groups were compared with the log-rank test .


Potential prognostic factors were investigated by using receiver operating characteristic analysis and logistic regression .


In all , 548 ( 74 % ) of 739 patients had PET-negative residues after chemotherapy ; these patients did not receive additional radiotherapy and showed a 4-year PFS of 91.5 % .


The 191 PET-positive patients ( 26 % ) receiving additional radiotherapy had a 4-year PFS of 86.1 % ( P = .022 ) .


CT alone did not allow further separation of patients in partial remission by risk of recurrence ( P = .9 ) .


In the subgroup of the 54 PET-positive patients with a relative reduction of less than 40 % , the risk of progression or relapse within the first year was 23.1 % compared with 5.3 % for patients with a larger reduction ( difference , 17.9 % ; 95 % CI , 5.8 % to 30 % ) .


Patients with HL who have PET-positive residual disease after chemotherapy and poor tumor shrinkage are at high risk of progression or relapse .


There is a need to investigate the treatment ( artesunate and quinine ) of severe malaria , as this will influence the outcome of morbidity and the mortality of the disease .


An open randomized trial conducted at Kassala , Sudan .


Patients with severe P. falciparum malaria were randomly assigned to either intravenous artesunate at 2.4 mg/kg at 0 , 12 , and 24 hours , then daily , or intravenous quinine at a 20 mg/kg loading dose , then 10 mg/kg three times a day .


Fever and parasite clearance and coma resolution time were compared between the two groups .


The two groups ( 47 in each group ) were well matched in the clinical and biochemical characteristics .


Hypotension , convulsions , severe anemia , hypoglycemia , cerebral malaria , and jaundice were the predominant manifestations of severe malaria .


The mean ( SD ) of the fever clearance ( 10.8 [ 5.5 ] vs. 14.0 [ 8.1 ] hours , p = 0.028 ) and the parasite clearance time ( 16.5 [ 6.4 ] vs. 21.7 [ 11.3 ] hours , p = 0.007 ) were significantly shorter in the artesunate-treated patients .


In comatose patients , there was no difference between the two groups in coma resolution time .


Following quinine infusion , ten patients developed tinnitus ( p < 0.001 ) , and four had hypoglycemia ( p = 0.033 ) .


Tinnitus and hypoglycemia were not detected in the artesunate group .


One patient in the artesunate group died .


Artesunate is more effective than quinine , in term of parasite and fever clearance time , in the treatment of P. falciparum malaria in eastern Sudan .


The study found no difference between artesunate and quinine in coma resolution time .


A randomised , open label phase III trial was conducted to evaluate efficacy of nimotuzumab , a monoclonal antibody against epidermal growth factor receptor ( EGF-R ) added to standard therapy for newly diagnosed glioblastoma .


149 glioblastoma patients stratified as with or without residual tumour were randomly assigned to receive either intravenous nimotuzumab 400mg weekly added to standard radiochemotherapy followed by 400mg biweekly after twelve weeks or standard radiochemotherapy .


Progression status after 52 weeks ( 12moPFS ) and progression-free survival ( PFS ) based on Macdonald criteria were co-primary and overall survival ( OS ) , toxicity and quality of life secondary end-points .


142 patients were evaluated for efficacy ( per protocol cohort ) .


12 moPFS was 25.6 % in the experimental arm and 20.3 % in the control group .


In residual tumour patients ( n = 81 ) median PFS was 5.6 versus 4.0 months , ( hazard ratio ( HR ) , 0.87 ; 95 % confidence interval ( CI ) , 0.55-1 .37 ) , for patients without residual tumour ( n = 61 ) it was 10.6 versus 9.9 months , ( HR , 1.01 ; 95 % CI , 0.57-1 .77 ) .


Median OS in patients with residual tumour was 19.5 versus 16.7 months , ( HR , 0.90 ; 95 % CI , 0.52-1 .57 ; P = 0.7061 ) , for patients without 23.3 versus 21.0 months ( HR , 0.77 ; 95 % CI , 0.41-1 .44 ; P = 0.4068 ) .


A small cohort of MGMT non-methylated patients with residual tumour showed PFS of 6.2 versus 4.0 months ( HR , 0.77 ; 95 % CI , 0.35-1 .67 ; P = 0.4997 ) and OS of 19.0 versus 13.8 months ( HR , 0.66 ; 95 % CI , 0.27-1 .64 ; P = 0.3648 ) .


EGF-R amplification did not correlate with clinical efficacy of nimotuzumab .


Nimotuzumab was well tolerated .


This study , albeit negative , contains hypothesis generating signals supporting evaluation of correlative , efficacy-predicting tumour parameters for nimotuzumab in the treatment of glioblastoma .


To determine if acute pain response in infants after administration of pentavalent diphtheria ( polio , tetanus , acellular pertussis and B Type Hemophilus influenzae : Pentavac ) and meningitis C vaccine ( NeisVacC ) vary according to the administration order .


A multicenter , randomized control trial , double-blind was performed in three pediatric nursing consultations of three healthcare centers between December 2010 , and December 2011 .


Two months healthy children in subjected to a routine immunization .


Routine immunizations are given in a different order to children ; first NeisVac C and then Pentavac are given to the Group A and first Pentavac and then NeisVac C are given to the Group B. Was measured infant pain during the injection of the vaccine using a validates method , the Modified Behavioral Pain Scale ( MBPS ) .


Parents measured pain with the VAS scale and evaluated the presence of tears before the beginning of vaccination .


Within the 184 infants , 92 received the A order , and 92 the B order .


There were no differences between groups in terms of sociodemographic characteristics .


The average ( AV ) pain scores per infant after receiving injections were significantly lower when Pentavac was administered in a second place in A Group .


MBPS 5.6 ( SD 1.5 ) versus NeisVac C 7.6 ( SD 1.3 ) ( p = 0.0001 ) , EVA 3.6 Parents ( SD ) versus 5.4 ( DE 1.9 ) ( p = 0.0001 ) .


In B Group , the average for Pentavac '' BPS pain was 7.6 ( SD 1.5 ) versus 7.9 ( DE 1.2 ) to NeisVac C Parents EVA 5.5 ( SD 1.8 ) versus 6.3 ( SD 1.6 ) ( p = 0.004 ) .


Pain was reduced when Pentavac vaccine was administered before NeisVac C in infants subjected to a routine vaccination .


It is recommended that the order of injections of the vaccine will be first Pentavac followed by NeisVac C.


Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia .


This study compared the efficacy and safety of two intravenous iron products ( ferumoxytol [ Feraheme injection ] and iron sucrose [ Venofer ] ) in patients with CKD and iron deficiency anemia .


In this phase II , randomized , open-label , active-controlled , multicenter clinical trial , patients were randomized 1:1 to either 1.02 g ferumoxytol ( 2 510-mg injections ) or 1.0 g iron sucrose administered as either a slow injection or infusion ( 10 doses for dialysis patients and 5 doses for nondialysis patients ) .


Inclusion criteria included hemoglobin < 11.0 g/dl , transferrin saturation < 30 % , and eGFR < 60 ml/min per 1.73 m ( 2 ) or a diagnosis of underlying CKD ( e.g. , nephropathy or nephritis ) .


The primary end point was change in hemoglobin from baseline to week 5 .


In total , 162 patients were randomized .


Demographics were balanced between the treatment groups .


Adverse event profiles of the two regimens were fairly similar : overall adverse events , 48 % ferumoxytol versus 65 % iron sucrose ; related adverse events , 10 % ferumoxytol versus 16 % iron sucrose ; and adverse events leading to study discontinuation , 1 % ferumoxytol versus 5 % iron sucrose .


Rates of serious adverse events and related serious adverse events were similar between the ferumoxytol and iron sucrose groups : serious adverse events , 9 % versus 7 % , respectively and related serious adverse events , 1 % versus 1 % , respectively .


Overall , increases in hemoglobin were similar between treatment groups .


Based on an ANOVA model adjusted for baseline hemoglobin level and dialysis status , the least squares mean change from baseline to week 5 was 0.8 0.1 g/dl in the ferumoxytol-treated group and 0.7 0.1 g/dl in the iron sucrose group .


The difference in the mean change from baseline between the two treatment groups was 0.1 g/dl ( 95 % confidence interval , -0.2 to 0.4 ) .


In this randomized , controlled trial , ferumoxytol and iron sucrose showed comparable efficacy and adverse events rates .


To determine whether a transtheoretical model-based exercise stage-matched intervention ( ESMI ) has positive effects on the exercise behavior of sedentary patients with coronary heart disease ( CHD ) .


The study was a randomized controlled trial with a repeated measures design .


Participants ( N = 196 ) were randomly allocated to either a conventional ( C ) group , a patient education ( PE ) group , or an ESMI group .


Exercise behavior was measured by exercise stages of change , exercise self-efficacy , exercise decisional balance , and duration of moderate exercise at baseline , immediate post-intervention , and at 3 - and 6-month follow-up .


Our results showed that the ESMI group demonstrated a more positive shift in exercise stages of change ( p < 0.01 ) , higher exercise self-efficacy ( p < 0.01 ) , greater exercise benefits ( p < 0.01 ) , fewer exercise barriers ( p < 0.01 ) , and longer moderate exercise duration ( minutes/week ) ( p < 0.01 ) after completion of the 8-week intervention compared with the C and PE groups .


These significantly positive effects were maintained at 3 - and 6-month follow-up .


The transtheoretical model-based ESMI had significantly positive effects on the exercise behavior of sedentary CHD patients .


It is important to provide a structured education program for CHD patients , preferably guided by the transtheoretical model .


Previous investigations in pancreatic cancer suggested a prognostic role for secreted protein acidic and rich in cysteine ( SPARC ) expression in the peritumoral stroma but not for cytoplasmic SPARC expression .


The aim of this study was to evaluate the impact of SPARC expression in pancreatic cancer patients treated with gemcitabine compared with untreated patients .


CONKO-001 was a prospective randomized phase III study investigating the role of adjuvant gemcitabine when compared with observation .


Tissue samples of 160 patients were available for SPARC immunohistochemistry on tissue microarrays to evaluate its impact on patient outcome .


Strong stromal SPARC expression was associated with worse disease-free survival ( DFS ) and overall survival ( OS ) in the overall study population ( DFS : P = 0.005 , OS : P = 0.033 ) .


Its negative prognostic impact was restricted to patients treated with gemcitabine ( DFS : P = 0.007 , OS : P = 0.006 ) .


High cytoplasmic SPARC expression also was associated with worse patient outcome ( DFS : P = 0.041 , OS : P = 0.011 ) .


Again the effect was restricted to patients treated with gemcitabine ( DFS : P = 0.002 , OS : P = 0.003 ) .


In multivariable analysis , SPARC expression was independently predictive of patient outcome .


Our data confirm the prognostic significance of SPARC expression after curatively intended resection .


The negative prognostic impact was restricted to patients who received adjuvant treatment with gemcitabine , suggesting SPARC as a predictive marker for response to gemcitabine .


The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams ( EMDTs ) vs. ` usual care ' for the treatment of pressure ulcers in long term care ( LTC ) facilities in Ontario , Canada


We conducted a multi-method study : a pragmatic cluster randomized stepped-wedge trial , ethnographic observation and in-depth interviews , and an economic evaluation .


Long term care facilities ( clusters ) were randomly allocated to start dates of the intervention .


An advance practice nurse ( APN ) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment , supported by an off-site hospital based expert multi-disciplinary wound care team via email , telephone , or video link as needed .


The primary outcome was rate of reduction in pressure ulcer surface area ( cm2/day ) measured on before and after standard photographs by an assessor blinded to facility allocation .


Secondary outcomes were time to healing , probability of healing , pressure ulcer incidence , pressure ulcer prevalence , wound pain , hospitalization , emergency department visits , utility , and cost .


12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design .


137 residents with a total of 259 pressure ulcers ( stage 2 or greater ) were recruited over the 17 month study period .


No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes .


The economic evaluation demonstrated a mean reduction in direct care costs of $ 650 per resident compared to ` usual care ' .


The qualitative study suggested that onsite support by APN wound specialists was welcomed , and is responsible for reduced costs through discontinuation of expensive non evidence based treatments .


Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing .


Enhanced multi-disciplinary wound care teams were cost effective , with most benefit through cost reduction initiated by APNs , but did not improve the treatment of pressure ulcers in nursing homes .


Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities , through outreach by APNs .


ClinicalTrials.gov identifier NCT01232764 .


Pharmacokinetic parameters of sedative-hypnotic medications can be influenced by age and gender .


This study analyzed pharmacokinetic parameters of zolpidem , formulated as a sublingual zolpidem tartrate tablet ( ZST ; Intermezzo ) , in healthy elderly males and females ( mean age 72 years ) and in non-elderly males and females ( 34 years ) .


This was a randomized , single-dose , open-label , two-way crossover study evaluating pharmacokinetic parameters of 1.75 and 3.5 mg dosages of ZST in elderly subjects ( n = 22 ) , and 3.5 mg dosages of ZST in non-elderly subjects ( n = 24 ) .


Main outcome measures were pharmacokinetic parameters , including area under the plasma concentration-time curve ( AUC ) , maximum observed concentration ( C ( max ) ) , time to reach C ( max ) ( T ( max ) ) , elimination half-life ( T ( ) ) , and apparent oral clearance ( CL/F ) .


Dose proportionality in zolpidem exposure was maintained between 1.75 and 3.5 mg doses for both elderly females and males .


With administration of the 3.5 mg dose of ZST to elderly and non-elderly subjects , significantly higher systemic exposure was seen in elderly females ( C ( max ) +44.6 % , P < 0.01 ; AUC +40.4 % ) compared with non-elderly females .


However , systemic exposure was only modestly higher in elderly males compared with non-elderly males .


Greater exposure was seen in elderly females compared to males ( C ( max ) +46.8 % , P < 0.01 ; AUC +31.4 % ) .


In this study , exposure between non-elderly females and males was equivalent .


Changes in T ( ) and T ( max ) values were not observed , with no significant age effect on oral clearance .


There were no apparent differences in tolerability among age and gender groups .


Elderly individuals were found to have higher C ( max ) and AUC values compared with non-elderly subjects .


C ( max ) and AUC were greater in elderly women compared with elderly men .


Umbilical-cord blood has been used as the source of hematopoietic stem cells in an estimated 30,000 transplants .


The limited number of hematopoietic cells in a single cord-blood unit prevents its use in recipients with larger body mass and results in delayed hematopoietic recovery and higher mortality .


Therefore , we hypothesized that the greater numbers of hematopoietic cells in two units of cord blood would be associated with improved outcomes after transplantation .


Between December 1 , 2006 , and February 24 , 2012 , a total of 224 patients 1 to 21 years of age with hematologic cancer were randomly assigned to undergo double-unit ( 111 patients ) or single-unit ( 113 patients ) cord-blood transplantation after a uniform myeloablative conditioning regimen and immunoprophylaxis for graft-versus-host disease ( GVHD ) .


The primary end point was 1-year overall survival .


Treatment groups were matched for age , sex , self-reported race ( white vs. nonwhite ) , performance status , degree of donor-recipient HLA matching , and disease type and status at transplantation .


The 1-year overall survival rate was 65 % ( 95 % confidence interval [ CI ] , 56 to 74 ) and 73 % ( 95 % CI , 63 to 80 ) among recipients of double and single cord-blood units , respectively ( P = 0.17 ) .


Similar outcomes in the two groups were also observed with respect to the rates of disease-free survival , neutrophil recovery , transplantation-related death , relapse , infections , immunologic reconstitution , and grade II-IV acute GVHD .


However , improved platelet recovery and lower incidences of grade III and IV acute and extensive chronic GVHD were observed among recipients of a single cord-blood unit .


We found that among children and adolescents with hematologic cancer , survival rates were similar after single-unit and double-unit cord-blood transplantation ; however , a single-unit cord-blood transplant was associated with better platelet recovery and a lower risk of GVHD .


( Funded by the National Heart , Lung , and Blood Institute and the National Cancer Institute ; ClinicalTrials.gov number , NCT00412360 . )


To compare 12-month outpatient healthcare expenditures of at-risk and not-at-risk drinkers aged 60 and older .


Secondary analysis of data from Project Senior Health and Alcohol Risk Education , a cluster , randomized trial to test the efficacy of an intervention to reduce at-risk drinking .


Seven primary care clinics in or near Santa Barbara , California .


Current drinkers aged 60 and older who completed a baseline survey ( N = 2,779 ) and did not receive the study intervention , including 628 at-risk drinkers and 2,151 not-at-risk drinkers .


Comparisons of at-risk and not-at-risk drinkers for baseline demographic characteristics , health indicators , alcohol consumption , and adjusted and unadjusted outpatient healthcare expenditures incurred over 12 months after baseline .


At-risk drinkers were younger , more often male , and more likely to be married and had higher education and incomes than not-at-risk drinkers .


Unadjusted 12-month mean outpatient healthcare expenditures were $ 1,333 2,973 for at-risk drinkers and $ 1,417 2,952 for the not-at-risk drinkers .


There were no statistically significant differences in expenditures between groups before and after controlling for sociodemographic and health characteristics .


In this short-term study , no adjusted differences in healthcare expenditures were observed between at-risk and not-at-risk older drinkers .


Future study is warranted to determine the role of at-risk drinking in long-term healthcare expenditures in older adults .


Examinations today are often computerized and the primary motivation and curriculum is often based on the examinations .


This study aims to test if competition widgets in e-learning quiz modules improve post-test and follow-up test results and self-evaluation .


The secondary aim is to evaluate improvements during the training period comparing test-results and number of tests taken .


Two groups were randomly assigned to either a quiz-module with competition widgets or a module without .


Pre - , post - and follow up test-results were recorded .


Time used within the modules was measured and students reported time studying .


Students were able to choose questions from former examinations in the quiz-module .


Students from the competing group were significantly better at both post-and follow-up-test and had a significantly better overall learning efficiency than those from the non-competing group .


They were also significantly better at guessing their post-test results .


Quiz modules with competition widgets motivate students to become more active during the module and stimulate better total efficiency .


They also generate improved self-awareness regarding post-test-results .


Suboptimal vitamin D status can be corrected by vitamin D supplementation , but individual responses to supplementation vary .


We aimed to examine genetic and nongenetic determinants of change in serum 25-hydroxyvitamin D ( 25 ( OH ) D ) after supplementation .


We used data from a pilot randomized controlled trial in which 644 adults aged 60 to 84 years were randomly assigned to monthly doses of placebo , 30 000 IU , or 60 000 IU vitamin D3 for 12 months .


Baseline characteristics were obtained from a self-administered questionnaire .


Eighty-eight single-nucleotide polymorphisms ( SNPs ) in 41 candidate genes were genotyped using Sequenom MassArray technology .


Serum 25 ( OH ) D levels before and after the intervention were measured using the Diasorin Liaison platform immunoassay .


We used linear regression models to examine associations between genetic and nongenetic factors and change in serum 25 ( OH ) D levels .


Supplement dose and baseline 25 ( OH ) D level explained 24 % of the variability in response to supplementation .


Body mass index , self-reported health status , and ambient UV radiation made a small additional contribution .


SNPs in CYP2R1 , IRF4 , MC1R , CYP27B1 , VDR , TYRP1 , MCM6 , and HERC2 were associated with change in 25 ( OH ) D level , although only CYP2R1 was significant after adjustment for multiple testing .


Models including SNPs explained a similar proportion of variability in response to supplementation as models that included personal and environmental factors .


Stepwise regression analyses suggest that genetic variability may be associated with response to supplementation , perhaps suggesting that some people might need higher doses to reach optimal 25 ( OH ) D levels or that there is variability in the physiologically normal level of 25 ( OH ) D.


The benefit or harm of trabectedin discontinuation in patients with non-progressive soft-tissue sarcoma remains unclear .


We report the final analysis of a phase 2 trial investigating the clinical benefit of continuation of trabectedin treatment until progression versus interruption of therapy after six treatment cycles in patients with advanced soft-tissue sarcoma .


For this open-label , non-comparative , multicentre , phase 2 study , eligible adult patients with advanced soft-tissue sarcomas , who had previously received doxorubicin-based chemotherapy and were able to receive trabectedin , were enrolled from 14 centres of the French Sarcoma Group .


Trabectedin was administered at a dose of 15 mg/m ( 2 ) through a central venous line as a 24-h continuous infusion every 3 weeks .


After the initial six cycles of trabectedin , patients who were free from progressive disease were randomly assigned in a 1:1 ratio either to continuous treatment or therapy interruption .


Randomisation was done centrally by a computer-generated system using permuted blocks of four patients , stratified by tumour grade and performance status .


Patients allocated to the interruption group were allowed to restart trabectedin in case of progressive disease .


The primary endpoint was progression-free survival at 6 months after randomisation , analysed by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT01303094 .


In 178 evaluable patients , 91 ( 51 % ) patients had not progressed after six cycles .


Of these patients , 53 patients were randomly assigned to the two treatment groups : 27 to the continuation group and 26 to the interruption group .


Overall , patients in the two groups received a similar median number of trabectedin cycles ( continuation group : 11 cycles [ range 6-31 + ] vs interruption group : 11 [ range 6-23 + ] ) .


After randomisation , progression-free survival at 6 months was 519 % ( 95 % CI 319-686 ) in the continuation group versus 231 % ( 94-403 ) in the interruption group ( p = 00200 ) .


The occurrence of treatment-related grade 3 adverse events ( four [ 16 % ] of 25 patients in the continuation group vs three [ 14 % ] of 21 in the interruption group ) and grade 4 adverse events ( one [ 4 % ] vs none ) was similar in both groups .


The most common grade 3 and 4 toxicities were alanine aminotransferase or aspartate aminotransferase increases ( one [ 4 % ] in the interruption group vs three [ 14 % ] in the continuation group ) , neutropenia ( two [ 8 % ] vs two [ 10 % ] ) , and intestinal occlusion ( one [ 4 % ] vs one [ 5 % ] ) .


We do not recommend trabectedin discontinuation in patients with advanced , doxorubicin-refractory soft-tissue sarcoma who have not progressed after six cycles of treatment .


The French National Cancer Institute ( INCa ) and PharmaMar SA .


To determine the clinical safety and efficacy of alfaxalone in bitches undergoing caesarean section ( CS ) and their puppies when it is administered for induction of anaesthesia followed by maintenance with isoflurane and oxygen and in conjunction with perioperative pharmaceuticals .


A multicentre , randomised , positive-controlled clinical study .


A total of 74 bitches were enrolled in the study with 48/74 ( 65 % ) and 26/74 ( 35 % ) receiving alfaxalone and propofol , respectively , for induction of anaesthesia .


Bitches were examined prior to induction and monitored during induction , surgery and recovery .


Assessments were made for quality of induction , maintenance and recovery from anaesthesia .


Assessments were made on pup viability for suction , dorsal flexion , withdrawal and anogenital reflexes .


Of the 48 bitches receiving alfaxalone , 47 ( 98 % ) and 39 ( 81 % ) scored a top score of excellent for induction and anaesthesia effectiveness , respectively .


For the same parameters with propofol in 26 bitches , 23 ( 88 % ) and 17 ( 65 % ) scored excellent .


Average scores for recovery were not different between the two treatment groups with alfaxalone 46/48 ( 96 % ) and 25/26 ( 96 % ) of propofol induced bitches scoring a good or excellent rating .


Bitches tolerated a number of concurrent medications throughout the peri-operative period .


No bitch fatalities were observed in this study .


There were no statistically significant differences between treatment groups for the puppy variables .


Live puppies born by CS to bitches having been administered alfaxalone or propofol had similar survival rates 24h after birth ( i.e. 205/213 ( 96 % ) and 124/131 ( 95 % ) , respectively ) .


This study confirms the safety and efficacy of alfaxalone for the purpose of anaesthetic induction for CS in the bitch .


In addition , alfaxalone had a negligible effect on the neonate with > 95 % of puppies alive 24h after the bitch had recovered from anaesthesia with alfaxalone induction .


Post-operative pain continues to be a major problem .


Some previous studies have suggested that patients anaesthetised with propofol have less pain after surgery than those anesthetised with volatiles .


However , the results of previous studies are conflicting .


We designed a large-scale trial to study , whether propofol or sevoflurane is more analgesic than the other .


We measured opioid consumption in the acute post-operative phase after laparoscopic hysterectomy .


In a randomised , prospective single-blind trial , we evaluated the consumption of oxycodone and pain intensity in 148 women for 20h after laparoscopic hysterectomy under propofol or sevoflurane anaesthesia .


The primary endpoint was the cumulative amount of oxycodone consumed .


Secondary endpoints were pain scores [ numeric rating scale ( NRS ) ] at rest and with coughing , severity of nausea and state of sedation .


The consumption of oxycodone and the NRS pain scores did not differ between the groups .