Limited previous findings have detailed biomechanical advantages following implantation with mobile bearing ( MB ) prostheses after total knee replacement ( TKR ) surgery during walking .


The aim of this study was to compare three dimensional spatiotemporal , kinematic , and kinetic parameters during walking to examine whether MBs offer functional advantages over fixed bearing ( FB ) designs .


Sixteen patients undergoing primary unilateral TKR surgery were randomised to receive either a FB ( n = @ ) or MB ( n = @ ) total knee prosthesis .


Eight age and gender matched controls underwent the same protocol on one occasion .


A @ camera Vicon system integrated with four force plates was used .


Patients were tested pre-surgery and nine months post-surgery .


No significant differences between FB and MB groups were found at any time point in the spatiotemporal parameters .


The MB group was found to have a significantly reduced frontal plane knee range of motion ( ROM ) at pre-surgery than the FB group ( FB = @ ; MB = @ ) , with the difference not observed post-surgery .


No further significant kinematic or kinetic differences were observed between FB and MB groups .


Fixed bearing and MB groups both displayed spatiotemporal , kinematic , and kinetic differences when compared to controls .


Fixed bearing and MB groups differed from controls in six and five parameters at nine months post-surgery , respectively .


No functional advantages were found in knees implanted with MB prostheses during walking , with both groups indicative of similar differences when compared to normal knee biomechanics following prosthesis implantation .


Level II .


Hypofibrinogenaemia is one of the main reasons for development of perioperative coagulopathy during major paediatric surgery .


The aim of this study was to assess whether prophylactic maintenance of higher fibrinogen concentrations through administration of fibrinogen concentrate would decrease the volume of transfused red blood cell ( RBCs ) .


In this prospective , randomised , clinical trial , patients aged @ months to @ yr undergoing craniosynostosis and scoliosis surgery received fibrinogen concentrate ( @ mg kg ( -@ ) ) at two predefined intraoperative fibrinogen concentrations -LSB- ROTEM ( ) FIBTEM maximum clot firmness ( MCF ) of < @ mm ( conventional ) or < @ mm ( early substitution ) -RSB- .


Total volume of transfused RBCs was recorded over @ h after start of surgery .


Thirty children who underwent craniosynostosis surgery and @ children who underwent scoliosis surgery were treated per protocol .


During craniosynostosis surgery , children in the early substitution group received significantly less RBCs ( median , @ ml kg ( -@ ) ; IQR , @ to @ ml kg ( -@ ) ) compared with the conventional fibrinogen trigger of < @ mm ( median , @ ml kg ( -@ ) ; IQR , @ to @ ml kg ( -@ ) ) ( P = @ ) .


Calculated blood loss as per cent of estimated total blood volume decreased from a median of @ % ( IQR , @-@ % ) to a median of @ % ( IQR , @-@ % ) ( P = @ ) .


No significant changes were observed in the scoliosis surgery population .


No bleeding events requiring surgical intervention , postoperative transfusions of RBCs , or treatment-related adverse events were observed .


Intraoperative administration of fibrinogen concentrate using a FIBTEM MCF trigger level of < @ mm can be successfully used to significantly decrease bleeding , and transfusion requirements in the setting of craniosynostosis surgery , but not scoliosis .


This study sought to determine whether circadian patterns in ventricular arrhythmias ( VAs ) occur in a current primary prevention defibrillator ( implantable cardioverter-defibrillator -LSB- ICD -RSB- ) population .


Cardiovascular events , including VAs , demonstrate biorhythmic periodicity .


We tested for deviation from the previously described occurrences of a morning peak , early morning nadir , and peak on Mondays in ICD therapies using generalized estimating equations and Student t tests .


All hypothesis tests were performed in the entire cohort of patients with VAs as well as pre-specified subgroups .


Of @ patients with an ICD , @ subjects experienced @ ICD therapy episodes for life-threatening VA. .


There was no morning ( @ am to @ pm ) peak in therapies for the entire cohort or any subgroups .


The overall cohort and several subgroups had a typical early morning ( @ am to @ am ) nadir in therapies , with significantly less than @ % of therapies occurring during this @-h block ( all p < @ ) .


A significant peak in therapies on Mondays occurred only in patients not on beta-blocker therapy ( @ % of events for the week , p = @ ) .


In the SCD-HeFT ( Sudden Cardiac Death in Heart Failure Trial ) population , the distribution of life-threatening VA failed to show a typical early morning peak or increased VA events on Mondays .


A typical early morning nadir was seen in the entire cohort .


An increased rate of events on Mondays was found in the subgroup of subjects not on beta-blocker therapy .


These findings may indicate suppression of the neurohormonal triggers for VA by current heart failure therapy , particularly the use of beta-blockers in heart failure .


The study objective was to identify the predictors of outcomes in a contemporary cohort of patients from the Reduction in cardiovascular Events by acaDesine in patients undergoing CABG ( RED-CABG ) trial .


Despite the increasing risk profile of patients who undergo coronary artery bypass grafting , morbidity and mortality have remained low , and identification of the current predictors of adverse outcomes may permit new treatments to further improve outcomes .


The RED-CABG trial was a multicenter , randomized , double-blind , placebo-controlled study that determined that acadesine did not reduce adverse events in moderately high-risk patients undergoing nonemergency coronary artery bypass grafting .


The primary efficacy end point was a composite of all-cause death , nonfatal stroke , or the need for mechanical support for severe left ventricular dysfunction through postoperative day @ .


Logistic regression modeling with stepwise variable selection identified which prespecified baseline characteristics were associated with the primary outcome .


A second logistic model included intraoperative variables as potential covariates .


The @ independent preoperative risk factors predictive of the composite end point were ( @ ) a history of heart failure ( odds ratio , @ ) ; ( @ ) increasing age ( odds ratio , @ per decade ) ; ( @ ) a history of peripheral vascular disease ( odds ratio , @ ) ; and ( @ ) receiving aspirin before coronary artery bypass grafting ( odds ratio , @ ) , which was protective .


The duration of the cardiopulmonary bypass ( odds ratio , @ ) was the only intraoperative variable that contributed to adverse outcomes .


Patients who had heart failure and preserved systolic function had a similar high risk of adverse outcomes as those with low ejection fractions , and new approaches may mitigate this risk .


Recognition of patients with excessive atherosclerotic burden may permit perioperative interventions to improve their outcomes .


The contemporary risks of coronary artery bypass grafting have changed , and their identification may permit new methods to improve outcomes .


Treatments for childhood obesity are critically needed because of the risk of developing co-morbidities , although the interventions are frequently time-consuming , frustrating , difficult , and expensive .


We conducted a longitudinal , randomised , clinical study , based on a per protocol analysis , on @ obese children and adolescents ( n = @ males and @ females ; median age , @ years ) with family history of obesity and type @ diabetes mellitus ( T@DM ) .


The patients were divided into three arms : Arm A ( n = @ patients ) , Arm B ( n = @ patients ) , and Arm C ( n = @ patients ) patients were treated with a low-glycaemic-index ( LGI ) diet and Policaptil Gel Retard , only a LGI diet , or only an energy-restricted diet ( ERD ) , respectively .


The homeostasis model assessment of insulin resistance ( HOMA-IR ) and the Matsuda , insulinogenic and disposition indexes were calculated at T@ and after @ year ( T@ ) .


At T@ , the BMI-SD scores were significantly reduced from @ to @ ( p < @ ) in Arm A and from @ to @ ( p < @ ) in Arm B. Acanthosis nigricans was significantly reduced in Arm A ( @ % to @ % ; p < @ ) , and glycosylated-haemoglobin levels were significantly reduced in Arms A ( p < @ ) .


The percentage of glucose-metabolism abnormalities was reduced , although not significantly .


However , the HOMA-IR index was significantly reduced in Arms A ( p < @ ) and B ( p < @ ) , with Arm A showing a significant reduction in the insulinogenic index ( p < @ ) .


Finally , the disposition index was significantly improved in Arms A ( p < @ ) and B ( p < @ ) .


A LGI diet , particularly associated with the use of Policaptil Gel Retard , may reduce weight gain and ameliorate the metabolic syndrome and insulin-resistance parameters in obese children and adolescents with family history of obesity and T@DM .


The degree of antiplatelet response to clopidogrel has been associated with clinical outcomes .


Studies have investigated whether adjustment of antiplatelet therapies based on a single platelet function test is beneficial .


The aim of the study was to test the stability of platelet reactivity measurements over time among patients treated with standard and double doses of clopidogrel .


The ELEVATE-TIMI @ ( Escalating Clopidogrel by Involving a Genetic Strategy-Thrombolysis In Myocardial Infarction @ ) investigators genotyped @ patients with coronary artery disease and randomized them to various clopidogrel regimens .


Patients with at least @ platelet function results on the same maintenance dose of clopidogrel ( @ mg or @ mg ) were analyzed .


Platelet aggregation was measured using P@Y@ reaction units ( PRU ) .


In total , the mean platelet reactivity and the total number of nonresponders ( PRU @ ) with clopidogrel did not change between @ periods for the @-mg ( @ % vs. @ % ; p = @ ) and @-mg doses of clopidogrel ( @ % vs. @ % ; p = @ ) .


In contrast , when evaluating each patient individually , @ % of patients taking clopidogrel @ mg and @ % of patients taking @ mg had a change in their responder status when tested at @ different time points ( p < @ ) .


Despite being treated with the same dose of clopidogrel , > @ % of patients had a change in PRU > @ on serial sampling , which approximates the average PRU difference caused by increasing the clopidogrel dose from @ mg to @ mg .


Measurements of platelet reactivity vary over time in a significant proportion of patients .


Thus , treatment adjustment according to platelet function testing at a single time point might not be sufficient for guiding antiplatelet therapy in clinical or research settings .


( Escalating Clopidogrel by Involving a Genetic Strategy-Thrombolysis In Myocardial Infarction @ -LSB- ELEVATE-TIMI @ -RSB- ; NCT@ ) .


To date , studies assessing the risk of post-transplant hepatocellular carcinoma ( HCC ) recurrence have focused on tumour characteristics .


This study investigated the impact of donor characteristics and graft quality on post-transplant HCC recurrence .


Using the Scientific Registry of Transplant Recipients patients with HCC who received a liver transplant between @ and @ were included , and post-transplant HCC recurrence was assessed .


A multivariable competing risk regression model was fitted , adjusting for confounders such as recipient sex , age , tumour volume , - fetoprotein , time on the waiting list and transplant centre .


A total of @ liver transplant recipients were included .


Patients receiving a graft procured from a donor older than @ years ( adjusted hazard ratio ( HR ) @ , @ per cent c.i. @ to @ ; P = @ ) , a donor with a history of diabetes ( adjusted HR @ , @ to @ ; P = @ ) and a donor with a body mass index of @ kg/m ( @ ) or more ( adjusted HR @ , @ to @ ; P = @ ) had an increased rate of post-transplant HCC recurrence .


In @ patients with documented steatosis , severe graft steatosis ( more than @ per cent ) was also linked to an increased risk of recurrence ( adjusted HR @ , @ to @ ; P = @ ) .


Recipients of organs from donation after cardiac death donors with prolonged warm ischaemia had higher recurrence rates ( adjusted HR @ , @ to @ ; P = @ ) .


Donor-related factors such as donor age , body mass index , diabetes and steatosis are associated with an increased rate of HCC recurrence after liver transplantation .


Considering that adolescent mothers may be more vulnerable to discontinuing exclusive breastfeeding ( EBF ) before @months and that their mothers may exert a negative influence on this practice , this study was conducted with the objective of evaluating the efficacy of breastfeeding counselling for adolescent mothers and their mothers in increasing EBF duration .


A clinical trial was performed in @ adolescent mothers with newborns and their mothers randomized in four groups : ( @ ) not living with mother , without intervention ; ( @ ) not living with mother , with intervention ; ( @ ) living with mother , without intervention , ( @ ) living with mother , with intervention .


The intervention consisted of five counselling sessions directed to mother and grandmother , in the maternity hospital and on follow-up .


Information about feeding practices during the newborn 's first six months of life was collected monthly by telephone .


Intervention 's efficacy was measured through Cox regression and comparison of exclusive breastfeeding medians and survival curves for the different groups .


The intervention increased the duration of EBF by@ days for the group which included grandmothers ( HR = @ ; CI @ % = @-@ @ ) and @days for the group which did not include grandmothers ( HR = @ ; CI @ % = @-@ @ ) .


Counselling sessions in the first four months of children 's lives proved to be effective in increasing EBF duration among adolescent mothers .


Analysis of progression-free survival ( PFS ) as the primary endpoint in advanced epithelial ovarian , fallopian tube , and primary peritoneal cancer ( AEOC ) trials may be confounded by the difficulty of radiologic evaluation of disease progression and the potential for discrepancy between investigator and blinded independent central assessments .


PFS as assessed by local investigator ( INV ) was the primary endpoint of AGO-OVAR@ , a randomized , double-blind trial of pazopanib maintenance therapy in AEOC .


To confirm the robustness of the primary analysis , PFS was also evaluated by blinded independent central review ( BICR ) .


Patients with histologically confirmed AEOC ( N = @ ) were randomized @:@ to receive pazopanib @ mg/day or placebo for up to @ months .


Tumor response in the intent-to-treat population was evaluated by CT/MRI every @ months and analyzed per RECIST @ .


Pazopanib prolonged PFS versus placebo by INV ( median @ vs @ months ; hazard ratio -LSB- HR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- : @-@ @ ; P = @ ) .


Results for PFS by BICR were similar ( median @ vs @ months ; HR = @ , @ % CI : @-@ @ ; P = @ ) .


Progression events were recorded later by INV in @ % of pazopanib-treated patients and @ % of placebo-treated patients .


The overall concordance between INV and BICR assessments was @ % and @ % in the pazopanib and placebo arms , respectively .


By INV and BICR assessments , maintenance therapy with pazopanib in AEOC provided a significantly longer PFS than placebo .


The good overall concordance between INV and BICR assessments , as well as HR and P value consistency , supports the reliability of investigator-assessed PFS as the primary endpoint in AGO-OVAR@ .


The aim of this study was to evaluate the effectiveness of sitagliptin , alone or in combination with metformin , in kidney transplant patients with newly diagnosed new-onset diabetes mellitus after transplant who had inadequate glycemic control , compared with a group of patients receiving insulin glargine with special emphasis on weight gain .


Newly diagnosed renal transplant patients with new-onset diabetes mellitus after a transplant was defined by a blood glucose @ mmol/L after an oral glucose tolerance test were examined .


They were treated with standard immunosuppression composed of triple therapy with tacrolimus or cyclosporine , mycophenolate mofetil or azathioprine , and prednisone .


They had stable graft function for more than @ months after the transplant .


Patients with new-onset diabetes mellitus after transplant ( n = @ ) whose glycemia was not controlled adequately with oral hypoglycemic agents ( either alone or in combination ) received oral sitagliptin @ mg once daily in addition to existing therapy for @ weeks .


Patients who received insulin glargine as add-on therapy ( n = @ ) served as the control group .


Data analyses included glycated hemoglobin , fasting plasma glucose , lipid profile , body weight , and the occurrence of hypoglycemia .


We found significant reductions in glycated hemoglobin and fasting plasma glucose values after @ weeks of additional sitagliptin therapy that were comparable to those with insulin glargine .


While the addition of stagliptin resulted in a small weight loss ( @ kg ) , the addition of insulin glargine resulted in a weight gain ( @ kg ) .


The overall incidence of adverse experiences was low and generally mild in both groups .


In a group of renal transplant recipients with new-onset diabetes mellitus after a transplant in whom glycemia was not controlled adequately by oral hypoglycemic agents , the addition of sitagliptin helped to achieve glycemic control similar to insulin glargine but with a marginal weight advantage .


Microvascular obstruction seems to predict poor outcome in patients undergoing elective percutaneous coronary intervention ( PCI ) , but the underlying mechanism is still unclear .


We analyzed whether serum thromboxane B@ , a stable metabolite of thromboxane A@ , may be implicated in post-PCI microvascular obstruction .


We enrolled @ patients ( @ males , @ years ) on chronic low-dose aspirin therapy ( aspirin , @ mg daily ) scheduled for elective PCI and randomly assigned to receive aspirin reload ( @ mg orally , n = @ ) or no reload ( control group , n = @ ) @ hour before elective PCI .


Serum levels of thromboxane B@ , reperfusion indexes ( corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade ) , and serum cardiac troponin I were assessed before and after PCI .


Serum thromboxane B@ significantly increased after @ minutes ( P = @ ) from PCI in control but not in aspirin reload group .


After PCI , both groups showed a statistically significant reduction in corrected Thrombolysis In Myocardial Infarction frame count more evident in aspirin reload group ( P = @ ) .


Moreover , after PCI , @ % of patients allocated to aspirin reload and only @ % of patients allocated to control group reached normal microcirculatory reperfusion ( myocardial blush grade = @ ) ; patients with myocardial blush grade = @ exhibited lower values of serum thromboxane B@ compared with those with myocardial blush grade < @ ( P = @ ) .


Periprocedural cardiac troponin I significantly increased ( F = @ ; P = @ ) and correlated with serum thromboxane B@ ( = @ ; P = @ ) in control but not in aspirin reload group .


In addition , left ventricular ejection fraction significantly increased after PCI only in the aspirin reload group ( P = @ ) .


Aspirin loading dose before elective PCI improves myocardial reperfusion and injury indexes , suggesting a possible role of platelet thromboxane A@ in microvascular occlusion .


To study the analgesic effect of electroacupuncture ( EA ) as perioperative adjunctive therapy added to a systemic analgesic strategy ( including tramadol and ketamine ) for postoperative pain , opioid-related side effects and patient satisfaction .


In a sham-controlled participant - and observer-blinded trial , @ patients undergoing radical prostatectomy were randomly assigned to two groups : ( @ ) EA ( n = @ ; tramadol + ketamine + EA ) and ( @ ) control ( n = @ ; tramadol + ketamine ) .


EA ( @Hz frequency ) was applied at LI@ bilaterally during the closure of the abdominal walls and EA ( @Hz ) was applied at ST@ and LI@ bilaterally immediately after extubation .


The control group had sham acupuncture without penetration or stimulation .


The following outcomes were evaluated : postoperative pain using the Numerical Rating Scale ( NRS ) and McGill Scale ( SF_MPQ ) , mechanical pain thresholds using algometer application close to the wound , cortisol measurements , rescue analgesia , Spielberger State Trait Anxiety Inventory ( STAI Y-@ item ) , patient satisfaction and opioid side effects .


Pain scores on the NRS and SF_MPQ were significantly lower and electronic pressure algometer measurements were significantly higher in the EA group than in the control group ( p < @ ) at all assessments .


In the EA group a significant decrease in rescue analgesia was observed at @min ( p < @ ) and a significant decrease in cortisol levels was also observed ( p < @ ) .


Patients expressed satisfaction with the analgesia , especially in the EA group ( p < @ ) .


Significant delays in the start of bowel movements were observed in the control group at @min ( p < @ ) and @h ( p < @ ) .


Adding EA perioperatively should be considered an option as part of a multimodal analgesic strategy .


Contemporary studies suggest an association between venous thromboembolism and a higher incidence of major cardiovascular events , mostly attributed to arterial atherothrombosis .


Using data from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research ( NAVIGATOR ) trial , we assessed the association of venous thromboembolism with major cardiovascular events .


In NAVIGATOR , patients with impaired glucose tolerance were randomly allocated to receive valsartan or placebo and nateglinide or placebo in addition to lifestyle modification .


Baseline characteristics and prior history of venous thromboembolism were assessed .


After adjusting for important baseline covariates , Cox proportional hazards regression models were used to assess the association between venous thromboembolism and major cardiovascular outcomes .


Of the @ patients enrolled , @ ( @ % ) had a history of venous thromboembolism .


Patients with venous thromboembolism were older , more frequently white and female , and had a higher body mass index .


Patients with venous thromboembolism had higher @-year event rates for the composite of death , myocardial infarction , and stroke , as compared with patients without venous thromboembolism ( @ % vs @ % ; P < @ ; adjusted hazard ratio @ ; @ % confidence interval , @-@ @ ; P = @ ) .


In patients with impaired glucose tolerance at high risk for cardiovascular events , the prevalence of venous thromboembolism was rare but associated with worse long-term cardiovascular outcomes , including arterial events .


Venous thromboembolism is a marker of risk , and attention should be paid to this high-risk group of patients .


Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults .


Several randomized controlled trials show yoga is an effective treatment .


However , the comparative effectiveness of yoga and physical therapy , a common mainstream treatment for chronic low back pain , is unknown .


This is a randomized controlled trial for @ predominantly low-income minority adults with chronic low back pain , comparing yoga , physical therapy , and education .


Inclusion criteria are adults @-@ years old with non-specific low back pain lasting @ weeks and a self-reported average pain intensity of @ on a @-@ scale .


Recruitment takes place at Boston Medical Center , an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods .


The @-week study has an initial @-week Treatment Phase where participants are randomized in a @:@:@ ratio into i ) a standardized weekly hatha yoga class supplemented by home practice ; ii ) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method , individually delivered by a physical therapist and supplemented by home practice ; and iii ) education delivered through a self-care book .


Co-primary outcome measures are @-week pain intensity measured on an @-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire .


In the subsequent @-week Maintenance Phase , yoga participants are re-randomized in a @:@ ratio to either structured maintenance yoga classes or home practice only .


Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only .


Education participants continue to follow recommendations of educational materials .


We will also assess cost effectiveness from the perspectives of the individual , insurers , and society using claims databases , electronic medical records , self-report cost data , and study records .


Qualitative data from interviews will add subjective detail to complement quantitative data .


The objective of this study was to compare cervicovaginal fetal fibronectin ( FFN ) versus transvaginal sonographic cervical length as predictors of preterm birth in twin pregnancy and to test whether @-hydroxyprogesterone caproate ( @OHPc ) modifies the predictive value of FFN .


Secondary analysis of a randomized trial of @OHPc versus placebo in dichorionic-diamniotic twins , analyzing the subset with screening FFN ( N = @ ) and/or cervical length ( N = @ ) at @ to @ weeks of gestation .


Positive FFN was found in @ % , cervical length @ mm in @ % , and both positive FFN and cervical length @ mm in @ % .


Birth < @ , < @ , and < @ weeks occurred in @ , @ , and @ % , respectively .


In logistic regression analysis controlling for FFN , cervical length , prior preterm birth , and treatment group , positive FFN was significantly associated with birth < @ and < @ weeks ( odds ratio @ -LSB- @ % confidence interval @-@ -RSB- , @ -LSB- @-@ -RSB- , respectively , p < @ for both ) but cervical length @ mm was not ( odds ratio @ -LSB- @-@ @ -RSB- , @ -LSB- @-@ @ -RSB- ) .


Positive FFN was stronger than cervical length @ mm in predicting early preterm birth in twins , regardless of @OHPc use .


Treatment with @OHPc did not appear to alter the predictive value of FFN .


The purpose of this study was to compare the clinical outcomes of immediate rotator cuff repair with capsular release and those of rotator cuff repair after the stiffness was treated with rehabilitative therapy .


Between June @ and December @ , we recruited @ patients with rotator cuff tears and stiffness .


In @ patients arthroscopic rotator cuff repair was performed with capsular release simultaneously ( group I ) .


In @ patients arthroscopic rotator cuff repair was performed after @ months of preoperative rehabilitation for stiffness ( group II ) .


The American Shoulder and Elbow Surgeons score , Simple Shoulder Test score , Constant score , and visual analog scale score for pain and range of motion ( ROM ) were assessed at the start of the study ; at @ , @ , and @ months ; and at the last visit .


The postoperative cuff tendon integrity was assessed between @ and @ months using magnetic resonance or ultrasound images .


There were no significant differences in preoperative demographic data between the groups ( P > @ ) .


The mean follow-up period was @ months .


After treatment , there was significant improvement in ROM and functional scores in both groups , as measured at the last follow-up ( P < @ ) .


No statistical differences were found in clinical scores and ROM at the last follow-up ( P > @ ) .


On assessment of the magnetic resonance or ultrasound images taken @ to @ months postoperatively , the retear rate for the repaired cuff tendon in each group was @ % in group I and @ % in group II .


In the treatment of rotator cuff tears with stiffness , satisfactory results can be achieved either by repairing the tear with simultaneous capsular release or by waiting to perform the repair after preoperative rehabilitation for stiffness .


Because a delayed rotator cuff repair after improving ROM offered no clear advantage over an immediate operation , we recommend surgically treating rotator cuff tears with concomitant stiffness early using a simultaneous capsular release method to save time and to avoid unnecessary rehabilitation .


Level II , prospective comparative study .


Antiretroviral ( ARV ) medications differentially penetrate across the blood-brain barrier into central nervous system ( CNS ) tissues , potentially influencing their effectiveness in treating brain infection .


This randomized controlled clinical trial ( RCT ) called for @ participants at @ study sites to be randomized @:@ to CNS-targeted ( CNS-T ) or non-CNS-T ART .


Entry clinical factors such as ARV experience were balanced across arms using an adaptive randomization approach .


The primary outcome , change in neurocognitive performance , was measured as the difference in global deficit score ( GDS ) from baseline to week @ .


The study was terminated early on the recommendation of its data safety monitoring board on the basis of slow accrual and a low likelihood of detecting a difference in the primary outcome .


No safety concerns were identified .


Of @ participants screened , @ met entry criteria and were randomized .


The primary intent-to-treat analysis included @ participants who completed week @ .


These comprised @ men and @ women with a mean age of @ years ( SD , @ years ) , and median nadir and current CD@ ( + ) T-cell counts of @ cells/L and @ cells/L , respectively .


The proportional improvement in GDS from baseline was nonsignificantly larger ( @ % ; @ % confidence interval -LSB- CI -RSB- , -@ % to @ % ) in the CNS-T arm than in the non-CNS-T arm , representing a treatment effect size of @ ( @ % CI , -@ to @ ) .


Prespecified secondary analysis showed a trend interaction ( P = @ ) , indicating that participants who had baseline plasma virologic suppression may have benefited from CNS-T .


This study found no evidence of neurocognitive benefit for a CNS-T strategy in HIV-associated neurocognitive disorders .


A benefit for a subgroup or small overall benefits could not be excluded .


Clinical Trials Registration NCT@ .


This study aimed to examine whether long working hours and short sleep duration were associated with an increased risk of acute myocardial infarction ( AMI ) or severe coronary heart diseases ( SCHD ) , independent of established psychosocial work-related factors .


A case-control study was conducted .


Cases were @ men , aged < @ years and economically active , who were admitted to hospital with a first diagnosed AMI or SCHD during @-@ , of whom @ were confirmed AMI and the other @ were angiography-confirmed SCHD .


Controls were @ men who were drawn from a national survey and were matched to the cases on age , education and area of residence .


Odds ratios of total CHD and confirmed AMI in relation to average weekly working hours and daily hours of sleep were calculated .


Men with average working hours longer than @ h/week were found to have significantly increased risks for total CHD ( OR = @ ) as compared to those with weekly working hours in @-@ h , and those with daily hours of sleep fewer than @ h were found to have increased risks for CHD ( OR = @ ) as compared to those with sleeping hours in @-@ h. Restriction to confirmed AMI yielded a greater risk and these associations remained consistent with adjustment of smoking status , body mass index and psychosocial work factors including job demands , job control , workplace justice , job insecurity and shift work .


The results support the hypothesis that long working hours and short sleep duration contribute independently to the risk of cardiovascular diseases in men .


To investigate the impact of tocilizumab treatment on growth and growth-related laboratory parameters in patients with systemic juvenile idiopathic arthritis ( JIA ) enrolled in a phase III clinical trial .


Patients with systemic JIA ages @-@ years ( n = @ ) received tocilizumab in a @-week , randomized , placebo-controlled period and a long-term open-label extension .


Height velocity and standard deviation ( SD ) score ; levels of insulin-like growth factor @ ( IGF-@ ) , osteocalcin ( OC ) , and C-telopeptide of type I collagen ( CTX-I ) ; and Juvenile Arthritis Disease Activity Score in @ joints ( JADAS-@ ) were measured in a post hoc analysis of @ patients who never received growth hormone and did not reach Tanner stage @ by the end of the first year of treatment .


Patients had stunted growth at baseline ( mean height SD score -@ ) .


During tocilizumab treatment , males ( @ % ) and females ( @ % ) experienced above-normal mean height velocities of @ cm/year ( P < @ versus World Health Organization norms ) .


Mean height SD score increases during year @ ( @ ) and year @ ( @ ) were significant ( both P < @ ) .


The mean SD score for IGF-@ levels increased significantly ( -@ for year @ and -@ for year @ versus -@ at baseline ; both P < @ ) .


Mean OC and CTX-I levels ( both P < @ ) and the OC : CTX-I ratio ( P = @ ) significantly increased from baseline to year @ .


In multiple regression analysis , first-year height velocity had a significant inverse relationship to JADAS-@ at year @ , age , mean glucocorticoid dosage during the year , and height SD score at baseline .


Our findings indicate that during treatment with tocilizumab , patients with systemic JIA experience significant catch-up growth , normalization of IGF-@ levels , and bone balance improvement favoring bone formation .


It is widely supported that multicentric disease of the breast ( MCDB ) is a contraindication of breast conservative surgery ( BCS ) .


This is a multicentric study ( two breast cancer units from Greece , one from France ) involving patients with at least two primary tumors in separate quadrants of the breast and no diffuse suspicious microcalcifications on mammography .


Sixty-one patients were included in the study , but @ were followed up to the end .


Patients were randomly assigned in total mastectomy ( TM ) and BCS groups .


End point of the study was disease-free survival rates three and five years after initial operation .


Three years after BCS , local recurrence ( LR ) was observed in two patients ( @ % ) and one after five years ( total recurrence rate : @ % ) .


A TM was performed in these patients , and in two there was no LR or distant metastasis ( DM ) five years after .


The third patient was disease free two-years later .


Three years after TM , eight patients ( @ % ) had DM and @ ( @ % ) did not ( p = @ ) .


Five years after TM , eight patients ( @ % ) had DM and @ patients ( @ % ) di not ( p = @ ) .


The results showed that conservative surgery was an alternative surgical option in multicentric breast cancer with good results regarding disease-free survival and recurrence .


As lithium treatment might be effective in reducing the risk of deliberate self-harm ( DSH ) in adult patients with unipolar affective disorders , we designed a pragmatic randomised trial to assess its efficacy in more than @ patients with treatment-resistant depression .


However , we randomised @ patients only .


The aim of this report is therefore twofold : first , to disseminate the results of this underpowered study which may be incorporated into future meta-analytical reviews ; second , to analyse some critical aspects of the study which might explain failure to reach the target sample size .


We carried out a randomised , parallel group , assessor-blinded superiority clinical trial .


Adults with a diagnosis of major depression , an episode of DSH in the previous @ months and inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode were allocated to add lithium to usual care ( intervention arm ) versus usual care alone ( control arm ) .


Suicide completion and acts of DSH during the @ months of follow-up constituted the composite primary outcome .


Of @ patients screened for inclusion , @ were allocated to lithium plus usual care and @ were assigned to usual care without lithium .


Six patients in the lithium plus usual care group and seven in the usual care group committed acts of DSH during the follow-up phase .


The survival probability did not differ between the two treatment arms ( Chi@ = @ , p = @ ) .


With regard to changes in the severity of depressive symptomatology from baseline to endpoint , no significant differences were detected .


The present study failed to achieve the minimum sample size needed to detect a clinically meaningful difference between the two treatment arms .


Consequently , the finding that lithium , in addition to usual care , did not exert a positive effect in terms of reduction of DSH after @ months of follow-up is likely due to the lack of sufficient statistical power to detect a difference , if a difference existed .


The dissemination of the results of this underpowered study will inform future meta-analytical reviews on lithium and suicide-related outcomes .


Intensive follow-up after surgery for colorectal cancer is common practice but is based on limited evidence .


To assess the effect of scheduled blood measurement of carcinoembryonic antigen ( CEA ) and computed tomography ( CT ) as follow-up to detect recurrent colorectal cancer treatable with curative intent .


Randomized clinical trial in @ National Health Service hospitals in the United Kingdom ; @ eligible participants were recruited between January @ and August @ who had undergone curative surgery for primary colorectal cancer , including adjuvant treatment if indicated , with no evidence of residual disease on investigation .


Participants were randomly assigned to @ of @ groups : CEA only ( n = @ ) , CT only ( n = @ ) , CEA+CT ( n = @ ) , or minimum follow-up ( n = @ ) .


Blood CEA was measured every @ months for @ years , then every @ months for @ years ; CT scans of the chest , abdomen , and pelvis were performed every @ months for @ years , then annually for @ years ; and the minimum follow-up group received follow-up if symptoms occurred .


The primary outcome was surgical treatment of recurrence with curative intent ; secondary outcomes were mortality ( total and colorectal cancer ) , time to detection of recurrence , and survival after treatment of recurrence with curative intent .


After a mean @ ( SD , @ ) years of observation , cancer recurrence was detected in @ participants ( @ % ; @ % CI , @ % -@ % ) overall ; @ of @ participants ( @ % ; @ % CI , @ % -@ % ) were treated for recurrence with curative intent , with little difference according to Dukes staging ( stage A , @ % -LSB- @/@ -RSB- ; stage B , @ % -LSB- @/@ -RSB- ; stage C , @ % -LSB- @/@ -RSB- ) .


Surgical treatment of recurrence with curative intent was @ % ( @/@ ) in the minimum follow-up group , @ % ( @/@ ) in the CEA group , @ % ( @/@ ) in the CT group , and @ % ( @/@ ) in the CEA+CT group .


Compared with minimum follow-up , the absolute difference in the percentage of patients treated with curative intent in the CEA group was @ % ( @ % CI , @ % -@ % ; adjusted odds ratio -LSB- OR -RSB- , @ ; @ % CI , @-@ @ ) , in the CT group was @ % ( @ % CI , @ % -@ % ; adjusted OR , @ ; @ % CI , @-@ @ ) , and in the CEA+CT group was @ % ( @ % CI , @ % -@ % ; adjusted OR , @ ; @ % CI , @-@ @ ) .


The number of deaths was not significantly different in the combined intensive monitoring groups ( CEA , CT , and CEA+CT ; @ % -LSB- @/@ -RSB- ) vs the minimum follow-up group ( @ % -LSB- @/@ -RSB- ; difference , @ % ; @ % CI , -@ % to @ % ) .


Among patients who had undergone curative surgery for primary colorectal cancer , intensive imaging or CEA screening each provided an increased rate of surgical treatment of recurrence with curative intent compared with minimal follow-up ; there was no advantage in combining CEA and CT. .


If there is a survival advantage to any strategy , it is likely to be small .


Bacterial prostatitis ( BP ) is a common condition accounting responsible for about @-@ % of all prostatitis cases ; chronic bacterial prostatitis ( CBP ) classified as type II , are less common but is a condition that significantly hampers the quality of life , ( QoL ) because not only is it a physical condition but also a psychological distress .


Commonly patients are treated with antibiotics alone , and in particular fluoroquinolones are suggested by the European Urology guidelines .


This approach , although recommended , may not be enough .


Thus , a multimodal approach to the prolonged antibiotic therapy may be helpful .


@ patients affected by chronic bacterial prostatitis were enrolled in the study .


All patients were positive to Meares-Stamey test and symptoms duration was > @ months .


The purpose of the study was to evaluate the efficacy of a long lasting therapy with a fluoroquinolone in association with a nutraceutical supplement ( prulifloxacin @ mg for @ days and an association of Serenoa repens @ mg , Lactobacillus Sporogens @ mg , Arbutin @ mg for @ days ) .


Patients were randomized in two groups ( A and B ) receiving respectively antibiotic alone and an association of antibiotic plus supplement .


Biological recurrence at @ months in Group A was observed in @ patients ( @ % ) and in Group B in @ patients ( @ % ) .


Uropathogens found at the first follow-up were for the majority Gram - ( E. coli and Enterobacter spp . )


A statistically significant difference was found at the time of the follow-up between Group A and B in the NIH-CPSI questionnaire score , symptoms evidence and serum PSA .


Broad band , short-lasting antibiotic therapy in association with a nutritional supplement ( serenoa repens , lactobacillus sporogens and arbutin ) show better control and recurrence rate on patients affected by chronic bacterial prostatitits in comparison with antibiotic treatment alone .


Limited comparative , prospective data exist regarding cardiovascular risk factors in HIV-infected women starting antiretroviral therapy in Africa .


In @ African countries , @ women with CD@ < @ cells/mm were randomized to tenofovir/emtricitabine ( TDF/FTC ) plus either nevirapine ( NVP , n = @ ) or lopinavir/ritonavir ( LPV/r , n = @ ) .


Lipids and blood pressure ( BP ) were evaluated at entry , @ , @ , and @ weeks .


Multivariable linear and logistic regression models were used to evaluate mean risk factor changes and clinically relevant risk factor changes .


At entry , both NVP and LPV/r groups were similar regarding age -LSB- mean = @ ( SD = @ ) years -RSB- , CD@ -LSB- @ ( @ ) cells/mm -RSB- , and HIV-@ RNA -LSB- @ ( @ ) log@ copies/mL -RSB- .


Nearly , all women had normal lipids and BP except for high-density lipoprotein ( HDL ) - cholesterol .


Over @ weeks , the LPV/r compared with NVP group had significantly greater mean lipid increases ( eg , non-HDL : +@ vs. +@ mg/dL ) and smaller HDL increases ( +@ vs. +@ mg/dL ) .


In contrast , the NVP compared with LPV/r group had greater mean increases in BP ( eg , diastolic BP : +@ vs. -@ mm Hg ) .


Significantly , more women assigned LPV/r had week @ `` abnormal '' lipid levels ( eg , HDL @ % vs. @ % and triglycerides @ % vs. @ % ) , and significantly , more women assigned NVP had `` abnormal '' BP ( eg , diastolic BP @ % vs. @ % ) .


Most differences remained significant when adjusted for baseline risk factor , age , CD@ , and HIV-@ RNA .


In HIV-infected women initiating antiretroviral therapy in Africa , LPV/r + TDF/FTC was associated with less favorable changes in lipids , and use of NVP + TDF/FTC was associated with less favorable changes in BP .


Sepsis treatment guidelines recommend macrocirculatory hemodynamic optimization ; however , microcirculatory dysfunction is integral to sepsis pathogenesis .


We aimed to test the hypothesis that following macrocirculatory optimization , inhaled nitric oxide would improve microcirculation in patients with sepsis and that improved microcirculation would improve lactate clearance and multiple organ dysfunction .


Randomized , sham-controlled clinical trial .


Single urban academic medical center .


Adult patients with severe sepsis and systolic blood pressure less than @ mm Hg despite intravascular volume expansion and/or serum lactate greater than or equal to @ mmol/L .


After achievement of macrocirculatory resuscitation goals , we randomized patients to @ hours of inhaled nitric oxide ( @ ppm ) or sham inhaled nitric oxide administration .


We administered study drug via a specialized delivery device that concealed treatment allocation so that investigators and clinical staff remained blinded .


We performed sidestream dark-field videomicroscopy of the sublingual microcirculation prior to and @ hours after study drug initiation .


The primary outcome measure was the change in microcirculatory flow index .


Secondary outcomes were lactate clearance and change in Sequential Organ Failure Assessment score .


We enrolled @ patients ( @ of @ -LSB- @ % -RSB- requiring vasopressor agents ; @ of @ -LSB- @ % -RSB- died ) .


Although inhaled nitric oxide significantly raised plasma nitrite levels , it did not improve microcirculatory flow , lactate clearance , or organ dysfunction .


In contrast to previous studies conducted during the earliest phase of resuscitation , we found no association between changes in microcirculatory flow and lactate clearance or organ dysfunction .


Following macrocirculatory optimization , inhaled nitric oxide at @ ppm did not augment microcirculatory perfusion in patients with sepsis .


Further , we found no association between microcirculatory perfusion and multiple organ dysfunction after initial resuscitation .


Survivors of breast cancer experience stress and are at risk for depressive symptoms following primary treatment .


Group-based interventions such as cognitive-behavioral stress management ( CBSM ) delivered postsurgery for nonmetastatic breast cancer ( BCa ) were previously associated with fewer depressive symptoms over a @-month follow-up ; few studies have examined the longer-term benefits of such psychosocial interventions .


This @-year follow-up study of a previously conducted trial ( #NCT @ ) tested whether group-based CBSM following surgery for nonmetastatic BCa was associated with fewer depressive symptoms .


Women ( N = @ ) with Stage @-IIIb BCa were recruited @-@ weeks postsurgery and randomized to a @-week CBSM intervention group or a @-day psycho-educational control group .


Women were recontacted @ years poststudy enrollment and reconsented to participate in the follow-up study ( N = @ ) .


Depressive symptomatology was assessed using the Center for Epidemiologic Studies-Depression scale ( CES-D ) .


ANOVA and ANCOVA analyses were employed to test for group differences on the CES-D at @-year follow-up accounting for relevant covariates .


Participants assigned to CBSM reported significantly fewer depressive symptoms ( M = @ , SE = @ ) at the follow-up compared with those in the control group ( M = @ , SE = @ ) , p = @ .


With covariates , the group difference remained significant , p = @ .


Women who received CBSM postsurgery for BCa reported fewer depressive symptoms than those in the control group in this @-year follow-up .


Psychosocial interventions early in treatment may influence long-term psychological well-being in BCa survivors .


Speckle tracking is a relatively new , largely angle-independent technique used for the evaluation of myocardial longitudinal strain ( LS ) .


However , significant differences have been reported between LS values obtained by speckle tracking with the first generation of software products .


To compare LS values obtained with the most recently released equipment from two manufacturers .


Systematic scanning with head-to-head acquisition with no modification of the patient 's position was performed in @ patients with equipment from two different manufacturers , with subsequent off-line post-processing for speckle tracking LS assessment ( Philips QLAB @ and General Electric -LSB- GE -RSB- EchoPAC BT@ ) .


The interobserver variability of each software product was tested on a randomly selected set of @ echocardiograms from the study population .


GE and Philips interobserver coefficients of variation ( CVs ) for global LS ( GLS ) were @ % and @ % , respectively , indicating good reproducibility .


Reproducibility was very variable for regional and segmental LS values , with CVs ranging from @ % to @ % with both software products .


The concordance correlation coefficient ( CCC ) between GLS values was high at @ , indicating substantial agreement between the two methods .


While good agreement was observed between midwall and apical regional strains with the two software products , basal regional strains were poorly correlated .


The agreement between the two software products at a segmental level was very variable ; the highest correlation was obtained for the apical cap ( CCC @ ) and the poorest for basal segments ( CCC range @-@ @ ) .


A high level of agreement and reproducibility for global but not for basal regional or segmental LS was found with two vendor-dependent software products .


This finding may help to reinforce clinical acceptance of GLS in everyday clinical practice .


Tight glucose control ( TGC ) reduces morbidity and mortality in patients undergoing elective cardiac surgery , but only limited data about its optimal timing are available to date .


The purpose of this article was to compare the effects of perioperative vs postoperative initiation of TGC on postoperative adverse events in cardiac surgery patients .


This was a single center , single-blind , parallel-group , randomized controlled trial .


The setting was an academic tertiary hospital .


Participants were @ hemodynamically stable patients undergoing major cardiac surgery with expected postoperative intensive care unit treatment for at least @ consecutive days .


Intensive insulin therapy was initiated perioperatively or postoperatively with a target glucose range of @ to @ mmol/L .


Adverse events from any cause during postoperative hospital stay were compared .


In the whole cohort , perioperatively initiated TGC markedly reduced the number of postoperative complications ( @ % vs @ % , @ % confidence interval -LSB- CI -RSB- , @-@ @ ) despite only minimal improvement in glucose control ( blood glucose , @ @ vs @ @ mmol/L , P < @ ; time in target range , @ % @ % vs @ % @ % , P < @ ) .


The positive effects of TGC on postoperative complications were driven by nondiabetic subjects ( @ % vs @ % , @ % CI , @-@ @ ; blood glucose @ @ vs @ @ mmol/L , not significant ; time in target range , @ % @ % vs @ % @ % , not significant ) , whereas no significant effect was seen in diabetic patients ( @ % vs @ % , @ % CI , @-@ @ ) despite significantly better glucose control in the perioperative group ( blood glucose , @ @ vs @ @ mmol/L , P < @ ; time in target range , @ % @ % vs @ % @ % , P < @ ) .


Perioperative initiation of intensive insulin therapy during cardiac surgery reduces postoperative morbidity in nondiabetic patients while having a minimal effect in diabetic subjects .


Proof-of-concept evidence suggests that mechanical ischaemic post-conditioning ( PostC ) reduces infarct size when applied immediately after culprit coronary artery re-opening in ST-elevation myocardial infarction ( STEMI ) patients with thrombolysis in myocardial infarction @-@ ( TIMI @-@ ) flow grade at admission .


Whether PostC might also be protective in patients with a TIMI @-@ flow grade on admission ( corresponding to a delayed application of the post-conditioning algorithm ) remains undetermined .


In this multi-centre , randomized , single-blinded , controlled study , STEMI patients with a @-@ TIMI coronary flow grade at admission underwent direct stenting of the culprit lesion , followed ( PostC group ) or not ( control group ) by four cycles of ( @ min inflation/@ min deflation ) of the angioplasty balloon to trigger post-conditioning .


Infarct size was assessed both by cardiac magnetic resonance at Day @ ( primary endpoint ) and cardiac enzymes release ( secondary endpoint ) .


Ninety-nine patients were prospectively enrolled .


Baseline characteristics were comparable between control and PostC groups .


Despite comparable size of area at risk ( AAR ) ( @ @ vs. @ @ % of the LV circumference , respectively , P = @ ) and similar time from onset to intervention ( @ @ vs. @ @ min , respectively , P = @ ) in the two groups , PostC did not significantly reduce cardiac magnetic resonance infarct size ( @ @ and @ @ g in the treated vs. control group , respectively , P = @ ) .


Similar results were found when using creatine kinase and troponin I release , even after adjustment for the size of the AAR .


This study shows that infarct size reduction by mechanical ischaemic PostC is lost when applied to patients with a TIMI @-@ flow grade at admission .


This indicates that the timing of the protective intervention with respect to the onset of reperfusion is a key factor for preventing lethal reperfusion injury in STEMI patients .


In the AFFIRM trial of patients with metastatic castration-resistant prostate cancer after progression with docetaxel treatment , enzalutamide significantly increased overall survival compared with placebo .


Here we present the prospectively defined analyses of some secondary endpoints , including occurrence of skeletal-related events , measures of pain control , and patient-reported health-related quality of life ( HRQoL ) .


In this phase @ , double-blind trial , patients were randomly assigned ( @:@ ) to receive enzalutamide @ mg/day or placebo orally , stratified by ECOG baseline performance status ( @ or @ vs @ ) and mean pain score ( Brief Pain Inventory-Short Form -LSB- BPI-SF -RSB- question @ worst pain , score @ vs @ ) .


Secondary endpoints were time to first skeletal-related event ( defined as radiation therapy or surgery to bone ) ; change from baseline to week @ in pain severity and interference ; pain palliation and progression at week @ ; time to pain progression ; overall improvement in HRQoL ; improvements in HRQoL domains ; and time to HRQoL deterioration .


Analysis was done on the intention-to-treat population for each endpoint .


AFFIRM is registered with ClinicalTrials.gov , number NCT@ .


Median time to first skeletal-related event in the enzalutamide ( n = @ ) and placebo ( n = @ ) groups was @ months ( @ % CI @ to @ ) and @ months ( @ % CI @ to not yet reached ) , respectively ( hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- ; p = @ ) .


Pain progression at week @ occurred in @ ( @ % ) of @ evaluable patients in the enzalutamide group versus @ ( @ % ) of @ patients in the placebo group ( difference -@ % , @ % CI -@ to -@ ; p = @ ) .


Median time to pain progression was not yet reached in the enzalutamide group ( @ % CI not yet reached to not yet reached ) versus @ ( @ to not yet reached ) months in the placebo group ( HR @ -LSB- @ % CI @ to @ -RSB- ; p = @ ) .


Mean treatment effects for pain severity ( mean change from baseline in the enzalutamide group -@ , @ % CI -@ to -@ , vs placebo @ , @ to @ ; difference -@ , @ % CI -@ to -@ ; p < @ ) and interference ( -@ , -@ to @ , vs @ , @ to @ ; respectively , difference -@ , @ % -@ to -@ ; p < @ ) were significantly better with enzalutamide than with placebo .


@ ( @ % ) of @ evaluable patients in the enzalutamide group reported pain palliation at week @ versus one ( @ % ) of @ in the placebo group ( difference @ % , @ % CI @-@ ; p = @ ) .


Overall improvement in HRQoL was reported in more patients receiving enzalutamide ( @ -LSB- @ % -RSB- of @ ) than in those receiving placebo ( @ -LSB- @ % -RSB- of @ ; p < @ ) .


Patients in the enzalutamide group had longer median time to HRQoL deterioration than did those in the placebo group ( @ months , @ % CI @-@ , vs @ months , @ % CI @-@ ; HR @ , @ % CI @-@ ; p < @ ) in risk of deterioration .


Our results show that , in addition to improving overall survival , enzalutamide improves wellbeing and everyday functioning of patients with metastatic castration-resistant prostate cancer .


MK-@ is a short ragweed sublingual tablet under investigation for immunotherapy of ragweed pollen-induced allergic rhinitis .


To characterize the safety and tolerability of a ragweed sublingual tablet ( Merck/ALK-Abell ) in ragweed-allergic adults with or without conjunctivitis .


Data from @ randomized , double-blinded , placebo-controlled trials of MK-@ ( @ @-day and @ @-week trials ) were evaluated .


Pooled analyses examined short-term safety over @ days from all @ trials and long-term safety from the @-week trials .


Across all studies , @ , @ , @ , and @,@ subjects were randomized to placebo or @ , @ , or @ Amb a @-U of MK-@ , respectively .


Treatment-related adverse events were more frequent in the @ - and @-Amb a @-U MK-@ groups than in the placebo group and were primarily local application-site reactions occurring in the first few days of treatment .


There was no treatment-associated loss of asthma control or worsening of asthma associated with treatment .


No swellings led to airway obstruction or respiratory compromise .


No treatment-related anaphylactic shock , life-threatening , or serious treatment-related adverse events were reported for any MK-@ dose .


Of the @,@ MK-@-treated subjects , @ systemic ( anaphylactic ) reaction was reported ( @ % ) .


The @-week long-term assessment was generally similar to the safety profile based on the @-day assessment .


MK-@ doses up to and including @ Amb a @-U were well tolerated , with no unexpected safety findings .


Sublingual immunotherapy risks such as worsening asthma or airway swellings that could cause airway obstruction were not observed .


Systemic reactions and use of epinephrine were uncommon .


In these studies , after the first dose was administered in a health care setting , self-administration was well tolerated .


The Hopkins Symptom Checklist-@ ( HSCL-@ ) has often been used in cross-cultural settings and in studies focussing on asylum seekers , refugees etc. .


It is available in a number of languages .


The present study investigates the psychometric properties of the German version of the HSCL-@ and delivers population-based norms .


Psychometric properties are investigated in a population-based representative sample of the German general population ( N = @ ) .


Seven different factorial models are compared using confirmatory factor analysis .


Two out of the seven models show the best model fit .


Because of the high inter-correlations of the factors of the tripartite model , the bifactor model is the preferable factor solution .


The internal consistencies ( Cronbach 's alpha ) were @ , @ , and @ for the anxiety , the depression and the total score , respectively .


The correlations of both subscales of this model with the subscales of the Brief-Symptom-Inventory-@ or the Patient Health Questionnaire-@ point out , that there is only marginal differential information of the subscales .


Considering the third ( `` general '' ) factor of the bifactor model with all items loading on it and the absence of differential correlations of the subscales with the external criteria ( PHQ-@ , BSI-@ ) the HSCL-@ seems to assess something like `` mental distress '' with a focus on symptoms of depression and anxiety .


The population-based norms support the application of the HSCL-@ for individual diagnostics as well as for the comparison of specific samples with the general population .


Effective antiinflammatory therapies are needed for the treatment of asthma , but preferably without the systemic adverse effects of glucocorticosteroids .


We evaluated the effect of an inhaled nonsteroidal glucocorticoid receptor agonist , AZD@ , on allergen-induced responses .


Twenty subjects with mild allergic asthma were randomized to receive @ days of treatment with nebulized AZD@ ( @ or @ g ) once daily , budesonide @ g twice daily via Turbuhaler , or placebo in a double-blind , four-period , crossover design study .


Allergen challenge was performed on Day @ .


FEV@ was measured repeatedly for @ hours after allergen challenge for early and late asthmatic responses .


Sputum inflammatory cells was measured before and at @ and @ hours after allergen challenge , and methacholine airway responsiveness was measured before and @ hours after allergen challenge .


AZD@ significantly attenuated the fall in FEV@ during the late asthmatic response ( both doses led to an @ % fall ) versus placebo ( @ % fall ) ( P < @ ) with no effect of budesonide ( @ % fall ) versus placebo ( P > @ ) .


There was no effect on the fall in FEV@ during early asthmatic response .


AZD@ @ and @ g significantly attenuated allergen-induced sputum eosinophilia by @ and @ % at @ hours , respectively , and by @ and @ % at @ hours after allergen challenge , respectively , versus placebo ( all P < @ ) .


Budesonide did not reduce allergen-induced sputum eosinophilia versus placebo .


AZD@ at @ g significantly attenuated allergen-induced airway hyperresponsiveness at @ hours after allergen challenge versus placebo ( P < @ ) .


Both doses of AZD@ were well tolerated .


Seven-day treatment with inhalation of the nonsteroidal glucocorticoid receptor agonist AZD@ effectively reduced allergen-induced responses in subjects with mild allergic asthma .


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


The incidence of stent restenosis ( SR ) has risen with as more patients are being treated with drug-eluting stents ( DESs ) .


Trimetazidine has multiple favorable effects on the cardiovascular system .


Here , we aimed to evaluate whether chronic treatment with trimetazidine reduced the incidence of SR. .


From January @ to December @ at Chinese PLA General Hospital , @ patients were enrolled and randomized into the trimetazidine treatment group ( TG , n = @ ) and control group ( CG , n = @ ) .


After DES implantation , all patients were treated with regular medication .


In the TG , trimetazidine was administrated at @mg tid for at least @days .


All patients received follow-up angiography @-@ months after discharge .


Major adverse cardiac and cerebrovascular events ( MACCEs ) were recorded .


Six hundred thirty-five patients were included in the final analysis ( TG , n = @ ; CG , n = @ ) .


SR occurred in @ ( @ % ) patients .


The TG had a lower incidence of SR compared to the CG ( @ % vs. @ % , p = @ ) .


At the @-day follow-up , the TG exhibited a higher left ventricular ejection fraction than the CG ( @ @ vs. @ @ , p = @ ) .


The incidence of MACCEs was also lower in the TG at the @-year follow-up ( @ % vs. @ % , p = @ ) .


Further multivariate analysis revealed that trimetazidine treatment was a predictor for SR ( OR : @ ; @ % CI : @-@ @ ; p = @ ) .


Trimetazidine treatment effectively reduced the incidence of SR and MACCEs after DES implantation at the @-year follow-up .


Postoperative atrial fibrillation ( POAF ) remains common after coronary artery bypass grafting ( CABG ) .


Limited efforts to intervene on cardiac autonomic ganglionic plexi ( AGP ) during surgery show mixed results .


In this pilot study , we evaluated the safety and feasibility of map-guided ablation of AGPs during isolated CABG in the prevention of POAF .


In this pilot study , patients undergoing isolated CABG were randomized into an intervention group ( mapping and ablation of AGP -LSB- AGP + -RSB- group ) , and a control group ( no mapping and ablation -LSB- AGP - -RSB- group ) .


Using high-frequency stimulation , active AGPs were identified and ablated intraoperatively using radiofrequency .


Continuous rhythm monitoring , serum electrolytes , postoperative medications , and postoperative complications were recorded until discharge .


Randomization of @ patients ( @ AGP + and @ AGP - ) resulted in similar baseline characteristics , past medical history , and preoperative medication use .


The intervention added a median of @ minutes to the operative time .


The incidence of POAF , mean time inPOAF , and median length of stay in hospital were : AGP + @ % vs AGP - @ % ; AGP + @ minutes vs AGP - @ minutes ; AGP + @ days vs AGP - @ days ; respectively ) .


Postoperative complications , medication use , and daily serum electrolyte profiles were similar in both groups .


This pilot study demonstrated the safety and feasibility of mapping and ablation of AGP during CABG with minimal added operative time .


Results further suggest a potentially clinically significant effect on POAF .


A multicentre trial is warranted .


We have previously shown that @ml of a foamed drink ( ` foam ' ) significantly improved appetite versus a non-foamed control .


The objectives of this research were to assess the effect of smaller volumes of foams on appetite , and the potential benefits of foam ingestion and its timing on appetite measures in a reduced-energy context .


Two randomized , parallel design studies ( pre - and main study ) were conducted using healthy adult subjects .


Pre-study : @ subjects ( age @-@ years , body mass index ( BMI ) @-@kgm ( -@ ) ) each consumed either @ , @ , @ , @ , @ or @ml foamed meal replacer ( ~ @ kcalml ( -@ ) ) , @min after a fixed breakfast .


Main study : four groups of subjects ( n = @ ; age @-@ years , BMI @-@ @ kgm ( -@ ) ) consumed @ml/@kcal foam ( based on pre-study results ) immediately after main meals ( M ) , after snacks ( S ) , in-between snacks and main meals ( I ) or not at all ( control , C ) within @ day of a reduced-energy meal plan consisting of three main meals and three snacks .


Measurements included self-reported appetite ( six scales , reported as area under the curve ( AUC ) ) and ( main study only ) end-of-day appetite questionnaire .


Pre-study : the strongest effect on appetite was produced by @ml ( consistent across scales ) , whereas @ml showed more pronounced effects than @ and @ml in most scales .


Volumes @ and @ml had no effects on any scale .


Main study : @ml foam reduced appetite AUC substantially in all treatments , particularly M ( for example , hunger AUC reduced by @ % ( P < @ ) , @ % ( P < @ ) and @ % ( P = @ ) for M , S and I , respectively versus C ) .


A strong reduction in ` appetite for a snack ' was seen for all timings ( all P < @ ) .


The end-of-day appetite ratings confirmed these findings .


Modest amounts of a low-energy foam can reduce appetite measures during a @-day reduced-energy meal plan .


To provide comparisons and a worked example of item - and scale-level evaluations based on three psychometric methods used in patient-reported outcome development-classical test theory ( CTT ) , item response theory ( IRT ) , and Rasch measurement theory ( RMT ) - in an analysis of the National Eye Institute Visual Functioning Questionnaire ( VFQ-@ ) .


Baseline VFQ-@ data from @ participants with diabetic macular edema from a randomized , double-masked , multicenter clinical trial were used to evaluate the VFQ at the total score level .


CTT , RMT , and IRT evaluations were conducted , and results were assessed in a head-to-head comparison .


Results were similar across the three methods , with IRT and RMT providing more detailed diagnostic information on how to improve the scale .


CTT led to the identification of two problematic items that threaten the validity of the overall scale score , sets of redundant items , and skewed response categories .


IRT and RMT additionally identified poor fit for one item , many locally dependent items , poor targeting , and disordering of over half the response categories .


Selection of a psychometric approach depends on many factors .


Researchers should justify their evaluation method and consider the intended audience .


If the instrument is being developed for descriptive purposes and on a restricted budget , a cursory examination of the CTT-based psychometric properties may be all that is possible .


In a high-stakes situation , such as the development of a patient-reported outcome instrument for consideration in pharmaceutical labeling , however , a thorough psychometric evaluation including IRT or RMT should be considered , with final item-level decisions made on the basis of both quantitative and qualitative results .


The potential negative metabolic interaction between proton pump inhibitors and clopidogrel is an unsolved issue .


We hypothesized that doubling the clopidogrel maintenance dose ( @ mg ) would be less effective than switching to prasugrel @ mg maintenance dose ( MD ) to overcome this negative interaction .


In a randomized study with a factorial design , @ stable coronary artery disease patients treated with @ mg clopidogrel MD and aspirin were assigned to receive in a double blind fashion lansoprazole ( @ mg/day ) or placebo and to receive in an open fashion @ mg clopidogrel MD or @ mg prasugrel MD. .


The primary endpoint was the relative change in residual platelet reactivity over the @-day study period -LSB- ( RPA@day-RPAbaseline ) / RPAbaseline -RSB- .


The effect of doubling the clopidogrel MD on relative change in RPA was neutralized by lansoprazole ( -@ % versus +@ % without and with lansoprazole , respectively , p = @ ) whereas @ mg of prasugrel MD dramatically reduced RPA irrespective of lansoprazole co-administration ( -@ % @ % vs. -@ % @ % without and with lansoprazole , respectively , p = NS ) .


Lansoprazole exposure was the only parameter with a significant interaction with RPA among subgroups .


The higher platelet inhibitory effect obtained by doubling the clopidogrel MD was totally neutralized by the co-administration of lansoprazole .


This drug interaction was not observed with prasugrel @ mg .


Children undergoing procedures in pediatric health care facilities and their families have been shown to benefit from psychosocial services and interventions such as those provided by a Certified Child Life Specialist ( CCLS ) .


The comprehensive impact of a CCLS in a pediatric imaging department is well recognized anecdotally but has not been examined in a prospective or randomized controlled fashion .


We prospectively assessed the impact of a CCLS on parent satisfaction , staff satisfaction , child satisfaction , and parent and staff perceptions of child pain and distress in a pediatric imaging department .


Eligible children between @ and @ years of age ( n = @ ) presenting to the pediatric imaging department for an imaging procedure were randomly assigned to an intervention or control arm .


Those assigned to the intervention received the comprehensive services of a CCLS .


The control group received standard of care , which did not include any child life services .


Quantitative measures of satisfaction and perception of child pain and distress were assessed by parents and staff using a written @-point Likert scale questionnaire after the imaging procedure .


Children @ and older were asked to answer @ questions on a @-point scale .


Statistically significant differences between the intervention and control groups were found in @ out of @ measures .


Parents in the intervention group indicated higher satisfaction and a lower perception of their child 's pain and distress .


Staff in the intervention group indicated greater child cooperation and a lower perception of the child 's pain and distress .


Children in the intervention group indicated a better overall experience and less fear than those in the control group .


Child life specialists have a quantifiably positive impact on the care of children in imaging departments .


Measures of parent satisfaction , staff satisfaction , child satisfaction , child pain and child distress are shown to be positively impacted by the services of a CCLS .


These results have significant implications for hospitals striving to increase satisfaction , decrease costs and improve quality of care .


In a health care landscape that is changing quickly and increasingly focused on the cost of care , future research should assess whether the core tenants of the child life profession support and contribute quantifiably to high-quality , cost-effective practices in health care .


The first semester of college has been associated with increased drinking and sexual risk .


However , it remains unclear why some drinking occasions result in experiencing negative sexual consequences whereas others do not .


The current study used a diary-based approach to assess the event-level effect of alcohol use and previous adult/adolescent sexual victimization ( PSV ) on experiencing negative sex-related consequences in first-year college women .


Participants ( N = @ ) provided repeated measures of weekend drinking and sex-related consequences on the Friday and Saturday nights of six different weekends over the course of their first semester , resulting in @ measured drinking occasions .


A multilevel model was used to assess both between - and within-person effects of alcohol use and between-person effects of PSV on the likelihood of experiencing negative alcohol-related sexual consequences .


Findings revealed an important within-person association , such that every drink consumed above one 's mean was associated with a @ % increase in the likelihood of experiencing negative consequences .


In addition , PSV had a significant main effect on experiencing negative sex-related consequences .


Individuals with PSV experienced nearly @ times more sexual consequences than individuals without PSV .


These results yield important implications for prevention , particularly with respect to limiting `` above average '' alcohol consumption among women with a history of sexual victimization .


Metabolic syndrome ( MetS ) is increasingly present in breast cancer survivors , possibly worsened by cancer-related treatments , such as chemotherapy .


MetS greatly increases risk of cardiovascular disease and diabetes , co-morbidities that could impair the survivorship experience , and possibly lead to cancer recurrence .


Exercise has been shown to positively influence quality of life ( QOL ) , physical function , muscular strength and endurance , reduce fatigue , and improve emotional well-being ; however , the impact on MetS components ( visceral adiposity , hyperglycemia , low serum high-density lipoprotein cholesterol , hypertriglyceridemia , and hypertension ) remains largely unknown .


In this trial , we aim to assess the effects of combined ( aerobic and resistance ) exercise on components of MetS , as well as on physical fitness and QOL , in breast cancer survivors soon after completing cancer-related treatments .


This study is a prospective randomized controlled trial ( RCT ) investigating the effects of a @-week supervised progressive aerobic and resistance exercise training intervention on MetS in @ breast cancer survivors .


Main inclusion criteria are histologically-confirmed breast cancer stage I-III , completion of chemotherapy and/or radiation within @ months prior to initiation of the study , sedentary , and free from musculoskeletal disorders .


The primary endpoint is MetS ; secondary endpoints include : muscle strength , shoulder function , cardiorespiratory fitness , body composition , bone mineral density , and QOL .


Participants randomized to the Exercise group participate in @ supervised weekly exercise sessions for @ weeks .


Participants randomized to the Control group are offered the same intervention after the @-week period of observation .


This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors .


Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform intervention programs that will optimally improve physiological and psychosocial health during cancer survivorship , and that are ultimately aimed at improving prognosis .


Our objective was to evaluate the effectiveness of combination therapy consisting of low-dose corticosteroids with weekly methotrexate in patients with cardiac sarcoidosis in whom long-term therapy is required .


Combination therapy was selected because long-term standard corticosteroid therapy tends to result in various adverse effects and the steroid-sparing effects of methotrexate have been reported .


This study was a small open-label study comparing long-term functional changes between patients who received combination therapy ( @-@ mg/day of prednisolone and @ mg/week of methotrexate ) and patients who received corticosteroids alone .


The comparative analysis was based on the following therapeutic indexes : ejection fraction ( EF ) , left ventricular end-diastolic diameter ( LVDd ) on echocardiography , serum N-terminal fragment pro-brain natriuretic peptide ( NT-proBNP ) and cardiothoracic ratio ( CTR ) on plain chest radiographs .


Seventeen patients with cardiac sarcoidosis were examined in the sarcoidosis clinic .


Cardiac sarcoidosis was diagnosed based on the Japanese diagnostic guidelines published in @ .


The EF was significantly stabilized in the combination therapy group but not in the corticosteroids alone group at three years after the first treatment .


The CTR and NT-proBNP levels were significantly stabilized in the combination therapy group compared with those observed in the corticosteroids alone group at both three and five years after the first treatment .


The LVDd values tended to be stable in the combination therapy group compared with those observed in the corticosteroids alone group .


The combination therapy was associated with few adverse effects .


Weekly methotrexate therapy with daily small doses of corticosteroids stabilized the EF , CTR and NT-proBNP levels in the serum without eliciting adverse effects longitudinally .


In a multicenter study , patients of the German statutory insurance were encouraged to deal with their own rehabilitation goals using a questionnaire sent in advance of rehabilitation .


How patients and physicians assess the benefits and practicability of this method should , in particular , be examined .


In a randomized controlled study a questionnaire , based on the preparation booklet of the DRV Bund , was sent by the German statutory insurance to @ rehabilitation patients ( n ( ortho ) = @ , n ( onco ) @ , n ( psy ) = @ ) .


For the intervention group , the questionnaire included , in addition to general information about rehabilitation goals , free text fields for the formulation of own goals .


Patients were asked to bring the completed questionnaire to the admission interview .


At the end of rehabilitation , satisfaction with participation in the goal-setting process and perceived usefulness of information on rehabilitation goals were captured .


The doctors/psychologists responded to standardized items regarding various aspects of utility and practicability of the questionnaire .


@ % of the targeted rehabilitation patients brought the completed questionnaire to the admission interview .


For most of the rehabilitation patients goal setting is important ; @ % reported the information obtained to rehabilitation goals to be very , and @ % particularly helpful .


For practitioners , the questionnaire is likely to orient rehabilitation patients to rehabilitation goals : they reported that @ % of the patients reflected about their goals and that @ % were more familiar with the subject .


Physicians rated the handling and integration of the questionnaire into the interview , its format and layout as well as its benefits more positively than the surveyed psychologists .


These were more optimistic about the ability of rehabilitation patients to answer the questionnaire ( @ % , physicians @ % ) and define own goals ( @ % , physicians @ % ) .


The applied questionnaire has been well accepted by the majority of rehabilitation patients and practitioners as well as was judged to be practical and useful in important aspects .


A comprehensive implementation of the questionnaire proves to be promising , particularly in the context of oncological and orthopedic rehabilitation .


To increase the return of the questionnaire , alternative delivery options should be explored in future .


Against the background that rehabilitation patients and practitioners of psychosomatic medicine perceived the questionnaire as less helpful , it is also prudent to investigate whether indication-specific implementation strategies would be advantageous .


To evaluate the postoperative analgesic effects of epidural administration of morphine and neostigmine , either alone or in combination , in dogs .


@ dogs undergoing orthopedic surgery on a pelvic limb .


Anesthetic protocols were standardized .


At the end of surgery , @ dogs each received @ of @ epidural treatments : morphine ( @ mg/kg ) , neostigmine ( @ g/kg ) , or morphine plus neostigmine ( @ mg/kg and @ g/kg , respectively ) .


Postoperative pain scores and the need for rescue analgesia were evaluated for @ hours .


Pain scores were higher in the neostigmine group , compared with scores for the morphine-neostigmine group , at @ and @ hours after surgery and higher in the morphine group than in the morphine-neostigmine group at @ and @ hours .


During @ hours , rescue analgesia was provided for @ , @ , and @ of @ dogs each in the morphine , neostigmine , and morphine-neostigmine groups , respectively .


The number of dogs given rescue analgesia was significantly different among groups at @ , @ , @ , and @ hours after surgery .


Dogs in the morphine and morphine-neostigmine groups had a lower probability of receiving rescue analgesia within @ hours than did dogs in the neostigmine group .


When administered epidurally , morphine alone or in combination with neostigmine provided effective postoperative analgesia in most dogs after orthopedic surgery , whereas neostigmine alone did not .


Findings for this study suggested a potential role for neostigmine as an adjuvant for epidural analgesia in dogs undergoing orthopedic surgeries on the pelvic limbs .


Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites .


Among Hispanic women diagnosed with gestational diabetes mellitus ( GDM ) , @ % will go on to develop type @ diabetes within @ years of the index pregnancy .


Although randomised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type @ diabetes , such programs have not been tested in high-risk postpartum women .


The overall goal of this randomised controlled trial is to test the efficacy of a culturally and linguistically modified , individually-tailored lifestyle intervention to reduce risk factors for type @ diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy .


Hispanic pregnant women who screen positive for GDM will be recruited and randomly assigned to a Lifestyle Intervention ( n = @ ) or a Health & Wellness ( control ) Intervention ( n = @ ) .


Multimodal contacts ( i.e. , in-person , telephone , and mailed materials ) will be used to deliver the intervention from late pregnancy ( @ weeks gestation ) to @ months postpartum .


Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss ; American Congress of Obstetrician and Gynecologist guidelines for physical activity ; and American Diabetes Association guidelines for diet .


The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific cultural and environmental challenges faced by low-income Hispanic women .


Assessments will be conducted at enrollment , and at @-weeks , @-months , and @-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm .


Efficacy will be assessed via postpartum weight loss and biomarkers of insulin resistance and cardiovascular risk .


Changes in physical activity and diet will be measured via @-day actigraph data and three unannounced @-hour dietary recalls at each assessment time period .


Hispanic women are the fastest growing minority group in the U.S. and have the highest rates of sedentary behavior and postpartum diabetes after a diagnosis of GDM .


This randomised trial uses a high-reach , low-cost strategy that can readily be translated into clinical practice in underserved and minority populations .


Patients with chronic hepatitis C virus ( HCV ) infection and prior null response ( < @ log HCV RNA decline after @ weeks of PegIFN/RBV ) have limited options .


We evaluated daclatasvir plus once - or twice-daily asunaprevir in non-cirrhotic genotype @ null responders .


In this randomized , phase @a , open-label , @-week treatment study , @ patients received daclatasvir ( @ mg ) once-daily .


In addition , @ genotype @b patients received asunaprevir ( @mg ) twice - ( DUAL A@ ) or once-daily ( DUAL A@ ) ; @ genotype @a and @ genotype @b patients received asunaprevir twice - ( QUAD B@ ) or once-daily ( QUAD B@ ) plus PegIFN/RBV ; and @ genotype @a and @ genotype @b patients received asunaprevir twice-daily plus ribavirin ( TRIPLE B@ ) .


The primary endpoint was undetectable HCV RNA @ weeks post-treatment ( sustained virologic response , SVR@ ) .


Across all groups , mean HCV RNA was @ log IU/ml , and @ % of patients had a non-CC IL@B genotype .


SVR@ rates were @ % ( A@ ) , @ % ( A@ ) , @ % ( B@ ) , and @ % ( B@ ) .


In B@ , most genotype @a patients experienced virologic breakthrough .


The most common adverse events were headache , diarrhea , and asthenia .


Grade @-@ aminotransferase elevations were infrequent and not treatment-limiting .


In genotype @ null responders , daclatasvir plus twice-daily asunaprevir DUAL therapy is effective for most genotype @b patients , and daclatasvir , asunaprevir , and PegIFN/RBV QUAD therapy is effective for nearly all genotype @a and @b patients ; but neither DUAL nor TRIPLE therapy is effective for genotype @a patients .


Interferon-free regimens including daclatasvir and twice-daily asunaprevir for genotype @ null responders should be tailored to subtype .


The high-risk strategy has been proven effective in preventing cardiovascular disease ; however , the population benefits from these interventions remain unknown .


This study aims to assess , at the population level , the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China .


The study will employ a cluster-randomized controlled trial in which a total of @ villages in five northern provinces of China , will be assigned to either intervention ( @ villages ) or control ( @ villages ) .


Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify , treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village .


The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for @ years .


We will draw two different ( independent ) random samples , before and after the intervention , @ men aged@ years and @ women aged@ years from each village in each sample and a total of @,@ participants from @ samples to measure the study outcomes at the population level .


The primary outcome will be the pre-post difference in mean systolic blood pressure , analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect .


Secondary outcomes will include monthly clinic visits , provision of lifestyle advice , use of antihypertensive medications and use of aspirin .


Process and economic evaluations will also be conducted .


This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease .


The results are expected to provide important information ( effectiveness , cost-effectiveness , feasibility and acceptability ) to guide policy making for rural China as well as other resource-limited countries .


This phase @/@ , randomized , placebo-controlled , observer-blinded study assessed the immunogenicity , reactogenicity , and safety of an inactivated , split-virion H@N@ influenza vaccine ( A/Indonesia/@ / @ ) in children aged @ months through @ years .


Children received @ influenza vaccine doses @ days apart , each containing @ g of hemagglutinin and AS@B adjuvant ( @ mg of - tocopherol ) .


The randomization ratio was @:@ for vaccine to placebo , with equal allocation between @ age strata ( @-@ months , @-@ years , and @-@ years ) .


Immunogenicity against the vaccine strain was assessed @ days after the first and second vaccine doses for all vaccinees , at day @ for half , and at day @ for the remaining half .


Reactogenicity after each dose and safety up to @ year after vaccination were evaluated .


Within each age stratum , the lower limit of the @ % confidence interval for the day @ seroprotection rate was @ % , thus fulfilling the US and European licensure criteria .


The immune responses elicited by vaccine persisted well above baseline levels for @ year .


The vaccine was more reactogenic than placebo , but no major safety concerns were identified .


AS@B-adjuvanted H@N@ influenza vaccine was immunogenic and showed an acceptable safety profile in all age groups studied .


Clinical Trials Registration : NCT@ .


The effect of eating speed at a meal on appetite gut hormone responses and future food consumption is not clear .


This study examined the effect of eating speed at breakfast on postprandial gut hormone responses , subjective appetite , and daily food consumption .


Twenty-five participants -LSB- @ % men ; age , @ ( @ ) years ; body mass index , @ ( @ ) kg/m -RSB- were recruited .


Each participant consumed the same breakfast at a slow ( @ minutes ) and fast ( @ minutes ) speed , on @ separate days , in a randomized crossover design .


Blood samples were collected in the fasting state and @ hours postprandially during each eating condition .


Appetite was assessed over the same period using visual analog scales .


Blood concentrations of orexigenic hormone , ghrelin , and anorexigenic hormones , glucagon-like peptide-@ ( GLP-@ ) and peptide YY ( PYY ) , were determined .


Daily food intake was measured , by food recall , after the slow and fast breakfast .


Mixed-model repeated-measures analysis showed no eating condition or eating condition by time interaction effect on ghrelin , GLP-@ , PYY , hunger , or fullness .


Significant eating speed by time interaction effect on desire to eat was found ( P = @ ) .


Desire to eat was lower at @ minutes ( P = @ ) after breakfast began during the slow versus fast eating condition .


Eating speed at breakfast did not affect daily energy and macronutrient intake .


Eating speed at breakfast did not affect postprandial ghrelin , GLP-@ , PYY , hunger , and fullness values or daily energy and macronutrient intake .


Desire to eat was lower at @ minutes in the slow versus fast eating condition , but this result could not be explained by the changes in meal-related hormones measured in the study .


The conventional diet approach to gestational diabetes mellitus ( GDM ) advocates carbohydrate restriction , resulting in higher fat ( HF ) , also a substrate for fetal fat accretion and associated with maternal insulin resistance .


Consequently , there is no consensus about the ideal GDM diet .


We hypothesized that , compared with a conventional , lower-carbohydrate/HF diet ( @ % carbohydrate/@ % fat/@ % protein ) , consumption of a higher-complex carbohydrate ( HCC ) / lower-fat ( LF ) Choosing Healthy Options in Carbohydrate Energy ( CHOICE ) diet ( @/@/@ % ) would result in @-h glucose area under the curve ( AUC ) profiles within therapeutic targets and lower postprandial lipids .


Using a randomized , crossover design , we provided @ GDM women ( BMI @ @ kg/m@ ) with two @-day isocaloric diets at @ @ weeks ( washout between diets ) and performed continuous glucose monitoring .


On day @ of each diet , we determined postprandial ( @ h ) glucose , insulin , triglycerides ( TGs ) , and free fatty acids ( FFAs ) following a controlled breakfast meal .


There were no between-diet differences for fasting or mean nocturnal glucose , but @-h AUC was slightly higher ( @ % ) on the HCC/LF CHOICE diet ( P = @ ) .


The continuous glucose monitoring system ( CGMS ) revealed modestly higher @ - and @-h postprandial glucose on CHOICE ( @ h , @ @ vs. @ @ mg/dL , P @ ; @ h , @ @ vs. @ @ mg/dL , P = @ ) but well below current targets .


After breakfast , @-h glucose and insulin AUCs were slightly higher ( P < @ ) , TG AUC was no different , but the FFA AUC was significantly lower ( @ % ; P @ ) on the CHOICE diet .


This highly controlled study randomizing isocaloric diets and using a CGMS is the first to show that liberalizing complex carbohydrates and reducing fat still achieved glycemia below current treatment targets and lower postprandial FFAs .


This diet strategy may have important implications for preventing macrosomia .


This study evaluated the impact of blood sampling via peripheral arterial catheters on cerebral oxygenation and blood volume as a function of blood sampling velocity .


Near-infrared spectroscopy was applied to @ very low-birthweight infants during peripheral arterial blood sampling .


Changes in cerebral oxygenated , deoxygenated and total haemoglobin , cerebral blood volume and cerebral oxygenation index were recorded .


Heart rate and oxygen saturation were measured continuously .


To assess the impact of blood sampling velocity , both fast @-sec and slow @-sec sampling procedures were performed in a crossover study design , in which the order of sampling velocities was randomised for each patient .


Both fast and slow blood sampling procedures resulted in a significant decrease in cerebral oxygenation index ( fast , p = @ , slow , p = @ ) , and an increase in mean heart rate ( both p = @ ) and mean blood pressure ( p = @ and @ ) .


Oxygenated and total haemoglobin and cerebral blood volume only decreased significantly after slow blood sampling ( p < @ ) .


Blood sampling from peripheral arterial catheters leads to significant fluctuations in cerebral oxygenation independent of the sampling velocity .


Changes are comparable to those reported from umbilical blood sampling .


We advise that blood sampling should be restricted as much as possible .


Unilateral spinal anesthesia is performed to provide restriction of sensory and motor block .


The aim of this study was to compare unilateral and bilateral spinal anesthesia , with regard to limiting the nerve block exclusively to the area of surgery .


This was a prospective , randomised , double-blind study , conducted in @ consecutive outpatients scheduled for unilateral inguinal regional surgery .


Patients in both groups received @ % hyperbaric bupivacaine @ mg + morphine @ mg .


Patients in the unilateral group ( Group U ) were placed in the lateral decubitus position for @ minutes ( min ) on their side to be operated , while patients in the bilateral group ( Group B ) were placed in the supine position .


The pin-prick test was used to assess the times to reach L@ , T@ and T@ sensory blocks and the times to reach motor block .


In addition , the sensory and motor block recovery times were recorded using a modified Bromage scale .


Furthermore , the duration of the operation and the times to first analgesic requirement were noted .


There were significant differences between Group U and Group B in the times to reach L@ , T@ and T@ dermatome levels of sensory block , and the times to reach motor block using the modified Bromage scale on three levels .


However , there was no difference in the time to ambulation , the time to complete sensory regression and the time to first analgesic requirement .


The time to reach sensory and motor blocks for unilateral spinal anesthesia could provide an advantage over bilateral spinal anesthesia in inguinal region operations .


The objectives were to describe the frequency of repeat enrollment within a specific exception from informed consent trial testing benzodiazepine treatment of prehospital status epilepticus and to estimate the effect of repeat enrollments on the analysis of the primary outcome .


This was a secondary analysis of data collected as part of the Rapid Anticonvulsant Medication Prior to Arrival Trial ( RAMPART ) , a study comparing intramuscular midazolam to intravenous lorazepam given by paramedics to patients with prehospital status epilepticus .


Subjects in RAMPART achieved a successful primary outcome if they had cessation of seizures by the time of emergency department arrival .


Data were collected on all subjects , but only the first enrollment for each individual was used in the primary analysis .


The patterns of repeat enrollment are described , along with the demographics of these subjects .


In addition , an intraclass correlation coefficient ( ICC ) was estimated to assess the amount of within-subject correlation and its effect on the estimated treatment effect when all enrollments are included in the analysis .


A total of @,@ enrollments occurred in RAMPART among @ unique individuals ( range of repeat enrollment observed = two to @ ) .


The ICC for seizure cessation within individual was low at @ ; when excluding subjects with benzodiazepine crossover , the ICC was @ .


In clinical trials of emergency conditions with interval complete resolution , accounting for repeat enrollments is feasible .


The RAMPART experience demonstrated that in this setting the within-subject correlation is low and can be accounted for at relatively low statistical cost .


Histaminergic H@ receptors may play a role in modulating cholinergic and monoaminergic neurotransmission .


This Phase II study evaluated the efficacy and safety of GSK@ , a highly potent , brain penetrant H@ receptor antagonist as monotherapy treatment for subjects with mild-to-moderate probable Alzheimer 's disease ( AD ) .


In this @-week , double-blind , randomized , parallel group study , @ currently untreated subjects with mild-tomoderate AD ( Mini Mental State Examination -LSB- MMSE -RSB- @-@ ) received GSK@ ( n = @ ) ; or placebo ( n = @ ) administered orally each morning .