The efficacy , safety , and tolerability of the combination of simeprevir , a one-pill , once-daily , oral HCV NS@/@A protease inhibitor versus placebo , plus peginterferon alfa @a or @b plus ribavirin was assessed in treatment-naive patients with HCV genotype @ infection .


In the QUEST-@ , phase @ study , done at @ sites in @ countries ( Europe , and North and South Americas ) , patients with confirmed chronic HCV genotype @ infection and no history of HCV treatment were randomly assigned with a computer-generated allocation sequence in a ratio of @:@ and stratified by HCV genotype @ subtype and host IL@B genotype to receive simeprevir ( @ mg once daily , orally ) , peginterferon alfa @a ( @ g once weekly , subcutaneous injection ) or @b ( according to bodyweight ; @ g , @ g , @ g , @ g , or @ g once weekly , subcutaneous injection ) , plus ribavirin ( @-@ mg/day or @-@ mg/day , orally ; simeprevir group ) or placebo ( once daily , orally ) , peginterferon alfa @a or @b , plus ribavirin ( placebo group ) for @ weeks , followed by just peginterferon alfa @a or @b plus ribavirin .


Total treatment duration was @ weeks or @ weeks ( simeprevir group ) based on criteria for response-guided therapy ( ie , HCV RNA < @ IU/mL undetectable or detectable at week @ and undetectable week @ ) or @ weeks ( placebo ) .


Patients , study personnel , and the sponsor were masked to treatment assignment .


The primary efficacy endpoint was sustained virological response at @ weeks after the planned end of treatment ( SVR@ ) .


Analyses were by intention to treat .


The trial is registered with ClinicalTrials.gov , number NCT@ .


Results from the primary ( SVR@ , week @ ) analysis are presented .


@ ( @ % ) of @ patients in the simeprevir group and @ ( @ % ) of @ in the placebo group had SVR@ ( adjusted difference @ % , @ % CI @-@ ; p < @ ) .


The incidences of adverse events were similar in the simeprevir and placebo groups at @ weeks ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) and for the entire treatment ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , irrespective of the peginterferon alfa used .


The most common adverse events were headache , fatigue , pyrexia , and influenza-like illness at @ weeks ( @ -LSB- @ % ) vs @ -LSB- @ % -RSB- , @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , and @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , respectively ) and for the entire treatment ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , and @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , respectively ) .


Rash and photosensitivity frequencies were higher in the simeprevir group than in the placebo group ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- and ten -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- , respectively ) .


There was no difference in the prevalence of anaemia between the simeprevir and placebo groups ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , respectively , at @ weeks , and @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , respectively , during the entire treatment ) .


Addition of simeprevir to either peginterferon alfa @a or peginterferon alfa @b plus ribavirin improved SVR in treatment-naive patients with HCV genotype @ infection , without worsening the known adverse events associated with peginterferon alfa plus ribavirin .


Bread can contribute to the regulation of appetite .


The objective of this study was to investigate the appetite ratings and postprandial glucose , insulin , and gastrointestinal hormone responses related to hunger and satiety after the intake of a cereal-based bread .


A randomized , controlled crossover trial was conducted in @ healthy adults ( @ men and @ women ) aged @-@ y with body mass index of @-@ @ .


Each volunteer consumed the cereal-based bread and the control bread @ times , with a @-wk wash-out period , over a total of @ sessions .


The cereal-based bread contained a variety of cereal flours ( wheat , oat , and spelt ) and consisted of @ % dried fruits ( figs , apricots , raisins , and prunes ) .


It was also enriched with both fiber ( @ % from wheat cross-linked maltodextrins and pea ) and protein ( @-@ % from wheat gluten and hydrolyzed wheat proteins ) .


The control bread consisted of white bread with margarine and jam to control for energy density , fat , and sugar content .


We measured appetite ratings using standardized visual analogue scales and glucose , insulin , and gastrointestinal hormone responses over a postprandial time of @ h after the ingestion of each bread .


Linear mixed-effects models were used to compare the areas under the curve ( AUCs ) for different variables .


Consuming the cereal-based bread decreased prospective consumption more than consumption of the control bread ( -@ @ m min and -@ @ m min , respectively ; P = @ ) and increased satiety more ( @ @ m min and @ @ m min , respectively ; P = @ ) , although subsequent ad libitum energy intake @ h later did not differ .


Postprandial blood glucose , insulin , ghrelin , glucagon-like peptide @ and gastric inhibitory polypeptide AUCs were lower after the ingestion of the cereal-based bread , whereas the pancreatic polypeptide AUC was higher than with the control bread ( P < @ ) .


Consumption of the cereal-based bread contributed to appetite control by reducing hunger and enhancing satiety .


In addition , consumption of this bread improved glycemic , insulinemic , and gastrointestinal hormone responses in healthy adults .


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


The purpose was to assess the effectiveness of @ % oral glucose solution in reducing pain in preterm infants during intramuscular injection .


We conducted a prospective , randomized , controlled , unblinded trial to investigate the effect of glucose solution on the pain of intramuscular injection in preterm infants ( N = @ ) .


Infants who received oral glucose had significantly lower pain scores ( p < @ ) , less crying time ( p < @ ) , higher oxygen saturation ( p < @ ) , and lower heart rate after compared with during the procedure ( p = @ ) .


Our results suggest that oral glucose , even if used in the lowest dose , may have a pain-relieving effect in preterm infants if administered pre-procedure .


There are limited data about the effects of sodium-glucose cotransporter @ inhibitors when used with insulin .


We report the efficacy and safety of canagliflozin in patients with type @ diabetes using insulin .


The CANagliflozin CardioVascular Assessment Study is a double-blind , placebo-controlled study that randomized participants to placebo , canagliflozin @ mg , or canagliflozin @ mg once daily , added to a range of therapies .


The primary end point of this substudy was the change in HbA@c from baseline at @ weeks among patients using insulin ; @-week effects were also examined .


Individuals receiving insulin at baseline were randomized to receive placebo ( n = @ ) , canagliflozin @ mg ( n = @ ) , or canagliflozin @ mg ( n = @ ) .


These individuals were @ % male and had a median age of @ years , mean HbA@c of @ % ( @ mmol/mol ) , BMI of @ kg/m ( @ ) , estimated glomerular filtration rate of @ mL/min/@ @ m ( @ ) , fasting plasma glucose of @ mmol/L , and a median daily insulin dose of @ IU .


Most individuals were using basal/bolus insulin .


Reductions in HbA@c with canagliflozin @ and @ mg versus placebo were -@ % ( @ % CI -@ , -@ ; -@ mmol/mol -LSB- @ % CI -@ , -@ -RSB- ; P < @ ) and -@ % ( @ % CI -@ , -@ ; -@ mmol/mol -LSB- @ % CI -@ , -@ -RSB- ; P < @ ) at @ weeks and -@ % ( @ % CI -@ , -@ ; -@ mmol/mol -LSB- @ % CI -@ , -@ -RSB- ) and -@ % ( @ % CI -@ , -@ ; -@ mmol/mol -LSB- @ % CI -@ , -@ -RSB- ) at @ weeks .


There were significant falls in fasting plasma glucose , body weight , and blood pressure at both time points and there was a greater incidence of hypoglycemia , genital mycotic infections , and hypovolemia with both canagliflozin doses .


Canagliflozin added to insulin therapy improved glycemic control and decreased body weight .


There was a greater frequency of several anticipated side effects , although few led to discontinuation of treatment .


To assess the short-term efficacy of a video-based cognitive behavioral therapy for insomnia ( CBT-I ) as compared to a professionally administered CBT-I and to a no-treatment group .


Randomized controlled trial .


Radio-oncology department of a public hospital affiliated with Universit Laval ( CHU de Qubec ) .


Two hundred forty-two women with breast cancer who had received radiation therapy in the past @ mo and who had insomnia symptoms or were using hypnotic medications were randomized to : ( @ ) professionally administered CBT-I ( PCBT-I ; n = @ ) ; ( @ ) video-based CBT-I ( VCBT-I ; n = @ ) ; and ( @ ) no treatment ( CTL ; n = @ ) .


PCBT-I composed of six weekly , individual sessions of approximately @ min ; VCBT-I composed of a @-min animated video + six booklets .


Insomnia Severity Index ( ISI ) total score and sleep parameters derived from a daily sleep diary and actigraphy , collected at pretreatment and posttreatment .


PCBT-I and VCBT-I were associated with significantly greater sleep improvements , assessed subjectively , as compared to CTL .


However , relative to VCBT-I , PCBT-I was associated with significantly greater improvements of insomnia severity , early morning awakenings , depression , fatigue , and dysfunctional beliefs about sleep .


The remission rates of insomnia ( ISI < @ ) were significantly greater in PCBT-I as compared to VCBT-I ( @ % versus @ % , P < @ ) .


A self-administered cognitive behavioral therapy for insomnia ( CBT-I ) using a video format appears to be a valuable treatment option , but face-to-face sessions remain the optimal format for administering CBT-I efficaciously in patients with breast cancer .


Self-help interventions for insomnia may constitute an appropriate entry level as part of a stepped care model .


To explore the experience of breast cancer patients who either received acupuncture or were allocated to the control group .


Focus group/interviews nested within our multi-site randomised controlled trial .


Participants were recruited from the standard care and experimental arm .


The interviews/focus groups were transcribed and analysed thematically .


Of the @ eligible participants @ % ( n = @ ) contributed to the focus groups/interviews , across three study sites in the UK .


Five common themes were identified , including : drivers to take part , the experience of receiving acupuncture , being allocated standard care ( control ) and reflections on taking part in the trial .


The subgroup of control group participants ( n = @ ) reported disappointment on hearing their allocation , but recognised the value of their role to the study .


Recipients of acupuncture reported beneficial effects in managing fatigue and related symptoms .


The finding that control participants were disappointed warrants further investigation and consideration when designing interventional studies .


The aim of this study was to explore the impact of dynamic contrast-enhanced ( DCE ) computer tomography ( CT ) as a biomarker in metastatic renal cell carcinoma ( mRCC ) .


Twelve patients with favorable or intermediate Memorial Sloan Kettering Cancer Center risk group and clear cell mRCC participating in an ongoing prospective randomized phase II trial comprising interleukin-@-based immunotherapy and bevacizumab were included in this preliminary analysis .


All patients had a follow-up time of at least @ years .


Interpretation of DCE-CT ( max slope method ) was performed blinded to treatment group .


The DCE-CT scans were performed at baseline , at weeks @ and @ , and thereafter every third month .


Blood flow ( BF ; mL/min/@ mL ) , peak enhancement ( Hounsfield units ) , time to peak ( seconds ) , and blood volume ( BV ; mL/@ g ) were calculated .


Parameters for DCE-CT were correlated with sum of diameters ( defined by Response Evaluation Criteria in Solid Tumors @ ) , progression-free survival ( PFS ) , and overall survival ( OS ) using Wilcoxon , Man-Whitney , Kaplan-Meier , and log rank statistics , as appropriate .


Blood flow at baseline ranged from @ to @ mL/min/@ mL ( median , @ ; @th percentile , @ ; @th percentile , @ ) .


Patients with high baseline BF ( using quartiles as cutoffs ) had significantly longer OS ( not reached vs @ months , P = @ ) and longer PFS ( not reached vs @ months , P = @ ) .


Blood volume at baseline ranged from @ to @ mL/@ g tissue ( median , @ ) , and at week @ , from @ to @ mL/@ g ( median , @ ) .


Relative changes in BV between baseline and week @ ranged from -@ % to +@ % ( median , -@ % ; @th percentile , -@ % ; @th percentile , +@ % ) and were significantly associated with OS using quartiles as cutoffs ( @ months vs not reached , P = @ ) and PFS using the median as cutoff ( @ months vs not reached , P = @ ) , with larger reductions associated with longer survival .


Using medians as cutoffs , relative changes in both BF and BV between baseline and week @ were significantly associated with OS ( for both , @ months vs not reached , P = @ ) .


Dynamic contrast-enhanced CT is a potential biomarker in patients with mRCC .


High baseline BF and reductions in BF and BV during early treatment are associated with improved outcome .


Large-scale studies are required .


The aims of this study were to ( i ) evaluate the efficacy of phoneme discrimination training for hearing and cognitive abilities of adults aged @ to @ years with mild sensorineural hearing loss who were not users of hearing aids , and to ( ii ) determine participant compliance with a self-administered , computer-delivered , home - and game-based auditory training program .


This study was a randomized controlled trial with repeated measures and crossover design .


Participants were trained and tested over an @ - to @-week period .


One group ( Immediate Training ) trained during weeks @ and @ .


A second waitlist group ( Delayed Training ) did no training during weeks @ and @ , but then trained during weeks @ and @ .


On-task ( phoneme discrimination ) and transferable outcome measures ( speech perception , cognition , self-report of hearing disability ) for both groups were obtained during weeks @ , @ , and @ , and for the Delayed Training group only at week @ .


Robust phoneme discrimination learning was found for both groups , with the largest improvements in threshold shown for those with the poorest initial thresholds .


Between weeks @ and @ , the Immediate Training group showed moderate , significant improvements on self-report of hearing disability , divided attention , and working memory , specifically for conditions or situations that were more complex and therefore more challenging .


Training did not result in consistent improvements in speech perception in noise .


There was no evidence of any test-retest effects between weeks @ and @ for the Delayed Training group .


Retention of benefit at @ weeks post-training was shown for phoneme discrimination , divided attention , working memory , and self-report of hearing disability .


Improved divided attention and reduced self-reported hearing difficulties were highly correlated .


It was observed that phoneme discrimination training benefits some but not all people with mild hearing loss .


Evidence presented here , together with that of other studies that used different training stimuli , suggests that auditory training may facilitate cognitive skills that index executive function and the self-perception of hearing difficulty in challenging situations .


The development of cognitive skills may be more important than the development of sensory skills for improving communication and speech perception in everyday life .


However , improvements were modest .


Outcome measures need to be appropriately challenging to be sensitive to the effects of the relatively small amount of training performed .


Expiratory asynchrony during pressure support ventilation ( PSV ) has been recognized as a cause of patient discomfort , increased workload , and impaired weaning process .


We evaluated breathing pattern , patient comfort , and patient effort during PSV comparing @ flow termination criteria : fixed at @ % of peak inspiratory flow vs automatic , real-time , breath-by-breath adjustment within the range of @ % to @ % .


Randomized crossover clinical trial .


Sixteen awake patients , in the process of weaning , under PSV for more than @ hours were subjected to @ phases of PSV , each lasting @ hour and using @ of the @ aforementioned termination criteria .


Effective pressure support during automatic adjustment ( AA ) was @ cm H@O vs @ cm H@O ( P = @ ) with the fixed termination criterion , and external positive end-expiratory pressure was @ vs @ ( P < @ ) .


The effective termination criterion was higher during AA ( @ % -LSB- @-@ -RSB- vs @ % -LSB- @-@ -RSB- ; P < @ ) , but without producing premature breath terminations .


Pressure overshoots and alternative cycling-off were also decreased .


Throughout the AA period , we observed a higher respiratory rate ( @ breaths/min vs @ breaths/min ; P < @ ) , lower tidal volume ( @ @ mL vs @ mL ; P < @ ) , and shorter inspiratory times ( @ seconds vs @ seconds ; P < @ ) .


Automatic adjustment was associated with lower airway occlusion pressure after @ second ( P@ @ ) ( @ cm H@O vs @ cm H@O ; P < @ ) , lower pressure-time product to trigger the ventilator , and lower subjective discomfort ( visual analog scale , @ vs @ ; P < @ ) .


When compared with a fixed termination criterion , the use of a variable , real-time-adjusted termination criterion improved some indices of patient-ventilator synchrony , producing better breathing pattern , less discomfort , and slightly lower patient effort during PSV .


Several studies have suggested that cognitive training is a potentially effective way to improve cognition and postpone cognitive decline in older adults with mild cognitive impairment ( MCI ) .


The MEMO + study is a randomized , controlled , single-blind trial designed to test the efficacy , specificity , and long-term effect of a cognitive training intervention and a psychosocial intervention in persons with MCI .


One hundred and sixty-two participants with MCI will be recruited .


They will be randomized into three groups : cognitive training , psychosocial intervention , and no-contact .


Each intervention will last for eight weeks ( one session per week ) and a booster training session will be provided three months after the end of the intervention .


Various proximal and distal outcomes will be measured at pre-intervention as well as at one week , three months , and six months post-training .


Proximal outcomes include memory and psychological health measures .


Distal outcomes focus on self-rated functioning in complex daily activities and strategies used in daily life to enhance function .


Socio-demographic factors ( age , gender , and education ) , general cognition , personality traits , engagement in activities , and self-efficacy will be used as moderators .


Enrolment began in April @ and will be completed by December @ .


This study is likely to have a significant impact on the well-being of persons with MCI by contributing to the development of adapted and scientifically supported cognitive and psychosocial interventions .


To identify risk factors for early study termination and motivators for adherence to a long-term followup trial and to improve completeness of long-term studies .


Risk factors for early termination in @ included patients were identified through Cox regression analysis .


Patients completing the @-year followup filled in a questionnaire on possible motives for continued study participation .


Risk factors for early termination were higher age ( hazard ratio -LSB- HR -RSB- @ , @ % confidence interval -LSB- @ % CI -RSB- @-@ @ ) , functional disability during the preceding year ( HR @ , @ % CI @-@ @ ) , having achieved drug-free remission ( HR @ , @ % CI @-@ @ ) , limited joint damage ( HR @ , @ % CI @-@ @ for actual damage ; HR @ , @ % CI @-@ @ for damage progression ) , and few adverse events ( HR @ , @ % CI @-@ @ ) .


A total of @ of @ patients ( @ % ) attending the last visit answered the questionnaire .


The majority mentioned contributing to scientific research ( @ % agreed ) , helping other patients ( @ % ) , and learning about new treatment strategies ( @ % ) and their disease ( @ % ) as reasons to continue participation .


Next , patients mentioned tight control ( @ of @ patients ) , good treatment strategy ( @ of @ ) , good medication ( @ of @ ) , and good half-term results ( @ of @ ) as motivators .


More than @ % of patients experienced participation `` as expected '' or `` better than expected . ''


Additional examinations during yearly visits ( extra questionnaires , imaging ) were mentioned as `` worse than expected '' ( @ % ) , as was answering routine questionnaires ( @ % ) .


Continued participation was relatively high in the Treatment Strategies for Rheumatoid Arthritis ( BeSt ) Study .


Higher age , functional disability , drug-free remission , little joint damage , and few adverse events predicted early study termination .


Main motives for continued participation were a willingness to contribute to research , help future patients , and because patients had good experiences with the study protocol .


The surgical results of treating thoracolumbar and lumbar burst fractures were reported to be comparable between patients with and without fusion in an intermediate-term follow-up .


To our knowledge , no prior report has compared the results of fusion and non-fusion with long-term follow-up .


This study was designed to provide long-term evaluation of patients with a burst fracture of the thoracolumbar and lumbar spine treated with short-segment fixation who were randomly assigned to a fusion or non-fusion group .


Patients older than sixty years of age at the time of injury and those who were lost to follow-up were excluded .


Functional outcomes were evaluated using the Greenough Low-Back Outcome Score and the visual analog scale for back pain .


Radiographic outcomes were focused on the vertebral body height of the injured vertebra , the kyphotic angle , and the regional segmental motion .


Twenty-two patients were enrolled in the non-fusion group , and twenty-four patients were enrolled in the fusion group .


The average follow-up period was @ months ( range , @ to @ months ) .


The average preoperative kyphotic angle was @ for the non-fusion group and @ for the fusion group .


The average postoperative kyphotic angle was @ for the non-fusion group and @ for the fusion group .


At the time of the latest follow-up , the average kyphotic angle was @ for the non-fusion group and @ for the fusion group .


The average kyphotic angle between the two groups was similar at all follow-up times .


A progressive decrease of the kyphotic angle was significant ( p < @ ) with time , regardless of fusion .


The radiographic outcomes were similar between these two groups at all follow-up times , as were functional outcomes .


More patients in the non-fusion group underwent additional surgery to remove implants .


Regional segmental motion was preserved in the non-fusion group , with a mean motion ( and standard deviation ) of @ @ .


The long-term results of short segmental fixation with and without fusion for burst fractures of the thoracolumbar and lumbar spine were comparable .


Regional segmental motion could be preserved without fusion , and bone graft donor site complications could be eliminated .


Therapeutic Level II .


See Instructions for Authors for a complete description of levels of evidence .


Little is known about the reliability of different methods of survey administration in low back pain trials .


This analysis was designed to determine the reliability of responses to self-administered paper surveys compared to computer assisted telephone interviews ( CATI ) for the primary outcomes of pain intensity and back-related function , and secondary outcomes of patient satisfaction , SF-@ , and global improvement among participants enrolled in a study of yoga for chronic low back pain .


Pain intensity , back-related function , and both physical and mental health components of the SF-@ showed excellent reliability at all three time points ; ICC scores ranged from @ to @ .


Pain medication use showed good reliability ; kappa statistics ranged from @ to @ .


Patient satisfaction had moderate to excellent reliability ; ICC scores ranged from @ to @ .


Global improvement showed poor reliability at @weeks ( ICC = @ ) and @weeks ( ICC = @ ) .


CATI shows excellent reliability for primary outcomes and at least some secondary outcomes when compared to self-administered paper surveys in a low back pain yoga trial .


Having two reliable options for data collection may be helpful to increase response rates for core outcomes in back pain trials .


To evaluate the efficacy of manual lymphatic drainage ( MLD ) in improving health-related quality of life ( HRQOL ) , symptomatology , and physical status in patients with chronic venous insufficiency ( CVI ) .


Single-blind randomized controlled trial .


Health community attendant service .


Subjects with CVI ( N = @ ) were randomly assigned to an experimental group ( n = @ ; mean age , @ y ) or control group ( n = @ ; mean age , @ y ) .


The experimental group completed @ lower extremity MLD sessions over @ weeks and @ educational session .


The control group only attended the educational session .


Outcome measures were taken at baseline ( t@ ) , at the end of @ weeks ( t@ ) , and after @ months for follow-up ( t@ ) .


HRQOL was assessed with the Chronic Venous Insufficiency Quality of Life Questionnaire-@ , symptoms ( fatigue , heaviness ) were assessed with a visual analog scale , severity of the disease was assessed with the Venous Clinical Severity Score ( VCSS ) ( total score , score for each item ) , leg volumetry was assessed with perimeters , and plantar/dorsiflexion strength and ankle range of motion ( ROM ) were assessed with dynamometry .


A significant interaction grouptime effect was found for pain on HRQOL ( F@ ,@ = @ ; P = @ ; partial @ = @ ) , clinical severity ( F@ ,@ = @ ; P = @ ; partial @ = @ ) , especially for venous edema ( assessed with the VCSS ) , fatigue ( F@ @,@ = @ ; P = @ ; partial @ = @ ) , and heaviness ( F@ @,@ = @ ; P = @ ; partial @ = @ ) , with the experimental group improving from t@ to t@ and t@ to t@ in all of these outcomes .


No effect of MLD treatment could be found for ankle muscle strength , ankle ROM , and leg volume .


Short-term MLD treatment ameliorates CVI severity and related edema , symptoms , and pain HRQOL in patients with CVI .


Identifying patients with recent stroke or transient ischemic attack ( TIA ) at high risk of major vascular events ( MVEs ; stroke , myocardial infarction , or vascular death ) may help optimize the intensity of secondary preventive interventions .


We evaluated the relationships between the baseline Framingham Coronary Risk Score ( FCRS ) and a novel risk prediction model and with the occurrence of MVEs after stroke or TIA in subjects enrolled in the Stroke Prevention by Aggressive Reduction in Cholesterol Level ( SPARCL ) trial .


Data from the @ subjects enrolled in the SPARCL study were analyzed .


Hazard ratios ( HRs ) from Cox regression models were used to determine the risk of subsequent MVEs based on the FCRS predicting @ % or more @-year coronary heart disease risk .


The novel risk model was derived based on multivariable modeling with backward selection .


Model discrimination ( c-statistics ) was assessed using the areas under the receiver operating characteristic curves .


Of @ subjects with complete data , @ % had a baseline FCRS of @ % or more .


In multivariable analysis , an FCRS of @ % or more was associated with twice the risk of subsequent MVEs ( HR = @ , @ % confidence interval -LSB- CI -RSB- : @-@ @ ) .


The novel model based on a multivariable analysis included age ( HR = @ , @ % CI : @-@ @ per @ years ) , diabetes ( HR = @ , @ % CI : @-@ @ ) , male sex ( HR = @ , @ % CI : @-@ @ ) , and an apolipoprotein ( APO ) - B/APO-A @ ratio ( HR = @ , @ % CI : @-@ @ ) .


The c-statistic was @ ( @ % CI : @ -@ ) for the FCRS of @ % or more and @ ( @ % CI : @ -@ ) for the novel model .


Both a baseline FCRS of @ % or more and a novel predictive model were associated with future MVEs in SPARCL trial subjects .


The novel model needs to be validated , and the benefits of using either the FCRS or the novel model in clinical practice needs to be assessed .


Juvderm Voluma XC ( VYC-@L ) is approved in the United States for correction of age-related volume loss in the midface region in adults .


To characterize the effects of VYC-@L in @ midface subregions based on injection volumes .


In this single-blind controlled trial , subjects with midface volume deficit received VYC-@L in @ of @ facial subregions ( zygomaticomalar , anteromedial cheek , and submalar ) , with touch-up treatment available @ days later .


Responders achieved @-point improvement on the Mid-Face Volume Deficit Scale ( MFVDS ) , analyzed by facial subregion and stratified by injection volume quartiles .


Subject satisfaction and safety were assessed .


The treatment arm comprised @ subjects aged @ to @ years .


Month @ MFVDS responder rates were @ % for zygomaticomalar , @ % for anteromedial cheek , and @ % for submalar subregions .


Higher responder rates were observed with increasing injection volume quartiles for each subregion .


Similar median injection volumes ( @ mL total ) of VYC-@L provided correction durations of @ to @ months : @ months for anteromedial cheek , @ months for zygomaticomalar , and @ months for submalar subregions .


Subject satisfaction was high across injection volume quartiles .


No unanticipated treatment-site adverse reactions occurred .


VYC-@L is effective at restoring midface volume , with high subject satisfaction and an acceptable safety profile .


Intensive lifestyle change prevents type @ diabetes but is difficult to sustain .


Preliminary evidence suggests that yoga may improve metabolic factors .


We tested a restorative yoga intervention vs. active stretching for metabolic outcomes .


In @-@ , we conducted a @-week randomized trial comparing restorative yoga vs. stretching among underactive adults with the metabolic syndrome at the Universities of California , San Francisco and San Diego .


We provided lifestyle counseling and a tapering series of @-min group classes in the @-week intervention period and @-week maintenance period .


Fasting and @-h glucose , HbA@c , triglycerides , HDL-cholesterol , insulin , systolic blood pressure , visceral fat , and quality of life were assessed at baseline , @ - and @-months .


@ participants were randomized and @ ( @ % ) completed the trial .


At @ months , fasting glucose decreased more in the yoga group than in the stretching group ( -@ mmol/L vs. -@ mmol/L ; p = @ ) ; there were no other significant differences between groups .


At @ months favorable changes within the yoga group included reductions in fasting glucose , insulin , and HbA@c and an increase in HDL-cholesterol that were not sustained at @ year except changes in fasting glucose .


The stretching group had a significant reduction in triglycerides at @ months which was not sustained at @ year but had improved quality of life at both time-points .


Restorative yoga was marginally better than stretching for improving fasting glucose but not other metabolic factors .


While the Carotid Revascularization Endarterectomy Versus Stenting Trial ( CREST ) has been widely accepted as a landmark trial establishing an equivalent risk of major adverse events following carotid endarterectomy ( CEA ) or carotid artery stenting ( CAS ) , the applicability of these findings to single centers has been questioned owing to the rigid selection criteria for investigators in the study .


Although refuted by the findings of a subsequent study , a substudy of CREST established a higher periprocedural stroke rate for CAS when the surgeon was a vascular surgeon .


To present our @-day results of stroke , death , myocardial infarction , and composite major adverse events to determine if a single vascular surgeon 's outcomes at our hospital are consistent with the results of CREST .


A retrospective analysis of patients with high-grade carotid artery stenosis treated with CEA or CAS by a vascular surgeon at our institution from September @ , @ , through December @ , @ , was performed .


A @ analysis was used to compare the incidence of specific high-risk patient characteristics in each group .


The Fisher exact test was used to compare the risks of stroke , death , myocardial infarction , and composite major adverse events between CEA and CAS .


These results were then compared with those reported in CREST .


A total of @ cases ( @ CAS and @ CEA ) performed by a single vascular surgeon were included for analysis .


While in CREST the periprocedural risk of stroke was higher following CAS ( @ % vs @ % , P = @ ) and the risk of myocardial infarction was higher following CEA ( @ % vs @ % , P = @ ) , there was no significant difference in the incidence of these outcomes between the @ treatment modalities in our study .


When compared with CREST , our rates of myocardial infarction , stroke , death , and composite adverse events ( CEA , @ % vs @ % ; P = @ ; CAS , @ % vs @ % ; P > @ ) were no different .


Similar to CREST , the @-day risk of composite major adverse events was equivalent for the @ treatment modalities .


We attribute our comparable incidence of perioperative stroke with CAS and CEA to improved patient selection .


We excluded most patients older than @ years and those with complex anatomy from consideration for CAS .


Our results confirm those of CREST and demonstrate that both CEA and CAS can be performed safely by a vascular surgeon in properly selected patients .


The efficacy of functional restoration programs for the treatment of chronic back pain is well documented .


Nevertheless , there are only a few such centres in Germany and few trials have been conducted in German-speaking regions to demonstrate that implementing such programs in everyday clinical settings with large numbers of patients is just as effective as in a research setting .


The present study examined whether the positive effects of such programs can also be observed in the clinically relevant context of a standardized day clinic treatment regimen .


A total of @ back pain patients in @ German cities were examined at @ measurement points ( before and immediately after the program , as well as @ and @ months after treatment ) using a comprehensive questionnaire on perceived pain and symptoms of anxiety and depression , as well as the work situation .


In both cities significant and long-term improvements in back pain , pain-related impairment and degree of chronification were observed , as well as a high return-to-work rate after treatment .


Hence , the quality of such programs was also confirmed for a large patient population .


We conducted a @-month , randomized , double-blind , placebo-controlled study to assess safety , tolerability , and efficacy of deferiprone in Friedreich ataxia ( FRDA ) .


Seventy-two patients were treated with deferiprone @ , @ , or @mg/kg/day or placebo , divided into @ daily doses .


Safety was the primary objective ; secondary objectives included standardized neurological assessments ( Friedreich Ataxia Rating Scale -LSB- FARS -RSB- , International Cooperative Ataxia Rating Scale -LSB- ICARS -RSB- , @-Hole Peg Test -LSB- @HPT -RSB- , Timed @-Foot Walk , Low-Contrast Letter Acuity ) , general functional status ( Activities of Daily Living ) , and cardiac assessments .


Deferiprone was well tolerated at @mg/kg/day , whereas more adverse events occurred in the @mg/kg/day than in the placebo group .


The @mg/kg/day dose was discontinued due to worsening of ataxia in @ patients .


One patient on deferiprone @mg/kg/day experienced reversible neutropenia , but none developed agranulocytosis .


Deferiprone-treated patients receiving @ or @mg/kg/day showed a decline in the left ventricular mass index , compared to an increase in the placebo-treated patients .


Patients receiving @mg/kg/day of deferiprone had no significant change in FARS , similar to the placebo-treated patients , whereas those receiving @mg/kg/day had worsening in FARS and ICARS scores .


The lack of deterioration in the placebo arm impaired the ability to detect any potential protective effect of deferiprone .


However , subgroup analyses in patients with less severe disease suggested a benefit of deferiprone @mg/kg/day on ICARS , FARS , kinetic function , and @HPT .


This study demonstrated an acceptable safety profile of deferiprone at @mg/kg/day for the treatment of patients with FRDA .


Subgroup analyses raise the possibility that , in patients with less severe disease , deferiprone @mg/kg/day may reduce disease progression , whereas higher doses appear to worsen ataxia .


We describe a new approach to blocking the sciatic and saphenous nerves in the proximal thigh ( level of the lesser trochanter or immediately below ) using a single-penetration dual-injection ( SPEDI ) technique .


The popliteal-sciatic approach necessitates repositioning of the leg exposing the popliteal fossa and an extra injection for the saphenous nerve ( SAN ) block at the midthigh level .


We introduce an alternative , effective , and possibly faster method .


Sixty patients undergoing leg and foot surgery under general anesthesia were included .


We deposited @ mL of ropivacaine @ % around the sciatic nerve ( SCN ) and @ mL of ropivacaine @ % at the SAN .


Patients were randomized to the popliteal-sciatic/saphenous technique or the SPEDI technique .


The primary outcome measure was performance time .


Positioning time , pain assessment , nausea in the postanesthesia care unit , sufentanil demand , dermatomal anesthesia , and degree of motor blockade were also recorded .


Performance time was significantly faster with the SPEDI technique ( median time , @ seconds -LSB- range , @-@ seconds -RSB- vs @ seconds -LSB- range , @-@ seconds -RSB- ; P < @ ) .


Positioning time was significantly shorter with the SPEDI technique ( P < @ ) .


No other statistically significant differences were recorded .


The SPEDI block resulted in significantly faster performance time and reduced positioning time with statistically equal efficacy in relation to pain assessment , nausea , sufentanil demand , dermatomal anesthesia , and motor blockade .


The SPEDI block is statistically an equally effective alternative to the traditional popliteal-sciatic/saphenous block combination for leg and foot surgery , but it is faster , requires only @ skin penetration , and does not require repositioning of the leg .


Near-infrared ( NIR ) light therapy is purported to act as an ergogenic aid by enhancing the contractile function of skeletal muscle .


Improving muscle function is a new avenue for research in the area of laser therapy ; however , very few researchers have examined the ergogenic effects of NIR light therapy and the influence it may have on the recovery process during rehabilitation .


To evaluate the ergogenic effect of NIR light therapy on skeletal muscle function .


Crossover study .


Controlled laboratory .


Thirty-nine healthy men ( n = @ ) and women ( n = @ ; age = @ @ years , height = @ @ cm , mass = @ @ kg , body mass index = @ @ kg/m ( @ ) ) .


Each participant received active and sham treatments on the biceps brachii muscle on @ separate days .


The order of treatment was randomized .


A class @ laser with a cumulative dose of @ J was used for the active treatment .


After receiving the treatment on each day , participants completed an elbow-flexion resistance-exercise protocol .


The dependent variables were elbow range of motion , muscle point tenderness , and strength ( peak torque ) .


Analysis of variance with repeated measures was used to assess changes in these measures between treatments at baseline and at follow-up , @ hours postexercise .


Additionally , immediate strength loss postexercise was compared between treatments using a paired t test .


Preexercise to postexercise strength loss for the active laser treatment , although small , was less than with the sham treatment ( P = @ ) .


Applied to skeletal muscle before resistance exercise , NIR light therapy effectively attenuated strength loss .


Therefore , NIR light therapy may be a beneficial , noninvasive modality for improving muscle function during rehabilitation after musculoskeletal injury .


However , future studies using higher treatment doses are warranted .


Efficient fat digestion requires fat processing within the stomach and fat sensing in the intestine .


Both processes also control gastric emptying and gastrointestinal secretions .


We aimed to visualize the influence of the intragastric stability of fat emulsions on their dynamics of gastric processing and structuring and to assess the effect this has on gastrointestinal motor and secretory functions .


Eighteen healthy subjects with normal body mass index ( BMI ) were studied on @ separate occasions in a double-blind , randomized , crossover design .


Magnetic resonance imaging ( MRI ) data of the gastrointestinal tract and blood triglycerides were recorded before and for @ min after the consumption of the following @ different fat emulsions : lipid emulsion @ ( LE@ ; acid stable , @ m ) , lipid emulsion @ ( LE@ ; acid stable , @ m ) , lipid emulsion @ ( LE@ ; acid unstable , solid fat , @ m ) , and lipid emulsion @ ( LE@ ; acid unstable , liquid fat , @ m ) .


Intragastric emulsion instability was associated with a change in gastric emptying .


Acid-unstable emulsions exhibited biphasic and faster emptying profiles than did the @ acid-stable emulsions ( P @ ) .


When combined with solid fat ( LE@ ) , different dynamics of postprandial gallbladder volume were induced ( P @ ) .


For acid-stable emulsions , a reduction of droplet size by @ orders of magnitude -LSB- LE@ ( @ m ) compared with LE@ ( @ m ) -RSB- delayed gastric emptying by @ min .


Although acid-stable ( LE@ and LE@ ) and redispersible ( LE@ ) emulsions caused a constant increase in blood triglycerides , no increase was detectable for LE@ ( P < @ ) .


For LE@ , MRI confirmed the generation of large fat particles during gastric processing , which emptied into and progressed through the small intestine .


MRI allows the detailed characterization of the in vivo fate of lipid emulsions .


The acute effects of lipid emulsions on gastric emptying , gallbladder volume , and triglyceride absorption are dependent on microstructural changes undergone during consumption .


Gastric peristalsis and secretion were effective at redispersing pools of liquid fat in the stomach .


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


To explore a new method of patient-involved digital design , esthetic outcome prediction and fabrication for the esthetic rehabilitation of anterior teeth , and to provide an alternative choice for the restoration of anterior teeth .


In this study , @ patients with esthetic problems in their anterior teeth were included and divided into two groups randomly : the experimental group ( @ patients ) and control group ( @ patients ) .


In the experimental group , the dentition and facial images were obtained by intra-oral scanning and Three-dimensional ( @D ) facial scanning and then calibrated .


The design of the rehabilitation and the esthetic outcome prediction were created by computer-aided design ( CAD ) software .


After morphologic modification according to the patients ' opinions , prostheses were fabricated according to the final design by computer-aided manufacturing ( CAM ) equipment .


As for the control group , the regular design method was applied to restore their anterior teeth .


The time consuming in the first insertion of each restoration in both groups was recorded .


The quality of the prostheses was assessed by another prosthedontist .


The satisfaction to prostheses and the facial appearance were evaluated by the patients .


The process of the patient-involved digital design and outcome anticipation was successfully established .


The patients were satisfied with the esthetic effects of the anterior restoration made by the digital technique .


The acceptance rate of the patients on the digital rehabilitation in the experimental group was @ % .


There was no significant difference of the quality of the prostheses between the two groups .


The satisfaction rate of the patients on prostheses and facial appearance was significantly higher in the experimental group than in the control group ( P < @ ) .


In addition , the time consuming in the first insertion of the experimental group was much shorter than that in the control group ( P < @ ) .


The new method of the patient-involved digital design , esthetic outcome prediction and fabrication for the esthetic rehabilitation of anterior teeth is a practical technique .


This method is useful in shortening the time consuming of the restoration of anterior teeth and improving the patient satisfaction with the esthetic outcome .


The purpose of the study was to evaluate the clinical effects of the Shenzhu Tiaopi granule ( SZTP ) combined with a lifestyle intervention in patients with impaired glucose tolerance ( IGT ) , who also had a spleen deficiency and damp overabundance syndrome ( SDDOS ) .


After a one-month washout period , a total of @ patients were randomly assigned to the control ( lifestyle intervention ) and experimental ( SZTP plus lifestyle intervention ) groups , with @ patients in each group .


Patients in the control group received the lifestyle intervention ( diet and exercise ) for @ months , while the patients in the experimental group were treated with SZTP plus the lifestyle intervention for @ months .


The Traditional Chinese Medicinal ( TCM ) symptom scores were observed in each group before and after treatment ; the conversion rates from IGT to diabetes mellitus ( DM ) were also measured .


Following @ months of treatment , the conversion rate from IGT to DM in the experimental group was significantly lower than in the control group ( @ % vs. @ % , P < @ ) .


A significantly higher number of patients with IGT reverted to normal blood glucose levels in the experimental group than in the control group ( @ % vs. @ % , P < @ ) .


In addition , after following the treatment for @ months , the TCM symptoms of patients in the experimental group were markedly alleviated , as compared to the control group ( P < @ ) .


The combination of SZTP and lifestyle intervention showed a reduction in the conversion from IGT to DM , and an increase in the conversion from IGT to normal blood glucose levels .


To determine whether a single bout of resistance exercise produces an analgesic effect in individuals with knee osteoarthritis ( OA ) .


Eleven participants with knee OA ( @ @ yrs ) , and @ old ( @ @ yrs ) and @ young ( @ @ yrs ) healthy adults performed separate bouts of upper and lower body resistance exercise .


Baseline and post-exercise pressure pain thresholds were measured at eight sites across the body and pressure pain tolerance was measured at the knee .


Pressure pain thresholds increased following exercise for all three groups , indicating reduced pain sensitivity .


For the young and old healthy groups this exercise-induced analgesia ( EIA ) occurred following upper or lower body resistance exercise .


In contrast , only upper body exercise significantly raised pain thresholds in the knee OA group , with variable non-significant effects following lower body exercise .


Pressure pain tolerance was unchanged in all groups following either upper or lower body exercise .


An acute bout of upper or lower body exercise evoked a systemic decrease in pain sensitivity in healthy individuals irrespective of age .


The decreased pain sensitivity following resistance exercise can be attributed to changes in pain thresholds , not pain tolerance .


While individuals with knee OA experienced EIA , a systemic decrease in pain sensitivity was only evident following upper body exercise .


After vidian neurectomy , low reported rates of dry eye syndrome ( DES ) seemed incompatible with the high success rate of nerve severance in previous studies .


This study aimed at understanding of the pathophysiology of lacrimation and evaluating the effect of thermal injury through the distal stump on the sphenopalatine ganglion ( SPG ) after vidian neurectomy .


A randomized , double-blind , controlled study was performed to evaluate the DES .


Eighty precise vidian neurectomies were randomized in a @:@ ratio to groups @ and @ .


Group @ represented the cauterization and was used in both distal and proximal nerve stumps , whereas only the proximal nerve stump was cauterized in group @ subjects .


The DES was evaluated with Schirmer 's test and ocular surface disease index ( OSDI ) before and after surgery at @-@ days and @ days , respectively .


In group @ , the Schirmer 's test showed a mean decline of @ mm ( @/@ , @ % ) at @-@ days and @ mm ( @/@ , @ % ) at @ days .


In group @ , the Schirmer 's test revealed significantly lesser dry eye problems , with a mean decline of @ mm ( @/@ ; @ % ) at @-@ days and @ mm ( @/@ ; @ % ) at @ days .


The significantly less postoperative dry eye problems in group @ can be shown by the OSDI at @-@ days , but not at @ days .


The mean follow-up period was @ months .


No recurrence of nasal allergy symptoms was noted in the follow up period .


The significant advantage of preservation of the SPG function is justified by Schirmer 's test , although the effect did not appear to be comparable with the clinical manifestations evaluated by OSDI at @ days .


Nevertheless , the preservation of distal stump from preventive cauterization can still offer better eye ball moisture in the early evaluation of DES .


To investigate the effect of flavonoid-rich dark chocolate and non-flavonoid-rich white chocolate on retinal vessel diameter in glaucoma patients and age-matched controls .


Thirty glaucoma patients and @ age-matched subjects were assigned to dark or white chocolate by randomization with forced equal distribution .


The number in each of the four groups was @ .


Measured parameters included systemic blood pressure ( BP ) , blood glucose levels , static retinal vessel analysis , as measured by central retinal artery equivalent ( CRAE ) ( which relates to the diameter of the central retinal artery ) , central retinal vein equivalent ( CRVE ) ( which relates to the diameter of central retinal vein ) and the arterio-venous ratio ( AVR ) , which represents the CRAE/CRVE ratio , dynamic retinal vessel analysis as measured by the change in vessel diameter in response to flicker light stimulation .


Three recording cycles from each were averaged .


Blood pressure parameters ( systolic BP , diastolic BP and pulse ) , IOP and blood glucose levels did not differ significantly between both groups before and after consumption of white or dark chocolate .


Static vessel analysis did not show any significant changes in CRAE , CRVE or AVR before and after dark or white chocolate in both groups ( p > @ ) .


Mean dilatation of the venules in the control group was @ @ % before dark chocolate and @ @ % after dark chocolate intake , which was statistically significantly different ( p = @ ) .


Mean dilatation of the arterioles in the control group was @ @ % before dark chocolate and @ @ % after dark chocolate intake with a trend to statistical significance ( p = @ ) , but not reaching the significance level .


Mean diameter changes in the glaucoma group did not show any significant differences after dark chocolate consumption .


The present study showed a significant improvement of venous vasodilatation @ hr after dark chocolate intake in the control group , but not in the glaucoma group .


This effect might be indicative of an increased bioavailability of nitric oxide ( NO ) after dark chocolate consumption .


The lack of finding a significant venous response after dark chocolate in the glaucoma group might be related to the already impaired endothelial function in these patients .


The United States has the highest rate of lumbar spine surgery in the world , with rates increasing over @ % since @ .


Medicare spends over $ @ billion annually on lumbar spine surgery .


Despite surgical advances , up to @ % of patients report chronic pain and disability following surgery .


Our work has demonstrated that fear of movement is a risk factor for increased pain and disability and decreased physical function in patients following lumbar spine surgery for degenerative conditions .


Cognitive-behavioral therapy and self-management treatments have the potential to address psychosocial risk factors and improve outcomes after spine surgery , but are unavailable or insufficiently adapted for postoperative care .


Our research team developed a cognitive-behavioral based self-management approach to postoperative rehabilitation ( Changing Behavior through Physical Therapy ( CBPT ) ) .


Pilot testing of the CBPT program demonstrated greater improvement in pain , disability , physical and mental health , and physical performance compared to education .


The current study compares which of two treatments provided by telephone - a CBPT Program or an Education Program about postoperative recovery - are more effective for improving patient-centered outcomes in adults following lumbar spine surgery for degenerative conditions .


A multi-center , comparative effectiveness trial will be conducted .


Two hundred and sixty patients undergoing lumbar spine surgery for degenerative conditions will be recruited from two medical centers and community surgical practices .


Participants will be randomly assigned to CBPT or Education at @weeks following surgery .


Treatments consist of six weekly telephone sessions with a trained physical therapist .


The primary outcome will be disability and secondary outcomes include pain , general health , and physical activity .


Outcomes will be assessed preoperatively and at @weeks , @months and @months after surgery by an assessor masked to group allocation .


Effective rehabilitation treatments that can guide clinicians in their recommendations , and patients in their actions will have the potential to effect change in current clinical practice .


To evaluate operative time after adjunctive misoprostol or mifepristone compared with overnight osmotic dilators alone for cervical preparation before dilation and evacuation at @-@ @/@ weeks of gestation .


This double-blind , three-arm , multicenter , randomized trial compared overnight osmotic dilators alone , dilators plus @ micrograms buccal misoprostol @ hours preoperatively , and dilators plus @ mg oral mifepristone during dilator placement for dilation and evacuation .


Our primary outcome was dilation and evacuation operative time within two cohorts : @-@ @/@ weeks of gestation ( N = @ ) and @-@ @/@ weeks of gestation ( N = @ ) .


Three hundred women were required for @ % power to detect a @-minute difference in operative time .


Secondary outcomes included initial cervical dilation , side effects , physician satisfaction by Likert scale , and complications .


Between February @ and February @ we randomized @ women evenly across treatment arms .


Group demographics were similar .


We found no difference in operative time in either gestational cohort ( early cohort -LSB- minutes -RSB- : @ dilators alone , @ misoprostol , @ mifepristone , P = @ ; late cohort -LSB- minutes -RSB- : @ dilators alone , @ misoprostol , @ mifepristone , P = @ ) .


In the early cohort , initial dilation was greater with misoprostol than dilators alone ( @ compared with @ cm , P = @ ) .


Patients given misoprostol had significantly more pain , fever , and chills .


In the late cohort , dilation and evacuation procedures were less difficult after mifepristone ( @ % , @ % confidence interval -LSB- CI -RSB- @-@ @ ) than misoprostol ( @ % , @ % CI @-@ @ ) or dilators alone ( @ % , @ % CI @-@ @ ; P = @ ) .


We had inadequate power to infer differences in complications : dilators alone ( @ % , @ % CI @-@ @ ) compared with misoprostol ( @ % , @ % CI @-@ @ ) compared with mifepristone ( @ % , @ % CI @-@ @ ) .


Despite no difference in operative time , adjunctive mifepristone facilitates later dilation and evacuation compared with osmotic dilators alone and is better tolerated than misoprostol .


Rilotumumab , an investigational , monoclonal antibody , inhibits MET-mediated signalling .


In a randomized phase @ trial of rilotumumabepirubicin/cisplatin/capecitabine in gastric or oesophagogastric junction cancer , patients receiving rilotumumab showed a trend towards improved survival , especially in MET-positive patients , but no clear dose-response relationship was observed .


Exposure-response and biomarker analyses were used for dose selection and to differentiate patient subpopulations that may benefit most from treatment .


Here , we analyse rilotumumab exposure-survival and exposure-safety and the impact of MET expression on these relationships .


Individual rilotumumab exposure parameters were generated using population pharmacokinetic modelling .


Relationships among rilotumumab dose ( @ and @mgkg ( -@ ) ) , exposure , and clinical outcomes ( progression-free survival ( PFS ) and overall survival ( OS ) ) were evaluated with Cox regression models and Kaplan-Meier plots .


MET status and other baseline covariates were evaluated in subgroup and multivariate analyses .


Treatment-emergent adverse events were summarised by exposure .


Among MET-positive patients , higher rilotumumab exposure , vs placebo and low exposure , was associated with improved median PFS ( @ % CI : @ ( @-@ @ ) vs @ ( @-@ @ ) and @ ( @-@ @ ) months ) and OS ( @ ( @-@ @ ) vs @ ( @-@ @ ) and @ ( @-@ @ ) months ) without increased toxicity .


No rilotumumab benefit was seen among MET-negative patients .


Rilotumumab had an exposure-dependent treatment effect in patients with MET-positive gastric or oesophagogastric junction cancer .


Neoangiogenesis is particularly abundant in small-cell lung cancer ( SCLC ) and is associated with poor prognosis .


As a result of the promising nature of phase II studies , a randomized phase III trial was designed to assess the efficacy of adding bevacizumab to first-line chemotherapy with cisplatin-etoposide for treatment of extensive disease SCLC .


We present the treatment rationale and study design of GOIRC trial ( FARM@PMFJM study ) , a multicenter randomized phase III study , supported by AIFA ( Agenzia Italiana del Farmaco ) .


Patients are randomized to receive either cisplatin @ mg/m ( @ ) and etoposide @ mg/m ( @ ) intravenously on days @ to @ ( control arm ) or the same chemotherapy combined with bevacizumab @ mg/kg intravenously on day @ ( experimental arm ) .


Treatment is repeated every @ weeks and for a maximum of @ courses .


Patients randomized to the experimental arm in the absence of disease progression after @ cycles continue bevacizumab alone until progression or for a maximum of @ courses .


Tumor assessment is done every @ cycles .


Major eligibility criteria are : age @ years ; histologically or cytologically documented extensive disease SCLC ; Eastern Cooperative Oncology Group performance status @ ; adequate hematological , hepatic and renal functions ; no history of grade @ or higher hemoptysis ; and no evidence of tumor cavitation .


The primary end point of this study is overall survival .


Secondary end points include response rate , time to progression , and toxicity .


An interim futility analysis was performed by an Independent Data Monitoring Committee in September @ and the trial obtained approval to continue .


As of July @ , @ , @ patients of @ planned have been randomized .


Severe mental illness ( SMI ) , including schizophrenia , bipolar disorder and severe depression , is responsible for a substantial proportion of disability in the population .


This article describes the aims and design of a research study that takes a novel approach to targeted prevention of SMI .


It is based on the rationale that early developmental antecedents to SMI are likely to be more malleable than fully developed mood or psychotic disorders and that low-risk interventions targeting antecedents may reduce the risk of SMI .


Families Overcoming Risks and Building Opportunities for Well-being ( FORBOW ) is an accelerated cohort study that includes a large proportion of offspring of parents with SMI and embeds intervention trials in a cohort multiple randomized controlled trial ( cmRCT ) design .


Antecedents are conditions of the individual that are distressing but not severely impairing , predict SMI with moderate-to-large effect sizes and precede the onset of SMI by at least several years .


FORBOW focuses on the following antecedents : affective lability , anxiety , psychotic-like experiences , basic symptoms , sleep problems , somatic symptoms , cannabis use and cognitive delay .


Enrolment of offspring over a broad age range ( @ to @ years ) will allow researchers to draw conclusions on a longer developmental period from a study of shorter duration .


Annual assessments cover a full range of psychopathology , cognitive abilities , eligibility criteria for interventions and outcomes .


Pre-emptive early interventions ( PEI ) will include skill training for parents of younger children and courses in emotional well-being skills based on cognitive behavioural therapy for older children and youth .


A sample enriched for familial risk of SMI will enhance statistical power for testing the efficacy of PEI .


FORBOW offers a platform for efficient and unbiased testing of interventions selected according to best available evidence .


Since few differences exist between familial and ` sporadic ' SMI , the same interventions are likely to be effective in the general population .


Comparison of short-term efficacy of PEI on antecedents and the long term efficacy for preventing the onset of SMI will provide an experimental test of the etiological role of antecedents in the development of SMI .


To evaluate the effectiveness of naproxen @ mg taken orally @ minutes before , endometrial biopsy for pain relief during the procedure .


A double blind , randomized , placebo-controlled trial was conducted in @ patients with indication for endometrial biopsy at Ramathibodi Hospital between April @ and January @ .


The patients were randomly allocated into two groups to receive naproxen @ mg ( n = @ ) or placebo ( n = @ ) , @ minutes before endometrial biopsy .


Pain score was assessed using Visual Analogue Scale during and @ minutes after the procedure .


Adverse events were observed .


The mean pain score during endometrial biopsy in the treatment group was significantly lower compared to the placebo group ( @ @ vs. @ @ , respectively , p-value < @ ) .


However , the mean pain score at @ minutes after endometrial sampling were minimal and had non-statistical significance in both groups .


( @ @ vs. @ @ , p-value @ ) .


Naproxen @ mg taken orally @ minutes before endometrial biopsy significantly reduce pain score during the procedure .


To investigate the effects of different anesthesia depth on stress response in elderly patients undergoing elective laparoscopic surgery for colorectal cancer .


A total of @ ASA I-III patients aged @-@ years undergoing elective laparoscopic surgery for colorectal cancer with general anesthesia were randomized into @ groups , namely group A with a target Narcotrend index ( NI ) maintained at D@ level , group B with a NI at D@ level , and group C with a NI at E@ level .


The anesthetics ( profopol and remifentanil ) were adjusted according to Narcotrend monitoring results to maintain the specified anesthesia depth .


The patients ' heart rate ( HR ) and mean artery pressure ( MAP ) were recorded before anesthesia ( T@ ) , before intubation ( T@ ) , immediately after intubation ( T@ ) , at @ min before pneumoperitoneum ( T@ ) , @ min after pneumoperitoneum ( T@ ) , at the end of the surgery ( T@ ) and extubation ( T@ ) .


Serum levels of cortisol , adrenocorticotropic hormone ( ACTH ) , endothelin-@ ( ET-@ ) , tumor necrosis factor - ( TNF - ) , interleukin-@ ( IL-@ ) and C-reactive protein ( CRP ) were measured by standard ELISA and radioimmunoassay before anesthesia ( Ta ) , at the end of the surgery ( Tb ) and @ day after the surgery ( Tc ) .


HR and MAP in group A increased significantly at T@ , T@ , and T@ compared to those at T@ ( P < @ ) , and were higher than those in group B and group C ( P < @ ) .


The MAP in all the @ groups all decreased at T@ and T@ ( P < @ or P < @ ) , and was markedly lower in group C than in groups A and B ( P < @ ) .


The incidence of hypertension was significantly higher in group A than in groups B and C ( P < @ ) , while the incidence of hypotension was much higher in group C ( P < @ ) .


There were no obvious differences in serum levels of cortisol , ACTH , CRP , IL-@ , TNF-a , or ET-@ among the groups at Ta ( P > @ ) .


The serum levels of ACTH in the @ groups all significantly increased at Tb and Tc ( P < @ ) .


CRP , IL-@ and TNF-a levels in group A were increased at Tb and Tc ( P < @ or P < @ ) and significantly higher than those in groups B and C ( P < @ or P < @ ) .


Cortisol in groups A and B increased at Tb and Tc ( P < @ ) to a significantly higher level than that in group C ( P < @ ) .


ET-@ level in group C at Tb and Tc was lower than those in groups A and B ( P < @ or P < @ ) .


Maintaining the anesthesia depth for a NI at the D@ and E@ level can both attenuate the stress response in elderly patients undergoing laparoscopic surgery for colorectal cancer , but the hemodynamic stability can be better at a D@ level .


The study purpose was to analyze midterm outcomes in a prospective trial of alemtuzumab ( Alem ) versus rabbit anti-thymocyte globulin ( rATG ) induction in simultaneous pancreas-kidney transplantation ( SPKT ) .


From February @ to October @ , @ SPKTs ( @ portal-enteric drainage ) were prospectively randomized as part of a larger kidney transplant study to receive either single-dose Alem ( @ mg intraoperatively ) or multiple-dose rATG antibody induction ( starting intraoperatively , minimum three doses administered ) with tacrolimus/mycophenolate steroids .


Of @ kidney transplant patients enrolled in the study , @ received SPKTs ; @ ( @ % ) received Alem and @ ( @ % ) rATG induction .


Follow-up ranged from @ to @ months ( mean @ months ) .


There were no significant differences between the two groups in @ years actual patient ( @ % Alem vs @ % rATG ) , kidney ( @ % Alem vs @ % rATG , p = @ ) or pancreas ( @ % Alem vs @ % rATG ) graft survival rates .


Five years death-censored kidney ( @ % Alem vs @ % rATG , p = @ ) and pancreas ( @ % Alem vs @ % rATG , p = @ ) graft survival rates were slightly higher in patients receiving Alem .


Acute rejection ( @ % Alem vs @ % rATG , p = @ ) and major infection ( @ % Alem vs @ % rATG , p = @ ) rates were slightly lower in the Alem group ; cytomegalovirus infections were significantly lower ( @ Alem vs @ % rATG , p = @ ) .


The incidence of late acute rejection was low in both groups .


There were no differences in early pancreas thrombosis ( @ % Alem vs @ % rATG ) , postoperative bleeding ( @ % Alem vs @ rATG ) , other surgical complications , readmissions or freedom from steroids between groups .


In patients with functioning grafts , @ years mean serum creatinine ( @ Alem vs @ mg/dl rATG ) , calculated abbreviated modification of diet in renal disease glomerular filtration rate ( @ Alem vs @ ml/min/@ @ m ( @ ) rATG ) , hemoglobin A@c ( both @ % ) and C-peptide ( @ Alem vs @ ng/ml rATG ) levels were similar .


Single-dose Alem and multiple-dose rATG induction provide similar midterm patient survival and graft functional outcomes with no major differences in morbidity or resource utilization .


The aim of this investigation is to study the relationship between gastric morphology and serum biomarkers before and after Helicobacter pylori eradication .


First-degree relatives of gastric cancer patients underwent gastroscopy before and @ years after H. pylori eradication .


The morphological changes in two categories ( normal to mild and moderate to severe ) were compared with level of pepsinogens I and II before eradication ( n = @ ) , after eradication ( n = @ ) , and in those with persistent infection ( n = @ ) .


After eradication , pepsinogen I decreased to @ % and pepsinogen II to @ % of the previous values .


Unlike pepsinogen II and pepsinogen I to II ratio that were affected by the severity of inflammation and atrophy in corpus in all groups , pepsinogen I generally did not change .


After eradication , subjects with high mononuclear infiltration in corpus had lower pepsinogen I ( @ versus @ / mL ) , higher pepsinogen II ( @ versus @ / mL ) , and lower ratio ( @ versus @ ) than those without ( P < @ ) .


Pepsinogen II is a good marker of corpus morphological changes before and after H. pylori eradication .


To study the efficacy of Xiaoyao Powder ( XYP ) combined with interferon alpha ( IFN-alpha ) in treating HBeAg positive chronic hepatitis B ( CHB ) patients and the effect on their quality of life ( QOL ) .


Totally @ patients with HBeAg-positive CHB confirmed by liver biopsy were randomly assigned to @ groups , Group A ( @ cases ) and Group B ( @ cases ) .


IFN-alpha@b was subcutaneously injected to patients in Group A at the dose of @ microg , thrice per week .


Those in Group B additionally took XYP .


The therapeutic course for all was @ weeks .


Clinical efficacy was observed by assessing ALT restoration rate , HBeAg negative rate , HBeAg conversion rate , HBV DNA negative rate , complete response rate , partial response rate , and symptoms integral .


The evaluation of QOL was performed by using chronic liver disease questionnaire ( CLDQ ) score .


Adverse reaction occurrence rate was observed in the two groups .


Better effects were obtained in Group A on ALT restoration rate , HBeAg negative rate , HBV DNA negative rate , complete response rate , partial response rate , TCM symptoms integral , the total effective rate of TCM sysmptoms , CLDQ score , and adverse reaction rates , showing statistical difference when compared with Group B ( P < @ , P < @ ) .


XYP could elevate the efficacy of TCM symptoms of HBeAg-positive CHB patients and anti-viral effect , improve their QOL , and reduce adverse reaction of IFN-alpha .


To evaluate long-term efficacy and safety profiles during @ years of individualized ranibizumab treatment in patients with visual impairment due to diabetic macular edema ( DME ) .


Phase IIIb , multicenter , @-month , randomized core study and @-month open-label extension study .


Of the @ patients who completed the randomized RESTORE @-month core study , @ entered the extension study .


In the extension study , patients were eligible to receive individualized ranibizumab treatment as of month @ guided by best-corrected visual acuity ( BCVA ) and disease progression criteria at the investigators ' discretion .


Concomitant laser treatment was allowed according to the Early Treatment Diabetic Retinopathy Study guidelines .


Based on the treatments received in the core study , the extension study groups were referred to as prior ranibizumab , prior ranibizumab + laser , and laser .


Change in BCVA and incidence of ocular and nonocular adverse events ( AEs ) over @ years .


Overall , @ patients ( @ % ) completed the extension study .


In patients treated with ranibizumab during the core study , consecutive individualized ranibizumab treatment during the extension study led to an overall maintenance of BCVA and central retinal subfield thickness ( CRST ) observed at month @ over the @-year extension study ( +@ letters , -@ m -LSB- prior ranibizumab -RSB- and +@ letters , -@ m -LSB- prior ranibizumab + laser -RSB- from baseline at month @ ) with a median of @ injections ( mean , @ injections ; prior ranibizumab ) and @ ( mean , @ injections ; prior ranibizumab + laser ) .


In the prior laser group , a progressive BCVA improvement ( +@ letters ) and CRST reduction ( -@ m ) at month @ were observed after allowing ranibizumab during the extension study , with a median of @ injections ( mean , @ injections ) from months @ to @ .


Patients in all @ treatment groups received a mean of < @ injections in the final year .


No cases of endophthalmitis , retinal tear , or retinal detachment were reported .


The most frequently reported ocular and nonocular adverse effects over @ years were cataract ( @ % ) and nasopharyngitis ( @ % ) .


Eight deaths were reported during the extension study , but none were suspected to be related to the study drug/procedure .


Ranibizumab was effective in improving and maintaining BCVA and CRST outcomes with a progressively declining number of injections over @ years of individualized dosing .


Ranibizumab was generally well tolerated with no new safety concerns over @ years .


Physical therapy treatment of patients with lymphedema includes treatment based on the principles of ` Complete Decongestive Therapy ' ( CDT ) .


CDT consists of the following components ; skin care , manual lymphatic drainage , bandaging and exercises .


The scientific evidence regarding what type of treatment is most effective is sparse .


The objective of this study is to investigate whether CDT is equally effective if it includes manual lymphatic drainage or not in the treatment of arm lymphedema among patients with breast cancer .


A randomized , single-blind , equivalence trial .


A total of @ breast cancer patients with arm lymphedema will be recruited from @ hospitals and randomized into one of two treatment groups A : Complete Decongestive Therapy including manual drainage or B : Complete Decongestive Therapy without manual lymphatic drainage .


The intervention period will be approximately @ weeks followed by a @ month follow-up period ( @ months from baseline ) .


Primary outcome variable : the percentage volume reduction of lymphedema ( % ) from baseline to @ months .


Secondary outcome variables : Differences from baseline to week @ and from week @ to month @ in circumference of the arm ( cm ) , body weight ( kg ) , patient sensation of heaviness ( scale range : @-@ ) , patient sensation of tension ( scale range : @-@ ) , and quality of life ( EQ-@D-@ L-questionnaire ) .


All measurements are standardized and will be performed before randomization , after @ weeks and after @ months .


This randomized controlled study seeks to provide data on an effective treatment for patients with breast cancer related arm lymphedema and which at the same time causes minimal patient inconvenience .


To determine the effects of lipid based nutritional supplements with either whey or soy protein in patients with HIV during the first three months of antiretroviral treatment ( ART ) and to explore effects of timing by comparing supplementation at the start of ART and after three months delay .


Randomised controlled trial .


Three public ART facilities in Jimma , Oromia region , Ethiopia .


Adults with HIV eligible for ART with body mass index ( BMI ) > @ .


Daily supplementation with @ g ( @ kJ ) of supplement containing whey or soy during either the first three or the subsequent three months of ART .


Primary : lean body mass assessed with deuterium dilution , grip strength measured with dynamometers , and physical activity measured with accelerometer and heart rate monitors .


Secondary : viral load and CD@ counts .


Auxiliary : weight and CD@ and CD@ counts .


Of @ patients enrolled , @ ( @ % ) were women , mean age was @ ( SD @ ) , and mean BMI was @ ( SD @ ) .


At three months , participants receiving the supplements containing whey or soy had increased their lean body mass by @ kg ( @ % confidence interval @ kg to @ kg ) and @ kg ( @ kg to @ kg ) , respectively , more than controls .


This was accompanied by an increased gain of grip strength of @ kg ( -@ kg to @ kg ) for the whey supplement group and @ kg ( @ kg to @ kg ) for the soy supplement group .


There were no effects on physical activity .


Total weight gain increased by @ kg ( @ kg to @ kg ) and @ kg ( @ kg to @ kg ) for the whey and soy groups , respectively .


In addition , in the whey supplement group overall CD@ counts improved by @ cells/L ( @ to @ cells/L ) , of which @ cells/L ( @ to @ cells/L ) were CD@ and @ cells/L ( -@ to @ cells/L ) were CD@ .


Effects of the soy containing supplement on immune recovery were not significant .


The effects of the two supplements , however , were not significantly different in direct comparison .


Exploratory analysis showed that relatively more lean body mass was gained by patients with undetectable viral load at three months .


Patients receiving delayed supplementation had higher weight gain but lower gains in functional outcomes .


Lipid based nutritional supplements improved gain of weight , lean body mass , and grip strength in patients with HIV starting ART .


Supplements containing whey were associated with improved immune recovery .


Trial registration Controlled-trials .


com ISRCTN@ .


Daikenchuto ( DKT ) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility .


The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy .


Two hundred and forty-five gastric cancer patients who underwent total gastrectomy were enrolled .


Patients received either DKT ( @ g/d ) or matching placebo from postoperative days @ to @ .


Primary end points were time to first flatus , time to first bowel movement ( BM ) , and frequency of BM .


Secondary end points included quality of life , C-reactive protein level , symptoms indicative of a severe gastrointestinal disorder , and incidence of postoperative ileus .


A total of @ patients ( DKT , n = @ ; placebo , n = @ ) were included in the per-protocol set analysis .


There were no significant differences between the groups in terms of patient background characteristics .


Median time to first BM was shorter in the DKT group than in the placebo group ( @ hours vs @ hours ; p = @ ) .


In patients with high medication adherence , median time to first BM was significantly shorter in the DKT group than in the placebo group ( @ hours vs @ hours ; p = @ ) .


Significantly fewer patients in the DKT group had @ symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day @ ( p = @ ) .


Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function .


To determine the effects of Ginkgo biloba extract ( EGB ) on major periodontal pathogens in subgingival plaque .


Sixty patients with moderate to severe periodontitis were selected and randomly assigned to @ groups : EGB group , a positive ( periocline ) and a negative control groups .


Subgingival plaque samples were collected before treatment and @ week , @ months and @ months after treatment .


The detection rates of @ major periodontal pathogens-Treponema denticola ( Td ) , Tannerella forsythus ( Tf ) , Prevotella intermedia ( Pi ) , and Porphyromonas gingivalis ( Pg ) - were detected by polymerase chain reaction ( PCR ) .


Clinical indicators were examined before treatment , @ and @ months after treatment .


EGB significantly decreased the detection rate of all the @ pathogens @ week after treatment , and then gradually increased at @ and @ months .


EGB 's inhibition effect was better than or comparable to periocline , except for Pg in short-term .


The difference of plaque index ( PLI ) and bleeding index ( BI ) was not statistically significant among the groups , while for probing depth ( PD ) and attachment loss ( AL ) , the difference was statistically significant between the EGB group and negative control group at @ and @ months after treatment .


EGB significantly inhibited major periodontal pathogens and can be used as an adjuvant for periodontitis treatment .


Instructional methods for the simple suture technique vary widely and are seldom based on educational research .


Published data indicate that video primers and structured instruction and evaluation decrease learning time and improve skill acquisition .


To determine the amount of practice needed to attain simple suture proficiency and to identify the optimal teaching schedule for retention of skill .


First-year and second-year medical students at the Icahn School of Medicine at Mount Sinai with little to no suturing experience were randomly divided into @ equal groups , with one being taught on day @ and tested for proficiency on day @ ( control group ) and the other being taught on day @ and tested for proficiency on days @ , @ , and @ ( experimental group ) .


Students were evaluated using the objective structured assessment of technical skills method and a checklist .


Those initially not proficient on a given day were immediately prompted to practice and retest .


This cycle continued until proficiency was achieved for that day .


The study was conducted from April @ , @ , to June @ , @ .


Simple suture proficiency at @ days and the mean number of practice sutures needed for proficiency on day @ .


All students ultimately achieved proficiency .


The mean ( SD ) number of practice sutures required to achieve proficiency at the initial training was @ ( @ ) .


Students in the control group had a @ % pass rate at the @-day initial proficiency test , while students in the experimental group had a @ % pass rate at day @ ( P < @ ) .


There were no differences in instructional time , cumulative number of sutures , or objective structured assessment of technical skills scores at proficiency between groups across the study .


Single instructional sessions may not be sufficient to maintain simple suture proficiency over the course of a @-day elective .


We propose the use of preparatory instructional videos , followed by instructor demonstration to introduce the technique .


Independent practice with intermittent evaluation and critique allows for skill acquisition and time efficiency at the initial training .


Students should view instructional videos and practice at least @ repetitions every @ days to maintain their skill .


There have been no studies of the effect of continuous positive airway pressure ( CPAP ) therapy on erectile dysfunction ( ED ) and serum testosterone in men with type @ diabetes and obstructive sleep apnoea ( OSA ) , a patient group at increased risk of ED and hypogonadism .


The aim of this study was to determine whether CPAP improves sexual and gonadal function in males with type @ diabetes and a pre-CPAP apnoea-hypopnoea index > @/h .


Substudy of a trial assessing the effect of @ months of CPAP on cardiovascular risk in type @ diabetes .


Of @ males starting CPAP , @ ( mean SD age @ @ years , median -LSB- interquartile range -RSB- diabetes duration @ -LSB- @-@ @ -RSB- years ) completed the trial .


Serum total and free testosterone , responses to the Androgen Deficiency in the Aging Aale ( ADAM ) and Sexual Health Inventory for Men ( SHIM ) questionnaires .


There were no significant changes in mean total or free testosterone ( baseline concentrations @ @ nm and @ @ pm , respectively ) , or SHIM score ( baseline @ -LSB- @-@ -RSB- ) , after @ months of CPAP ( P > @ ) .


The ADAM score ( baseline @ @ ) fell after @ month ( to @ @ ) and was maintained at this level at @ months ( P = @ ) .


The Epworth Sleepiness Scale score decreased and self-reported physical activity increased over @ months ( P @ ) without a change in body mass index ( P = @ ) .


These findings imply that CPAP therapy improves somnolence and promotes exercise in men with type @ diabetes , but that there is no direct benefit for gonadal or sexual function .


GH treatment significantly increased adult height ( AH ) in a dose-dependent manner in short non-GH-deficient children in a randomized , controlled , clinical trial ; the mean gain in height SD score ( heightSDS ) was @ ( range @-@ ) , compared with @ in the untreated group .


The objective of the study was to analyze the relationship between IGF-@SDS , IGF binding protein-@ SDS ( IGFBP@SDS ) , and their ratioSDS with a gain in the heightSDS until AH in non-GH-deficient short children .


This was a randomized , controlled , multicenter clinical trial .


The intervention included GH treatment : @ or @ g/kg d plus untreated controls .


One hundred fifty-one non-GH-deficient short children were included in the intent-to-treat ( ITT ) population and @ in the per-protocol ( PP ) population ; @ children in the ITT and @ children in the PP populations had idiopathic short stature ( ISS ) .


Increments from baseline to on-treatment study mean IGF-@SDS ( IGF-@SDS ) , IGFBP@SDS , and IGF-@ to IGFBP@ ratioSDS were assessed in relationship to the gain in heightSDS .


Sixty-two percent of the variance in the gain in heightSDS in children on GH treatment could be explained by four variables : IGF-@SDS ( explaining @ % ) , bone age delay , birth length ( the taller the better ) , and GH dose ( the higher the better ) .


The lower IGF-@SDS was at baseline , the higher was its increment during treatment .


For both the AllPP - and the ISSPP-treated groups , the attained IGF-@SDS study level did not correlate with height gain .


In short non-GH-deficient children , the GH dose-related increment in IGF-@SDS from baseline to mean study level was the most important explanatory variable for long-term growth response from the peripubertal period until AH , when IGF-@SDS , IGFBP@SDS , and their ratioSDS were compared concurrently .


The aim of the study was to compare intermittent ( IAD ) and continuous ( CAD ) androgen deprivation therapy ( ADT ) between locally advanced ( M@ ) and metastatic ( M@ ) prostate cancer , and the effect of ADT on the quality of life .


In total , @ men with advanced prostate cancer were enrolled to receive goserelin acetate for @ weeks .


Of these , @ patients whose prostate-specific antigen ( PSA ) decreased to less than @ ng/ml or by at least @ % ( < @ ng/ml at baseline ) were randomized to IAD or CAD .


In the IAD arm , ADT was resumed for at least @ weeks whenever PSA increased to greater than @ ng/ml or above baseline .


Median follow-up time was @ months .


Median times from randomization to progression , death , prostate cancer death and treatment failure in M@ and M@ patients were @ and @ , @ and @ , @ and @ , and @ and @ months , respectively ( p < @ ) .


No significant differences emerged between IAD and CAD .


ADT showed a beneficial effect on pain , activity limitation and social functioning in M@ patients , and a deleterious effect on physical capacity in M@ patients and on sexual functioning in both groups .


IAD offered extra benefit for activity limitation , social functioning and recovery of sexual functioning .


IAD is as efficient as CAD in treatment of locally advanced and metastatic prostate cancer .


ADT improves quality of life in M@ patients , with IAD offering extra benefit .


Recombinant interleukin-@ ( rIL-@ ) induces cellular cytotoxicity against leukemia blasts .


Patients with acute myeloid leukemia ( AML ) in first complete remission ( CR ) may harbor minimal residual disease that is susceptible to rIL-@-activated effector cells .


In the Cancer and Leukemia Group B ( CALGB ) @ study , patients with AML in first CR were randomly assigned after all planned chemotherapy to receive a @-day course of subcutaneously administered rIL-@ or no further therapy .


The primary objective was to compare disease-free survival ( DFS ) between the @ treatment arms .


A total of @ patients achieved a CR , @ of whom were randomized .


Six courses of low-dose daily rIL-@ were given for the expansion of cytotoxic effector cells , each followed by @-day high-dose boluses given to trigger cytotoxicity against minimal residual disease .


On the protocol-specified intention-to-treat analysis , the hazards ratio for DFS was @ ( @ % confidence interval , @-@ @ ; P = @ ) ; the @-year DFS rate was @ % in the observation arm and @ % in the rIL-@ treatment arm .


The hazards ratio for overall survival ( OS ) was @ ( @ % confidence interval , @-@ @ ; P = @ ) ; the @-year OS rate was @ % for the observation arm and @ % for the rIL-@ treatment arm .


Twenty-five of the @ patients randomized to treatment with rIL-@ either refused or were unable to initiate therapy and @ patients did not complete their assigned therapy .


However , significant toxicities were not commonly observed .


The trial design did not anticipate the difficulties patients would encounter with protocol compliance .


The efficacy of immunotherapy with rIL-@ administered after intensive postremission treatment was not assessed as planned because of unexpected refusals by patients and/or their physicians to comply with protocol-directed therapy .


Neither DFS nor OS was found to be significantly improved .


Older patients discharged from the emergency department ( ED ) have difficulty comprehending discharge plans and are at high risk of adverse outcomes .


The authors investigated whether a postdischarge telephone call-mediated intervention by a nurse would improve discharge care plan adherence , specifically by expediting post-ED visit physician follow-up appointments and/or compliance with medication changes .


The second objectives were to determine if this telephone call intervention would reduce return ED visits and/or hospitalizations within @days of the index ED visit and to determine potential cost savings of this intervention .


This was a @-week randomized , controlled trial among patients aged @ and older discharged to home from an academic ED .


At @ to @days after each patient 's index ED visit , a trained nurse called intervention group patients to review discharge instructions and assist with discharge plan compliance ; placebo call group patients received a patient satisfaction survey call , while the control group patients were not called .


Data collection calls occurred at @ to @days and @ to @days after the index ED visits for all three groups .


Chi-square or Fisher 's exact tests were performed for categorical data and the Kruskal-Wallis test examined group differences in time to follow-up .


A total of @ patients completed the study .


Patients were @ % female and @ % white , with a mean age of @years ( standard deviation -LSB- SD -RSB- @ years ) .


Intervention patients were more likely to follow up with medical providers within @days of their ED visits than either the placebo or the control group patients ( @ , @ , and @ % , respectively ; p = @ ) .


All groups performed well in medication acquisition and comprehension of medication indications and dosage .


There were no differences in return visits to the ED or hospital within @days of the index ED visit for intervention patients , compared to placebo or control group patients ( @ , @ , and @ % , respectively ; p = @ ) .


An economic analysis showed an estimated @ % chance that this intervention would reduce total costs .


Telephone call follow-up of older patients discharged from the ED resulted in expedited follow-up for patients with their primary care physicians .


Further study is warranted to determine if these results translate into improved patient outcomes , decreased return ED visits or hospital admissions , and cost savings resulting from this intervention .


To compare characteristics of hypoglycemic episodes in patients with type @ diabetes receiving saxagliptin or glipizide add-on therapy to metformin .


This was a post hoc analysis of an international , randomized , parallel-group , double-blind , active-controlled , phase @ trial .


The @-week trial and @-week extension were conducted from December @ to August @ .


Patients aged @ years with glycated hemoglobin ( HbA@c ) > @ % to @ % receiving stable metformin doses ( @mg/d ) were randomized @:@ to add-on therapy with saxagliptin @mg/d or glipizide @ to @mg/d ( titrated to optimal effect or highest tolerable dose during the initial @ weeks ) .


Hypoglycemic episodes were recorded in patient diaries .


Confirmed hypoglycemic events were defined as fingerstick glucose @mg/dL ( @ mmol/L ) with associated symptoms .


Of @ patients randomized , @ received saxagliptin + metformin , and @ received glipizide + metformin .


Saxagliptin was noninferior to glipizide in lowering HbA@c .


Hypoglycemia with saxagliptin + metformin and glipizide + metformin was reported by @ ( @ events ) and @ ( @ events ) patients , respectively , through week @ .


The mean ( SD ) number of hypoglycemic events per patient reporting hypoglycemia was lower with saxagliptin + metformin versus glipizide + metformin through weeks @ ( @ -LSB- SD @ -RSB- vs @ -LSB- SD @ -RSB- , respectively ) and @ ( @ -LSB- SD @ -RSB- vs @ -LSB- SD @ -RSB- ) .


Most patients receiving glipizide + metformin with hypoglycemia had multiple events ( @/@ patients -LSB- @ % -RSB- ) .


Confirmed hypoglycemia , major events , and severe events occurred only with glipizide + metformin .


Time to first hypoglycemic event was shorter with glipizide versus saxagliptin .


Limitations of this analysis include its post hoc nature , a high rate of study discontinuation , and exclusion of patients with serious comorbidities and complications .


Saxagliptin + metformin was associated with fewer patients reporting hypoglycemia and fewer and less severe hypoglycemic events in those experiencing hypoglycemia compared with glipizide + metformin .


ClinicalTrials.gov registration number : NCT@ .


This study is a comparative evaluation of the TVT , TOT , and our own modification of TOT ( mTOT ) in the treatment of female stress urinary incontinence from a single center experience .


The study was conducted on @ patients with SUI diagnosed on the basis of urodynamic studies .


They were divided into three groups -- TVT : n = @ , ( TOT ) : n = @ , and mTOT : n = @ .


All of the patients underwent evaluation at @ , @ , and @ months after surgery .


Results were statistically analysed and compared .


Objective and subjective effectiveness after the surgery were not significantly different in the study groups and ranged from @ % to @ % .


Mean surgery time was @ , @ , and @ in the TVT , TOT , and mTOT , respectively .


Mean hospitalization time was @ days .


Mean catheter maintenance time was significantly higher in the TVT than in other groups .


In the TVT group total incidence of complications was @ % , and it was significantly higher than that in TOT and mTOT ( @ % and @ % , resp . )


TVT , TOT , and mTOT are highly effective and safe methods in the treatment of SUI .


There are no differences in the efficacy between the methods with a little higher percentage of complications in the TVT group .


The Lower Mississippi Delta ( LMD ) region of the United States is characterized by high levels of obesity and physical inactivity .


The objective was to test the effectiveness of adapting the @ Dietary Guidelines for Americans ( DG ) , with and without a physical activity ( PA ) component , for attenuating weight gain .


Overall , @ white and African-American adults ( @-@ years ; body mass index @-@ @ kg/m ( @ ) ) were randomized to a DG only group ( n = @ ) or a DG + PA group ( n = @ ) .


Both groups received a @-week dietary education and behavior change intervention .


The DG + PA group also received PA education and a pedometer .


Changes in weight ( kg ) , % weight , and waist circumference ( WC ; cm ) were determined .


Analyses considered all completers ( n = @ ) and those who engaged with @ % of the intervention ( n = @ ) .


General linear models compared mean changes between groups after adjustment for baseline values , race , and sex .


Weight , % weight , and WC significantly decreased from baseline to follow-up in both groups ( p < @ ; unadjusted values ) .


Adjusted analysis showed a main effect of group for weight ( p = @ ) and % weight ( p = @ ) in the completers analysis , and WC ( p = @ ) in the @ % attendance analysis , with the DG + PA group improving weight-related outcomes more .


Low-burden behavioral interventions could be effective strategies in attenuating unhealthy weight gain in the LMD .


The goal of the present research was the examination of overlap between @ research traditions on interpersonal personality traits in major depression .


We hypothesized that Blatt 's ( @ ) dimensions of depressive experiences around the dimensions of relatedness ( i.e. , dependency ) and self-definition ( i.e. , self-criticism ) are associated with specific interpersonal problems according to the interpersonal circumplex model ( Leary , @ ) .


In addition , we examined correlations of interpersonal characteristics with depression severity .


Analyses were conducted on @ patients with major depressive disorder combined from @ samples .


Of the patients , @ participated in a randomized controlled trial in the United States , and @ patients were recruited in an inpatient unit in Germany .


Patients completed measures of symptomatic distress , interpersonal problems , and depressive experiences .


Dependency was associated with more interpersonal problems related to low dominance and high affiliation , while self-criticism was associated with more interpersonal problems related to low affiliation .


These associations were independent of depression severity .


Self-criticism showed high overlap with cognitive symptoms of depression .


The findings support the interpersonal nature of Blatt 's dimensions of depressive experiences .


Self-criticism is associated with being too distant or cold toward others as well as greater depression severity , but is not related to the dimension of dominance .


Long-term macrolide treatment has proven benefit in inflammatory airways diseases , but whether it leads to changes in the composition of respiratory microbiota is unknown .


We aimed to assess whether long-term , low-dose erythromycin treatment changes the composition of respiratory microbiota in people with non-cystic fibrosis bronchiectasis .