In a double-masked randomized clinical trial ( the Age-Related Eye Disease Study 2 [ AREDS2 ] ) , retinal specialists in 82 US academic and community medical centers enrolled and observed participants who were at risk for developing late age-related macular degeneration ( AMD ) from October 2006 to December 2012 .


In addition to annual eye examinations , several validated cognitive function tests were administered via telephone by trained personnel at baseline and every 2 years during the 5-year study .


Long-chain polyunsaturated fatty acids ( LCPUFAs ) ( 1 g ) and/or lutein ( 10 mg ) / zeaxanthin ( 2 mg ) vs placebo were tested in a factorial design .


All participants were also given varying combinations of vitamins C , E , beta carotene , and zinc .


The main outcome was the yearly change in composite scores determined from a battery of cognitive function tests from baseline .


The analyses , which were adjusted for baseline age , sex , race , history of hypertension , education , cognitive score , and depression score , evaluated the differences in the composite score between the treated vs untreated groups .


The composite score provided an overall score for the battery , ranging from -22 to 17 , with higher scores representing better function .


A total of 89 % ( 3741/4203 ) of AREDS2 participants consented to the ancillary cognitive function study and 93.6 % ( 3501/3741 ) underwent cognitive function testing .


The mean ( SD ) age of the participants was 72.7 ( 7.7 ) years and 57.5 % were women .


There were no statistically significant differences in change of scores for participants randomized to receive supplements vs those who were not .


The yearly change in the composite cognitive function score was -0.19 ( 99 % CI , -0.25 to -0.13 ) for participants randomized to receive LCPUFAs vs -0.18 ( 99 % CI , -0.24 to -0.12 ) for those randomized to no LCPUFAs ( difference in yearly change , -0.03 [ 99 % CI , -0.20 to 0.13 ] ; P = .63 ) .


Similarly , the yearly change in the composite cognitive function score was -0.18 ( 99 % CI , -0.24 to -0.11 ) for participants randomized to receive lutein/zeaxanthin vs -0.19 ( 99 % CI , -0.25 to -0.13 ) for those randomized to not receive lutein/zeaxanthin ( difference in yearly change , 0.03 [ 99 % CI , -0.14 to 0.19 ] ; P = .66 ) .


Analyses were also conducted to assess for potential interactions between LCPUFAs and lutein/zeaxanthin and none were found to be significant .


Among older persons with AMD , oral supplementation with LCPUFAs or lutein/zeaxanthin had no statistically significant effect on cognitive function .


clinicaltrials.gov Identifier : NCT00345176 .


Increasing epithelial repair and regeneration may hasten resolution of lung injury in patients with the acute respiratory distress syndrome ( ARDS ) .


In animal models of ARDS , keratinocyte growth factor ( KGF ) reduces injury and increases epithelial proliferation and repair .


The effect of KGF in the human alveolus is unknown .


To test whether KGF can attenuate alveolar injury in a human model of ARDS .


Volunteers were randomized to intravenous KGF ( 60 g/kg ) or placebo for 3 days , before inhaling 50 g LPS .


Six hours later , subjects underwent bronchoalveolar lavage ( BAL ) to quantify markers of alveolar inflammation and cell-specific injury .


KGF did not alter leukocyte infiltration or markers of permeability in response to LPS .


KGF increased BAL concentrations of surfactant protein D , matrix metalloproteinase ( MMP ) -9 , IL-1Ra , granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , and C-reactive protein .


In vitro , BAL fluid from KGF-treated subjects inhibited pulmonary fibroblast proliferation , but increased alveolar epithelial proliferation .


Active MMP-9 increased alveolar epithelial wound repair .


Finally , BAL from the KGF-pretreated group enhanced macrophage phagocytic uptake of apoptotic epithelial cells and bacteria compared with BAL from the placebo-treated group .


This effect was blocked by inhibiting activation of the GM-CSF receptor .


KGF treatment increases BAL surfactant protein D , a marker of type II alveolar epithelial cell proliferation in a human model of acute lung injury .


Additionally , KGF increases alveolar concentrations of the antiinflammatory cytokine IL-1Ra , and mediators that drive epithelial repair ( MMP-9 ) and enhance macrophage clearance of dead cells and bacteria ( GM-CSF ) .


Clinical trial registered with ISRCTN 98813895 .


This randomized controlled trial tested the efficacy of early intervention to prevent adult psychopathology and improve well-being in early-starting conduct-problem children .


Kindergarteners ( N = 9,594 ) in three cohorts ( 1991-1993 ) at 55 schools in four communities were screened for conduct problems , yielding 979 early starters .


A total of 891 ( 91 % ) consented ( 51 % African American , 47 % European American ; 69 % boys ) .


Children were randomly assigned by school cluster to a 10-year intervention or control .


The intervention goal was to develop social competencies in children that would carry them throughout life , through social skills training , parent behavior-management training with home visiting , peer coaching , reading tutoring , and classroom social-emotional curricula .


Manualization and supervision ensured program fidelity .


Ninety-eight percent participated during grade 1 , and 80 % continued through grade 10 .


At age 25 , arrest records were reviewed ( N = 817 , 92 % ) , and condition-blinded adults psychiatrically interviewed participants ( N = 702 ; 81 % of living participants ) and a peer ( N = 535 ) knowledgeable about the participant .


Intent-to-treat logistic regression analyses indicated that 69 % of participants in the control arm displayed at least one externalizing , internalizing , or substance abuse psychiatric problem ( based on self - or peer interview ) at age 25 , in contrast with 59 % of those assigned to intervention ( odds ratio = 0.59 , CI = 0.43-0 .81 ; number needed to treat = 8 ) .


This pattern also held for self-interviews , peer interviews , scores using an `` and '' rule for self - and peer reports , and separate tests for externalizing problems , internalizing problems , and substance abuse problems , as well as for each of three cohorts , four sites , male participants , female participants , African Americans , European Americans , moderate-risk , and high-risk subgroups .


Intervention participants also received lower severity-weighted violent ( standardized estimate = -0.37 ) and drug ( standardized estimate = -0.43 ) crime conviction scores , lower risky sexual behavior scores ( standardized estimate = -0.24 ) , and higher well-being scores ( standardized estimate = 0.19 ) .


This study provides evidence for the efficacy of early intervention in preventing adult psychopathology among high-risk early-starting conduct-problem children .


Most patients with Crohn 's disease need an intestinal resection , but a majority will subsequently experience disease recurrence and require further surgery .


This study aimed to identify the optimal strategy to prevent postoperative disease recurrence .


In this randomised trial , consecutive patients from 17 centres in Australia and New Zealand undergoing intestinal resection of all macroscopic Crohn 's disease , with an endoscopically accessible anastomosis , received 3 months of metronidazole therapy .


Patients at high risk of recurrence also received a thiopurine , or adalimumab if they were intolerant to thiopurines .


Patients were randomly assigned to parallel groups : colonoscopy at 6 months ( active care ) or no colonoscopy ( standard care ) .


We used computer-generated block randomisation to allocate patients in each centre to active or standard care in a 2:1 ratio .


For endoscopic recurrence ( Rutgeerts score i2 ) at 6 months , patients stepped-up to thiopurine , fortnightly adalimumab with thiopurine , or weekly adalimumab .


The primary endpoint was endoscopic recurrence at 18 months .


Patients and treating physicians were aware of the patient 's study group and treatment , but central reading of the endoscopic findings was undertaken blind to the study group and treatment .


Analysis included all patients who received at least one dose of study drug .


This trial is registered with ClinicalTrials.gov , number NCT00989560 .


Between Oct 13 , 2009 , and Sept 28 , 2011 , 174 ( 83 % high risk across both active and standard care groups ) patients were enrolled and received at least one dose of study drug .


Of 122 patients in the active care group , 47 ( 39 % ) stepped-up treatment .


At 18 months , endoscopic recurrence occurred in 60 ( 49 % ) patients in the active care group and 35 ( 67 % ) patients in the standard care group ( p = 0.03 ) .


Complete mucosal normality was maintained in 27 ( 22 % ) of 122 patients in the active care group versus four ( 8 % ) in the standard care group ( p = 0.03 ) .


In the active care arm , of those with 6 months recurrence who stepped up treatment , 18 ( 38 % ) of 47 patients were in remission 12 months later ; conversely , of those in remission at 6 months who did not change therapy recurrence occurred in 31 ( 41 % ) of 75 patients 12 months later .


Smoking ( odds ratio [ OR ] 2.4 , 95 % CI 1.2-4 .8 , p = 0.02 ) and the presence of two or more clinical risk factors including smoking ( OR 2.8 , 95 % CI 1.01-7 .7 , p = 0.05 ) increased the risk of endoscopic recurrence .


The incidence and type of adverse and severe adverse events did not differ significantly between patients in the active care and standard care groups ( 100 [ 82 % ] of 122 vs 45 [ 87 % ] of 52 ; p = 0.51 ) and ( 33 [ 27 % ] of 122 vs 18 [ 35 % ] of 52 ; p = 0.36 ) , respectively .


Treatment according to clinical risk of recurrence , with early colonoscopy and treatment step-up for recurrence , is better than conventional drug therapy alone for prevention of postoperative Crohn 's disease recurrence .


Selective immune suppression , adjusted for early recurrence , rather than routine use , leads to disease control in most patients .


Clinical risk factors predict recurrence , but patients at low risk also need monitoring .


Early remission does not preclude the need for ongoing monitoring .


AbbVie , Gutsy Group , Gandel Philanthropy , Angior Foundation , Crohn 's Colitis Australia , and the National Health and Medical Research Council .


Oxidative stress plays an important role in atherosclerosis .


Both F2-isoprostane ( 8-iso-PGF2a ) and oxidized low-density lipoprotein ( ox-LDL ) have emerged as biomarkers of oxidative stress and have been proposed as useful biomarkers that could potentially be used as indicators of cardiovascular disease .


This is a prespecified analysis of a prospective , randomized , open-label , blinded endpoint ( PROBE ) study ( ClinicalTrials.gov identifier : NCT01010516 ) .


Patients ( N = 100 ) with mixed dyslipidemia on a standard statin dose ( 10-40mg simvastatin or 10-20mg atorvastatin or 5-10mg rosuvastatin ) who had not achieved lipid targets were randomized to switch to the highest dose of rosuvastatin ( 40mg/day ) or to add-on-statin extended release nicotinic acid ( ER-NA ) / laropiprant ( LRPT ) ( 1000/20mg/day for the first 4weeks followed by 2000/40mg/day for the next 8weeks ) or to add-on-statin micronized fenofibrate ( 200mg/day ) for a total of 3months .


Levels of plasma and urine F2-isoprostane and plasma ox-LDL were assessed at baseline and 3months later .


Plasma F2-isoprostane levels decreased similarly in all groups .


On the other hand , both ox-LDL and urine F2-isoprostane levels decreased similarly in the add-on ER-NA/LRPT and rosuvastatin monotherapy group , while a less pronounced decrease was observed in the add-on fenofibrate group .


All treatment interventions reduced the concentration of the assessed oxidative stress markers , but the reduction was more pronounced in the add-on ER-NA/LRPT and rosuvastatin monotherapy groups , compared with add-on fenofibrate .


Specifically designed studies should address the abovementioned risk factors modulation in terms of cardiovascular risk .


The aim of this study was to detect the effect of the laryngeal mask airway ( LMA ) versus the endotracheal tube ( ETT ) on postoperative nasal bleedings in and outside the operation room ( OR ) after intranasal surgery .


134 patients undergoing elective intranasal surgeries were randomly allocated to receive LMA or ETT during general anesthesia .


The incidence , episodes , and severity of nasal bleeding were evaluated in the OR and within the postoperative 24 hours in the ward .


Furthermore , medical assistance and severe complications were assessed .


THE overall incidence of postoperative nasal bleeding throughout the observation period was similar between the two groups .


The LMA reduced nasal bleeding in the OR .


However , outside the OR , the incidence of the first episode of postoperative nasal bleeding in the LMA group was higher than that in the ETT group ( difference : -26.5 % ; 95 % CI : -42.2 % to -10.7 % ; P < 0.001 ) .


In the LMA group , more patients needed medical assistance ( P = 0.029 ) , and the number of assistance was also higher ( P = 0.027 ) in the ward .


No severe complications occurred during the observation period .


The LMA does not alleviate nasal bleeding conditions and even increases the demands of medical service outside the OR after intranasal surgery , although it reduces epistaxis during extubation .


Relaxation training can be an important adjunct in reducing symptoms associated with Parkinson 's disease ( PD ) .


Autogenic Training ( AT ) is a simple , easily administered and inexpensive technique for retraining the mind and the body to be able to relax .


AT uses visual imagery and body awareness to promote a state of deep relaxation .


To investigate whether AT when used as an adjunct to Physiotherapy ( PT ) improves motor performances in PD in comparison with a control group receiving PT alone .


Randomized , controlled , single blinded trial .


Movement Disorder Clinic and Department of Physiotherapy , Sree Chithira Thirunal Institute of Medical Sciences and Technology in Trivandrum , Kerala , India .


Patients with PD of grade 2 or 3 of Hoehn & Yahr ( H&Y ) scale ( N = 66 ) .


AT group or control group .


The techniques were administered by Physiotherapists trained in AT and consisted of 40 sessions per patient over 8 weeks .


Motor score subscale of Unified Parkinson 's Disease Rating Scale ( UPDRS ) was used to measure the motor performances .


The primary outcome measure was the difference in Motor score subscale of UPDRS scores between Week 1 ( pretest score ) , Week 8 ( posttest score ) , and follow-up at Week 12 after randomization .


The simple main effects analysis showed that the AT group performed better than the control group in weeks 8 and 12 ( P < .005 ) .


Patients in the AT and control groups reported a 51.78 % and 35.24 % improvement , respectively , in their motor performances in Week 8 compared with that in Week 1 , which persisted , in the follow-up ( Week 12 ) as 30.82 % in the AT group and 21.42 % in the control group .


This study provides evidence that AT when used as an adjunct to PT is more effective than PT alone in improving motor performances in PD patients .


To evaluate the margin quality of direct resin composite restorations comparing the enamel-dentin adhesive standard procedure with additional use of adhesive layer at the external outline .


A total of 648 teeth with Class I occlusal lesions in molars and premolars were randomly selected and distributed into two groups of 324 each in order to compare the margin quality with two restoration strategies .


Lesions were sealed with the standard adhesion procedure for direct resin composite restorations ( Group 1 ) and with an additional procedure of enamel adhesive on the outer boundary of the finished restoration ( Group 2 ) .


Evaluation of marginal quality at 6 , 12 , 24 , 36 and 48 months was performed and described as good marginal adaption or as poor quality defined as Inadequacy A ( IA ) : overhanging resin or change of color ; Inadequacy B ( IB ) : the presence of a gap at the enamel-composite interface that retained the probe tip ; or Inadequacy C ( IC ) presence of gap at the enamel-composite interface with explorer tip penetration of more than 1 mm .


Data showed a higher number of Inadequacy A for restorations with the additional technique for marginal seal ( Group 2 ) : 16 of 24 total ( 57 % ) at 6 months ; 28 of 37 total ( 76 % ) at 12 months ; 36 of 44 total ( 82 % ) at 18 months ; 22 of 33 total ( 67 % ) at 24 months ; 14 of 21 total ( 70 % ) at 36 months and 16 of 25 total ( 64 % ) at 48 months .


The Inadequacy B and C of marginal seal were more prevalent for restorations without the additional marginal seal ( Group 1 ) : 18 of 28 total ( 64 % ) at 12 months with inadequacy B ; 19 of 25 total ( 76 % ) with inadequacy B and 16 total ( 100 % ) with inadequacy C at 18 months ; 9 of 17 total ( 53 % ) with Inadequacy B and 13 total ( 100 % ) with Inadequacy C at 24 months ; 12 of 17 total ( 70 % ) with Inadequacy B and 9 of 13 total ( 73 % ) with Inadequacy C at 36 months ; 14 of 24 total ( 58 % ) with Inadequacy B and 7 of 11 total ( 63 % ) with Inadequacy C at 48 months .


The purpose of this study was to evaluate the relationship between gestational age ( GA ) and induction of labor ( IOL ) and the rate of cesarean delivery in women with mild gestational diabetes mellitus .


We conducted a secondary analysis of data from a multicenter randomized controlled trial of mild gestational diabetes mellitus treatment .


Cesarean delivery rate of women delivering at term ( 37 weeks ' gestation ) was evaluated by 2 complementary approaches : ( 1 ) IOL vs spontaneous labor : women who were induced at each GA compared with those who spontaneously labored at the same GA and ( 2 ) IOL vs expectant management : women who delivered after IOL at each GA compared with those who delivered after spontaneous labor at the same GA or subsequently after spontaneous or induced labor ( outcome at each week compared with expectant management at that week ) .


Logistic regression adjusted for potential confounders .


The overall cesarean delivery rate was 13 % .


When compared with 39 weeks ' gestation ( either IOL or spontaneous labor ) as the referent , there was no significant difference in the cesarean delivery rate in women who delivered at 37 , 38 , or 40 weeks ' gestation .


However , IOL was associated with a 3-fold increase in cesarean delivery rate at 41 weeks ' gestation and beyond , as compared with IOL at 39 weeks ' gestation .


Similarly , there was a 3-fold increase in the cesarean delivery rate in women who were induced when compared with those who were treated expectantly at 40 completed weeks ' gestation .


Induction of labor in women with mild gestational diabetes mellitus does not increase the rate of cesarean delivery at < 40 weeks ' gestation .


To investigate the optimal dosage/regimen and to evaluate the efficacy and safety of albiglutide in Japanese patients with type 2 diabetes mellitus .


This was a randomized , double-blind , placebo-controlled , multicenter , parallel-group , dose-ranging , superiority study in Japanese patients with type 2 diabetes mellitus .


Patients ( n = 215 ) who were treatment naive or washed out of one oral antidiabetic drug were randomized to placebo or albiglutide 15mg weekly , 30mg weekly , or 30mg every other week ( biweekly ) .


NCT01098461 .


The primary end point was the change from baseline in HbA1c at week 16 , measured using the Japan Diabetes Society standardization scheme and presented here using the National Glycohemoglobin Standardization Program equivalents .


Other measures of efficacy as well as safety and population pharmacokinetics and pharmacokinetics/pharmacodynamics of albiglutide were assessed .


Baseline HbA1c was 8.53 % .


There was a statistically significant difference between each albiglutide treatment group and placebo for change from baseline in HbA1c at week 16 , with treatment effects of -0.89 % for 15mg weekly , -1.55 % for 30mg weekly , and -1.10 % for 30mg biweekly ( P < 0.0001 for all groups vs placebo ) .


By week 16 , 63.0 % and 33.3 % of patients in the 30mg weekly albiglutide group compared with 6.0 % and 0 % of patients in the placebo group achieved HbA1c < 7.4 % and < 6.9 % , respectively .


No serious adverse events were related to study therapy ; no deaths occurred .


Nasopharyngitis was the most frequently reported adverse event in all treatment groups ( n = 43 [ 20.3 % ] ) .


Albiglutide exhibited therapeutic hypoglycemic effects with good tolerability among Japanese patients with type 2 diabetes mellitus ; the 30mg weekly dose was the most efficacious in this study .


The 16 week duration of the study prevents generalizing these conclusions to longer treatment periods .


Currently , instructional effects generated by Cognitive load theory ( CLT ) are limited to visual and auditory cognitive processing .


In contrast , `` embodied cognition '' perspectives suggest a range of gestures , including pointing , may act to support communication and learning , but there is relatively little research showing benefits of such `` embodied learning '' in the health sciences .


This study investigated whether explicit instructions to gesture enhance learning through its cognitive effects .


Forty-two university-educated adults were randomly assigned to conditions in which they were instructed to gesture , or not gesture , as they learnt from novel , paper-based materials about the structure and function of the human heart .


Subjective ratings were used to measure levels of intrinsic , extraneous and germane cognitive load .


Participants who were instructed to gesture performed better on a knowledge test of terminology and a test of comprehension ; however , instructions to gesture had no effect on subjective ratings of cognitive load .


This very simple instructional re-design has the potential to markedly enhance student learning of typical topics and materials in the health sciences and medicine .


Various trials have been conducted on the management and treatment of androgenic alopecia ( AGA ) or male pattern hair loss using a variety of laser and light sources .


For this feasibility study , the population was composed of males between the ages of 20 and 60years who have been experiencing active hair loss within the last 12months and the diagnosis of AGA .


They also had a Norwood-Hamilton classification of 3 , 3A , 3V , 4 , 4A , or 5 for the hair thinning patterns and skin type I , II , III , or IV on the Fitzpatrick skin type scale .


This two-arm randomized , parallel group study design employed stratifying randomization to balance treatment assignment within three investigational centers with at least 2 subjects enrolled in each Fitzpatrick skin type .


A statistically significant positive trend in hair growth was observed from this pilot study , to evaluate the efficacy of the novel cold X5 hairlaser device for treating male androgenic alopecia .


From the repeated measures analysis of variance , difference in mean hair counts over time was statistically significant ( F = 7.70 ; p-value < 0.0001 ) .


Subsequent , linear regression of mean hair counts at each time point was performed , and post-hoc analysis found an increasing trend of hair growth over time that was statistically significant ( p-value < 0.0001 ) with the estimated slope of 1.406 .


Increased hair counts from the baseline to the end of the 26-week period were found to be strongly significant ( p-value = 0.0003 ) .


Albeit , sham device failure and resultant missing data from the control group , the positive trend hair growth , was observed due to the chronic use of X5hairlaser device .


This positive benefit while in full agreement with other low laser hair devices requires intensive further investigation .


NCT02067260 .


Recent preclinical work has suggested that postprandial flow of bile acids into the small intestine potentiates nutrient-induced glucagon-like peptide 1 ( GLP1 ( GCG ) ) secretion via bile acid-induced activation of the G protein-coupled receptor TGR5 in intestinal L cells .


The notion of bile-induced GLP1 secretion combined with the findings of reduced postprandial gallbladder emptying in patients with type 2 diabetes ( T2DM ) led us to speculate whether reduced postprandial GLP1 responses in some patients with T2DM arise as a consequence of diabetic gallbladder dysmotility .


In a randomised design , 15 patients with long-standing T2DM and 15 healthy age - , gender - and BMI-matched control subjects were studied during 75-g oral glucose tolerance test ( OGTT ) and three isocaloric ( 500kcal ) and isovolaemic ( 350ml ) liquid meals : i ) 2.5 g fat , 107g carbohydrate and 13g protein ; ii ) 10g fat , 93g carbohydrate and 11g protein ; and iii ) 40g fat , 32g carbohydrate and 3g protein .


Basal and postprandial plasma concentrations of glucose , insulin , C-peptide , glucagon , GLP1 , glucose-dependent insulinotropic polypeptide ( GIP ) , cholecystokinin and gastrin were measured .


Furthermore , gallbladder emptying and gastric emptying were examined .


Gallbladder emptying increased with increasing meal fat content , but no intergroup differences were demonstrated .


GIP and GLP1 responses were comparable among the groups with GIP levels being higher following high-fat meals , whereas GLP1 secretion was similar after both OGTT and meals .


In conclusion , patients with T2DM exhibited normal gallbladder emptying to meals with a wide range of fat content .


Incretin responses were similar to that in controls , and an association with postprandial gallbladder contraction could not be demonstrated .


Deaths due to road traffic injuries , particularly motorcycle crashes , have increased rapidly in many African nations and context-specific strategies to improve preventative behaviours are needed .


Although adhering to conspicuity measures by wearing reflective safety vests is a highly effective crash prevention strategy and mandated by law among motorcycle-taxi drivers in some African countries , actual use is currently low .


We aimed to test whether eliminating cost-barriers through the provision of free reflective , fluorescent motorcycle safety vests would lead to increased utilisation among a high-risk population of motorcycle-taxi drivers in Tanzania .


A cluster randomised controlled trial was conducted among 180 motorcycle-taxi drivers .


Participants randomised to the intervention arm ( 90 ) received free , reflective , fluorescent vests ; participants randomised to the control arm ( 90 ) did not receive free vests .


Participants ' use of reflective vests was then observed on city streets over a three month period and differential uptake was estimated using mixed-effects logistic regression .


Baseline use of reflective vests was 3.3 % in both arms .


Seventy-nine drivers in the intervention arm and 82 drivers in the control arm were observed during follow-up .


The average proportion of observations during which motorcycle drivers were using a reflective vest was 9.5 % in the intervention arm , compared to 2.0 % in the control arm ( odds ratio : 5.5 , 95 % confidence interval : 1.1-26 .9 , p-value : 0.04 ) .


Although distribution of free reflective vests led to a statistically significant increase in vest usage , the absolute increase was modest .


Additional strategies beyond removing economic barriers are important to augment adherence to road safety behaviours for injury prevention .


Kaposi 's sarcoma ( KS ) is a common childhood cancer in places where HIV is endemic and access to antiretroviral therapy ( ART ) is delayed .


Despite this there are no randomised trials to compare and assess chemotherapeutic regimens .


An open label , randomised trial comparing intravenous vincristine alone , vincristine and bleomycin and oral etoposide , was carried out in children with Kaposi 's sarcoma in the Queen Elizabeth Central Hospital , Blantyre , Malawi .


HIV infected children were given ART after 2-3 courses of chemotherapy if they were not already on treatment .


Neither HIV nor widespread KS are curable and treatment is aimed at disease reduction and improved quality of life .


Tumour reduction was assessed by measuring the size of sentinel KS nodules and quality of life ( QoL ) by using the Lansky score .


Follow up was until death or for one year .


92 children were enrolled of whom 46 % were nave to ART ; 10 ( 11 % ) were HIV negative .


Survival was not influenced by age or gender but was better in the oral etoposide and the vincristine and bleomycin groups .


P = 0.0045 .


The group receiving oral etoposide had a better quality of life .


Toxicity was not significant , and any drop in haemoglobin or white cell count could have been causally related to HIV infection rather than cytotoxic therapy .


Oral etoposide is a safe , effective treatment to contain KS and improve QoL which can be achieved without many visits to the hospital and intravenous injections .


Artemisinin combination therapy effectively clears asexual malaria parasites and immature gametocytes but does not prevent posttreatment malaria transmission .


Ivermectin ( IVM ) may reduce malaria transmission by killing mosquitoes that take blood meals from IVM-treated humans .


In this double-blind , placebo-controlled trial , 120 asymptomatic Plasmodium falciparum parasite carriers were randomized to receive artemether-lumefantrine ( AL ) plus placebo or AL plus a single or repeated dose ( 200 g/kg ) of ivermectin ( AL-IVM1 and AL-IVM2 , respectively ) .


Mosquito membrane feeding was performed 1 , 3 , and 7 days after initiation of treatment to determine Anopheles gambiae and Anopheles funestus survival and infection rates .


The AL-IVM combination was well tolerated .


IVM resulted in a 4 - to 7-fold increased mortality in mosquitoes feeding 1 day after IVM ( P < .001 ) .


Day 7 IVM plasma levels were positively associated with body mass index ( r = 0.57 , P < .001 ) and were higher in female participants ( P = .003 ) , for whom An .


gambiae mosquito mortality was increased until 7 days after a single dose of IVM ( hazard rate ratio , 1.34 [ 95 % confidence interval , 1.07-1 .69 ] ; P = .012 ) .


Although we found no evidence that IVM reduced Plasmodium infection rates among surviving mosquitoes , the mosquitocidal effect of AL-IVM1 and AL-IVM2 resulted in 27 % and 35 % reductions , respectively , in estimated malaria transmission potential during the first week after initiation of treatment .


We conclude that IVM can be safely given in combination with AL and can reduce the likelihood of malaria transmission by reducing the life span of feeding mosquitoes .


NCT0160325 .


To evaluate the prevalence of respiratory impairment and dyspnea and their associations with objectively measured physical inactivity and performance-based mobility in sedentary older persons .


Cross-sectional .


Lifestyle Interventions and Independence for Elders Study .


Community-dwelling older persons ( n = 1,635 , mean age 78.9 ) who reported being sedentary ( < 20 min/wk of regular physical activity and < 125 min/wk of moderate physical activity in past month ) .


Respiratory impairment was defined as low ventilatory capacity ( forced expiratory volume in 1 second less than lower limit of normal ( LLN ) ) and respiratory muscle weakness ( maximal inspiratory pressure < LLN ) .


Dyspnea was defined as moderate to severe ratings on the modified Borg index , immediately after a 400-m walk test ( 400-MWT ) .


Physical inactivity was defined according to high sedentary time as the highest quartile of participants with accelerometry-measured activity of < 100 counts/min .


Performance-based mobility was evaluated using the Short Physical Performance Battery ( 7 defined as moderate to severe mobility impairment ) and 400-MWT gait speed ( < 0.8 m/s defined as slow ) .


Prevalence rates were 17.7 % for low ventilatory capacity , 14.7 % for respiratory muscle weakness , 31.6 % for dyspnea , 44.7 % for moderate to severe mobility impairment and 43.6 % for slow gait speed .


Significant associations were found between low ventilatory capacity and slow gait speed ( adjusted odds ratio ( aOR ) = 1.41 , 95 % confidence interval ( CI ) = 1.03-1 .92 ) , between respiratory muscle weakness and moderate to severe mobility impairment ( aOR = 1.42 , 95 % CI = 1.03-1 .95 ) , and between dyspnea and high sedentary time ( aOR = 1.98 , 95 % CI = 1.28-3 .06 ) and slow gait speed ( aOR = 1.70 , 95 % CI = 1.22-2 .38 ) .


Respiratory impairment and dyspnea are prevalent in sedentary older persons and are associated with objectively measured physical inactivity and poor performance-based mobility .


Because they are modifiable , respiratory impairment and dyspnea should be considered in the evaluation of sedentary older persons .


The Single-Tablet Regimen ( STaR ) study ( GS-US-264-0110 ) is a 96-week phase 3b study evaluating the safety and efficacy of 2 single-tablet regimens , rilpivirine/emtricitabine/tenofovir DF ( RPV/FTC/TDF ) , and efavirenz/emtricitabine/tenofovir DF ( EFV/FTC/TDF ) in treatment-naive HIV-1-infected subjects .


Genotypic analyses ( population sequencing ) of HIV-1 protease and reverse transcriptase were performed at screening ; subjects with pre-existing resistance to study drugs were excluded .


The primary protocol-defined resistance analysis population ( RAP ) had genotypic/phenotypic analyses at failure and baseline for protease and reverse transcriptase .


At week 48 , the primary RAP included 20/394 subjects ( 5.1 % ) receiving RPV/FTC/TDF and 7/392 subjects ( 1.8 % ) receiving EFV/FTC/TDF .


In the RPV/FTC/TDF arm , isolates from 17/394 subjects ( 4.3 % ) developed nonnucleoside reverse transcriptase inhibitor ( NNRTI ) and/or nucleoside reverse transcriptase inhibitor ( NRTI ) resistance mutations , and 16/17 isolates had both NNRTI and NRTI resistance mutations .


In the EFV/FTC/TDF arm , isolates from 3/392 subjects ( 0.8 % ) developed NNRTI and/or NRTI resistance mutations .


When stratified by baseline viral load of either 100,000 or > 100,000 copies/mL , 5/260 ( 1.9 % ) versus 12/134 ( 9.0 % ) RPV/FTC/TDF-treated subjects and 2/250 ( 0.8 % ) versus 1/142 ( 0.7 % ) EFV/FTC/TDF-treated subjects developed resistant isolates , respectively .


The presence of pre-existing NRTI - and NNRTI-associated resistance mutations not excluded at screening ( not related to study drugs ) did not impact treatment response to either regimen .


Among subjects in the primary RAP , resistance development to RPV/FTC/TDF consisted of NNRTI and NRTI mutations and was more frequent than resistance development to EFV/FTC/TDF .


In subjects with baseline viral load 100,000 copies/mL , resistance development was low ( < 2 % ) for both RPV/FTC/TDF and EFV/FTC/TDF arms and less frequent compared with subjects with baseline viral load > 100,000 copies/mL , for RPV/FTC/TDF .


The adverse health effects of insufficient physical activity ( PA ) result in high costs to society .


The economic burden of insufficient PA , which increases in our aging population , stresses the urgency for cost-effective interventions to promote PA among older adults .


The current study provides insight in the cost-effectiveness and cost-utility of different versions of a tailored PA intervention ( Active Plus ) among adults aged over fifty .


The intervention conditions ( i.e. print-delivered basic ( PB ; N = 439 ) , print-delivered environmental ( PE ; N = 435 ) , Web-based basic ( WB ; N = 423 ) , Web-based environmental ( WE ; N = 432 ) ) and a waiting-list control group were studied in a clustered randomized controlled trial .


Intervention costs were registered during the trial .


Health care costs , participant costs and productivity losses were identified and compared with the intervention effects on PA ( in MET-hours per week ) and quality-adjusted life years ( QALYs ) 12months after the start of the intervention .


Cost-effectiveness ratios ( ICERs ) and cost-utility ratios ( ICURs ) were calculated per intervention condition .


Non-parametric bootstrapping techniques and sensitivity analyses were performed to account for uncertainty .


As a whole ( i.e. the four intervention conditions together ) the Active Plus intervention was found to be cost-effective .


The PB-intervention ( ICER = -55 / MET-hour ) , PE-intervention ( ICER = -94 / MET-hour ) and the WE-intervention ( ICER = -139 / MET-hour ) all resulted in higher effects on PA and lower societal costs than the control group .


With regard to QALYs , the PB-intervention ( ICUR = 38,120 / QALY ) , the PE-intervention ( ICUR = 405,892 / QALY ) and the WE-intervention ( ICUR = -47,293 / QALY ) were found to be cost-effective when considering a willingness-to-pay threshold of 20,000 / QALY .


In most cases PE had the highest probability to be cost-effective .


The Active Plus intervention was found to be a cost-effective manner to increase PA in a population aged over fifty when compared to no-intervention .


The tailored Active Plus intervention delivered through printed material and with additional environmental information ( PE ) turned out to be the most cost-effective intervention condition as confirmed by the different sensitivity analyses .


By increasing PA at relatively low costs , the Active Plus intervention can contribute to a better public health .


Dutch Trial Register : NTR2297 .


The effectiveness of acupuncture in relieving acute postoperative pain is still controversial .


This patient-evaluator blinded and sham auricular acupuncture ( AA ) - controlled study tested whether acupuncture is effective in controlling acute postoperative pain after total knee arthroplasty .


Patients were randomly assigned to receive true acupuncture ( knee , scalp , and AA ) or sham AA .


All procedures were conducted under general anesthesia , and the AA needles were retained in situ for 3 days .


Postoperative pain was managed with intravenous fentanyl using a patient-controlled analgesia pump .


The amount of postoperative fentanyl required , the time to the first fentanyl request , pain intensity on a 100-mm visual analog scale , incidence of analgesia-related adverse effects , and success of patients ' blinding were recorded .


This study comprised 60 patients ( 30 in the study group and 30 in the control group ) .


The fentanyl requirement via patient-controlled analgesia in the study group was lower [ mean ( SD ) , 620.7 ( 258.2 ) vs 868.6 ( 319.3 ) g ; P = 0.002 ) .


The time to first request for fentanyl was longer in the study group .


Pain intensity on a 100-mm visual analog scale was lower in the study group in the first 24 hours after the operation .


The incidence of analgesia-related adverse effects of nausea and vomiting was lower in the study group .


The success of blinding was not significantly different between the 2 groups ( P = 0.731 ) .


The data obtained from this clinical trial demonstrate the potential advantages of using acupuncture for postoperative pain control after total knee arthroplasty .


Exercise capacity , which is predictive of all-cause mortality and cardiovascular disease risk , is reduced significantly in patients with non-dialysis-dependent chronic kidney disease .


This pilot study examined the effect of moderate-intensity exercise training on kidney function and indexes of cardiovascular risk in patients with progressive chronic kidney disease stages 3 to4 .


Single-blind , randomized , controlled , parallel trial .


20 patients ( aged 18-80 years ; 17 men ) randomly assigned to rehabilitation ( n = 10 ) or usual care ( n = 10 ) .


Participants were included if they were 18 years or older and had evidence of rate of decline in creatinine-based estimated glomerular filtration rate ( eGFRcr ) 2.9 mL/min/1 .73 m ( 2 ) per year for 12 months preintervention .


Patients were excluded if they had unstable medical conditions or had recently started regular exercise .


The rehabilitation group received resistance and aerobic training ( 3 days per week ) for a 12-month period .


The usual care group received standard care .


Kidney function assessed by comparing mean rate of change in eGFRcr ( mL/min/1 .73 m ( 2 ) per year ) from a 12-month preintervention period against the 12-month intervention period .


Pulse wave velocity ( PWV ) , peak oxygen uptake ( Vo2peak ) , and waist circumference assessed at 0 , 6 , and 12 months .


eGFR assessed using creatinine , cystatin C ( eGFRcys ) , and a combination of both values ( eGFRcr-cys ) .


18 participants ( rehabilitation , 8 ; usual care , 10 ) completed the study .


A significant mean difference in rate of change in eGFRcr ( +7.83.0 [ 95 % CI , 1.1-13 .5 ] mL/min/1 .73 m ( 2 ) per year ; P = 0.02 ) was observed between the rehabilitation and usual care groups , with the rehabilitation group demonstrating a slower decline .


No significant between-group mean differences existed in absolute eGFRcr , eGFRcr-cys , or eGFRcys at 12 months of study intervention .


Significant between-group mean differences existed in PWV ( -2.30 [ 95 % CI,-3 .02 to-1 .59 ] m/s ) , waist circumference ( -7.112.8 [ 95 % CI,-12 .4 to-3 .2 ] cm ) , and Vo2peak ( 5.7 [ 95 % CI , 1.34-10 .10 ] mL/kg/min ) .


Change in eGFRcr was correlated inversely with PWV ( r = -0.5 ; P = 0.04 ) at 12 months .


Small sample size , inconsistency between primary and secondary measures of kidney function .


The effect of a 1-year exercise intervention on progression of kidney disease is inconclusive .


A larger study with longer follow-up may be necessary .


A total of 102 patients were randomized to either mono-therapy with simvastatin ( 40 mg daily ) or triple-therapy with simvastatin ( 40 mg daily ) , extended-release niacin ( 1500 mg daily ) , and ezetimibe ( 10 mg daily ) .


MRI was performed at baseline and 6 , 12 , and 24 months .


SFA wall , lumen , and total vessel volumes were quantified .


MRI-derived SFA parameters and lipids were analyzed with multilevel models and nonparametric tests , respectively .


Baseline characteristics did not differ between mono and triple-therapy groups , except for ethnicity ( p = 0.02 ) .


SFA wall , lumen , and total vessel volumes increased non-significantly for both groups between baseline and 24-months .


Non-high-density lipoprotein cholesterol was significantly reduced at 12 months with triple-therapy compared with mono-therapy ( p = 0.01 ) .


No significant differences were observed between mono-therapy using simvastatin and triple-therapy with simvastatin , extended-release niacin , and ezetimibe for 24-month changes in SFA wall , lumen , and total vessel volumes .


NCT00687076 ; Link : http://clinicaltrials.gov/ct2/show/NCT00687076 .


We examined the prognostic impact of specific KRAS mutations in patients with stage III colon adenocarcinoma receiving adjuvant FOLFOX alone or combined with cetuximab in a phase III trial ( N0147 ) .


Analysis was restricted to BRAF-wild-type tumors , because BRAF mutation was associated with poor prognosis , and BRAF and KRAS mutations are mutually exclusive .


The seven most common KRAS mutations in codon 12 and codon 13 were examined in 2,478 BRAF-wild-type tumors .


Because KRAS mutations in codon 12 ( n = 779 ) or 13 ( n = 220 ) were not predictive of adjuvant cetuximab benefit , study arms were pooled for analysis .


Disease-free survival ( DFS ) was evaluated by HRs using Cox models .


KRAS mutations in codon 12 ( multivariate HR , 1.52 ; 95 % confidence interval , CI , 1.28-1 .80 ; P < 0.0001 ) or codon 13 ( multivariate HR , 1.36 ; 95 % CI , 1.04-1 .77 ; P = 0.0248 ) were significantly associated with shorter DFS compared with patients with wild-type KRAS/BRAF tumors , independent of covariates .


KRAS codon 12 mutations were independently associated with proficient mismatch repair ( P < 0.0001 ) , proximal tumor site ( P < 0.0001 ) , low grade , age , and sex , whereas codon 13 mutations were associated with proximal site ( P < 0.0001 ) .


KRAS mutations in either codon 12 or 13 are associated with inferior survival in patients with resected stage III colon cancer .


These data highlight the importance of accurate molecular characterization and the significant role of KRAS mutations in both codons in the progression of this malignancy in the adjuvant setting .


Clin Cancer Res ; 20 ( 11 ) ; 3033-43 .2014 AACR .


Administration of vaccines by needle-free technology such as jet injection might offer an alternative to needles and syringes that avoids the issue of needle phobia and the risk of needle-stick injury .


We aimed to assess the immunogenicity and safety of trivalent influenza vaccine given by needle-free jet injector compared with needle and syringe .


For this randomised , comparator-controlled trial , we randomly assigned ( 1:1 ) healthy adults ( aged 18-64 years ) who attended one of four employee health clinics in the University of Colorado health system , with stratification by site , to receive one dose of the trivalent inactivated influenza vaccine Afluria given either intramuscularly with a needle-free jet injector ( Stratis ; PharmaJet , Golden , CO , USA ) or with needle and syringe .


Randomisation was done with a computer-generated randomisation schedule with a block size of 100 .


Because of the nature of the study , masking of participants was not possible .


Immunogenicity was assessed by measurement of the hemagglutination inhibition antibody titres in serum for the three viral strains included in the vaccine .


We included six coprimary endpoints : three strain-specific geometric mean titre ratios and the absolute differences in three strain-specific seroconversion rates .


The immune response of the jet injector group was regarded as non-inferior to that of the needle and syringe group if both the upper bound of each of the three 95 % CIs for the strain-specific geometric mean titre ratios was 1.5 or less , and the upper bound of the three 95 % CIs for the strain-specific seroconversion rate differences was less than 10 percentage points .


We used t test for group comparison .


This study is registered with ClinicalTrials.gov , number NCT01688921 .


During the 2012-13 influenza season of the northern hemisphere , we allocated 1250 participants to receive vaccination by needle-free jet injector ( n = 627 ) or needle and syringe ( n = 623 ) .


In the intention-to-treat immunogenicity population , all participants with two serum samples were included ( 575 in the jet injector group and 574 in the needle and syringe group ) .


The immune response to Afluria when given by needle-free jet injector met the criteria for non-inferiority for all six coprimary endpoints .


The jet injector group met the geometric mean titre criterion for non-inferiority for the A/H1N1 , A/H3N2 , and B strains ( upper bound of the 95 % CI for the geometric mean titre ratios were 110 for A/H1N1 , 117 for A/H3N2 , and 104 for B strains ) .


The jet injector group met the seroconversion rate criterion for non-inferiority for the A/H1N1 , A/H3N2 , and B strains ( upper bound of the 95 % CI of the seroconversion rate differences were 60 % for A/H1N1 , 70 % for A/H3N2 , and 57 % for B strains ) .


We recorded serious adverse events in three participants , none of which were study related .


The immune response to influenza vaccine given with the jet injector device was non-inferior to the immune response to influenza vaccine given with needle and syringe .


The device had a clinically acceptable safety profile , but was associated with a higher frequency of local injection site reactions than was the use of needle and syringe .


The Stratis needle-free jet injector device could be used as an alternative method of administration of Afluria trivalent influenza vaccine .


Biomedical Advanced Research and Development Authority ( BARDA ) , PATH , bioCSL , and PharmaJet .


Preclinical and human laboratory research suggests that ( a ) progesterone may decrease drug reward , craving , and smoking behavior , and ( b ) estradiol may enhance drug reward and smoking behavior .


A modest majority of treatment research examining the relationship between menstrual cycle phase and outcomes suggests that the luteal menstrual phase , with its uniquely higher progesterone levels , is associated with better cessation outcomes .


However , no studies to date have examined the effects of naturally occurring variation in progesterone and estradiol levels on medication-assisted smoking cessation .


The present study sought to fill this notable gap in the treatment literature .


Weekly plasma progesterone and estradiol levels were obtained from nicotine-dependent female smokers enrolled in a 4-week cessation trial .


Participants ( N = 108 ) were randomized to receive a 4-week course of either varenicline ( VAR ) tablets and placebo patches or placebo tablets and nicotine patches .


Plasma samples were obtained 1 week before their cessation attempt and weekly during medication administration .


Abstinence was assessed weekly .


Weekly hormone data replicated commonly observed menstrual cycle patterns of progesterone and estradiol levels .


Importantly , increases in progesterone level were associated with a 23 % increase in the odds for being abstinent within each week of treatment .


This effect was driven primarily by nicotine patch-treated versus VAR-treated females .


This study was the first to identify an association between progesterone level ( increasing ) and abstinence outcomes in free-cycling women smokers who participated in a medication-based treatment .


Furthermore , the potential benefits of progesterone may vary across different pharmacotherapies .


Implications of these findings for smoking cessation intervention are discussed .


The purpose of the present study was to investigate the effect of high-dose inhaled terbutaline on muscle strength , maximal sprinting , and time-trial performance in trained men .


Nine non-asthmatic males with a VSOmax of 58.9 3.1 ml min ( -1 ) kg ( -1 ) ( mean SEM ) participated in a double-blinded randomized crossover study .


After administration of inhaled terbutaline ( 30 0.5 mg ) or placebo , subjects ' maximal voluntary isometric contraction ( MVC ) of m.quadriceps was measured .


After MVC , subjects performed a 30-s Wingate test .


Sixty minutes following the Wingate test , subjects exercised for 10 min at 80 % of VSOmax and completed a 100-kcal time trial .


Aerobic contribution was determined during the Wingate test by indirect calorimetry .


Furthermore , plasma terbutaline , lactate , glucose , and K ( + ) were measured .


Inhalation of 15 mg terbutaline resulted in systemic concentrations of terbutaline of 23.6 1.1 ng ml ( -1 ) 30 min after administration , and elevated plasma lactate ( P = 0.001 ) and glucose ( P = 0.007 ) .


MVC was higher for terbutaline than placebo ( 738 64 vs. 681 68 N ) ( P = 0.007 ) .


In addition , Wingate peak power and mean power were 2.2 0.8 ( P = 0.019 ) and 3.3 1.0 % ( P = 0.009 ) higher for terbutaline than placebo .


Net accumulation of plasma lactate was higher ( P = 0.003 ) for terbutaline than placebo during the Wingate test , whereas [ Formula : see text ] above baseline was unchanged by terbutaline ( P = 0.882 ) .


Time-trial performance was not different between treatments ( P = 0.236 ) .


High-dose inhaled terbutaline elicits a systemic response that enhances muscle strength and sprint performance .


High-dose terbutaline should therefore continue to be restricted in competitive sport .


Fewer than one in 10 adolescents with substance use disorders ( ASUDs ) will receive specialty treatment , and even fewer will receive treatment designated as evidence-based practice ( EBP ) .


Traditional efforts to increase the utilization of EBP by ASUDs typically focus on practitioners-either in substance use clinics or allied health settings .


Direct-to-consumer ( DTC ) marketing that directly targets parents of ASUDs represents a potentially complementary paradigm that has yet to be evaluated .


The current study is the first to evaluate the relevance of a well-established marketing framework ( the Marketing Mix ) and measurement approach ( measurement of perceived service quality [ PSQ ] ) with parents of ASUDs in need of treatment .


A mixed-methods design is employed across three study phases , consistent with well-established methods used in the field of marketing science .


Phase 1 consists of formative qualitative research with parents ( and a supplementary sample of adolescents ) in order to evaluate and potentially adapt a conceptual framework ( Marketing Mix ) and measure of PSQ .


Phase 2 is a targeted survey of ASUD parents to elucidate their marketing preferences , using the adapted Marketing Mix framework , and to establish the psychometric properties of the PSQ measure .


The survey will also gather data on parents ' preferences for different targeted marketing messages .


Phase 3 is a two-group randomized controlled trial comparing the effectiveness of targeted marketing messages versus standard clinical information .


Key outcomes will include parents ' ratings of PSQ ( using the new measure ) , behavioral intentions to seek out information about EBP , and actual information-seeking behavior .


The current study will inform the field whether a well-established marketing framework and measurement approach can be used to increase demand for EBP among parents of ASUDs .


Results of this study will have the potential to immediately inform DTC marketing efforts by professional organizations , federal agencies , clinicians , and clinical researchers .


To evaluate the efficacy and safety of entecavir maleate ( ETV ) versus ETV in Chinese patients with hepatitis B e antigen ( HBeAg ) - positive chronic hepatitis B ( CHB ) .


The patient population of this previously published randomized , double-blind , double-dummy , controlled , multicenter study was expanded by patients in the 0.5 mg/day ETV maleate group ( total n = 110 ) and patients in the 0.5 mg/day ETV group ( total n = 108 ) .


At treatment weeks 12 , 24 and 48 , hepatitis B virus ( HBV ) DNA levels were measured by the Roche Cobas Ampliprep/Cobas Taqman PCR assay .


Adverse events ( AE ) were recorded .


As in the original analysis , the two treatment groups showed similar characteristics at baseline .


In addition , the results for the all therapeutic effects showed identical trends to the results obtained in the original analysis , including the statistically similar effects of ETV and ETV maleate treatment-induced decreases in mean HBV DNA level at weeks 12 , 24 , and 48 ( ETV : by 4.28 , 5.00 , and 5.53 log10 IU/ml vs. ETV maleate : by 4.46 , 4.99 , and 5.51 log10 IU/ml , respectively ; all vs. baseline P more than 0.05 ) , achievement of undetectable levels of serum HBV DNA ( less than 20 IU/ml ) at week 48 ( ETV : 38.18 % vs. ETV maleate : 35.19 % ; P more than 0.05 ) , HBeAg loss rates at week 48 ( ETV : 10.91 % vs. ETV maleate : 12.96 % ; P more than 0.05 ) , HBeAg seroconversion rates at week 48 ( ETV : 7.77 % vs. ETV maleate : 10.38 % ; P more than 0.05 ) , normalization of alanine aminotransferase at week 48 ( ETV : 75.47 % vs. ETV maleate : 82.86 % ; P more than 0.05 ) , and overall incidence of AE ( ETV : 18.02 % vs. ETV maleate : 17.43 % ; P more than 0.05 ) .


Performing analysis of the therapeutic efficacies of entecavir maleate versus entecavir with a larger study population confirmed our original findings of similar efficacy and safety profiles for these two drugs in patients with HBeAg-positive CHB .


To examine potential mechanisms underlying nicotine 's effects on male sexual arousal by exploring the mediating role of heart rate variability ( HRV ) .


The sample comprised 22 healthy , nicotine-nave men ( mean age = 20.91 years ; standard deviation = 2.43 ) .


Data were taken from a double-blind , randomized , placebo-controlled , crossover trial previously completed and published elsewhere .


During each laboratory visit , time-domain parameters of HRV ( standard deviation of normal-to-normal [ NN ] intervals , square root of the mean squared difference of successive NN intervals , and percent of NN intervals for which successive heartbeat intervals differed by at least 50 ms [ pNN50 ] ) along with the objective ( via penile plethysmography ) and subjective indices of sexual arousal were assessed .


Acute nicotine ingestion ( compared with placebo ) was associated with dysregulated sympathovagal balance , which in turn was related to relatively reduced erectile tumescence .


HRV did not mediate relations between nicotine intake and self-reported indices of sexual arousal .


HRV mediated the association between nicotine ingestion and erectile capacity .


Findings suggest that dysfunctional cardiac autonomic tone may be an underlying mechanism by which nicotine exerts its deleterious effects on erectile health .


To study the frequency of vitamin D deficiency in patients with hepatitis C virus ( HCV ) infection and to evaluate the role of vitamin D supplementation in improving antiviral therapy .


Sixty-six children aged from 7-14 years ( mean SD , 11.172.293 ) diagnosed with HCV infection were matched to 28 healthy controls .


Serum levels of 25 ( OH ) D3 , calcium , phosphorus , alkaline phosphatase and plasma level of parathormone were measured .


Quantitative PCR for HCV was performed Bone density was determined by dual energy X-ray absorptiometry .


All cases received conventional therapy , and only 33 patients received vitamin D supplementation .


Children with HCV showed significantly increased levels of HCV RNA ( P < 0.001 ) , parathormone ( P < 0.01 ) and decreased vitamin D levels ( P < 0.05 ) ( 33.3 % deficient and 43.3 % insufficient ) compared with controls .


Abnormal bone status ( Z score -1.980.75 ) was found in ribs , L-spine , pelvis and total body .


Cases treated with vitamin D showed significant higher early ( P < 0.04 ) and sustained ( P < 0.05 ) virological response .


There was a high frequency of vitamin D deficiency among the Egyptian HCV children , with significant decrease in bone density .


The vitamin D level should be assessed before the start of antiviral treatment with the correction of any detected deficiency .


Adding vitamin D to conventional Peg/RBV therapy significantly improved the virological response and helped to prevent the risk of emerging bone fragility .


To investigate the effects of the plasma containing Qianlongtong Capsule ( QLT ) - containing plasma on the expression of the Smad4 gene in prostate stromal cells in vitro and provide some experimental evidence for the treatment of benign prostatic hyperplasia ( BPH ) with Chinese medicinal compound .


Fifteen cases of BPH were equally randomized to three groups to be treated with QLT at a high dose ( 6 capsules once ) , a medium dose ( 3 capsules once ) , and a low dose ( 1.5 capsules once ) , tid , for 7 days consecutively .


QLT-containing plasma was collected from the patients .


Prostate stromal cells were identified by immunofluorescence when they became monolayered and cultured in the QLT-containing plasma for 24 hours , followed by detection of the expression of the Smad4 gene by real-time quantitative PCR and that of the Smad4 protein by Western blot .


After treatment with the QLT-containing plasma , the expression of the Smad4 gene in the stromal cells was significantly increased in a dose-dependent manner as compared with the blank control and no-QLT groups ( P < 0.01 ) .


The expression of the Smad4 protein was also markedly elevated after treatment .


The differences were statistically significant between the blank control and medium-dose groups ( P < 0.01 ) , low-dose and medium-dose groups ( P < 0.05 ) , and high-dose and the other groups ( P < 0.01 ) , but not between the blank control and low-dose groups ( P > 0.05 ) .


QLT-containing plasma could inhibit the proliferation and improve the apoptotic index of prostate stromal cells in vitro , which was related to the elevation of the mRNA and protein expressions of Smad4 .


This study evaluated in-office balloon dilation of maxillary sinus ostia and ethmoid infundibula to treat chronic rhinosinusitis ( CRS ) and recurrent acute rhinosinusitis ( RARS ) .


Seventy-four patients with disease in the maxillary and anterior ethmoid sinuses on computed tomography were prospectively enrolled across 12 study centers .


All procedures were performed in the office .


The primary outcomes were clinical effectiveness and health-care utilization at 1 year , measured by the validated surveys Sino-Nasal Outcome Test ( SNOT-20 ) and Rhinosinusitis Symptom Inventory ( RSI ) .


Dilation was successful in 69 patients ( 93.2 % ) , and the average periprocedural pain level was 3.2 ( scale of 0 to 10 ) .


The mean improvement on the SNOT-20 at 1 year was clinically and statistically significant ( p < 0.0001 ) , with no significant difference between the CRS and RARS patient outcomes .


The treatment effect was the same in the CRS and RARS subgroups and was either `` moderate '' or `` large '' for 10 of 12 symptoms .


The mean numbers of antibiotic courses ( p < or = 0.001 ) , sinus-related physician visits ( p < 0.0001 ) , and number of acute sinus infections ( p < 0.001 ) decreased significantly in both subgroups .


There were no serious device-related adverse events , and the rate of revision surgery was 5.8 % .


Stand-alone balloon dilation of the maxillary sinus ostia and ethmoid infundibula performed in the office is well tolerated and effectively treats both CRS and RARS .


This study investigated the effect of the knee position during wound closure on early knee function recovery after total knee arthroplasty ( TKA ) .


This study included 80 primary total knee arthroplasties due to osteoarthritis .


The patients were randomized according to the type of wound closure : extension group for full extension and flexion group for 90 flexion .


The incision of articular capsule was marked for precise wound alignment .


In the flexion group , the knee was kept in high flexion for 1 to 2 min after wound closure .


The two groups were treated with the same postoperative rehabilitation exercises .


The range of motion ( ROM ) , visual analogue scale ( VAS ) score of anterior knee pain , Knee Society Score ( KSS ) and postoperative complications were assessed at 6 weeks , 3 months and 6 months , postoperatively .


At 6 weeks and 3 months postoperatively , the ROM in flexion group was 98.9510.33 and 110.054.93 respectively , with 87.628.92 and 95.626.51 in extension group , respectively ; The VAS score of anterior knee pain in flexion group was 2.021.38 and 2.210.87 , respectively , with 2.571.07 and 2.870.83 in extension group , respectively .


The ROM and VAS pain score of the two groups were significantly different at these two time points , with no significant difference at 6 months postoperatively .


The two groups were not significantly different in KSS , and no apparent complication was observed at three time points .


Marking the articular capsule incision , wound closure in flexion and high flexion after wound closure can effectively decrease anterior knee pain after TKA and promote the early recovery of ROM .


The live attenuated 17DD Yellow Fever vaccine is one of the most successful prophylactic interventions for controlling disease expansion ever designed and utilized in larger scale .


However , increase on worldwide vaccine demands and manufacturing restrictions urge for more detailed dose sparing studies .


The establishment of complementary biomarkers in addition to PRNT and Viremia could support a secure decision-making regarding the use of 17DD YF vaccine subdoses .


The present work aimed at comparing the serum chemokine and cytokine kinetics triggered by five subdoses of 17DD YF Vaccine .


Neutralizing antibody titers , viremia , cytokines and chemokines were tested on blood samples obtained from eligible primary vaccinees .


The results demonstrated that a fifty-fold lower dose of 17DD-YF vaccine ( 587 IU ) is able to trigger similar immunogenicity , as evidenced by significant titers of anti-YF PRNT .


However , only subdoses as low as 3,013 IU elicit viremia kinetics with an early peak at five days after primary vaccination equivalent to the current dose ( 27,476 IU ) , while other subdoses show a distinct , lower in magnitude and later peak at day 6 post-vaccination .


Although the subdose of 587 IU is able to trigger equivalent kinetics of IL-8 / CXCL-8 and MCP-1 / CCL-2 , only the subdose of 3,013 IU is able to trigger similar kinetics of MIG/CXCL -9 , pro-inflammatory ( TNF , IFN - and IL-2 ) and modulatory cytokines ( IL-5 and IL-10 ) .


The analysis of serum biomarkers IFN - and IL-10 , in association to PRNT and viremia , support the recommendation of use of a ten-fold lower subdose ( 3,013 IU ) of 17DD-YF vaccine .


To compare the effects of different anesthesia techniques on tourniquet-related ischemia-reperfusion by measuring the levels of malondialdehyde ( MDA ) , ischemia-modified albumin ( IMA ) and neuromuscular side effects .


Sixty ASAI-II patients undergoing arthroscopic knee surgery were randomised to three groups .


In Group S , intrathecal anesthesia was administered using levobupivacaine .


Anesthesia was induced and maintained with sevoflurane in Group I and TIVA with propofol in Group T. Blood samples were obtained before the induction of anesthesia ( t1 ) , 30 min after tourniquet inflation ( t2 ) , immediately before ( t3 ) , and 5 min ( t4 ) , 15 min ( t5 ) , 30 min ( t 6 ) , 1 h ( t7 ) , 2 h ( t8 ) , and 6 h ( t9 ) after tourniquet release .


MDA and IMA levels increased significantly compared with baseline values in Group S at t2-t 9 and t2-t7 .


MDA levels in Group T and Group I were significantly lower than those in Group S at t2-t8 and t2-t9 .


IMA levels in Group T were significantly lower than those in Group S at t2-t7 .


Postoperatively , a temporary 1/5 loss of strength in dorsiflexion of the ankle was observed in 3 patients in Group S and 1 in Group I.


TIVA with propofol can make a positive contribution in tourniquet-related ischemia-reperfusion .


To determine the amount and type of feedback needed to improve pharmacy students ' problem-solving skills using team-based learning ( TBL ) and a problem-solving rubric .


A problem-solving rubric was developed to assess the ability of pharmacy students ' to prioritize , organize , and defend the best and alternative options on TBL cases The study involved 3 groups of pharmacy students : second-year students in a cardiology class who received no feedback ( control group ) , third-year students in an endocrinology class who received written feedback only , and third-year students in an endocrinology class who received written and verbal feedback .


Students worked in groups on all TBL cases except the first and last one ( beginning and end of course ) , which students completed independently as it served as a pretest and posttest .


Significant improvements were seen in the ability of the third-year students who received verbal and written feedback to prioritize the information presented in the case and in their total score on the problem-solving rubric .


Providing pharmacy students with written and verbal explanations may help them improve their problem-solving skills overall .


During verbal feedback , faculty members can provide more examples of how to improve and can field questions if needed .


In vitro and animal studies have reported conflicting results regarding an independent role for FSH in the regulation of bone turnover .


Our objective was to test the hypothesis that suppressing serum FSH while holding serum gonadal steroid levels stable in the eugonadal range will affect biochemical markers of bone metabolism in healthy men .


Eugonadal men aged 20 to 50 years participated in this randomized controlled trial at a tertiary care academic teaching hospital .


Participants received monthly GnRH analog injections to suppress FSH secretion plus daily topical testosterone gel in prespecified doses ( intervention group ) .


Controls received matching placebos ( control group ) .


Subjects in the intervention group were individually matched with subjects in the control group to ensure that the mean testosterone and estradiol levels ( measured every 4 weeks during the 16-week study period ) in the 2 groups were similar .


Biochemical markers of bone resorption ( serum N-terminal telopeptide and C-terminal telopeptide ) , bone formation ( serum osteocalcin ) , and FSH were measured at baseline and after 16 weeks of treatment .


Serum FSH declined by 2 % in the control group and by 60 % in the intervention group ( P < .0001 for the between-group difference ) .


Despite the substantial suppression of serum FSH in the intervention group , serum N-terminal telopeptide , C-terminal telopeptide , and osteocalcin did not change in the intervention group , nor were any between-group differences observed .


When gonadal steroid levels are held constant , short-to midterm suppression of FSH does not affect bone turnover in men .


FSH does not appear to be a significant regulator of bone metabolism in eugonadal men .


We analyzed data collected during the Active Ulcerative Colitis Trials ( ACT-1 and ACT-2 ) to assess relationships between serum concentrations of infliximab and outcomes of adults with moderate-to-severe ulcerative colitis .


We compared serum concentrations of infliximab with outcomes of 728 patients with moderately-to-severely active ulcerative colitis who participated in ACT-1 or ACT-2 ; efficacy data were collected at weeks 8 , 30 , and 54 ( for ACT-1 only ) .


Relationships between serum concentration of infliximab and efficacy outcomes were assessed using trend , logistic regression , and receiver operating characteristic curve analyses .


We also evaluated factors that affected the relationship between exposure and response .


Median serum concentrations of infliximab at weeks 8 , 30 , and/or 54 were significantly higher in patients with clinical response , mucosal healing , and/or clinical remission than in patients who did not meet these response criteria .


There were statistically significant relationships between quartile of infliximab serum concentration and efficacy at these time points ( P < .01 ) .


Infliximab therapy was effective for a smaller proportion of patients in the lowest quartile , and these patients had lower serum levels of albumin and a higher incidence of antibodies to infliximab than patients in other quartiles .


Although the relationship between exposure to infliximab and response varied among patients , approximate serum concentrations of 41 g/mL infliximab at week 8 of induction therapy and 3.7 g/mL at steady-state during maintenance therapy produced optimal outcomes in patients .


Serum concentrations of infliximab are associated with efficacy in patients with moderate-to-severe ulcerative colitis ; however , complex factors determine the relationship between exposure to this drug and response .


A prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies .


Clinicaltrials.gov numbers : NCT00036439 and NCT00096655 .


To determine the feasibility of a multicentre randomised controlled trial ( RCT ) to investigate whether digital rotation of the fetal head from occiput posterior ( OP ) position in the second stage of labour reduces the risk of operative delivery ( defined as caesarean section ( CS ) or instrumental delivery ) .


We conducted the study between December 2010 and December 2011 in a tertiary referral hospital in Australia .


A transabdominal ultrasound was performed early in the second stage of labour on women with cephalic , singleton pregnancies to determine the fetal position .


Those women with a fetus in the OP position were randomised to either a digital rotation or a sham procedure .


In all other ways , participants received their usual intrapartum care .


Data regarding demographics , mode of delivery , labour , post natal period and neonatal outcomes were collected .


One thousand and four women were consented , 834 achieved full dilatation , and 30 were randomised .


An additional portable ultrasound scan and a blinded ` sham ' digital rotation were acceptable to women and staff .


Operative delivery rates were 13/15 in the digital rotation ( four CS and nine instrumental ) and 12/15 in the sham ( three CS and nine instrumental ) groups , respectively .


A large double-blinded multicentre RCT would be feasible and acceptable to women and staff .


Strategies to improve recruitment such as consenting women with an effective epidural in active labour should be considered .


This would be the first RCT to answer a clinically important question which could significantly affect the operative delivery rate in Australia and internationally .


To observe the curative effects of rh-endostatin combined with DP regimen in treating patients with advanced esophageal cancer and analyze the correlation of CT perfusion ( CTP ) parameters and the expression of vascular endothelial growth factor ( VEGF ) .


Twenty patients with esophageal cancer confirmed pathologically were randomly divided into combined treatment ( rh-endostatin + DP regimen ) group and single chemotherapy group , 10 patients in each group , respectively .


All patients were given conventional CT examination and CTP imaging for primary tumor .


The level of VEGF , the size of tumor and CTP parameters ( BF , BV , PS and MTT ) before treatment and after 2 cycles of treatment were determined for the comparison and the correlation between CTP parameters and VEGF expression was analyzed .


the therapeutic effect of rh-endostatin + DP regimen group was superior to single chemotherapy group .


VEGF level after treatment in rh - endostatin + DP regimen group was obviously lower than single chemotherapy group ( P < 0.01 ) .


The expression of VEGF had positive correlation with BF and BV but negative correlation with MTT .


Compared with treatment before for rh-endostatin + DP regimen group , BF , BV and PS decreased while MTT increased after treatment ( P < 0.05 ) .


However , there were no significant differences between treatment before and after treatment in single chemotherapy ( P > 0.05 ) .


Rh-endostatin can down-regulate the expression of VEGF in esophageal cancer , change the state of hypertransfusion and high permeability of tumor vessels and had the better curative effect and slighter adverse reactions when combined with chemotherapy .


Although its excellent results , laparoscopic sleeve gastrectomy ( LSG ) presents major complications ranging from 0 % to 29 % .


Among them , the staple line leak presents an incidence varying from 0 % to 7 % .


Many trials debated about different solutions in order to reduce leaks ' incidence .


No author has investigated the role of gastric decompression in the prevention of this complication .


Aim of our work is to evaluate if this procedure can play a role in avoiding the occurrence of staple line leaks after LSG .


Between January 2008 and November 2012 , 145 patients were prospectively and randomly included in the study .


Seventy patients composed the group A , whose operations were completed with placement of nasogastric tube ; the other 75 patients were included in the group B , in which no nasogastric tube was placed .


No statistical differences were observed between group A and group B regarding gender distribution , age , weight , and BMI .


No intraoperative complications and no conversion occurred in both groups .


Intraoperative blood loss ( 50.1 42.3 vs. 52.5 37.6 ml , respectively ) and operative time ( 65.4 25.5 vs. 62.6 27.8 min , respectively ) were comparable between the two groups ( p : NS ) .


One staple line leak ( 1.4 % ) occurred on 6th postoperative day in group A patients .


No leak was observed in group B patients .


Postoperative hospital stay was significantly longer in group A vs. group B patients ( 7.6 3.4 vs. 6.2 3.1 days , respectively , p : 0.04 ) .


Routine placement of nasogastric tube in patients operated of LSG seems not useful in reducing leaks ' incidence .


To investigate the feasibility of conducting a cohort , factorial randomized controlled trial ( RCT ) in the treatment of patients with low back pain ( LBP ) .


Pragmatic feasibility factorial RCT nested within an observational cohort study in two general practices in York , United Kingdom .


Eight hundred forty-five patients aged between 18 and 65years who had consulted their general practitioner about LBP within the preceding 12months were mailed an invitation to participate in a cohort trial , with the possibility of later joining a treatment RCT .


One hundred twenty-four patients consented to participate in the cohort and treatment trial , and one consented only to the cohort only .


Ultimately , 59 patients were randomized into the nested RCT .


Outcomes included recruitment , acceptability , and attrition rates as measures of the feasibility of the design and Roland Morris Disability Questionnaire .


No statistically significant differences in outcome between treatment groups and usual care were found .


The design was feasible for the evaluation of different back pain treatments .


We found zero attrition after randomization and showed that for a remitting relapsing condition , the design allows us to recruit initially ineligible patients from the cohort .


Additional statistical analysis using regression discontinuity can also be used with this design .


Low-frequency nevirapine ( NVP ) - resistant variants have been associated with virologic failure ( VF ) of initial NVP-based combination antiretroviral therapy ( cART ) in women with prior exposure to single-dose NVP ( sdNVP ) .


We investigated whether a similar association exists in women without prior sdNVP exposure .


Pre-cART plasma was analyzed by allele-specific polymerase chain reaction to quantify NVP-resistant mutants in human immunodeficiency virus-infected African women without prior sdNVP who were starting first-line NVP-based cART in the OCTANE/A5208 trial 2 .


Associations between NVP-resistant mutants and VF or death were determined and compared with published results from women participating in the OCTANE/A5208 trial 1 who had taken sdNVP and initiated NVP-based cART .


Pre-cART NVP-resistant variants were detected in 18 % ( 39/219 ) of women without prior sdNVP exposure , compared to 45 % ( 51/114 ) with prior sdNVP exposure ( P < .001 ) .


Among women without prior sdNVP exposure , 8 of 39 ( 21 % ) with NVP-resistant variants experienced VF or death vs 31 of 180 ( 17 % ) without such variants ( P = .65 ) ; this compares with 21 of 51 ( 41 % ) vs 9 of 63 ( 14 % ) among women with prior exposure ( P = .001 ) .


The risk of VF on NVP-based cART from NVP-resistant variants differs between sdNVP-exposed and - unexposed women .


This difference may be driven by drug-resistance mutations emerging after sdNVP exposure that are linked on the same viral genome .


NCT00089505 .


The neurobehavioural symptoms and pain following traumatic brain injury ( TBI ) can be long-lasting .


The condition impairs the persons ' ability to function in their work , studies and gatherings with family and friends .


The aim of this study was to investigate dosage , safety and effects of methylphenidate on mental fatigue and pain .


Twenty-nine physically-well rehabilitated TBI victims , 28 with a mild TBI and one with TBI and also with pain in the neck , shoulders and head were included in the study .


Methylphenidate was tested in each patient using three treatment strategies : no medication , low dose ( 5mg3 ) and normal dose ( 20mg3 ) for 4 weeks using a randomized cross-over design .


Twenty-four patients completed the three treatment periods .


Five participants discontinued , four females due to adverse reactions and one male due to attenuated motivation .


Only minor adverse events were reported .


Methylphenidate significantly decreased mental fatigue , as evaluated by the Mental Fatigue Scale ( p < 0.001 ) , and the effects on mental fatigue were dose-dependent .


No effect on pain was detected .


Methylphenidate decreased mental fatigue for subjects suffering a traumatic brain injury , the treatment is considered to be safe and is recommended , starting with a low dose .


Patients with severe OSA consume greater amounts of cholesterol , protein , and fat as well as have greater caloric expenditure .


However , it is not known whether their activity levels or diet change after treatment with CPAP .


To investigate this issue , serial assessments of activity and dietary intake were performed in the Apnea Positive Pressure Long-term Efficacy Study ( APPLES ) ; a 6-month randomized controlled study of CPAP vs. sham CPAP on neurocognitive outcomes .


Subjects were recruited into APPLES at 5 sites through clinic encounters or public advertisement .


After undergoing a diagnostic polysomnogram , subjects were randomized to CPAP or sham if their AHI was 10 .


Adherence was assessed using data cards from the devices .


At the Tucson and Walla Walla sites , subjects were asked to complete validated activity and food frequency questionnaires at baseline and their 4-month visit .


Activity and diet data were available at baseline and after 4 months treatment with CPAP or sham in up to 231 subjects ( 117 CPAP , 114 Sham ) .


Mean age , AHI , BMI , and Epworth Sleepiness Score ( ESS ) for this cohort were 55 13 [ SD ] years , 44 27 / h , 33 7.8 kg/m ( 2 ) , and 10 4 , respectively .


The participants lacking activity and diet data were younger , had lower AHI and arousal index , and had better sleep efficiency ( p < 0.05 ) .


The BMI was higher among women in both CPAP and Sham groups .


However , compared to women , men had higher AHI only in the CPAP group ( 50 vs. 34 ) .


Similarly , the arousal index was higher among men in CPAP group .


Level of adherence defined as hours of device usage per night at 4 months was significantly higher among men in CPAP group ( 4.0 2.9 vs. 2.6 2.6 ) .


No changes in consumption of total calories , protein , carbohydrate or fat were noted after 4 months .


Except for a modest increase in recreational activity in women ( 268 85 vs. 170 47 calories , p < 0.05 ) , there also were no changes in activity patterns .


Except for a modest increase in recreational activity in women , OSA patients treated with CPAP do not substantially change their diet or physical activity habits after treatment .


The present experiment evaluated whether training involving throwing transferred to metric distance estimation ( i.e. , describing in feet and inches the distance between oneself and targets ) .


In prior work , we found that metric estimation training negatively transferred to throwing .


We explained our results in terms of cognitive intrusion .


The present study tested that possibility by swapping our training and transfer tasks .


During pretesting , participants verbally estimated the metric distances between themselves and targets , or they threw a beanbag to targets .


During training , participants donned goggles that distorted their vision .


While wearing the goggles , they threw a beanbag to targets .


Half received feedback .


During posttesting , participants removed the distorting goggles and completed the same task that they performed during pretesting .


The results indicated that the distorting goggles degraded throwing at the beginning of training , visual feedback improved throwing during training , the effects of training with feedback persisted into the throwing posttest , and the effects of training with feedback did not transfer to the verbal metric estimation posttest .


Training involving throwing was effective , but did not transfer to verbal metric distance estimation .


This supports our argument that the negative transfer observed in our previous study stemmed from cognitive intrusion .


The present experiment suggests that the creation of distance estimation training should begin with a careful analysis of the transfer task , and that distance estimation training programs should explicitly teach trainees that their training will not generalize to all distance estimation tasks .


Daily application of oral chlorhexidine gluconate ( CHX ) following intubation to reduce the risk of ventilator-associated pneumonia ( VAP ) is now the standard of care in many ICUs .


This randomized clinical trial evaluated the benefit of adding a preintubation CHX dose to the known benefit of postintubation CHX to reduce the risk of early-onset VAP .


A secondary aim was to test the effect of a preintubation oral application of CHX on early endotracheal tube ( ETT ) colonization .


Subjects ( N = 314 ) were recruited from two teaching hospitals and were randomly assigned to oral application of 5 mL CHX 0.12 % solution before intubation ( intervention group , n = 157 ) , or to a control group ( n = 157 ) who received no CHX before intubation .


All subjects received CHX bid after intubation .


Groups were compared using a repeated-measures model with Clinical Pulmonary Infection Score ( CPIS ) as the response variable .


In a planned subset of subjects , ETTs were cultured at extubation .


Application of a preintubation dose of CHX did not provide benefit over the intervention period beyond that afforded by daily oral CHX following intubation .


ETT colonization at extubation was < 20 % in both groups ( no statistically significant difference ) .


Mean CPIS remained below 6 ( VAP threshold score ) in both groups .


Although it is feasible to deliver CHX prior to intubation ( including emergent or urgent intubation ) , the results suggest that preintubation CHX may be inconsequential when the ventilator bundle , including daily oral CHX , is in place .


During the preintubation period , providers should focus their attention on other critical activities .


ClinicalTrials.gov ; No. : NCT00893763 ; URL : www.clinicaltrials.gov .


Linagliptin is a novel , highly selective and long acting DPP-4 inhibitor for the treatment of type 2 diabetes mellitus ( T2DM ) .


Linagliptin exhibits non-linear pharmacokinetics ( PK ) due to saturable binding to plasma and tissue DPP-4 .


The aim of this study was to characterize the PK and PK/DPP -4 inhibition relationship of linagliptin in Japanese patients with T2DM using a population PK/DPP -4 model and to support the rationale for the therapeutic dose in Japanese patients by simulation .


Linagliptin plasma concentration and DPP-4 inhibition measurements from a placebo-controlled , parallel group multiple ( 28 days ) dose trial that included 36 T2DM patients ( 18 patients each in 2.5 mg and 10 mg dose group ) were used for analysis .


Modeling was performed using FOCE INTERACTION estimation method implemented in NONMEM V.


The linagliptin plasma concentration - and DPP-4 inhibition - time profiles were simulated for Japanese patients receiving 5 mg linagliptin once daily by the model established .


Nonlinear PK of linagliptin in T2DM patients were well described by a 2-compartment model assuming concentration-dependent binding to DPP-4 in the central and peripheral compartment .


Plasma DPP-4 inhibition was integrated in the model by relating the model-predicted DPP-4 occupancy with linagliptin linearly to DPP-4 inhibition .


The simulation predicted that for the 5 mg dose group the trough DPP-4 inhibition at steady-state was 84.2 % , which is higher than the target inhibition ( 80 % ) for an effective dose of DPP-4 inhibitor .


In 2.5 mg dose group , steady-state DPP-4 inhibition of > 80 % was not maintained over 24 hours ( observed and simulated ) .


The nonlinear PK of linagliptin and its plasma DPP-4 inhibition in patients were well characterized by a target-mediated drug disposition model relating DPP-4 occupancy with linagliptin to DPP-4 inhibition .


Simulations of plasma DPP-4 inhibition suggest that 5 mg linagliptin once daily is an appropriate therapeutic dose for Japanese patients with T2DM .


To compare the difference in the clinical efficacy on premature ovarian failure ( POF ) between the acupoint catgut implantation combined with artifical periodic therapy and the simple artificial periodic therapy and explore its effect mechanism .


Sixty-five patients of POF were randomized into the two groups .


In a western medication group , 32 cases were treated with the artificial periodic therapy with the oral administration of medroxyprogesterone acetate tablets .


In a catgut implantation + western medication group , 33 cases were treated with the acupoint catgut implantation combined with artificial periodic therapy .


The acupoints of Neiguan ( PC 6 ) , Zusanli ( ST 36 ) , Guanyuan ( CV 4 ) and Sanyinjiao ( SP 6 ) were selected .


The treatment was lasted for half a year and the follow-up visit was for another half a year in the two groups .


Kupperman index was used to assess the improvements in the clinical symptoms .


The levels of serum sexual hormones such as follicle stimulating hormone ( FSH ) and estradiol ( E2 ) were evaluated of the patients in the two groups before and after treatment .


The efficacy was compared between the two groups .


The scores of the clinical symptoms were all significantly improved after treatment and in the follow-up in the two groups ( P < 0.01 , P < 0.05 ) .


In the 6-month follow-up visit after treatment , the result in the catgut implantation + western medication group was better than that in the western medication group ( 8.17 + / - 1.19 vs 13.68 + / - 1.08 , P < 0.01 ) .


FSH was reduced after treatment in the two groups ( all P < 0.01 ) and E2 was increased ( all P < 0.05 ) .


The curative and remarkably effective rates were 75.8 % ( 25/33 ) and 81.8 % ( 27/22 ) after treatment and in the follow-up visit in the catgut implantation + western medication group , which were better than 67.9 % ( 19/28 ) and 53.6 % ( 15/28 ) in the western medication group separately ( P < 0.05 , P < 0.01 ) .


The acupoint catgut implantation combined with artificial periodic therapy achieve the remarkable improvements in the clinical symptoms of POF in the patients and the better results as compared with the simple western medication therapy .


The combined therapys efficacy is stable and the long-term efficacy is apparently superior .


The effect mechanism is related to the improvements in the serum sexual hormone levels .


MicroRNAs have emerged as important epigenetic regulators in cardiovascular diseases ( CVDs ) .


Using an observational meta-analysis design , we previously characterized a gain-of-function microRNA-410 target site polymorphism ( rs13702T > C ) in the 3 ` untranslated region of the lipoprotein lipase ( LPL ) gene .


The C allele was associated with lower triglycerides , and this association was modulated by fat intake .


We aimed to extend our findings by assessing the interaction between the rs13702 polymorphism and fat intake on triglycerides at baseline and longitudinally by using a dietary intervention design .


We also examined as a primary outcome the association of this variant with CVD incidence and its modulation by the Mediterranean diet ( MedDiet ) .


We studied 7187 participants in the PREDIMED ( Prevencin con Dieta Mediterrnea ) randomized trial that tested a MedDiet intervention compared with a control diet , with a median 4.8-y follow-up .


LPL polymorphisms and triglycerides were determined and CVD assessed .


Gene-diet interactions for triglycerides were analyzed at baseline ( n = 6880 ) and after a 3-y intervention ( n = 4131 ) .


Oxidative stress parameters were investigated in a subsample .


The rs13702T > C polymorphism was strongly associated with lower triglycerides in C allele carriers and interacted synergistically with dietary monounsaturated ( P = 0.038 ) and unsaturated fat intake ( P = 0.037 ) , decreasing triglycerides at baseline .


By 3 y , we observed a gene-diet interaction ( P = 0.025 ) in which the C allele was associated with a greater reduction in triglycerides after intervention with MedDiet , high in unsaturated fat .


Although the polymorphism was associated with lower stroke risk ( HR : 0.74 ; 95 % CI : 0.57 , 0.97 ; P = 0.029 per C allele ) , this association reached statistical significance only in the MedDiet intervention ( HR : 0.58 ; 95 % CI : 0.37 , 0.91 ; P = 0.019 in C compared with TT carriers ) , not in the control group ( HR : 0.94 ; 95 % CI : 0.55 , 1.59 ; P = 0.805 ) .


We report a novel association between a microRNA target site variant and stroke incidence , which is modulated by diet in terms of decreasing triglycerides and possibly stroke risk in rs13702 C allele carriers after a high-unsaturated fat MedDiet intervention .


Exercise and adequate self-management capacity may be important strategies in the management of venous leg ulcers .


However , it remains unclear if exercise improves the healing rates of venous leg ulcers and if a self-management exercise program based on self-efficacy theory is well adhered to .


This is a randomised controlled in adults with venous leg ulcers to determine the effectiveness of a self-efficacy based exercise intervention .


Participants with venous leg ulcers are recruited from 3 clinical sites in Australia .


After collection of baseline data , participants are randomised to either an intervention group or control group .


The control group receive usual care , as recommended by evidence based guidelines .


The intervention group receive an individualised program of calf muscle exercises and walking .


The twelve week exercise program integrates multiple elements , including up to six telephone delivered behavioural coaching and goal setting sessions , supported by written materials , a pedometer and two follow-up booster calls if required .


Participants are encouraged to seek social support among their friends , self-monitor their weekly steps and lower limb exercises .


The control group are supported by a generic information sheet that the intervention group also receive encouraging lower limb exercises , a pedometer for self-management and phone calls at the same time points as the intervention group .


The primary outcome is the healing rates of venous leg ulcers which are assessed at fortnightly clinic appointments .


Secondary outcomes , assessed at baseline and 12 weeks : functional ability ( range of ankle motion and Tinetti gait and balance score ) , quality of life and self-management scores .


This study seeks to address a significant gap in current wound management practice by providing evidence for the effectiveness of a home-based exercise program for adults with venous leg ulcers .


Theory-driven , evidence-based strategies that can improve an individual 's exercise self-efficacy and self-management capacity could have a significant impact in improving the management of people with venous leg ulcers .


Information gained from this study will provide much needed information on management of this chronic disease to promote health and independence in this population .


Australian New Zealand Clinical Trials Registry ACTRN12612000475842 .


There is evidence from nonrandomized studies that a proportion of ipilimumab-treated patients with advanced melanoma experience long-term survival .


To demonstrate a long-term survival benefit with ipilimumab , we evaluated the 5-year survival rates of patients treated in a randomized , controlled phase III trial .


A milestone survival analysis was conducted to capture the 5-year survival rate of treatment-naive patients with advanced melanoma who received ipilimumab in a phase III trial .


Patients were randomly assigned 1:1 to receive ipilimumab at 10 mg/kg plus dacarbazine ( n = 250 ) or placebo plus dacarbazine ( n = 252 ) at weeks 1 , 4 , 7 , and 10 followed by dacarbazine alone every 3 weeks through week 22 .


Eligible patients could receive maintenance ipilimumab or placebo every 12 weeks beginning at week 24 .


A safety analysis was conducted on patients who survived at least 5 years and continued to receive ipilimumab as maintenance therapy .


The 5-year survival rate was 18.2 % ( 95 % CI , 13.6 % to 23.4 % ) for patients treated with ipilimumab plus dacarbazine versus 8.8 % ( 95 % CI , 5.7 % to 12.8 % ) for patients treated with placebo plus dacarbazine ( P = .002 ) .


A plateau in the survival curve began at approximately 3 years .


In patients who survived at least 5 years and continued to receive ipilimumab , grade 3 or 4 immune-related adverse events were observed exclusively in the skin .


The additional survival benefit of ipilimumab plus dacarbazine is maintained with twice as many patients alive at 5 years compared with those who initially received placebo plus dacarbazine .


These results demonstrate a durable survival benefit with ipilimumab in advanced melanoma .


Urinary retention is one of the most common complications contributing to surgical procedures .


Recent studies have shown the benefits of alpha-adrenergic blockers in preventing post-operative urinary retention ( POUR ) .


The aim of this prospective study was to compare the prophylactic effect of tamsulosin with placebo on postoperative urinary retention .


In this randomized placebo controlled , clinical trial , 232 male patients aged 18 to 50 years old admitted to Razi University Hospital for varicocelectomy , inguinal herniorrhaphy , and scrotal surgery were randomly assigned to receive either three doses of 0.4 mg tamsulosin ( n = 118 ) or placebo ( n = 114 ) , 14 and 2 hours before , and 10 hours after surgery .


Patients were closely monitored for the development of urinary retention 24 hours after surgical intervention .


The primary endpoint was to investigate the effect of tamsulosin in prevention of post-operative urinary retention during the first 24 hours after surgical intervention .


Collected data were analyzed using SPSS software version 18 and the P < 0.05 was considered statistically significant .


One hundred and eighteen patients were included in tamsulosin arm and 114 in placebo arm .


POUR in patients who received tamsulosin was significantly lower than placebo , as 5.9 % of the patients treated with tamsulosin and 21.1 % placebo group , reported urinary retention following surgery ( P = 0.001 ) .


No serious adverse effects were seen in both groups .


This study suggests that short perioperative treatment with tamsulosin can reduce the incidence of urinary retention and the need for catheterization after varicocelectomy , inguinal herniorrhaphy , and scrotal surgery .