Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics , if brief risk reduction counseling is not offered .


The risk of persistent tardive dyskinesia ( TD ) was compared in patients with acute psychosis or agitation aged 55 years or older who were treated with olanzapine ( OLZ ) or conventional antipsychotic ( CNV ) drug therapy .


Patients without TD were randomized to treatment with OLZ ( 2.5-20 mg/d ; n = 150 ) or CNV ( dosed per label ; n = 143 ) .


Following a 6-week drug tapering/initiation period , patients without TD were treated with OLZ or CNV for up to 1 year .


The a priori defined primary outcome end point was persistent TD defined as Abnormal Involuntary Movement Scale ( AIMS ) scores = 2 on at least 2 items or 3 on at least 1 item ( items 1-7 ) lasting at least for 1 month ( Criterion A ) .


Post hoc analyses assessed persistent TD meeting the criterion of moderate severity defined as AIMS score 3 on at least 1 item persisting for 1 month ( Criterion B ) and probable TD defined as elevated AIMS scores ( Criterion A or B ) not persisting for 1 month .


Treatment groups were compared using Kaplan-Meier curve with log-rank exact test .


On average , patients were 78 years of age ; the predominant diagnosis was dementia ( 76.7 % in the OLZ group and 82.5 % in the CNV group ) .


Approximately , 40.6 % of patients in the CNV group received haloperidol .


No significant difference in time to developing persistent TD was observed during treatment with OLZ or CNV ( cumulative incidence : OLZ , 2.5 % [ 95 % confidence interval [ 95 % CI ] : 0.5-7 .0 ] ; CNV , 5.5 % [ 95 % CI : 2.1-11 .6 ] , P = .193 ) .


The exposure-adjusted event rates per 100 person-years were not significantly different between treatment groups : OLZ ( 2.7 ) and CNV ( 6.3 ; ratio : 0.420 ; 95 % CI : 0.068-1 .969 ) .


Post hoc analyses revealed a significantly lower risk of at least moderately severe persistent TD persisting for 1 month ( P = .012 ) and probable TD not persisting for 1 month ( Criterion A , P = .030 ; Criterion B , P = .048 ) in OLZ-treated patients .


For those patients without significant extrapyramidal symptoms at baseline , significantly more patients in the CNV treatment group developed treatment-emergent parkinsonism than for patients in the OLZ treatment group ( CNV : 70 % , 35 of 50 patients ; OLZ 44 % , 25 of 57 patients ; P = .011 ) .


No significant difference between the groups was observed for treatment-emergent akathisia ( CNV : 6 % , 7 of 117 patients ; OLZ : 10 % , 13 of 130 patients ; P = .351 ) .


The cumulative incidence of persistent TD was low and the risk of persistent TD did not differ significantly among predominantly older adult patients having dementia with acute psychosis or agitation treated with OLZ or CNV .


The effect of anaesthesia on postoperative outcome is unclear .


Cardioprotective properties of volatile anaesthetics have been demonstrated experimentally and in haemodynamically stable patients undergoing coronary artery bypass grafting .


Their effects in patients undergoing high-risk cardiac surgery have not been reported .


We performed a multicentre , randomized , parallel group , controlled study among patients undergoing high-risk cardiac surgery ( combined valvular and coronary surgery ) in 2008-2011 .


One hundred subjects assigned to the treatment group received sevoflurane for anaesthesia maintenance , while 100 subjects assigned to the control group received propofol-based total i.v. anaesthesia .


The primary outcome was a composite of death , prolonged intensive care unit ( ICU ) stay , or both .


Thirty day and 1 yr follow-up , focused on mortality , was performed .


All 200 subjects completed the follow-up and were included in efficacy analyses , conducted according to the intention-to-treat principle .


Death , prolonged ICU stay , or both occurred in 36 out of 100 subjects ( 36 % ) in the propofol group and in 41 out of 100 subjects ( 41 % ) in the sevoflurane group ; relative risk 1.14 , 95 % confidence interval 0.8-1 .62 ; P = 0.5 .


No difference was identified in postoperative cardiac troponin release [ 1.1 ( 0.7-2 ) compared with 1.2 ( 0.6-2 .4 ) ng ml ( -1 ) , P = 0.6 ] , 1 yr all-cause mortality [ 11/100 ( 11 % ) compared with 11/100 ( 11 % ) , P = 0.9 ] , re-hospitalizations [ 20/89 ( 22.5 % ) compared with 11/89 ( 12.4 % ) , P = 0.075 ] , and adverse cardiac events [ 10/89 ( 11.2 % ) compared with 9/89 ( 10.1 % ) , P = 0.8 ] .


There was no observed beneficial effect of sevoflurane on the composite endpoint of prolonged ICU stay , mortality , or both in patients undergoing high-risk cardiac surgery .


ClinicalTrials.gov : identifier NCT00821262 .


Eudra CT ( 2008-001752-43 ) .


Characteristics and outcomes of patients with heart failure and reduced ejection fraction receiving care at Veterans Affairs ( VA ) versus non-VA hospitals have not been previously reported .


In the randomized controlled Beta-blocker Evaluation of Survival Trial ( BEST ; 1995-1999 ) , of the 2707 ( bucindolol = 1353 ; placebo = 1354 ) patients with heart failure and left ventricular ejection fraction 35 % , 918 received care at VA hospitals , of which 98 % ( n = 898 ) were male .


Of the 1789 receiving care at non-VA hospitals , 68 % ( n = 1216 ) were male .


Our analyses were restricted to these 2114 male patients .


VA patients were older with higher symptom and comorbidity burdens .


There was no significant between-group difference in unadjusted primary end point of 2-year all-cause mortality ( 35 % VA versus 32 % non-VA ; hazard ratio associated with VA hospitals , 1.09 ; 95 % confidence interval , 0.94-1 .26 ) , which remained unchanged after adjustment for age and race ( hazard ratio , 1.00 ; 95 % confidence interval , 0.86-1 .16 ) or multivariable adjustment , including cardiovascular morbidities ( hazard ratio , 0.94 ; 95 % confidence interval , 0.80-1 .10 ) .


There was no between-group difference in cause-specific mortalities or hospitalizations .


Chronic kidney disease , pulmonary edema , left ventricular ejection fraction < 20 % , and peripheral arterial disease were significant predictors of mortality for both groups .


African America race , New York Heart Association class IV symptoms , atrial fibrillation , and right ventricular ejection fraction < 20 % were associated with higher mortality among non-VA hospital patients only ; however , these differences from VA patients were not significant .


Patients with heart failure and reduced ejection fraction receiving care at VA hospitals were older and sicker ; yet their risk of mortality and hospitalization was similar to younger and healthier patients receiving care at non-VA hospitals .


http://www.clinicaltrials.gov .


Unique identifier : NCT00000560 .


The aim of this study was to assess the effectiveness and safety of different strategies of ivabradine therapy by comparing the effects on heart rate ( HR ) , blood pressure ( BP ) , and image quality of coronary CT angiography ( CTA ) .


A total of 192 consecutive patients were randomly assigned to 3 groups of oral premedication with ivabradine 15 mg ( single dose ) , 10 mg ( single dose ) , and 5 mg twice daily for 5 days , prospectively .


Patients using HR-lowering drugs and patients with - blockade contraindication were excluded .


The target HR was 65 beats/min .


In addition 5 to 10 mg of intravenous metoprolol was administered to the patients at the CT unit , if required .


The systolic and diastolic blood BP values and the HRs were recorded .


Image quality was assessed for 8 of 15 coronary segments with a 4-point grading scale .


Results were compared with the Kruskal-Wallis test , one-way ANOVA , and 2 test .


Reductions in mean HR after the treatment were 18 6 , 14 4 , and 17 7 beats/min for groups 1 , 2 , and 3 , respectively .


With the total additional therapies , 81.3 % , 67.2 % , and 84.3 % of the patients achieved HR < 65 beats/min in groups 1 , 2 , and 3 , respectively .


The mean BP values before coronary CTA were not significantly changed except for patients in group 2 .


Unacceptable ( score 0 ) image quality was obtained in only 4.5 % , 10.2 % , and 4.2 % of all the coronary segments , in groups 1 , 2 , and 3 , respectively .


Our study indicates that coronary CTA with premedication with oral ivabradine in all 3 strategies is safe and effective in reducing HR , in particular with a - blockade combination .


All 3 ivabradine regimes may be an alternative strategy for HR lowering in patients undergoing coronary CTA .


Ivabradine 15 mg ( single dose ) and ivabradine 5 mg twice daily for 5 days are superior to the ivabradine 10-mg single-dose regime for HR lowering without adjunctive intravenous - blocker usage .


There has been no systematic investigation of the individual and combined effects of impaired glucose tolerance ( IGT ) and obesity on cognitive function in the absence of ageing .


The aims were to examine the effects of IGT and increased waist circumference on cognitive function in ostensibly healthy adults , and to investigate whether a low glycaemic load ( GL ) breakfast can attenuate cognitive impairments in these populations .


Sixty five females aged 30-50 years were classified into one of four groups following waist circumference ( WC ) measurements and an oral glucose tolerance test : NGT/low WC ( n = 25 ) , NGT/high WC ( n = 22 ) , IGT/low WC ( n = 9 ) , IGT/high WC ( n = 9 ) .


Memory , psychomotor and executive functions were examined 30 and 120 min after consuming low GL , high GL and water breakfasts according to a randomised , crossover , counterbalanced design .


IGT was associated with impairment of verbal and spatial memory , and psychomotor function relative to females with NGT , independent of waist circumference .


Increased waist circumference was associated with impairment of verbal memory and executive function relative to females with low WC , independent of IGT .


Consumption of the LGL breakfast attenuated verbal memory impairment in the IGT/high WC group relative to the HGL breakfast and no energy control .


Increased central adiposity and abnormalities in glucose tolerance preceding type 2 diabetes can have demonstrable negative effects on cognitive function , even in ostensibly healthy , middle-aged females .


The potential for GL manipulations to modulate glycaemic response and cognitive function in type 2 diabetes and obesity merits further investigation .


Tracheal intubation with Macintosh laryngoscope is taught to medical students as it is a lifesaving procedure .


However , it is a difficult technique to learn and the consequences of intubation failure are potentially serious .


The Airtraq optical laryngoscope is a relatively novel intubation device , which allows visualization of the glottic plane without alignment of the oral , pharyngeal , and tracheal axes , possessing advantages over Macintosh for novice personnel .


We introduced a teaching mode featured with a progressive evaluation scheme for preparation and performance of tracheal intubation with medical students in this prospective randomized crossover trial who had no prior airway management experience to find the superior one .


Twenty-six medical students of the 8-year programme in the 6th year participated in this trial , when they did their one-week rotation in the department of anaesthesiology .


Each of the students intubated 6 patients , who were scheduled for surgeries under general anaesthesia , each laryngoscope for 3 patients respectively .


One hundred and forty-nine consecutive patients scheduled for surgical procedures requiring tracheal intubation were enrolled .


Patients were randomly allocated to undergo tracheal intubation using Macintosh ( n = 75 ) or Airtraq ( n = 74 ) laryngoscope .


The progressive evaluation scheme was applied to each intubation attempt .


Intubation success rate was significantly higher in Airtraq group than Macintosh group ( 87.8 % vs. 66.7 % , P < 0.05 ) .


Duration of glottis exposure was significantly shorter in Airtraq group compared to Macintosh group ( 50 19 s vs. 81 27 s , P < 0.001 ) .


A grade I Cormack and Lehane glottic view was obtained in 94.6 % of patients in the Airtraq group versus 32 % of patients in the Macintosh group ( P < 0.001 ) .


Duration of intubation in Airtraq group was significantly shorter ( 68 21 s vs. 96 22 s , P < 0.05 ) compared to Macintosh group .


Airtraq laryngoscope is easier to master for novice personnel with a higher intubation success rate and shorter intubation duration compared with the Macintosh laryngoscope .


Trial registration number is ChiCTR-TRC-13003987 , approval date Dec 12 , 2013 .


Previously considered as a disease of the affluent , west or urban people and not of public health importance , diabetes mellitus is increasingly becoming a significant cause of morbidity and mortality in sub-Saharan Africa .


However , population-based data to inform prevention , treatment and control are lacking .


Using the WHO STEPwise approach to chronic disease risk factor surveillance , a population-based , nationwide cross-sectional survey was conducted between July and September 2009 on participants aged 25-64 years .


A multi-stage cluster sample design and weighting were used to produce a national representative data for that age range .


Detailed findings on the magnitude of diabetes mellitus and impaired fasting blood glucose are presented in this paper .


Fasting blood glucose measurement was conducted on 3056 participants ( 70.2 % females , 87.9 % from rural areas ) .


The age - sex standardised population-based mean fasting blood glucose was 4.3 mmol/L ( 95 % CI 4.1-4 .4 mmol/L ) with no significant differences by age , sex and location ( urban/rural ) .


The overall prevalence of impaired fasting blood glucose was 4.2 % ( 95 % CI 3.0 % -5.4 % ) .


Prevalence of impaired blood glucose was higher in men than in women , 5.7 % ( 95 % CI 3.9 % -7.5 % ) vs 2.7 % ( 95 % CI 1.6 % - 3.8 % ) , p < 0.01 .


In both men and women , prevalence of raised fasting blood glucose or currently on medication for diabetes was 5.6 % ( 95 % CI 2.6 % - 8.5 % ) .


Although the prevalence of diabetes was higher in men than women , 6.5 % ( 95 % CI 2.6 % -10.3 % ) vs 4.7 % ( 95 % CI 2.4 % -7.0 % ) , in rural than urban , 5.4 % ( 95 % CI 2.4 % -8.4 % ) vs 4.4 % ( 95 % CI 2.8 % -5.9 % ) and in males in rural than males in urban , 6.9 % ( 95 % CI 2.8 % -11.0 % ) vs 3.2 % ( 95 % CI 0.1 % -6.3 % ) , the differences were not statistically significant , p > 0.05 .


Compared to previous estimates , prevalence of diabetes increased from < 1.0 % in 1960s to 5.6 % in 2009 ( this study ) .


High prevalence of impaired fasting blood glucose and diabetes mellitus call for the implementation of primary healthcare approaches such as the WHO package for essential non-communicable diseases to promote healthy lifestyles , early detection , treatment and control .


Malaria rapid diagnostic tests ( RDTs ) are a valid alternative to malaria testing with microscopy and are recommended for the testing of febrile patients before prescribing an antimalarial .


There is a need for interventions to support the uptake of RDTs by health workers .


To evaluate the cost-effectiveness of introducing RDTs with basic or enhanced training in health facilities in which microscopy was available , compared with current practice .


A three-arm cluster randomized trial was conducted in 46 facilities in central and northwest Cameroon .


Basic training had a practical session on RDTs and lectures on malaria treatment guidelines .


Enhanced training included small-group activities designed to change health workers ' practice and reduce the consumption of antimalarials among test-negative patients .


The primary outcome was the proportion of febrile patients correctly treated : febrile patients should be tested for malaria , artemisinin combination therapy should be prescribed for confirmed cases , and no antimalarial should be prescribed for patients who are test-negative .


Individual patient data were obtained from facility records and an exit survey .


Costs were estimated from a societal perspective using project reports and patient exit data .


The analysis used bivariate multilevel modeling and adjusted for imbalance in baseline covariates .


Incremental cost per febrile patient correctly treated was $ 8.40 for the basic arm and $ 3.71 for the enhanced arm .


On scale-up , it was estimated that RDTs with enhanced training would save $ 0.75 per additional febrile patient correctly treated .


Introducing RDTs with enhanced training was more cost-effective than RDTs with basic training when each was compared with current practice .


Functional decline and frailty are common in community dwelling older adults , increasing the risk of adverse outcomes .


Given this , we investigated the prevalence of frailty-associated risk factors and their distribution according to the severity of perceived risk in a cohort of community dwelling older adults , using the Risk Instrument for Screening in the Community ( RISC ) .


A cohort of 803 community dwelling older adults were scored for frailty by their public health nurse ( PHN ) using the Clinical Frailty Scale ( CFS ) and for risk of three adverse outcomes : i ) institutionalisation , ii ) hospitalisation and iii ) death , within the next year , from one ( lowest ) to five ( highest ) using the RISC .


Prior to scoring , PHNs stated whether they regarded patients as frail .


The median age of patients was 80years ( interquartile range 10 ) , of whom 64 % were female and 47.4 % were living alone .


The median Abbreviated Mental Test Score ( AMTS ) was 10 ( 0 ) and Barthel Index was 18/20 ( 6 ) .


PHNs regarded 42 % of patients as frail , while the CFS categorized 54 % ( scoring 5 ) as frail .


Dividing patients into low-risk ( score one or two ) , medium-risk ( score three ) and high-risk ( score four or five ) using the RISC showed that 4.3 % were considered high risk of institutionalization , 14.5 % for hospitalization , and 2.7 % for death , within one year of the assessment .


There were significant differences in median CFS ( 4/9 versus 6/9 versus 6/9 , p < 0.001 ) , Barthel Index ( 18/20 versus 11/20 versus 14/20 , p < 0.001 ) and mean AMTS scores ( 9.51 versus 7.57 versus 7.00 , p < 0.001 ) between those considered low , medium and high risk of institutionalisation respectively .


Differences were also statistically significant for hospitalisation and death .


Age , gender and living alone were inconsistently associated with perceived risk .


Frailty most closely correlated with functional impairment , r = -0.80 , p < 0.001 .


The majority of patients in this community sample were perceived to be low risk for adverse outcomes .


Frailty , cognitive impairment and functional status were markers of perceived risk .


Age , gender and social isolation were not and may not be useful indicators when triaging community dwellers .


The RISC now requires validation against adverse outcomes .


Currently , there is limited data on the prevention of chemotherapy-induced nausea and vomiting ( CINV ) in Indian patients .


This post hoc study assessed the efficacy and safety of fosaprepitant compared with aprepitant for prevention of CINV in the Indian population .


A subgroup analysis was performed from data collected in a phase 3 study of intravenous ( IV ) fosaprepitant or oral aprepitant , plus the 5-HT 3 antagonist ondansetron and the corticosteroid dexamethasone , in cisplatin-nave patients with solid malignancies .


Patients scheduled to receive cisplatin ( 70 mg/m 2 ) were administered a single IV dose of fosaprepitant dimeglumine ( 150 mg ) on day 1 or a 3-day dosing regimen of oral aprepitant ( day 1:125 mg , days 2 and 3:80 mg ) with standard doses of ondansetron and dexamethasone .


Patients recorded nausea and/or vomiting episodes and their use of rescue medication and were monitored for adverse events ( AEs ) and tolerability .


Differences in response rates between fosaprepitant and aprepitant were calculated using the Miettinen and Nurminen method .


In the Indian subpopulation ( n = 372 ) , efficacy was similar for patients in both the fosaprepitant or aprepitant groups ; complete response in the overall , acute , and delayed phases and no vomiting in all phases were approximately 4 percentage points higher in the fosaprepitant group compared with the aprepitant group .


Fosaprepitant was generally well-tolerated ; common AEs were similar to oral aprepitant .


IV fosaprepitant is as safe and effective as oral aprepitant in the Indian subpopulation and offers an alternative to the oral formulation .


Collaborative stepped care ( CSC ) may be an appropriate model to provide evidence-based treatment for anxiety disorders in primary care .


In a cluster randomised controlled trial , the effectiveness of CSC compared to care as usual ( CAU ) for adults with panic disorder ( PD ) or generalised anxiety disorder ( GAD ) in primary care was evaluated .


Thirty-one psychiatric nurses who provided their services to 43 primary care practices in the Netherlands were randomised to deliver CSC ( 16 psychiatric nurses , 23 practices ) or CAU ( 15 psychiatric nurses , 20 practices ) .


CSC was provided by the psychiatric nurses ( care managers ) in collaboration with the general practitioner and a consultant psychiatrist .


The intervention consisted of 3 steps , namely guided self-help , cognitive behavioural therapy and antidepressants .


Anxiety symptoms were measured with the Beck Anxiety Inventory ( BAI ) at baseline and after 3 , 6 , 9 and 12 months .


We recruited 180 patients with a DSM-IV diagnosis of PD or GAD , of whom 114 received CSC and 66 received usual primary care .


On the BAI , CSC was superior to CAU [ difference in gain scores from baseline to 3 months : -5.11 , 95 % confidence interval ( CI ) -8.28 to -1.94 ; 6 months : -4.65 , 95 % CI -7.93 to -1.38 ; 9 months : -5.67 , 95 % CI -8.97 to -2.36 ; 12 months : -6.84 , 95 % CI -10.13 to -3.55 ] .


CSC , with guided self-help as a first step , was more effective than CAU for primary care patients with PD or GAD .


Optimizing assessments of rate of progression in Parkinson disease ( PD ) is important in designing clinical trials , especially of potential disease-modifying agents .


To examine the value of measures of impairment , disability , and quality of life in assessing progression in early PD .


Inception cohort analysis of data from 413 patients with early , untreated PD who were enrolled in 2 multicenter , randomized , double-blind clinical trials .


Participants were randomly assigned to 1 of 5 treatments ( 67 received creatine , 66 received minocycline , 71 received coenzyme Q10 , 71 received GPI-1485 , and 138 received placebo ) .


We assessed the association between the rates of change in measures of impairment , disability , and quality of life and time to initiation of symptomatic treatment .


Time between baseline assessment and need for the initiation of symptomatic pharmaceutical treatment for PD was the primary indicator of disease progression .


After adjusting for baseline confounding variables with regard to the Unified Parkinson 's Disease Rating Scale ( UPDRS ) Part II score , the UPDRS Part III score , the modified Rankin Scale score , level of education , and treatment group , we assessed the rate of change for the following measurements : the UPDRS Part II score ; the UPDRS Part III score ; the Schwab and England Independence Scale score ( which measures activities of daily living ) ; the Total Functional Capacity scale ; the 39-item Parkinson 's Disease Questionnaire , summary index , and activities of daily living subscale ; and version 2 of the 12-item Short Form Health Survey Physical Summary and Mental Summary .


Variables reaching the statistical threshold in univariate analysis were entered into a multivariable Cox proportional hazards model using time to symptomatic treatment as the dependent variable .


More rapid change ( ie , worsening ) in the UPDRS Part II score ( hazard ratio , 1.15 [ 95 % CI , 1.08-1 .22 ] for 1 scale unit change per 6 months ) , the UPDRS Part III score ( hazard ratio , 1.09 [ 95 % CI , 1.06-1 .13 ] for 1 scale unit change per 6 months ) , and the Schwab and England Independence Scale score ( hazard ratio , 1.29 [ 95 % CI , 1.12-1 .48 ] for 5 percentage point change per 6 months ) was associated with earlier need for symptomatic therapy .


AND RELEVANCE In early PD , the UPDRS Part II score and Part III score and the Schwab and England Independence Scale score can be used to measure disease progression , whereas the 39-item Parkinson 's Disease Questionnaire and summary index , Total Functional Capacity scale , and the 12-item Short Form Health Survey Physical Summary and Mental Summary are not sensitive to change .


clinicaltrials.gov Identifiers : NCT00063193 and NCT00076492 .


To examine the effects of complex cognitive ( mahjong ) and physical ( Tai Chi ) activities on dementia severity in nursing home residents with dementia .


Cluster-randomized open-label controlled design .


110 residents were randomized by nursing home into three conditions : mahjong , Tai Chi , and simple handicrafts ( control ) .


Activities were conducted three times a week for 12 weeks .


Clinical Dementia Rating ( CDR ) was taken at 0 ( baseline ) , 3 ( post-treatment ) , 6 , and 9 months .


The outcome measure was CDR sum-of-box , which is a composite measure of both cognitive and functional deterioration in dementia .


Intent-to-treat analyses were performed using multilevel regression models .


Apolipoprotein E 4 allele and education were included as covariates .


Neither treatments had effects on the cognitive and functional components of the CDR , but mahjong had a significant interaction with time on the CDR sum-of-box total , suggesting a slower rate of global deterioration in the mahjong group as compared with the control group .


Mahjong led to a gradual improvement in global functioning and a slightly slower rate of dementia progression over time .


The effect was generalized and was not specific to cognition or daily functioning .


There are limited treatment options for tissue restoration and the prevention of degenerative changes in the knee .


Stem cells have been a focus of intense preclinical research into tissue regeneration but limited clinical investigation .


In a randomized , double-blind , controlled study , the safety of the intra-articular injection of human mesenchymal stem cells into the knee , the ability of mesenchymal stem cells to promote meniscus regeneration following partial meniscectomy , and the effects of mesenchymal stem cells on osteoarthritic changes in the knee were investigated .


A total of fifty-five patients at seven institutions underwent a partial medial meniscectomy .


A single superolateral knee injection was given within seven to ten days after the meniscectomy .


Patients were randomized to one of three treatment groups : Group A , in which patients received an injection of 50 10 allogeneic mesenchymal stem cells ; Group B , 150 10 allogeneic mesenchymal stem cells ; and the control group , a sodium hyaluronate ( hyaluronic acid/hyaluronan ) vehicle control .


Patients were followed to evaluate safety , meniscus regeneration , the overall condition of the knee joint , and clinical outcomes at intervals through two years .


Evaluations included sequential magnetic resonance imaging ( MRI ) .


No ectopic tissue formation or clinically important safety issues were identified .


There was significantly increased meniscal volume ( defined a priori as a 15 % threshold ) determined by quantitative MRI in 24 % of patients in Group A and 6 % in Group B at twelve months post meniscectomy ( p = 0.022 ) .


No patients in the control group met the 15 % threshold for increased meniscal volume .


Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control , on the basis of visual analog scale assessments .


There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells .


These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects .


Amyotrophic lateral sclerosis patients have significant respiratory abnormalities with incomplete understanding of respiratory control .


This study analyzes electromyography ( EMG ) of the diaphragm ( dEMG ) using implanted diaphragm pacing ( DP ) electrodes .


Retrospective analysis of dEMG data were obtained during Institutional Review Board and US Food and Drug Administration approved trials .


The electrodes were used to analyze epochs of dEMG during multiple respiratory cycles .


Fifty-three patients were implanted .


Thirty-six had bilateral dEMG assessments , 18 had continuous overnight readings with pulse oximetry , and 19 had serial analysis .


Several findings revealed an alteration in the central respiratory drive including central apnea , hypoventilation , and hypercarbia .


The electrodes showed unilateral dysfunction and demonstrated noninvasive ventilation suppression of diaphragm activity .


DP can be used for serial monitoring , to decrease hypercarbia , improve sleep , and decrease atrophy .


Multiple abnormalities of respiratory control can be seen in amyotrophic lateral sclerosis patients using dEMG through therapeutic DP electrodes .


DP is used to overcome instability of respiratory control when there are intact diaphragm motor units leading to improved survival .


Atherosclerotic cardiovascular disease ( CVD ) is the most common cause of morbidity and mortality among hemodialysis ( HD ) patients .


It has been attributed , among other causes , to hypertension and dyslipidemia .


The aim of the present study was to investigate the effect of a year-long consumption of Pomegranate juice ( PJ ) , on two traditional cardiovascular ( CV ) risk factors : hypertension and lipid profile , as well as on cardiovascular events .


101 HD patients were randomized to receive 100cc of PJ ( 0.7 mM polyphenols ) or matching placebo juice , three times a week for one year .


The primary endpoints were traditional CV risk factors ; blood pressure and lipid profile .


Systolic , diastolic and pulse pressure , plasma levels of triglycerides ( TG ) , high density lipoprotein ( HDL ) , low density lipoprotein ( LDL ) and total cholesterol were monitored quarterly during the study year .


Secondary endpoint was incidence of cardiovascular events .


PJ consumption yielded a significant time response improvement in systolic blood pressure , pulse pressure , triglycerides and HDL level ; an improvement that was not observed in the placebo intake group .


These beneficial outcomes were more pronounced among patients with hypertension , high level of triglycerides and low levels of HDL .


Regular PJ consumption by HD patients reduced systolic blood pressure and improved lipid profile .


These favorable changes may reduce the accelerated atherosclerosis and high incidence of CVD among HD patients .


ClinicalTrials.gov registry , Identifier number : NCT00727519 .


Statins and calcium channel blockers have been proven beneficial toward improvement of endothelial function .


The aim of this study was to compare the effect of combination therapy of statin and calcium channel blocker with solo treatment in patients with cardiac syndrome X.


Sixty-eight patients with cardiac syndrome X were divided randomly into three groups : fluvastatin ( 40 mg/day , n = 23 ) , diltiazem ( 90 mg/day , n = 22 ) , and combination of fluvastatin ( 40 mg/day ) and diltiazem ( 90 mg/day , n = 23 ) .


At the end of 90 days , the coronary flow reserve was improved in the three groups ( fluvastatin-treated group : 23.2 % ; diltiazem-treated group : 12.4 % ; fluvastatin + diltiazem-treated group : 29.1 % , all P < 0.05 ) .


The time to 1 mm ST segment depression increased significantly in the fluvastatin-treated group ( from 24197 to 410140 s , P < 0.05 ) , the diltiazem-treated group ( from 25891 to 392124 s , P < 0.05 ) , and the fluvastatin + diltiazem-treated group ( from 250104 to 446164 s , P < 0.05 ) .


The improvement in coronary flow reserve and prolonged time to 1 mm ST segment depression in the combination treatment group were more remarkable than in those who received monotherapy .


Combination therapy also induced a significant increase ( 35.6 % , P < 0.05 ) in nitric oxide and an apparent reduction ( 48.7 % , P < 0.05 ) in endothelin-1 .


Combination treatment with fluvastatin and diltiazem is more effective on endothelial function and exercise tolerance than solo treatment in patients with cardiac syndrome X.


The benefits of these drugs may be related to the elevation of nitric oxide and reduction of endothelin-1 .


Pulmonary embolism ( PE ) is the third most common cause of death from cardiovascular disease .


Computed-tomographic pulmonary angiography ( CTPA ) is an accurate and safe test for diagnosing PE .


The aim of this retrospective analysis was to evaluate the effects on image quality ( IQ ) of electrocardiogram ( ECG ) gating during CTPA .


Fifty consecutive patients presenting for CTPA were included in the study .


A single acquisition was performed , resulting in two reconstructions : one at 75 % of the R-R interval and the other without ECG influence .


IQ evaluation was undertaken by two radiologists , focusing on respiratory and cardiac motion , image noise , low-contrast resolution , vessel and lung clarity , contrast media opacification and artefacts .


Various regions of the lungs and vasculature were evaluated , and IQ scores were statistically compared .


For the ECG-tagged reconstructions , IQ was noted to be better overall with regard to vessel clarity ( P < 0.05 ) and cardiac motion ( P < 0.05 ) , while lung clarity was better only in the left lower zone ( P < 0.05 ) .


IQ was better with regard to image noise ( P < 0.05 ) and low-contrast resolution ( P < 0.05 ) in the non-ECG-tagged reconstructions .


No statistical IQ difference between the two types of reconstruction was noted with regard to respiratory motion , contrast media opacification or presence of artefacts .


The two types of reconstruction provide complementary information for evaluating CTPA results .


Adaptive support ventilation ( ASV ) is a closed loop mode of mechanical ventilation ( MV ) that provides a target minute ventilation by automatically adapting inspiratory pressure and respiratory rate with the minimum work of breathing on the part of the patient .


The aim of this study was to determine the effect of ASV on total MV duration when compared with pressure assist/control ventilation .


Adult medical patients intubated and mechanically ventilated for > 24 h in a medical ICU were randomized to either ASV or pressure assist/control ventilation .


Sedation and medical treatment were standardized for each group .


Primary outcome was the total MV duration .


Secondary outcomes were the weaning duration , number of manual settings of the ventilator , and weaning success rates .


Two hundred twenty-nine patients were included .


Median MV duration until weaning , weaning duration , and total MV duration were significantly shorter in the ASV group ( 67 [ 43-94 ] h vs 92 [ 61-165 ] h , P = .003 ; 2 [ 2-2 ] h vs 2 [ 2-80 ] h , P = .001 ; and 4 [ 2-6 ] days vs 4 [ 3-9 ] days , P = .016 , respectively ) .


Patients in the ASV group required fewer total number of manual settings on the ventilator to reach the desired pH and Paco2 levels ( 2 [ 1-2 ] vs 3 [ 2-5 ] , P < .001 ) .


The number of patients extubated successfully on the first attempt was significantly higher in the ASV group ( P = .001 ) .


Weaning success and mortality at day 28 were comparable between the two groups .


In medical patients in the ICU , ASV may shorten the duration of weaning and total MV duration with a fewer number of manual ventilator settings .


ClinicalTrials.gov ; No. : NCT01472302 ; URL : www.clinicaltrials.gov .


We aim to test the hypothesis that high plasma YKL-40 is associated with short progression-free survival ( PFS ) and overall survival ( OS ) in patients with metastatic colorectal cancer ( mCRC ) treated with first-line oxaliplatin and 5-flourouracil with or without cetuximab .


A total of 566 patients in the NORDIC VII Study were randomized 111 to arm A ( Nordic FLOX ) , arm B ( Nordic FLOX + cetuximab ) , or arm C ( Nordic FLOX + cetuximab for 16 weeks followed by cetuximab alone as maintenance therapy ) .


Pretreatment plasma samples were available from 510 patients .


Plasma YKL-40 was determined by ELISA and dichotomized according to the age-corrected 95 % YKL-40 level in 3130 healthy subjects .


Pretreatment plasma YKL-40 was elevated in 204 patients ( 40 % ) , and median YKL-40 was higher in patients with mCRC than in healthy subjects ( age adjusted , P < 0.001 ) .


Patients with elevated YKL-40 had shorter PFS than patients with normal YKL-40 ( 7.5 vs. 8.2 months ; hazard ratio ( HR ) = 1.27 95 % confidence interval ( CI ) 1.05-1 .53 P = 0.013 ) and shorter OS ( 16.8 vs. 23.9 months ; HR = 1.33 , 1.04-1 .69 , P = 0.024 ) .


Multivariate Cox analysis demonstrated that elevated pretreatment YKL-40 was an independent biomarker of short OS ( HR = 1.12 , 1.01-1 .25 , P = 0.033 ) .


The ratio of the updated plasma YKL-40 ( i.e. level after 1 , 2 , 8 weeks of treatment , and at end of treatment compared to the baseline level ) was associated with OS ( HR = 1.27 , 1.06-1 .52 , P = 0.011 ) .


Plasma YKL-40 is an independent prognostic biomarker in patients with mCRC treated with first-line oxaliplatin-based therapy alone or combined with cetuximab .


Intra-myocardial transplantation of CD133 ( + ) bone marrow stem cells ( BMC ) yielded promising results in clinical pilot trials .


We now performed the double-blinded , randomized , placebo-controlled CARDIO133 trial to determine its impact on left ventricular ( LV ) function and clinical symptoms .


Sixty patients with chronic ischaemic heart disease and impaired LV function ( left ventricular ejection fraction , LVEF < 35 % ) were randomized to undergo either coronary artery bypass grafting ( CABG ) and injection of CD133 ( + ) BMC in the non-transmural , hypokinetic infarct border zone ( CD133 ) , or CABG and placebo injection ( placebo ) .


Pre-operative LVEF was 27 6 % in CD133 patients and 26 6 % in placebo patients .


Outcome was assessed after 6 months , and the primary endpoint was LVEF measured by cardiac magnetic resonance imaging ( MRI ) at rest .


The incidence of adverse events was similar in both groups .


There was no difference in 6-min walking distance , Minnesota Living with Heart Failure score , or Canadian Cardiovascular Society ( CCS ) class between groups at follow-up , and New York Heart Association class improved more in the placebo group ( P = 0.004 ) .


By cardiac MRI , LVEF at 6 months was 33 8 % in the placebo group and 31 7 % in verum patients ( P = 0.3 ) , with an average inter-group difference of -2.1 % ( 95 % CI -6.3 to 2.1 ) .


Systolic or diastolic LV dimensions at 6 months were not different , either .


In the CD133 group , myocardial perfusion at rest recovered in more LV segments than in the placebo group ( 9 vs. 2 % , P < 0.001 ) .


Scar mass decreased by 2.2 5 g in CD133 ( + ) patients ( P = 0.05 ) , but was unchanged in the placebo group ( 0.3 4 g , P = 0.7 ; inter-group difference in change = 2 g ( 95 % CI -1.1 to 5 ) ) .


By speckle-tracking echocardiography , cell-treated patients showed a better recovery of regional wall motion when the target area was posterior .


Although there may be some improvements in scar size and regional perfusion , intra-myocardial injection of CD133 ( + ) BMC has no effect on global LV function and clinical symptoms .


Improvements in regional myocardial function are only detectable in patients with posterior infarction , probably because the interventricular septum after anterior infarction is not accessible by trans-epicardial injection .


This trial was registered at http://www.clinicaltrials.gov under NCT00462774 .


Although adolescent girls are the main population for prophylactic human papillomavirus ( HPV ) vaccines , adult women who remain at risk of cervical cancer can also be vaccinated .


We report data from the interim analysis of the ongoing VIVIANE study , the aim of which is to assess the efficacy , safety , and immunogenicity of the HPV 16/18 AS04-adjuvanted vaccine in adult women .


In this phase 3 , multinational , double-blind , randomised controlled trial , we randomly assigned healthy women older than 25 years to the HPV 16/18 vaccine or control ( 1:1 ) , via an internet-based system with an algorithm process that accounted for region , age stratum , baseline HPV DNA status , HPV 16/18 serostatus , and cytology .


Enrolment was age-stratified , with about 45 % of participants in each of the 26-35 and 36-45 years age strata and 10 % in the 46 years and older stratum .


Up to 15 % of women in each age stratum could have a history of HPV infection or disease .


The primary endpoint was vaccine efficacy against 6-month persistent infection or cervical intraepithelial neoplasia grade 1 or higher ( CIN1 + ) associated with HPV 16/18 .


The primary analysis was done in the according-to-protocol cohort for efficacy , which consists of women who received all three vaccine or control doses , had negative or low-grade cytology at baseline , and had no history of HPV disease .


Secondary analyses included vaccine efficacy against non-vaccine oncogenic HPV types .


Mean follow-up time was 403 months .


This study is registered with ClinicalTrials.gov , number NCT00294047 .


The first participant was enrolled on Feb 16 , 2006 , and the last study visit for the present analysis took place on Dec 10 , 2010 ; 5752 women were included in the total vaccinated cohort ( n = 2881 vaccine , n = 2871 control ) , and 4505 in the according-to-protocol cohort for efficacy ( n = 2264 vaccine , n = 2241 control ) .


Vaccine efficacy against HPV 16/18-related 6-month persistent infection or CIN1 + was significant in all age groups combined ( 811 % , 977 % CI 521-940 ) , in the 26-35 years age group ( 835 % , 450-968 ) , and in the 36-45 years age group ( 772 % , 28-969 ) ; no cases were seen in women aged 46 years and older .


Vaccine efficacy against atypical squamous cells of undetermined significance or greater associated with HPV 16/18 was also significant .


We also noted significant cross-protective vaccine efficacy against 6-month persistent infection with HPV 31 ( 791 % , 977 % CI 276-959 ) and HPV 45 ( 769 % , 185-956 ] ) Serious adverse events occurred in 285 ( 10 % ) of 2881 women in the vaccine group and 267 ( 9 % ) of 2871 in the control group ; five ( < 1 % ) and eight ( < 1 % ) of these events , respectively , were believed to be related to vaccination .


In women older than 25 years , the HPV 16/18 vaccine is efficacious against infections and cervical abnormalities associated with the vaccine types , as well as infections with the non-vaccine HPV types 31 and 45 .


GlaxoSmithKline Biologicals SA .


To describe the predictors of nurse actions in response to a mobile health decision-support system ( mHealth DSS ) for guideline-based screening and management of tobacco use .


Observational design focused on an experimental arm of a randomized , controlled trial .


Acute and ambulatory care settings in the New York City metropolitan area .


14,115 patient encounters in which 185 RNs enrolled in advanced practice nurse ( APN ) training were prompted by an mHealth DSS to screen for tobacco use and select guideline-based treatment recommendations .


Data were entered and stored during nurse documentation in the mHealth DSS and subsequently stored in the study database where they were retrieved for analysis using descriptive statistics and logistic regressions .


Predictor variables included patient gender , patient race or ethnicity , patient payer source , APN specialty , and predominant payer source in clinical site .


Dependent variables included the number of patient encounters in which the nurse screened for tobacco use , provided smoking cessation teaching and counseling , or referred patients for smoking cessation for patients who indicated a willingness to quit .


Screening was more likely to occur in encounters where patients were female , African American , and received care from a nurse in the adult nurse practitioner specialty or in a clinical site in which the predominant payer source was Medicare , Medicaid , or State Children 's Health Insurance Program .


In encounters where the patient payer source was other , nurses were less likely to provide tobacco cessation teaching and counseling .


mHealth DSS has the potential to affect nurse provision of guideline-based care .


However , patient , nurse , and setting factors influence nurse actions in response to an mHealth DSS for tobacco cessation .


The combination of a reminder to screen and integration of guideline-based recommendations into the mHealth DSS may reduce racial or ethnic disparities to screening , as well as clinician barriers related to time , training , and familiarity with resources .


Although iron supplementation in malaria-free areas mostly reduces infectious morbidity , it can sometimes increase morbidity from infections as a result of the dependence of pathogenic microorganisms on iron .


Supplementation with n-3 ( -3 ) long-chain polyunsaturated fatty acids ( LCPUFAs ) improved morbidity in several human studies .


However , information on the combined effect of iron and n-3 LCPUFA supplementation on infectious morbidity is limited .


We determined whether n-3 LCPUFAs and iron supplementation , alone or in combination , affected absenteeism and illness in iron-deficient schoolchildren with low fish intake .


A total of 321 South African children ( aged 6-11 y ) with iron deficiency ( ID ) were randomly divided into 4 groups to receive 1 ) iron plus placebo , 2 ) a mixture of docosahexaenoic acid and eicosapentaenoic acid ( DHA/EPA ) plus placebo , 3 ) iron plus DHA/EPA , or 4 ) placebo plus placebo as oral supplements 4 times/wk for 8.5 mo. .


Morbidity was recorded , and iron-status indexes were measured .


The total phospholipid fatty acid composition of peripheral blood mononuclear cell membranes was analyzed in a subsample ( n = 130 ) .


Iron supplementation increased the number of days with illness when all symptoms were considered ( B : 0.87 ; 95 % CI : 0.71 , 1.03 ) as well as illness that was specifically caused by respiratory symptoms ( B : 1.45 ; 95 % CI : 1.21 , 1.70 ) , whereas DHA/EPA reduced the number of days with illness at school ( B : -0.96 ; 95 % CI : -1.33 , -0.59 ) .


The increases caused by iron were reduced to the levels seen in the placebo plus placebo group when iron was provided in combination with DHA/EPA as indicated by significant iron DHA/EPA interactions ( both P < 0.001 ) .


Iron supplementation increased morbidity ( mostly respiratory ) in iron-deficient South African schoolchildren with low DHA/EPA intake , but when iron was given in combination with DHA/EPA , this effect was prevented .


Anorexia nervosa ( AN ) is a serious disorder with high rates of morbidity and mortality .


Family-based treatment ( FBT ) is an evidence-based therapy for adolescent AN , but less than half of those who receive this approach recover .


Hence , it is important to identify other approaches to prevent the development of the chronic form of AN for which there is no known evidence-based treatment .


To compare FBT with systemic family therapy ( SyFT ) for the treatment of adolescent-onset AN .


Research in Anorexia Nervosa ( RIAN ) is a 2-group ( FBT and SyFT ) randomized trial conducted between September 2005 and April 2012 .


Interviewers were blinded to the treatment condition .


A total of 564 adolescents receiving care at 6 outpatient clinics experienced in the treatment of AN were screened .


Of these , 262 adolescents did not meet the inclusion criteria and 138 declined to participate ; hence , 164 adolescents ( aged 12-18 years ) of both sexes meeting the criteria for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , AN ( except for amenorrhea ) were enrolled .


Three participants were withdrawn from FBT and 7 were withdrawn from SyFT after serious adverse events occurred .


Two manualized family therapies with 16 one-hour sessions during 9 months .


Family-based therapy focuses on the facilitation of weight gain , whereas SyFT addresses general family processes .


The primary outcomes were percentage of ideal body weight ( IBW ) and remission ( 95 % of IBW ) .


The a priori hypothesis was that FBT would result in faster weight gain early in treatment and at the end of treatment ( EOT ) .


There were no statistically significant differences between treatment groups for the primary outcome , for eating disorder symptoms or comorbid psychiatric disorders at the EOT or follow-up .


Remission rates included FBT , 33.1 % at the EOT and 40.7 % at follow-up and SyFT , 25.3 % and 39.0 % , respectively .


Family-based therapy led to significantly faster weight gain early in treatment , significantly fewer days in the hospital , and lower treatment costs per patient in remission at the EOT ( FBT , $ 8963 ; SyFT , $ 18005 ) .


An exploratory moderator analysis found that SyFT led to greater weight gain than did FBT for participants with more severe obsessive-compulsive symptoms .


The findings of this study suggest that FBT is the preferred treatment for adolescent AN because it is not significantly different from SyFT and leads to similar outcomes at a lower cost than SyFT .


Adolescents with more severe obsessive-compulsive symptoms may receive more benefits with SyFT .


clinicaltrials.gov Identifier NCT00610753 .


The aim of the present study was to assess the efficacy of structured education in insulin-treated type 2 diabetes mellitus ( T2DM ) patients .


In a 16-week open-label randomized controlled study , 1511 T2DM patients with inadequate responses to two or more oral antidiabetic drugs ( OADs ) for > 3 months ( HbA1c > 7.5 % ) were randomized ( 1:1 ) to either an education group ( structured diabetes education plus insulin therapy ) or a control group ( usual care plus insulin therapy ) .


Both groups discontinued previous OADs ( except biguanides and - glucosidase inhibitors ) and started twice daily injections of 30 % soluble-70 % isophane recombinant insulin .


The primary endpoint was the change in HbA1c from baseline .


Efficacy and safety data were analyzed for within - and between-group differences .


Of the initial 1511 patients , 1289 completed the study ( 643 in the control group ; 646 in the education group ) .


At the end of the study , significant reductions in HbA1c versus baseline were evident in both groups , but the reduction was greater in the education group ( 2.16 % vs. 2.08 % ; P < 0.05 ) .


A higher proportion of patients in the education group achieved target HbA1c levels < 7 % ( 43.81 % vs. 36.86 % ; P < 0.05 ) and 6.5 % ( 28.48 % vs. 22.71 % ; P < 0.05 ) .


In addition , patients in the education group showed greater increments in scores and improvement in the Morisky Medication Adherence Scale ( P < 0.05 ) .


The overall incidence of hypoglycemic events was similar in the two groups .


Structured education can promote the ability of patients to self-manage and their compliance with medications , thereby achieving better outcomes .


The present study is a comparison of two point-of-care ( POC ) tests as endpoints of protamine titration after CPB .


The authors hypothesized that using the heparinase-kaolin thromboelastography ( TEG-HK ) R-time difference would more readily identify residual heparin necessitating additional protamine than when using activated coagulation time ( ACT ) .


The primary endpoint was the between-group difference in protamine dose .


Whether this approach would lessen postoperative bleeding and sequelae also was investigated .


Single center , blinded , prospective , randomized study .


University teaching hospital .


Eighty-two adult patients for on-pump coronary artery bypass and/or valve surgery .


Patients were randomized .


In the ACT group , protamine was titrated until ACT did not exceed baseline by more than 10 % .


In the TEG group , a TEG-HK R-time difference less than 20 % was targeted .


Protamine was repeated to achieve the endpoints .


Clinicians in the ACT group were blinded to TEG data and vice versa .


There was no between-group difference in total protamine dose ( 3.9 0.6 and 4.2 0.7 ; 95 % CI of the difference between means : -0.544 to 0.008 mg/kg ; p = 0.057 ) or protamine : heparin ratios ( 1.3:1 and 1.4:1 ; 95 % CI of the difference between means : -0.05 to 0.03 mg/mg ; p = 0.653 ) .


In the ACT group , 17 % of patients required a second protamine dose , and in the TEG group , 24 % of patients required a second protamine dose .


No between-group differences in the postoperative transfusion requirements or intensive care unit length of stay were demonstrated .


No difference was identified in protamine dosing using either ACT or TEG-HK R-time difference as endpoints .


Heparinase TEG may be useful for monitoring heparin reversal .


Clinical practice guidelines are considered important instruments to improve quality of care .


However , success is dependent on adherence , which may be improved using peer assessment , a strategy in which professionals assess performance of their peers in a simulated setting .


The aim of this study was to determine whether peer assessment is more effective than case-based discussions to improve knowledge and guideline-consistent clinical reasoning in the Dutch physical therapy guideline for low back pain ( LBP ) .


A cluster randomized controlled trial was conducted .


Ten communities of practice ( CoPs ) of physical therapists were cluster randomized ( N = 90 ) : 6 CoPs in the peer-assessment group ( n = 49 ) and 4 CoPs in the case-based discussion group ( control group ) ( n = 41 ) .


Both groups participated in 4 educational sessions and used clinical patient cases .


The peer-assessment group reflected on performed LBP management in different roles .


The control group used structured discussions .


Outcomes were assessed at baseline and at 6 months .


The primary outcome measure was knowledge and guideline-consistent reasoning , measured with 12 performance indicators using 4 vignettes with specific guideline-related patient profiles .


For each participant , the total score was calculated by adding up the percentage scores ( 0-100 ) per vignette , divided by 4 .


The secondary outcome measure was reflective practice , as measured by the Self-Reflection and Insight Scale ( 20-100 ) .


Vignettes were completed by 78 participants ( 87 % ) .


Multilevel analysis showed an increase in guideline-consistent clinical reasoning of 8.4 % in the peer-assessment group , whereas the control group showed a decline of 0.1 % ( estimated group difference = 8.7 % , 95 % confidence interval = 3.9 to 13.4 ) .


No group differences were found on self-reflection .


The small sample size , a short-term follow-up , and the use of vignettes as a proxy for behavior were limitations of the study .


Peer assessment leads to an increase in knowledge and guideline-consistent clinical reasoning .


Eczema is one of the most common chronic inflammatory skin diseases , affecting about 20 % of children .


The pathogenic mechanisms of eczema are still not fully understood , and current treatment of moderate-severe eczema is often difficult .


Recently , it has been suggested that Vitamin D plays a key role in this disease , even if mechanisms are only partially known .


The purpose of our study was to assess the 25-Hydroxyvitamin D serum levels in a pediatric population suffering from chronic eczema ( IgE-mediated and non-IgE-mediated ) , and to correlate these phenotypes with the SCORAD severity and selected clinical and biological parameters .


Moreover , we aimed to evaluate whether a supplementation of Vitamin D3 could affect the same clinical and laboratory parameters .


89 children with chronic eczema were enrolled in the study .


Severity of eczema was assessed with the SCORAD index .


Past and present history was taken , and patients were divided into two groups according to the state of sensitization .


According to a randomization schedule , the enrolled children were assigned to the following groups : supplementation group , which received a daily oral Vitamin D3 supplementation ( 2000 IUs ) for 3 months ; control group which received no supplementation .


Vitamin D concentrations in patients with moderate and severe eczema were not statistically different from Vitamin D concentration detected in the serum of patients with mild eczema .


Furthermore , we did not find any correlation between Vitamin D levels , total IgEs and SCORAD index , both in the Sensitized and in the Not-Sensitized group .


The Vitamin D3 supplementation did not influence the SCORAD severity or the total IgEs concentration .


To our knowledge , our study is the first one that shows no correlation between serum levels of Vitamin D , eczema severity and IgE sensitization in a pediatric population suffering from chronic eczema .


Up to 25 % of severely injured patients develop trauma-induced coagulopathy .


To study interventions for this vulnerable population for whom consent can not be obtained easily , the Food and Drug Administration issued regulations for emergency research with an exception from informed consent ( ER-EIC ) .


We describe the community consultation and public disclosure ( CC/PD ) process in preparation for an ER-EIC study , namely the Control Of Major Bleeding After Trauma ( COMBAT ) study .


The CC/PD was guided by the four bioethical principles .


We used a multimedia approach , including one-way communications ( newspaper ads , brochures , television , radio , and web ) and two-way communications ( interactive in-person presentations at community meetings , printed and online feedback forms ) to reach the trials catchment area ( Denver County 's population : 643,000 and the Denver larger metro area where commuters reside : 2.9 million ) .


Particular attention was given to special-interests groups ( eg , Jehovah Witnesses , homeless ) and to Spanish-speaking communities ( brochures and presentations in Spanish ) .


Opt-out materials were available during on-site presentations or via the COMBAT study website .


A total of 227 community organizations were contacted .


Brochures were distributed to 11 medical clinics and 3 homeless shelters .


The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area , the majority via one-way communication and 1900 in two-way communications .


This resource intensive process cost more than $ 84,000 .


The CC/PD process is resource-intensive , costly , and complex .


Although the multimedia CC/PD reached a large audience , the effectiveness of this process remains elusive .


The templates can be helpful to similar ER-EIC studies .


To assess the clinical curative effect of fuzi-cake-separated moxibustion at Zhongji ( CV 3 ) and Guanyuan ( CV 4 ) for preventing dysuria after internal fixation of lower limb fractures .


Sixty patients conforming to the inclusion standards were randomly divided into a treatment group ( n = 30 ) and a control group ( n = 30 ) .


Fuzi-cake-separated moxibustion was performed at Guanyuan ( CV 4 ) and Zhongji ( CV 3 ) , 20 min at a time , twice a day , for 3 days before operation in the treatment group .


No fuzi-cake-separated moxibustion was performed in the control group .


After treatment , the score for symptoms of first urination , urinary time , urinary volume , 24 h remaining urinary volume , incidence of uroschesis , and rate of controlling dysuria were compared to evaluate the curative effect of preventing post-operative dysuria .


The score for symptoms of first urination , 24 h remaining urinary volume ( maximum 120 mL vs 250 ml , and less than 10 ml in 24 cases vs 15 cases ) , and the rate of controlling dysuria ( 83.34 % vs 30 % ) were significantly better ( P < 0.05 , P < 0.05 , and P < 0.001 , respectively ) in the treatment compared with the control group .


There was no statistical difference ( P > 0.05 ) between the two groups in first post-operative urinary time , urinary volume , or incidence of 24 h uroschesis .


Fuzi-cake-separated moxibustion at Zhongji ( CV 3 ) and Guanyuan ( CV 4 ) can better prevent post-operative dysuria , effectively promote the functional restoration of the urinary bladder , and control the incidence of post-operative dysuria .


Chronic angina is a profoundly symptomatic disease .


We evaluated the relationship between angina frequency and health utility .


We used data from stable angina patients reporting 3 attacks/week enrolled in the Efficacy of Ranolazine in Chronic Angina ( ERICA ) trial .


Angina frequency was classified using the Seattle Angina Questionnaire angina frequency ( SAQAF ) domain into no ( 100 ) ; monthly ( 61-99 ) ; weekly ( 31-60 ) ; and daily ( 0-30 ) angina .


EuroQol ( EQ ) -5 D health utility scores were derived from SAQ data using two mapping equations .


Median EQ-5D utility scores for each SAQAF classification after the 6-week trial period were calculated ( reported as : Equation 1/Equation 2 ) .


Changes in EQ-5D utility scores from baseline to end-of-trial for patients achieving and not achieving a 20-point improvement in SAQAF score and improving and not improving 1 SAQAF classification were compared .


Median EQ-5D utility scores ( n = 548 ) were 0.68 / 0.60 .


Compared to patients reporting no angina symptoms ( n = 28 ; 0.89 / 0.87 ) patients reporting monthly ( n = 188 ; 0.80 / 0.76 ) , weekly ( n = 283 ; 0.72 / 0.65 ) and daily ( n = 49 ; 0.65 / 0.54 ) symptoms had poorer health utility ( p < 0.001 for both equations ) .


Patients improving 1SAQAF classification ( n = 254/541 , 47 % ) experienced a median 0.05 / 0.07 greater improvement in EQ-5D health utility compared to those not improving 1 classification ( p < 0.001 for both equations ) .


Patients improving 20-points on the SAQAF ( n = 355/541 , 66 % ) experienced a median 0.06 / 0.07 greater improvement in health utility compared to those not achieving a 20-point improvement ( p < 0.001 for both ) .


Chronic angina patient health utility decreases as angina frequency increases .


Patients reporting clinically important improvement in angina frequency experience a tangible improvement in health utility .


NCT00091429 .


Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed .


Recently , the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms .


The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes , but had fewer manic symptoms during the trial .


It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage , social activity , physical activity , and mobility .


The Monsenso system , for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial .


The MONARCA II trial uses a randomized controlled single-blind parallel-group design .


Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder , Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians ( the intervention group ) or to the use of a smartphone for normal communicative purposes ( the control group ) for a 9-month trial period .


The trial was started in September 2014 and recruitment is ongoing .


The outcomes are : differences in depressive and manic symptoms ; rate of depressive and manic episodes ( primary ) ; automatically generated objective data on measures of illness activity ; number of days hospitalized ; psychosocial functioning ( secondary ) ; perceived stress ; quality of life ; self-rated depressive symptoms ; self-rated manic symptoms ; recovery ; empowerment and adherence to medication ( tertiary ) between the intervention group and the control group during the trial .


Ethical permission has been obtained .


Positive , neutral and negative findings will be published .


If the system is effective in reducing depressive and/or manic symptoms ( and other symptoms of bipolar disorder ) and the rate of episodes , there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale .


ClinicalTrials.gov NCT02221336 .


Registered 26th of September 2014 .


There are scarce data regarding the impact of sphincterotome design on cannulation success .


We aimed to compare two different 5.5 Fr standard sphincterotomes to determine initial cannulation success .


Adult patients with naive papillae were enrolled in a prospective , randomized , crossover study .


Two different 5.5 Fr sphincterotomes preloaded with guidewire ( GW ) were used in two groups with 140 patients included per group .


A total of five papillary attempts and two pancreatic channel entries were allowed as maximum targets .


In a case of more than two pancreatic entries , a double GW technique was attempted before crossover .


If choledochal cannulation was not achieved within ten papillary attempts or more than four pancreatic entries despite crossover , access papillotomy was performed .


Successful biliary cannulation was the primary outcome .


Secondary outcomes were incidence of early complications and overall cannulation success .


Higher initial cannulation success was achieved in group I compared with group II ( 88.5 vs. 77.1 % , p = 0.011 ) .


The crossover and double GW techniques reduced the need for precut from 11.7 to 5.3 % .


The overall cannulation success including precut for failed cases was 99.2 % ( group I ) and 98.5 % ( group II ) .


Sphincterotome type , presence of crossover , and number of cannulation attempts were predictors of successful cannulation in multivariate analysis .


There was a significant difference in cannulation success between two different 5.5 Fr sphincterotomes .


The cannulation success was mainly governed by sphincterotome design which serves a proper spatial orientation during the procedure .


The combined use of crossover and double GW techniques may substantially decrease precut necessity .


Providing written medicine information to consumers enables them to make informed decisions about their medicines , playing an important role in educating and improving health literacy .


In Australia , standardized written medicine information called Consumer Medicine Information ( CMI ) is available for medicines as package inserts , computer prints , or leaflets .


Consumers want and read CMI , but may not always ask for it .


General practitioners ( GPs ) and pharmacists are an important source of written medicine information , yet may not always provide CMI in their practice .


To examine and compare the awareness , use and provision of CMI by consumers , pharmacists and general practitioners ( GPs ) .


Based on previous studies , structured questionnaires were developed and administered to a national sample of consumers ( phone survey ) ; community pharmacists and GPs ( postal surveys ) about utilization of CMI .


Descriptive , comparative and logistic regression analyses were conducted .


The respondents comprised of 349 pharmacists , 181 GPs and 1000 consumers .


Two-thirds of consumers , nearly all ( 99 % ) pharmacists and 90 % of GPs were aware of CMI .


About 88 % of consumers reported receiving CMI as a package insert , however most pharmacists ( 99 % ) and GPs ( 56 % ) reported providing computer-generated CMI .


GPs ' and pharmacists ' main reason for providing CMI was on patient request .


Reasons for not providing were predominantly because consumers were already taking the medicine , concerns regarding difficulty understanding the information , or potential non-adherence .


Of the 691 consumers reportedly reading CMI , 35 % indicated concerns after reading .


Factors associated with reading included gender , type of CMI received and frequency of provision .


Consumers want and read information about their medicines , especially when received from their GP or pharmacist .


Healthcare professionals report usually discussing CMI when providing it to patients , although continued improvements in dissemination rates are desirable .


Regular use of CMI remains a challenge , and ongoing strategies to promote CMI use are necessary to improve uptake of CMI in Australia .


The aim of this study was to compare the contrast-to-noise ratio ( CNR ) values of infarct and remote myocardium as well as infarct and blood after application of 0.1 mmol/kg gadobutrol and 0.1 mmol/kg gadobenate dimeglumine on late gadolinium enhancement magnetic resonance ( MR ) images .


The study was a prospective randomized controlled clinical study .


After informed consent was obtained , 20 patients ( 12 men , 8 women ; mean age , 67 11 years ) with known chronic myocardial infarction were included for an intraindividual comparison of a single-dose gadobutrol and a single-dose gadobenate dimeglumine .


Two MR imaging examinations were performed within a period of 28 days in a crossover design .


Late gadolinium enhancement imaging was performed 10 minutes after gadolinium administration using a 2-dimensional phase-sensitive inversion recovery gradient echo sequence at 3 T. Infarct size , signal intensities ( SIs ) , signal-to-noise ratio , and CNR were determined on phase-sensitive MR images .


Values for CNR were calculated as CNRinfarct/myocardium = ( SIinfarct - SImyocardium ) / SDnoise and CNRinfarct/blood = ( SIinfarct - SIblood ) / SDnoise .


In addition , the areas of myocardial infarction were determined on single slices .


The entire infarct volumes were calculated by adding the areas with hyperenhancement multiplied by the slice thickness .


Late gadolinium enhancement was present in all patients .


Median values of the infarct area , infarct volume , and transmurality for gadobutrol and gadobenate dimeglumine showed good to excellent concordance ( rc = 0.85 , rc = 0.95 , and rc = 0.71 , respectively ) .


The mean signal-to-noise ratio values for infarct , remote myocardium , and ventricular blood were 18.6 6.5 , 4.1 3.7 , and 14.6 7.5 , respectively , for gadobutrol and 18.8 8.9 , 4.9 4.5 , and 17.8 10.1 , respectively , for gadobenate dimeglumine ( P = 0.93 , P = 0.48 , and P = 0.149 , respectively ) .


The mean values of CNRinfarct/myocardium and CNRinfarct/blood were 14.5 5.9 and 4.0 4.6 , respectively , for gadobutrol and 13.9 6.1 and 0.9 4.5 , respectively , for gadobenate dimeglumine ( P = 0.69 and P = 0.02 , respectively ) .


Both gadobutrol and gadobenate dimeglumine allow for successful late gadolinium enhancement imaging of chronic myocardial infarction after a single-dose application ( 0.1 mmol/kg ) at 3 T. Gadobutrol provides a higher CNR between infarct and blood .


The CNRs between infarct and normal myocardium , infarct size , and transmural extent were similar for both contrast agents .


Patients undergoing breast cancer surgery frequently experience chronic postoperative pain .


The primary objective of this randomized study was to determine if thoracic paravertebral block ( TPVB ) reduced the incidence of chronic pain after a modified radical mastectomy ( MRM ) when compared with general anesthesia ( GA ) .


One hundred eighty women undergoing MRM were randomized to 1 of 3 study groups : group 1 : standardized GA , group 2 : GA with a single-injection TPVB and placebo paravertebral infusion , and group 3 : GA with a continuous TPVB .


Outcomes assessed postoperatively included acute postoperative pain and analgesic consumption and , at 3 and 6 months , the incidence and severity of chronic pain and physical and mental health-related quality of life ( HRQOL ) .


There was no significant difference in the incidence of chronic pain at 3 months ( P = 0.13 ) and 6 months ( P = 0.79 ) after the MRM between the study groups .


The relative risk of developing chronic pain ( P = 0.25 ) was also similar between the groups .


There was no difference in acute pain ( P = 0.22 ) or postoperative analgesic consumption ( P = 0.67 ) between the groups .


Nevertheless , differences were observed in chronic pain-related secondary outcome variables .


The TPVB groups reported lower chronic pain scores ( P < 0.05 ) , exhibited fewer symptoms and signs of chronic pain ( P 0.01 ) , and also experienced better physical and mental HRQOL than did the GA group .


Chronic pain scores also decreased with time in all study groups ( P < 0.05 ) .


There is no significant difference in the incidence or relative risk of chronic pain at 3 and 6 months after an MRM when TPVB is used in conjunction with GA. .


Nevertheless , patients who receive a TPVB report less severe chronic pain , exhibit fewer symptoms and signs of chronic pain , and also experience better physical and mental HRQOL .


Narrative exposure therapy ( NET ) is a brief , manualised treatment for Posttraumatic Stress Disorder ( PTSD ) .


It has been shown to have therapeutic benefits for a wide range of individuals and settings .


This study , following our previous work applying the original NET in earthquake survivors , aimed to revise NET to be adaptable for treating PTSD after a natural disaster .


A randomised waiting-list controlled study was conducted with 30 adult participants with PTSD who were randomly allocated to NET ( n = 10 ) , revised NET ( NET-R ; n = 10 ) or a waiting list condition ( WL ; n = 10 ) .


Participants in NET and NET-R received treatment immediately ; those in the WL condition received NET-R treatment after a waiting period .


All groups were assessed on PTSD , general distress , anxiety , depression , social support , coping and posttraumatic change before and after treatment and three-month follow-up .


Compared with WL , both NET and NET-R groups showed significant reductions in PTSD and related symptoms .


Significant increases were found in posttraumatic growth , active coping and perceived social support .


The WL group showed similar improvements after treatment .


Further reductions on PTSD symptoms were found at three months , showing that NET-R is as effective as the original NET in treating post-earthquake traumatic symptoms in adult Chinese earthquake survivors .


NET-R is a feasible and cost-effective intervention for Chinese earthquake survivors .


Further studies are needed to replicate these findings in other survivor populations , and with larger samples and over longer periods .


This study highlighted the value of oral narrative approach , which is well-accepted and useful in the context of single natural disaster and lower - income area .


Chinese Clinical Trial Registry : ChiCTR-TRC-12002931 .


The objective of the study was to test the diagnostic performance of low-dose computed tomography pulmonary angiography ( CTPA ) at peak tube voltage of 80 kVp with both reduced radiation and reduced contrast material ( CM ) dose .


In this single-center , single-blinded prospective randomized trial , 501 patients with body weights of less than 100 kg with suspected acute pulmonary embolism ( PE ) were assigned to normal-dose CTPA ( 100-kVp tube energy and 100-mL CM , 255 patients ) and low-dose CTPA ( 80-kVp tube energy and 75-mL CM , 246 patients ) .


Primary end points were evidence of PE in CTPA and accuracy of CTPA on a composite reference standard .


Results were compared by calculating the odds ratio with the 95 % confidence interval .


The reference diagnosis was equivocal in 20 of the 501 patients .


Diagnosis of CTPA was correct in 240 patients and incorrect in 5 in the normal-dose group .


Computed tomography pulmonary angiography was correct in 230 patients and incorrect in 6 in the low-dose group ( odds ratio , 1.25 ; 95 % confidence interval , 0.38-4 .16 ; P = 0.77 ) .


Sensitivity was 96.9 % and 100 % and specificity was 98.1 % and 97.1 % in the normal-dose and low-dose groups , respectively .


No PE or PE-related death occurred during the 90-day follow-up .


The size-specific dose estimates were 30 % lower at 80 kVp ( 4.8 1.0 mGy ) compared with that at 100 kVp ( 6.8 1.2 mGy ; P < 0.001 ) .


The accuracy of low-dose CTPA at 80 kVp with a 30 % reduced radiation dose and a 25 % lower CM volume is not significantly different from that of normal-dose CTPA at 100 kVp in detecting acute PE in patients weighing less than 100 kg .


To evaluate the association of subretinal hyperreflective material ( SHRM ) with visual acuity ( VA ) , geographic atrophy ( GA ) , and scar in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .


Prospective cohort study within a randomized clinical trial .


The 1185 CATT participants .


Masked readers graded scar and GA on fundus photography and fluorescein angiography and graded SHRM on time-domain and spectral-domain ( SD ) optical coherence tomography ( OCT ) throughout 104 weeks .


Measurements of SHRM height and width in the fovea , within the center 1 mm ( 2 ) , or outside the center 1mm ( 2 ) were obtained on SD OCT images at 56 ( n = 76 ) and 104 ( n = 66 ) weeks .


Presence of SHRM , as well as location and size , and associations with VA , scar , and GA. .


Among CATT participants , the percentage with SHRM at enrollment was 77 % , decreasing to 68 % at 4 weeks after treatment and to 54 % at 104 weeks .


At 104 weeks , scar was present more often in eyes with persistent SHRM than in eyes with SHRM that resolved ( 64 % vs. 31 % ; P < 0.0001 ) .


Among eyes with detailed evaluation of SHRM at weeks 56 ( n = 76 ) and 104 ( n = 66 ) , mean VA letter score was 73.5 ( standard error [ SE ] , 2.8 ) , 73.1 ( SE , 3.4 ) , 65.3 ( SE , 3.5 ) , and 63.9 ( SE , 3.7 ) when SHRM was absent , present outside the central 1 mm ( 2 ) , present within the central 1 mm ( 2 ) but not the foveal center , or present at the foveal center ( P = 0.02 ) , respectively .


When SHRM was present , the median maximum height under the fovea , within the central 1 mm ( 2 ) including the fovea and anywhere within the scan , was 86 m , 120 m , and 122 m , respectively .


Visual acuity was decreased with greater SHRM height and width ( P < 0.05 ) .


In eyes with neovascular age-related macular degeneration ( AMD ) , SHRM is common and often persists after anti-vascular endothelial growth factor treatment .


At 2 years , eyes with scar were more likely to have SHRM than other eyes .


Greater SHRM dimensions were associated with worse VA. .


In eyes with neovascular AMD , SHRM is an important morphologic biomarker .


A phase 3 randomized clinical trial was designed to test whether bardoxolone methyl , a nuclear factor erythroid-2-related factor 2 ( Nrf2 ) activator , slows progression to end-stage renal disease in patients with stage 4 chronic kidney disease and type 2 diabetes mellitus .


The trial was terminated because of an increase in heart failure in the bardoxolone methyl group ; many of the events were clinically associated with fluid retention .


We randomized 2,185 patients with type 2 diabetes mellitus ( T2DM ) and stage 4 chronic kidney disease ( CKD ) ( estimated glomerular filtration rate 15 to < 30 mL min ( -1 ) 1.73 m ( -2 ) ) to once-daily bardoxolone methyl ( 20 mg ) or placebo .


We used classification and regression tree analysis to identify baseline factors predictive of heart failure or fluid overload events .


Elevated baseline B-type natriuretic peptide and previous hospitalization for heart failure were identified as predictors of heart failure events ; bardoxolone methyl increased the risk of heart failure by 60 % in patients with these risk factors .


For patients without these baseline characteristics , the risk for heart failure events among bardoxolone methyl - and placebo-treated patients was similar ( 2 % ) .


The same risk factors were also identified as predictors of fluid overload and appeared to be related to other serious adverse events .


Bardoxolone methyl contributed to events related to heart failure and/or fluid overload in a subpopulation of susceptible patients with an increased risk for heart failure at baseline .


Careful selection of participants and vigilant monitoring of the study drug will be required in any future trials of bardoxolone methyl to mitigate the risk of heart failure and other serious adverse events .


Small studies suggest that low-dose dopamine or low-dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction ; however , neither strategy has been rigorously tested .


To test the 2 independent hypotheses that , compared with placebo , addition of low-dose dopamine ( 2 g/kg/min ) or low-dose nesiritide ( 0.005 g/kg/min without bolus ) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction .


Multicenter , double-blind , placebo-controlled clinical trial ( Renal Optimization Strategies Evaluation [ ROSE ] ) of 360 hospitalized patients with acute heart failure and renal dysfunction ( estimated glomerular filtration rate of 15-60 mL/min/1 .73 m2 ) , randomized within 24 hours of admission .


Enrollment occurred from September 2010 to March 2013 across 26 sites in North America .


Participants were randomized in an open , 1:1 allocation ratio to the dopamine or nesiritide strategy .


Within each strategy , participants were randomized in a double-blind , 2:1 ratio to active treatment or placebo .


The dopamine ( n = 122 ) and nesiritide ( n = 119 ) groups were independently compared with the pooled placebo group ( n = 119 ) .


Coprimary end points included 72-hour cumulative urine volume ( decongestion end point ) and the change in serum cystatin C from enrollment to 72 hours ( renal function end point ) .


Compared with placebo , low-dose dopamine had no significant effect on 72-hour cumulative urine volume ( dopamine , 8524 mL ; 95 % CI , 7917-9131 vs placebo , 8296 mL ; 95 % CI , 7762-8830 ; difference , 229 mL ; 95 % CI , -714 to 1171 mL ; P = .59 ) or on the change in cystatin C level ( dopamine , 0.12 mg/L ; 95 % CI , 0.06-0 .18 vs placebo , 0.11 mg/L ; 95 % CI , 0.06-0 .16 ; difference , 0.01 ; 95 % CI , -0.08 to 0.10 ; P = .72 ) .


Similarly , low-dose nesiritide had no significant effect on 72-hour cumulative urine volume ( nesiritide , 8574 mL ; 95 % CI , 8014-9134 vs placebo , 8296 mL ; 95 % CI , 7762-8830 ; difference , 279 mL ; 95 % CI , -618 to 1176 mL ; P = .49 ) or on the change in cystatin C level ( nesiritide , 0.07 mg/L ; 95 % CI , 0.01-0 .13 vs placebo , 0.11 mg/L ; 95 % CI , 0.06-0 .16 ; difference , -0.04 ; 95 % CI , -0.13 to 0.05 ; P = .36 ) .


Compared with placebo , there was no effect of low-dose dopamine or nesiritide on secondary end points reflective of decongestion , renal function , or clinical outcomes .


In participants with acute heart failure and renal dysfunction , neither low-dose dopamine nor low-dose nesiritide enhanced decongestion or improved renal function when added to diuretic therapy .


clinicaltrials.gov Identifier : NCT01132846 .


The administration of statins seems to be a promising new avenue in the treatment of patients suffering from major depressive disorder ( MDD ) , though patients suffering from severe MDD remain unstudied in this respect .


The aim of the present study was therefore to investigate , in a randomized double-blind clinical trial , the influence of adjuvant atorvastatin on symptoms of depression in patients with MDD .


A total of 60 patients suffering from MDD ( mean age : 32.25 years ; 53 % males ) received a standard medication of 40 mg/d citalopram .


Next , patients were randomly assigned either to the atorvastatin group ( 20 mg/d ) or to the placebo group .


Blood lipid values were assessed at baseline and on completion of the study 12 weeks later .


Experts rated depressive symptoms via Hamilton Depression Rating Scales ( HDRS ) at baseline and 3 , 6 and 12 weeks later .


HDRS scores decreased over time ; the significant Time by Group interaction showed that symptoms of depression decreased more in the atorvastatin than in the placebo group .


Compared to the placebo group , in the atorvastatin group cholesterol , triglyceride , and Low Density Lipids ( LDL ) significantly decreased , and High Density Lipids ( HDL ) significantly increased over time .


HDRS scores and blood lipid values were generally not associated .


The pattern of results suggests that adjuvant atorvastatin favorably influences symptoms of depression among patients with severe MDD .


Given that after 12 weeks of monotherapy and adjuvant atorvastatin patients were still moderately to severely depressed , more powerful treatment algorithms such as augmentation and change of medication are highly recommended .


To compare measurement properties of the P4 pain scale , Western Ontario and McMaster Universities Arthritis Index pain subscale ( WOMAC-pain ) , and Intermittent and Constant Osteoarthritis Pain ( ICOAP ) measure in patients with knee osteoarthritis ( OA ) .


A secondary analysis from a randomized controlled trial included participants ( n = 156 ) with knee OA that were consulting with a surgeon regarding knee arthroplasty .


They completed pain measures ( P4 , WOMAC-pain , ICOAP ) and WOMAC-function subscale ( WOMAC-function ) at baseline and 2 weeks .


Measurement properties assessed in various subgroups included floor/ceiling effects , test-retest reliability using intraclass correlation coefficients ( ICC2 ,1 ) , internal consistency using Cronbach 's , factorial structure of each pain measure combined with WOMAC-function using principal component analysis , and responsiveness using standardized response mean ( SRM ) .


P4 had low floor and ceiling effects ( < 1 % ) .


P4 test-retest reliability ( ICC2 ,1 = 0.72 ) , internal consistency ( Chronbach 's = 0.91 ) , and responsiveness ( SRM = 0.56 ) were similar to the values for WOMAC-pain and ICOAP .


Factorial structure of P4 and ICOAP were separate from WOMAC-function items .


WOMAC-pain and WOMAC-function items loaded on similar factors .


ICOAP-constant subscale had a large floor effect ( 33 % ) .


P4 should be used to measure pain in patients with knee OA .


It had acceptable measurement properties which is comparable to more widely used pain measures .


WOMAC-pain shared a factorial structure with WOMAC-function indicating these measures might be capturing the same construct , questioning its validity to measure pain separately from function .


ICOAP had acceptable properties .


More work should compare pain measures in less severely affected OA populations .


Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence .


Maintenance antidepressants for at least 2 years is the current recommended treatment , but many individuals are interested in alternatives to medication .


Mindfulness-based cognitive therapy ( MBCT ) has been shown to reduce risk of relapse or recurrence compared with usual care , but has not yet been compared with maintenance antidepressant treatment in a definitive trial .


We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment ( MBCT-TS ) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months .


In this single-blind , parallel , group randomised controlled trial ( PREVENT ) , we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants , from primary care general practices in urban and rural settings in the UK .


Participants were randomly assigned to either MBCT-TS or maintenance antidepressants ( in a 1:1 ratio ) with a computer-generated random number sequence with stratification by centre and symptomatic status .


Participants were aware of treatment allocation and research assessors were masked to treatment allocation .


The primary outcome was time to relapse or recurrence of depression , with patients followed up at five separate intervals during the 24-month study period .


The primary analysis was based on the principle of intention to treat .


The trial is registered with Current Controlled Trials , ISRCTN26666654 .


Between March 23 , 2010 , and Oct 21 , 2011 , we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices .


212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants .


The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months ( hazard ratio 089 , 95 % CI 067-118 ; p = 043 ) , nor did the number of serious adverse events .


Five adverse events were reported , including two deaths , in each of the MBCT-TS and maintenance antidepressants groups .


No adverse events were attributable to the interventions or the trial .


We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence .


Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence , residual depressive symptoms , and quality of life .


National Institute for Health Research ( NIHR ) Health Technology Assessment ( HTA ) programme , and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula .


To compare the effects of exergaming with conventional weight-shift training on balance function in patients with chronic stroke .


Single-blind randomized controlled trial .


Medical center .


Patients ( N = 30 ) with chronic stroke and balance deficits .


Twelve weeks of Wii Fit training or conventional weight-shift training .


Static balance was assessed using posturography .


We recorded the stability index and percentage of weight bearing on the affected leg in 8 positions .


We also used the timed Up and Go and forward reach tests for dynamic balance evaluation , Falls Efficacy Scale-International for fear of falling assessment , and Physical Activity Enjoyment Scale for estimating the enjoyment of training .


The exergaming group showed more improvement in stability index than the control group in head straight with eyes open while standing on a foam surface , eyes closed while standing on a solid surface with head turned 30 to the left , and eyes closed while standing on a solid surface with head turned up positions ( time-group interaction P = .02 , .04 , and .03 , respectively ) ; however , the effects were not maintained .


At 3-month follow-up , the control group showed more improvement in weight-bearing symmetry in the head straight with eyes open while standing on a solid surface position than the exergaming group ( time-group interaction P = .03 ) .


Both groups showed improvement in the timed Up and Go test , forward reach test , and fear of falling .


The improvement in fear of falling was not maintained .


The exergaming group enjoyed training more than the control group ( P = .03 ) .


Exergaming is enjoyable and effective for patients with chronic stroke .


The aim of this study was to compare the recurrence rates for primary pterygia after fibrin glue-assisted conjunctival autograft ( CAG ) versus conjunctivolimbal autograft ( CLAG ) transplantation , using a technique of limited conjunctival resection and Tenon extended removal .


In this comparative case series , 49 eyes of 47 patients with primary nasal pterygium were included .


Patients were randomized into 2 groups to undergo fibrin glue-assisted CAG ( group 1 , 24 eyes ) or fibrin glue-assisted CLAG ( group 2 , 25 eyes ) following excision of pterygium .


The surgical technique used in all patients involved limited conjunctival resection combined with extensive removal of the Tenon capsule up to the caruncle medially and also 5 mm beyond the inferior and superior free edges of the conjunctiva .


The main outcome measure studied was the absence or presence of recurrence .


There was 0 % recurrence rate in both groups after a mean follow-up of 63 weeks ( range , 54-81 weeks ) with all eyes completing at least 1-year of follow-up .


Fibrin glue-assisted CAG and CLAG using the technique of conjunctival resection and Tenon extended removal were equally efficacious in terms of preventing recurrences in patients with primary pterygia in our series .


Acellular pertussis vaccines do not control pertussis .


A new approach to offer protection to infants is necessary .


BPZE1 , a genetically modified Bordetella pertussis strain , was developed as a live attenuated nasal pertussis vaccine by genetically eliminating or detoxifying 3 toxins .


We performed a double-blind , placebo-controlled , dose-escalating study of BPZE1 given intranasally for the first time to human volunteers , the first trial of a live attenuated bacterial vaccine specifically designed for the respiratory tract .


12 subjects per dose group received 10 , 10 or 10 colony-forming units as droplets with half of the dose in each nostril .


12 controls received the diluent .


Local and systemic safety and immune responses were assessed during 6 months , and nasopharyngeal colonization with BPZE1 was determined with repeated cultures during the first 4 weeks after vaccination .


Colonization was seen in one subject in the low dose , one in the medium dose and five in the high dose group .


Significant increases in immune responses against pertussis antigens were seen in all colonized subjects .


There was one serious adverse event not related to the vaccine .


Other adverse events were trivial and occurred with similar frequency in the placebo and vaccine groups .


BPZE1 is safe in healthy adults and able to transiently colonize the nasopharynx .


It induces immune responses in all colonized individuals .


BPZE1 can thus undergo further clinical development , including dose optimization and trials in younger age groups .


ClinicalTrials.gov NCT01188512 .


This study aimed to evaluate the internal consistency reliability and construct validity of the Fitzpatrick Skin Type Scale during radiation therapy in a cohort of women receiving treatment for breast cancer .


The assessment of the scale was performed as a nested study within a randomised controlled trial of two creams used for radiation therapy skin care for breast cancer patients .


The sample consisted of 244 female patients undergoing radiation therapy for breast cancer .


Participants completed a modified version of the Fitzpatrick Skin Type Scale .


Internal consistency as measured by Cronbach 's alpha was 0.505 , 0.829 and 0.339 for the Genetic Disposition , Sun Exposure and Tanning Habits subscales respectively .


Only the Sun Exposure subscale surpassed the 0.70 cut-off , indicating good internal consistency .


Maximum likelihood factor analysis with promax rotation method confirmed the a priori factor structure for the Sun Exposure subscale as well as providing evidence of construct validity for this subscale .


Analysis for the other two subscales highlighted issues with internal reliability and construct validity suggesting that not all items on each subscale truly measure the intended trait .


The study findings support reliability and validity of the Sun Exposure subscale of the Fitzpatrick Skin Type Scale in a convenience sample of women receiving radiation therapy for cancer .


Despite limitations with two of the three subscales , this tool continues to be used in clinical practice .


Treatment impact on quality of life ( QoL ) informs treatment management decisions in advanced nonsquamous non-small-cell lung cancer ( NS NSCLC ) .


QoL outcomes from the phase III PointBreak trial are reported .


Chemonaive patients ( n = 939 ) with stage IIIB/IV nonsquamous non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status 0 to 1 were randomized ( 1:1 ) to pemetrexed-carboplatin-bevacizumab ( pemetrexed arm ) or paclitaxel-carboplatin-bevacizumab ( paclitaxel arm ) .


Patients without progressive disease received maintenance pemetrexed-bevacizumab ( pemetrexed arm ) or bevacizumab ( paclitaxel arm ) .


QoL was assessed using Functional Assessment of Cancer Therapy ( FACT ) - General ( FACT-G ) , FACT-Lung ( FACT-L ) , and FACT/Gynecologic Oncology Group-Neurotoxicity ( FACT-Ntx ) instruments .


Subscale scores , total scores , and trial outcome indices were analyzed using linear mixed-effects models .


Post hoc analyses examined the association between baseline FACT scores and overall survival ( OS ) .


Mean score differences in change from baseline significantly favored the pemetrexed arm for the neurotoxicity subscale score , FACT-Ntx total scores , and FACT-Ntx trial outcome index .


They occurred at cycle 2 ( p < 0.001 ) and persisted through induction cycles 2 to 4 and six maintenance cycles .


Investigator-assessed , qualitative , drug-related differences in grade 2 ( 1.6 % versus 10.6 % ) and grade 3 ( 0.0 % versus 4.1 % ) sensory neuropathy and grade 3/4 fatigue ( 10.9 % versus 5.0 % , p = 0.0012 ) were observed between the pemetrexed and paclitaxel arms .


Baseline FACT-G , FACT-L , and FACT-Ntx scores were significant prognostic factors for OS ( p < 0.001 ) .


Randomized patients reported similar changes in QoL , except for less change from baseline in neurotoxicity on the pemetrexed arm ; investigators reported greater neurotoxicity on the paclitaxel arm and greater fatigue on the pemetrexed arm .


Higher baseline FACT scores were favorable prognostic factors for OS .


Initiation of epidural anesthesia with long-lasting local anesthetics consumes a significant amount of time , which could be problematic in busy obstetric anesthesia suites .


We have hypothesized that a combination of articaine and ropivacaine provides faster onset and even an early recovery of sensory-motor block characteristics .