Stress , as measured by Cohens perceived stress questionnaire is not an inclusion criteria , thus participants can participate regardless of their stress level.We will implement an individualized intervention addressing biopsychosocial elements of musculoskeletal pain with the following components ; i ) increasing physical capacity through strength - and motor control training ; ii ) lowering or preventing development of stress through mindfulness practice and learning de-catastrophizing pain management strategies through cognitive training.The primary outcome at 10-week follow-up is the between-group difference in intensity of perceived musculoskeletal pain during the last week ( average value of back , neck , shoulder , elbow and hand ) assessed by questionnaire ( modified visual analogue scale 0-10 ) .


This study will provide experimental evidence to guide workplace initiatives designed towards reducing chronic musculoskeletal pain and stress .


ClinicalTrials.gov NCT02047669 .


Because of the increasing number of interventional endovascular procedures with fluoroscopy and the corresponding high annual dose for interventionalists , additional dose-protecting measures are desirable .


The purpose of this study was to evaluate the effect of disposable radiation-absorbing surgical drapes in reducing scatter radiation exposure for interventionalists and supporting staff during an endovascular aneurysm repair ( EVAR ) procedure .


This was a randomized control trial in which 36 EVAR procedures were randomized between execution with and without disposable radiation-absorbing surgical drapes ( Radpad : Worldwide Innovations & Technologies , Inc. , Kansas City , US , type 5511A ) .


Dosimetric measurements were performed on the interventionalist ( hand and chest ) and theatre nurse ( chest ) with and without the use of the drapes to obtain the dose reduction and effect on the annual dose caused by the drapes .


Use of disposable radiation-absorbing surgical drapes resulted in dose reductions of 49 % , 55 % , and 48 % , respectively , measured on the hand and chest of the interventionalist and the chest of the theatre nurse .


The use of disposable radiation-absorbing surgical drapes significantly reduces scatter radiation exposure for both the interventionalist and the supporting staff during EVAR procedures .


Clonidine may help prevent cardiac complications in patients undergoing non-cardiac surgery and receiving chronic beta-blocker therapy .


We conducted a multicentre pilot randomized trial to estimate recruitment rates for a full-scale trial and to assess the safety and tolerability of combining clonidine with chronic beta-blockade .


Patients who were at elevated perioperative cardiac risk , receiving chronic beta-blockade , and scheduled for major non-cardiac surgery were recruited in a blinded ( participants , clinicians , outcome assessors ) placebo-controlled randomized trial at three Canadian hospitals .


Participants were randomized to clonidine ( 0.2 mg oral tablet one hour before surgery , plus 0.2 mgday ( -1 ) transdermal patch placed one hour before surgery and removed four days after surgery or hospital discharge , whichever came first ) or matching placebo .


Feasibility was evaluated based on recruitment rates , with each centre being required to recruit 50 participants within 12-18 months .


Additionally , we reviewed study drug withdrawals and safety outcomes , including clinically significant hypotension or bradycardia .


Eighty-two of the 168 participants were randomized to receive clonidine and 86 to receive placebo .


The average time to recruit 50 participants at each centre was 14.3 months .


Six patients ( 7 % ) withdrew from clonidine , while four ( 5 % ) withdrew from placebo .


Based on qualitative review , there were no major safety concerns related to clonidine .


There was a moderate overall rate of cardiac morbidity , with 18 participants ( 11 % ) suffering postoperative myocardial infarction .


This pilot randomized trial confirmed the feasibility , safety , and tolerability of a full-scale trial of oral and transdermal clonidine for reducing the risk of cardiac complications during non-cardiac surgery .


This trial was registered at www.clinicaltrials.gov : NCT00335582 .


To explore the effect and feasibility of acupuncture in uterine involution after cesarean section .


Seventy cases of cesarean section in primipara were randomized into an observation group ( 33 cases ) and a control group ( 37 cases ) .


In the control group , the conventional treatment was adopted after cesarean section .


In the observation group , on the basic treatment as the control group , acupuncture was applied at Sanyinjiao ( SP 6 ) , Hegu ( LI 4 ) , Qihai ( CV 6 ) and Guanyuan ( CV 4 ) .


In 2 h after operation , acupuncture started , once a day , continuously for five times .


The daily height of uterine fundus , daily uterine fundus decreasing degree , postpartum blood loss , lochia duration and ultrasonic B test in 42 days of postpartum were compared between the two groups .


The therapeutic methods of the two groups all promoted uterine contraction .


The postpartum height of uterine fundus in the observation group was lower than that in the control group ( all P < 0.05 ) and the uterine fundus decreasing degree was higher than that in the control group ( all P < 0.05 ) .


The blood loss in 2 h , 6 to 12 h and 24 to 48 h of postpartum was less than that in the control group ( all P < 0.05 ) .


The lochia duration in the observation group was shorter than that in the control group ( P < 0.05 ) .


Acupuncture promotes uterine contraction , reduces postpartum blood loss and lochia duration and benefits uterine involution after cesarean section .


We compared the efficacy and safety of indacaterol and tiotropium in patients with severe chronic obstructive pulmonary disease ( COPD ) and a history of at least one moderate to severe exacerbation in the previous 12 months .


In this multicentre , randomised , blinded , double-dummy , parallel group study , we enrolled patients aged 40 years or older with severe COPD and at least one exacerbation within the previous year .


We used a computer-generated sequence to randomly allocate patients ( 1:1 ; stratified by baseline inhaled corticosteroid use , with the balance of treatments maintained at country level ) to receive either indacaterol ( 150 g ) or tiotropium ( 18 g ) once-daily for 52 weeks .


Our primary and key secondary objectives were to investigate whether indacaterol was non-inferior to tiotropium for trough forced expiratory volume in 1 s ( FEV1 ) at week 12 ( primary endpoint ) , and for rate of exacerbations at week 52 ( secondary endpoint ) .


Analysis populations for the primary and key secondary endpoints were per-protocol sets .


The safety set included all patients who received at least one dose of study drug .


This study is registered with ClinicalTrials.gov , number NCT00845728 .


Between March 16 , 2009 , and July 5 , 2012 , we enrolled and randomly allocated 3444 patients : 1723 to indacaterol and 1721 to tiotropium .


At week 12 , the estimated least squares mean trough FEV1 difference between the groups was -0.011 L ( least squares mean with indacaterol [ n = 1450 ] 1.134 L [ SE 0.008 ] vs tiotropium [ n = 1467 ] 1.145 L [ 0.008 ] ; one-sided 97.5 % CI lower limit -0.026 L ; p < 0.0001 ) .


The lower limit of the 97.5 % CI was above the prespecified non-inferiority margin of -0.055 L , suggesting that indacaterol was non-inferior to tiotropium .


Indacaterol did not show non-inferiority in terms of annualised exacerbation rates : 0.79 ( indacaterol , n = 1529 ) versus 0.61 ( tiotropium , n = 1543 ) ; ratio 1.29 ( one-sided 97.5 % CI upper limit 1.44 ) .


In the safety set , we recorded no between-group difference in the number of patients who had adverse events ( indacaterol 1119 [ 65 % ] of 1721 patients vs tiotropium 1065 [ 62 % ] of 1718 patients ) or serious adverse events ( indacaterol , 263 [ 15 % ] of 1721 patients vs tiotropium , 255 [ 15 % ] of 1718 patients ) .


Respiratory disorders , particularly worsening of COPD , were the most common adverse events ( COPD : indacaterol , 747 [ 43 % ] of 1721 patients and tiotropium , 665 [ 39 % ] of 1718 patients ) and serious adverse events ( COPD : indacaterol , 147 [ 9 % ] of 1721 patients and tiotropium , 121 [ 7 % ] of 1718 patients ) .


Indacaterol and tiotropium provided clinically relevant improvements in lung function with comparable safety profiles .


Tiotropium afforded greater protection from exacerbations , although the absolute number of events was small and the difference between treatments is of uncertain clinical importance .


The present data offer evidence consistent with current guidelines .


Novartis Pharma AG .


To estimate and compare the cost-effectiveness and safety of nebivolol with sustained-release metoprolol in reducing blood pressure by 1 mm of Hg per day in hypertensive patients .


This was a prospective , randomized , open label , observational analysis of cost-effectiveness , in a questionnaire-based fashion to compare the cost of nebivolol ( 2.5 mg , 5 mg , 10 mg ) and sustained released metoprolol succinate ( 25 mg , 50 mg , 100 mg ) in hypertensive patients using either of the two drugs .


A total of 60 newly detected drug nave hypertensive patients were considered for the comparison , of which 30 patients were prescribed nebivolol and the other 30 were prescribed metoprolol succinate as per the recommended dosage .


Based on the data , statistical analysis was carried out using GraphPad Prism 5 and MS Excel Spreadsheet 2007 .


The cost of reducing 1 mm of Hg blood pressure per day with nebivolol was 0.60 , 0.70 , and 1.06 INR , whereas that of metoprolol succinate was 0.93 , 1.18 , and 1.25 INR at their respective equivalent doses , hence significantly lower with the nebivolol group as compared to the metoprolol group ( P < 0.05 ) .


This pharmacoeconomic analysis shows that nebivolol is more cost-effective as compared to metoprolol when the cost per reduction in blood pressure per day is considered .


This may affect the patients economically during their long-term use of these molecules for the treatment of hypertension .


Female breast cancer patients with a BRCA1/2 mutation have an increased risk of contralateral breast cancer .


We investigated the effect of rapid genetic counselling and testing ( RGCT ) on choice of surgery .


Newly diagnosed breast cancer patients with at least a 10 % risk of a BRCA1/2 mutation were randomised to an intervention group ( offer of RGCT ) or a control group ( usual care ; ratio 2:1 ) .


Primary study outcomes were uptake of direct bilateral mastectomy ( BLM ) and delayed contralateral prophylactic mastectomy ( CPM ) .


Between 2008 and 2010 , we recruited 265 women .


On the basis of intention-to-treat analyses , no significant group differences were observed in percentage of patients opting for a direct BLM ( 14.6 % for the RGCT group vs 9.2 % for the control group ; odds ratio ( OR ) 2.31 ; confidence interval ( CI ) 0.92-5 .81 ; P = 0.08 ) or for a delayed CPM ( 4.5 % for the RGCT group vs 5.7 % for the control group ; OR 0.89 ; CI 0.27-2 .90 ; P = 0.84 ) .


Per-protocol analysis indicated that patients who received DNA test results before surgery ( 59 out of 178 women in the RGCT group ) opted for direct BLM significantly more often than patients who received usual care ( 22 % vs 9.2 % ; OR 3.09 , CI 1.15-8 .31 , P = 0.03 ) .


Although the large majority of patients in the intervention group underwent rapid genetic counselling , only a minority received DNA test results before surgery .


This may explain why offering RGCT yielded only marginally significant differences in uptake of BLM .


As patients who received DNA test results before surgery were more likely to undergo BLM , we hypothesise that when DNA test results are made routinely available pre-surgery , they will have a more significant role in surgical treatment decisions .


To assess links between comorbid health status , severe excess weight , and weight-related quality of life ( WRQOL ) in adolescents with severe obesity and undergoing weight-loss surgery ( WLS ) to inform clinical care .


Baseline ( preoperative ) data from Teen Longitudinal Assessment of Bariatric Surgery , a prospective multicenter observational study of 242 adolescents with severe obesity ( MedianBMI = 50.5 kg/m ( 2 ) ; Meanage = 17.1 ; 75.6 % female ; 71.9 % white ) undergoing WLS , were used to examine the impact of demographics , body mass index ( BMI ) , presence/absence of 16 comorbid conditions , and a cumulative comorbidity load ( CLoad ) index on WRQOL scores ( Impact of Weight on Quality of Life-Kids ) .


WRQOL was significantly lower than reference samples of healthy weight , overweight , and obese samples .


Of 16 comorbid conditions , the most prevalent were dyslipidemia ( 74.4 % ) , chronic pain ( 58.3 % ) , and obstructive sleep apnea ( 56.6 % ) .


Male subjects had a greater CLoad ( P = .01 ) and BMI ( P = .01 ) , yet less impairment in total WRQOL ( P < .01 ) than females .


CLoad was a significant predictor of male WRQOL .


For females , psychosocial ( vs physical ) comorbidities , BMI , and white race were significant predictors of WRQOL impairment .


Less prevalent conditions ( eg , stress urinary incontinence ) also emerged as contributors to lower WRQOL .


WRQOL impairment is substantial for adolescents with severe obesity undergoing WLS , with predictors varying by sex .


These patient-data highlight targets for education , support , and adjunctive care referrals before WLS .


Furthermore , they provide a comprehensive empirical base for understanding heterogeneity in adolescent WRQOL outcomes after WLS , as weight and comorbidity profiles change over time .


To evaluate the effects and safety of penetrating needling on head acupoints for perennial allergic rhinitis ( PAR ) .


Eighty-one cases of PAR were randomly divided into an acupuncture group ( 41 cases ) and a medication group ( 40 cases ) .


Penetrating needling at head acupoints was adopted from Baihui ( GV 20 ) to Qianding ( GV 21 ) and from Shangxing ( GV 23 ) to Shenting ( GV 24 ) in the acupuncture group .


A to tal 4-week treatment was given to the patients with 3 treatments a week .


Loratadine tablet and azelastine hydrochloride nasal spray were given to the medication group continuously for 12 days .


A follow-up was carried out 3 months after the treatment .


The efficacy , symptom score and physical sign score , and side accidents were observed in both groups .


The total effective rate was 95.1 % ( 39/41 ) in the acupuncture group , which was better than 82.5 % ( 33/40 ) in the medication group ( P < 0.05 ) .


The total scores of clinical symptoms and each partial scores after the treatment , and total scores of clinical symptoms in follow-up were obviously decreased in both groups ( all P < 0.01 ) , the nasal obstruction score and the total scores of clinical symptoms in the acupuncture group were better than those in the medication group ( P < 0.01 , P < 0.05 ) .


Obvious side-effect had not been found during the treatment .


Penetrating needling at head acupoints is a safe therapy for patients with PAR , and favorable effects can be found in both short term and long term .


Skin fragments during lumbar punctures may develop intraspinal epidermoid tumors .


The aim of this study was to determine the incidence of epithelial cells that reflow along with the fi rst and third drops of CSF of patients undergoing spinal anesthesia .


Samples of the fi rst and third drops of cerebrospinal fluid were collected from 39 adult patients undergoing spinal anesthesia with a 25G Quincke needle .


Four microscope slides were prepared : one for the fi rst drop , one for third drop , one for the needle , and one with a drop of saline for control .


A pathologist examined the slides randomly .


Squamous epithelial cells were identified in 35 ( 89.7 % ) samples from the fi rst drop , 34 ( 87.2 % ) from the third drop , and 24 ( 61.5 % ) from spinal needle .


The third drop showed a mean number of cells larger than the fi rst drop ( p = 0.046 ) .


Nucleated epithelial cells were found in a sample of the fi rst drop ( 2.56 % ) , in four samples of third drop ( 10.25 % ) , and in one spinal needle ( 2.56 % ) .


Third drop showed a mean number of nucleated cells higher than fi rst drop with no statistical difference ( p = 0.257 ) .


High percentage of epithelial cells was found in the fi rst ( 89.7 % ) and third ( 87.2 % ) drops of CSF reflow and in used needles ( 61.5 % ) .


Skin cells were found even using small gauge disposable needles with well-adapted mandrel .


Omega-3 fatty acids ( n-3 FAs ) may have beneficial clinical effects , and n-3 FA supplements may improve outcome after surgery .


In a randomized double-blind placebo-controlled trial in single centre , patients referred for elective colorectal cancer surgery received either an n-3 FA-enriched oral nutritional supplement ( ONS ) ( Supportan , 200 ml twice daily ) providing 2.0 g eicosapentaenoic acid ( EPA ) and 1.0 g docosahexaenoic acid ( DHA ) per day , or a standard isocaloric and isonitrogenous ONS , for 7 days before and 7 days after surgery .


The primary endpoint was infectious and non-infectious complications within 30 days of surgery .


Secondary endpoints were length of hospital stay , intensive care unit admission , readmissions , and concentrations of marine n-3 FAs and arachidonic acid in granulocyte membranes .


Some 148 consecutive patients ( 68 women , 80 men ; mean age 71 ( range 41-89 ) years ) were randomized .


There was no significant difference between groups in infectious or non-infectious postoperative complications ( P = 1.000 ) .


Granulocyte levels of EPA , DHA and docosapentaenoic acid ( DPA ) were significantly higher in the n-3 FA-enriched supplement group compared with the control group ( P < 0.001 ) .


The arachidonic acid level in granulocytes was significantly lower in the enriched group than in the control group ( P < 0.001 ) .


EPA , DHA and DPA were incorporated into granulocytes in patients receiving n-3 FAs , but this was not associated with improved postoperative outcomes .


NCT00488904 ( http://www.clinicaltrials.gov ) .


The aim of this study was to investigate and evaluate the efficacy of Rheum emodi in the management of primary dysmenorrhoea .


A randomized , single-blind , standard controlled trial compared efficacy of R. emodi against mefenamic acid on diagnosed subjects of primary dysmenorrhoea for three consecutive cycles .


Experimental group ( n = 30 ) received capsules of R. emodi powder two times a day , two days before the expected date of menstruation , and continued first three days of menstruation , while control group ( n = 15 ) participants received mefenamic acid capsules three times a day on the same protocol .


The primary outcome measures were reduced in severity and duration of pain , assessed by visual analogue scale ( VAS ) and verbal multidimensional scoring system ( VMSS ) , and secondary outcome measures were overall improvement of dysmenorrhoea and improved in quality of life ( QOL ) .


Statistical analysis was done by repeated measures analysis of variance and Chi-square/Fisher Exact test .


The menstrual pain was significantly decreased in both groups after three-cycle intervention .


Significant changes were observed in VAS ( p < 0.001 ) and VMSS ( p < 0.001 ) in the experimental group .


There is a significant ( p < 0.001 ) reduction in duration of pain in both the groups .


Associated symptoms and QOL were markedly improved after treatment ( p < 0.001 ) .


It has been clear from the above result that R. emodi is an effective herb in alleviating symptoms of primary dysmenorrhoea .


It can serve as an alternative treatment without any apparent side effects .


These results deserve further investigations .


To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks ( IANB ) .


A randomized , triple-blind clinical trial comprising 109 patients who required lower third molar removal was performed .


In the control group , all patients received an IANB using the conventional Halsted technique , whereas in the experimental group , a modified technique using a more inferior injection point was performed .


A total of 100 patients were randomized .


The modified technique group showed a significantly higher onset time in the lower lip and chin area , and was frequently associated to a lingual electric discharge sensation .


Three failures were recorded , 2 of them in the experimental group .


No relevant local or systemic complications were registered .


Both IANB techniques used in this trial are suitable for lower third molar removal .


However , performing an inferior alveolar nerve block in a more inferior position ( modified technique ) extends the onset time , does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries .


In a randomized trial comparing nevirapine ( NVP ) - based versus lopinavir/ritonavir ( LPV/r ) - based antiretroviral therapy ( ART ) in HIV-infected children [ primary endpoint discontinuation of study treatment for any reason or virologic failure by week 24 ] aged 2 months to 3 years , we assessed whether clinical , virologic , immunologic and safety outcomes varied by prior single-dose NVP exposure ( PrNVP ) for prevention of mother-to-child HIV transmission and other covariates .


Efficacy was assessed by time to ART discontinuation or virologic failure , virologic failure/death and death ; safety by time to ART discontinuation because of a protocol-defined toxicity and first grade 3 adverse event ; immunology and growth by changes in CD4 % , weight/height World Health Organization z-scores from entry to week 48 .


Cox proportional hazards and linear regression models were used to test whether treatment differences depended on PrNVP exposure and other covariates .


Over a median follow up of 48 ( PrNVP ) and 72 ( no PrNVP ) weeks , there was no evidence of differential treatment effects by PrNVP exposure or any other covariates .


LPV/r-based ART was superior to NVP-based ART for efficacy and safety outcomes ; however , those on NVP had larger improvements in CD4 % , weight and height z-scores .


Lower pretreatment CD4 % and higher HIV-1 RNA levels were associated with reduced efficacy , lower pretreatment CD4 % with shorter time to ART discontinuation because of a protocol-defined toxicity , and no PrNVP with shorter time to first grade 3 adverse event .


Differences between LPV/r and NVP ART in efficacy , safety , immunologic and growth outcomes did not depend on PrNVP exposure , prior breast-feeding , sex , HIV-1 subtype , age , pretreatment CD4 % , HIV-1 RNA or World Health Organization disease stage .


This finding should be considered when selecting an ART regimen for young children .


To describe characteristics associated with neurotoxicity ( NT ) in advanced ovarian cancer patients treated on Gynecologic Oncology Group 218 and examine effect of substituting docetaxel for paclitaxel in these patients .


The development of NT was defined as Common Toxicity Criteria grade ( G ) 1 .


The association between substitution with docetaxel and NT improvement was explored with generalized estimating equations adjusting for treatment cycle and NT grading at previous cycle .


Of 1864 evaluable patients , 1329 ( 71 % ) developed G1 NT during the study .


Nearly half appeared within the first two cycles of chemotherapy , with 31 % experiencing G2 .


Older patients or those with worse quality of life ( QoL ) scores at baseline ( p < 0.05 ) were more likely to experience NT .


One-hundred-six patients received docetaxel as substitute for paclitaxel .


Of them , 47 patients started with docetaxel at cycle one due to reaction to paclitaxel ( n = 32 ) , fear of NT ( n = 4 ) , and other reasons ( n = 11 ) , whereas 59 patients switched to docetaxel during cycle 2-6 due to NT ( n = 32 ) , reaction to paclitaxel ( n = 19 ) , and other reasons ( n = 8 ) .


Although the protocol instructed otherwise , the majority continued paclitaxel despite G2 NT symptoms .


There was no evidence that substitution with docetaxel improved NT ( Odds Ratio : 1.57 ; 95 % CI 0.98-2 .54 ; p > 0.05 ) .


Of 59 patients who switched to docetaxel , only seven ( 12 % ) discontinued taxane prior to chemotherapy completion .


A roughly equal chance of worsening NT was reported on paclitaxel ( 6 % ) as on docetaxel ( 5 % ) .


Age and worse QoL at baseline are associated with NT .


Substitution of docetaxel did not improve NT symptoms .


In a randomized phase III study , trametinib prolonged progression-free survival and improved overall survival versus chemotherapy in patients with BRAF V600 mutation-positive melanoma .


Patients ' quality of life ( QOL ) was assessed at baseline and follow-up visits using the European Organisation for Research and Treatment of Cancer Core QOL questionnaire .


In the primary efficacy population ( BRAF V600E + , no brain metastases ) from baseline to weeks 6 and 12 , patients ' global health status scores worsened by 4-5 points with chemotherapy but improved by 2-3 points with trametinib .


Rapid and substantive reductions in QOL functionality ( e.g. role functioning , 8-11 points at weeks 6 and 12 ) and symptom exacerbation ( e.g. fatigue , 4-8 points ; nausea and vomiting , 5 points , both at weeks 6 and 12 ) were observed in chemotherapy-treated patients .


In contrast , trametinib-treated patients reported small improvements or slight worsening from baseline at week 12 , depending on the functional dimension and symptom .


The mean symptom-scale scores for chemotherapy-treated patients increased from baseline ( symptoms worsened ) for seven of eight symptoms at week 6 ( except insomnia ) and six of eight symptoms at week 12 ( except dyspnea and insomnia ) .


In contrast , at weeks 6 and 12 , the mean symptom-scale scores for trametinib decreased from baseline ( symptoms improved ) for pain ( 11-12 points ) , insomnia ( 10-12 points ) , and appetite loss ( 1-5 points ) , whereas those for diarrhea worsened ( 15-16 points ) .


Mixed-model repeated-measures analyses showed significant ( P < 0.05 ) and/or clinically meaningful improvements ( small to moderate ) from baseline in favor of trametinib for global health ; physical , role , and social functioning ; fatigue ; pain ; insomnia ; nausea and vomiting ; constipation ; dyspnea ; and appetite at weeks 6 and/or 12 .


QOL results for the intent-to-treat population were consistent .


This first QOL assessment for a MEK inhibitor in metastatic melanoma demonstrated that trametinib was associated with less functional impairment , smaller declines in health status , and less exacerbation of symptoms versus chemotherapy .


Daily azithromycin decreases acute exacerbations of chronic obstructive pulmonary disease ( AECOPD ) , but long-term side effects are unknown .


To identify the types of exacerbations most likely to be reduced and clinical subgroups most likely to benefit from azithromycin , 250 mg daily , added to usual care .


Enrollment criteria included irreversible airflow limitation and AECOPD requiring corticosteroids , emergency department visit , or hospitalization in the prior year or use of supplemental oxygen .


Recurrent events and cumulative incidence analyses compared treatment received for AECOPD by randomization group , stratified by subgroups of interest .


Cox proportional hazards models estimated treatment effects in subgroups adjusted for age , sex , smoking status , FEV1 % predicted , concomitant COPD medications , and oxygen use .


Azithromycin was most effective in reducing AECOPD requiring both antibiotic and steroid treatment ( n = 1,113 ; cumulative incidence analysis , P = 0.0002 ; recurrent events analysis , P = 0.002 ) .


No difference in treatment response by sex ( P = 0.75 ) , presence of chronic bronchitis ( P = 0.19 ) , concomitant inhaled therapy ( P = 0.29 ) , or supplemental oxygen use ( P = 0.23 ) was observed .


Older age and milder Global Initiative for Chronic Obstructive Lung Disease stage were associated with better treatment response ( P = 0.02 and 0.04 , respectively ) .


A significant interaction between treatment and current smoking was seen ( P = 0.03 ) and azithromycin did not reduce exacerbations in current smokers ( hazard ratio , 0.99 ; 95 % confidence interval , 0.71-1 .38 ; P = 0.95 ) .


Azithromycin is most effective in preventing AECOPD requiring both antibiotic and steroid treatment .


Adjusting for confounders , we saw no difference in efficacy by sex , history of chronic bronchitis , oxygen use , or concomitant COPD therapy .


Greater efficacy was seen in older patients and milder Global Initiative for Chronic Obstructive Lung Disease stages .


We found little evidence of treatment effect among current smokers .


Clinical trial registered with www.clinicaltrials.gov ( NCT0011986 and NCT00325897 ) .


Current osteoporosis medications increase bone mineral density ( BMD ) modestly and reduce , but do not eliminate , fracture risk .


Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful .


Conversely , 12 months of concomitant denosumab and teriparatide therapy increases BMD more than either drug alone .


The purpose of this study was to determine whether 24 months of combined denosumab and teriparatide will increase hip and spine BMD more than either individual agent .


Preplanned continuation of the Denosumab and Teriparatide Administration ( DATA ) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide ( 20 g daily ) , denosumab ( 60 mg every 6 months ) , or both medications for 24 months .


Participants were 94 postmenopausal women with osteoporosis .


Lumbar spine , femoral neck , total hip , and distal radius BMD and serum markers of bone turnover were measured .


At 24 months , lumbar spine BMD increased more in the combination group ( 12.9 5.0 % ) than in either the teriparatide ( 9.5 5.9 % , P = .01 ) or denosumab ( 8.3 3.4 % , P = .008 ) groups .


Femoral neck BMD also increased more in the combination group ( 6.8 3.6 % ) than in either the teriparatide ( 2.8 3.9 % , P = .003 ) or denosumab ( 4.1 3.8 % , P = .008 ) groups .


Similarly , total hip BMD increased more in the combination group ( 6.3 2.6 % ) than in the teriparatide ( 2.0 3.0 % ) or denosumab ( 3.2 2.5 % ) groups ( P < .001 for both ) .


Although spine and hip BMD continued to increase in the second year in all groups , these year 2 increases did not differ among groups .


Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the denosumab and combination groups , whereas osteocalcin decreased more in the denosumab group than in the combination group , a difference that persisted , but lessened , in the second year of therapy .


Two years of concomitant teriparatide and denosumab therapy increases BMD more than therapy with either medication alone and more than has been reported with any current therapy .


The combination of these agents may prove to be an important treatment option in patients at high risk of fracture .


Biocompatible solutions may lower peritonitis rates , but are more costly than conventional solutions .


The aim of the present study was to assess the additional costs and health outcomes of biocompatible over conventional solutions in incident peritoneal dialysis patients to guide practice decisions .


Secondary economic evaluation of a randomized controlled trial .


185 participants in the balANZ trial .


Cost-effectiveness of biocompatible compared to standard solution over the 2 years using an Australian health care funder perspective .


Intervention group received biocompatible solutions and control group received standard solutions over 2 years .


Costs included dialysis charges , costs of treating peritonitis , non-peritonitis-related hospital stays , and medication .


Peritonitis was the health outcome of interest ; incremental cost-effectiveness ratios were reported in terms of the additional cost per additional patient avoiding peritonitis at 2 years .


Mean total per-patient costs were A$ 57,451 and A$ 53,930 for the biocompatible and standard-solution groups , respectively .


The base-case analysis indicated an incremental cost of A$ 17,804 per additional patient avoiding peritonitis at 2 years for biocompatible compared to standard solution .


In a sensitivity analysis excluding extreme outliers for non-peritonitis-related hospitalizations , mean per-patient costs were A$ 49,159 and A$ 52,009 for the biocompatible and standard-solution groups , respectively .


Consequently , the incremental cost-effectiveness ratio also was reduced significantly : biocompatible solution became both less costly and more effective than standard solution and , in economic terms , was dominant over standard solution .


Peritonitis was a secondary outcome of the balANZ trial .


Health outcomes measured only in terms of patients avoiding peritonitis over 2 years may underestimate the longer term benefits ( eg , prolonged technique survival ) .


Biocompatible dialysis solutions may offer a cost-effective alternative to standard solutions for peritoneal dialysis patients .


Reductions in peritonitis-related hospital costs may offset the higher costs of biocompatible solution .


Nasal polyposis ( NP ) is defined as a specific form of chronic rhinosinusitis ( CRS ) , characterized by bilateral and multifocal polyps .


Functional endoscopic sinus surgery represents the gold standard therapy when medical treatment fails .


The availability of different tools raises the question of which one provides significant advances in technique and surgical outcome .


This study considered the outcome of the surgical treatment of NP in relation to several comorbidities and the surgical device used : the microdebrider versus the Blakesley traditional forceps .


Other studies compared the two instruments but did not evaluate the clinical relevance of history of comorbidities such as asthma , allergy , and eosinophilia .


A prospective randomized single-blind study was designed to analyze 311 cases of bilateral CRS with NP .


Each patient served as his/her own control , meaning that one side was operated on using the Blakesley forceps and the opposite side using the microdebrider .


The follow-up period was 13.3 1.2 months .


The Blakesley forceps caused a significantly lower NP recurrence rate than the microdebrider ( p < 0.001 ) , which was more effective in preventing synechia formation ( p < 0.05 ) .


Only asthma was significantly associated with a higher recurrence rate , without being influenced by the instrument used ( p < 0.001 ) .


The manual instrument allowed for a significantly lower recurrence incidence but yielded a higher rate of synechia formation compared with the microdebrider .


Only asthma was significantly associated with a poorer clinical outcome , and gender , age , allergy , and eosinophilia did not affect the surgical prognosis .


We assessed the effectiveness of a worksite management intervention ( the 3W program ) for overweight and obese hotel employees .


The program was tested in a 2-year cluster-randomized trial involving 30 hotels that employed nearly 12,000 individuals .


All participating hotels were on Oahu , Hawaii .


The intervention was implemented within hotel worksites .


Participants were included in the analysis if they had an initial body mass index ( BMI ) 25 , were assessed at least twice , were not missing other data needed for the analysis , and did not switch to employment at a hotel in a different experimental condition .


Of the 6519 employees we assessed , data from 1207 individuals ( intervention : 598 ; control : 610 ) met these criteria and contributed to the analysis .


The intervention had two components : ( 1 ) group meetings and ( 2 ) a workplace environment intervention .


Weight and waist to height ratio ( WHtR ) were measured at three annual assessments .


The effect of the intervention on change in BMI and WHtR was estimated in hierarchical mixed regression models using full maximum likelihood to estimate model parameters .


The effects on change in BMI and WHtR were in the expected direction but were not statistically significant .


The 3W program was not effective .


The low intensity of the intervention may have contributed to its ineffectiveness .


To determine whether kangaroo holding of healthy preterm infants over the first eight weeks of an infant 's life facilitates co-regulation of salivary cortisol between mother and infant .


Randomized control trial .


Infants were assigned to receive 1h of daily kangaroo ( skin-to-skin contact on the chest of mother ) or blanket holding ( dressed and held in mother 's arms ) .


A registered nurse visited mothers weekly for eight weeks to encourage holding and provide information about infant development .


A control group had no holding restrictions and received weekly brief social visits .


The study included 79 preterm infants , born between 32 and 35weeks gestational age and were a mean of 15days ( 5.7 ) at enrollment .


Co-regulation was conceptualized as progressive reduction in the absolute difference between mother and infant cortisol levels across 60min of holding at each holding session .


Mother and infant cortisol levels were measured before holding and at 30 and 60min after holding began during three holding sessions ( baseline and at two and eight weeks after study initiation ) .


Primary analyses were conducted using hierarchical linear models .


There was much variability in cortisol levels .


Levels of mother and infant cortisol decreased during holding .


No significant co-regulation occurred in any group at any holding session or over time .


Decreasing level of cortisol in both mothers and infants suggests that holding promoted the expected decline in stress hormone levels .


However , supported holding methods did not differentially affect co-regulation compared to controls .


Holding is pleasurable and stress may need to be present in order for mothers and infants to demonstrate co-regulation in cortisol levels .


The drug treatments of choice for obsessive-compulsive disorder ( OCD ) are serotonin reuptake inhibitors ( SRIs ) .


However , a correlation between the neuropeptide oxytocin in cerebrospinal fluid and the severity of OCD has previously been shown , and oxytocin and serotonin are interconnected within the brain .


Few studies have investigated whether SRIs have any effect on oxytocin ; thus , our aim was to explore the possibility that oxytocinergic mechanisms contribute to the anti-obsessive effect of SRIs .


In a randomized , double-blind trial , comparing SRIs ( clomipramine and paroxetine ) with placebo in 36 adults with OCD ( characterized for subtypes ) , plasma oxytocin was measured with radioimmunoassay after plasma extraction , at baseline , after 1 week , and after 4 weeks of treatment , and related to baseline severity and clinical response after 12 weeks , as measured by the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) .


Baseline oxytocin levels correlated positively with baseline Y-BOCS ratings , but only among the future SRI responders .


Patients with early onset of OCD had higher baseline oxytocin .


During treatment , plasma oxytocin did not differ between SRI and placebo treatment .


In SRI responders , plasma oxytocin first decreased and then increased ; in non-responders ( to SRI as well as to placebo ) , the reverse was the case .


After 4 weeks , treatment responders had attained higher oxytocin levels compared to non-responders .


The intra-individual range ( i.e. , the variability ) of plasma oxytocin between measurements was the measure that best differentiated responders from non-responders .


This range was higher in responders than non-responders , and lower in patients with autistic traits .


SRIs have highly variable effects on plasma oxytocin between individuals .


The associations between baseline oxytocin and OCD severity and between oxytocin changes and treatment response support the notions that oxytocin is involved in OCD pathophysiology , and that the anti-obsessive effects of SRIs are partly exerted through oxytocinergic mechanisms .


To investigate the intra-ocular pressure ( IOP ) - lowering effects of a selective Rho kinase inhibitor , ripasudil ( K-115 ) , over 24 hr in patients with primary open-angle glaucoma ( POAG ) or ocular hypertension ( OHT ) .


In this multicenter , prospective , randomized , open-label , 3-period , Latin-square crossover clinical study , 28 patients with POAG or OHT whose IOP level was 21 mmHg or higher were subdivided into three groups .


Each patient was treated with placebo and ripasudil in concentrations of 0.2 and 0.4 % , at 9:00 and 21:00 on day 1 through a total of 3 periods separated by washout periods .


IOP was measured at 9:00 , 10:00 , 11:00 , 13:00 , 16:00 , 19:00 , 21:00 , 22:00 and 23:00 on day 1 , and 1:00 , 4:00 , 7:00 and 9:00 on day 2 in sitting position using Goldmann applanation tonometer .


Main outcome measure was the IOP reduction of placebo and ripasudil from baseline .


The mean IOP reduction was -5.2 mmHg for 0.2 % , -6.4 mmHg for 0.4 % and -2.0 mmHg for placebo at 2 hr after the first instillation .


Also , the corresponding values were -6.8 mmHg for 0.2 % , -7.3 mmHg for 0.4 % and -4.1 mmHg for placebo at 2 hr after the second instillation .


Statistically significant IOP reduction , compared with placebo , was found for both 0.2 and 0.4 % from 1 through 7 hr after each instillation .


In safety , conjunctival hyperaemia was observed in 22 patients ( 79 % ) for 0.2 % , 27 patients ( 96 % ) for 0.4 % and three patients ( 11 % ) for placebo .


Ripasudil is a promising new topical medication to lower IOP for at least 7 hr after instillations in patients with POAG or OHT .


Extremely preterm babies ( delivered at < 28 completed weeks of gestation ) are frequently diagnosed with hypotension and treated with inotropic and pressor drugs in the immediate postnatal period .


Dopamine is the most commonly used first-line drug .


Babies who are treated for hypotension more frequently sustain brain injury , have long-term disability or die compared to those who are not .


Despite the widespread use of drugs to treat hypotension in such infants , evidence for efficacy is lacking , and the effect of these agents on long-term outcomes is unknown .


In extremely preterm babies , restricting the use of dopamine when mean blood pressure ( BP ) values fall below a nominal threshold and using clinical criteria to determine escalation of support ( ` restricted ' approach ) will result in improved neonatal and longer-term developmental outcomes .


RESEARCH PLAN : In an international multi-centre randomised trial , 830 infants born at < 28 weeks of gestation , and within 72 h of birth , will be allocated to 1 of 2 alternative treatment options ( dopamine vs. restricted approach ) to determine the better strategy for the management of BP , using a conventional threshold to commence treatment .


The first co-primary outcome of survival without brain injury will be determined at 36 weeks ' postmenstrual age and the second co-primary outcome ( survival without neurodevelopmental disability ) will be assessed at 2 years of age , corrected for prematurity .


It is essential that appropriately designed trials be performed to define the most appropriate management strategies for managing low BP in extremely preterm babies .


Cytotoxic T-lymphocyte-associated antigen 4 ( CTLA-4 ) blockade with ipilimumab prolongs survival in patients with metastatic melanoma .


CTLA-4 blockade and granulocyte-macrophage colony-stimulating factor ( GM-CSF ) - secreting tumor vaccine combinations demonstrate therapeutic synergy in preclinical models .


A key unanswered question is whether systemic GM-CSF ( sargramostim ) enhances CTLA-4 blockade .


To compare the effect of ipilimumab plus sargramostim vs ipilimumab alone on overall survival ( OS ) in patients with metastatic melanoma .


The Eastern Cooperative Oncology Group ( ECOG ) conducted a US-based phase 2 randomized clinical trial from December 28 , 2010 , until July 28 , 2011 , of patients ( N = 245 ) with unresectable stage III or IV melanoma , at least 1 prior therapy , no central nervous system metastases , and ECOG performance status of 0 or 1 .


Patients were randomized to receive ipilimumab , 10 mg/kg , intravenously on day 1 plus sargramostim , 250 g subcutaneously , on days 1 to 14 of a 21-day cycle ( n = 123 ) vs ipilimumab alone ( n = 122 ) .


Ipilimumab treatment included induction for 4 cycles followed by maintenance every fourth cycle .


Primary end point : comparison of length of OS .


Secondary end point : progression-free survival ( PFS ) , response rate , safety , and tolerability .


Median follow-up was 13.3 months ( range , 0.03-19 .9 ) .


Median OS as of December 2012 for ipilimumab plus sargramostim was 17.5 months ( 95 % CI , 14.9-not reached ) vs 12.7 months ( 95 % CI , 10.0-not reached ) for ipilimumab .


The 1-year survival rate for ipilimumab plus sargramostim was 68.9 % ( 95 % CI , 60.6 % -85.5 % ) compared to 52.9 % ( 95 % CI , 43.6 % -62.2 % ) for ipilimumab alone ( stratified log-rank 1-sided P = .01 ; mortality hazard ratio 0.64 [ 1-sided 90 % repeated CI , not applicable-0 .90 ] ) .


A planned interim analysis was conducted at 69.8 % of expected events ( 104 observed with 149 expected deaths ) .


Planned interim analysis using the O'Brien-Fleming boundary was crossed for improvement in OS .


There was no difference in PFS .


Median PFS for ipilimumab plus sargramostim was 3.1 months ( 95 % CI , 2.9-4 .6 ) vs 3.1 months ( 95 % CI , 2.9-4 .0 ) for ipilimumab alone .


Grade 3 to 5 adverse events occurred in 44.9 % ( 95 % CI ; 35.8 % -54.4 % ) of patients in the ipilimumab plus sargramostim group vs 58.3 % ( 95 % CI , 49.0 % -67.2 % ) of patients in the ipilimumab-alone group ( 2-sided P = .04 ) .


Among patients with unresectable stage III or IV melanoma , treatment with ipilimumab plus sargramostim vs ipilimumab alone resulted in longer OS and lower toxicity , but no difference in PFS .


These findings require confirmation in larger studies with longer follow-up .


clinicaltrials.gov Identifier : NCT01134614 .


This paper aimed to evaluate the effects of coadministered immediate-release morphine and ethanol on safety , pharmacokinetic , and pharmacodynamic measures .


In the first stage of a randomized , double-blind , placebo-controlled , crossover study , 16 healthy men with a history of moderate drinking received morphine 50 mg + ethanol 0.7 g/kg , morphine 50 mg + ethanol placebo , and morphine placebo + ethanol 0.7 g/kg .


In the second stage , participants received either a lower ( 30 mg ) or higher ( 80 mg ) morphine dose ( alone and in combination with ethanol ) depending on their tolerability to treatments in stage 1 .


Safety , pharmacodynamic ( including visual analog scales , pupillometry , capnography , and psychomotor and cognitive measures ) , and pharmacokinetic assessments were conducted .


With the exception of one severe adverse event ( AE ) , all others were mild or moderate in intensity .


Morphine resulted in dose-related increases in AEs .


When morphine was administered with ethanol , similar AEs were observed ( dizziness , headache , somnolence , nausea , and vomiting ) , but these were sometimes more frequent compared with those observed with either drug alone .


No consistent additive or interaction effects were observed on pharmacodynamic measures .


Ethanol had no apparent effects on the pharmacokinetics of morphine or its metabolites .


Coadministration of single doses of morphine and ethanol tested in this study did not affect the safety , pharmacodynamics , or pharmacokinetics of morphine or ethanol administered alone .


Copyright 2014 John Wiley & Sons , Ltd. .


To assess the plaque removal efficacy of an oscillating-rotating power brush relative to a newly-introduced sonic power brush .


This study used a randomized , examiner-blind , single-center , two-treatment , parallel group 4-week design .


Subjects with pre-existing plaque scores of at least 1.75 on the Turesky Modification of the Quigley-Hein Plaque Index ( TMQHPI ) were evaluated for baseline whole mouth and approximal plaque scores .


They received either the oscillating-rotating brush ( Oral-B Professional Care 1000 , sold as Oral-B Professional Care 600 in some regions , with the Oral-B Precision Clean brush head , D16u/EB20 ) or the sonic brush ( Colgate ProClinical C200 with Colgate Triple Clean brush head ) and brushed twice-daily with the assigned brush and a standard fluoride dentifrice for 4 weeks before returning for plaque measurements .


Prior to baseline and the Week 4 measurements , participants abstained from oral hygiene for 12 hours and from eating , chewing gum and drinking for 4 hours .


A total of 131 subjects were enrolled in the study at baseline , with all completing the study : 65 in the oscillating-rotating group , and 66 in the sonic group .


Both brushes significantly reduced plaque over the 4-week study period .


The oscillating-rotating brush was statistically significantly more effective in reducing plaque ( P < 0.001 ) than the sonic brush .


Compared to the sonic power brush , the adjusted mean plaque reduction scores for the oscillating-rotating power brush were more than five times greater for whole mouth and approximal areas .


The objective of this study was to evaluate possible mechanisms for functional improvement and compare ambulation training with surface peroneal nerve stimulation vs. usual care via quantitative gait analysis .


This study is a randomized controlled clinical trial .


The setting of this study is a teaching hospital of an academic medical center .


One hundred ten chronic stroke survivors ( > 12 wks poststroke ) with unilateral hemiparesis participated in this study .


The subjects were randomized to a surface peroneal nerve stimulation device or usual care intervention .


The subjects were treated for 12 wks and followed up for 6-mo posttreatment .


Spatiotemporal , kinematic , and kinetic parameters of gait were the main outcome measures .


Cadence ( F3 ,153 = 5.81 , P = 0.012 ) , stride length ( F3 ,179 = 20.01 , P < 0.001 ) , walking speed ( F3 ,167 = 18.2 , P < 0.001 ) , anterior-posterior ground reaction force ( F3 ,164 = 6.61 , P = 0.004 ) , peak hip power in preswing ( F3 ,156 = 8.76 , P < 0.001 ) , and peak ankle power at push-off ( F3 ,149 = 6.38 , P = 0.005 ) all improved with respect to time .


However , peak ankle ankle dorsiflexion in swing ( F3 ,184 = 4.99 , P = 0.031 ) worsened .


In general , the greatest change for all parameters occurred during the treatment period .


There were no significant treatment group time interaction effects for any of the spatiotemporal , kinematic , or kinetic parameters .


Gait training with peroneal nerve stimulation and usual care was associated with improvements in peak hip power in preswing and peak ankle power at push-off , which may have resulted in improved cadence , stride length , and walking speed ; however , there were no differences between treatment groups .


Both treatment groups also experienced a decrease in peak ankle ankle dorsiflexion in swing , although the clinical implications of this finding are unclear .


To investigate the effectiveness of four-channel FES based on a normal gait pattern on improving functional ability in subjects early after ischemic stroke .


Forty-five subjects were randomly assigned into a four-channel FES group ( n = 16 ) , a placebo group ( n = 15 ) , or a dual-channel group ( n = 14 ) .


Stimulation lasted for 30min in each session with 1 session/day , 5 days a week for 3 weeks .


All subjects were assessed at baseline , at 3 weeks of treatment , and at 3 months after the treatment had finished .


The assessments included Fugl-Meyer Assessment ( FMA ) , the Postural Assessment Scale for Stroke Patients ( PASS ) , Berg Balance Scale ( BBS ) , Functional Ambulation Category ( FAC ) , and the Modified Barthel Index ( MBI ) .


All 3 groups demonstrated significant improvements in all outcome measurements from pre - to posttreatment and further gains at followup .


The score of FMA and MBI improved significantly in the four-channel group at the end of the 3 weeks of training .


And the scores of PASS , BBS , MBI , and FAC in the four-channel group were significantly higher than those of the placebo group .


This study indicated that four-channel FES can improve motor function , balance , walking ability , and performance of activities of daily living in subjects with early ischemic stroke .


Topical application of tranexamic acid to the knee joint before closure in total knee arthroplasty reduces postoperative bleeding without increase in complication .


However , it is unknown the effectiveness of topic TXA performed with other topical medications , like povidone-iodine solution .


One hundred and twenty-five patients were randomized to receive 100mL of povidone-iodine solution ( control : group A ) or 1.5 ( group B ) and 3.0 g ( group C ) of topical TXA in povidone-iodine solution applied into the knee before closure in total knee arthroplasty .


The patients in the TXA groups had higher mean postoperative hemoglobin levels ( P = 0.01 and P = 0.03 in groups B and C , respectively ) and a reduced postoperative blood loss in the TXA groups ( P = 0.07 and P = 0.09 in groups B and C , respectively ) .


No significant complications were observed .


In this study , topical application of tranexamic acid after total knee arthroplasty together with povidone-iodine solution results in higher postoperative hemoglobin levels and lower blood loss compared with those in the control group without other complications .


I - I : high-powered prospective randomized trial .


Identifying pretreatment dietary habits that are associated with weight-loss intervention outcomes could help guide individuals ' selection of weight-loss approach among competing options .


A pretreatment factor that may influence weight-loss outcomes is macronutrient intake .


Overweight and obese Durham Veterans Affairs outpatients were randomised to a weight-loss intervention with a low-carbohydrate diet ( n = 71 ) or orlistat medication therapy plus a low-fat diet ( n = 73 ) .


Percentage fat , carbohydrate and protein intake prior to treatment were measured using 4-day food records .


Linear mixed-effects models were used to determine whether pretreatment percentage macronutrient intake influenced weight trajectories and weight loss in each weight-loss condition .


Participant 's mean age was 53 years , baseline body mass index was 39.3 kg m ( -2 ) and 72 % were male .


A higher pretreatment percentage carbohydrate intake was associated with less rapid initial weight loss ( P = 0.02 ) and less rapid weight regain ( P = 0.03 ) in the low-carbohydrate diet condition but was not associated with weight trajectories in the orlistat plus low-fat diet condition .


In both conditions , a higher pretreatment percentage fat intake was associated with more rapid weight regain ( P < 0.01 ) .


Pretreatment percentage protein intake was not associated with weight trajectories .


None of the pretreatment macronutrients were associated with weight loss on study completion in either condition .


Selection of a weight-loss approach on the basis of pretreatment macronutrient intake is unlikely to improve weight outcomes at the end of a 1-year treatment .


However , pretreatment macronutrient intake may have implications for tailoring of interventions to slow weight regain after weight loss .


Chronic severe tinnitus can be greatly detrimental to quality of life .


Some authors have reported benefit of repetitive transcranial magnetic stimulation , others of electrical cortical stimulation by stimulating the Heschl 's gyrus or secondary auditory areas .


To evaluate the efficacy of chronic electrical epidural stimulation of the auditory cortex on severe and disabling tinnitus .


In this double-blind randomized cross-over , patients with chronic ( at least 2 years ) , severe ( Strukturierte Tinnitus-Interview , STI score > 19 ) , unilateral or strongly lateralized tinnitus were included .


After open-phase stimulation for 4 months , patients were randomized into 2 groups for double-blind stimulation with cross-over between significant and non-significant phases and wash-out in between .


Each of the 3 phases was 2 weeks in duration .


Patients were chronically stimulated and followed if not explanted .


A decrease of STI score > 35 % was considered as clinically significant .


None of the 9 patients included achieved significant improvement during the double-blind phase .


Four were explanted , 2 owing to lack of effect , one for breast cancer under the stimulator , and another for psychiatric decompensation .


Five are still stimulated .


Three felt slight to great subjective effectiveness , the remaining 2 reported benefits and still requested stimulation .


This study did not find an objective efficiency of chronic cortical stimulation for severe and resistant tinnitus .


The discordance between the results in double-blind and open evaluations could be related to a placebo effect of surgery , but may also be explained by a poorly defined target , a too short randomized phase , or inappropriate outcome measures .


Clinical trial reference : NCT00486577 .


To evaluate critically visual field ( VF ) improvement in participants in the Collaborative Initial Glaucoma Treatment Study ( CIGTS ) .


Prospective , comparative case series from a randomized clinical trial comparing trabeculectomy and topical medications in treating open-angle glaucoma ( OAG ) .


A total of 607 subjects with newly diagnosed OAG were identified for study .


Baseline and follow-up VF tests were obtained and mean deviation ( MD ) change from baseline over follow-up was analyzed .


Clinically substantial change ( loss or improvement ) was defined as change from baseline of 3 decibels in MD. .


Baseline factors were inspected to determine their association with VF improvement in repeated measures regression models .


The percentage of participants showing substantial VF improvement over time was similar to that showing VF loss through 5 years after initial treatment , after which VF loss became more frequent .


Measures of better intraocular pressure ( IOP ) control during treatment were significantly predictive of VF improvement , including a lower mean IOP , a lower minimum IOP , and lower sustained levels of IOP over follow-up .


Other predictive factors included female sex ( odds ratio [ OR ] = 1.73 ) , visits 1 year prior to cataract extraction ( OR = 0.11 ) , and an interaction between treatment and baseline MD wherein surgically treated subjects with worse baseline VF loss were more likely to show VF improvement .


In the CIGTS , substantial VF loss and improvement were comparable through 5 years of follow-up , after which VF loss became more frequent .


Predictive factors for VF improvement included several indicators of better IOP control , which supports the postulate that VF improvement was real .


To examine the effect of cost , a traditionally `` inactive '' trait of intervention , as contributor to the response to therapeutic interventions .


We conducted a prospective double-blind study in 12 patients with moderate to severe Parkinson disease and motor fluctuations ( mean age 62.4 7.9 years ; mean disease duration 11 6 years ) who were randomized to a `` cheap '' or `` expensive '' subcutaneous `` novel injectable dopamine agonist '' placebo ( normal saline ) .


Patients were crossed over to the alternate arm approximately 4 hours later .


Blinded motor assessments in the `` practically defined off '' state , before and after each intervention , included the Unified Parkinson 's Disease Rating Scale motor subscale , the Purdue Pegboard Test , and a tapping task .


Measurements of brain activity were performed using a feedback-based visual-motor associative learning functional MRI task .


Order effect was examined using stratified analysis .


Although both placebos improved motor function , benefit was greater when patients were randomized first to expensive placebo , with a magnitude halfway between that of cheap placebo and levodopa .


Brain activation was greater upon first-given cheap but not upon first-given expensive placebo or by levodopa .


Regardless of order of administration , only cheap placebo increased activation in the left lateral sensorimotor cortex and other regions .


Expensive placebo significantly improved motor function and decreased brain activation in a direction and magnitude comparable to , albeit less than , levodopa .


Perceptions of cost are capable of altering the placebo response in clinical studies .


This study provides Class III evidence that perception of cost is capable of influencing motor function and brain activation in Parkinson disease .


To compare two strategies for colorectal cancer screening : one-time colonoscopy versus fecal immunochemical testing ( FIT ) ( and colonoscopy for positive ) every 2 years , in order to determine which strategy provides the highest participation and detection rates in groups of sex and age .


This analysis was performed with data from the first screening round within the COLONPREV study , a population-based , multicenter , nationwide trial carried out in Spain .


Several logistic regression models were applied to identify the influence of the screening test on participation rates and detection of proximal and distal neoplasms , as well to identify the influence of age and sex : women aged 50-59 years , women aged 60-69 years , men aged 50-59 years , and men aged 60-69 years .


Participation was higher in women than in men , especially among women aged 50-59 years ( 25.91 % for colonoscopy and 35.81 % for FIT ) .


Crossover from colonoscopy to FIT was higher among women than men , especially among those aged 60-69 years ( 30.37 % ) .


In general , detection of any neoplasm and advanced adenoma was higher with colonoscopy than with FIT , but no significant differences were found between the two strategies for colorectal cancer detection .


Detection of advanced adenoma in both arms was lower in women [ specifically in women aged 50-59 years ( OR 0.31 ; 95 % CI 0.25-0 .38 ) than in men aged 60-69 years ] .


Women aged 50-59 years in the colonoscopy arm had a higher probability of detection of advanced adenoma ( OR 4.49 ; 95 % CI 3.18-6 .35 ) , as well as of detection of neoplasms in proximal and distal locations ( proximal OR 19.34 ; 95 % CI 12.07-31 .00 ; distal OR 11.04 ; 95 % CI 8.13-15 .01 ) than women of the same age in the FIT arm .


These differences were also observed in the remaining groups but to a lesser extent .


Women were more likely to participate in a FIT-based strategy , especially those aged 50-59 years .


The likelihood of detection of any neoplasm was higher in the colonoscopy arm for all the population groups studied , especially in women aged 50-59 years .


Distinct population groups should be informed of the benefits of each screening strategy so that they may take informed decisions .


The inverse association between physical activity and cancer risk may be mediated by higher melatonin levels .


However , few studies have examined the effect of increased physical activity on melatonin levels .


The parent study was a randomized controlled trial that randomized 51 men and 49 women to a 12-month moderate-to-vigorous aerobic exercise intervention ( `` exercisers '' ) and 51 men and 51 women to a stretching control ( `` controls '' ) .


Participants were of ages 40 to 75 years , and previously sedentary .


Levels of the principal urinary metabolite of melatonin , 6-sulfatoxymelatonin ( aMT6s ) , corrected for creatinine levels , were measured in spot morning urine samples by immunoassay at baseline and 12 months .


Changes in levels between exercisers and controls were compared using generalized estimating equations for linear regression .


We observed no statistically significant difference in the change in aMT6s levels from baseline to 12 months in exercisers compared with controls ( change in aMT6s levels : exercisers , +6.5 % ; controls , +13 % ; P = 0.66 ) .


There was no evidence of effect modification by age , sex , or body mass index .


A 12-month moderate-intensity exercise intervention did not affect levels of aMT6s .


Further research needs to focus on other potential mechanisms through which physical activity may reduce the risk of cancer .


Cancer Epidemiol Biomarkers Prev ; 23 ( 8 ) ; 1696-9 .2014 AACR .


Studies from European-American cultures consistently reported that expressive suppression was associated with worse emotional consequence ( e.g. depression ) in comparison with acceptance .


However , this conclusion may not apply to Chinese , as suppressing emotional displays to maintain relational harmony is culturally valued in East Asian countries .


Thus , the present study examined the effects of suppression and acceptance on the depressive mood induced by a frustrating task in a Chinese sample .


Sixty-four subjects were randomly assigned to one of three instructions : suppression , acceptance or no-regulation during a frustrating arithmetic task .


The experience of depressive emotion and skin conductance response ( SCR ) were recorded during pre-frustration baseline , frustration induction and post-frustration recovery phases , respectively .


Compared with the control and acceptance instructions , suppression instruction was associated with decreased depressive experiences and smaller SCR activity during frustration .


There were no significant differences between acceptance and control groups in both subjective depression and SCR activity during frustration .


Moreover , the suppression group showed a better emotional recovery after the frustrating task , in comparison with the acceptance and control groups .


Correlation analyses verified that SCR reactivity was a reliable index of experienced depression during the frustration .


Expressive suppression is effective in reducing depressive experiences and depression-related physiological activity ( SCR ) when Chinese people are involved .


By contrast , the acceptance of depressive emotion in Chinese people does not produce a similar regulation effect .


These findings suggest that cultural context should be considered in understanding the emotional consequences of suppression and acceptance strategies .


We evaluated the efficacy and safety of obeticholic acid ( OCA , - ethylchenodeoxycholic acid ) in a randomized controlled trial of patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid therapy .


We performed a double-blind study of 165 patients with primary biliary cirrhosis ( 95 % women ) and levels of alkaline phosphatase ( ALP ) 1.5 - to 10-fold the upper limit of normal .


Patients were randomly assigned to groups given 10 mg , 25 mg , or 50 mg doses of OCA or placebo , once daily for 3 months .


Patients maintained their existing dose of ursodeoxycholic acid throughout the study .


The primary outcome was change in level of ALP from baseline ( day 0 ) until the end of the study ( day 85 or early termination ) .


We also performed an open-label extension of the trial in which 78 patients were enrolled and 61 completed the first year .


OCA was superior to placebo in achieving the primary end point .


Subjects given OCA had statistically significant relative reductions in mean ALP from baseline to the end of the study ( P < .0001 all OCA groups vs placebo ) .


Levels of ALP decreased 21 % -25 % on average from baseline in the OCA groups and 3 % in the placebo group .


Sixty-nine percent ( 68 of 99 ) of patients given OCA had at least a 20 % reduction in ALP compared with 8 % ( 3 of 37 ) of patients given placebo ( P < .0003 ) .


Among secondary end points , levels of - glutamyl transpeptidase decreased 48 % -63 % , on average , among subjects given OCA , vs a 7 % decrease in the group given placebo ; levels of alanine aminotransferase decreased 21 % -35 % on average among subjects given OCA vs none of the patients given placebo .


Pruritus was the principal adverse event ; incidence values in the OCA 10 mg , 25 mg , and 50 mg groups were 47 % ( not significantly different ) , 87 % ( P < .0003 ) , and 80 % ( P < .006 ) , respectively , vs 50 % in the placebo group .


In the extension study , levels of ALP continued to decrease to a mean level of 202 11 U/L after 12 months vs 285 15 U/L at baseline .


Daily doses of OCA , ranging from 10 to 50 mg , significantly reduced levels of ALP , - glutamyl transpeptidase , and alanine aminotransferase , compared with placebo , in patients with primary biliary cirrhosis who had inadequate responses to ursodeoxycholic acid .


The incidence and severity of pruritus were lowest among patients who received 10 mg/d OCA .


Biochemical responses to OCA were maintained in a 12-month open-label extension trial .


ClinicalTrials.gov ID : NCT00550862 .


Functional endoscopic sinus surgery ( FESS ) is the mainstay of surgical treatment for sinonasal disease .


This surgery carries certain risks .


Most of these risks relate to the quality of the surgical field .


Thus , mechanisms by which the surgical field can be improved are important to study .


We sought to determine whether positive end-expiratory pressure ( PEEP ) had a deleterious effect on the quality of the surgical field in patients undergoing primary FESS .


Forty-seven patients were randomized to a ventilation strategy using either 5 cm H2O of PEEP or zero added PEEP .


The quality of the surgical field was measured every 15 minutes using a validated surgical scoring method .


The addition of PEEP did not have any measurable effect on the surgical field scores after onset of surgery ( odds ratio [ OR ] ( 95 % confidence interval [ CI ] ) = 1.06 ( 0.44-2 .58 ) , P = 0.895 for side 1 ; OR ( 95 % CI ) = 0.56 ( 0.16-1 .93 ) , P = 0.356 for side 2 ) .


The peak inspiratory pressure did have an effect on surgical grades .


Every cm H2O of added pressure over 15 cm H2O total pressure contributing to increased odds of higher surgical field score .


For each cm H2O increase in inspiratory pressure above 15cm H2O increased the surgical field score ( OR [ 95 % CI ] 1.13 [ 1.04-1 .22 ] , P = 0.002 ) .


During FESS surgery if PEEP is added , it is important to keep the mean inspiratory pressure below 15cm H2O to avoid worsening surgical field conditions .


In Japan , a traditional herbal medicine , Tokishigyakukagoshuyushokyoto ( TJ-38 ) , is often used for the treatment of peripheral coldness , which is a common complaint among Japanese women .


However , the effects of this herbal medicine have yet to be examined in a randomized controlled trial .


In the current study , the effect of TJ-38 on the peripheral blood flow in women experiencing peripheral coldness was investigated using a parallel-group randomized controlled trial .


Fifty-eight women aged 23 to 79 years with peripheral coldness were randomly divided into the intervention or control group .


They were examined using cold bathing tests , physical examinations , and questionnaires in January 2010 for the baseline and in March 2010 for the follow-up , and January 2011 and March 2011 , respectively .


At the baseline , there were no differences in clinical characteristics between the two groups .


In the intervention group , peripheral coldness improved after the intervention term ; however , it persisted in the control group .


Mean values of percentage recovery of the peripheral blood flow after cold bathing tests were 17.2 % and -28.2 % for the intervention and control groups , respectively ( p = 0.007 ) , and the proportions for percentage recovery of > 50 % were 32 % and 0 % , respectively ( p = 0.0007 ) .


Mean values of percent recovery of skin temperature did not differ between the two groups .


The present clinical trial supports that a traditional herbal medicine relieves peripheral coldness in women probably through the improvement of peripheral blood flow .


The aim of this study was to compare CKD-810 ( test docetaxel ) with Taxotere ( ) ( reference docetaxel ) in terms of pharmacokinetics and safety for patients with advanced or metastatic carcinoma .


A randomized , open-label , two-way crossover study was conducted in eligible patients .


Patients received with reference or test drugs of 75 mg/m ( 2 ) docetaxel by intravenous infusion for 60 min in the first period and the alternative drug in the second period with a washout of 3 weeks .


Plasma concentrations of docetaxel were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection .


Pharmacokinetic parameters , including the maximum plasma concentration ( C ( max ) ) and the area under the concentration-time curve ( AUC ) , were determined by non-compartmental analysis .


A total of 44 patients were included in the study , 21 patients received test drug and 23 received reference drug for the first cycle .


The C ( max ) of docetaxel was 2,658.77 ng/mL for test drug and 2,827.60 ng/mL for reference drug , and two drugs showed no difference with a statistical significance .


Time to reach C ( max ) ( T ( max ) ) of CKD-810 ( 0.94 h ) versus reference docetaxel ( 0.97 h ) was also not significantly different .


Other pharmacokinetic parameters including the plasma AUC , elimination half-life , and total body clearance exhibited similar values without a significant difference .


The most common grade 3 or 4 toxicity was neutropenia ( CKD-810 19.5 or 29.3 % ; reference docetaxel 14.6 or 41.5 % ) .


Febrile neutropenia was experienced by only one patient in each group .


Two patients died of progression of disease during the study .


Docetaxel anhydrous CKD-810 use with patients suffering advanced or metastatic solid malignancies was equivalent to reference docetaxel in terms of pharmacokinetic parameters and safety profile .


Additionally , the test and reference drug met the regulatory criteria for pharmacokinetic equivalence .


Young adulthood is a critical transition period for the development of health behaviors .


We present here the results of a randomized controlled trial of an online avatar-hosted personal health makeover program designed for young adult smokers .


We conducted a three-group randomized trial comparing delivery of general lifestyle content ( Tx1 ) , personally tailored health information ( Tx2 ) , and personally tailored health information plus online video-based peer coaching ( Tx3 ) as part of a 6-week online health program .


Participants were asked to set weekly goals around eating breakfast , exercise , alcohol use , and cigarette smoking .


Eligibility criteria included age ( 18-30 years ) and smoking status ( any cigarette use in the previous 30 days ) .


The primary outcome was self-reported 30-day abstinence measured 12 weeks postenrollment .


Participant ( n = 1698 ) characteristics were balanced across the groups ( 72 % women , mean age 24 , 26 % nonwhite , 32 % high school education or less , and 50 % daily smokers ) .


Considering intention to treat , 30-day smoking abstinence rates were statistically significantly higher in the intervention groups ( Tx1 = 11 % , Tx2 = 23 % , Tx3 = 31 % , P < .001 ) .


Participants in the intervention groups were also more likely to reduce their number of days spent on binge drinking and increase their number of days eating breakfast and exercising .


Overall , intervention group participants were much more likely to make positive changes in at least three or four of the target behaviors ( Tx1 = 19 % , Tx2 = 39 % , Tx3 = 41 % , P < .001 ) .


This online avatar-hosted personal health makeover `` show '' increased smoking abstinence and induced positive changes in multiple related health behaviors .


Addition of the online video-based peer coaching further improved behavioral outcomes .


Baseline abstinence goal is a robust predictor of cigarette abstinence .


However , important questions about goal remain unanswered .


These include variables correlating with goal , changes in goal , relationship of goal and abstinence status over time , and predictors of change .


The current study aimed to address these questions .


Participants were treatment-seeking volunteers in two clinical trials .


In Clinical Trial 1 ( N = 402 ) , participants smoked 10 cigarettes per day ( CPD ) and were 50years of age .


In Clinical Trial 2 ( N = 406 ) , participants smoked 10 CPD , smoked within 30min of arising , and were 18years of age .


The outcome variables were biochemically verified 7-day abstinence from cigarettes at weeks 12 , 24 , 52 , and 104 .


Abstinence goal , demographic , psychological , and smoking related variables were assessed via standard instruments .


At baseline , the greater the desire to quit and one 's expectations of success , and the lesser the educational level , the more likely participants were to have a quit forever goal .


Throughout the two-year study , abstinence from cigarettes and a lower educational level were correlated with a goal of quit forever ; 37 % of participants changed goal .


There were no predictors of goal change .


Abstinence goal was related to abstinence status across the study period .


The goal predicted abstinence status at subsequent assessments , even when status was controlled .


Lesser educational levels were consistent predictors of a more stringent goal .


Abstinence goal changes over time .


These findings suggest that repeated counseling about goal is advisable and participants would benefit from such counseling , independent of demographic characteristics and smoking status .


We investigated the satisfaction of patients and endoscopists and concurrently safety aspects of an `` alfentanil only '' and two clinically routinely used sedation regimes in patients undergoing colonoscopy in a teaching hospital .


One hundred and eighty patients were prospectively randomized in three groups : M ( midazolam/fentanyl ) , A ( alfentanil ) , and P ( propofol/alfentanil ) ; M and A were administered by an endoscopy nurse , P by an anesthesia nurse .


Interventions , heart rate , saturation , electrocardiogram , noninvasive blood pressure , and expiratory CO were monitored using video assistance .


After endoscopy , patients and gastroenterologists completed questionnaires about satisfaction .


A high level of satisfaction was found in all groups , with patients in group P being more satisfied with their sedation experience ( median 1.75 , p < 0.001 ) .


Gastroenterologist satisfaction varied not significantly between the three alternatives .


Patients in group A felt less drowsy , could communicate more rapidly than patients in both other groups , and met discharge criteria immediately after the end of the procedure .


Respiratory events associated with sedation were observed in 43 % patients in group M , 47 % in group P , but only 13 % in group A ( p < 0.001 ) .


These results suggest that alfentanil could be an alternative for sedation in colonoscopy even in the setting of a teaching hospital .


It results in satisfied patients easily taking up information , and recovering rapidly .


Although one might expect to observe more respiratory depression with an `` opioid only '' sedation technique without involvement of anesthesia partners , respiratory events were less frequent than when other methods were used .


`` Difficult visits '' are common in primary care and may contribute to primary care provider ( PCP ) career dissatisfaction and burnout .


Patient requests occur in approximately half of primary care visits and may be a source of clinician-patient miscommunication or conflict , contributing to perceived visit difficulty .


We aimed to determine associations between types of patient requests and PCP-perceived visit difficulty .


This was an observational study , nested in a multicenter randomized trial of depression engagement interventions .


We included 824 patient visits within 135 PCP practices in Northern California occurring from June 2010 to March 2012 .


PCP-perceived visit difficulty was quantified using a three-item scale ( relative visit difficulty , amount of effort required , and amount of time required ; Cronbach 's = 0.81 ) .


Using linear regression , the difficulty scale ( score range 0-2 from least to most difficult ) was modeled as a function of : patient requests for diagnostics tests , pain medications , and specialist referrals ; PCP perception of likely depression or likely substance abuse ; patient sociodemographics , comorbidity , depression ; PCP characteristics and practice setting .


Patients requested diagnostic tests , pain medications , and specialist referrals in 37.2 , 20.0 and 30.0 % of visits , respectively .


After adjustment for patient medical and psychiatric complexity , perceived difficulty was significantly higher when patients requested diagnostic tests [ parameter estimate ( PE ) 0.11 , ( 95 % CI : 0.03 , 0.20 ) ] but not when patients requested pain medications [ PE -0.04 ( 95 % CI : -0.15 , 0.08 ) ] or referrals [ PE 0.04 ( 95 % CI : -0.07 , 0.25 ) ] .


PCP-perceived visit difficulty is associated with patient requests for diagnostic tests , but not requests for pain medications or specialist referrals .


In this era of `` choosing wisely , '' PCPs may be challenged to respond to diagnostic test requests in an evidence-based manner , while maintaining the provider-patient relationship and PCP career satisfaction .


To determine whether the Canine Orthopedic Index ( COI ) can detect changes in dogs with osteoarthritis ( OA ) treated with either non-steroidal anti-inflammatory drugs ( NSAID ) or placebo .


Double blind randomized placebo controlled trial .


Dogs ( n = 80 ) with OA .


Owners completed the COI on Day 0 .


Dogs were administered either carprofen or placebo on days 1 through 14 .


Owners completed the COI again on Day 14 .


The change in total instrument , stiffness , gait , function , and quality of life scores were assessed between groups .


Dogs administered carprofen had significant decreases in the total instrument score ( P = .002 ) as well as 3 of the 4 factor scores compared to dogs treated with placebo ( stiffness score P = .015 ; gait score P = .001 ; and function score = 0.008 ) .


The change in quality of life score was not significantly different between carprofen and placebo treated dogs ( P = .124 ) .


The COI delivered the decreases in total instrument , stiffness , gait , and function scores that one would expect in dogs with OA treated with an NSAID compared with placebo administration .


In this cohort of dogs , the quality of life score was not sensitive to the changes associated with NSAID administration .


Various voice therapy techniques include not only phonation exercises but also measure to regulate tonus of non-larynx related muscles .


This is based on the belief that the use of non-laryngeal muscles may affect laryngeal muscle action during phonation onset und phonation .


Here we raised the question if indeed a well defined activation of muscles distant to the larynx may effect phonation onset time and the vibratory cycles following thereafter .


Prospective partly randomized single center pilot study with 8 healthy volunteers .


Analysed variables were time of phonation onset and closed quotient ( Qx ) derived via electroglottgraphy .


According to a randomization protocol volunteers had to press a training device ( + condition ) or to keep the hand quiet ( - condition ) .


Comparism of both conditions did not reveal any significant difference , however Qx tended to be higher in the + condition .


The data presented here does not confirm that activation of hand muscles influences phonation onset time .


However the preceding vibratory cycles may be altered towards a higher tone of intralaryngeal muscles regulating vocal fold tension .


Further studies including more volunteers or patients with functional voice disorders and protocols employing the activation of other muscle groups are warranted in order to shed more light into the interrelationship between larynx and other muscle activation during phonation .


This study was aimed to evaluate the accuracy of `` True Fast Imaging with Steady-State Precession '' ( TrueFISP ) MR angiography ( MRA ) for diagnosis of renal arterial stenosis ( RAS ) in hypertensive patients .


Twenty-two patients underwent both TrueFISP MRA and contrast-enhanced MRA ( CE-MRA ) on a 1.5-T MR imager .


Volume of main renal arteries , length of maximal visible renal arteries , number of visualized branches , stenotic grade , and subjective quality were compared .


Paired 2-tailed Student t test and Wilcoxon signed rank test were applied to evaluate the significance of these variables .


Volume of main renal arteries , length of maximal visible renal arteries , and number of branches indicated no significant difference between the 2 techniques ( P > 0.05 ) .


Stenotic degree of 10 RAS was greater on CE-MRA than on TrueFISP MRA .


Qualitative scores from TrueFISP MRA were higher than those from CE-MRA ( P < 0.05 ) .


TrueFISP MRA is a reliable and accurate method for evaluating RAS .


The Roland Morris Questionnaire ( RMQ ) is a widely used health status measure for low back pain ( LBP ) .


It is not preference-based , and there are currently no established algorithms for mapping between the RMQ and preference-based health-related quality-of-life measures .


Using data from randomized controlled trials of treatment for LBP , we sought to develop algorithms for mapping between RMQ scores and health utilities derived using either the EuroQol five-dimensional questionnaire ( EQ-5D ) or the six-dimensional health state short form ( derived from Medical Outcomes Study 36-Item Short-Form Health Survey ) ( SF-6D ) .


This study is based on data from the Back Skills Training Trial in which data were collected from 701 patients at baseline and subsequently at 3 , 6 , and 12 months postrandomization using a range of outcome measures , including the RMQ , the EQ-5D , and the Short Form 12 item Health Survey ( SF-12 ) ( from which SF-6D utilities can be derived ) .


We used baseline trial data to estimate models using both direct and response mapping approaches to predict EQ-5D and SF-6D health utilities and dimension responses .


A multistage model selection process was used to assess the predictive accuracy of the models .


We then explored different techniques and mapping models that made use of repeated follow-up observations in the data .


The estimated mapping algorithms were validated using external data from the UK Back Pain Exercise and Manipulation trial .


A number of models were developed that accurately predict health utilities in this context .


The best performing model for RMQ to EQ-5D mapping was a beta regression with Bayesian quasi-likelihood estimation that included 24 dummy variables for RMQ responses , age , and sex as covariates ( mean squared error 0.0380 ) based on repeated data .


The model selected for RMQ to SF-6D mapping was a finite mixture model that included the overall RMQ score , age , sex , RMQ score squared , age squared , and an interaction term for age and RMQ score as covariates ( mean squared error 0.0114 ) based on repeated data .


It is possible to reasonably predict EQ-5D and SF-6D health utilities from RMQ scores and responses using regression methods .


Our regression equations provide an empirical basis for estimating health utilities when EQ-5D or SF-6D data are not available .


They can be used to inform future economic evaluations of interventions targeting LBP .


To investigate the role of preoperative biometry for selecting initial contact lens power .


Patients randomized to receive contact lenses in the Infant Aphakia Treatment Study ( IATS ) were retrospectively analyzed .


Inclusion criteria were availability of both a preoperative immersion axial length measurement and a 1-month postoperative refractive value .


The target contact lens power for distance was determined using 1-month postoperative spherical equivalent refraction ( after adjusting for a vertex distance ) over the known contact lens power .


We compared targeted contact lens power for distance with three other treatment techniques : ( 1 ) 30 D contact lens ( 32 D minus 2 D overcorrection for near vision based on IATS protocol ) ; ( 2 ) regression-estimated contact lens power of 84.4 - 3.2 axial length ; and ( 3 ) IOL power calculated using the Sanders-Retzlaff-Kraff ( SRK/T ) regression formula with a modified A-constant ( 112.176 ) .


Prediction error ( targeted minus estimated contact lens power ) and its absolute values were calculated .


A total of 34 eyes of 34 patients met inclusion criteria .


Age at the time of cataract surgery was 2.4 1.7 months .


Follow-up refraction was performed at 31 3 days after surgery .


Target contact lens power for distance was 26.0 4.5 D for the IATS cohort ( which excluded infants with corneal diameter < 9 mm ) .


The mean prediction error was -4.0 , -1.0 , and -2.0 D and mean absolute prediction error was 4.4 , 2.2 , and 2.9 D , respectively , for 30 D contact lens , regression , and SRK/T-estimated power .


Preoperative biometry can be used to estimate contact lens power for distance if an accurate refraction can not be obtained initially .


Despite the availability of psychosocial evidence-based practices ( EBPs ) , treatment and outcomes for persons with mental disorders remain suboptimal .


Replicating Effective Programs ( REP ) , an effective implementation strategy , still resulted in less than half of sites using an EBP .


The primary aim of this cluster randomized trial is to determine , among sites not initially responding to REP , the effect of adaptive implementation strategies that begin with an External Facilitator ( EF ) or with an External Facilitator plus an Internal Facilitator ( IF ) on improved EBP use and patient outcomes in 12 months .


This study employs a sequential multiple assignment randomized trial ( SMART ) design to build an adaptive implementation strategy .


The EBP to be implemented is life goals ( LG ) for patients with mood disorders across 80 community-based outpatient clinics ( N = 1,600 patients ) from different U.S. regions .


Sites not initially responding to REP ( defined as < 50 % patients receiving 3 EBP sessions ) will be randomized to receive additional support from an EF or both EF/IF .


Additionally , sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF .


The EF provides technical expertise in adapting LG in routine practice , whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice .


The primary outcome is mental health-related quality of life ; secondary outcomes include receipt of LG sessions , mood symptoms , implementation costs , and organizational change .


This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF .


ClinicalTrials.gov identifier : NCT02151331 .


Tonsillectomy causes discomfort in children .


Positive therapeutic suggestions ( TS ) may be given to patients while they are emerging from general anesthesia as a potential tool to decrease distress .


This study examined impact of TS on outcomes , when delivered to children emerging from general anesthesia post tonsillectomy .


A double blinded randomized controlled trial was conducted with 94 patient/parent pairs .


TS and noise recordings were played via headphones post tonsillectomy upon arrival to the Post Anesthesia Care Unit until the child showed signs of waking .


Pain scores at 30 minutes post extubation show significantly lower pain in the TS group , P = .04 ( Mann Whitney U for independent samples ) .


The TS group had 70 % increased likelihood of receiving less intravenous ( IV ) opioid .


TS may help lower pain in children post tonsillectomy and decrease demand for IV opioid pain management in the 4 - to 8-year-old tonsillectomy population .


Hemorrhage and liver failure are the two major complications in partial hepatectomy .


The finger fracture or clamp crushing technique has been a standard technique used for transection of liver parenchyma .


Hepatic vascular Inflow occlusion ( Pringle maneuver , PM ) is often used to minimize blood loss , but hepatic ischemia-reperfusion may result with an increased risk of post-operative liver failure .


The Harmonic scalpel ( HS ) has been shown to be effective in reducing blood loss during liver parenchymal transection without any hepatic vascular inflow occlusion .


A randomized controlled trial was carried out to evaluate the impact of the two different hepatic transection techniques .


The post-operative short-term results were compared .


During the study period , 160 of 212 patients who received partial hepatectomy in our hospital were randomized into 2 groups : the PM group ( n = 80 ) and the HS group ( n = 80 ) .


The numbers of patient who had a poor liver function on post-operative day 5 ( ISLGS Grade B ) were 30 , and 18 , respectively ( p < 0.05 ) .


The post-operative complication rate was significantly higher in the PM group ( 41.3 % versus 22.5 % , p < 0.05 ) .


The HS group had significantly less blood loss and blood transfusion requirements than the PM group ( p < 0.05 ) .


In conclusion , liver resection carried out using HS without hepatic vascular occlusion was better than using finger fracture or clamp crushing technique with Pringle maneuver .


The use of HS allowed liver resection to be safely performed , with earlier recovery of liver function , and less surgical complication .


To evaluate the rotational stability of a new one-piece hydrophobic acrylic toric intraocular lens ( IOL ) using a custom-developed software for analysis of slit-lamp photographs .


In a prospective , multicenter study , 174 eyes were implanted with the TECNIS Toric IOL ( Abbott Medical Optics , Inc. , Santa Ana , CA ) .


A custom-developed software was used to analyze high-resolution slit-lamp photographs of 156 eyes taken at day 1 ( baseline ) and 1 , 3 , and 6 months postoperatively .


The software uses iris and sclera landmarks to align the baseline image and later images for comparison .


Validation of software was performed through repeated analyses of protractor images rotated from 0.1 to 10.0 and randomly selected photographs of 20 eyes .


Software validation showed precision ( repeatability plus reproducibility variation ) of 0.02 using protractor images and 2.22 using slit-lamp photographs .


Good quality slit-lamp images and clear landmarks were necessary for precise measurements .


At 6 months , 94.2 % of eyes had 5 or less change in IOL orientation versus baseline ; only 2 eyes ( 1.4 % ) had axis shift greater than 30 .


Most eyes were within 5 or less of rotation between 1 and 3 months ( 92.9 % ) and 3 and 6 months ( 94.1 % ) .


Mean absolute axis change ( standard deviation ) from 1 day to 6 months was 2.70 5.51 .


The new custom software was precise and quick in analyzing slit-lamp photographs to determine postoperative toric IOL rotation .


The aim was to compare real-time language/cognitive processing in picture naming in adults who stutter ( AWS ) versus typically-fluent adults ( TFA ) .


Participants named pictures preceded by masked prime words .


Primes and target picture labels were identical or mismatched .


Priming effects on naming and picture-elicited ERP activity were analyzed .


Vocabulary knowledge correlations with these measures were assessed .


Priming improved naming RTs and accuracy in both groups .


RTs were longer for AWS , and correlated positively with receptive vocabulary in TFA .


Electrophysiologically , posterior-P1 amplitude negatively correlated with expressive vocabulary in TFA versus receptive vocabulary in AWS .


Frontal/temporal-P 1 amplitude correlated positively with expressive vocabulary in AWS .


Identity priming enhanced frontal/posterior-N 2 amplitude in both groups , and attenuated P280 amplitude in AWS .


N400 priming was topographically-restricted in AWS .


Results suggest that conceptual knowledge was perceptually-grounded in expressive vocabulary in TFA versus receptive vocabulary in AWS .


Poorer expressive vocabulary in AWS was potentially associated with greater suppression of irrelevant conceptual information .


Priming enhanced N2-indexed cognitive control and visual attention in both groups .


P280-indexed focal attention attenuated with priming in AWS only .


Topographically-restricted N400 priming suggests that lemma/word form connections were weaker in AWS .


Real-time language/cognitive processing in picture naming operates differently in AWS .


l-Theanine ( N-ethyl-l-glutamine ) is an amino acid uniquely found in green tea .


Growing evidence has suggested the possible effects of l-theanine on cognition .


Previously , we found that l-theanine attenuates MK-801-induced deficit in prepulse inhibition ( PPI ) in mice .


In this study , we examined the effect of l-theanine in increasing the PPI in healthy humans .


The subjects were 14 healthy adults who underwent PPI testing as a measure of sensorimotor gating 90min after an oral intake of l-theanine ( 0 , 200 , 400 , or 600mg ) .


PPI tests were done by examiners who were blind to the dose .


The administration of 200mg of l-theanine and that of 400mg , but not 600mg , significantly increased the % PPI compared to the baseline ( 0mg ) .


There was no significant relation between the dose of l-theanine and the startle magnitude or the habituation of startle response .


The plasma concentrations of l-theanine correlated with the dose of l-theanine .


The observed effect with 200-400mg of l-theanine on PPI suggested that l-theanine at a particular dose range increases sensorimotor gating in humans .


Estimate the efficacy of amoxicillin for acute uncomplicated lower-respiratory-tract infection ( LRTI ) in primary care and demonstrate the use of randomisation-based efficacy estimators .


Secondary analysis of a two-arm individually-randomised placebo-controlled trial .


Primary care practices in 12 European countries .