A 26 % reduction in the rate of injuries caused by falls at home per year exposed to the intervention was estimated in people allocated to the treatment group compared with those assigned to the control group , after adjustment for age , previous falls , sex , and ethnic origin ( relative rate 0.74 , 95 % CI 0.58-0 .94 ) .


Injuries specific to the home-modification intervention were cut by 39 % per year exposed ( 0.61 , 0.41-0 .91 ) .


Our findings suggest that low-cost home modifications and repairs can be a means to reduce injury in the general population .


Further research is needed to identify the effectiveness of particular modifications from the package tested .


Health Research Council of New Zealand .


Enterovirus 71 ( EV71 ) has caused several epidemics of hand , foot and mouth diseases ( HFMD ) in Asia .


No effective EV71 vaccine is available .


A randomized and open-label phase I clinical study registered with ClinicalTrials.gov #NCT 01268787 , aims to evaluate the safety , reactogenicity and immunogenicity of a formalin-inactivated EV71 vaccine candidate ( EV71vac ) at 5 - and 10-g doses .


In this study we report the cross-neutralizing antibody responses from each volunteer against different subgenotypes of EV71 and CVA16 .


Sixty eligible healthy adults were recruited and vaccinated .


Blood samples were obtained on day 0 , 21 and 42 and tested against B1 , B4 , B5 , C2 , C4A , C4B and CVA16 for cross-neutralizing antibody responses .


The immunogenicity of both 5 - and 10 - g doses were found to be very similar .


Approximately 45 % of the participants had < 8 pre-vaccination neutralization titers ( Nt ) against the B4 vaccine strain .


After the first EV71vac immunization , 95 % of vaccinees have > 4-fold increase in Nt , but there was no further increase in Nt after the second dose .


EV71vac induced very strong cross-neutralizing antibody responses in > 85 % of volunteers without pre-existing Nt against subgenotype B1 , B5 and C4A .


EV71vac elicited weak cross-neutralizing antibody responses ( 20 % of participants ) against a C4B and Coxsackie virus A16 .


Over 90 % of vaccinated volunteers did not develop cross-neutralizing antibody responses ( Nt < 8 ) against a C2 strain .


EV71vac can boost and significantly enhance the neutralizing antibody responses in volunteers who already had pre-vaccination antibodies against EV71 and/or CVA16 .


EV71vac is efficient in eliciting cross-neutralizing antibody responses against EV71 subgenotypes B1 , B4 , B5 , and C4A , and provides the rationale for its evaluation in phase II clinical trials .


ClinicalTrials.gov NCT01268787 .


Microemboli are frequently detected entering the middle cerebral arteries during coronary angiography ( CA ) .


Recent studies have reported that cerebral microemboli , especially particulate cerebral microemboli , may cause silent ischemic cerebral lesions .


To investigate whether the occurrence of particulate cerebral microemboli during diagnostic CA is influenced by which guidewire technique is used .


Patients with stable angina pectoris or non-ST elevation acute coronary syndrome , referred for CA , were randomized to initial advancement of catheters with a leading guidewire over the aortic arch or to initial guidewire withdrawal in the descending aorta with advancement of catheters alone .


After completed CA ( part 1 ) , new catheters and guidewires were advanced with guidewire technique contrary to the one first used ( part 2 ) .


Patients were continuously monitored with transcranial Doppler ( TCD ) , and cerebral microemboli were automatically counted and differentiated .


Statistical analysis was performed on 41 patients .


The results in part 1 were confirmed in part 2 .


The median number ( interquartile range ) of particulate cerebral microemboli was significantly higher when catheters were advanced with , compared to without , a guidewire over the aortic arch ; overall , 6 ( IQR , 1-9 ) vs 1 ( IQR , 0-3 ) ; P = .01 .


Advancement of catheters with a leading guidewire over the aortic arch with subsequent flushing in the ascending aorta consistently generated more particulate cerebral microemboli , implying that the choice of guidewire technique has an impact on the risk for cerebral lesions during CA .


Bortezomib-melphalan-prednisone ( VMP ) has improved overall survival in multiple myeloma .


This randomized trial compared VMP plus thalidomide ( VMPT ) induction followed by bortezomib-thalidomide maintenance ( VMPT-VT ) with VMP in patients with newly diagnosed multiple myeloma .


We randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT ( nine 5-week cycles of VMPT followed by 2 years of VT maintenance ) or VMP ( nine 5-week cycles without maintenance ) .


In the initial analysis with a median follow-up of 23 months , VMPT-VT improved complete response rate from 24 % to 38 % and 3-year progression-free-survival ( PFS ) from 41 % to 56 % compared with VMP .


In this analysis , median follow-up was 54 months .


The median PFS was significantly longer with VMPT-VT ( 35.3 months ) than with VMP ( 24.8 months ; hazard ratio [ HR ] , 0.58 ; P < .001 ) .


The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group ( HR , 0.52 ; P < .001 ) .


The 5-year overall survival ( OS ) was greater with VMPT-VT ( 61 % ) than with VMP ( 51 % ; HR , 0.70 ; P = .01 ) .


Survival from relapse was identical in both groups ( HR , 0.92 ; P = .63 ) .


In the VMPT-VT group , the most frequent grade 3 to 4 adverse events included neutropenia ( 38 % ) , thrombocytopenia ( 22 % ) , peripheral neuropathy ( 11 % ) , and cardiologic events ( 11 % ) .


All of these , except for thrombocytopenia , were significantly more frequent in the VMPT-VT patients .


Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation .


Binge-eating disorder ( BED ) , a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome , lacks approved pharmacotherapies .


To examine the efficacy and safety of lisdexamfetamine dimesylate , a dextroamphetamine prodrug , to treat moderate to severe BED .


We performed a randomized , double-blind , parallel-group , forced dose titration , placebo-controlled clinical trial at 30 sites from May 10 , 2011 , through January 30 , 2012 .


Safety and intention-to-treat analyses included 259 and 255 adults with BED , respectively .


Lisdexamfetamine dimesylate at dosages of 30 , 50 , or 70 mg/d or placebo were provided to study participants ( 1:1:1:1 ) .


Dosages were titrated across 3 weeks and maintained for 8 weeks .


We followed up participants for a mean ( SD ) of 7 ( 2 ) days after the last dose .


We assessed the change in binge-eating ( BE ) behaviors measured as days per week ( baseline to week 11 ) with a mixed-effects model using transformed log ( BE days per week ) +1 .


Secondary measures included BE cessation for 4 weeks .


Safety assessments included treatment-emergent adverse events , vital signs , and change in weight .


At week 11 , log-transformed BE days per week decreased with the 50-mg/d ( least squares [ LS ] mean [ SE ] change , -1.49 [ 0.066 ] ; P = .008 ) and 70-mg/d ( LS mean [ SE ] change , -1.57 [ 0.067 ] ; P < .001 ) treatment groups but not the 30-mg/d treatment group ( LS mean [ SE ] change , -1.24 [ 0.067 ] ; P = .88 ) compared with the placebo group .


Nontransformed mean ( SD ) days per week decreased for placebo and the 30 - , 50 - , and 70-mg/d treatment groups by -3.3 ( 2.04 ) , -3.5 ( 1.95 ) , -4.1 ( 1.52 ) , and -4.1 ( 1.57 ) , respectively .


The percentage of participants achieving 4-week BE cessation was lower with the placebo group ( 21.3 % ) compared with the 50-mg/d ( 42.2 % [ P = .01 ] ) and 70-mg/d ( 50.0 % [ P < .001 ] ) treatment groups .


The incidence of any treatment-emergent adverse events was 58.7 % for the placebo group and 84.7 % for the combined treatment group .


In the treatment groups , 1.5 % of participants had serious treatment-emergent adverse effects .


Events with a frequency of at least 5 % and changes in heart rate were generally consistent with the known safety profile .


The mean ( SD ) change in body weight was -0.1 ( 3.09 ) , -3.1 ( 3.64 ) , -4.9 ( 4.43 ) , -4.9 ( 3.93 ) , and -4.3 ( 4.09 ) kg for the placebo group , the 30 - , 50 - , and 70-mg/d treatment groups , and the combined treatment groups , respectively ( P < .001 for each dose vs placebo group comparison in post hoc analysis ) .


The 50 - and 70-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days , BE cessation , and global improvement .


The safety profile was generally consistent with previous findings in adults with attention-deficit/hyperactivity disorder .


Further investigation of lisdexamfetamine in BED is ongoing .


clinicaltrials.gov Identifier : NCT01291173 .


To investigate the safety and satisfaction of patients treated 14 days after unilateral bunionectomy with extended-release oxycodone/acetaminophen ( ER OC/APAP ) , a biphasic ( ER and immediate release ) fixed-dose combination analgesic being developed for moderate to severe acute pain .


This was an open-label extension ( OLE ) of a randomized , double-blind , placebo-controlled trial ( DBRCT ) of patients undergoing bunionectomy .


Patients who consented to the OLE before entering the 48 hour DBRCT entered the OLE upon completing the DBRCT and during the OLE received two tablets of ER OC/APAP ( 15/650mg total dose ) every 12 hours for 14 days .


ClinicalTrials identifier : NCT01484652 .


Treatment-emergent adverse events , physical examinations , vital sign measurements , and clinical laboratory testing were assessed throughout the study .


Global assessments of treatment satisfaction were made at the end of the DBRCT and at each clinic visit during the OLE .


A total of 146 patients consented to the OLE before entering the DBRCT and 129 completed the OLE .


Tolerability of ER OC/APAP during the OLE was consistent with that of an opioid product .


Adverse events occurred during the OLE in 64 patients ( 43.8 % ) ; the most common were gastrointestinal events including nausea ( 17.8 % ) , vomiting ( 7.5 % ) , and constipation ( 6.2 % ) .


No changes in vital signs or clinical laboratory tests were considered by the investigator to be clinically significant .


At all visits during the OLE , the majority of patients were satisfied or very satisfied with their medication .


Limitations include a 14 day postprocedure study duration that may be confounded with natural healing time , and lack of a placebo arm .


These results show that ER OC/APAP demonstrated an expected safety and tolerability profile and good patient satisfaction in a postsurgical model of acute pain .


To assess whether the addition of heated humidified gas ( HHG ) at delivery and until neonatal unit arrival improved admission temperatures of preterm infants .


This multicenter , randomized controlled trial was performed in New Zealand and The Netherlands .


Infants < 32 weeks ' gestation who required respiratory support after delivery were randomized to either cold , dry gas or HHG from birth .


Standard measures to prevent hypothermia included heated delivery rooms , the use of radiant warmers , body wrap , and head covering .


The primary outcome was axillary temperature in the normothermic ( 36.5-37 .5 C ) range on admission to a neonatal intensive care unit .


Secondary outcomes were measures of respiratory support and neonatal morbidities .


The effect of humidification was analyzed by the use of logistic regression .


Of 203 randomized infants , 100 received HHG ( humidifier set to 37C ) and 103 received cold , dry gas .


In the HHG group , 69 ( 69 % ) were normothermic compared with 57 ( 55 % ) in the cold , dry gas group ( unadjusted OR 1.8 , 95 % CI 1.01-3 .19 ) .


A greater number of infants < 28 weeks were normothermic on admission in the HHG group ( 24/35 ; ie , 69 % ) compared with the cold , dry gas group ( 16/38 ; ie , 42 % ; P = .03 ) .


In addition , 2 ( 2 % ) infants in the HHG group had admission temperatures < 35.5 C compared with 12 ( 12 % ) in the cold , dry gas group ( P = .007 ) .


Respiratory and short-term outcomes were not different .


Adding HHG during respiratory support in preterm infants from birth increased the incidence of normothermia at admission .


On-call duty ( OCD ) is frequently associated with health and safety risks for both physicians and patients .


The lack of studies conducted in clinical care environments and the ongoing public dialogue concerning OCD led to a detailed investigation of a working schedule including sleep fragmentation and extended work hours .


Within-person randomized cross-over trial .


Comparison of a 24h on-call shift ( OCD ) compared to a routine working-day ( non on call , NOC ) in hospital .


30 residents and senior physicians of the Department of Internal Medicine , Neurology and Otorhinolaryngology at the University Hospital Innsbruck .


Sleep variables , cognitive performance ( Concentration-Endurance d2 test ) , emotional status ( Eigenschaftswoerterliste 60S ) , serum-cortisol , urinary cortisol and noradrenaline , heart-rate variability , and saccadic eye movements were determined before and after OCD and NOC respectively .


Concentration-endurance performance was significantly reduced after OCD as compared to NOC by 16.4 % ( p < 0.001 ) .


Changes in emotional status consisted in a reduction of subjective concentration and performance related activation after OCD by 17.4 % ( p < 0.001 ) and 16.0 % ( p < 0.001 ) respectively together with a 21.8 % increase of general deactivation ( p < 0.001 ) and a 29.2 % rise of fatigue ( p < 0.001 ) .


On the contrary , subjective activation and raised mood showed an 18.3 % and 21.7 % increase after OCD ( p < 0.01 ) .


Urinary noradrenaline excretion ( 46 g/24 h , 19-97 ) was greater during OCD when compared to NOC ( 36 g/24 h , 10-54 , p < 0.01 ) .


Sympathetic activity measured by heart rate variability was significantly higher during OCD in contrast to NOC ( p < 0.05 ) .


Serum-cortisol was lower in the morning after ( 132 ng/l , 60-273 ) than the morning before OCD ( p < 0.01 ) .


Finally , the number of short saccadic latencies was reduced after OCD ( p < 0.05 ) compared to NOC .


24 h OCD alters both , the sympathetic-adrenomedullary system as well as the hypothalamic pituitary-adrenocortical axis .


Moreover , physicians ' emotional state , cognitive and oculomotor performance seems to be influenced independently from sleep interruptions .


The discrepancy between subjective feeling and objective cognitive impairments pose a risk for performing complex manual and cognitive tasks .


Hence , our findings argue against an oversimplified interpretation of alterations in the physicians ' psychoneuroendocrine structure in terms of impaired mood and neurocognitive deterioration combined with up - / dysregulated stress axes associated with OCD as a consequence of sleep deprivation .


Tooth loss affects oral health-related life quality .


More than a third of edentulous patients are not fully satisfied with their complete dentures and mainly complain of insufficient stability , retention , and pain during mastication .


Solving the problem may include relining by materials that are based on silicone or acrylic .


The aim of this study was to determine the level of patients ' satisfaction before and after relining upper dentures with soft and rigid liners .


The patients ( n = 24 ) were divided into two study groups .


Maxillary denture relining of the first group of patients was performed with hard acrylic based resins while in the second group of patients complete denture was relined with a silicone-based soft liner .


They were asked the questions from the specifically adapted the Oral Health Impact Profile Questionnaire for edentulous patients before and three months after relining dentures .


After relining the patients showed a higher degree of satisfaction with their dentures in all the tested domains ( masticatory function , psychological discomfort , social disability and retention and hygiene ) .


The padents with soft denture relines were more satisfied .


Refining of maxillary complete dentures significantly positively impacts the quality of life of patients in all the tested domains ( masticatory function , psychological discomfort , social disability , pain and oral hygiene ) .


Better results were achieved using a silicone-based soft liner , which recommends it as the material of choice for relining dentures .


Evidence that rider training reduces motorcycle-related injuries or crashes is currently lacking .


However , significant community demand for training persists , which in turn can influence policy .


The present study aims to contribute to the understanding of this demand via two objectives : to ( 1 ) offer a method , namely , contingent valuation , to measure the value motorcyclists place on training and ( 2 ) examine determinants of such value .


Value was elicited through a willingness to question , using a bidding format , novice motorcyclists who were randomly assigned to groups either offered the training or not .


The group that was offered and subsequently received training provided a lower mean perceived value of the training than the group that was not .


Perceived value increased with rider age and decreased with training participation and near-crash experiences , controlling for bidding order , income , education , and experience of other training .


This study demonstrates the utility of contingent valuation in quantifying the perceived value of training , as well as the modifiability of perceived value , with age , training participation , and near-crash experiences as key determinants .


This indicates that research to determine ways to align the perceived value with evidence on training effectiveness is worthwhile in order to facilitate more appropriate and justified allocation of road safety resources .


Potential options to explore and evaluate may include community education on evidence of training effectiveness as well as alternative measures with demonstrated effectiveness in reducing crash risks .


Earlier antiretroviral therapy ( ART ) initiation in cryptococcal meningitis resulted in higher mortality compared with deferred ART initiation ( 1-2 weeks vs 5 weeks postmeningitis diagnosis ) .


We hypothesized this was due to ART-associated immune pathology , without clinically recognized immune reconstitution inflammatory syndrome .


Three macrophage activation markers and 19 cytokines/chemokines were measured from cryopreserved cerebrospinal fluid ( CSF ) and serum during the Cryptococcal Optimal ART Timing ( COAT ) trial .


Comparisons were made between trial arms ( early vs deferred ) at 1 , 8 , 14 , and 21 days following meningitis diagnosis .


More participants with early ART initiation had CSF white cell count ( WCC ) 5/L at day 14 ( 58 % vs 40 % ; P = .047 ) , after a median of 6-days ART .


Differences were mainly driven by participants with CSF WCC < 5/L at meningitis diagnosis : 28 % ( 10/36 ) of such persons in the early ART group had CSF WCC 5/L by day 14 , compared with 0 % ( 0/27 ) in the deferred arm ( P = .002 ) .


Furthermore , Kampala participants ( the largest site ) receiving early ART had higher day-14 CSF levels of interleukin-13 ( P = .04 ) , sCD14 ( P = .04 ) , sCD163 ( P = .02 ) , and CCL3/MIP -1 ( P = .02 ) , suggesting increased macrophage/microglial activation .


Early ART initiation in cryptococcal meningitis increased CSF cellular infiltrate , macrophage/microglial activation , and T helper 2 responses within the central nervous system .


This suggests that increased mortality from early ART in the COAT trial was immunologically mediated .


Bronchiectasis is characterised by chronic cough , sputum production , and recurrent chest infections .


Pathogenesis is poorly understood , but excess neutrophilic airway inflammation is seen .


Accumulating evidence suggests that statins have pleiotropic effects ; therefore , these drugs could be a potential anti-inflammatory treatment for patients with bronchiectasis .


We did a proof-of-concept randomised controlled trial to establish if atorvastatin could reduce cough in patients with bronchiectasis .


Patients aged 18-79 years were recruited from a secondary-care clinic in Edinburgh , UK .


Participants had clinically significant bronchiectasis ( ie , cough and sputum production when clinically stable ) confirmed by chest CT and two or more chest infections in the preceding year .


Individuals were randomly allocated to receive either high-dose atorvastatin ( 80 mg ) or a placebo , given orally once a day for 6 months .


Sequence generation was done with a block randomisation of four .


Random allocation was masked to study investigators and patients .


The primary endpoint was reduction in cough from baseline to 6 months , measured by the Leicester Cough Questionnaire ( LCQ ) score , with a lower score indicating a more severe cough ( minimum clinically important difference , 13 units ) .


Analysis was done by intention-to-treat .


The trial is registered with ClinicalTrials.gov , number NCT01299181 .


Between June 23 , 2011 , and Jan 30 , 2011 , 82 patients were screened for inclusion in the study and 22 were excluded before randomisation .


30 individuals were assigned atorvastatin and 30 were allocated placebo .


The change from baseline to 6 months in LCQ score differed between groups , with a mean change of 15 units in patients allocated atorvastatin versus -07 units in those assigned placebo ( mean difference 22 , 95 % CI 05-39 ; p = 001 ) .


12 ( 40 % ) of 30 patients in the atorvastatin group improved by 13 units or more on the LCQ compared with five ( 17 % ) of 30 in the placebo group ( difference 23 % , 95 % CI 1-45 ; p = 004 ) .


Ten ( 33 % ) patients assigned atorvastatin had an adverse event versus three ( 10 % ) allocated placebo ( difference 23 % , 95 % CI 3-43 ; p = 002 ) .


No serious adverse events were recorded .


6 months of atorvastatin improved cough on a quality-of-life scale in patients with bronchiectasis .


Multicentre studies are now needed to assess whether long-term statin treatment can reduce exacerbations .


Chief Scientist 's Office .


An association between GB virus C ( GBV-C ) and improved outcomes of human immunodeficiency virus ( HIV ) infection has been reported in HIV-positive individuals with active GBV-C coinfection .


This study provides insights into the immune mechanisms underlying the protective role of GBV-C in HIV-infected patients .


The concentrations of 64 cytokines and chemokines were measured in plasma samples obtained from the Viral Activation Transfusion Study cohort before transfusion and longitudinally from 30 patients positive for both HIV and GBV-C ( hereafter , `` cases '' ) and 30 patients positive for HIV and negative for GBV-C ( hereafter , `` controls '' ) .


Cases had lower HIV viral loads and higher CD4 T-cell counts than controls after acquisition of GBV-C infection .


Most of the modulated cytokines and chemokines were reduced after GBV-C detection , including many proinflammatory cytokines , suggesting an overall antiinflammatory effect of GBV-C in HIV-positive subjects .


Most pathways and functions of the measured cytokines were downregulated in cases , except cell death pathways , which were upregulated in various cell subsets in the 3 months after GBV-C detection .


GBV-C has a protective effect , in part through a competition mechanism leading to decreased inflammation and improved HIV disease outcome in cases .


Further studies are necessary to establish whether GBV-C may have deleterious effects on the host at the cellular level , including depleting the cells that are the targets of HIV .


Atrial fibrillation and heart failure with reduced left ventricular ejection fraction have interrelated pathophysiologies .


New-onset atrial fibrillation in heart failure patients has been associated with increased mortality , but has not been definitively related to clinical heart failure progression .


To test the hypothesis that new-onset atrial fibrillation is related to clinical heart failure progression , in 2392 patients without atrial fibrillation at randomization in the Beta-blocker Evaluation of Survival Trial we measured clinical endpoints in patients who did ( Group 1 , n = 190 ) or did not ( Group 2 , n = 2202 ) develop new-onset atrial fibrillation .


Results were also compared with the 303 patients who entered the trial in atrial fibrillation ( Baseline/chronic group ) , and in Group 1/2 patients we conducted a multivariate analysis of covariates potentially related to time to first heart failure hospitalization .


Compared with Group 2 , Group 1 patients post atrial fibrillation onset had a 2-fold increase in mortality ( P < .0001 ) and a 4.5-fold increase in all-cause or heart failure hospitalization days/patient ( hospitalization burden , both P < .0001 ) .


In Group 1 , both types of hospitalization burden were 2.9-fold greater than in the Baseline/chronic group ( P < .001 ) , and hospitalization burden increased 6-fold ( P < .0001 ) compared with the pre-event period .


On multivariate analysis , new-onset atrial fibrillation was a highly significant ( P < .00001 ) predictor of heart failure hospitalization .


In addition to being a discrete electrophysiologic event , in heart failure patients , new-onset atrial fibrillation is a predictor of and trigger for clinical heart failure progression .


Neoadjuvant endocrine therapy with an aromatase inhibitor has shown efficacy comparable to that of neoadjuvant chemotherapy in patients with postmenopausal breast cancer .


Preclinical and clinical studies have shown that the antidiabetic drug metformin has anti-tumor activity .


This prospective , multicenter , phase II randomized , placebo controlled trial was designed to evaluate the direct anti-tumor effect of metformin in non-diabetic postmenopausal women with estrogen-receptor ( ER ) positive breast cancer .


Patients meeting the inclusion criteria and providing written informed consent will be randomized to 24 weeks of neoadjuvant treatment with letrozole ( 2.5 mg/day ) and either metformin ( 2000 mg/day ) or placebo .


Target accrual number is 104 patients per arm .


The primary endpoint will be clinical response rate , as measured by calipers .


Secondary endpoints include pathologic complete response rate , breast conserving rate , change in Ki67 expression , breast density change , and toxicity profile .


Molecular assays will be performed using samples obtained before treatment , at week 4 , and postoperatively .


This study will provide direct evidence of the anti-tumor effect of metformin in non-diabetic , postmenopausal patients with ER-positive breast cancer .


ClinicalTrials.gov Identifier NCT01589367 .


Investigate the effect of inhaling 1600 g salbutamol for 6 weeks on endurance , strength , and power performances .


Randomized double-blind , mixed-model repeated measures .


Sixteen male athletes ( mean SD : age , 20.1 1.6 years ; height , 179.9 8.2 cm ; weight , 74.6 9.1 kg ) .


Participants were assigned to either a placebo inhaler ( PLA ) or inhaled 1600 g salbutamol group ( SAL ) .


Over 6 weeks , participants inhaled PLA or SAL and completed 4 training sessions per week that focused on endurance , strength , and power .


Participants completed the assessments of peak oxygen consumption ( V [ Combining Dot Above ] O2peak ) , 3-km time trial , vertical jump height , 1 repetition maximum ( 1RM ) bench and leg press , and peak torque knee flexion and extension .


Assessments were undertaken at baseline , week 3 , and week 6 .


Over the 6 weeks , PLA and SAL groups improved V [ Combining Dot Above ] O2peak ( 51.7 4.7 vs 56.8 7.1 mLminkg ; 53.1 6.1 vs 55.0 6.7 mLminkg ) ; 3-km running time trial ( 988.6 194.6 vs 947.5 155.5 seconds ; 1040.4 187.4 vs 1004.2 199.4 seconds ) ; 1RM bench press ( 65.7 15.4 vs 70.3 13.8 kg ; 64.3 14.0 vs 72.5 15.3 kg ) ; and leg press ( 250.0 76.4 vs 282.5 63.6 kg ; 217.9 54.0 vs 282.8 51.9 kg ) .


The SAL group did not improve significantly greater in any endurance or strength and power measure when compared with the PLA group .


Inhaling 1600 g salbutamol daily over 6 weeks does not result in significant improvements in endurance , or strength and power performances .


Athletes using inhaled salbutamol to treat bronchoconstriction during exercise on a daily basis will not gain an advantage over nonasthmatic athletes not using inhaled salbutamol .


Neurology is complex , abstract , and difficult for students to learn .


However , a good learning method for neurology clerkship training is required to help students quickly develop strong clinical thinking as well as problem-solving skills .


Both the traditional lecture-based learning ( LBL ) and the relatively new team-based learning ( TBL ) methods have inherent strengths and weaknesses when applied to neurology clerkship education .


However , the strengths of each method may complement the weaknesses of the other .


Combining TBL with LBL may produce better learning outcomes than TBL or LBL alone .


We propose a hybrid method ( TBL+LBL ) and designed an experiment to compare the learning outcomes with those of pure LBL and pure TBL .


One hundred twenty-seven fourth-year medical students attended a two-week neurology clerkship program organized by the Department of Neurology , Sun Yat-Sen Memorial Hospital .


All of the students were from Grade 2007 , Department of Clinical Medicine , Zhongshan School of Medicine , Sun Yat-Sen University .


These students were assigned to one of three groups randomly : Group A ( TBL+LBL , with 41 students ) , Group B ( LBL , with 43 students ) , and Group C ( TBL , with 43 students ) .


The learning outcomes were evaluated by a questionnaire and two tests covering basic knowledge of neurology and clinical practice .


The practice test scores of Group A were similar to those of Group B , but significantly higher than those of Group C.


The theoretical test scores and the total scores of Group A were significantly higher than those of Groups B and C.


In addition , 100 % of the students in Group A were satisfied with the combination of TBL+LBL .


Our results support our proposal that the combination of TBL+LBL is acceptable to students and produces better learning outcomes than either method alone in neurology clerkships .


In addition , the proposed hybrid method may also be suited for other medical clerkships that require students to absorb a large amount of abstract and complex course materials in a short period , such as pediatrics and internal medicine clerkships .


To study the short-term response and tolerance of different doses of amino acids in parenteral nutrition among preterm infants .


This study included 86 preterm infants who had a birth weight between 1000 to 2000g and were admitted to the hospital within 24 hours of birth between March 2013 and June 2014 .


According to the early application of different doses of amino acids , they were randomized into low-dose group ( n = 29 , 1.0 g/kg per day with an increase of 1.0 g/kg daily and a maximum of 3.5 g/kg per day ) , medium-dose group ( n = 28 , 2.0 g/kg per day with an increase of 1.0 g/kg daily and a maximum of 3.7 g/kg per day ) , and high-dose group ( n = 29 , 3.0 g/kg per day with an increase of 0.5-1 .0 g/kg daily and a maximum of 4.0 g/kg per day ) .


Other routine parenteral nutrition and enteral nutrition support were also applied .


The maximum weight loss was lower and the growth rate of head circumference was greater in the high-dose group than in the low-dose group ( P < 0.05 ) .


The infants in the medium - and high-dose groups had faster recovery of birth weight , earlier attainment of 100 kcal / ( kgd ) of enteral nutrition , shorter duration of hospital stay , and less hospital cost than those in the low-dose group ( P < 0.05 ) .


Blood urea nitrogen ( BUN ) levels in the high-dose group increased compared with the other two groups 7 days after birth ( P < 0.05 ) .


The levels of creatinine , pH , bicarbonate , bilirubin , and transaminase and the incidence of complications showed no significant differences between groups ( P > 0.05 ) .


Parenteral administration of high-dose amino acids in preterm infants within 24 hours after birth can improve the short-term nutritional status of preterm infants , but there is a transient increase in BUN level .


Prospective randomized studies comparing internal fixation and a cemented hip replacement in the treatment of displaced femoral neck fractures have shown favorable short-term results for prosthetic replacement .


The present report compares the results after a minimum of fifteen years .


From 1994 to 1998 , 143 patients ( 146 hips ) were randomized to closed reduction and internal fixation with two screws ( n = 78 ) or a cemented total hip replacement ( n = 68 ) .


The average age of the patients was eighty-four years ( range , seventy-five to 101 years ) , and 38 % were classified as mentally impaired .


Failure after internal fixation was defined as early redisplacement , nonunion , symptomatic segmental collapse , or deep infection .


In the arthroplasty group , failure was defined as two dislocations or more , implant loosening , deep infection , or a periprosthetic fracture .


For the lucid patients , the failure rate was 55 % after internal fixation compared with 5 % after total hip replacement .


For patients with mental impairment , it was 16 % in both groups .


Total hip replacement is superior to internal fixation in the treatment of a displaced femoral neck fracture .


Ultrasound-guided needle placement is a widely used technical skill that can be challenging to learn .


The SonixGPS is a novel ultrasound needle-tracking system that has the potential to improve performance over traditional ultrasound systems .


The objective of our study was to determine if the use of the SonixGPS ultrasound system improves performance of novice practitioners in ultrasound-guided needle placement compared with conventional ultrasound in the out-of-plane approach on a simulation model .


Twenty-six medical students without previous ultrasound experience were randomized into 2 groups .


Each group performed 30 simulated ultrasound nerve blocks on a porcine meat tissue simulation ( phantom ) model .


Both groups used the SonixGPS ultrasound ; however , the study group had the needle-tracking system activated , whereas the control group did not .


The participants were assessed for success rate , technical aspects of block performance , and certain behaviors that could compromise the quality of the block .


Learning curves were developed to assess competence .


The needle guidance group reached competence more often .


This group had fewer attempts and quality-compromising behaviors than did those using conventional ultrasound .


Use of the SonixGPS ultrasound needle guidance system improves the performance of technical needling skills of novice trainees in an ex vivo model .


The place of this technology in the wider education of ultrasound-guided regional anesthesia remains to be established .


To compare a comprehensive lifestyle intervention for overweight children performed in groups of families with a conventional single-family treatment .


Two-year follow-up data on anthropometric and psychological outcome are presented .


Overweight and obese children aged 6-12years with body mass index ( BMI ) corresponding to 27.5 kg/m ( 2 ) in adults were randomised to multiple-family ( n = 48 ) or single-family intervention ( n = 49 ) in a parallel design .


Multiple-family intervention comprised an inpatient programme with other families and a multidisciplinary team , follow-up visits in their hometown , weekly physical activity and a family camp .


Single-family intervention included counselling by paediatric nurse , paediatric consultant and nutritionist at the hospital and follow-up by a community public health nurse .


Primary outcome measures were change in BMI kg/m ( 2 ) and BMI SD score after 2years .


BMI increased by 1.29 kg/m ( 2 ) in the multiple-family intervention compared with 2.02 kg/m ( 2 ) in the single-family intervention ( p = 0.075 ) .


BMI SD score decreased by 0.20 units in the multiple-family group and 0.08 units in the single-family intervention group ( p = 0.046 ) .


A between-group difference of 2.4 cm in waist circumference ( p = 0.038 ) was detected .


Pooled data from both treatment groups showed a significant decrease in BMI SD score of 0.14 units and a significant decrease in parent-reported and self-reported Strength and Difficulty Questionnaire total score of 1.9 units .


Two-year outcome showed no between-group difference in BMI .


A small between-group effect in BMI SD score and waist circumference favouring multiple-family intervention was detected .


Pooled data showed an overall improvement in psychological outcome measures and BMI SD score .


NCT00872807 , http://www.clinicaltrials.gov .


Patients can potentially monitor disease activity of RA through self-assessed swollen joints ( clinical synovitis ) , but reliability is poor .


The objective is to evaluate the use of education by US feedback on the ability of patients to assess for clinical synovitis in RA .


We performed a 6 month , single-centre , randomized controlled trial on patients with established RA to study the effect of education on self-assessment of joints that included initial brief patient training on tender ( TJC ) and swollen ( SJC ) joint counts followed by US feedback every 3 months vs standard care without education .


Patient and physician independently performed 28-joint counts at each visit .


Outcome variables included the percentage of patients with good agreement with physician-derived swollen joints [ prevalence-adjusted bias-adjusted kappa ( PABAK ) > 0.6 ] as well as agreement in the SJC ( Bland and Altman 95 % limits of agreement ) , feasibility/patient satisfaction survey and disease activity at 6 months .


Of the 101 randomized patients , 95 were included ( 51 in the education arm and 44 in the standard care arm ) .


At 6 months there was a significant difference in the proportion of patients with swollen joint PABAK > 0.6 in the education arm compared with standard care ( 98 vs 85 % , P = 0.02 ) .


Limits of agreement for the SJC difference between physician and patients were reduced only in the education arm .


The training method is considered feasible , with 94 % of patients reporting it as useful .


A trend of higher rates of disease remission ( 28-joint DAS < 2.6 ) in the education arm vs standard care ( 47 % vs 29 % , P = 0.07 ) was seen .


A short course of education with US feedback may be helpful in educating patients to assess for clinical synovitis .


Clinical trials.gov , https://clinicaltrials.gov , NCT02351401 .


Transient lower esophageal sphincter relaxation ( TLESR ) is the major mechanism of gastroesophageal reflux ( GER ) but the regulation of TLESR by stimuli in the esophagus is incompletely understood .


If stimuli in the esophagus can influence TLESR , then such regulation may perpetuate or limit GER .


We addressed the hypothesis that acid in the esophagus enhances TLESRs .


We evaluated the effect of acid infusion into the distal esophagus on TLESRs evoked by a standard meal in a paired randomized study in healthy subjects .


TLESRs were evaluated by using high resolution manometry ( HRM ) .


We found that acid in the esophagus enhanced meal-induced TLESRs .


Compared to control infusion the number of TLESRs ( median [ interquartile range ] ) was increased during 2h following the acid infusion ( 11 [ 9-14 ] vs 17 [ 12.5-20 ] , p < 0.01 ) .


The average duration of individual TLESRs was not affected .


The time-course analysis revealed that a robust increase in TLESRs occurred already in the first hour when the number of TLESRs nearly doubled ( 6 [ 5.5-7 .5 ] vs 11 [ 7.5-12 .5 ] , p < 0.05 ) .


In contrast to the enhancement of TLESRs , the number of swallows was not changed .


The acid infusion into the esophagus increases the number of meal-induced TLESRs in healthy subjects .


Our results provide evidence for the concept that the stimuli in the esophagus can influence TLESRs .


The regulation of TLESR by stimuli in the esophagus may contribute to pathogenesis of GER in some patients .


Previously we conducted a double-blind controlled , randomized efficacy field trial of gD-2 HSV vaccine adjuvanted with ASO4 in 8323 women .


Subjects had been previously selected to be seronegative for HSV-1 and HSV-2 .


We found that vaccine was 82 % protective against HSV-1 genital disease , but offered no significant protection against HSV-2 genital disease .


To better understand the results of the efficacy study , post-vaccination anti-gD-2 antibody concentrations from all HSV infected subjects and matched uninfected controls were measured .


Three models were used to determine whether thes responses correlated with protection against HSV infection or disease .


Similarly , cellular immune responses from a subset of subjects and matched controls were evaluated for a correlation with HSV protection .


Antibodies to gD-2 correlated with protection against HSV-1 infection with higher antibody concentration associated with higher efficacy .


Cellular immune responses to gD-2 did not correlate with protection .


The protection against HSV-1 infection observed in the Herpevac Trial for Women was associated with antibodies directed against the vaccine .


Clinical Trials RegistrationNCT00057330 .


People with substance use disorders who present with suicidal behavior are at high risk of subsequent suicide .


There are few effective treatments specifically tailored for this population that diminish this risk .


We aimed to assess the impact of an opportunistic cognitive behavioral intervention package ( OCB ) among adult outpatients with a substance use and comorbid suicide risk .


A randomized controlled trial was conducted across 2 sites in which 185 patients presenting with suicide risk and concurrent substance use received either OCB ( 8 sessions plus group therapy ) or treatment as usual ( TAU ) over a 6-month period .


Primary outcomes were suicidal behavior ( suicide attempts , suicidal intent and presence of suicide ideation ) and level of drug and alcohol consumption .


Secondary outcomes were changes in psychological measures of suicide ideation , depression , anxiety , and self-efficacy .


There were no completed suicides , and only 2 participants reported suicide attempts at follow-up .


Suicide ideation , alcohol consumption , and cannabis use fell over time but no significant Treatment Time differences were found .


There were also no differences between OCB and TAU over time on psychological measures of depression , anxiety , or self-efficacy .


Suicide ideation at 6-month follow-up was predicted by cannabis use and higher scores on the Brief Psychiatric Rating Scale at baseline .


The opportunistic cognitive behavioral intervention package did not appear to be beneficial in reducing suicide ideation , drug and alcohol consumption , or depression relative to treatment as usual .


To compare bariatric surgery versus intensive medical weight management ( MWM ) in patients with type 2 diabetes mellitus ( T2DM ) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products ( sRAGE ) is a biomarker to identify patients most likely to benefit from surgery .


There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35 .


Fifty-seven patients with T2DM and BMI 30 to 35 , who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery ( bypass , sleeve or band , based on patient preference ) .


The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance ( HOMA-IR ) and diabetes remission .


Secondary outcomes included changes in HbA1c , weight , and sRAGE .


The surgery group had improved HOMA-IR ( -4.6 vs +1.6 ; P = 0.0004 ) and higher diabetes remission ( 65 % vs 0 % , P < 0.0001 ) than the MWM group at 6 months .


Compared to MWM , the surgery group had lower HbA1c ( 6.2 vs 7.8 , P = 0.002 ) , lower fasting glucose ( 99.5 vs 157 ; P = 0.0068 ) , and fewer T2DM medication requirements ( 20 % vs 88 % ; P < 0.0001 ) at 6 months .


The surgery group lost more weight ( 7 .


vs 1.0 BMI decrease , P < 0.0001 ) .


Higher baseline sRAGE was associated with better weight loss outcomes ( r = -0.641 ; P = 0.046 ) .


There were no mortalities .


Surgery was very effective short-term in patients with T2DM and BMI 30 to 35 .


Baseline sRAGE may predict patients most likely to benefit from surgery .


These findings need to be confirmed with larger studies.ClinicalTrials.gov ID : NCT01423877 .


Susceptibility to encapsulated bacteria is well known in sickle cell disease ( SCD ) .


Hydroxyurea use is common in adults and children with SCD , but little is known about hydroxyurea 's effects on immune function in SCD .


Because hydroxyurea inhibits ribonucleotide reductase , causing cell cycle arrest at the G1-S interface , we postulated that hydroxyurea might delay transition from naive to memory T cells , with inhibition of immunologic maturation and vaccine responses .


T-cell subsets , naive and memory T cells , and antibody responses to pneumococcal and measles , mumps , and rubella vaccines were measured among participants in a multicenter , randomized , double-blind , placebo-controlled trial of hydroxyurea in infants and young children with SCD ( BABY HUG ) .


Compared with placebo , hydroxyurea treatment resulted in significantly lower total lymphocyte , CD4 , and memory T-cell counts ; however , these numbers were still within the range of historical healthy controls .


Antibody responses to pneumococcal vaccination were not affected , but a delay in achieving protective measles antibody levels occurred in the hydroxyurea group .


Antibody levels to measles , mumps , and rubella showed no differences between groups at exit , indicating that effective immunization can be achieved despite hydroxyurea use .


Hydroxyurea does not appear to have significant deleterious effects on the immune function of infants and children with SCD .


Additional assessments of lymphocyte parameters of hydroxyurea-treated children may be warranted .


No changes in current immunization schedules are recommended ; however , for endemic disease or epidemics , adherence to accelerated immunization schedules for the measles , mumps , and rubella vaccine should be reinforced .


To evaluate acupuncture as treatment for glaucoma .


Prospective double-masked randomized crossover study .


setting : Clinical practice .


One eye per patient with primary open-angle glaucoma and stable intraocular pressure ( IOP ) .


Patients were randomized to receive 1 acupuncture series ( 12 sessions with either eye-related [ eye-points ] or non-eye-related [ non-eye-points ] acupoints ) and then crossed over to receive the other series .


IOP , blood pressure ( BP ) , heart rate ( HR ) , best-corrected visual acuity ( BCVA ) , visual field ( VF ) , optic disc and peripapillary retinal nerve fiber layer ( RNFL ) measurements , compliance , and adverse reactions .


Probability to detect 3 mm Hg IOP difference between series was 90 % .


Twenty-two patients volunteered and 11 ( 50.0 % ) completed the study ; 8 ( 36.4 % ) did not complete treatment owing to changes of health , moving away , lack of transportation , or family crisis ; and 3 ( 13.6 % ) were withdrawn owing to needle sensitivity or IOP elevation ( 8 mm Hg ) in the contralateral eye .


After an acupuncture session , mean IOP increased slightly with both eye-points ( from 12.9 1.8 mm Hg to 13.6 2.0 mm Hg , P = .019 ) and non-eye-points ( from 13.0 1.5 mm Hg to 13.5 1.7 mm Hg , P = .073 ) series .


HR , diurnal IOP , and BCVA showed no statistically significant changes after 12 sessions of either series .


Systolic and diastolic BP were reduced after 12 sessions of non-eye-points series ( P = .040 , P = .002 , respectively ) .


Optic disc , RNFL , and VF showed no statistically significant changes .


Acupuncture has no overall effect on diurnal IOP or BCVA but may temporally increase the IOP immediately after a treatment session .


BP is lowered by acupuncture with non-eye-points , but not with eye-points .


Compliance and adverse event rates were low .


Scarce data are available on the effect of the traditional Mediterranean diet ( TMD ) on heart failure biomarkers .


We assessed the effect of TMD on biomarkers related to heart failure in a high cardiovascular disease risk population .


A total of 930 subjects at high cardiovascular risk ( 420 men and 510 women ) were recruited in the framework of a multicentre , randomized , controlled , parallel-group clinical trial directed at testing the efficacy of the TMD on the primary prevention of cardiovascular disease ( The PREDIMED Study ) .


Participants were assigned to a low-fat diet ( control , n = 310 ) or one of two TMDs [ TMD + virgin olive oil ( VOO ) or TMD + nuts ] .


Depending on group assignment , participants received free provision of extra-virgin olive oil , mixed nuts , or small non-food gifts .


After 1year of intervention , both TMDs decreased plasma N-terminal pro-brain natriuretic peptide , with changes reaching significance vs. control group ( P < 0.05 ) .


Oxidized low-density lipoprotein decreased in both TMD groups ( P < 0.05 ) , the decrease in TMD+VOO group reaching significance vs. changes in control group ( P = 0.003 ) .


Changes in lipoprotein ( a ) after TMD+VOO were less than those in the control group ( P = 0.046 ) in which an increase ( P = 0.035 ) was observed .


No changes were observed in urinary albumin or albumin/creatinine ratio .


Individuals at high risk of cardiovascular disease ( CVD ) who improved their diet toward a TMD pattern reduced their N-terminal pro-brain natriuretic peptide compared with those assigned to a low-fat diet .


The same was found for in vivo oxidized low-density lipoprotein and lipoprotein ( a ) plasma concentrations after the TMD+VOO diet .


From our results TMD could be a useful tool to mitigate against risk factors for heart failure .


From our results TMD could modify markers of heart failure towards a more protective mode .


Previous qualitative research among adults and parents of children with phenylketonuria ( PKU ) has identified inattention as an important psychiatric aspect of this condition .


The parent-reported ADHD Rating Scale-IV ( ADHD RS-IV ) and the Adult ADHD Self-Report Scale ( ASRS ) have been validated for measuring inattention symptoms in persons with attention-deficit/hyperactivity disorder ( ADHD ) ; however , their psychometric attributes for measuring PKU-related inattention have not been established .


The primary objective of this investigation was to demonstrate the reliability , validity , and responsiveness of the ADHD RS-IV and ASRS inattention symptoms subscales in a randomized controlled trial of patients with PKU aged 8 years or older .


A post hoc analysis investigated the psychometric properties ( Rasch model fit , reliability , construct validity , and responsiveness ) of the ADHD RS-IV and ASRS inattention subscales using data from a phase 3b , double-blind , placebo-controlled clinical trial in those with PKU aged 8 years or older .


The Rasch results revealed good model fit , and reliability analyses revealed strong internal consistency reliability ( 0.87 ) and reproducibility ( intraclass correlation coefficient 0.87 ) for both measures .


Both inattention measures demonstrated the ability to discriminate between known groups ( P < 0.001 ) created by the Clinical Global Impression-Severity scale .


Correlations between the ADHD RS-IV and the ASRS with the Clinical Global Impression-Severity scale and the age-appropriate Behavior Rating Inventory of Executive Function Working Memory subscale were consistently moderate to strong ( r 0.56 ) .


Similarly , results of the change score correlations were of moderate magnitude ( r 0.43 ) for both measures when compared with changes over time in Behavior Rating Inventory of Executive Function Working Memory subscales .


These findings of reliability , validity , and responsiveness of both the ADHD RS-IV and the ASRS inattention scales , in addition to content validation results , support their use for the assessment of inattention symptoms among persons with PKU aged 8 years or older in both clinical and research settings .


To evaluate the relationship between lipid content and plaque morphometry as well as the process of lesion progression and regression in patients with significant coronary artery disease .


The present study , using data from the YELLOW trial , was conducted in patients having significant coronary lesions ( fractional flow reserve < 0.8 ) who underwent serial intravascular ultrasound ( IVUS ) and near-infrared spectroscopy ( NIRS ) at baseline and after 7 weeks .


For each coronary plaque ( 50 % plaque burden that was 5 mm in length ) , we evaluated plaque characteristics and the extent of lipid-rich plaque [ LRP , defined as the 4 mm long segment with the maximum lipid-core burden index ( maxLCBI4 mm ) ] on NIRS .


Among 66 patients ( age 63.0 10.1 years ; 82 % statin use at baseline ) , 94 plaques were identified .


The extent of LRP at baseline was positively correlated with IVUS plaque burden ( r = 0.317 , P = 0.002 ) .


A large LRP ( maxLCBI4 mm 500 ) was present only in plaques with a large plaque burden ( 70 % ) .


Multivariate analysis demonstrated that plaque burden was the best predictor of the extent of LRP ( P < 0.001 ) .


In lesions with a large plaque burden and a large amount of LRP at baseline , a reduction in LRP was seen in all lesions in patients receiving intensive statin therapy ( P = 0.004 ) without a significant change in plaque burden .


Coronary lesions containing a large amount of LRP also had a large plaque burden .


Short-term regression of LRP ( without a change in plaque burden ) was observed mainly in plaques with a large plaque burden and a large amount of LRP at baseline .


http://www.clinicaltrials.gov .


Unique identifier : NCT01567826 .


High blood pressure is common in acute stroke and associated with a worse functional outcome .


Many patients who present with acute stroke are taking prescribed antihypertensive therapy before their stroke .


ENOS tested whether lowering blood pressure and continuing pre-stroke antihypertensive therapy are each safe and effective .


This study is an international multi-centre prospective randomized single-blind blinded-endpoint parallel-group partial-factorial controlled trial of transdermal glyceryl trinitrate ( a nitric oxide donor , given for seven-days ) vs. no glyceryl trinitrate , and of continuing vs. stopping ( temporarily for seven-days ) pre-stroke antihypertensive drugs if relevant , inpatients with acute ischaemic stroke or intracerebral haemorrhage and high systolic blood pressure ( 140220 mmHg ) .


Recruitment ran from July 2001 to October 2013 .


Four thousand eleven patients [ 2097 ( 523 % ) in the continue/stop arm ] were recruited from 173 sites across 23 countries in 5 continents ( Asia 14 % , Continental Europe 16 % , UK 64 % ) .


Baseline characteristics include : mean age 70 ( standard deviation 12 ) years ; male 57 % ; mean time from stroke to recruitment 26 ( 13 ) h ; mean severity ( Scandinavian Stroke Scale ) 34 ( 13 ) of 58 ; mean blood pressure 167 ( 19 ) / 90 ( 13 ) mmHg ; ischaemic stroke 83 % ; and intracerebral haemorrhage 16 % .


The main trial results will be presented in May 2014 .


The results will also be presented in updated Cochrane systematic reviews and included in individual patient data meta-analyses of all relevant randomized controlled trials .


ENOS is a large completed international trial of blood pressure management in acute stroke and includes patients representative of many stroke services worldwide .


To assess the role of pelvic plexus block ( PPB ) in reducing pain during transrectal ultrasonography ( TRUS ) - guided prostate biopsy , compared with the conventional periprostatic nerve block ( PNB ) .


A prospective , double-blind observational study was conducted with patients being randomised into three groups .


Group-1 ( 47 patients ) received intrarectal local anaesthesia ( IRLA ) with 10 mL 2 % lignocaine jelly along with pelvic plexus block ( PPB ) with 2.5 mL 2 % lignocaine injection bilaterally .


Group-2 ( 46 patients ) received IRLA with periprostatic nerve block ( PNB ) .


Group-3 ( 46 patients ) received only IRLA without any type of nerve block .


The patients were requested to rate the level of pain from 0 to 10 on a visual analogue scale ( VAS ) at two time points : VAS-1 : during biopsy procedure and VAS-2 : 30 min after the procedure .


The mean age of the patients , mean volume of the prostates and mean serum PSA values were comparable among the three groups .


The mean pain score during biopsy was significantly less in the PPB group [ mean ( range ) sore of 2.91 ( 2-4 ) ] compared with the PNB group [ mean ( range ) score of 4 ( 3-5 ) ] , and both these groups were superior to the no nerve block group [ mean score of 5.4 ( 3-7 ) ] .


There was no significant difference between the mean pain scores , 30 min after the procedure among the three groups with the mean ( range ) scores being 2.75 ( 2-4 ) , 2.83 ( 2-4 ) and 2.85 ( 2-4 ) , respectively .


PPB is superior to conventional periprostatic nerve block ( PNB ) for pain control during TRUS-guided biopsy and both are in turn superior to no nerve block .


To study the effects of four different rigid alignment approaches on both time-concentration curves ( TCCs ) and perfusion maps in computed tomography perfusion ( CTp ) studies of liver and lung tumors .


Eleven data sets in patients who were subjected to axial CTp after contrast agent administration were assessed .


Each data set consists of four different sequences , according to the different rigid alignment configurations considered to compute blood flow perfusion maps : no alignment , translational , craniocaudal , and three dimensional ( 3D ) .


The color maps were built on TCCs according to the maximum slope method .


The effects of motion correction procedures on the reliability of TCCs and perfusion maps were assessed both quantitatively and visually .


TCCs built after 3D alignments show the best indices as well as producing the most reliable maps .


We show examinations in which the translational alignment only yields more accurate TCCs , but less reliable perfusion maps , than those achieved with no alignment .


Furthermore , we show color maps with two different perfusion patterns , both considered reliable by radiologists , achieved with different motion correction approaches .


The quantitative index we conceived allows relating quality of 3D alignment and reliability of perfusion maps .


A better alignment does not necessarily yield more reliable perfusion values : color maps resulting from either alignment procedure must be critically assessed by radiologists .


This achievement will hopefully represent a step forward for the clinical use of CTp studies for staging , prognosis , and monitoring values of therapeutic regimens .


The purpose of this study was to explore the effectiveness and safety of three-dimensional ( 3D ) digitalized planning for the sural neurovascular island flap in repair of soft tissue defects in the ankle and foot .


This study included 40 patients with soft tissue defects of the ankle and foot who underwent soft tissue reconstruction between October 2008 and June 2012 .


The patients were randomly assigned into two groups : 3D-reconstruction group ( Group A , n = 20 ) and control group ( Group B , n = 20 ) .


Three-dimensional , digitalized virtual planning was performed in the patients in Group A , who underwent computed topographic angiography .


The survival rate , operation time , and surgical accuracy were compared between the two groups .


All flaps in Group A survived and the recipient site primarily healed , but 4 flaps in Group B had marginal necrosis after the operation .


During the 6-12 month follow-up period , all flaps in Group A had good skin quality .


In Group B , hard scarring and mild contracture occurred in 4 cases , and the patients experienced pain when walking .


The survival rate of the flap in Group A ( 100 % ) was significantly higher than in Group B ( 70 % ) .


The operation time in Group A was significantly less than in Group B.


The surgical accuracy in Group A was significantly better than in Group B.


The preoperative use of 3D digitalized virtual planning for the sural neurovascular island flap improves the surgical accuracy , decreases the operation time , and increases the survival rate of the flap .


Therapeutic III .


To evaluate clinical remission with subcutaneous abatacept plus methotrexate ( MTX ) and abatacept monotherapy at 12months in patients with early rheumatoid arthritis ( RA ) , and maintenance of remission following the rapid withdrawal of all RA treatment .


In the Assessing Very Early Rheumatoid arthritis Treatment phase 3b trial , patients with early active RA were randomised to double-blind , weekly , subcutaneous abatacept 125mg plus MTX , abatacept 125mg monotherapy , or MTX for 12months .


Patients with low disease activity ( Disease Activity Score ( DAS ) 28 ( C reactive protein ( CRP ) ) < 3.2 ) at month 12 entered a 12-month period of withdrawal of all RA therapy .


The coprimary endpoints were the proportion of patients with DAS28 ( CRP ) < 2.6 at month 12 and both months 12 and 18 , for abatacept plus MTX versus MTX .


Patients had < 2years of RA symptoms , DAS28 ( CRP ) 3.2 , anticitrullinated peptide-2 antibody positivity and 95.2 % were rheumatoid factor positive .


For abatacept plus MTX versus MTX , DAS28 ( CRP ) < 2.6 was achieved in 60.9 % versus 45.2 % ( p = 0.010 ) at 12months , and following treatment withdrawal , in 14.8 % versus 7.8 % ( p = 0.045 ) at both 12 and 18months .


DAS28 ( CRP ) < 2.6 was achieved for abatacept monotherapy in 42.5 % ( month 12 ) and 12.4 % ( both months 12 and 18 ) .


Both abatacept arms had a safety profile comparable with MTX alone .


Abatacept plus MTX demonstrated robust efficacy compared with MTX alone in early RA , with a good safety profile .


The achievement of sustained remission following withdrawal of all RA therapy suggests an effect of abatacept 's mechanism on autoimmune processes .


NCT01142726 .


Sealing of the femoral canal , usually with autologous bone , is a surgical procedure that is often performed during TKA surgery to decrease blood loss in the postoperative period .


However , evidence as to the effectiveness of this surgical procedure is not conclusive .


The objective of this study was to assess the effectiveness of this surgical action in reducing postoperative blood loss and the blood transfusion rate .


A randomized prospective study that included 201 TKAs divided into three groups ( 67 in each one ) was carried out .


The three groups were ; A ) bone graft sealing , B ) cement sealing and C ) unsealed canal .


All groups were comparable with regard to pre and intra-operative data .


The haemoglobin decrease at 2 , 24 and 72 h was compared to the preoperative haemoglobin value .


Subsequently , blood drainage at 12 and 24h and the rate of blood transfusion were also assessed .


The different complications that arose were reported .


No statistical differences were obtained with regard to blood drainage at 12h ( p = 0.102 ) and 24h ( p = 0.542 ) , the haemoglobin value decrease at 72 h ( p = 0.95 ) and the number of blood transfusions ( p = 0.597 ) in the three groups studied .


There was no significant difference , whether sealing the femoral canal with a bone graft , cement or when it was left unsealed , in decreasing blood loss or blood transfusion requirements in the postoperative period .


Therapeutic type I.


To observe the clinical efficacy and safety of electroacupuncture ( EA ) combined with herbal acupoint sticking in the treatment of Bell 's palsy and provide optimizations for the clinic .


One hundred and two cases of Bell 's palsy were randomized into an EA combined with herbal acupoint sticking group ( group A , 50 cases ) and an EA group ( group B , 52 cases ) , EA at Cuanzhu ( BL 2 ) , Yangbai ( GB 14 ) , Taiyang ( EX-HN 5 ) , Quanliao ( SI 18 ) , Xiaguan ( ST 7 ) , Yingxiang ( LI 20 ) , etc. were applied in both groups and `` facial paralys No.I '' was applied at Yifeng ( TE 17 ) in group A , once daily and 10 times totally were needed .


The score of facial nerve function , clinical efficacy were compared before and after treatment .


At 1 and 3 month follow up visit , the quality of life scale ( WHOQOL-BREF ) and the occurrence of complication were observed .


The scores of facial nerve function in group A and group B were all significantly improved compared with those before treatment ( 48.2 + / - 2.9 vs 25.7 + / - 4.9 , 45.9 + / - 6.2 vs 25.8 + / - 5.5 , both P < O. 01 ) , the cured rate in group A [ 82.0 % ( 41/50 ) ] were significantly superior to that in group B [ 67.3 % ( 35/52 ) ] ( P < 0.05 ) ; the difference of WHOQOL-BREF in both groups at 1 and 3 month follow up visit was not significant ( all P > 0.05 ) .


The occurrence of complication in group A ( 1 case ) was significantly less than that in group B ( 8 cases , P 0.05 ) .


Compared with EA , the combination of EA and acupoint sticking therapy for Bell 's palsy can not only improve the clinical efficacy and reduce the occurrence of complication but also reliable without any side effect .


The combination of dutasteride and tamsulosin may be more effective for the treatment of symptomatic benign prostatic hyperplasia than either treatment alone .


We report the results of three pharmacokinetics and tolerability studies , which used a dutasteride/tamsulosin HCl ( 0.5 mg/0 .2 mg ) fixed-dose combination ( FDC ) capsules containing a small dutasteride soft gelatin capsule ( smaller than commercial Avodart ) and modified-release tamsulosin pellets that have different amounts of enteric coating .


These studies compared the test products to commercial Avodart ( dutasteride 0.5 mg ) and two different commercial tamsulosin HCl 0.2 mg products , Harnal Capsules or Harnal-D Tablets , which are reportedly bioequivalent to each other .


All three studies were randomized single-dose studies in healthy male adults .


Study 1 [ N = 86 ( NCT01254071 ) ] was a two-period crossover study of a dutasteride/tamsulosin HCl FDC versus coadministered Avodart and Harnal-D Tablets .


The pharmacokinetics of both dutasteride and tamsulosin were studied .


Study 2 [ N = 27 ( NCT01471678 ) ] was a four-period crossover study of dutasteride/tamsulosin HCl FDC formulations versus Avodart and Harnal Capsules or Harnal-D Tablets .


Only the pharmacokinetics of tamsulosin were studied .


Study 3 [ N = 40 ( NCT01495026 ) ] was a two-period study of dutasteride/tamsulosin HCl FDC formulations versus coadministered Avodart and Harnal-D Tablets .


In this study , only the pharmacokinetics of tamsulosin were studied .


Study 2 assessed fed-state pharmacokinetics .


Studies 1 and 3 assessed fed - and fasted-state pharmacokinetics .


All dutasteride/tamsulosin HCl FDC formulations and coadministered treatments were well-tolerated .


In Study1 , the FDC dutasteride was bioequivalent to Avodart coadministered with tamsulosin under fed and fasted conditions .


In Study1 , the FDC tamsulosin had a slower release than commercial Harnal-D Tablets coadministered with dutasteride ( fed and fasted state ) .


In Study2 , the FDC tamsulosin containing 15 % by weight enteric-coated tamsulosin pellets was bioequivalent to Harnal Capsules coadministered with dutasteride in the fed state .


In Study3 , the FDC containing 15 % by weight enteric-coated tamsulosin pellets combined with uncoated tamsulosin pellets ( coated : uncoated = 10:90 ) were bioequivalent to Harnal-D Tablets coadministered with dutasteride in the fasted state but not the fed state .


The FDC formulations were well-tolerated and some FDC formulations were comparable with concomitant administration of commercially available dutasteride and tamsulosin .


GastroGard , an omeprazole powder paste formulation , is considered the standard treatment for gastric ulcers in horses and is highly effective .


Gastrozol , an enteric-coated omeprazole formulation for horses , has recently become available , but efficacy data are controversial and sparse .


To investigate the efficacy of GastroGard and Gastrozol at labeled doses ( 4 and 1 mg of omeprazole per kg bwt , respectively , PO q24h ) in healing of gastric ulcers .


40 horses ; 9.5 4.6 years ; 491 135 kg .


Prospective , randomized , blinded study .


Horses with an ulcer score 1 ( Equine Gastric Ulcer Council ) were randomly divided into 2 groups and treated for 2 weeks each with GastroGard followed by Gastrozol ( A ) or vice versa ( B ) .


After 2 and 4 weeks , scoring was repeated and compared with baseline .


Plasma omeprazole concentrations were measured on the first day of treatment after administration of GastroGard ( n = 5 ) or Gastrozol ( n = 5 ) .


Compared with baseline ( squamous score ( A ) 1.65 0.11 , ( B ) 1.98 0.11 ) , ulcer scores at 2 weeks ( ( A ) 0.89 0.11 , ( B ) 1.01 0.11 ) and 4 weeks ( ( A ) 1.10 0.12 , ( B ) 0.80 0.12 ) had significantly decreased in both groups ( P < .001 ) , independent of treatment ( P = .7 ) .


Plasma omeprazole concentrations were significantly higher after GastroGard compared with Gastrozol administration ( AUCGG = 2856 ( 1405-4576 ) ng/mL h , AUCGZ = 604 ( 430-1609 ) ng/mL h ; P = .03 ) .


The bioavailability for Gastrozol was 1.26 ( 95 % CI 0.56-2 .81 ) times higher than for GastroGard .


Both Gastrozol and GastroGard , combined with appropriate environmental changes , promote healing of gastric ulcers in horses .


However , despite enteric coating of Gastrozol , plasma omeprazole concentrations after single labeled doses were significantly higher with GastroGard .


There is a need for the accurate assessment of circadian phase outside of the clinic/laboratory , particularly with the gold standard dim light melatonin onset ( DLMO ) .


We tested a novel kit designed to assist in saliva sampling at home for later determination of the DLMO .


The home kit includes objective measures of compliance to the requirements for dim light and half-hourly saliva sampling .


Participants were randomized to one of two 10-day protocols .


Each protocol consisted of two back-to-back home and laboratory phase assessments in counterbalanced order , separated by a 5-day break .


Laboratory or participants ' homes .


Thirty-five healthy adults , age 21-62 y.


N/A .


Most participants received at least one 30-sec epoch of light > 50 lux during the home phase assessments ( average light intensity 4.5 lux ) , but on average for < 9 min of the required 8.5 h. Most participants collected every saliva sample within 5 min of the scheduled time .


Ninety-two percent of home DLMOs were not affected by light > 50 lux or sampling errors .


There was no significant difference between the home and laboratory DLMOs ( P > 0.05 ) ; on average the home DLMOs occurred 9.6 min before the laboratory DLMOs .


The home DLMOs were highly correlated with the laboratory DLMOs ( r = 0.91 , P < 0.001 ) .


Participants were reasonably compliant to the home phase assessment procedures .


The good agreement between the home and laboratory dim light melatonin onsets ( DLMOs ) demonstrates that including objective measures of light exposure and sample timing during home saliva sampling can lead to accurate home DLMOs .


Circadian Phase Assessments at Home , http://clinicaltrials.gov/show/NCT01487252 , NCT01487252 .


Both short wavelength ( blue ) light and caffeine have been studied for their mood enhancing effects on humans .


The ability of blue light to increase alertness , mood and cognitive function via non-image forming neuropathways has been suggested as a non-pharmacological countermeasure for depression across a range of occupational settings .


This experimental study compared blue light and caffeine and aimed to test the effects of blue light/placebo ( BLU ) , white light/240-mg caffeine ( CAF ) , blue light/240-mg caffeine ( BCAF ) and white light/placebo ( PLA ) , on mood .


A randomised , controlled , crossover design study was used , in a convenience population of 20 healthy volunteers .


The participants rated their mood on the Swedish Core Affect Scales ( SCAS ) prior to and after each experimental condition to assess the dimensions of valence and activation .


There was a significant main effect of light ( p = 0.009 ) , and the combination of blue light and caffeine had clear positive effects on core effects ( ES , ranging from 0.41 to 1.20 ) and global mood ( ES , 0.610.53 ) .


The benefits of the combination of blue light and caffeine should be further investigated across a range of applications due to the observed effects on the dimensions of arousal , valence and pleasant activation .


To evaluate the efficacy of the five ear acupuncture points ( Shen-men , Spleen , Stomach , Hunger , Endocrine ) , generally used in Korean clinics for treating obesity , and compare them with the Hunger acupuncture point .


A randomised controlled clinical trial was conducted in 91 Koreans ( 16 male and 75 female , body mass index ( BMI ) 23 ) , who had not received any other weight control treatment within the past 6 months .


Subjects were divided randomly into treatment I , treatment II or sham control groups and received unilateral auricular acupuncture with indwelling needles replaced weekly for 8 weeks .


Treatment I group received acupuncture at the five ear acupuncture points , treatment II group at the Hunger acupuncture point only and the sham control group received acupuncture at the five ear acupuncture points used in treatment I , but the needles were removed immediately after insertion .


BMI , waist circumference , weight , body fat mass ( BFM ) , percentage body fat and blood pressure were measured at baseline and at 4 and 8 weeks after treatment .


For the 58 participants who provided data at 8 weeks , significant differences in BMI , weight and BFM were found between the treatment and control groups .


Treatment groups I and II showed 6.1 % and 5.7 % reduction in BMI , respectively ( p < 0.004 ) .


There were no significant differences between the two treatment groups .


This finding suggests that the five ear acupuncture points , generally used in Korean clinics , and the Hunger point alone treatment are both effective for treating overweight people .


There are limited data regarding factors associated with spontaneous left ventricular reverse remodeling ( S-LVRR ) among mildly symptomatic heart failure ( HF ) patients and its prognostic implications on clinical outcomes .


Best subsets logistic regression analysis was used to identify factors associated with S-LVRR ( defined as 15 % reduction in left ventricular end-systolic volume at 1-year of follow-up ) among 612 patients treated with internal cardioverter defibrillator-only therapy in Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) and to create a score for the prediction of S-LVRR .


Cox proportional hazards regression modeling was used to assess the clinical outcome of all internal cardioverter defibrillator-only patients ( n = 714 ) with a high S-LVRR score .


S-LVRR occurred in 25 % of internal cardioverter defibrillator-only patients .


Predictors of S-LVRR included systolic blood pressure140 mm Hg , serum creatinine < 1.0 mg/dL , QRS 130 to 160 ms , and nonischemic cardiomyopathy .


Multivariate analysis showed that each 1-point increment in S-LVRR score ( range , 0-7 ) was associated with an 11 % ( P = 0.019 ) reduction in the risk of HF or death .


Treatment with cardiac resynchronization therapy was associated with a significant reduction in the risk of HF or death only among internal cardioverter defibrillator-treated patients with a low ( Q1-3 ) S-LVRR score ( hazard ratio = 0.55 ; P < 0.001 ) , but not among those with a higher ( Q4 ) score ( hazard ratio = 1.06 ; P = 0.72 ) .


Our data suggest that approximately one quarter of mild HF patients eligible for biventricular pacing experience S-LVRR .


Combined assessment of clinical factors associated with S-LVRR can be used to identify mild HF patients with a low risk for clinical events without cardiac resynchronization therapy intervention .


http://www.clinicaltrials.gov .


Unique identifier : NCT00180271 .


Early injection of atropine during dobutamine stress echocardiography ( DSE ) has been demonstrated in retrospective analyses to reduce the duration and dose of dobutamine infusion , while preserving a similar diagnostic accuracy with a lower incidence of adverse effects .


This study explores the safety of using atropine as a start drug before dobutamine infusion ( ADSE protocol ) in comparison with the conventional protocol ( DASE protocol ) in older patients undergoing DSE for ischemia evaluation .


One hundred consecutive older patients were prospectively enrolled .


When eligible , they were randomly assigned to undergo either the DASE protocol ( group A , 50 patients ) or the ADSE protocol ( group B , 50 patients ) when atropine ( 1.0 mg ) was first administered 3 min before dobutamine infusion followed by 0.5 mg increments ( maximum 1.0 mg ) thereafter .


Patients were monitored for adverse drug effects .


Test duration was calculated .


The mean age of the whole study cohort was 67.84.3 years and 58 ( 58 % ) were men .


Patients in group A had longer test duration ( 21.81.3 versus 13.70.77 min , p < 0.001 ) and higher mean dobutamine infusion rate ( 398.2 versus 28.29.5 g/kg/min , p < 0.001 ) .


The two groups received a similar total dose of atropine .


Group A patients showed significantly higher incidence of extrasystoles , nonsustained ventricular tachycardia and severe hypotension ( p < 0.05 ) .


In older patients undergoing DSE , using atropine as a start drug , that is , adopting the ADSE protocol , is associated with shorter test duration , lower mean dobutamine infusion rate and consequently fewer adverse effects .


Headaches are a common medical problem , yet few studies , particularly trials , have evaluated therapies that might prevent or control headaches .


We , thus , investigated the effects on the occurrence of headaches of three levels of dietary sodium intake and two diet patterns ( the Dietary Approaches to Stop Hypertension ( DASH ) diet ( rich in fruits , vegetables and low-fat dairy products with reduced saturated and total fat ) and a control diet ( typical of Western consumption patterns ) ) .


Randomised multicentre clinical trial .


Post hoc analyses of the DASH-Sodium trial in the USA .


In a multicentre feeding study with three 30day periods , 390 participants were randomised to the DASH or control diet .


On their assigned diet , participants ate food with high sodium during one period , intermediate sodium during another period and low sodium during another period , in random order .


Occurrence and severity of headache were ascertained from self-administered questionnaires , completed at the end of each feeding period .


The occurrence of headaches was similar in DASH versus control , at high ( OR ( 95 % CI ) = 0.65 ( 0.37 to 1.12 ) ; p = 0.12 ) , intermediate ( 0.57 ( 0.29 to 1.12 ) ; p = 0.10 ) and low ( 0.64 ( 0.36 to 1.13 ) ; p = 0.12 ) sodium levels .


By contrast , there was a lower risk of headache on the low , compared with high , sodium level , both on the control ( 0.69 ( 0.49 to 0.99 ) ; p = 0.05 ) and DASH ( 0.69 ( 0.49 to 0.98 ) ; p = 0.04 ) diets .


A reduced sodium intake was associated with a significantly lower risk of headache , while dietary patterns had no effect on the risk of headaches in adults .


Reduced dietary sodium intake offers a novel approach to prevent headaches .


NCT00000608 .


The altered visual function induced by changes in corneal curvature following filtration surgery is distressing to patients .


The aim of this study was to evaluate surgically induced astigmatism following trabeculectomy in comparison with deep sclerectomy .


In a prospective interventional comparative study , patients with primary open-angle glaucoma were randomly allocated to either group A or B ; deep sclerectomy with mitomycin C 0.2 mg/mL and trabeculectomy with mitomycin C 0.2 mg/mL , respectively .


Keratometry was performed using Topcon KR-7000P autokerato-refractometer preoperatively and at 6 months postoperatively .


Vector analysis was used to analyze the surgically induced astigmatism .


Sixty eyes of 45 patients in group A , and 60 eyes of 42 patients in group B were enrolled for vector analysis .


The mean preoperative astigmatic vector power was -0.491.65 D and +0.472.18 D in groups A and B , respectively .


The mean postoperative astigmatic vector power was -1.141.55 D in group A and -0.351.8 D in group B.


The mean change in astigmatic vector powers was -0.671.63 D in group A and -0.822.0 D in group B.


When compared with preoperative data in either group , the differences were significant , P = 0.001 & 0.007 in groups A and B respectively , whereas the postoperative difference between either group was insignificant ( P = 0.723 ) .


A total of 40 % of corneas got flatter in group B compared with 25 % in group A , P = 0.057 .


Both trabeculectomy and deep sclerectomy induced considerable postoperative astigmatism .


A longer follow-up period is recommended to study the different patterns of astigmatism in either procedure .


Based on promising efficacy in a single-arm study , a randomized phase II trial was designed to compare the efficacy and safety of adding rh-endostatin ( Endostar ) to first-line standard etoposide and carboplatin ( EC ) chemotherapy for treatment of extensive-stage small-cell lung cancer .


One hundred forty Chinese patients with pathologically confirmed , extensive-stage small-cell lung cancer were randomly assigned to EC alone or rh-endostatin + EC for 4-6 cycles , followed by single-agent rh-endostatin until progression or unacceptable toxicity .


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


The secondary endpoints included overall survival , Objective response rate ( ORR ) , and quality of life .


Median PFS was 6.4 months with rh-endostatin + EC ( n = 69 ) and 5.9 months with EC ( n = 69 ) ( hazard ratio 0.8 [ 95 % confidence interval 0.6-1 .1 ] ) .


PFS was significantly higher with rh-endostatin + EC than with EC ( hazard ratio 0.4 [ 0.2-0 .9 ; p = 0.020 ] ) in female .


Median overall survival was similar in both groups ( 12.1 versus 12.4 months , respectively [ p = 0.82 ] ) .


ORR was higher in the rh-endostatin + EC group ( 75.4 % ) than in the EC group ( 66.7 % ) ( p = 0.348 ) .


The efficacy of rh-endostatin + EC relative to that of EC was reflected by greater improvements in patient-assessed quality of life scores after 4 and 6 weeks of treatment .


There was no difference between each regimen in the incidence of nonhematological or Grade III-IV hematological toxicities .


Addition of rh-endostatin to EC for the treatment of extensive-stage small-cell lung cancer had an acceptable toxicity profile , but did not improve overall survival , PFS , and ORR .


Optical trapping is a laser-based method for probing the physiological and mechanical properties of cells in a noninvasive manner .


As sperm motility is an important criterion for assessing the male fertility potential , this technique is used to study sperm cell motility behavior and rotational dynamics .


An integrated optical system with near-infrared laser beam has been used to analyze rotational dynamics of live sperm cells from oligozoospermic and asthenozoospermic cases and compared with controls .


The linear , translational motion of the sperm is converted into rotational motion on being optically trapped , without causing any adverse effect on spermatozoa .


The rotational speed of sperm cells from infertile men is observed to be significantly less as compared to controls .


Distinguishing normal and abnormal sperm cells on the basis of beat frequency above 5.6 Hz may be an important step in modern reproductive biology to sort and select good quality spermatozoa .


The application of laser-assisted technique in biology has the potential to be a valuable tool for assessment of sperm fertilization capacity for improving assisted reproductive technology .


Recent studies have demonstrated safety , feasibility , and decreased hospital length of stay for patients with weakness acquired in the intensive care unit ( ICU ) who receive early physical rehabilitation .


The scored Physical Function in Intensive Care Test ( PFIT-s ) was specifically designed for this population and demonstrated excellent psychometrics in an Australian ICU population .


The purpose of this study was to determine the responsiveness and predictive capabilities of the PFIT-s in patients in the United States admitted to the ICU who required mechanical ventilation ( MV ) for 4 days or longer .


This nested study within a randomized trial administered the PFIT-s , Medical Research Council ( MRC ) sum score , and grip strength test at ICU recruitment and then weekly until hospital discharge , including at ICU discharge .


Spearman rho was used to determine validity .


The effect size index was used to calculate measurement responsiveness for the PFIT-s .


The receiver operating characteristic curve was used in predicting participants ' ability to perform functional components of the PFIT-s .


From August 2009 to July 2012 , 51 patients were recruited from 4 ICUs in the Denver , Colorado , metro area .


At ICU discharge , PFIT-s scores were highly correlated to MRC sum scores ( rho = .923 ) and grip strength ( rho = .763 ) ( P < .0005 ) .


Using baseline test with ICU discharge ( 26 pairs ) , test responsiveness was large ( 1.14 ) .


At ICU discharge , an MRC sum score cut-point of 41.5 predicted participants ' ability to perform the standing components of the PFIT-s .


The small sample size was a limitation .


However , the findings are consistent with those in a larger sample from Australia .


The PFIT-s is a feasible and valid measure of function for individuals who require MV for 4 days or longer and who are alert , able to follow commands , and have sufficient strength to participate .


Post-operative nausea and vomiting ( PONV ) ; early or late , has detrimental effects on surgical patients such as surgical wound disruption , esophageal tear and delayed discharge from the post anesthetic care unit .


This study evaluated the effects of dexamethasone-metoclopramide ( DM ) in the prevention of early and late PONV in women undergoing myomectomy under subarachnoid block .


Following approval from the Research and Ethics Committee of the Hospital , informed consent was obtained from each prospective patient .


Patients were randomly allocated to either the DM group , metoclopramide only ( MO ) group or dexamethasones only ( DO ) group using the computer-generated random numbers in sealed envelopes .


Immediately after the induction of spinal anesthesia , the DM group received intravenous ( i.v. ) dexamethasone 8 mg and metoclopramide 10 mg , the MO group received metoclopramide 10 mg i.v and the DO group received dexamethasone 8 mg i.v.


The incidence of early and late PONV formed the primary outcome .


A total of 90 patients , with aged range between 21-64 years were studied .


Dexamethasone alone group had the highest incidence of 40 % for early but no for late PONV ( P = 0.003 ) Metoclopramide alone group had an incidence of 29.97 % for early PONV and 26.6 % for late PONV .


There was reduced incidence of both early and late PONV in the DM group , but of lesser magnitude than DO or MO respectively .


Dexamethasone protects against the incidence of late PONV with a minimal effect on early PONV .


The combination of dexamethasone and metoclopramide had comparable effect on both and of better magnitude than metoclopramide alone .


The effects of family therapy for adolescent substance use on parent substance use have not been explored .


To determine the effects of Brief Strategic Family Therapy ( BSFT ) on parent substance use , and the relationship between parent substance use and adolescent substance use .


480 adolescents and parents were randomized to BSFT or Treatment as Usual ( TAU ) across eight outpatient treatment programs .


Parent substance use was assessed at baseline and at 12months post-randomization .


Adolescent substance use was assessed at baseline and monthly for 12months post-randomization .


Family functioning was assessed at baseline , 4 , 8 , and 12months post-randomization .


Parents in BSFT significantly decreased their alcohol use as measured by the ASI composite score from baseline to 12months ( ( 2 ) ( 1 ) = 4.46 , p = .04 ) .


Change in family functioning mediated the relationship between Treatment Condition and change in parent alcohol use .


Children of parents who reported drug use at baseline had three times as many days of reported substance use at baseline compared with children of parents who did not use or only used alcohol ( ( 2 ) ( 2 ) = 7.58 , p = .02 ) .


Adolescents in BSFT had a significantly lower trajectory of substance use than those in TAU ( = -7.82 , p < .001 ) if their parents used drugs at baseline .


BSFT is effective in reducing alcohol use in parents , and in reducing adolescents ' substance use in families where parents were using drugs at baseline .


BSFT may also decrease alcohol use among parents by improving family functioning .


To identify the clinical and laboratory predictors of clinical improvement in a cohort of myositis patients treated with rituximab .


We analyzed data for 195 patients with myositis ( 75 with adult polymyositis [ PM ] , 72 with adult dermatomyositis [ DM ] , and 48 with juvenile DM ) in the Rituximab in Myositis trial .


Clinical improvement was defined as 20 % improvement in at least 3 of the following 6 core set measures of disease activity : physician 's and patient 's / parent 's global assessment of disease activity , manual muscle testing , physical function , muscle enzymes , and extramuscular disease activity .


We analyzed the association of the following baseline variables with improvement : myositis clinical subgroup , demographics , myositis damage , clinical and laboratory parameters , core set measures , rituximab treatment , and myositis autoantibodies ( antisynthetase , anti-Mi-2 , anti-signal recognition particle , anti-transcription intermediary factor 1 [ TIF-1 ] , anti-MJ , other autoantibodies , and no autoantibodies ) .


All measures were univariately assessed for association with improvement using time-to-event analyses .


A multivariable time-dependent proportional hazards model was used to evaluate the association of individual predictive factors with improvement .


In the final multivariable model , the presence of an antisynthetase , primarily anti-Jo-1 ( hazard ratio [ HR ] 3.08 , P < 0.01 ) , anti-Mi-2 ( HR 2.5 , P < 0.01 ) , or other autoantibody ( HR 1.4 , P = 0.14 ) predicted a shorter time to improvement compared to the absence of autoantibodies .


A lower physician 's global assessment of damage ( HR 2.32 , P = 0.02 ) and juvenile DM ( versus adult myositis ) ( HR 2.45 , P = 0.01 ) also predicted improvement .


Unlike autoantibody status , the predictive effect of physician 's global assessment of damage and juvenile DM diminished by week 20 .


Rituximab treatment did not affect these associations .


Our findings indicate that the presence of antisynthetase and anti-Mi-2 autoantibodies , juvenile DM subset , and lower disease damage strongly predict clinical improvement in patients with refractory myositis .


In phase 2 studies , evolocumab , a fully human monoclonal antibody to PCSK9 , reduced LDL-C levels in patients receiving statin therapy .


To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate - vs high-intensity statin .


Phase 3 , 12-week , randomized , double-blind , placebo - and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries .


Patients ( n = 2067 ) were randomized to 1 of 24 treatment groups in 2 steps .


Patients were initially randomized to a daily , moderate-intensity ( atorvastatin [ 10 mg ] , simvastatin [ 40 mg ] , or rosuvastatin [ 5 mg ] ) or high-intensity ( atorvastatin [ 80 mg ] , rosuvastatin [ 40 mg ] ) statin .


After a 4-week lipid-stabilization period , patients ( n = 1899 ) were randomized to compare evolocumab ( 140 mg every 2 weeks or 420 mg monthly ) with placebo ( every 2 weeks or monthly ) or ezetimibe ( 10 mg or placebo daily ; atorvastatin patients only ) when added to statin therapies .


Percent change from baseline in low-density lipoprotein cholesterol ( LDL-C ) level at the mean of weeks 10 and 12 and at week 12 .


Evolocumab reduced LDL-C levels by 66 % ( 95 % CI , 58 % to 73 % ) to 75 % ( 95 % CI , 65 % to 84 % ) ( every 2 weeks ) and by 63 % ( 95 % CI , 54 % to 71 % ) to 75 % ( 95 % CI , 67 % to 83 % ) ( monthly ) vs placebo at the mean of weeks 10 and 12 in the moderate - and high-intensity statin-treated groups ; the LDL-C reductions at week 12 were comparable .


For moderate-intensity statin groups , evolocumab every 2 weeks reduced LDL-C from a baseline mean of 115 to 124 mg/dL to an on-treatment mean of 39 to 49 mg/dL ; monthly evolocumab reduced LDL-C from a baseline mean of 123 to 126 mg/dL to an on-treatment mean of 43 to 48 mg/dL .


For high-intensity statin groups , evolocumab every 2 weeks reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 35 to 38 mg/dL ; monthly evolocumab reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 33 to 35 mg/dL .


Adverse events were reported in 36 % , 40 % , and 39 % of evolocumab - , ezetimibe - , and placebo-treated patients , respectively .


The most common adverse events in evolocumab-treated patients were back pain , arthralgia , headache , muscle spasms , and pain in extremity ( all < 2 % ) .


In this 12-week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia , evolocumab added to moderate - or high-intensity statin therapy resulted in additional LDL-C lowering .


Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering .


clinicaltrials.gov Identifier : NCT01763866 .


IL-23 is associated with plaque psoriasis susceptibility and pathogenesis .


BI 655066 is a fully human IgG1 mAb specific for the IL-23 p19 subunit .


This first-in-human proof-of-concept study evaluated the clinical and biological effects of BI 655066 in patients with moderate-to-severe plaque psoriasis .


We performed a single-rising-dose , multicenter , randomized , double-blind , placebo-controlled , within-dose cohort phase I trial .


Patients received 0.01 , 0.05 , 0.25 , 1 , 3 , or 5 mg/kg BI 655066 intravenously , 0.25 or 1 mg/kg BI 655066 subcutaneously , or matched placebo .


The primary objective was safety evaluation .


Thirty-nine patients received single-dose BI 655066 intravenously ( n = 18 ) or subcutaneously ( n = 13 ) or placebo ( n = 8 ) .


Adverse events were reported with similar frequency in the BI 655066 and placebo groups .


Four serious adverse events ( not considered treatment related ) were reported among BI 655066-treated patients .


BI 655066 was associated with clinical improvement from week 2 and maintained for up to 66 weeks after treatment .


At week 12 , 75 % , 90 % , and 100 % decreases in the Psoriasis Area and Severity Index were achieved by 87 % , 58 % , and 16 % of BI 655066-treated patients ( any dose ) , respectively , versus none receiving placebo .


BI 655066 treatment resulted in reduced expression of lesional skin genes associated with IL-23 / IL-17 signaling pathways and normalization of psoriatic lesion gene expression profiles to a profile approaching that of nonlesional skin .


Significant correlation between treatment-associated molecular changes and psoriasis area and severity index improvement was observed ( r = 0.73 , P = 2 10 ( -6 ) ) .


BI 655066 was well tolerated and associated with rapid , substantial , and durable clinical improvement in patients with moderate-to-severe psoriasis , supporting a central role for IL-23 in psoriasis pathogenesis .


Accumulated evidence implicates sympathetic activation as inducing oxidative stress and systemic inflammation , which in turn lead to hypertension , endothelial dysfunction , and atherosclerosis in obstructive sleep apnea ( OSA ) .


Statins through their pleiotropic properties may modify inflammation , lipid profile , and cardiovascular outcomes in OSA .


This multicenter , randomized , double-blind study compared the effects of atorvastatin 40mg/day versus placebo over 12 weeks on endothelial function ( the primary endpoint ) measured by peripheral arterial tone ( PAT ) .


Secondary endpoints included office blood pressure ( BP ) , early carotid atherosclerosis , arterial stiffness measured by pulse wave velocity ( PWV ) , and metabolic parameters .


51 severe OSA patients were randomized .


Key demographics for the study population were age 54 11 years , 21.6 % female , and BMI 28.5 4.5 kg/m ( 2 ) .


In intention to treat analysis , mean PAT difference between atorvastatin and placebo groups was 0.008 ( -0.29 ; 0.28 ) , P = 0.979 .


Total and LDL cholesterol significantly improved with atorvastatin .


Systolic BP significantly decreased with atorvastatin ( mean difference : -6.34 mmHg ( -12.68 ; -0.01 ) , P = 0.050 ) whereas carotid atherosclerosis and PWV were unchanged compared to the placebo group .


In OSA patients , 3 months of atorvastatin neither improved endothelial function nor reduced early signs of atherosclerosis although it lowered blood pressure and improved lipid profile .


This trial is registered with NCT00669695 .


To determine whether a structured mentoring curriculum improves research mentoring skills .


The authors conducted a randomized controlled trial ( RCT ) at 16 academic health centers ( June 2010 to July 2011 ) .