Depressive symptoms were monitored during treatment by using the depression scale of Symptom Checklist-@ ( SCL-@ ) , Montgomery-Asberg Depression Rating Scale ( MADRS ) , and Beck Depression Inventory ( BDI ) at baseline and weeks @ , @ , and @ of antiviral therapy .


Depression occurred in @ patients receiving placebo and in @ patients receiving escitalopram ( Pearson , P = @ ) .


Combination of history of depression and intravenous drug use was associated with depression ( odds ratio = @ ; @ % CI , @-@ @ ; P < @ ) .


Moreover , treatment with selective serotonin reuptake inhibitor compared to placebo was associated with a significant reduction in estimated mean depressive symptoms measured by SCL-@ ( P = @ ) and BDI ( P = @ ) , but not with MADRS ( P = @ ) .


Patients infected by hepatitis C virus with a history of depression and intravenous drug use carry the highest risk to develop interferon-induced depression .


In this subset of patients , prophylaxis with escitalopram results in the most substantial decrease of interferon-induced depressive symptoms on the SCL-@ depression scale and the BDI .


One in @ men in the United States aged > @ years will have an osteoporosis-related fracture .


Fewer data are available on osteoporosis treatment in men than in women .


The purpose of this study was to evaluate denosumab therapy in men with low bone mineral density ( BMD ) .


This was a phase @ study with @ treatment periods : a previously reported @-month double-blind , placebo-controlled phase and a @-month open-label phase .


This was a multicenter study conducted in North America and Europe .


A total of @ men entered the open-label phase and @ completed the study .


Men from the original denosumab ( long-term ) and placebo ( crossover ) groups received @ mg of denosumab sc every @ months .


BMD , serum collagen type I C-telopeptide , and safety were measured .


During the open-label phase , continued BMD increases occurred with long-term denosumab treatment ( @ % lumbar spine , @ % total hip , @ % femoral neck , @ % trochanter , and @ % @/@ radius ) , resulting in cumulative @-month gains from baseline of @ % , @ % , @ % , @ % , and @ % , respectively ( all P < @ ) .


The crossover group showed BMD gains after @ months of denosumab treatment similar to those of the long-term denosumab group during the first treatment year .


Significant reductions in serum collagen type I C-teleopeptide were observed after denosumab administration .


Adverse event rates were similar between groups , and no new safety signals were identified .


In men with low BMD , denosumab treatment for a second year continued to increase BMD , maintained reductions in bone resorption , and was well tolerated .


BMD increased in men initiating denosumab during the second year .


These effects were similar to those previously seen in postmenopausal women with osteoporosis and in men with prostate cancer receiving androgen deprivation therapy .


Our recent pilot study demonstrated mindfulness-based cognitive therapy ( MBCT ) is a potentially efficacious headache pain treatment ; however , it was not universally effective for all participants .


This study sought to explore patient characteristics associated with MBCT treatment response and the potential processes of change that allowed treatment responders to improve and that were potentially lacking in the non-responders .


We implemented a mixed-methods analysis of quantitative and qualitative data .


The sample consisted of @ participants , @ of whom were classified as treatment responders ( @ % improvement in pain intensity and/or pain interference ) and seven as non-responders ( < @ % improvement ) .


The study was conducted at the Kilgo Headache Clinic and the University of Alabama Psychology Clinic .


Participants completed an @-week MBCT treatment for headache pain management .


Standardized measures of pain , psychosocial outcomes , and non-specific therapy factors were obtained ; all participants completed a post-treatment semi-structured interview .


Quantitative data indicated a large effect size difference between responders and non-responders for pre - to post-treatment change in standardized measures of pain acceptance and catastrophizing , and a small to medium effect size differences on treatment dose indicators .


Both groups showed improved psychosocial outcomes .


Qualitatively , change in cognitive processes was a more salient qualitative theme within treatment responders ; both groups commented on the importance of non-specific therapeutic factors .


Barriers to mindfulness meditation were also commented on by participants across groups .


Results indicated that change in pain related cognitions during an MBCT intervention for headache pain is a key factor underlying treatment response .


Many stroke survivors would benefit from modification of their lifestyle in order to reduce their risk of recurrent stroke .


We investigated if tailored smoking cessation advice would yield a higher smoking cessation rate and a higher rate with sustained abstinence in ex-smokers in the intervention group than among controls .


Patients admitted with an acute stroke or a transient ischaemic attack were included in a randomised controlled trial focusing on control of lifestyle risk factors and hypertension .


Here , we report the intervention focused on smoking cessation .


We used multiple logistic regression analysis to identify patient characteristics associated with smoking cessation .


Analyses were by intention to treat excluding those who died or suffered severe disease .


We included @ patients with a history of smoking .


Two years after inclusion , @ of @ ( @ % ) baseline smokers in the intervention group had stopped smoking versus eight of @ ( @ % ) among controls ( p = @ ) .


Living with a partner ( p = @ ) , having at least ten years of education ( p = @ ) , and not being exposed to smoking at home ( p = @ ) were independent predictors of smoking cessation .


We did not achieve our aim of higher smoking cessation rates in the intervention group .


Future smoking cessation interventions should be more intensive , focus on patients ' social circumstances and , if possible , involve patients ' relatives .


To test the hypothesis that promoting breakfast cereal consumption , as part of a web-based programme , results in loss of body mass .


Single centre , single blind , randomised parallel study .


Test group followed a fully interactive website ( B ) with ` prescribed ' breakfast cereals .


Control group followed website ( A ) giving standard advice on weight loss.Study site visits at @ , @ , @ and @ weeks for measurements of height , weight , skinfolds , body fat , waist and hip circumference .


@ subjects were randomly allocated to two equal groups.Subjects were in good health and aged @ years , with a BMI ranging from @ kg/m @ .


At baseline there was no difference in mean age or BMI between the two groups .


The percentage change in body mass loss was greater when following website B than website A ( n = @ ; ITT repeated measures p = @ ) .


For completers ( website A : n = @ , website B : n = @ ) , the percentage change in body mass loss was also greater for website B than website A ( repeated measures p = @ ) .


The advice and motivation offered by an interactive website , including provision and consumption of breakfast cereals , results in significantly greater loss of body mass compared to the use of a standard website .


It is not possible to discern which of the three factors is responsible .


This randomized , double-blind , placebo-controlled parallel-group study assessed the effects of sodium glucose cotransporter @ inhibition by dapagliflozin on insulin sensitivity and secretion in subjects with type @ diabetes mellitus ( T@DM ) , who had inadequate glycemic control with metformin ( with or without an insulin secretagogue ) .


Forty-four subjects were randomized to receive dapagliflozin @ mg or matching placebo once daily for @ weeks .


Subjects continued stable doses of background antidiabetes medication throughout the study .


Insulin sensitivity was assessed by measuring the glucose disappearance rate ( GDR ) during the last @ min of a @-h hyperinsulinemic , euglycemic clamp .


Insulin secretion was determined as the acute insulin response to glucose ( AIRg ) during the first @ min of a frequently sampled intravenous glucose tolerance test .


Where noted , data were adjusted for baseline values and background antidiabetes medication .


An adjusted mean increase from baseline in GDR ( last observation carried forward ) , at Week @ , was observed with dapagliflozin ( @ % ) versus a decrease with placebo ( -@ % ) .


The @ % ( @ % confidence interval @-@ @ ) difference in GDR versus placebo was statistically significant ( P = @ ) .


A change from baseline in adjusted mean AIRg of @ mU/L min was observed with dapagliflozin at Week @ , versus -@ mU/L min with placebo ( P = @ ) .


Over @ weeks , numerical reductions from baseline in glycosylated hemoglobin ( HbA@c ) , fasting plasma glucose , and body weight were observed with dapagliflozin ( -@ % , -@ mmol/L , and -@ % , respectively ) versus slight numerical increases with placebo ( @ % , @ mmol/L , and @ % , respectively ) .


In patients with T@DM and inadequate glycemic control , dapagliflozin treatment improved insulin sensitivity in the setting of reductions in HbA@c and weight .


We examined the causes of hospitalization and death of people who inject drugs participating in the Bangkok Tenofovir Study , an HIV preexposure prophylaxis trial .


The Bangkok Tenofovir Study was a randomized , double-blind , placebo-controlled trial conducted during @ to @ among @ people who inject drugs .


We reviewed medical records to define the causes of hospitalization and death , examined participant characteristics and risk behaviors to determine predictors of death , and compared the participant mortality rate with the rate of the general population of Bangkok , Thailand .


Participants were followed an average of @ years ; @ died : @ ( @ % ) from overdose , @ ( @ % ) from traffic accidents , and @ ( @ % ) from sepsis .


In multivariable analysis , older age ( @-@ years ; P = @ ) , injecting drugs ( P = @ ) , and injecting midazolam ( P < @ ) were associated with death .


The standardized mortality ratio was @ .


People who injected drugs were nearly @ times as likely to die as were those in the general population of Bangkok and injecting midazolam was independently associated with death .


Drug overdose and traffic accidents were the most common causes of death , and their prevention should be public health priorities .


We aimed to explore the influence of a motivationally-enhanced instructional design on motivation to learn and knowledge , hypothesizing that outcomes would be higher for the enhanced instructional format .


Medicine residents completed four online learning modules on primary care topics .


Using a crossover design , learners were randomized to receive two standard and two motivationally-enhanced learning modules .


Both formats had self-assessment questions , but the enhanced format questions were framed to place learners in a supervisory/teaching role .


Learners received a baseline motivation questionnaire , a short motivation survey before and after each module , and a knowledge posttest .


One hundred twenty seven residents were randomized .


@ residents ( @ % ) completed at least one knowledge posttest and @ ( @ % ) completed all four posttests .


Across all modules , a one-point increase in the pretest short motivation survey was associated with a @-point increase in posttest knowledge .


The change in motivation was significantly higher for the motivationally enhanced format ( standard mean change -@ , enhanced mean change +@ , difference = @ , CI @ to @ ; p = @ ) .


Mean posttest knowledge score was similar ( standard mean @ , enhanced mean @ , difference = @ , CI -@ to @ ; p = @ ) .


The motivationally enhanced instructional format improved motivation more than the standard format , but impact on knowledge scores was small and not statistically significant .


Learners with higher pre-intervention motivation scored better on post-intervention knowledge tests , suggesting that motivation may prove a viable target for future instructional enhancements .


To study the effects of a health check by a nurse alone or combined with an exercise intervention in middle-aged men at increased cardiovascular risk .


A randomized controlled trial .


Primary care in Kirkkonummi municipality with @ @ inhabitants .


A health check by a nurse alone or combined with an exercise intervention to controls with no intervention was compared .


A total of @ men aged @ to @ years with at least two cardiovascular risk factors and physical activity ( PA ) frequency < @ times a week .


Metabolic syndrome ( MetS ) as defined by International Diabetes Federation/American Heart Association and self-reported PA frequency .


Overall , focusing on health increased physical activity frequency in middle-aged men .


After one year , @ % had increased PA to @ times a week ( @ % CI @-@ ) .


All study groups increased PA to @ times : @ % of men in the exercise intervention group , @ % of men in the health check group , and @ % of controls .


The differences between the groups were not statistically significant .


The intervention did not have any meaningful impact on MetS or other cardiovascular outcomes at one-year follow up .


Physical activity increased in all study groups of middle-aged men in this health-promotion trial .


The interventions had no effect on metabolic syndrome or other cardiovascular outcomes in the participants .


The trial increased awareness and collaboration in physical activity promotion among municipal health care and exercise services .


Vegetable consumption among preschool children is below recommended levels .


New evidence-based approaches to increase preschoolers ' vegetable intake , particularly in the child care setting , are needed .


This study tests the effectiveness of two community-based randomized interventions to increase vegetable consumption and willingness to try vegetables : ( @ ) the pairing of a vegetable with a familiar , well-liked food and ( @ ) enhancing the visual appeal of a vegetable .


Fifty-seven preschoolers enrolled in a Child and Adult Care Food Program-participating child care center participated in the study ; complete lunch and snack data were collected from @ and @ children , respectively .


A within-subjects , randomized design was used , with order of condition counterbalanced .


For lunch , steamed broccoli was served either on the side of or on top of cheese pizza .


For a snack , raw cucumber was served either as semicircles with chive and an olive garnish or arranged in a visually appealing manner ( in the shape of a caterpillar ) .


Paired t-tests were used to determine differences in consumption of meal components , and McNemar 's test was performed to compare willingness to taste .


Neither visual appeal enhancement nor pairing with a liked food increased vegetable consumption .


Pairing increased willingness to try the vegetable from @ % to @ % of children ( p = @ ) .


Greater vegetable intake occurred at snack than at lunch .


Further research should explore the strategy of pairing vegetables with liked foods .


Greater consumption at snack underscores snack time as a critical opportunity for increasing preschool children 's vegetable intake .


To compare the difference in the clinical efficacy on cervical spondylosis of vertebral artery type ( CSA ) treated with thermosensitive moxibustion at different dosages .


Sixty cases of CSA were randomized into a saturated moxa dosage group and a regular moxa dosage group , @ cases in each one .


The thermosensitive moxibustion was adopted in the two groups .


The mild suspended moxibustion was applied at two acupoints with the strongest thermosensitization .


In the saturated moxa dosage group , the moxibustion time was determined by the disappearance of thermosensitization .


In the regular moxa dosage group , @ min was required on each acupoint .


The treatment was given twice a day for first @ days in the two groups .


Since the @th day , the treatment was given once a day , continuously for @ times , and totally @ days were required .


The score of symptoms and function and clinical efficacy were compared between the two groups before and after treatment as well as @-month follow-up after treatment .


The curative and effective rate was @ % ( @/@ ) after treatment and @ % ( @/@ ) in @-month follow-up after treatment in the saturated moxa dosage group , which were superior to @ % ( @/@ ) and @ % ( @/@ ) in the regular moxa dosage group respectively ( P < @ , P < @ ) .


The scores of clinical symptoms and function after treatment and in follow-up were improved apparently as compared with those before treatment in both groups ( all P < @ ) .


The scores of clinical symptoms and function after treatment and in follow-up in the saturated moxa dosage group were increased much more apparently than those in the regular moxa dosage group ( after treatment : @ + / - @ vs @ + / - @ ; in follow-up : @ + / - @ vs @ + / - @ , both P < @ ) .


The thermosensitization moxibustion of saturated dosage achieves the superior short-term and long-term efficacies in the treatment of CSA as compared with the regular moxibustion dosage .


To investigate changes in standard base excess ( SBE ) when administering two different infusion regimens for elective hip replacement within a goal-directed haemodynamic algorithm .


This prospective , double-blind , randomized , controlled study enrolled patients scheduled for primary hip replacement surgery , who were randomized to receive either an unbalanced crystalloid ( chloride : @ mmol/l ) or a @ : @ mixture of a balanced crystalloid and a balanced colloid ( @ % w/v hydroxyethyl starch @/@ @ ; chloride : @ and @ mmol/l , respectively ) .


Fluid management was goal-directed to optimize stroke volume using oesophageal Doppler .


A total of @ patients ( @ female/@ male ) participated in the study .


After surgery , median ( @-@ % percentiles ) SBE was significantly lower in the unbalanced group compared with the balanced group : -@ mmol/l ( -@ to -@ ) versus -@ mmol/l ( -@ to @ ) , respectively .


This difference was mainly due to greater plasma chloride concentrations in the unbalanced group .


The amount of study medication required to reach haemodynamic stability ( median @ ml ) did not differ between the two groups .


SBE decreased in the unbalanced group without influence on fluid requirements and haemodynamic stability .


Bacterial resistance development is one of the most urgent problems in healthcare worldwide .


In Europe , dentistry accounts for a comparatively high amount of antibiotic prescriptions .


In light of increasing levels of bacterial resistance , this development is alarming .


So far , very few interventional studies have been performed , and further research is urgently needed .


By means of a complex educational intervention , the DREAM trial aims at optimising antibiotic prescribing behaviour of general dentists in Germany .


This is a cluster-randomised controlled trial , where each cluster consists of one dental practice and all of its patients in a defined period .


Participants are general dentists practicing in the German region of Mecklenburg-Western Pomerania .


Randomisation takes place after baseline data collection ( @months ) and will be stratified by the antibiotic prescribing rates of the participating dental practices .


Dentists randomised into the intervention group will participate in a complex small group educational seminar that aims at : increasing knowledge on bacterial resistance , pharmacology , and prophylaxis of infectious endocarditis ; increasing awareness of dentist-patient communication using video-taped vignettes of dentist-patient communication on antibiotic treatment ; improving collaboration between general dentists , general practitioners , and practice-based cardiologists on the necessity of antibiotic prophylaxis ; enhancing awareness of the dentists ' own prescribing habits by providing antibiotic prescribing feedback ; and increasing patient knowledge on antibiotic treatment by providing patient-centred information material on antibiotic prophylaxis of endocarditis .


The dentists randomised into the control group will not receive any educational programme and provide care as usual .


Primary outcome is the overall antibiotic prescribing rate measured at T@ ( period of six months after intervention ) .


In a subgroup of adult patients affected by odontogenic infections , microbiological analyses for antibiotic resistance of oral streptococci are performed .


Major aim of the study is to improve the process of decision making with regard to antibiotic prescribing .


The approach is simple to implement and might be used rapidly in graduate and post-graduate medical education .


We expect the results of this trial to have a major impact on antibiotic prescription strategies and practices in Germany .


Renal impairment in cancer patients can affect treatment tolerability and outcomes .


This analysis evaluated the safety and efficacy of nab-paclitaxel ( nab-P ) versus solvent-based paclitaxel ( sb-P ) , both in combination with carboplatin ( C ) , in patients with advanced non-small-cell lung cancer ( NSCLC ) and renal impairment .


Untreated patients with stage IIIB/IV disease with NSCLC and a performance status of @/@ were randomly assigned ( @:@ ) to receive @ mg/m ( @ ) nab-P weekly plus C ( under the curve = @ , every @ weeks ) or @ mg/m ( @ ) sb-P plus C ( under the curve = @ ) every @ weeks .


The primary end point was overall response rate .


Of @ treated patients in the phase III trial , @ % had mild renal impairment ( creatinine clearance > @ to @ mL/min ; n = @ for nab-P/C and n = @ for sb-P/C ) and @ % had moderate renal impairment ( creatinine clearance @ mL/min : n = @ for nab-P/C and n = @ for sb-P/C ) .


For nab-P/C versus sb-P/C , the treatment difference in efficacy in patients with either level of renal impairment was comparable to the overall population but did not reach statistical significance , with an overall response rate of @ % versus @ % ( response rate ratio , @ ; P = @ ) in patients with mild renal impairment , and @ % versus @ % ( response rate ratio , @ ; P = @ ) in patients with moderate renal impairment .


Overall survival and progression-free survival were nonsignificantly longer for nab-P/C versus sb-P/C in these subsets .


Patients with renal impairment experienced less grade @ or higher neutropenia and sensory neuropathy , but more thrombocytopenia and anemia with nab-P/C versus sb-P/C .


nab-P/C proved beneficial and tolerable in patients with advanced NSCLC and mild and moderate renal impairment .


The effect of aspirin upon platelet function is well documented although experimental studies suggest that aspirin may also affect oxidative stress , vascular inflammation , endothelial dysfunction and dysglycaemia .


The optimal dose of aspirin for cardiovascular protection in type @ diabetes is still debated .


We examined the effects of different doses of aspirin upon these novel markers of cardiovascular risk and any association between aspirin-mediated changes in these markers .


Subjects with type @ diabetes attended for baseline evaluation including BMI , glycaemic and lipid markers , endothelial function ( photoplethysmography ) , insulin resistance ( HOMA ) , inflammation ( sVCAM-@ and Hs-CRP ) and markers of oxidative stress -LSB- total anti-oxidant status ( TAOS and FRAP ) , whole blood total glutathione ( GSH ) assays -RSB- .


Subjects then received in random , sequential , blinded fashion aspirin @ mg day ( -@ ) , aspirin @ mg day ( -@ ) , aspirin @ g day ( -@ ) or placebo for @ weeks with a @-week washout .


The above investigations were repeated after each intervention .


Aspirin-related changes compared with placebo were analysed using repeated measures ANOVA .


Subjects = @ ( M - @ ; F - @ ) , mean age - @ @ years ( mean @ SD ) , HbA@c - @ @ mmol mol ( -@ ) ( @ @ % ) , total cholesterol @ @ mmol l ( -@ ) .


At baseline TAOS value was @ @ M AEAC ( Ascorbate Equivalent Anti-oxidant Concentration ) , glutathione @ @ mmol l ( -@ ) and FRAP @ @ mM FeII .


None of the aspirin doses had a significant impact upon BMI , blood pressure , lipid parameters , insulin sensitivity ( HOMA ) , FRAP , TAOS , GSH , endothelial function , glycaemic control ( fructosamine ) or inflammation ( sVCAM-@ and HsCRP ) .


Aspirin exhibited no significant dose-dependent effect on markers of vascular inflammation , oxidative stress , insulin resistance and endothelial function ( photoplethysmography ) when used in type @ diabetes over a @-week period .


Acetazolamide has been used to attenuate Hunter-Cheyne-Stokes breathing with central sleep apnea ( CSA ) associated with heart failure .


However , the mechanisms underlying this improvement remain to be fully elucidated .


We hypothesized that acetazolamide stabilizes CSA by attenuating the ventilatory sensitivity to CO@ , which is increased in patients with heart failure and is thought to be the major mechanism mediating CSA .


Six consecutive male patients with stable systolic heart failure and CSA ( apnea-hypopnea index -LSB- AHI -RSB- @ episodes/h ) were randomized to a double-blind crossover protocol with acetazolamide or placebo received @ hour before bedtime for six nights with @ weeks of wash-out .


Under both conditions , we measured the hypercapnic ventilatory response ( HCVR ) , arterial blood Pco@ , steady-state metabolic CO@ production , overnight attended polysomnography , and also assessed cardiac and pulmonary function .


Compared with placebo , acetazolamide significantly decreased the AHI ( @ @ vs. @ @ events/h , mean SD ) .


Acetazolamide increased the HCVR slope by @ % ( @ @ vs. @ @ L/min/mm Hg ; P = @ ) , an increase that far exceeded the @ % fall in arterial Pco@ ( P = @ ) .


The acetazolamide-induced change in the balance of these effects ( HCVR Pco@ ) was inversely associated with the reduction in AHI ( r = @ ; P = @ ) .


This placebo-controlled study indicates that acetazolamide improves CSA in patients with heart failure despite an increase in the slope of the HCVR .


However , because the degree of HCVR elevation inhibits the improvement in unstable breathing , an increased CO@ chemosensitivity may be a key mechanism underlying an incomplete resolution of CSA with acetazolamide .


The Medicare Accountable Care Organization ( ACO ) programs encourage integration of providers into large groups and reward provider groups for improving quality , but not explicitly for reducing health care disparities .


Larger group size and better overall quality may or may not be associated with smaller disparities .


To examine differences in patient characteristics between provider groups sufficiently large to participate in ACO programs and smaller groups ; the association between group size and racial disparities in quality ; and the association between quality and disparities among larger groups .


Using @ Medicare claims for @ million beneficiaries with cardiovascular disease or diabetes and linked data on provider groups , we compared racial differences in quality by provider group size , adjusting for patient characteristics .


Among larger groups , we used multilevel models to estimate correlations between group performance on quality measures for white beneficiaries and black-white disparities within groups .


Four process measures of quality , hospitalization for ambulatory care-sensitive conditions ( ACSCs ) related to cardiovascular disease or diabetes , and hospitalization for any ACSC .


Beneficiaries served by larger groups were more likely to be white and live in areas with less poverty and more education .


Larger group size was associated with smaller disparities in low-density lipoprotein ( LDL ) cholesterol testing and retinal exams , but not in other process measures or hospitalization for ACSCs .


Among larger groups , better quality for white beneficiaries in one measure ( hospitalization for ACSCs related to cardiovascular disease or diabetes ) was correlated with smaller racial disparities ( r = @ ; P = @ ) , but quality was not correlated with disparities in other measures .


Larger provider group size and better performance on quality measures were not consistently associated with smaller racial disparities in care for Medicare beneficiaries with cardiovascular disease or diabetes .


ACO incentives rewarding better quality for minority groups and payment arrangements supporting ACO development in disadvantaged communities may be required for ACOs to promote greater equity in care .


Our study aims to evaluate the image quality and feasibility of @-slice dual-energy CTA ( DE-CTA ) for supra-aortic arteries using reduced amounts of contrast medium ( CM ) .


A prospective study was performed in @ patients receiving CTA of the head and neck with a @-slice dual-source CT system .


Patients were randomized into two groups with a volume of either @ mL of CM ( Group I ) or @ mL of CM ( Group II ) .


Arterial and venous enhancements were recorded for quantitative assessment .


Qualitative assessments for images without bone removal ( BR ) were based on a ) the visualization of the circle of Willis and b ) streak artifacts due to residual CM in the subclavian or internal jugular veins ipsilateral to injection of CM .


Qualitative assessment of dual-energy images using BR was based on the presence of bone remnants and vessel integrity .


Quantitative data was compared using the Student t test .


The ( @ ) test was used for the qualitative measurements of streak artifacts in veins while the Mann-Whitney U test was used for the qualitative measurements of images with BR .


Arterial and venous attenuation was significantly higher in Group II ( P = @ ) .


Image quality regarding the circle of Willis was excellent in both groups ( @ for Group I and @ for Group II ) .


Imaging of the internal jugular veins was scored higher in Group I ( @ ) compared with Group II ( @ ) ( P = @ ) .


Within Group I using BR , mean scores for bone remnants did not differ significantly ( P > @ ) but mean scores of vessel integrity ( P < @ ) did .


Contrast-enhanced head and neck CTA is feasible using a scan protocol with low amounts of contrast medium ( @ mL ) on a @-slice dual-energy CTA .


The @-mL protocol provides satisfactory image quality before and after dual-energy bone-removal post-processing .


To evaluate the late cardiotoxicity ( CT ) of high-dose chemotherapy ( CT ) according to the modified NHL-BFM-@ ( mNHL-BFM-@ ) protocol in adult patients with diffuse large B-cell lymphoma ( DLBCL ) .


The results of electrocardiography ( ECG ) and echocardiography ( echoCG ) were analyzed in @ DLBCL patients treated according to the mNHL-BFM-@ program in the Hematology Research Center ( HRC ) , Russian Academy of Medical Sciences ( RAMS ) , in @ to @ .


A study group consisted of @ men and @ women whose age was @ to @ years ; median age was @ years at the time of their examination and the median follow-up time after therapy was @ years .


The individual cumulative dose of doxorubicin was @-@ mg/M@ .


A comparison group included @ patients receiving CHOP/R-CHOP CT in HRC , RAMS , in @ to @ .


Out of them , there were @ men and @ women whose age was @ to @ years median age was @ years at the time of their examination .


ECG and echoCG were carried out before and @ years or more after CT. .


Out of the @ patients with DLBCL , the signs of subclinical cardiomyopathy ( CMP ) were detected in @ ( @ % ) patients ; no clinical manifestations of congestive heart failure ( CHF ) were found in any patient .


In the comparison group of @ patients receiving CHOP/R-CHOP CT , @ ( @ % ) patients were found to have signs of subclinical CMP and no clinical signs of CHF .


The summary toxicity index significantly depended on age ( p = @ ) and a history of heart disease ( p = @ ) ; it was significantly higher after CHOP/R-CHOP CT ( p = @ ) .


There was a statistically significant relationship of the risk of subclinical CMP to the history of heart diseases ( p = @ ) .


Late cardiotoxicity of the mNHL-BFM-@ program does not exceed the toxicity of standard CHOP/R-CHOP therapy .


Post-CT Echo-CG and ECG findings showed that the patients with the most marked subclinical signs of CMP in both groups had cardiotoxicity risk factors , such as coronary heart disease , hypertensive disease , or diabetes in their history .


No clinically significant CHF was identified in any patient .


Patients with metastatic castration-resistant prostate cancer have few treatment options .


We investigated the safety and efficacy of lenalidomide , an immunomodulatory agent with anti-angiogenic properties , in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer .


In this randomised , double-blind , placebo-controlled , phase @ study , we randomly assigned chemotherapy-naive patients with progressive metastatic castration-resistant prostate cancer in a @:@ ratio to receive docetaxel ( @ mg/m ( @ ) ) on day @ and prednisone ( @ mg twice daily ) on days @-@ and either lenalidomide ( @ mg ) or placebo once daily on days @-@ of each @ day treatment cycle .


Permuted block randomisation was done with an interactive voice response system and stratified by Eastern Cooperative Oncology Group performance status , geographic region , and type of disease progression .


Clinicians , patients , and investigators were masked to treatment allocation .


The primary endpoint was overall survival .


Efficacy analysis was by intention to treat .


Patients who received at least one dose of study drug were included in the safety analyses .


This study is registered with ClinicalTrials.gov , number NCT@ .


@ patients were enrolled and randomly assigned between Nov @ , @ , and Nov @ , @ ( @ to the lenalidomide group and @ to the control group ) , and @ patients received study treatment ( @ in the lenalidomide group and @ in the placebo group ) .


At data cutoff ( Jan @ , @ ) after a median follow-up of @ months ( IQR @-@ ) , @ patients had died : @ in the lenalidomide group and @ in the placebo group .


Median overall survival was @ months ( @ % CI @-@ ) in the lenalidomide group and not reached in the placebo group ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ , p = @ ) .


The trial was subsequently closed early due to futility .


The number of deaths that occurred during treatment or less than @ days since the last dose were similar in both groups ( @ -LSB- @ % -RSB- of @ patients in the lenalidomide group vs @ -LSB- @ % -RSB- of @ patients ) .


@ ( @ % ) patients in the lenalidomide group and @ ( @ % ) in the placebo group died more than @ days from last dose , mainly due to disease progression .


At least one grade @ or higher adverse event was reported in @ ( @ % ) of @ patients receiving lenalidomide and @ ( @ % ) of @ patients receiving placebo .


Grade @-@ neutropenia ( @ -LSB- @ % -RSB- for lenalidomide vs @ -LSB- @ % -RSB- for placebo ) , febrile neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , diarrhoea ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , pneumonia ( @ -LSB- @ % -RSB- vs five -LSB- @ % -RSB- ) , dyspnoea ( @ -LSB- @ % -RSB- vs nine -LSB- @ % -RSB- ) , asthenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and pulmonary embolism ( @ -LSB- @ % -RSB- vs seven -LSB- @ % -RSB- ) occurred more frequently in the lenalidomide group than in the placebo group .


Overall survival with the combination of lenalidomide , docetaxel , and prednisone was significantly worse than with docetaxel and prednisone for chemotherapy-naive men with metastatic , castration-resistant prostate cancer .


Further research with this treatment combination is not warranted .


The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents .


Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed .


Within the National Cardiovascular Data Registry CathPCI Registry , we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study .


We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention ( PCI ) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry .


Standardized differences between groups were estimated .


Between September @ and July @ , @ million PCIs were performed among @ hospitals , of which @ ( @ % ) participated in the Dual Antiplatelet Therapy Study .


Participating hospitals were larger ( @ versus @ beds ) , more frequently located in urban settings ( @ % versus @ % ) , and had higher annual PCI volumes ( @ versus @ ) compared with nonparticipating hospitals , although hospital case mix and procedural outcomes were similar .


Compared with CathPCI patients , trial patients undergoing PCI with drug-eluting stents were similar with respect to race , sex , and rates of diabetes mellitus , hypertension , and smoking , although they had lower rates of prior cardiovascular disease .


Within the Dual Antiplatelet Therapy Study , clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites .


Although trial participants were representative of PCI patients with respect to race , sex and most comorbidities , they had a lower prevalence of chronic cardiovascular disease compared with registry patients .


Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients , differences between eligible patients and those actually enrolled remained .


To evaluate the safety and feasibility of the da Vinci Surgical System in transoral robotic-assisted surgery for benign indications .


A multicenter , single-arm , retrospective case series .


Perioperative outcomes were recorded for patients presenting with obstructive sleep apnea , airway obstruction , lingual tonsillar/tonsillar/tongue base hypertrophy , or dysphagia who underwent one or more transoral procedures , including lingual tonsillectomy and tongue base resection ( partial glossectomy ) at one of three US institutions .


Between January @ and October @ , @ patients ( age @ years , body mass index @ kg/m ( @ ) ) underwent @ procedures .


No conversions or blood transfusions were needed .


The average operative time was @ minutes , and the average volume of tissue resected ( lingual tonsil and tongue base ) was @ mL .


Hospital stays averaged @ days , and the postoperative complication rate was @ % .


There were no complications specifically related to the use the da Vinci Surgical System , and none of the complications were life threatening .


These results demonstrate that it is safe and feasible to use the da Vinci Surgical System to perform lingual tonsillectomy and base of tongue resection ( partial glossectomy ) procedures for benign indications .


The aim of this study was to investigate the efficacy of dezocine ( DEZ ) versus placebo control ( CON ) and @ % lidocaine ( LID ) in prevention of injection pain due to DEZ .


A prospective randomized double-blind , placebo-CON study was conducted in @ adults , American Society of Anesthesiologists physical status I or II , scheduled to undergo an elective surgery .


A total of @ patients were randomly assigned to one of the three groups , thus CON , group LID and group DEZ .


The groups received either @ ml of normal saline or @ ml @ % LID or @ mg/@ ml DEZ , respectively , as pre-treatment .


Propofol was injected @ min later .


A blinded researcher assessed the patient 's pain level using a four point verbal rating scale .


Less patients experienced pain due to propofol injection in the LID ( @ % ) and DEZ ( @ % ) groups compared with the CON ( @ % ) group ( P < @ ) .


Six patients ( @ % ) in the CON group reported severe pain during propofol injection but none in the other two groups .


Pre-treatment with DEZ decreases propofol injection pain as effectively as LID .


For most older women with early breast cancer , standard treatment after breast-conserving surgery is adjuvant whole-breast radiotherapy and adjuvant endocrine treatment .


We aimed to assess the effect omission of whole-breast radiotherapy would have on local control in older women at low risk of local recurrence at @ years .


Between April @ , @ , and Dec @ , @ , @ women aged @ years or older with early breast cancer judged low-risk ( ie , hormone receptor-positive , axillary node-negative , T@-T@ up to @ cm at the longest dimension , and clear margins ; grade @ tumour histology or lymphovascular invasion , but not both , were permitted ) , who had had breast-conserving surgery and were receiving adjuvant endocrine treatment , were recruited into a phase @ randomised controlled trial at @ centres in four countries .


Eligible patients were randomly assigned to either whole-breast radiotherapy ( @-@ Gy in @-@ fractions ) or no radiotherapy by computer-generated permuted block randomisation , stratified by centre , with a block size of four .


The primary endpoint was ipsilateral breast tumour recurrence .


Follow-up continues and will end at the @-year anniversary of the last randomised patient .


Analyses were done by intention to treat .


The trial is registered on ISRCTN.com , number ISRCTN@ .


@ women who had undergone breast-conserving surgery and who were receiving adjuvant endocrine treatment were randomly assigned to receive whole-breast irradiation and @ were allocated to no further treatment .


After median follow-up of @ years ( IQR @-@ ) , ipsilateral breast tumour recurrence was @ % ( @ % CI @-@ ; n = @ ) in women assigned to whole-breast radiotherapy and @ % ( @-@ ; n = @ ) in those assigned no radiotherapy ( p = @ ) .


Compared with women allocated to whole-breast radiotherapy , the univariate hazard ratio for ipsilateral breast tumour recurrence in women assigned to no radiotherapy was @ ( @ % CI @-@ ; p = @ ) .


No differences in regional recurrence , distant metastases , contralateral breast cancers , or new breast cancers were noted between groups .


@-year overall survival was @ % ( @ % CI @-@ ) in both groups ( p = @ ) .


@ women died ; eight of @ patients allocated to no radiotherapy and four of @ assigned to radiotherapy died from breast cancer .


Postoperative whole-breast radiotherapy after breast-conserving surgery and adjuvant endocrine treatment resulted in a significant but modest reduction in local recurrence for women aged @ years or older with early breast cancer @ years after randomisation .


However , the @-year rate of ipsilateral breast tumour recurrence is probably low enough for omission of radiotherapy to be considered for some patients .


To explore the impact and effect mechanism of electroacupuncture ( EA ) on oocyte quali ty in the patients with infertility of kidney deficiency pattern .


Sixty-six cases differentiated as kidney de ficiency and with in vitro fertilization-embryo transplantation ( IVF-ET ) , aged fromnt @ to @ years were rando - mized into an observation group and a control group , @ cases in each one .


The IVF-ET therapy of the long proto - col with gonadotrophin releasing hormone agonist was adopted in the two groups .


In the observation group .


on the @th day of menstruation in IVF cycle , EA was applied to Sanyinjiao ( SP @ ) .


Zigong ( EX CA @ ) , Zhongji ( CV @ ) and Guanyuan ( CV @ ) .


In the control group , the sham-acupuncture was applied to the same acupoints .


The treatment was given once every two days till the date of egg collection and the needles were retained for @ min each time .


The change in the score of kidney deficiency syndrome , the high-quality oocyte rate , the high-quality embryo rate and clinical pregnant rate were observed in the two groups .


The levels of insulin-like growth factor-i ( IGF-@ ) and IGF-@ in follicular fluid and the serum - endorphin - EP ) on the date of egg collection and the correlation with oocyte quality were compared bIetween the two groups .


@ ) In the observation group , the kidney deficiency syndrome score after treatment was reduced apparently as compared with that before treatment ( P < @ ) , the score after treatment in the observation group was reduced much more apparently as compared with the control group ( P < @ ) .


@ ) The high-quality egg rate and the high-quality embryo rate in the observation group were both higher than those in the control group -LSB- @ % ( @/@ ) vs @ % ( @/@ ) , @ % ( @/@ ) vs @ % ( @/@ ) , both P < @ -RSB- .


@ ) Compared with the control group .


the levels of IGF-@ and IGF-@ in follicular fluid and serum - EP on the day of egg collection were all increased obviously in the observation group ( all P < @ ) .


@ ) The levels of IGF-@ and IGF-@ in follicular fluid and serum - EP presented the linear positive correlation with the high-quality egg rate .


EA effectively improves the expressions of IGF in follicular fluid and serum - EP , increases the high-quality egg rate and high-quality embryo rate and relieves the symptoms of kidney deficiency .


The aim of this work was to evaluate the effect of long term supplementation with two moderate dose of Zn on plasma and cellular red-ox status markers in elderly volunteers .


In a double blind study @ healthy volunteers , aged @-@ years , were enrolled .


They were randomly divided in @ groups of treatment , receiving placebo , @ mg/day and @ mg/day of Zn for @ months .


Red-ox status markers were assessed at baseline and after @ months evaluating carotenoids , vitamin A and E in plasma ; glutathione ( GSH ) , thiol groups ( RSH ) , malondialdehyde ( MDA ) , percentage of haemolysis and methemoglobin in erythrocytes .


Zn supplementation had no significant effects on red-ox status markers except for vitamin A levels ( from @ to @ M in volunteers receiving @ mg of Zn and from @ to @ M in volunteers receiving @ mg of Zn ) , which increased proportionally to zinc dose .


It appears that , differently from unhealthy populations , long-term supplementation with two moderate doses of Zn in a healthy elderly population , with an adequate Zn nutritive status and macro and micronutrients intakes in the range of normality , is an inefficient way to increase antioxidant defences .


This study extends previous work on longitudinal patterns of spousal associations between functional impairments and psychological well-being in older couples in @ important ways : By examining Mexican Americans , by considering a broader range of functional limitations , and by assessing the role of health status , social integration , and socioeconomic resources in these associations .


Drawing on data from @ waves of the Hispanic Established Population for the Epidemiologic Study of the Elderly ( @-@ ) , we employed growth curve models to investigate the implications of the spouse 's functional limitations for the respondent 's age trajectories of depressive symptoms in older Mexican American couples .


Models were run separately for husbands and wives .


The spouse 's functional limitations were associated with higher levels of depressive symptoms in the respondent .


Personal resources can both ameliorate and intensify the adverse implications of the spouse 's functional limitations for the respondent 's depressive symptomatology .


The interplay among these factors can vary by gender and the type of the spouse 's functional impairment .


Future studies would benefit by examining caregiving patterns in older couples , by distinguishing between different dimensions of social support available to them , and by considering changes in couples ' marital quality and social ties over time .


Interleukin-@ ( IL-@ ) is a key mediator of ischaemic brain injury induced by stroke and subarachnoid haemorrhage ( SAH ) .


IL-@ receptor antagonist ( IL-@Ra ) limits brain injury in experimental stroke and reduces plasma inflammatory mediators associated with poor outcome in ischaemic stroke patients .


Intravenous ( IV ) IL-@Ra crosses the blood-brain barrier ( BBB ) in patients with SAH , to achieve cerebrospinal fluid ( CSF ) concentrations that are neuroprotective in rats .


A small phase II , double-blind , randomised controlled study was carried out across two UK neurosurgical centres with the aim of recruiting @ patients .


Adult patients with aneurysmal SAH , requiring external ventricular drainage ( EVD ) within @ hours of ictus , were eligible .


Patients were randomised to receive IL-@Ra ( @ mg bolus , then a @ mg/kg/hr infusion for @ hours ) or placebo .


Serial samples of CSF and plasma were taken and analysed for inflammatory mediators , with change in CSF IL-@ between @ and @ hours as the primary outcome measure .


Six patients received IL-@Ra and seven received placebo .


Concentrations of IL-@ in CSF and plasma were reduced by one standard deviation in the IL-@Ra group compared to the placebo group , between @ and @ hours , as predicted by the power calculation .


This did not reach statistical significance ( P = @ and P = @ , respectively ) , since recruitment did not reach the target figure of @ .


No adverse or serious adverse events reported were attributable to IL-@Ra .


IL-@Ra appears safe in SAH patients .


The concentration of IL-@ was lowered to the degree expected , in both CSF and plasma for patients treated with IL-@Ra .


Perioperative supplemental oxygen has been proposed to decrease the incidence of surgical site infection ( SSI ) in colorectal surgery with controversial results .


We have assessed the influence of hyperoxygenation on SSI by using the most homogeneous study population .


We studied , in a prospective randomized study , @ patients , who underwent elective open infraperitoneal anastomosis for rectal cancer .


Patients were assigned randomly to an oxygen/air mixture with a fraction of inspired oxygen ( FiO@ ) of @ % ( n = @ ) or @ % ( n = @ ) .


Administration was commenced after induction of anesthesia and maintained for @hours after surgery .


The overall wound infection rate was @ % : @ patients ( @ % ) had wound infections in the @ % FiO@ group and @ ( @ % ) in the @ % FiO@ group ( P < @ ) .


The risk of SSI was @ % lower in the @ % FiO@ group .


Supplemental @ % FiO@ reduced postoperative SSI with few risks to the patient and little associated cost .


Early goal-directed therapy refers to the use of predefined hemodynamic goals to optimize tissue oxygen delivery in critically ill patients .


Its application in high-risk abdominal surgery is , however , hindered by safety concerns and practical limitations of perioperative hemodynamic monitoring .


Arterial waveform analysis provides an easy , minimally invasive alternative to conventional monitoring techniques , and could be valuable in early goal-directed strategies .


We therefore investigate the effects of early goal-directed therapy using arterial waveform analysis on complications , quality of life and healthcare costs after high-risk abdominal surgery .


In this multicenter , randomized , controlled superiority trial , @ patients scheduled for elective , high-risk abdominal surgery will be included .


Patients are allocated to standard care ( control group ) or early goal-directed therapy ( intervention group ) using a randomization procedure stratified by center and type of surgery .


In the control group , standard perioperative hemodynamic monitoring is applied .


In the intervention group , early goal-directed therapy is added to standard care , based on continuous monitoring of cardiac output with arterial waveform analysis .


A treatment algorithm is used as guidance for fluid and inotropic therapy to maintain cardiac output above a preset , age-dependent target value .


The primary outcome measure is a combined endpoint of major complications in the first @ days after the operation , including mortality .


Secondary endpoints are length of stay in the hospital , length of stay in the intensive care or post-anesthesia care unit , the number of minor complications , quality of life , cost-effectiveness and one-year mortality and morbidity .


Before the start of the study , hemodynamic optimization by early goal-directed therapy with arterial waveform analysis had only been investigated in small , single-center studies , including minor complications as primary endpoint .


Moreover , these studies did not include quality of life , healthcare costs , and long-term outcome in their analysis .


As a result , the definitive role of arterial waveform analysis in the perioperative hemodynamic assessment and care for high-risk surgical patients is unknown , which gave rise to the present trial .


Patient inclusion started in May @ and is expected to end in @ .


To investigate the QT/QTc effects of orally administered moxifloxacin in healthy Chinese volunteers .


This was a single-blinded , randomized , single-dose , placebo-controlled , two-period cross-over study .


A total of @ healthy Chinese volunteers were enrolled , randomly assigned to two groups : one group received moxifloxacin ( @ mg , po ) followed by placebo with a @-d interval , another group received placebo followed by moxifloxacin with a @-d interval .


On the days of dosing , @-lead @ h Holter ECGs were recorded and evaluated by an ECG laboratory blind to the treatments .


Blood samples were collected to determine plasma concentrations of moxifloxacin .


The orally administered moxifloxacin significantly prolonged the mean QTc at all time points except @ h post-dose .


The largest time-matched difference in the QTcI was @ ms ( @ % CI : @ , @ ) at @ h post-dose .


The peak effect on QTcF was @ ms ( @ % CI : @ , @ ) at @ h post-dose .


A pharmacokinetic-QTc model suggested a @ ms increase in the QTc interval for every @ ng/mL increase in plasma concentration of moxifloxacin .


In addition , the orally administered moxifloxacin was well tolerated by the subjects .


Orally administered moxifloxacin significantly prolongs QTc , which supports its use as a positive control in ICH-E@ TQT studies in Chinese volunteers .


Cold atmospheric plasma ( CAP , i.e. ionized air ) is an innovating promising tool in reducing bacteria .


We conducted the first clinical trial with the novel PlasmaDerm VU-@ device to assess safety and , as secondary endpoints , efficacy and applicability of @ s/cm ( @ ) cold atmospheric plasma as add-on therapy against chronic venous leg ulcers .


From April @ to April @ , @ patients were randomized to receive standardized modern wound care ( n = @ ) or plasma in addition to standard care ( n = @ ) @ per week for @ weeks .


The ulcer size was determined weekly ( Visitrak , photodocumentation ) .


Bacterial load ( bacterial swabs , contact agar plates ) and pain during and between treatments ( visual analogue scales ) were assessed .


Patients and doctors rated the applicability of plasma ( questionnaires ) .


The plasma treatment was safe with @ SAEs and @ AEs approximately equally distributed among both groups ( P = @ and P = @ , Fisher 's exact test ) .


Two AEs probably related to plasma .


Plasma treatment resulted in a significant reduction in lesional bacterial load ( P = @ , Wilcoxon signed-rank test ) .


A more than @ % ulcer size reduction was noted in @/@ and @/@ patients in the standard and plasma groups , respectively , and a greater size reduction occurred in the plasma group ( plasma -@ cm ( @ ) , standard : -@ cm ( @ ) ) ( non-significant , P = @ , log-rank test ) .


The only ulcer that closed after @ weeks received plasma .


Patients in the plasma group quoted less pain compared to the control group .


The plasma applicability was not rated inferior to standard wound care ( P = @ , Wilcoxon-Mann-Whitney test ) .


Physicians would recommend ( P = @ , Wilcoxon-Mann-Whitney test ) or repeat ( P = @ , Wilcoxon-Mann-Whitney test ) plasma treatment by trend .


Cold atmospheric plasma displays favourable antibacterial effects .


We demonstrated that plasma treatment with the PlasmaDerm VU-@ device is safe and effective in patients with chronic venous leg ulcers .


Thus , larger controlled trials and the development of devices with larger application surfaces are warranted .


RT@ is a new injectable BoNTA product .


This formulation limits the spread of BoNTA , potentially permitting safe administration of larger doses and possibly extending its duration of action .


This phase @/@ clinical study was designed to establish the safety of RT@ for the treatment of moderate-to-severe glabellar lines .


Subjects were randomized into four groups ( N = @/group ) .


Cohorts @-@ received escalating doses of RT@ ranging from half the equivalent dose of approved toxins up to twice the current dose levels .


The safety of each dose was confirmed prior to administering the next dose .


Subjects in Cohort @ were treated with the highest dose and observed for @ weeks or until GLSS returned to baseline .


All doses of RT@ were well-tolerated .


Common AEs were headache and mild injection site reactions .


At Week @ , all doses of RT@ were highly effective at maximum frown .


Cohort @ achieved @ month median duration .


At @ months , @ % of subjects maintained a @-point improvement in Investigator GLSS and @ % maintained WSS of None or Mild .


Study limitations include an open-label design and modest number of subjects .


RT@ is a safe and effective BoNTA product with an extended duration of action .


To compare the clinical pregnancy rates in women who underwent fresh embryo transfer ( ET ) with and without one acupuncture session before and after the transfer using a modified Paulus protocol .


The prospective , physician-blinded study randomized @ women to either no intervention ( n = @ ) or acupuncture performed off-site ( n = @ ) .


Secondary outcomes were positive pregnancy test and live birth rates .


Intent-to-treat analysis and per protocol analysis were performed .


No difference in age and in vitro fertilization-embryo transfer ( IVF-ET ) parameters were detected .


Compared to the control group , the treatment group had a lower pregnancy rate ( @ % vs. @ % , p = @ ) .


More women in the control group had live births than did those in the acupuncture group ( @ % vs. @ % , respectively , p = @ ) .


Generalized mixed models revealed that patients who received acupuncture had lower odds of clinical pregnancy than those who did not undergo acupuncture treatment ( OR = @ , @ % CI @-@ @ ) .


Our study found that acupuncture performed off-site on the day of ET was detrimental to the success of the transfer .


More research is needed with a greater number of subjects to elucidate the role of acupuncture before and after ET , ideal treatment frequency , and to further explore the role of individualized acupuncture treatment on IVF-ET pregnancy rates .


The energy intake necessary to maintain weight and body composition is called the energy requirement for weight maintenance and can be determined by using the doubly labeled water ( DLW ) method .


The objective was to determine the energy requirements of nonobese men and women in the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy @ study .


Energy requirements were determined for @ healthy , weight-stable men and women -LSB- aged > @ to < @ y ; @ % female , @ % white ; body mass index ( BMI ; in kg/m ( @ ) ) @ to < @ ; @ % overweight -RSB- over @ d with @ consecutive @-d DLW assessments in addition to serial measures of body weight and fat-free mass and fat mass by dual-energy X-ray absorptiometry .


Energy intake and physical activity were also estimated by self-report over @ consecutive d in each DLW period .


Total daily energy expenditure ( TDEE ) was consistent between the @ DLW studies ( TDEE@ : @ @ kcal/d ; TDEE@ : @ @ kcal/d ; intraclass correlation coefficient = @ ) with a mean TDEE of @ @ kcal/d that was , on average , @ % ( @ kcal/d ) higher in men than in women ( P < @ ) .


The regression equation relating mean TDEE to demographics and weight was as follows : TDEE ( kcal/d ) = @ + @ ( weight , kg ) + @ ( age , y ) - @ ( sex : @ = female , @ = male ) ; R ( @ ) = @ .


When body composition was included , TDEE ( kcal/d ) = @ + @ ( fat-free mass , kg ) - @ ( fat mass , kg ) + @ ( age in y ) + @ ( sex : @ = female , @ = male ) ; R ( @ ) = @ .


Individuals significantly underreported energy intake ( @ kcal/d ; @ % ) , and underreporting by overweight individuals ( ~ @ kcal/d ; @ % ) was greater ( P < @ ) than that of normal-weight individuals ( ~ @ kcal/d ; @ % ) .


Estimates of TDEE from a @-d physical activity recall and measured resting metabolic rate also suggested that individuals significantly underreported physical activity ( ~ @ kcal/d ; @ % ; P < @ ) .


These new equations derived over @ mo during weight stability can be used to estimate the free-living caloric requirements of nonobese adults .


This trial was registered at clinicaltrials.gov as NCT@ .


To investigate the effect of vacuum drainage on blood circulation of expanded skin flap , so as to confirm suitable negative pressure for ear reconstruction .


@ patients ( Auricular Reconstructive Center of Plastic Surgery Hospital , PUMC ) were randomly divided into A , B , C @ groups to receive vacuum drainage of : -@ , -@ and -@ kPa , respectively .


The length and width of reconstructed ears , which represented the swelling degree , were measured instantly and @ , @ days postoperatively .


The changes were calculated and reflected venous drainage of flaps .


The temperature of proximal ( concha ) and distal ( helix ) part of the expanded flaps , which represented the arterial blood supply of flaps , was detected by infrared thermography after operation .


Five days after operation -LSB- ( @ + / - @ ) mm , ( @ + / - @ ) mm -RSB- and immediately -LSB- ( @ + / - @ ) mm , ( @ + / - @ ) mm ) -RSB- , the changes of the length and width of reconstructed ear in group B was significantly low , while there was no statistically difference between group A and C ( P > @ ) .


The data between @ days and @ days after operation showed the same result .


Along with the increase of the negative pressure , the swelling degree of reconstructed ears decreased firstly and then increased reversely ( P < @ ) .


The flap temperature of reconstructed ears increased ( P < @ ) , especially in proximal ( concha ) part ( P < @ ) , when the negative pressure increased ( @ to -@ kPa ) .


Vacuum drainage has effect on both the venous drainage and blood supply .


Negative pressure of -@ kPa can improve both the blood supply and venous drainage .


It should be as reference for clinical application .


Recent data suggest the possible benefits of - tocopherol and - carotene supplementation on liver cancer and chronic liver disease ( CLD ) , but the long-term trial data are limited .


We evaluated the efficacy of supplemental @mgday ( -@ ) - tocopherol and @mgday ( -@ ) - carotene on incident liver cancer and CLD mortality in a randomised trial of @,@ Finnish male smokers , who received supplementation for @-@ years and were followed for @ additional years for outcomes .


Supplemental - tocopherol , - carotene , or both , relative to placebo , did not reduce the risk of liver cancer or CLD , either overall , during the intervention or during the post-intervention period .


Long-term supplemental - tocopherol or - carotene had no effect on liver cancer or CLD mortality over @ years of follow-up .


The analgesic efficacy of sciatic nerve block ( SNB ) after total knee arthroplasty ( TKA ) is unclear .


Proximal and distal SNB are each reported to provide posterior knee analgesia , whereas others suggest that posterior knee pain is not important after TKA .


This prospective , randomized , double-blind , parallel-arm , placebo-controlled trial examined whether proximal or distal SNB provides superior analgesia in the posterior knee compared with no SNB after TKA .


Sixty patients undergoing TKA were randomized to single-shot SNB using either the infragluteal ( Proximal group ) or popliteal ( Distal group ) technique , or no SNB ( Placebo group ) .


All patients received spinal anesthesia and continuous-femoral nerve blockade .


A blinded observer assessed posterior and anterior knee pain at @ , @ , @ , @ , @ , and @ h postoperatively .


The primary outcome was moderate-to-severe posterior knee pain at @ h postoperatively ; secondary outcomes included SNB procedural time , needle passes , and discomfort .


Fifty-three patients were analyzed .


The proportion of patients ( Proximal : Distal : Placebo ) who experienced moderate-to-severe posterior knee pain was @ % :@ % :@ % ( P < @ ) at @ h , @ % :@ % :@ % ( P < @ ) at @ h , and @ % :@ % :@ % ( P = @ ) at @ h postoperatively .


For the anterior knee , the proportion of patients reporting moderate-to-severe pain was @ % :@ % :@ % ( P = @ ) at @ h , @ % :@ % :@ % ( P = @ ) at @ h , and @ % :@ % :@ % ( P = @ ) at @ h postoperatively .


Moderate-to-severe pain did not differ between groups beyond @ h. Both proximal and distal SNB reduced rest pain in the posterior and anterior knee up to @ h postoperatively compared with no SNB .


The popliteal technique required shorter procedural time , fewer needle passes , and produced less discomfort .


Proximal and distal SNB each reduce posterior and anterior knee pain after TKA compared with no SNB .


The aim of this study was to determine the role of omega-@ supplementation on NEFA concentration , insulin sensitivity and resistance , and glucose and lipid metabolism in type @ diabetic patients .


Forty-four type @ diabetic patients were randomly recruited into two groups .


Group A received @ g/day omega-@ soft gels , and group B received a placebo for @ wks .


Blood samples were collected after @-h fast .


Physical activity records , three-day food records , and anthropometric measurements were obtained from all participants at the beginning and end of the study .


Omega-@ supplementation caused a significant reduction in NEFA in the intervention group compared with the placebo group ( P = @ ) .


Additionally , the administration of omega-@ resulted in significantly greater changes ( Diff ) for the intervention group in various parameters , such as insulin and Quicki indices compared with the placebo group ( P < @ ) .


Omega-@ fatty acid supplementation in type @ diabetic patients improved insulin sensitivity , probably due to the decrease in NEFA concentrations .


The interleukin-@ receptor ( IL-@R ) blocker tocilizumab ( TCZ ) reduces inflammatory disease activity in rheumatoid arthritis ( RA ) but elevates lipid concentrations in some patients .


We aimed to characterise the impact of IL-@R inhibition on established and novel risk factors in active RA .


Randomised , multicentre , two-part , phase III trial ( @-week double-blind , @-week open-label ) , MEASURE , evaluated lipid and lipoprotein levels , high-density lipoprotein ( HDL ) particle composition , markers of coagulation , thrombosis and vascular function by pulse wave velocity ( PWV ) in @ patients with RA who received TCZ or placebo .


Median total-cholesterol , low-density lipoprotein-cholesterol ( LDL-C ) and triglyceride levels increased in TCZ versus placebo recipients by week @ ( @ % vs @ % , @ % vs @ % , @ % vs -@ % , respectively ; all p < @ ) .


There were no significant differences in mean small LDL , mean oxidised LDL or total HDL-C concentrations .


However , HDL-associated serum amyloid A content decreased in TCZ recipients .


TCZ also induced reductions ( > @ % ) in secretory phospholipase A@-IIA , lipoprotein ( a ) , fibrinogen and D-dimers and elevation of paraoxonase ( all p < @ vs placebo ) .


The ApoB/ApoA@ ratio remained stable over time in both groups .


PWV decreases were greater with placebo than TCZ at @weeks ( adjusted mean difference @ m/s ( @ % CI @ to @ ; p = @ ) ) .


These data provide the first detailed evidence for the modulation of lipoprotein particles and other surrogates of vascular risk with IL-@R inhibition .


When compared with placebo , TCZ induced elevations in LDL-C but altered HDL particles towards an anti-inflammatory composition and favourably modified most , but not all , measured vascular risk surrogates .


The net effect of such changes for cardiovascular risk requires determination .


in the treatment of early osteoartrosis , analgesics and non-steroidal anti-inflammatory drugs are frequently used to relieve pain .


Currently , platelet rich plasma is used as an alternative in the treatment of osteoartrosis .


The aim of this study was to evaluate the effect of platelet rich plasma compared to paracetamol as a treatment for patients with knee osteoartrosis grade I.


we evaluated @ patients who were randomized into two groups .


Group one was treated with @ mL of platelet rich plasma in two applications , while group two was treated with @ gr of oral paracetamol every @ hours for @ days .


Both patient groups received supervised physical rehabilitation during the @ month observation period .


Peripheral blood samples were taken to measure plasma IL-@ , TNF-a and TGF-@ levels at day @ and at @ months post-treatment .


Clinical evaluation was conducted using the KOOS at the start of the study and for every subsequent month during the study period .


the Knee injury and Osteoarthritis Outcome Score ( KOOS ) for group one at the start of the treatment was measured at @ points , whereas at the end , it was measured at @ points , showing a clinical improvement of @ % .


There were no statistically significant differences in IL-@ and TNF-a levels between groups treated either with platelet rich plasma or paracetamol .


Our patients treated with platelet rich plasma showed a statistically significant increase in the serum levels of TGF-@ , which was associated with an improvement in the clinical evaluation used ( KOOS ) .


High Frequency electrical Stimulation ( HFS ) of the skin induces enhanced brain responsiveness expressed as enhanced Event-Related Potential ( ERP ) N@ amplitude to stimuli applied to the surrounding unconditioned skin in healthy volunteers .


The aim of the present study was to investigate whether this enhanced ERP N@ amplitude could be a potential marker for altered cortical sensory processing in patients with persistent pain after surgery .


Nineteen male patients ; @ with and @ without persistent pain after inguinal hernia repair received HFS .


Before , directly after and thirty minutes after HFS evoked potentials and the subjective pain intensity were measured in response to electric pain stimuli applied to the surrounding unconditioned skin .


The results show that , thirty minutes after HFS , the ERP N@ amplitude observed at the conditioned arm was statistically significantly larger than the amplitude at the control arm across all patients .


No statistically significant differences were observed regarding ERP N@ amplitude between patients with and without persistent pain .


However , thirty minutes after HFS we did observe statistically significant differences of P@ amplitude at the conditioned arm between the two groups .


The P@ amplitude decreased in comparison to baseline in the group of patients with pain .


The ERP N@ effect , induced after HFS , was not different between patients with vs. without persistent pain .


The decreasing P@ amplitude was not observed in the patients without pain and also not in the previous healthy volunteer study and thus might be a marker for altered cortical sensory processing in patients with persistent pain after surgery .


Pilsicainide hydrochloride is a class IC antiarrhythmic agent used for the treatment of supraventricular and ventricular arrhythmias and atrial fibrillation .


The objective of the present study was to determine the pharmacokinetics ( PK ) of a pilsicainide hydrochloride injection in healthy Chinese adults .


The study was conducted to meet China State Food and Drug Administration requirements for the marketing of the new generic formulation of pilsicainide hydrochloride .


This Phase I , randomized , parallel-group , open-label , single-dose PK study was conducted in healthy Chinese volunteers .


Subjects were randomized to receive a single dose of @ - , @ - , and @-mg / kg pilsicainide hydrochloride with a @-minute intravenous infusion .


Serial blood and urine samples were collected up to @ hours after dosing ; drug concentrations in plasma and urine were then determined by using LC-MS/MS .


The PK parameters of pilsicainide were calculated from the plasma concentration-time data according to noncompartmental methods .


Safety profile was evaluated by monitoring adverse events , clinical laboratory parameters , and the results of @-lead ECGs .


Thirty healthy volunteers ( mean -LSB- SD -RSB- age , @ -LSB- @ -RSB- years ; weight , @ -LSB- @ -RSB- kg ; height , @ -LSB- @ -RSB- cm ; body mass index , @ -LSB- @ -RSB- kg/m ( @ ) ) were randomly divided into @ groups , each consisting of @ men and @ women .


After single-dose intravenous administration of @ , @ , and @ mg/kg of pilsicainide hydrochloride , mean Cmax was @ ( @ ) , @ ( @ ) , and @ ( @ ) g/mL , respectively ; AUC@-@ was @ ( @ ) , @ ( @ ) , and @ ( @ ) h g/mL ; and AUC@ - was @ ( @ ) , @ ( @ ) , and @ ( @ ) h g/mL .


The ranges for tz , CL , and Vz were @ to @ hours , @ to @ mL/min/kg , and @ to @ L/kg , respectively .


The mean urinary recovery rate within @ hours was @ % ( @ % ) , @ % ( @ % ) , and @ % ( @ % ) .


Men and women had significantly different AUC@-@ values in the @-mg / kg dose group ( P = @ ) , and Vz showed significant differences between men and women in all @ dose groups ( P = @ ) .


According to ECG parameters , PR intervals were significantly prolonged after administration at all @ doses ( P = @ , P < @ , and P = @ ) ; no significant changes were seen in QRS width , QTc interval , or other parameters .


Pilsicainide hydrochloride demonstrated linear PK , and the increase in the exposure of pilsicainide ( AUC@-@ and AUC@ - ) was dose proportional after single doses of @ , @ , and @ mg/kg .


All @ pilsicainide hydrochloride doses were well tolerated in these Chinese volunteers .


ChiCTR-ONC-@ .


Hyperthermia has long been used in combination with radiation for the treatment of cancers .


This study aimed to investigate the efficacy safety and impact on the immune function of the abdominal hyperthermia combining with radiotherapy .


Sixty-eight patients with post-operative local recurrent gastric carcinoma were divided randomly into two groups .


Patients in @DCRT + HT group received three-dimensional conformal radio therapy combined with abdominal hyperthermia while patients from @DCRT group only received the three-dimensional conformal radiation therapy .


The differences of efficacy , toxicity and the impact on immune function between two kinds of therapies were compared .


Response rate in @DCRT + HT group was @ % , which was significant higher than that in @DCRT group ( @ % ) ( P = @ ) .


Median local progression-free survival time of @DCRT + HT group ( @ months ) was significantly longer than @DCRT group ( @ months ) .


The peripheral blood T lymphocyte subsets analyses showed that , after the treatment , CD@ + , CD@ + , NK level and CD@ + / CD@ + ratio increased significantly , while there was no significant alterations for those immunological parameters in @DCRT group .


Abdominal hyperthermia combined with three-dimensional conformal radiotherapy could gain higher response rate , prolong median local progression-free survival time and improve immune function for the post-operative recurrentgastric cancer .


To compare the respiratory and circulatory parameters between intranasal and intravenous dexmedetomidine in gastroscopy .


@ patients undergoing elective gastroscopy were randomly divided into group D@ and D@ .


Dexmedetomidine ( @ g/kg , @ mL ) and normal saline ( NS , @ mL ) were given by intranasal route @ minutes before induction , and then NS ( @ mL ) and dexmedetomidine ( @ g/kg , @ mL ) were given intravenously @ minutes before induction , respectively , in groups D@ and D@ .


Propofol ( @ - @ mg/kg ) was used for induction .


Heart rate ( HR ) , mean arterial pressure ( MAP ) , pulse oxygen saturation ( SpO ) , and respiratory rate ( RR ) were monitored .


The latent period of falling asleep , the duration of gastroscopy , the time of awakening , and the total dose of propofol consumption were also recorded .


Postoperative sedation scale and adverse reactions were observed .


One patient in group D@ was excluded from the study due to atrioventricular block .


The HR and SpO were significantly lower , but RR was significantly higher in group D@ than in group D@ ( all p < @ ) .


The time of awakening was significantly longer and the rates of respiratory depression were significantly higher in group D@ than in group D@ ( all p < @ ) There were no significant differences in other parameters between both groups .


Intranasal dexmedetomidine is a new , safe , and effective approach for gastroscopy because it has more stable respiratory and circulatory parameters and less adverse reactions than intravenous dexmedetomidine .


In the SELECT trial , disease activity was reduced in patients with multiple sclerosis who received daclizumab high-yield process ( HYP ) for @ weeks .


The primary aim of the SELECTION extension study was to assess the safety and immunogenicity of extended treatment with daclizumab HYP .


A multicentre , randomised , double-blind , @-week extension trial was done in @ centres in the Czech Republic , Germany , Hungary , India , Poland , Russia , Ukraine , and the UK between Feb @ , @ , and Oct @ , @ .


Eligible patients were aged @-@ years , had relapsing-remitting multiple sclerosis , and had completed the SELECT study .


Patients who received placebo in SELECT were randomly assigned ( @:@ ) to receive @ mg or @ mg subcutaneous daclizumab HYP every @ weeks for @ weeks ( treatment initiation group ) ; those who had received daclizumab HYP were randomly assigned ( @:@ ) to continue their present dose with ( washout and re-initiation group ) or without ( continuous treatment group ) a washout period of @ weeks .


All randomisation was done with a centralised , interactive voice-response system .


Patients and personnel were masked to treatment assignment , except for the site pharmacist who prepared the study drug but had no interaction with patients .


The primary endpoints were the safety and immunogenicity of daclizumab HYP .


Analyses were by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT@ .


@ ( @ % ) of @ patients who completed the SELECT trial entered SELECTION , of whom @ were in the treatment initiation group , @ in the continuous treatment group , and @ in the washout and re-initiation group .


@ patients in the treatment initiation group ( @ % ) , @ in the continuous treatment group ( @ % ) , and ten in the washout and re-initiation group ( @ % ) had any serious adverse event other than relapse of multiple sclerosis .


One patient in the washout and re-initiation group ( @ mg daclizumab HYP ) died because of autoimmune hepatitis ; a contributory role of daclizumab HYP could not be excluded .


Seven patients tested positive for neutralising antidrug antibodies : one ( @ % ) of @ for whom data were available in the continuous treatment group ( this patient also tested positive at SELECTION baseline ) , four ( @ % ) in the treatment initiation group , and two ( @ % ) of @ in the washout and re-initiation group .


Adverse events and immunogenicity were not increased in the second year of continuous treatment with daclizumab HYP or during treatment washout and re-initiation .


These results support further assessment of daclizumab HYP for relapsing-remitting multiple sclerosis .


@-Agonists are the treatment of choice for exercise-induced bronchoconstriction ( EIB ) and act through specific receptors ( ADRB@ ) .


Arg@Gly polymorphisms have been shown to affect responses to regular use of @-agonists .


To evaluate the influence of the Arg@Gly receptor polymorphism on salmeterol bronchoprotection in EIB and assess predictors of bronchoprotection .


A prospective , genotype-blinded , randomized trial was performed in @ subjects ( @ Arg@Arg and @ Gly@Gly ) with EIB who were not on controller therapy .


Subjects were administered salmeterol , @ g twice a day for @ weeks , and underwent an exercise challenge @ hours after the first and last drug dose .


In addition to genotype , FEV@ , response to salmeterol , degree of EIB , and exhaled nitric oxide ( FE ( NO ) ) at baseline were examined for their association with loss of bronchoprotection ( LOB ) .


The maximum exercise-induced FEV@ fall was @ @ % during the run-in period , @ @ % ( @ @ % bronchoprotection ) after the first salmeterol dose , and @ @ % ( @ @ % bronchoprotection ) after @ weeks of salmeterol ( P = @ ) .


The Arg@Gly polymorphisms were not associated with the LOB in response to salmeterol .


FeNO values at baseline were significantly related to the LOB ( r = @ ; P = @ ) .


Mean change was a @ @ % LOB in subjects with FE ( NO ) levels greater than @ ppb and a @ @ % gain in bronchoprotection in those with FE ( NO ) levels less than @ ppb ( P = @ ) .


The LOB that occurs with chronic long-acting @-agonists use is not affected by ADRB@ Arg@Gly polymorphisms .


High FE ( NO ) was associated with marked LOB .


Use of long-acting @-agonists before achieving a reduction in FeNO may need to be avoided .


Clinical trial registered with www.clinicaltrials.gov ( NCT @ ) .


Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders .


A large number of patients with these conditions are treated by general practitioners in primary care .


Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms .


Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care .


The present study compares a practice team-supported , self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness .


This is a cluster randomised controlled superiority trial with a two-arm parallel group design .


General practices represent the units of randomisation .


General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases , version @ ( ICD-@ ) .


In the intervention group , patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner .


A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients .


In the control group , patients receive usual care from general practitioners .


Outcomes are measured at baseline ( T@ ) , at follow-up after six months ( T@ ) , and at follow-up after twelve months ( T@ ) .


The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory ( BAI ) .


To detect a standardised effect size of @ at T@ , @ patients from @ general practices are included in each group .


Secondary outcomes include anxiety-related clinical parameters and health-economic costs .


The aim of this study was to determine whether adherence to self-care modalities for breast cancer-related lymphedema ( BCRL ) predicts BCRL outcomes among @ breast cancer survivors who participated in the @-mo physical activity and lymphedema trial .


This was a prospective cohort study .


Adherence to ten BCRL self-care modalities , as recommended in the clinical practice guidelines for the management of BCRL , was assessed by a questionnaire at baseline .


BCRL outcomes assessed at baseline and @ mos included volumetry , circumferences , bioimpedence spectroscopy , the Norman lymphedema survey , and therapist-defined lymphedema exacerbations requiring treatment .


Generalized linear models were used to estimate the relationship between adherence to BCRL self-care modalities and the likelihood of experiencing a BCRL outcome .


Adherence to BCRL self-care activities did not predict experiencing any BCRL outcomes at @ mos .


Levels of adherence to BCRL self-care modalities did not predict a @ % or greater decrease in interlimb volume ( Ptrend = @ ) , @ % or greater decrease in the sum of interlimb arm circumferences ( Ptrend = @ ) , @ % or greater decrease in bioimpedence spectroscopy ( Ptrend = @ ) , @ or greater decrease in self-reported lymphedema symptoms ( Ptrend = @ ) , or therapist-defined lymphedema exacerbation requiring treatment ( Ptrend = @ ) .


Our findings suggest that levels of BCRL self-care adherence do not predict BCRL outcomes among breast cancer survivors with stable lymphedema who were followed for @ mos .


Electrocorticographic ( ECoG ) recordings from patients with medically intractable partial-onset seizures treated with a responsive neurostimulator system ( the RNS System ) that detects and stores physician-specified ECoG events provide a new data resource .


Interpretation of these recordings has not yet been validated .


The purpose was to evaluate the interrater interpretation of chronic ambulatory ECoG recordings obtained by the RNS System .


Five pairs of five experts independently classified @,@ ECoG recordings obtained from @ patients with medically intractable partial seizures who participated in a randomized controlled trial of the safety and efficacy of the RNS System .


ECoG detections -- `` long episodes '' or `` saturations '' -- were classified as `` seizures '' or `` not seizures '' based on a reference definition .


Interrater agreement rates and kappa score reliabilities were calculated between rater pairs from the ECoG sample as a whole and within individual patients who had more than the median number of individual ECoG recordings .


The overall interrater agreement was @ % , with a reliability = @ ( moderate agreement ) .


Agreement between pairs of reviewers ranged from @ to @ .


Agreement rates were @ % or better for @ % of patients .


Only @ % of patients had ECoG recordings agreement rates worse than @ % .


ECoGs with mixed interpretations ( one reviewer `` seizure '' / the other -- `` not seizure '' ) consisted of periods of low amplitude activity that evolved in amplitude or periodic discharges near @ Hz .


Although reliability as a whole was moderate , for the majority of patients , detections yielded highly reliably interpreted events of either electrographic seizures or nonictal epileptiform activity .


To assess nurse-midwife provision of early medical termination of pregnancy ( TOP ) in a high-resource setting where ultrasound examination for dating of pregnancy is part of the protocol .


Randomised controlled equivalence trial .


Out-patient family planning unit at a university hospital .


Women seeking early medical TOP .


A total of @ women were randomised , without any prior examination , to counselling , examination , and treatment by either nurse-midwife or gynaecologist .


Ultrasound was performed in all cases by the allocated provider .


The primary outcome was efficacy , defined as the successful completion of TOP without need for vacuum aspiration .


Secondary outcomes were safety , defined as need for hospitalisation or blood transfusion , and acceptability , defined as preferred provider were the women to have a medical TOP in the future .


A total of @ women in the nurse-midwife group and @ women in the doctor group were available for the final analysis .


The effectiveness of provision of medical TOP by nurse-midwife providers was superior to that provided by doctors ( risk difference @ % , @ % confidence interval @-@ @ % , which was within the set margin of equivalence ) .


There were no significant differences in safety parameters .


Women examined and counselled by a nurse-midwife were significantly more likely ( P < @ , @ % confidence interval @-@ @ ) to prefer seeing a nurse-midwife for the consultation were they to have another medical TOP in the future .


These findings show that nurse-midwife provision of early medical TOP in a high-resource setting , where ultrasound is part of the protocol , is effective , and can be safely implemented with high acceptability among women .


To evaluate the advantageous anesthetic properties , such as the decrease of intraoperative analgesic requirement , time to extubation and recovery , and early postoperative pain , of dexmedetomidine used as hypotensive agent compared with nitroglycerin in orthognathic surgery .


The authors implemented a prospective , single-blinded , randomized clinical trial .


The sample was composed of healthy patients who were admitted for bimaxillary osteotomies and were assigned to @ of @ groups by a computer-generated random number and blinded to the group .


Dexmedetomidine or nitroglycerin was used as the hypotensive drug for each group .


All patients underwent hypotensive anesthesia and surgery according to standard protocol .


Intraoperative amount of fentanyl , time to eye opening , time to follow basic verbal commands , time to extubation , early postoperative pain scores , and analgesics were recorded .


Compared means were analyzed using the unpaired Student t test .


A @-sided statistical test was used .


A P value less than @ was considered significant .


The sample was composed of @ participants .


The intraoperative fentanyl requirement was significantly lower in the dexmedetomidine group than in the nitroglycerin group ( @ and @ g , respectively ; P = @ ) .


Times to eye opening and following commands were considerably longer in the dexmedetomidine group , but the time to extubation showed no meaningful difference .


Early postoperative pain after @ and @ minutes and the requirement for meperidine were not meaningfully different between the @ groups .


Dexmedetomidine , used as a hypotensive drug , has anesthetic benefits compared with nitroglycerin .


Dexmedetomidine decreases the intraoperative fentanyl requirement and does not meaningfully change the time to extubation , early postoperative pain , and analgesic drug requirement .


This article aims to assess the efficacy and safety of atomoxetine in Korean adults with attention-deficit hyperactivity disorder ( ADHD ) .


This post hoc double-blind , placebo-controlled study of atomoxetine ( @-@mg / day ) over @ weeks in adults with ADHD at @ Japanese , Korean , and Taiwanese study sites focused on patient data from Korea ( atomoxetine , n = @ ; placebo , n = @ ) .


Primary efficacy outcome was change in baseline-to-endpoint Conners ' Adult ADHD Rating Scale-Investigator-rated : Screening Version ( CAARS-Inv : SV ) Total ADHD Symptoms score .


Secondary efficacy outcomes included changes in Adult ADHD Quality of Life ( AAQoL ) total , Behavior Rating Inventory of Executive Function-Adult Version Self-Report ( BRIEF-A : Self-Report ) , and Clinical Global Impression-ADHD-Severity ( CGI-ADHD-S ) scale scores .


Atomoxetine-treated patients demonstrated a mean @-point reduction in CAARS-Inv : SV total ADHD Symptoms score , compared with the @-point reduction in placebo-treated patients ( P@ @ ) .


Significantly greater improvement was found for atomoxetine versus placebo in CGI-ADHD-S ( P@ @ ) , BRIEF-A : Self-Report global executive composite ( P@ @ ) , and metacognition index ( P@ @ ) executive function scores .


Nausea , decreased appetite , and dry mouth were reported with significantly greater frequency by atomoxetine-treated patients , and only one placebo-treated patient discontinued because of adverse event .


A @-kg reduction in weight and a @-beat / minute increase in pulse rate were observed in atomoxetine-treated patients .


These data support a significant benefit of @ - to @-mg once daily atomoxetine versus placebo for treatment of ADHD in adult Korean patients .


A high placebo response rate was observed in this adult Korean sample ; a higher discontinuation rate was also observed in atomoxetine-treated patients .


These observations warrant further investigation .


The present trial evaluated incorporation of bright light therapy in the treatment of chronic nonspecific back pain ( CNBP ) .


A prospective , randomized , controlled , multicenter , open design with three parallel trial arms was used .


Subjects received a novel therapeutic , an expected therapeutic ineffective low dose , or no light exposure at three different medical centers .


A total of @ CNBP patients reporting pain intensity of @ points on item @ of the Brief Pain Inventory ( BPI ) were included .


Over @ weeks , @ active treatment , @ placebo controls , and @ controls received @ or no supplementary light exposures of @ lx or @lx , respectively .


Changes in self-reported scores of pain intensity ( BPI sub-score @ ) and depression ( Hospital Anxiety and Depression Questionnaire ) were the primary outcome measures .


Secondary outcome measures were changes in self-reported overall pain sensation ( BPI total score ) , grade of everyday life impairment ( BPI sub-score @ ) , mood ( visual analog scale ) , and well-being ( World Health Organization-Five Well-Being Index ) .


Changes in pain intensity were higher ( @ -LSB- @-@ @ -RSB- ) in the bright light group compared with controls ( @ -LSB- -@ -@ -RSB- ; effect size D = @ ) .


Changes in the depression score were also higher in the intervention group ( @ -LSB- @-@ @ -RSB- ) compared with controls ( @ -LSB- @-@ @ -RSB- ; effect size D = @ ) .


No differences were seen in change scores between intervention vs sham group .


The present randomized controlled trial shows that light therapy even in low dose could improve depressive symptoms and reduce pain intensity in CNBP patients .


Further research is needed for optimizing parameters of frequency , dose , and duration of therapeutic light exposure .


Osteopathy may decrease the severity of irritable bowel syndrome ( IBS ) .


About @ % of patients with quiescent Crohn 's disease ( CD ) continue to suffer from IBS-like symptoms with impaired quality of life ( Qol ) .


We aimed to evaluate the effect of osteopathy on the severity of IBS-like symptoms in quiescent CD patients .


We prospectively included @ patients with CD on remission over @ months while receiving infliximab every @ weeks .


Patients were randomized @/@ to receive three sessions of standardized osteopathy ( n = @ ) at @ , @ , and @ days after the last infusion of infliximab or simple follow-up .


The severity of IBS-like symptoms , psychological factors , and its impact on Qol were assessed using questionnaires .


Compared with baseline , the severity of IBS-like symptoms was significantly reduced in patients receiving osteopathy .


The decrease was significantly more pronounced in patients receiving osteopathy at day @ -LSB- -@ ( -@ to @ ) vs. @ ( -@ to @ ) , P = @ -RSB- , day @ -LSB- -@ ( -@ to @ ) vs. @ ( -@ to @ ) , P = @ -RSB- , and day @ -LSB- -@ ( -@ to -@ ) vs. @ ( -@ to @ ) , P = @ -RSB- with a concomitant increase in Qol ( P = @ at day @ , P = @ at day @ , P = @ at day @ ) .


Compared with baseline , the severity of fatigue was significantly reduced in patients receiving osteopathy , whereas depression and anxiety remained unchanged .


Three sessions of osteopathy reduced the severity of IBS-like symptoms associated with CD in remission .


Osteopathy should be viewed as a helpful therapeutic option to reduce the severity of abdominal pain and discomfort in patients with CD but in remission with IBS-like symptoms .


The aim of the present study was to evaluate the transverse effect of rapid maxillary expansion in patients with unilateral complete cleft lip and palate while comparing the Haas and Hyrax appliances .


The sample consisted of @ patients divided into two groups : Group I = @ patients treated with modified Haas appliance ( mean age : @ years and @ months ) ; and Group II = @ patients treated with Hyrax appliance ( mean age : @ years and @ months ) .


Cast models were taken during pre-expansion and after removal of the appliance , at the end of the retention period .


The models were scanned with the aid of the @ Shape R@ @D scanner .


Initial and final transverse distances were measured at cusp tips and cervical-palatal points of maxillary teeth by using the Ortho Analyzer @D software .


The mean expansion obtained between cusp tips and between cervical-palatal points was , respectively : for inter-canine width , @ mm and @ mm with the Haas appliance and @ mm and @ mm with the Hyrax appliance ; as for first deciduous molars or first deciduous premolars , the values obtained were @ mm and @ mm in the Haas group , and @ mm and @ mm in the Hyrax group ; with regard to first molars , values were @ mm and @ mm in the Haas group , and @ mm and @ mm in the Hyrax group .


Rapid maxillary expansion significantly increased the transverse dimensions of the upper dental arch in patients with cleft palate , with no significant differences between the Hass and Hyrax expanders .


Two replicate randomized , placebo-controlled six-month trials ( RCTs ) and an open-label treatment extension ( OLE ) comprised the pegloticase development program in patients with gout refractory to conventional therapy .


In the RCTs , approximately @ % of patients treated with the approved dose saw complete response ( CR ) of at least one tophus .


Here we describe the temporal course of tophus resolution , total tophus burden in patients with multiple tophi , tophus size at baseline , and the relationship between tophus response and urate-lowering efficacy .


Baseline subcutaneous tophi were analyzed quantitatively using computer-assisted digital images in patients receiving pegloticase ( @ mg biweekly or monthly ) or placebo in the RCTs , and pegloticase in the OLE .


Tophus response , a secondary endpoint in the trials , was evaluated two ways .


Overall tophus CR was the proportion of patients achieving a best response of CR ( without any new/enlarging tophi ) and target tophus complete response ( TT-CR ) was the proportion of all tophi with CR .