The application of NIV was superior to HFNC with regard to oxygenation before , during and after bronchoscopy in patients with moderate to severe hypoxaemia .


In patients with stable oxygenation under HFNC , subsequent bronchoscopy was well tolerated .


ClinicalTrials.gov NCT01870765 .


Registered 30 May 2013 .


Surgical ablation ( SA ) is commonly used in atrial fibrillation ( AF ) patients undergoing cardiac surgery .


However , its effect has been established in few randomized studies .


To assess the complete atrial fibrillation free ( AF-free ) survival in randomized study assessing the effects of additional concomitant SA of AF in patients primarily indicated for other cardiac surgery .


The PRAGUE-12 study was a prospective randomized study comparing the effect of adding SA to other cardiac surgery .


We examined the data from the PRAGUE-12 trial and grouped patients according to complete AF-free survival .


All patients had regular check-ups at 3 , 6 , 9 months , some of them with Holter recordings , and a final check-up at 12 months with Holter recording .


One hundred ninety-four patients were analyzed ; 104 originally randomized to surgery with adding SA ( SA group ) and 90 without it ( non-SA group ) .


Complete AF-free status was found in 46 patients from the SA group ( 44.2 % ) and 25 patients ( 27.8 % ) from the non-SA group ( p < 0.05 ) .


In a multivariate logistic regression , the SA group was associated with a greater chance for complete AF-free survival ( OR 1.87 , p < 0.05 ) .


In the multivariate analysis of the SA group , history of myocardial infarction ( OR 0.2 , p < 0.05 ) and a higher EuroSCORE ( OR 0.9 , p 0.05 ) were independently associated with a lower probability of AF-free survival .


Complete AF-free survival following SA was present in almost one half of patients .


Patients with a history of myocardial infarction and higher EuroSCOREs were less likely to benefit from an add-on SA procedure .


To compare the efficacy of autologous blood injection versus corticosteroid injection for lateral epicondylitis .


21 men and 59 women ( mean age , 45.2 years ) presenting with lateral epicondylitis were randomised to receive either autologous blood injection ( 2 ml of autologous venous blood mixed with 1 ml of 2 % prilocaine hydrochloride ) or corticosteroid injection ( 1 ml of 40 mg methylprednisolone acetate mixed with 1 ml of 2 % prilocaine hydrochloride ) given by a single physician .


Patients were assessed before ( day 0 ) and after ( days 15 , 30 , and 90 ) treatment for elbow pain ( using a visual analogue scale [ VAS ] ) , function ( using the patient-rated tennis elbow evaluation [ PRTEE ] questionnaire ) , and grip strength ( using a hydraulic hand dynamometer ) .


Patients were followed up at 6 months by telephone to assess elbow pain using the VAS .


No complications ( infection , skin atrophy , neurovascular damage , or tendon rupture ) were noted .


10 patients reported increased pain for up to 2 days after autologous blood injection .


In both groups , the VAS score for elbow pain , PRTEE score , and grip strength improved significantly after treatment ( p = 0.0001 ) , but the pattern of improvement differed .


Compared with autologous blood injection , corticosteroid injection improved all 3 scores at a faster rate over the first 15 days ( p = 0.0001 ) , and then started to decline slightly until day 90 .


After autologous blood injection , all 3 scores improved steadily and were eventually better ( p = 0.0001 ) .


If a 37 % decrease in PRTEE is defined as complete recovery , 38 ( 95 % ) of patients with autologous blood injection and 25 ( 62.5 % ) of patients with corticosteroid injection achieved complete recovery ( p = 0.0001 ) .


Autologous blood injection was more effective over the follow-up period than corticosteroid injection in improving pain , function , and grip strength .


It is recommended as a first-line injection treatment because it is simple , cheap , and effective .


Among CT scanners , 320-row instruments feature decreased photon energy and yield strong contrast enhancement .


Consequently , the contrast medium ( CM ) dose can be reduced .


The results of low-tube-voltage coronary CT angiography ( CCTA ) performed on 320-row scanners have not been adequately assessed .


We evaluated the effects of a low-contrast-dose protocol on the image quality of CCTA using 80 kVp tube voltage , iterative reconstruction ( IR ) , and a 320-row scanner .


We randomly assigned 90 patients ( mean body weight , 56.5 11.0 kg ) to 1 of 3 CCTA protocols .


Under protocol A , 30 were scanned using a conventional 120-kVp protocol and a standard CM dose ( 280 mg iodine/kg body weight [ mgI/kg ] ) .


Another 30 underwent scanning at 80 kVp with a 25 % CM dose reduction ( 210 mgI/kg ; protocol B ) .


Under protocol C , the remaining 30 patients were scanned at 80 kVp with a 50 % CM dose reduction ( 140 mgI/kg ) .


The 120 and 80 kVp images were processed with IR .


Images obtained under the 3 protocols were subjected to quantitative and qualitative analysis .


The amount of CM used in protocol A , B , and C was 43.6 10.1 , 30.3 4.4 , and 21.0 4.0 mL , respectively .


Mean CT attenuation of the coronary arteries tended to be higher under protocol B than the other 2 protocols .


The contrast-to-noise ratio was significantly higher under protocol B.


The mean visual scores were significantly higher for protocols A and B than protocol C.


The mean effective radiation dose was significantly lower under the 80-kVp protocol .


With a 320-row scanner and our refined CM injection and timing protocol , it is technically feasible to obtain sufficient vascular enhancement with a reduction in the CM and/or radiation dose at 80-kVp CCTA with IR .


Evaluate the sensitivity and specificity of pelvic ultrasound ( US ) and abdominopelvic computed tomography ( CT ) for the identification of ovarian torsion in women presenting to the emergency department with acute lower abdominal or pelvic pain .


This is a retrospective study of 20 cases of ovarian torsion and 20 control patients , all of whom had both US and CT performed in the emergency department .


Two radiologists who were blinded to clinical data interpreted all studies as ( 1 ) demonstrating an abnormal ovary or not , and ( 2 ) suggestive of torsion or not .


Sensitivity , specificity and interobserver variation were calculated for each imaging modality .


Pelvic US was interpreted as demonstrating an abnormal ovary in 90.0 % of ovarian torsion cases by reader 1 , and in 100.0 % by reader 2 , whereas CT was interpreted as revealing an abnormal ovary in 100.0 % of torsion cases by both readers .


Pelvic US for ovarian torsion was 80.0 % sensitive ( 95 % CI , 58.4-91 .9 % ) and 95.0 % specific ( 95 % CI , 76.4-99 .1 % ) for reader 1 , while 80.0 % sensitive ( 95 % CI , 58.4-91 .9 % ) and 85.0 % specific ( 95 % CI , 64.0-95 .0 % ) for reader 2 .


Interobserver agreement for pelvic US was fair ( Kappa = 0.60 ) .


Abdominopelvic CT for ovarian torsion was 100.0 % sensitive ( 95 % CI , 83.9-100 .0 % ) and 85.0 % specific ( 95 % CI , 64.0-94 .5 % ) for reader 1 , while 90.0 % sensitive ( 95 % CI , 69.9-97 .2 % ) and 90.0 % specific ( 95 % CI , 69.9-97 .2 % ) for reader 2 .


Interobserver agreement was excellent ( Kappa = 0.85 ) .


The diagnostic performance of CT is not shown to be significantly different from that of US in identifying ovarian torsion in this study .


These results suggest that when CT demonstrates findings of ovarian torsion , the performance of another imaging exam ( i.e. US ) that delays therapy is unlikely to improve preoperative diagnostic yield .


Previous research reveals an association between traumatic stress and an increased risk for numerous diseases , including cancer .


At the molecular level , stress may increase carcinogenesis via increased DNA damage and impaired DNA repair mechanisms .


We assessed DNA breakage in peripheral blood mononuclear cells from individuals with post-traumatic stress disorder ( PTSD ) and measured the cellular capacity to repair single-strand breaks after exposure to ionizing X-radiation .


We also investigated the effect of psychotherapy on both DNA breakage and DNA repair .


In a first study we investigated DNA breakage and repair in 34 individuals with PTSD and 31 controls .


Controls were subdivided into 11 trauma-exposed subjects and 20 individuals without trauma exposure .


In a second study , we analysed the effect of psychotherapy ( Narrative Exposure Therapy ) on DNA breakage and repair .


Thirty-eight individuals with PTSD were randomly assigned to either a treatment or a waitlist control condition .


Follow-up was performed 4 months and 1 year after therapy .


In study 1 we found higher levels of basal DNA breakage in individuals with PTSD and trauma-exposed subjects than in controls , indicating that traumatic stress is associated with DNA breakage .


However , single-strand break repair was unimpaired in individuals with PTSD .


In study 2 , we found that psychotherapy reversed not only PTSD symptoms , but also DNA strand break accumulation .


Our results show - for the first time in vivo - an association between traumatic stress and DNA breakage ; they also demonstrate changes at the molecular level , i.e. , the integrity of DNA , after psychotherapeutic interventions .


Postoperative pain remains an important challenge after scoliosis surgery in children .


Opioids are the mainstay of treatment , and adult studies demonstrate gabapentin as a useful adjunct to opioids in the management of postoperative pain .


Adolescent patients undergoing idiopathic scoliosis surgery were randomized to receive a single preoperative dose of gabapentin 600mg or placebo .


The primary outcome measure was total morphine consumption in mgkg ( -1 ) between 0 and 24h postoperatively .


Secondary outcome measures included time to first rescue analgesia , pain intensity scores at rest and with movement , incidence of nausea , vomiting , pruritus , sedation , dizziness , presence of persisting pain symptoms , and patient satisfaction .


Cumulative opioid consumption was calculated at each time point : 1 , 4 , 8 , 12 , 24 , 48 , and 72h .


The gabapentin group used 0.0870.06 mgkg ( -1 ) of morphine at 1h , 0.240.12 mgkg ( -1 ) at 4h , 0.440.17 mgkg ( -1 ) at 8h , and 1.290.44 mgkg ( -1 ) at 24h .


The placebo group used 0.1210.06 mgkg ( -1 ) of morphine at 1h , 0.350.16 mgkg ( -1 ) at 4h , 0.560.27 mgkg ( -1 ) at 8h , and 1.460.68 mgkg ( -1 ) at 24h .


There was no statistically significant reduction in opioid consumption in the patients receiving gabapentin .


There were no significant differences in secondary outcomes .


A single preoperative dose of gabapentin did not show a significant difference in opioid consumption or pain scores in adolescents undergoing idiopathic scoliosis surgery .


This study is the first pediatric randomized controlled trial to assess the effectiveness of a single dose of gabapentin on morphine consumption and analgesia following major surgery .


To evaluate transient , large visual acuity ( VA ) decreases , termed sporadic vision loss , during anti-vascular endothelial growth factor treatment for neovascular age-related macular degeneration ( AMD ) .


Cohort within a randomized clinical trial .


setting : Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .


study population : Total of 1185 CATT patients .


main outcome measures : Incidence of sporadic vision loss and odds ratio ( OR ) for association with patient and ocular factors .


Sporadic vision loss was a decline of 15 letters from the previous visit , followed by a return at the next visit to no more than 5 letters worse than the visit before the VA loss .


There were 143 sporadic vision loss events in 122 of 1185 patients ( 10.3 % ) .


Mean VA at 2 years for those with and without sporadic vision loss was 58.5 ( 20/63 ) and 68.4 ( 20/40 ) letters , respectively ( P < .001 ) .


Among patients treated pro re nata , no injection was given for 27.6 % ( 27/98 ) of sporadic vision loss events .


Multivariate analysis demonstrated that baseline predictors for sporadic vision loss included worse baseline VA ( OR 2.92 , 95 % confidence interval [ CI ] :1.65 -5.17 for 20/200 compared with 20/40 ) , scar ( OR 2.21 , 95 % CI :1.22 -4.01 ) , intraretinal foveal fluid on optical coherence tomography ( OR 1.80 , 95 % CI :1.11 -2.91 ) , and medical history of anxiety ( OR 1.90 , 95 % CI :1.12 -3.24 ) and syncope ( OR 2.75 , 95 % CI :1.45 -5.22 ) .


Refraction decreased the likelihood of sporadic vision loss ( OR 0.62 , 95 % CI : 0.42-0 .91 ) .


Approximately 10 % of CATT patients had sporadic vision loss .


Baseline predictors included AMD-related factors and factors independent of AMD .


These data are relevant for clinicians in practice and those involved in clinical trials .


This study sought to evaluate the safety and effectiveness of drug-eluting stents ( DES ) compared to bare-metal stents ( BMS ) for patients with large coronary vessels .


Randomized trials have demonstrated that DES reduce the risk of target vessel revascularization ( TVR ) compared to BMS .


This benefit is less pronounced as artery diameter increases .


Whether DES are superior to BMS for larger coronary arteries in the setting of routine clinical practice is unknown .


We analyzed data from 869 patients undergoing de novo lesion PCI with reference vessel diameter greater than or equal to 3.5 mm in the NHLBI Dynamic Registry according to whether they were treated with DES or BMS .


Patients were followed for 3 years for the occurrence of cardiovascular events .


At 3-year follow-up , rates of TVR at 3 years were similar and low in both groups ( 4.4 % vs. 3.7 % , P = 0.62 ) .


After adjustment for differences in baseline characteristics , the adjusted hazard ratio for 3-year MI for DES was 1.85 ( 95 % CI 0.93-3 .7 , P = 0.08 ) , for TVR at 3 years 1.14 ( 95 % CI 0.52-2 .49 , P = 0.75 ) and for mortality 0.89 ( 95 % CI 0.49-1 .62 , P = 0.71 ) .


In our study of the unrestricted use of DES for patients with lesions in larger diameter coronary arteries , first generation DES did not reduce 3-year risk of TVR .


Our findings do not support the preferred use of DES over BMS for patients with lesions located in arteries > 3.5 mm .


It is unknown whether secondary generation DES can offer better outcome compared to BMS in large coronary vessels .


Further study on this issue is warranted .


Informal caregivers play an important role in hospital-at-home schemes .


However they may increase their burden , especially chronic diseases , like COPD .


In the absence of clear differences in effectiveness and cost-effectiveness between hospital-at-home and usual hospital care , informal caregiver preferences play an important role .


This study investigated informal caregiver strain , satisfaction and preferences for place of treatment with a community-based hospital-at-homes scheme for COPD exacerbations .


The study was part of a larger randomised controlled trial .


By randomisation , patients were allocated to usual hospital care or hospital-at-home , which included discharge at day 4 of admission , followed by home treatment with homes visits by community nurses until day 7 of treatment .


Patients allocated to usual hospital care received care as usual in the hospital and were discharged at day 7 .


Patients were asked if they had an informal caregiver and who this was .


Patients and their caregivers were followed for 90 days .


Informal caregiver strain was assessed with the caregiver strain index .


Satisfaction and preference were assessed using questionnaires .


All measurements were performed at the end of the 7-day treatment and the end of the 90-days follow-up .


Of the 139 patients , 124 had an informal caregiver , of whom three-quarter was the patients ' spouse .


There was no significant difference in caregiver strain between hospital-at-home and usual hospital care at both time points ( mean difference at T +4 days 0.47 95 % CI -0.96 to 1.91 , p = 0.514 ; mean difference at T +90 days 0.36 95 % CI -1.85 to 1.35 , p = 0.634 ) .


At the end of the 7-day treatment , 33 % ( N = 15 ) of caregivers of patients allocated to hospital treatment and 71 % ( N = 37 ) of caregivers of patients allocated to home treatment preferred home treatment , if they could choose .


Caregivers were satisfied with the treatment the patient received within hospital-at-home .


There were no differences in caregiver strain between the community-based hospital-at-home scheme and usual hospital care .


Most caregivers were satisfied with the treatment .


In addition to other outcomes , our results support the wider implementation of hospital-at-home for COPD exacerbations .


To evaluate a new format of a summary , which presents research from synthesized evidence to patients and the public .


We conducted a randomized controlled trial in 143 members of the public from five countries ( Canada , Norway , Spain , Argentina , and Italy ) .


Participants received either a new summary format ( a plain language summary [ PLS ] ) or the current format used in Cochrane systematic reviews .


The new PLS presents information about the condition and intervention , a narrative summary of results , and a table of results with absolute numbers for effects of the intervention and quality of the evidence using Grading of Recommendations Assessment , Development , and Evaluation .


With the new PLS , more participants understood the benefits and harms and quality of evidence ( 53 % vs. 18 % , P < 0.001 ) ; more answered each of the five questions correctly ( P 0.001 for four questions ) ; and they answered more questions correctly , median 3 ( interquartile range [ IQR ] : 1-4 ) vs. 1 ( IQR : 0-1 ) , P < 0.001 ) .


Better understanding was independent of education level .


More participants found information in the new PLS reliable , easy to find , easy to understand , and presented in a way that helped make decisions .


Overall , participants preferred the new PLS .


This new PLS format for patients and the public is a promising tool to translate evidence from synthesized research .


To observe the clinical effect of Gushenyutai plaster administered at the Guanyuan ( CV 4 ) acupoint on male infertility associated with semen non-liquefaction .


Sixty-two male patients with infertility caused by semen non-liquefaction were randomized into a treatment and control group .


The control group received comprehensive therapy , which included oral administration of clarithromycin sustained release tablets , hip bath with Zhongyaoxiaoyan granules , prostate massage , and transurethral microwave treatment .


The treatment group was administered Gushenyutai plaster in addition to the comprehensive therapy .


Both groups were treated for 8 weeks .


After treatment , the clinical effect and pregnancy rate were assessed and compared between the two groups .


The effective rate of the treatment group was significantly higher than that of the control group ( 96.77 % vs 70.97 % , P < 0.05 ) and the pregnancy rates of the treatment group and control groups were 38.71 % and 16.13 % , respectively ( P < 0.05 ) .


The effect of Gushenyutai plaster plus comprehensive therapy was better than that of the comprehensive therapy alone on male infertility induced by semen non-liquefaction .


To evaluate the efficacy of sodium butyrate enemas ( NABUREN ) in prostate cancer radiation therapy ( RT ) in reducing the incidence , severity , and duration of acute RT-induced proctitis .


166 patients , randomly allocated to 1 of 4 groups ( rectal sodium butyrate 1 g , 2 g , or 4 g daily or placebo ) , were treated with NABUREN during and 2 weeks after RT. .


The grade of proctitis was registered in a daily diary .


The correlation between NABUREN and proctitis was investigated through ( 2 ) statistics .


The toxicity endpoints considered were as follows : total number of days with grade 1 proctitis ( G1 ) ; total number of days with grade 2 proctitis ( G2 ) ; G1 and G2 proctitis lasting at least 3 and 5 consecutive days starting from week 4 ( G1 +3 d , G2 +3 d ) ; damaging effects of RT on rectal mucosa as measured by endoscopy .


The relationship between endpoints and pretreatment morbidities , hormonal therapy , presence of diabetes or hypertension , abdominal surgery , or hemorrhoids was investigated by univariate analysis .


The patients were randomly allocated to the 4 arms .


No difference in the distribution of comorbidities among the arms was observed ( P > .09 ) .


The mean G1 and G2 proctitis were 7.8 and 4.9 for placebo and 8.9 and 4.7 for the NABUREN group , respectively .


No favorable trend in reduction of incidence , severity , and duration of G1 and G2 proctitis was observed with NABUREN use .


In univariate analysis , G1 +3 d toxicity was found to be related to hemorrhoids ( P = .008 ) , and a slight correlation was found between G2 proctitis and hormonal therapy ( P = .06 ) .


The RT effects on rectal mucosa as based on endoscopic assessment were mainly related to diabetes ( P < .01 ) .


Endoscopy data at 6 week showed no significant difference between the placebo and butyrate arms .


The other investigated endpoints were not correlated with any of the clinical risk factors analyzed .


There was no evidence of efficacy of NABUREN in reducing the incidence , severity , and duration of acute radiation proctitis .


There was a correlation between some endpoints and clinical risk factors .


Phenylalanine , which is an essential aromatic amino acid , is either used for protein synthesis or irreversibly hydroxylated to tyrosine .


The provision of optimal amounts of dietary phenylalanine is not only important for growth and development but might also influence catecholamine synthesis and release rates .


The current recommended aromatic amino acid requirement for infants aged 0-6 mo is based on the amino acid content of human milk .


We quantified the requirements for phenylalanine in the presence of excess tyrosine ( 166 or 177 mg/kg per day for term and preterm infants , respectively ) for term and preterm neonates by using the indicator amino acid oxidation method with l - [ 1 - ( 13 ) C ] lysine 2HCl as an indicator .


Hence , we determined the minimum obligatory phenylalanine requirement .


Fully enterally fed term and preterm infants received randomly graded amounts of phenylalanine ( 5-177 mg/kg per day ) as part of an elemental formula .


Data are expressed as means SDs .


Twenty term ( birth weight : 3.19 0.34 kg ; gestational age : 38.9 1 wk ) and 16 preterm ( birth weight : 1.75 0.17 kg ; gestational age : 32.5 0.6 wk ) Asian infants participated at a postnatal age of 17 8 d.


In total , 44 studies were performed .


The minimum obligatory phenylalanine requirement was 58 mg/kg per day ( 95 % CI : 38-78 mg/kg per day ) and 80 mg/kg per day ( 95 % CI : 40-119 mg/kg per day ) for term and preterm infants , respectively .


The determined mean phenylalanine-requirement estimates are lower than the contents of term and preterm formulas currently on the market .


This trial was registered at www.trialregister.nl as NTR1610 .


Cryptococcal meningitis ( CM ) is a severe AIDS-defining illness with 90-day case mortality as high as 70 % in sub-Saharan Africa , despite treatment .


It is the leading cause of death in HIV patients in Asia and Africa.No major advance has been made in the treatment of CM since the 1970s .


The mainstays of induction therapy are amphotericin B and flucytosine , but these are often poorly available where the disease burden is highest .


Adjunctive treatments , such as dexamethasone , have had dramatic effects on mortality in other neurologic infections , but are untested in CM .


Given the high death rates in patients receiving current optimal treatment , and the lack of new agents on the horizon , adjuvant treatments , which offer the potential to reduce mortality in CM , should be tested.The principal research question posed by this study is as follows : does adding dexamethasone to standard antifungal therapy for CM reduce mortality ?


Dexamethasone is a cheap , readily available , and practicable intervention .


A double-blind placebo-controlled trial with parallel arms in which patients are randomised to receive either dexamethasone or placebo , in addition to local standard of care .


The study recruits patients in both Asia and Africa to ensure the relevance of its results to the populations in which the disease burden is highest .


The 10-week mortality risk in the control group is expected to be between 30 % and 50 % , depending on location , and the target hazard ratio of 0.7 corresponds to absolute risk reductions in mortality from 30 % to 22 % , or from 50 % to 38 % .


Assuming an overall 10-week mortality of at least 30 % in our study population , recruitment of 824 patients will be sufficient to observe the expected number of deaths .


Allowing for some loss to follow-up , the total sample size for this study is 880 patients .


To generate robust evidence across both continents , we aim to recruit roughly similar numbers of patients from each continent .


The primary end point is 10-week mortality .


Ethical approval has been obtained from Oxford University 's Tropical Research Ethics Committee ( OxTREC ) , and as locally mandated at each site .


International Standard Randomised Controlled Trial Number : ISRCTN59144167 26-July-2012 .


To investigate whether electro-acupuncture or physical exercise influence serum anti-Mllerian hormone ( AMH ) , antral follicle count ( AFC ) or ovarian volume in women with polycystic ovary syndrome ( PCOS ) .


Secondary analyses of a prospective , randomized controlled clinical trial .


University Hospital , Sweden .


Seventy-four women with PCOS recruited from the general population .


Women with PCOS were randomized to 16 weeks of electro-acupuncture ( 14 treatments ) , exercise ( at least three times/week ) , or no intervention .


Serum AMH recorded at baseline , after 16 weeks of intervention , and at follow up at 32 weeks .


AFC , and ovarian volume assessed by magnetic resonance imaging at baseline and at follow up at 32 weeks .


After 16 weeks of intervention , serum levels of AMH were significantly decreased in the electro-acupuncture group by 17.5 % ( p < 0.001 ) , and differed from the change in the exercise group .


AMH remained decreased by 15 % ( p = 0.004 ) also at follow up at 32 weeks , but did not differ from the exercise or the no intervention groups .


There was a decrease by 8.5 % ( p = 0.015 ) in ovarian volume between baseline and follow up in the electro-acupuncture group , and by 11.7 % ( p = 0.01 ) in AFC in the physical exercise group .


No other variables were affected .


This study is the first to demonstrate that acupuncture reduces serum AMH levels and ovarian volume .


Physical exercise did not influence circulating AMH or ovarian volume .


Despite a within-group decrease in AFC , exercise did not lead to a between-group difference .


To evaluate outcomes of a registered nurse-led care management intervention for disabled Medicaid beneficiaries with high health care costs .


Washington State Department of Social and Health Services Client Outcomes Database , 2008-2011 .


In a randomized controlled trial with intent-to-treat analysis , outcomes were compared for the intervention ( n = 557 ) and control groups ( n = 563 ) .


A quasi-experimental subanalysis compared outcomes for program participants ( n = 251 ) and propensity score-matched controls ( n = 251 ) .


Administrative data were linked to describe costs and use of health services , criminal activity , homelessness , and death .


In the intent-to-treat analysis , the intervention group had higher odds of outpatient mental health service use and higher prescription drug costs than controls in the postperiod .


In the subanalysis , participants had fewer unplanned hospital admissions and lower associated costs ; higher prescription drug costs ; higher odds of long-term care service use ; higher drug/alcohol treatment costs ; and lower odds of homelessness .


We found no health care cost savings for disabled Medicaid beneficiaries randomized to intensive care management .


Among participants , care management may have the potential to increase access to needed care , slow growth in the number and therefore cost of unplanned hospitalizations , and prevent homelessness .


These findings apply to start-up care management programs targeted at high-cost , high-risk Medicaid populations .


PROGRESS randomized chronic hepatitis C genotype 1 patients with a baseline viral load 400,000 IU/mL weighing 85 kg to regimens of 180 g/week for 48 weeks or 360 g/week for 12 weeks followed by 180 g/week for 36 weeks peginterferon alfa-2a plus ribavirin .


This analysis explored pharmacokinetics and early viral kinetics ( VK ) and evaluates differences between groups .


Blood samples for pharmacokinetic and VK analyses were collected from 51 patients enrolled in the PROGRESS study .


Mean peginterferon alfa-2a trough concentration at week 12 was 11.74.3 ng/mL for 180 g and 23.411.3 ng/mL for 360 g. Early VK profiles suggested a trend towards an enhanced viral decline in the 360 g groups with a mean decrease in HCV RNA at 48 hours post first dose of 1.04 log10 ( IU/mL ) compared with 0.76 log10 ( IU/mL ) in the 180 g groups .


Mean beta slope increased with dose , ranging from 0.380.26 log10 IU/week at 180 g to 0.520.32 log10 IU/week at 360 g.


Early viral de clines may be enhanced with the 360 g dose .


These data may suggest the utility of high-dose peginterfer on alfa-2a plus direct-acting antivirals ( DAA ) in select difficult-to-treat populations .


This article reports the results of a community-based , culturally tailored diabetes prevention program for overweight Mexican American adults on weight loss , waist circumference , diet and physical activity self-efficacy , and diet behaviors .


The intervention used content from the Diabetes Prevention Program but culturally tailored the delivery methods into a community-based program for Spanish-speaking adults of Mexican descent .


The design was a randomized controlled trial ( N = 58 ) comparing the effects of a 5-month educational intervention with an attention control group .


The primary study outcome was weight loss .


Secondary outcomes included change in waist circumference , body mass index , diet self-efficacy , and physical activity self-efficacy .


There were significant intervention effects for weight , waist circumference , body mass index , and diet self-efficacy , with the intervention group doing better than the control group .


These effects did not change over time .


Findings support the conclusion that a community-based , culturally tailored intervention is effective in reducing diabetes risk factors in a 5-month program .


Salsalate treatment has been shown to improve glucose homeostasis , but the mechanism remains unclear .


The aim of this study was to evaluate the effect of salsalate treatment on insulin action , secretion , and clearance rate in nondiabetic individuals with insulin resistance .


This was a randomized ( 2:1 ) , single-blind , placebo-controlled study of salsalate ( 3.5 g daily for 4 weeks ) in nondiabetic individuals with insulin resistance .


All individuals had measurement of glucose tolerance ( 75-g oral glucose tolerance test ) , steady-state plasma glucose ( SSPG ; insulin suppression test ) , and insulin secretion and clearance rate ( graded-glucose infusion test ) before and after treatment .


Forty-one individuals were randomized to salsalate ( n = 27 ) and placebo ( n = 14 ) .


One individual from each group discontinued the study .


Salsalate improved fasting ( % mean change -7 % [ 95 % CI -10 to -14 ] vs. 1 % [ -3 to 5 ] , P = 0.005 ) but not postprandial glucose concentration compared with placebo .


Salsalate also lowered fasting triglyceride concentration ( -25 % [ -34 to -15 ] vs. -6 % [ -26 to 14 ] , P = 0.04 ) .


Salsalate had no effect on SSPG concentration or insulin secretion rate but significantly decreased insulin clearance rate compared with placebo ( -23 % [ -30 to -16 ] vs. 3 % [ -10 to 15 ] , P < 0.001 ) .


Salsalate was well tolerated , but four individuals needed a dose reduction due to symptoms .


Salsalate treatment in nondiabetic , insulin-resistant individuals improved fasting , but not postprandial , glucose and triglyceride concentration .


These improvements were associated with a decrease in insulin clearance rate without change in insulin action or insulin secretion .


Myringotomy and tympanostomy tube insertion ( MT ) is a common surgical procedure .


Although surgical simulation has proven to be an effective training tool , an anatomically sound simulation model for MT is lacking .


We developed such a model and assessed its impact on the operating room performance of senior medical students .


Prospective randomized trial .


A randomized single-blind controlled study of simulation training with the MT model versus no simulation training .


Each participant was randomized to either the simulation model group or control group , after performing an initial MT procedure .


Within two weeks of the first procedure , the students performed a second MT. All procedures were performed on real patients and rated with a Global Rating Scale by two attending otolaryngologists .


Time to complete the MT was also recorded .


Twenty-four senior medical students were enrolled .


Control and intervention groups did not differ at baseline on their Global Rating Scale score or time to complete the MT procedure .


Following simulation training , the study group received significantly higher scores ( P = .005 ) and performed the MT procedure in significantly less time ( P = .034 ) .


The control group did not improve their performance scores ( P > .05 ) or the time to complete the procedure ( P > .05 ) .


Our surgical simulation model shows promise for being a valuable teaching tool for MT for senior medical students .


Such anatomically appropriate physical simulators may benefit teaching of junior trainees .


Evidence concerning the importance of glucose lowering in the prevention of cardiovascular ( CV ) outcomes remains controversial .


Given the multi-faceted pathogenesis of atherosclerosis in diabetes , it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone .


The SGLT-2 inhibitor empagliflozin improves glucose control , body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes .


The aim of the ongoing EMPA-REG OUTCOME trial is to determine the long-term CV safety of empagliflozin , as well as investigating potential benefits on macro - / microvascular outcomes .


Patients who were drug-nave ( HbA1c 7.0 % and 9.0 % ) , or on background glucose-lowering therapy ( HbA1c 7.0 % and 10.0 % ) , and were at high risk of CV events , were randomized ( 1:1:1 ) and treated with empagliflozin 10 mg , empagliflozin 25 mg , or placebo ( double blind , double dummy ) superimposed upon the standard of care .


The primary outcome is time to first occurrence of CV death , non-fatal myocardial infarction , or non-fatal stroke .


CV events will be prospectively adjudicated by an independent Clinical Events Committee .


The trial will continue until 691 confirmed primary outcome events have occurred , providing a power of 90 % to yield an upper limit of the adjusted 95 % CI for a hazard ratio of < 1.3 with a one-sided of 0.025 , assuming equal risks between placebo and empagliflozin ( both doses pooled ) .


Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes ( time to first occurrence of CV death , non-fatal myocardial infarction , non-fatal stroke or hospitalization for unstable angina pectoris ) where non-inferiority is achieved .


Between Sept 2010 and April 2013 , 592 clinical sites randomized and treated 7034 patients ( 41 % from Europe , 20 % from North America , and 19 % from Asia ) .


At baseline , the mean age was 639 years , BMI 30.65.3 kg/m2 , HbA1c 8.10.8 % , and eGFR 7421 ml/min/1 .73 m2 .


The study is expected to report in 2015 .


EMPA-REG OUTCOME will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk , with the potential to show cardioprotection .


Clinicaltrials.gov NCT01131676 .


The clinical effects of osteoporosis include pain , fractures , and physical disability , causing a loss of independence and necessitating long-term care .


Whereas the effects of exercise therapy in decreasing body mass index and preventing fractures are well established , there is no consensus on back pain and quality of life in women with osteoporosis .


The aim of this study was to determine the efficacy of a brief course of rehabilitation , comprising group-adapted physical exercises , with regard to back pain , disability , and quality of life in women with postmenopausal osteoporosis who had no evidence of fractures .


The enrolled patients were randomized into two groups : the treatment group underwent ten sessions of rehabilitative exercises , and the control group received an instructional booklet with descriptions and figures of exercises that were to be performed at home .


Sixty patients completed the trial and assessments , including a 6-month follow-up .


The treatment was effective versus the control group , significantly improving pain ( Visual Analogue Scale : p < 0.001 at the end of the treatment and at the follow-up ; McGill Pain Questionnaire : p = 0.018 at the follow-up ) , disability ( Oswestry Disability Questionnaire : p < 0.001 at the end and follow-up ) , and quality of life ( Shortened Osteoporosis Quality of Life Questionnaire : p = 0.021 at the end of treatment ; p = 0.005 at follow-up ) .


Our results suggest that group rehabilitation reduces back pain and improves functional status and quality of life in women with postmenopausal osteoporosis , maintaining these outcomes for 6 months .


The use of physical exercises might strengthen the habit to training .


To assess the role that treatment response plays in a randomized controlled trial of an antidepressant among people with spinal cord injury ( SCI ) diagnosed with major depressive disorder ( MDD ) in explaining quality of life ( QOL ) , assessed both globally as life satisfaction and in terms of physical and mental health-related QOL .


Multivariable analyses were conducted , controlling for demographic , neurologic , and participatory factors and perceived functional limitations .


Rehabilitation centers .


Of the 133 persons who were randomized into the Project to Improve Symptoms and Mood after Spinal Cord Injury randomized controlled trial , 124 participated in this study .


All participants were between the ages of 18 and 64 years , at least 1 month post-SCI , met the Diagnostic and Statistical Manual of Mental Disorders , 4th edition , criteria for MDD , and completed the core measures used in this study .


Not applicable .


The Satisfaction with Life Scale and the physical and mental component summary scores of the Medical Outcomes Study 12-Item Short-Form Health Survey .


Reduction in depressive symptoms over the course of a 12-week trial was predictive of increased QOL , which was measured as life satisfaction and mental well-being , within the context of other explanatory factors .


However , reduction in symptoms did not explain differences in physical well-being among those with MDD .


Perceived functional disability explained all 3 indices of QOL .


Greater recognition has been given to QOL outcomes as endpoints of clinical trials because these often reflect participants ' reported outcomes .


Our findings support the association of QOL to the reduction of depression symptoms among trial participants .


This association differs depending on how QOL is defined and measured , with stronger relations observed with life satisfaction and mental well-being among those diagnosed with MDD .


The lack of association between depression and physical well-being may be explained by participants ' subjective interpretation of physical well-being after SCI and their expectations and perceptions of improved physical health-related QOL based on the use of assistive technology .


Consistent with our findings , pain is likely to play a role in decreasing physical QOL among those with incomplete injuries .


Practicing caution is suggested in using physical well-being as an endpoint in trials among people with SCI .


This randomized , double-blind , placebo-controlled trial evaluated intraperitoneal ( IP ) lidocaine administration and intravenous ( IV ) lidocaine infusion for postoperative pain control after laparoscopic cholecystectomy ( LC ) .


Patients who underwent LC were randomized to either group IV ( intravenous lidocaine infusion ) , group IP ( intraperitoneal lidocaine administration ) , or group C ( control , IP and IV saline ) .


Outcome measures were total postoperative pain severity ( TPPS ) , total fentanyl consumption ( TFC ) , frequency of administering patient-controlled analgesia ( FPB ) , and a pain control satisfaction score ( PCSS ) .


Significantly reduced TPPS , TFC and FPB scores were observed in groups IP ( n = 22 ) and IV ( n = 26 ) compared with controls ( n = 24 ) .


PCSS was higher in groups IP and IV than in controls .


At 2 h postoperation , TPPS was significantly lower in group IP than group IV ; at 0-2 h postoperation , FPB was lower in group IP than group IV .


The IP administration of lidocaine and IV lidocaine infusion significantly reduced postoperative pain and opioid consumption in LC patients , compared with control infusions .


For convenience , IV lidocaine could be used for pain reduction following LC ; IP administration places additional burden on the surgeon .


Many countries have over the last few years incorporated mental health assertive interventions in an attempt to address the repercussions of deinstitutionalization .


Recent publications have failed to duplicate the positive outcomes reported initially which has cast doubt on the future of these interventions .


We previously reported on 29 patients from a developing country who completed 12 months in an assertive intervention which was a modified version of the international assertive community treatment model .


We demonstrated reduction in readmission rates as well as improvements in social functioning compared to patients from the control group .


The obvious question was , however , if these outcomes could be sustained for longer periods of time .


This study aims to determine if modified assertive interventions in an under-resourced setting can successfully maintain reductions in hospitalizations .


Patients suffering from schizophrenia who met a modified version of Weidens ' high frequency criteria were randomized into two groups .


One group received a modified assertive intervention based on the international assertive community treatment model .


The other group received standard care according to the model of service delivery in this region .


Data was collected after 36 months , comparing readmissions and days spent in hospital .


The results demonstrated significant differences between the groups .


Patients in the intervention group had significantly less readmissions ( p = 0.007 ) and spent less days in hospital compared to the patients in the control group ( p = 0.013 ) .


Modified assertive interventions may be successful in reducing readmissions and days spent in hospital in developing countries where standard care services are less comprehensive .


These interventions can be tailored in such a way to meet service needs and still remain affordable and feasible within the context of an under-resourced setting .


Bupivacaine is a first choice for regional anesthesia considering its effectiveness , long duration and less motor blockade .


Bupivacaine ( S75-R25 ) is a mixture of optical isomers containing 75 % levobupivacaine ( S - ) and 25 % dextrobupivacaine ( R + ) created by a Brazilian pharmaceutical company .


This investigation compared cardiac safety and efficacy of bupivacaine S75-R25 with vasoconstrictor and ropivacaine for brachial plexus blockade .


Patients were randomized to receive brachial plexus anesthesia with either bupivacaine S75-R25 with epinephrine 1:200,000 ( bupi ) or ropivacaine ( ropi ) , both at 0.50 % , in 30 mL solution .


We registered a continuous Holter ECG throughout the procedure , as well as the Lovett scale of force in addition to monitoring ( heart rate , pulse oximetry and non-invasive blood pressure ) .


The incidence of adverse events was compared with the chi-square or Fisher test .


We allocated forty-four patients into two groups .


They did not show any difference related to age , weight or height , gender , as well as for surgical duration .


Supraventricular arrhythmias were not different before or after the plexus blockade , independent of the local anesthetic chosen .


Loss of sensitivity was faster for the bupivacaine group ( 23.1 11.7 min ) compared to the ropivacaine one ( 26.8 11.5 min ) , though not significant ( p = 0.205 , Student t ) .


There was a reduction in the cardiac rate , observed during the twenty-four-hour Holter monitoring .


This study showed similar efficacy between bupivacaine S75-R25 for brachial plexus blockade and ropivacaine , with similar incidences of supraventricular arrhythmias .


The purpose of this study was to compare breastfeeding duration in mothers after delivery who were assigned randomly to a behavioral educational intervention vs enhanced usual care .


We conducted a randomized trial .


Self-identified black and Latina mothers early after delivery were assigned randomly to receive a behavioral educational intervention or enhanced usual care .


The 2-step intervention aimed to prepare and educate mothers about postpartum symptoms and experiences ( including tips on breastfeeding and breast/nipple pain ) and to bolster social support and self-management skills .


Enhanced usual care participants received a list of community resources and received a 2-week control call .


Intention-to-treat analyses examined breastfeeding duration ( measured in weeks ) for up to 6 months of observation .


This study was registered with clinicaltrial.gov ( NCT01312883 ) .


Five hundred forty mothers were assigned randomly to the intervention ( n = 270 ) vs control subjects ( n = 270 ) .


Mean age was 28 years ( range , 18-46 years ) ; 62 % of the women were Latina , and 38 % were black .


Baseline sociodemographic , clinical , psychosocial , and breastfeeding characteristics were similar among intervention vs control subjects .


Mothers in the intervention arm breastfed for a longer duration than did the control subjects ( median , 12.0 vs 6.5 weeks , respectively ; P = .02 ) Mothers in the intervention arm were less likely to quit breastfeeding over the first 6 months after delivery ( hazard ratio , 0.79 ; 95 % confidence interval , 0.65-0 .97 ) .


A behavioral educational intervention increased breastfeeding duration among low-income , self-identified black and Latina mothers during the 6-month postpartum period .


Providing adequate nutritional support to promote optimal postnatal growth for very low birth weight ( VLBW ) infants has been a difficult problem to surmount in the NICU .


During the past 4 decades , improvements in neonatal critical care have made it possible for more VLBW infants to survive to discharge from NICUs .


The NICHD Neonatal Network reported that while intrauterine growth restriction was present in 22 % of VLBW infants at birth , 91 % demonstrated postnatal growth restriction by 36 weeks post menstrual age .


The persistence of this nearly universal growth deficit is associated with the inadequacy of protein and energy intake , which may account for 45-50 % of the postnatal growth restriction .


The purpose of this study was to assess whether increasing enteral intake , using supplemental protein , would improve postnatal growth for VLBW infants .


Randomized clinical trial .


Sixty-four infants were enrolled ( 34 in control group with 15 infants < 1000 g , and 30 in intervention group with 13 infants < 1000 g ) .


There were no sustained statistical differences between weekly measurements of weight , length , head circumference , and skinfold thickness between groups .


There were no significant differences between laboratory results except blood urea nitrogen at time of peak protein intake for intervention group .


Supplemental enteral protein had minimal to no effect on postnatal weight , length , head circumference , body mass , or length of stay .


It may be most important to provide consistent sustained nutritional support with protein from birth to reduce postnatal growth restriction , especially for those infants < 1000 g at birth .


Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue .


Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access .


The randomized multicentre MATRIX ( Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX ) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site ( transfemoral vs. transradial ) and to the anticoagulant therapy ( bivalirudin vs. heparin ) .


Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access .


For each access we evaluate the radiation dose absorbed at wrist , at thorax and at eye level .


Consequently the operator is equipped with three sets ( transfemoral , right transradial or left transradial access ) of three different dosimeters ( wrist , thorax and eye dosimeter ) .


Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax .


An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach .


Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach .


A further randomization for the radial approach is performed to compare right and left transradial access .


The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes .


Gastroesophageal reflux ( GER ) is a frequently occurring condition in infants capable of causing distressing symptoms .


The aim of our study is to evaluate the efficacy of Mg alginate plus simethicone ( Gastrotuss Baby , DMG Italia SRL , Pomezia , Italy ) , compared with rice-starch-thickened formula or with reassurance alone , in the treatment of GER in infants .


The present randomized controlled trial was conducted in full-term infants affected by symptoms suggestive of GER , evaluated through a validated questionnaire ( Infant Gastroesophageal Reflux Questionnaire Revised ) .


The patients were randomized into 3 groups according to treatment ( group A : Mg alginate plus simethicone ; group B : thickened formula ; group C : reassurance with lifestyle changes ) .


Evaluation of symptom scores was performed after 1 month ( T1 ) and 2 months ( T2 ) .


A total of 64 ( 85.3 % ) of 75 enrolled infants ( median age 5 months ; range 1-10 ) concluded the study .


After 1 month of treatment ( T1 ) , infants treated with Mg alginate plus simethicone showed a statistically significant improvement in symptoms compared with the thickened formula and reassurance ( P < 0.03 , < 0.0001 , respectively ) .


At the end of the study , all 3 groups of patients showed a significant reduction in symptom scores ( P < 0.002 , < 0.038 , < 0.03 , respectively ) .


Median symptom score values were more significantly reduced in group A than in group B and in group C ( group A vs group B P < 0.002 ; group A vs group C P < 0.0001 ; group B vs group C P < 0.001 ) .


Mg alginate plus simethicone seems to be more efficacious on GER symptom scores than thickened formula and reassurance with lifestyle changes alone .


To evaluate the safety and effectiveness of the Trulign toric intraocular lens ( IOL ) in adults with cataract .


Eight private practices in the United States and 1 in Canada .


Prospective randomized single-masked multicenter study .


A toric IOL ( 1.25 D , 2.00 D , or 2.75 D , determined by a toric calculator ) was implanted in eligible patients with age-related cataract requiring a 16.00 to 27.00 diopter ( D ) spherical IOL power and with a predicted postoperative astigmatism of 0.83 to 2.50 D. Eyes within the lowest cylinder range ( predicted postoperative astigmatism 0.83 to 1.32 D ) were randomized in a 1:1 ratio between the 1.25 D toric IOL group and the nontoric accommodating IOL ( Crystalens ) control group .


The toric 1.25 D group had a statistically significantly greater percentage reduction in absolute cylinder ( P < .001 ) and uncorrected distance visual acuity ( P = .002 ) than the control group at the 120 - to 180-day visit .


The mean monocular uncorrected vision at distance , intermediate , and near was 20/25 , 20/22 , and 20/39 , respectively , with the 1.25 D , 2.00 D , and 2.75 D toric IOLs in aggregate ( toric group ) .


In addition , 96.1 % of patients ( 123/128 ) had 5.0 degrees or less absolute IOL rotation postoperatively .


Regarding safety , the endpoints for preservation of corrected visual acuity and the incidence of complications and adverse events were met .


The toric IOL was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision .


Dr. Pepose is a consultant to Bausch & Lomb and was medical monitor of this study .


Drs. Buckhurst , Whitman , Feinerman , Hovanesian , Davies , Labor , and Carter are consultants to Bausch & Lomb .


At the time of the study , Drs. Hayashida , and Khodai were employees of Bausch & Lomb .


Drs. Colvard and Mittleman have financial or proprietary interest in any material or method mentioned .


The purpose of this study was to investigate the effect of low-level laser therapy ( LLLT ) before and after exercise on quadriceps muscle performance , and to evaluate the changes in serum lactate and creatine kinase ( CK ) levels .


The study was randomized , double blind , and placebo controlled .


A sample of 27 healthy volunteers ( male soccer players ) were divided into three groups : placebo , pre-fatigue laser , and post-fatigue laser .


The experiment was performed in two sessions , with a 1 week interval between them .


Subjects performed two sessions of stretching followed by blood collection ( measurement of lactate and CK ) at baseline and after fatigue of the quadriceps by leg extension .


LLLT was applied to the femoral quadriceps muscle using an infrared laser device ( 830 nm ) , 0.0028 cm ( 2 ) beam area , six 60 mW diodes , energy of 0.6 J per diode ( total energy to each limb 25.2 J ( 50.4 J total ) , energy density 214.28 J/cm ( 2 ) , 21.42 W/cm ( 2 ) power density , 70 sec per leg .


We measured the time to fatigue and number and maximum load ( RM ) of repetitions tolerated .


Number of repetitions and time until fatigue were primary outcomes , secondary outcomes included serum lactate levels ( measured before and 5 , 10 , and 15 min after exercise ) , and CK levels ( measured before and 5 min after exercise ) .


The number of repetitions ( p = 0.8965 ) , RM ( p = 0.9915 ) , and duration of fatigue ( p = 0.8424 ) were similar among the groups .


Post-fatigue laser treatment significantly decreased the serum lactate concentration relative to placebo treatment ( p < 0.01 ) and also within the group over time ( after 5 min vs. after 10 and 15 min , p < 0.05 both ) .


The CK level was lower in the post-fatigue laser group ( p < 0.01 ) .


Laser application either before or after fatigue reduced the post-fatigue concentrations of serum lactate and CK .


The results were more pronounced in the post-fatigue laser group .


Liver injury is a serious adverse event leading to permanent discontinuation of lapatinib in affected patients .


This study aimed to validate previously associated major histocompatibility complex ( MHC ) variants as predictors of risk of liver injury by using a large , randomized , placebo-controlled trial of lapatinib in human epidermal growth factor receptor 2-positive , early-stage breast cancer ( Tykerb Evaluation After Chemotherapy [ TEACH ] : Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer ) .


The frequency of ALT elevation cases was compared among four MHC variants in 1,194 patients randomly assigned to lapatinib .


Cumulative ALT elevation time courses during treatment were also compared between carriers and noncarriers of specified MHC variants .


In lapatinib-treated patients , there was a significant difference in ALT case incidence between HLA carriers and noncarriers .


The highly correlated alleles HLA-DRB1 * 07:01 and HLA-DQA1 * 02:01 ( study frequency , 22.4 % ) were associated with ALT elevation ( odds ratio , 14 ) between cases ( n = 37 ) and controls ( n = 1,071 ) .


These associations strengthened at higher ALT elevation thresholds and in Hy 's Law cases .


In lapatinib-treated patients , the overall risk for National Cancer Institute-Common Terminology Criteria for Adverse Events grade 3 ALT elevation ( > 5 upper limit of normal ) was 2.1 % ; HLA allele carriers had an increased risk of 7.7 % ; in noncarriers , risk was reduced to 0.5 % , comparable to ALT elevation for all patients receiving placebo .


The increase in ALT case incidence in the lapatinib arm showed no evidence of plateau during 1 year of lapatinib treatment .


These results validate HLA-DRB1 * 07:01 allele carriage as a predictor of increased risk of lapatinib-induced liver injury and implicate an immune pathology .


The HLA association could support clinical management of patients experiencing hepatotoxicity during lapatinib treatment .


To explore the safety and efficacy of PRT-201 applied to the outflow vein of a newly created arteriovenous graft ( AVG ) .


Randomized , double-blind , placebo-controlled , single-dose escalation study of PRT-201 ( 0.01 to 9 mg ) applied to the graft-vein anastomosis and adjacent outflow vein immediately after AVG placement .


The primary outcome measure was safety .


The efficacy measures were intraoperative increases in outflow vein diameter and blood flow rate , primary unassisted patency , and secondary patency by dose groups ( placebo , low , medium , high and All PRT-201 ) .


A total of 89 patients were treated ( 28 placebo and 61 PRT-201 ) .


There were no significant differences in the proportion of placebo and PRT-201 patients reporting adverse events .


Intraoperative outflow vein diameter increased 5 % ( p = 0.14 ) in the placebo group compared with 13 % ( p = 0.01 ) , 15 % ( p = 0.07 ) and 12 % ( p < 0.001 ) , in the low , medium and high groups , respectively .


The comparison between the high and placebo groups was marginally statistically significant ( p = 0.06 ) .


The intraoperative blood flow did not change in the placebo group , and increased in the low , medium and high groups by 19 % ( p = 0.34 ) , 36 % ( p = 0.09 ) and 46 % ( p = 0.02 ) , respectively .


The low group had the longest primary unassisted and secondary patency and the fewest procedures to restore or maintain patency ; however , the differences between groups were not statistically significant .


PRT-201 was well tolerated and increased AVG intraoperative outflow vein diameter and blood flow .


Low dose tended to increase secondary patency and decrease the rate of procedures to restore or maintain patency .


Larger studies with these doses will be necessary to confirm these results .


The blood glucose target range and optimal method to reach this range remain a matter of debate in the intensive care unit ( ICU ) .


A computer decision support system ( CDSS ) might improve the outcome of ICU patients through facilitation of a tighter blood glucose control .


We conducted a multi-center randomized trial in 34 French ICU .


Adult patients expected to require treatment in the ICU for at least 3 days were randomly assigned without blinding to undergo tight computerized glucose control with the CDSS ( TGC ) or conventional glucose control ( CGC ) , with blood glucose targets of 4.4-6 .1 and < 10.0 mmol/L , respectively .


The primary outcome was all-cause death within 90 days after ICU admission .


Of the 2,684 patients who underwent randomization to the TGC and CGC treatment groups , primary outcome was available for 1,335 and 1,311 patients , respectively .


The baseline characteristics of these treatment groups were similar in terms of age ( 61 16 years ) , SAPS II ( 51 19 ) , percentage of surgical admissions ( 40.0 % ) and proportion of diabetic patients ( 20.3 % ) .


A total of 431 ( 32.3 % ) patients in the TGC group and 447 ( 34.1 % ) in the CGC group had died by day 90 ( odds ratio for death in the TGC 0.92 ; 95 % confidence interval 0.78-1 .78 ; p = 0.32 ) .


Severe hypoglycemia ( < 2.2 mmol/L ) occurred in 174 of 1,317 patients ( 13.2 % ) in the TGC group and 79 of 1,284 patients ( 6.2 % ) in the CGC group ( p < 0.001 ) .


Tight computerized glucose control with the CDSS did not significantly change 90-day mortality and was associated with more frequent severe hypoglycemia episodes in comparison with conventional glucose control .


We evaluated the effect of ginkgo biloba extract on visual field defect and contrast sensitivity in a Chinese cohort with normal tension glaucoma .


In this prospective , randomized , placebo-controlled crossover study , patients newly diagnosed with normal tension glaucoma , either in a tertiary glaucoma clinic ( n = 5 ) or in a cohort undergoing routine general physical examinations in a primary care clinic ( n = 30 ) , underwent two 4-week phases of treatment , separated by a washout period of 8 weeks .


Randomization determined whether ginkgo biloba extract ( 40 mg , 3 times per day ) or placebo ( identical-appearing tablets ) was received first .


Primary outcomes were change in contrast sensitivity and mean deviation on 24-2 SITA standard visual field testing , while secondary outcomes included IOP and self-reported adverse events .


A total of 35 patients with mean age 63.7 ( 6.5 ) years were randomized to the ginkgo biloba extract-placebo ( n = 18 ) or the placebo-ginkgo biloba extract ( n = 17 ) sequence .


A total of 28 patients ( 80.0 % , 14 in each group ) who completed testing did not differ at baseline in age , sex , visual field mean deviation , contrast sensitivity , IOP , or blood pressure .


Changes in visual field and contrast sensitivity did not differ by treatment received or sequence ( P > 0.2 for all ) .


Power to have detected a difference in mean defect as large as previously reported was 80 % .


In contrast to some previous reports , ginkgo biloba extract treatment had no effect on mean defect or contrast sensitivity in this group of normal tension glaucoma patients .


( http://www.chictr.org number , ChiCTR-TRC-08000724 ) .


In vivo studies showing the effects of biologic healing-promoting factors on tendon-to-bone healing after rotator cuff repair have focused only on biologic healing-promoting factors and have not taken into consideration the effect of the carrier vehicle .


Moreover , most studies have evaluated the healing process using different carrier vehicles , each of which may have specific effects on tendon healing .


This may explain the large variability seen in outcomes in research studies .


In this study , we investigated the effects of Poloxamer 407 as a carrier vehicle on rotator cuff healing at the repair site and compared it with those of a collagen sponge , which is a commonly used carrier vehicle .


Fifty-seven adult male Sprague-Dawley rats underwent detachment and immediate repair of the bilateral supraspinatus tendons .


Rats were randomly assigned to three groups : repair only , repair with collagen sponge , and repair with Poloxamer 407 .


The repairs were evaluated at 1 , 2 , 4 , and 8 weeks after surgery with histological analysis and biomechanical testing .


At 4 weeks , more cellular organization , a greater number of collagen fibers , and increased maturity of collagen fibers were observed in the repair with Poloxamer 407 group than in the other groups .


The repair with collagen sponge group had delayed development and collagen fiber maturation .


Significant differences in the biomechanical properties were found between groups at 4 weeks .


Stiffness in the case of the repair with Poloxamer 407 group was significantly higher than that in the repair with collagen sponge group .


The modulus was significantly lower in the repair with collagen sponge group than in the repair only group .


However , the use of Poloxamer 407 versus the collagen sponge did not significantly affect the biomechanical properties of the repaired tendons at 8 weeks .


Carrier vehicles may have differing effects at the early stages of rotator cuff healing .


The use of Poloxamer 407 as a carrier vehicle may be useful for promoting the early stages of healing and for maintaining the initial biomechanical properties of the repaired rotator cuff tendon .


Low vitamin D serum levels have been associated with unfavourable lipid profile and poorer response to atorvastatin .


Aims of this study were to test the effects of 25-hydroxyvitamin D3 ( calcifediol ) compared to parental vitamin D3 ( cholecalciferol ) supplementation on modifications of plasma 25 ( OH ) D levels and lipid profile .


Fifty-seven postmenopausal women ( aged 59.03 6.73 years ) who were at low risk of fracture and with basal plasma 25 ( OH ) D < 30 ng/mL were included if they were on atorvastatin treatment prescribed as appropriate .


Recruited women were randomized to receive oral calcifediol or cholecalciferol , both at a dose of 140 g according to a weekly regimen .


At baseline , 25 ( OH ) D was negatively associated with BMI ( r = -0.37 ; P = 0.004 ) , total cholesterol ( r = -0.31 ; P = 0.01 ) and LDL-C ( r = -0.32 ; P = 0.02 ) .


After 24 weeks , 25 ( OH ) D increased significantly in both groups ( P < 0.001 ) , although higher levels were obtained with calcifediol as compared with cholecalciferol ( P < 0.001 ) .


Only in the calcifediol group , a significant reduction of LDL-C ( P = 0.01 ) and an increase of HDL-C ( P = 0.02 ) were obtained , even after adjustment for age , and baseline BMI , 25 ( OH ) D and lipid levels ( P < 0.05 ) .


The percentage changes in 25 ( OH ) D levels were associated with the variations of LDL-C ( r = -0.44 ; P = 0.01 ) and HDL-C levels ( r = 0.30 ; P = 0.10 ) .


Calcifediol administration in osteopenic and dyslipidemic postmenopausal women with low 25 ( OH ) D improves lipid profile when added to an ongoing atorvastatin treatment .


It is believed that gastric pH interferes in levothyroxine absorption .


Omeprazole , which acts by blocking the secretion of gastric acid , might interfere in hypothyroidism control in patients using levothyroxine and this effect could be dose dependent .


The present study aimed to investigate this possibility .


Twenty-one patients with primary hypothyroidism who had been using a stabilized levothyroxine dosage for at least one year were selected and randomly assigned to take omeprazole at the dosage of 40 mg or 20 mg per day .


The mean levels of thyroid-stimulating hormone ( TSH ) before and 3 months after omeprazole usage were compared in the entire sample and in each group .


Ten patients concluded the entire treatment protocol in the 20 mg group and nine patients in the 40 mg group .


There was no significant difference in TSH levels before and 3 months after omeprazole treatment in the entire patient sample ( median levels : 2.28 vs. 2.30 mU/L , respectively : p = 0.56 ) .


Analysis of each subgroup ( 20 and 40 mg ) showed no significant variation in TSH levels before and 3 months after omeprazole treatment ( median levels : 2.24 vs. 2.42 mU/L , p = 0.62 , and 2.28 vs. 2.30 mU/L , p = 0.82 , respectively ) .


No significant difference in the absolute ( p = 0.93 ) or relative ( p = 0.87 ) delta were observed between the two subgroups .


Omeprazole in the dosage of 20 or 40 mg/day does not interfere in a clinically relevant manner in the treatment of patients with hypothyroidism that was previously under control .


To compare the 6-month results of accelerated and standard collagen crosslinking ( CXL ) treatment of progressive keratoconus .


Noor Eye Hospital , Tehran , Iran .


Prospective randomized clinical trial .


Two groups of eyes ( intervention and control ) received corneal collagen crosslinking ( CXL ) treatment .


The intervention group received accelerated CXL ( 18 mW/cm ( 2 ) , 5 minutes ) , and the control group received standard CXL ( 3 mW/cm ( 2 ) , 30 minutes ) .


The eyes were evaluated for changes in the visual indices , refraction , and topography preoperatively and 1 , 3 , and 6 months postoperatively and regarding corneal rigidity indices and the endothelial cell count ( ECC ) preoperatively and at 6 months .


The study evaluated 62 eyes ( 31 patient ) in 2 groups .


The mean changes in uncorrected ( P = .733 ) and corrected ( P = .646 ) distance visual acuities and manifest refraction spherical equivalent ( P = .598 ) did not differ statistically significantly between the 2 groups .


The central corneal thickness was higher in the standard group than the accelerated group ( P = .025 ) .


The mean decrease in the maximum keratometry ( K ) ( P = .865 ) and mean K ( P = .974 ) and the mean changes in the asphericity ( P = .272 ) were not statistically significantly different between the 2 groups .


The mean changes in corneal hysteresis ( CH ) ( P = .548 ) and the corneal resistance factor ( CRF ) ( P = 1.000 ) , CH-CRF ( P = .282 ) , and the area under the peak 2 ( P = .260 ) were similar in both groups .


The mean decrease in the ECC was not statistically significantly different between the 2 groups ( P = .218 ) .


Based on 6-month results , accelerated and standard corneal CXL arrested the progression of keratoconus similarly .


No author has a financial or proprietary interest in any material or method mentioned .


Assess the efficacy and safety of etoricoxib 120mg compared with ibuprofen 600mg qid in the treatment of moderate to severe primary dysmenorrhea in Chinese women .


This multicenter , double-blind , two-period , cross-over study randomized healthy , Chinese women 18 years of age to etoricoxib 120mg qd or ibuprofen up to 2400mg ( 600mg qid ) upon onset of moderate or severe primary dysmenorrhea symptoms during two menstrual cycles .


The primary efficacy endpoint was Total Pain Relief score over the first 6 hours ( TOPAR6 ) .


Secondary endpoints included Sum of Pain Intensity Difference scores over the first 6 hours ( SPID6 ) and Patient 's Global Evaluation ( GLOBAL ) of pain at 6 and 24 hours post initial dose .


The primary hypothesis was that etoricoxib would be non-inferior to ibuprofen .


Adverse experiences ( AE ) were monitored and evaluated .


A total of 139 patients were included in this study .


Difference in least squares ( LS ) mean ( 95 % CI ) TOPAR6 score for etoricoxib vs. ibuprofen was 0.89 ( 0.03 , 1.76 ) ( p = 0.043 ) .


LS mean ( 95 % CI ) difference for etoricoxib vs. ibuprofen SPID6 , GLOBAL6 , and GLOBAL24 were 0.20 ( -1.16 , 1.57 ) ( p = 0.768 ) , 0.26 ( 0.07 , 0.45 ) ( p = 0.007 ) , and 0.36 ( 0.17 , 0.54 ) ( p < 0.001 ) , respectively .


AEs were rare , with the following AEs determined to be drug-related : hypomenorrhea ( two patients on etoricoxib ) and allergic dermatitis ( one patient on ibuprofen ) .


Limitations of the study design include a sample size that is not adequate for evaluation of rare adverse effects , an evaluation period that was limited to 24 hours , and inconsistent frequency of active treatment doses between etoricoxib ( once daily ) and ibuprofen ( up to four times daily ) .


The primary objective of the study was met , demonstrating that etoricoxib 120mg qd was non-inferior to ibuprofen 600mg qid ; further , etoricoxib was statistically superior to ibuprofen 600mg qid according to the primary endpoint ( TOPAR6 ) and patient global assessments of study medication .


Etoricoxib and ibuprofen were generally well tolerated .


The purpose of the study is to evaluate the effects of creatine supplementation on homocysteine ( Hcy ) plasma levels after acute exercise in humans .


Twenty-three young ( under-20 ) soccer players were divided into 2 groups : creatine ( Cr ) - and placebo ( Pla ) - supplemented groups .


The supplementation was performed in double-blind controlled manner using creatine or placebo tablets with 0.3 g/kg during 7 days .


Before and after 7 days of supplementation , the athletes performed an acute high-intensity sprint exercise ( two consecutive running-based anaerobic sprint test protocol consisted in 6 35 m sprint with 10 s between them ) .


Blood samples were collected before and after 7 days of supplementation as well as 0 and 1 h after exercise protocol .


Homocysteine concentration significant increased ( P < 0.05 ) 1 h after acute exercise ( 18 % ) .


Acute exercise also decreased red blood cell S-adenosylmethionine ( SAM ) 30 % with no changes in SAM/SAH ratio .


Seven days of creatine supplementation were able to increase ( P < 0.05 ) plasma creatine concentration ( Pla 130.1 21.7 vs Cr 1,557.2 220.3 mol/L ) as well as decrease ( P < 0.05 ) plasma guanidinoacetic acid ( 33 % ) .


Controversially , creatine supplementation did not change Hcy plasma level after 7-day supplementation ( Pla 6.9 0.2 vs Cr 7.2 0.2 mol/L ) or after acute exercise ( Pla 8.2 0.3 vs Cr 8.4 0.3 mol/L ) .


No changes in plasma vitamin B12 and folate as well as cysteine and methionine were found .


Seven days of creatine supplementation does not avoid increased plasma Hcy induced by acute sprint exercise in humans .


To evaluate the clinical efficacy of asthma at acute attack stage treated with `` Shao 's five needling therapy '' .


The randomized controlled method was applied to divide 210 cases into an observation group and a control group , 105 cases in each one .


In the observation group , `` Shao 's five needling therapy '' [ Feishu ( BL 13 ) , Dazhui ( GV 14 ) , Fengmen ( BL 12 ) ] and the combined therapy were adopted , including oxygen uptake , aerosol inhalation and oral administration of prednisone .


In the control group , the oral administration of theophylline sustained release tablet and the combined therapy were applied .


The treatment was continued for 7 days .


The clinical symptoms and physical signs such as wheezing , cough , expectoration , chest stuffiness , wheezing rale and shortness of breath , as well as lung function indices such as forced expiratory volume one second ( FEV1 ) and peak expiratory flow ( PEF ) were observed before and after treatment in the two groups .


In the observation group , 69 cases were cured clinically , 20 cases effective remarkably , 7 cases effective and 0 case failed .


In the control group , 49 cases were cured clinically , 31 cases effective remarkably , 15 cases effective and 0 case failed .


The difference in the efficacy was significant in comparison of the two groups ( P < 0.05 ) .


The therapeutic effect in the observation group was better than that in the control group .


The total score of the symptoms and physical signs , FEV1 and PEF after treatment were all improved significantly in the two groups ( all P < 0.01 ) .


And the results in the observation group were better than those in the control group ( all P < 0.01 ) .


`` Shao 's five needling therapy '' achieves the significant efficacy on asthma at acute attack stage .


It significantly relieves the symptoms and physical signs of the patients and improves lung functions .


The effect is better than that of theophylline sustained release tablet .


In a double-blind , randomized , placebo-controlled birth cohort , we have recently shown a beneficial effect of Lactobacillus rhamnosus HN001 ( HN001 ) for the prevention of eczema in children through to 6years of age but no effect of Bifidobacterium animalis subsp lactis HN019 ( HN019 ) .


Among this cohort of children , we aim to investigate whether these probiotics could modify the expression of genetic predisposition to eczema conferred by genetic variation in susceptibility genes .


Thirty-three eczema susceptibility SNPs ( in eleven genes ) were genotyped in 331 children of European ancestry .


Children who carried a genetic variant that put them at a high risk of developing eczema were less likely to develop eczema if they had been randomized to the HN001 intervention group compared to those in the placebo group .


HN019 was also able to protect against the effects of some SNPs .


As well as modifying genetic susceptibility to childhood eczema , HN001 was also found to modify genetic susceptibility to eczema severity and atopy risk .


This is the first study to show an effect of a probiotic on reducing eczema risk amongst those with particular eczema-associated genotypes .


Our findings suggest that Lactobacillus rhamnosus HN001 may be particularly effective in preventing eczema in children with specific high-risk genotypes .


The aim of this cadaveric study was to compare a polyaxial ( NCB , Zimmer ) to a fixed-angle monoaxial locking plate ( PERILOC , Smith & Nephew ) in comminuted fractures of the distal femur regarding stability of the construct .


Up to date there is no published biomechanical data concerning polyaxial plating in cadaveric distal femurs .


Fourteen formalin fixed femora were scanned by dual-energy x-ray absorptiometry .


As fracture model an unstable supracondylar comminuted fracture was simulated .


Fractures were pairwise randomly fixed either with a mono - ( group A ) or a polyaxial ( group B ) distal femur plate .


The samples were tested in a servohydraulic mechanical testing system starting with an axial loading of 200 N following an increase of 200 N in every step with 500 cycles in every sequence up to a maximum of 2 000 N.


The end points were implant failure or relevant loss of reduction .


Data records included for each specimen time , number of cycles , axial load and axial displacement .


Statistical analysis was performed using the exact Wilcoxon signed rank test .


The mean donor age at the time of death was 75 years .


The bone mass density ( BMD ) of the femurs in both groups was comparable and showed no statistically significant differences .


Five bones failed before reaching the maximum applied force of 2000 N. Distribution curves of all samples in both groups , showing the plastic deformation in relation to the axial force , showed no statistically significant differences .


Operative stabilization of distal femur fractures can be successfully and equally well achieved using either a monoaxial or a polyaxial locking plate .


Polyaxial screw fixation may have advantages if intramedullary implants are present .


The international standard of care for women with suspected advanced ovarian cancer is surgical debulking followed by platinum-based chemotherapy .


We aimed to establish whether use of platinum-based primary chemotherapy followed by delayed surgery was an effective and safe alternative treatment regimen .


In this phase 3 , non-inferiority , randomised , controlled trial ( CHORUS ) undertaken in 87 hospitals in the UK and New Zealand , we enrolled women with suspected stage III or IV ovarian cancer .


We randomly assigned women ( 1:1 ) either to undergo primary surgery followed by six cycles of chemotherapy , or to three cycles of primary chemotherapy , then surgery , followed by three more cycles of completion chemotherapy .


Each 3-week cycle consisted of carboplatin AUC5 or AUC6 plus paclitaxel 175 mg/m ( 2 ) , or an alternative carboplatin combination regimen , or carboplatin monotherapy .


We did the random assignment by use of a minimisation method with a random element , and stratified participants according to the randomising centre , largest radiological tumour size , clinical stage , and prespecified chemotherapy regimen .


Patients and investigators were not masked to group assignment .


The primary outcome measure was overall survival .


Primary analyses were done in the intention-to-treat population .


To establish non-inferiority , the upper bound of a one-sided 90 % CI for the hazard ratio ( HR ) had to be less than 1.18 .


This trial is registered , number ISRCTN74802813 , and is closed to new participants .


Between March 1 , 2004 , and Aug 30 , 2010 , we randomly assigned 552 women to treatment .


Of the 550 women who were eligible , 276 were assigned to primary surgery and 274 to primary chemotherapy .


All were included in the intention-to-treat analysis ; 251 assigned to primary surgery and 253 to primary chemotherapy were included in the per-protocol analysis .


As of May 31 , 2014 , 451 deaths had occurred : 231 in the primary-surgery group versus 220 in the primary-chemotherapy group .


Median overall survival was 22.6 months in the primary-surgery group versus 24.1 months in primary chemotherapy .


The HR for death was 0.87 in favour of primary chemotherapy , with the upper bound of the one-sided 90 % CI 0.98 ( 95 % CI 0.72-1 .05 ) .


Grade 3 or 4 postoperative adverse events and deaths within 28 days after surgery were more common in the primary-surgery group than in the primary-chemotherapy group ( 60 [ 24 % ] of 252 women vs 30 [ 14 % ] of 209 , p = 0.0007 , and 14 women [ 6 % ] vs 1 woman [ < 1 % ] , p = 0.001 ) .


The most common grade 3 or 4 postoperative adverse event was haemorrhage in both groups ( 8 women [ 3 % ] in the primary-surgery group vs 14 [ 6 % ] in the primary-chemotherapy group ) .


110 ( 49 % ) of 225 women receiving primary surgery and 102 ( 40 % ) of 253 receiving primary chemotherapy had a grade 3 or 4 chemotherapy related toxic effect ( p = 0.0654 ) , mostly uncomplicated neutropenia ( 20 % and 16 % , respectively ) .


One fatal toxic effect , neutropenic sepsis , occurred in the primary-chemotherapy group .


In women with stage III or IV ovarian cancer , survival with primary chemotherapy is non-inferior to primary surgery .


In this study population , giving primary chemotherapy before surgery is an acceptable standard of care for women with advanced ovarian cancer .


Cancer Research UK and the Royal College of Obstetricians and Gynaecologists .


Bone metastases from renal cell carcinoma ( RCC ) are a major cause of morbidity .


Post hoc analysis has suggested that bone turnover markers can identify patients at risk of skeletal-related events ( SREs ) among those receiving zoledronic acid .


This study sought to evaluate the effect on bone metastases of everolimus alone compared with everolimus plus zoledronic acid .


Thirty treatment-naive patients with RCC and 1 bone metastases were randomized 1:1 to everolimus ( 10 mg daily ) versus everolimus plus zoledronic acid ( 4 mg intravenously 4-weekly ) .


Bone-specific assessments were performed at baseline and at weeks 1 , 4 , 8 , and 12 .


Treatment was continued on allocated arm until progression per RECIST 1.1 ( Response Evaluation Criteria in Solid Tumors , version 1.1 ) .


The primary outcome measure was urine N-telopeptide ( uNTX ) level , with secondary measures of plasma C-telopeptide ( CTX ) , quality of life ( Functional Assessment of Cancer Therapy-Bone Pain [ FACT-BP ] , Brief Pain Inventory [ BPI ] ) , progression-free survival ( PFS ) , SREs , and safety .


After 12 weeks , reduction in mean uNTX and CTX on everolimus plus zoledronic acid relative to everolimus was 68.4 % ( 95 % CI , 60.1 % -74.9 % ; P < .0001 ) and 76.2 % ( 95 % CI , 67.3 % -82.7 % ; P < .0001 ) , respectively .


There was no evidence of a difference for FACT-BP ( P = .5 ) , but evidence was favorable for BPI Severity ( P = .05 ) and BPI Interference ( P = .06 ) .


Median PFS was 7.5 months ( 95 % CI , 3.4-11 .2 ) on everolimus plus zoledronic acid and 5.4 months ( 95 % CI , 3.2-6 .3 ) on everolimus ( P = .009 ) .


Median time to first SRE was 9.6 months ( 95 % CI , 4.3-15 .5 ) on everolimus plus zoledronic acid and 5.2 months ( 95 % CI , 1.6-8 .2 ) on everolimus ( P = .03 ) .


In this RCC population , the addition of zoledronic acid to everolimus significantly reduced bone resorption markers and may prolong tumor control .


Induced hypotension is widely used intraoperatively to reduce blood loss and to improve the surgical field during spinal surgery .


To determine the effect of milrinone on induced hypotension during spinal surgery in elderly patients .


Prospective randomized clinical trial .


Forty patients , 60 to 70 years old , ASA I-II , who underwent elective lumbar fusion surgery .


Intraoperative hemodynamics , blood loss , hourly urine output , and grade of surgical field .


All patients were randomized to group M or N.


The study drug was infused after perivertebral muscle retraction until complete interbody fusion .


In group M , 50 g/kg/min of milrinone was infused over 10 minutes as a loading dose followed by 0.6 g/kg/min of milrinone as a continuous dose .


In group N , an identical volume of normal saline was infused in the same fashion .


This study was not funded by commercial or other sponsorship and the authors confirm no conflicts of interest , financial or otherwise .


During infusion of the study drug , the systolic and mean blood pressures were maintained within adequate limits of induced hypotension in group M. Intraoperative blood loss was 445.0226.5 mL in group M and 765.0339.2 mL in group N ( p = .001 ) .


Hourly urine output was 1.40.6 mL in group M and 0.80.2 mL in group N ( p < .001 ) .


The grade of the surgical field was better in group M than in group N ( p = .004 ) .


We conclude that milrinone is useful for induced hypotension in elderly patients during spinal surgery .


The aim of this study was to determine whether providing information about the lifestyle changes required for an individual to lose weight following bariatric surgery would mitigate the negative judgments of that individual .


In an experimental design , participants provided their initial impressions of a woman with obesity before learning that she had lost a significant amount of weight through : ( 1 ) diet/exercise , ( 2 ) surgery , or ( 3 ) surgery + diet/exercise .


Participants then provided their impressions of the woman after she had lost weight .


For ratings of laziness , competence , and responsibility for weight loss , the individual who lost weight through surgery was rated most negatively , followed by the individual who lost weight through surgery + diet/exercise , with the individual who lost weight through diet/exercise alone rated as least lazy , most competent , and most responsible for her weight loss .


Mediation analyses further showed that group differences in target ratings of laziness/competence were due to perceptions of responsibility for weight loss .


Providing information about the lifestyle changes required for losing weight following bariatric surgery can somewhat dampen the negative evaluations of surgery patients .


These findings also highlight the importance of perceived effort in judgments of individuals with obesity .


We hypothesized that the Laryngoscope with Fiber Optic Reusable Flexible Tip English Macintosh blade ( TMAC ) is beneficial for the intubation of child manikins while performing cardiopulmonary resuscitation ( CPR ) .


In the present study , we evaluated the effectiveness of the conventional Macintosh laryngoscope ( MAC ) and TMAC in 3 simulated CPR scenarios .


A randomized crossover simulation trial was designed .


One hundred seven paramedics intubated the trachea of a PediaSIM CPR training manikin ( FCAE HealthCare , Sarasota , FL ) using the MAC and TMAC in a normal airway scenario ( scenario A ) , normal airway with chest compression scenario ( scenario B ) , and difficult airway with chest compression scenario ( scenario C ) .


The participants were directed to make a maximum of 3 attempts in each scenario .


The success rate , time required for intubation , Cormack-Lehane grade , dental compression , and the ease of intubation were measured .


The median time of intubation with MAC and TMAC in scenario A was 19.6 ( interquartile range [ IQR ] , 18-23 ) vs 19 ( IQR , 16.2-21 .8 ) ; in scenario B , 29.5 ( IQR , 25-31 ) vs 26 ( IQR , 23.5-29 ) seconds ; and in scenario C , 38 ( IQR , 32.5-45 ) vs 29 ( IQR , 25-31 ) seconds , respectively .


The overall efficacy for each of the scenarios was as follows : in scenario A , it was 100 % vs 100 % ; in scenario B , it was 79.4 % vs 100 % ( P = .007 ) ; and in scenario C , it was 68.2 % vs 90.7 % ( P < .001 ) , respectively .


The TMAC seems to be a superior intubating device compared with the conventional MAC when used in simulated normal and difficult child airway with chest compression scenarios .


Future studies should explore the efficacy of TMAC in pediatric clinical emergency settings .


The aim of the study was to assess the safety and efficacy of high - and low-dose oral , delayed-release mesalamine in a randomized , double-blind , active control study of children with mild-to-moderately active ulcerative colitis .


Patients ages 5 to 17 years , with a Pediatric Ulcerative Colitis Activity Index ( PUCAI ) score of 10 to 55 and a truncated Mayo Score of 1 for both rectal bleeding and stool frequency , were enrolled .


They received body weight-dependent doses of oral , delayed-release mesalamine for 6 weeks in a low - ( 27-71 mg g ( -1 ) day ( -1 ) ) or high-dose group ( 53-118 mg g ( -1 ) day ( -1 ) ) .


The primary endpoint was treatment success , defined as the proportion of patients who achieved remission ( PUCAI score < 10 ) or partial response ( PUCAI score 10 with a decrease from baseline by 20 points ) .


Secondary endpoints included truncated Mayo Score and global assessment of change of disease activity .


The modified intent-to-treat population included 81 of 83 patients enrolled .


Treatment success by PUCAI was achieved by 23 of 41 ( 56 % ) and 22 of 40 ( 55 % ) patients in the mesalamine low - and high-dose groups , respectively ( P = 0.924 ) .


Truncated Mayo Score ( low-dose 30 [ 73 % ] and high-dose 28 [ 70 % ] patients ) and other efficacy results did not differ between the groups .


The type and severity of adverse events were consistent with those reported in previous studies of adults with ulcerative colitis and did not differ between groups .


Both low - and high-dose oral , delayed-release mesalamine doses were equally effective as short-term treatment of mild-to-moderately active ulcerative colitis in children , without a specific benefit or risk to using either dose .


The p38 MAPK pathway seems to be involved in pathogenesis of chronic obstructive pulmonary disease ( COPD ) .


Losmapimod is a potent and selective inhibitor of p38 MAPK .


We assessed the effect of losmapimod on exercise tolerance in patients with COPD .


We did this randomised , parallel-group , placebo-controlled trial at 46 secondary care centres in Argentina , Czech Republic , Estonia , Germany , Norway , South Korea , Ukraine , and USA between Nov 4 , 2010 , and Dec 22 , 2011 .


We enrolled patients aged 40 years or older with moderate-to-severe COPD ( 6 min walking distance < 350 m ) who were current or previous smokers .


Patients were randomly assigned ( 1:1:1:1 ) by a computer generated sequence to one of losmapimod 25 mg , 75 mg , or 15 mg , or placebo , twice daily for 24 weeks .


Randomisation was stratified by country and exacerbation history ( block size eight ) .


Patients and investigators were masked to treatment assignment .


The primary outcome was change in 6 min walking distance between baseline and week 24 , assessed in the intention-to-treat population .


This study is registered with ClinicalTrial.gov , number NCT01218126 .


We screened 886 patients , of whom 602 were enrolled and received treatment .


The difference between the placebo group and the losmapimod groups for mean change of 6 min walk distance was not significant : -67 m ( 95 % CI -182 to 49 ) for losmapimod 25 mg , -47 m ( -161 to 68 ) for losmapimod 75 mg , and -34 m ( -151 to 82 ) for losmapimod 15 mg .


The safety profile was much the same in each group , although drug-related adverse events were more common with losmapimod 75 mg ( n = 19 , 13 % ) and losmapimod 15 mg ( n = 20 , 13 % ) than with placebo ( n = 11 , 7 % ) and losmapimod 25 mg ( n = 13 , 9 % ) .


The most common serious adverse events were COPD exacerbation resulting in admission to hospital ( eight patients [ 5 % ] taking placebo , six [ 4 % ] taking losmapimod 25 mg , two [ 1 % ] taking losmapimod 75 mg , and three [ 2 % ] taking losmapimod 15 mg ) and pneumonia ( four [ 3 % ] vs 0 [ 0 % ] vs 1 [ 1 % ] vs 4 [ 3 % ] ) .


Losmapimod did not cause an improvement in exercise tolerance or lung function , despite being well-tolerated in this COPD population .


GlaxoSmithKline .


Despite antirestenotic efficacy of coronary drug-eluting stents ( DES ) compared with bare metal stents ( BMS ) , the relative risk of stent thrombosis and adverse cardiovascular events is unclear .


Although dual antiplatelet therapy ( DAPT ) beyond 1 year provides ischemic event protection after DES , ischemic event risk is perceived to be less after BMS , and the appropriate duration of DAPT after BMS is unknown .


To compare ( 1 ) rates of stent thrombosis and major adverse cardiac and cerebrovascular events ( MACCE ; composite of death , myocardial infarction , or stroke ) after 30 vs 12 months of thienopyridine in patients treated with BMS taking aspirin and ( 2 ) treatment duration effect within the combined cohorts of randomized patients treated with DES or BMS as prespecified secondary analyses .


International , multicenter , randomized , double-blinded , placebo-controlled trial comparing extended ( 30-months ) thienopyridine vs placebo in patients taking aspirin who completed 12 months of DAPT without bleeding or ischemic events after receiving stents .


The study was initiated in August 2009 with the last follow-up visit in May 2014 .


Continued thienopyridine or placebo at months 12 through 30 after stent placement , in 11,648 randomized patients treated with aspirin , of whom 1687 received BMS and 9961 DES .


Stent thrombosis , MACCE , and moderate or severe bleeding .


Among 1687 patients treated with BMS who were randomized to continued thienopyridine vs placebo , rates of stent thrombosis were 0.5 % vs 1.11 % ( n = 4 vs 9 ; hazard ratio [ HR ] , 0.49 ; 95 % CI , 0.15-1 .64 ; P = .24 ) , rates of MACCE were 4.04 % vs 4.69 % ( n = 33 vs 38 ; HR , 0.92 ; 95 % CI , 0.57-1 .47 ; P = .72 ) , and rates of moderate/severe bleeding were 2.03 % vs 0.90 % ( n = 16 vs 7 ; P = .07 ) , respectively .


Among all 11,648 randomized patients ( both BMS and DES ) , stent thrombosis rates were 0.41 % vs 1.32 % ( n = 23 vs 74 ; HR , 0.31 ; 95 % CI , 0.19-0 .50 ; P < .001 ) , rates of MACCE were 4.29 % vs 5.74 % ( n = 244 vs 323 ; HR , 0.73 ; 95 % CI , 0.62-0 .87 ; P < .001 ) , and rates of moderate/severe bleeding were 2.45 % vs 1.47 % ( n = 135 vs 80 ; P < .001 ) .


Among patients undergoing coronary stent placement with BMS and who tolerated 12 months of thienopyridine , continuing thienopyridine for an additional 18 months compared with placebo did not result in statistically significant differences in rates of stent thrombosis , MACCE , or moderate or severe bleeding .


However , the BMS subset may have been underpowered to identify such differences , and further trials are suggested .


clinicaltrials.gov Identifier : NCT00977938 .


To evaluate the effectiveness of low-intensity pulsed ultrasound ( LIPUS ) for the improvement of lower limb bone stress injuries in a civilian population .


A prospective , randomized , double-blinded , placebo-controlled trial to compare LIPUS with placebo .


Civilian private practice population in Sydney , Australia .


Subjects were recruited if a grade II-IV bone stress injury was diagnosed on magnetic resonance imaging ( MRI ) of either the postero-medial tibia , fibula or second , third , or fourth metatarsal .


Subjects of all levels of sporting activity were included .


Thirty subjects were initially recruited , and 23 subjects were included in the final analysis .


Subjects were randomized into either the treatment or placebo arm and matched to the site of injury ( tibia , fibula , or metatarsal ) .


Subjects in both arms used either treatment or placebo devices for 20 minutes daily for 4 weeks .


Six clinical parameters ( night pain , pain at rest , pain on walking , pain with running , tenderness , and pain with single leg hop ) were compared before and after intervention .


The changes in MRI grade and bone marrow edema size were also compared .


There were no significant differences between the treatment and placebo conditions for changes in MRI grading ( 2.2 vs 2.4 , P = 0.776 ) or bone marrow edema size ( 3 vs 4.1 , P = 0.271 ) .


There were no significant differences between the treatment and placebo conditions for the 6 clinical parameters .


Low-intensity pulsed ultrasound was found not to be an effective treatment for the healing of lower limb bone stress injuries in this study .


However , this was measured over a relatively short duration of 4 weeks in a small , mostly female population .


This double-blinded , randomized , placebo-controlled trial has shown that LIPUS is not an effective treatment for lower limb bone stress injuries .


Vandetanib is an oral tyrosine kinase inhibitor of VEGFR-2 / 3 , EGFR and RET , which has demonstrated clinical activity as a single agent and in combination with taxanes .


We explored the efficacy , safety and toxicity of docetaxel and vandetanib in women with recurrent ovarian cancer ( OC ) .


Women with refractory or progressive OC were randomised 1:1 to docetaxel ( 75 mg/m ( 2 ) , IV ) + vandetanib ( 100mg daily , PO , D+V ) or docetaxel ( 75 mg/m ( 2 ) , D ) .


Up to three additional cytotoxic regimens for recurrence and prior anti-angiogenic agents ( as primary therapy ) were allowed .


The primary end-point was progression free survival ( PFS ) .