In comparison with control , intervention group participants reported lower average pain severity over time ( P = @ ) .


Mean pain interference scores over time were marginally different between groups ( P = @ ) ; mean depression and fatigue scores over time were statistically nonsignificant .


Feasibility outcomes and perspectives about study participation were positive .


Mean pre-post decreases in HRQoL were generally higher among intervention group participants ; pre-post changes in communication self-efficacy were equivalent .


Mixed findings of the study indicate the need for future research .


The resynchronization-defibrillation for ambulatory heart failure trial ( RAFT ) study demonstrated that adding cardiac resynchronization therapy ( CRT ) in selected patients requiring de novo implantable cardiac defibrillators ( ICD ) reduced mortality as compared with ICD therapy alone , despite an increase in procedure-related adverse events .


Data are lacking regarding the management of patients with ICD therapy who develop an indication for CRT upgrade .


Participating RAFT centers provided data regarding de novo CRT-D ( CRT with ICD ) implant , upgrade to CRT-D during RAFT ( study upgrade ) , and upgrade within @ months after presentation of study results ( substudy ) .


Substudy centers enrolled @ ( @ % ) patients in RAFT , including @ de novo , @ study upgrade , and @ substudy CRT attempts .


The success rate ( initial plus repeat attempts ) was @ % for de novo versus @ % for study upgrade and @ % for substudy CRT attempts ( P = @ ) .


Acute complications occurred among @ % of de novo versus @ % of study upgrade and @ % of substudy CRT implantation attempts ( P < @ ) .


The most common complication was left ventricular lead dislodgement .


The principal reasons for not yet attempting upgrade in the substudy were patient preference ( @ % ) , New York Heart Association Class I ( @ % ) , and a QRS < @ ms ( @ % ) .


Among a broad group of implant physicians , CRT upgrades were performed in patients with an ICD in situ with no difference in implant success rate and a reduced acute complication rate as compared with a de novo CRT implant .


Decisions to upgrade were influenced by predictors of benefit in subgroup analyses of the RAFT study and other trials .


Military deployment can have profound effects on physical and mental health .


Few studies have examined whether interventions prior to deployment can improve mechanisms underlying resilience .


Mindfulness-based techniques have been shown to aid recovery from stress and may affect brain-behavior relationships prior to deployment .


The authors examined the effect of mindfulness training on resilience mechanisms in active-duty Marines preparing for deployment .


Eight Marine infantry platoons ( N = @ ) were randomly selected .


Four platoons were assigned to receive mindfulness training ( N = @ ) and four were assigned to a training-as-usual control condition ( N = @ ) .


Platoons were assessed at baseline , @ weeks after baseline , and during and after a stressful combat training session approximately @ weeks after baseline .


The mindfulness training condition was delivered in the form of @ weeks of Mindfulness-Based Mind Fitness Training ( MMFT ) , a program comprising @ hours of classroom instruction plus daily homework exercises .


MMFT emphasizes interoceptive awareness , attentional control , and tolerance of present-moment experiences .


The main outcome measures were heart rate , breathing rate , plasma neuropeptide Y concentration , score on the Response to Stressful Experiences Scale , and brain activation as measured by functional MRI .


Marines who received MMFT showed greater reactivity ( heart rate -LSB- d = @ -RSB- ) and enhanced recovery ( heart rate -LSB- d = @ -RSB- , breathing rate -LSB- d = @ -RSB- ) after stressful training ; lower plasma neuropeptide Y concentration after stressful training ( d = @ ) ; and attenuated blood-oxygen-level-dependent signal in the right insula and anterior cingulate .


The results show that mechanisms related to stress recovery can be modified in healthy individuals prior to stress exposure , with important implications for evidence-based mental health research and treatment .


Malignant pleural effusion can complicate most cancers .


It causes breathlessness and requires hospitalisation for invasive pleural drainages .


Malignant effusions often herald advanced cancers and limited prognosis .


Minimising time spent in hospital is of high priority to patients and their families .


Various treatment strategies exist for the management of malignant effusions , though there is no consensus governing the best choice .


Talc pleurodesis is the conventional management but requires hospitalisation ( and substantial healthcare resources ) , can cause significant side effects , and has a suboptimal success rate .


Indwelling pleural catheters ( IPCs ) allow ambulatory fluid drainage without hospitalisation , and are increasingly employed for management of malignant effusions .


Previous studies have only investigated the length of hospital care immediately related to IPC insertion .


Whether IPC management reduces time spent in hospital in the patients ' remaining lifespan is unknown .


A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital , reduce costs and save healthcare resources .


The Australasian Malignant Pleural Effusion ( AMPLE ) trial is a multicentred , randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion .


This study will randomise @ adults with malignant pleural effusions ( @:@ ) to IPC management or talc slurry pleurodesis .


The primary end point is the total number of days spent in hospital ( for any admissions ) from treatment procedure to death or end of study follow-up .


Secondary end points include hospital days specific to pleural effusion management , adverse events , self-reported symptom and quality-of-life scores .


The pulsatile secretion pattern of growth hormone ( GH ) is an important parameter of GH action at peripheral tissues , and more information is needed on how exercise impacts GH secretion .


This study hypothesized that both aerobic and resistance exercise would exhibit dose-response relationships with respect to exercise duration and @-h postexercise GH secretion .


Eight healthy men randomly completed five separate conditions : @ ) control ( no exercise ; CON ) , @ ) a moderate-duration ( @-h ) aerobic exercise session ( MA ) , @ ) a long-duration ( @-h ) aerobic exercise session ( LA ) , @ ) a moderate-duration ( @-h ) resistance exercise session ( MR ) , and @ ) a long-duration ( @-h ) resistance exercise session ( LR ) .


Exercise intensity , diet , sleep , and physical activity were strictly controlled during each condition , and blood was sampled postexercise every @ min for @ h , and GH secretion parameters were analyzed via cluster and deconvolution analyses .


Only the @-h aerobic exercise bout resulted in a significant amplification of GH secretion as evidenced by increases in GH burst peak amplitude ( @ % ) , basal GH secretion rate ( @ % ) , total GH basal secretion ( @ % ) , total pulsatile secretion ( @ % ) , and total GH secretion ( @ % ) over the control ( i.e. , no exercise ) condition .


GH secretions for the resistance exercise conditions were not different from control .


The fact that the @-h aerobic exercise condition resulted in higher energy expenditure than the other exercise conditions could offer a partial explanation for the greater GH amplification because of the metabolic effects that GH exerts in stimulating postexercise lipolysis .


We conclude that extending the duration of aerobic exercise , but not resistance exercise , from @ - to @-h significantly amplifies GH secretion during a @-h period .


To compare the effective of short-segment pedicle instrumentation with bone grafting and pedicle screw implanting in injured vertebra and cross segment pedicle instrumentation with bone grafting in injured vertebra for treating thoracolumbar fractures .


A prospective randomized controlled study was performed in @ patients with thoracolumbar fracture who were in accordance with the inclusive criteria between June @ and June @ .


Of @ patients , @ received treatment with short-segment pedicle screw instrumentation with bone grafting and pedicle screw implanting in injured vertebra in group A , and @ received treatment with cross segment pedicle instrumentation with bone grafting in injured vertebra in group B.


There was no significant difference in gender , age , affected segment , disease duration , Frankel grade , Cobb angle , compression rate of anterior verterbral height , visual analogue scale ( VAS ) score , and Japanese Orthopaedic Association ( JOA ) score between @ groups before operation ( P > @ ) .


The operation time , blood loss , Cobb angle , compression rate of anterior vertebral height , loss of disc space height , Frankel grade , VAS and JOA scores were compared between @ groups .


There was no significant difference in the operation time and blood loss between @ groups ( P > @ ) .


Primary healing of incision was obtained in all patients , and no early complication of infection or lower limb vein thrombus occurred .


Forty patients were followed up @-@ months ( mean , @ months ) .


No breaking or displacement of internal fixation was observed .


The improvement of Frankel grading score was @ + / - @ in group A and @ + / - @ in group B , showing no significant difference ( t = @ , P = @ ) at @ months after operation .


The Cobb angle , compression rate of anterior verterbral height , and VAS score at @ week and @ months , and JOA score at @ months were significantly improved when compared with preoperative ones in @ groups ( P < @ ) .


No significant difference was found in Cobb angle , disc space height , VAS score , and JOA score between @ groups at each time point ( P > @ ) , but the compression rate of anterior verterbral height in group A was significantly lower than that in group B ( P < @ ) .


The loss of disc space height next to the internal fixation or the injured vertebra was observed in @ groups at @ months , but showing no significant difference ( P > @ ) .


Compared with cross segment pedicle instrumentation , short-segment pedicle screw instrumentation with bone grafting and pedicle screw implanting in injured vertebra can recover and maintain the affected vertebra height in treating thoracolumbar fractures , but it could not effectively prevent degeneration of adjacent segments and the loss of kyphosis correction degree .


To evaluate the effect of a novel divided attention task-walking under auditory constraints-on gait performance in older adults and to determine whether this effect was moderated by cognitive status .


Validation cohort .


General community .


Ambulatory older adults without dementia ( N = @ ) .


Not applicable .


In this pilot study , we evaluated walking under auditory constraints in @ older adults who completed @ pairs of walking trials on a gait mat under @ of @ randomly assigned conditions : @ pair without auditory stimulation and @ pairs with emotionally charged auditory stimulation with happy or sad sounds .


The mean age of subjects was @ years , and @ % ( n = @ ) were women .


The mean velocity during normal walking was @ cm/s , and the mean cadence was @ steps/min .


The effect of walking under auditory constraints on gait characteristics was analyzed using a @-factorial analysis of variance with a @-between factor ( cognitively intact and minimal cognitive impairment groups ) and a @-within factor ( type of auditory stimuli ) .


In both happy and sad auditory stimulation trials , cognitively intact older adults ( n = @ ) showed an average increase of @ cm/s in gait velocity ( F@ @,@ = @ ; P = @ ) and an average increase of @ steps/min in cadence ( F@ @,@ = @ ; P < @ ) as compared with trials without auditory stimulation .


In contrast , older adults with minimal cognitive impairment ( Blessed test score , @-@ ; n = @ ) showed an average reduction of @ cm/s in gait velocity ( F@ @,@ = @ ; P = @ ) and an average reduction of @ steps/min in cadence ( F@ @,@ = @ ; P = @ ) under both auditory stimulation conditions .


Neither baseline fall history nor performance of activities of daily living accounted for these differences .


Our results provide preliminary evidence of the differentiating effect of emotionally charged auditory stimuli on gait performance in older individuals with minimal cognitive impairment compared with those without minimal cognitive impairment .


A divided attention task using emotionally charged auditory stimuli might be able to elicit compensatory improvement in gait performance in cognitively intact older individuals , but lead to decompensation in those with minimal cognitive impairment .


Further investigation is needed to compare gait performance under this task to gait on other dual-task paradigms and to separately examine the effect of physiological aging versus cognitive impairment on gait during walking under auditory constraints .


To investigate the better method of digestive tract reconstruction in proximal gastrectomy for early gastroesophageal junction adenocarcinoma .


A total of @ cases of early gastroesophageal junction adenocarcinoma who were planned to receive radical proximal gastrectomy from January @ to December @ were prospectively enrolled and randomly divided into two groups by table of random number according to methods of digestive tract reconstruction , including @S anastomosis group ( @ cases , @S jejunal interposition ) and traditional anastomosis group ( @ cases , esophageal remnant gastric posterior wall anastomosis ) .


Postoperative complications , operative time , mortality , nutritional parameters and postoperative quality of life were compared between these two groups .


There were no significant differences between two groups in postoperative complications , operative time and mortality ( all P > @ ) .


@S anastomosis group was better in nutritional parameters than traditional group six months after operation ( P < @ ) .


As compared to traditional group , incidence of reflux esophagitis decreased -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P < @ -RSB- and gastric emptying time prolonged obviously -LSB- ( @ ) min vs. ( @ ) min , P < @ -RSB- in @S anastomosis group @ months after operation .


Postoperative QLQ-C@ rating scale revealed quality of life was significantly higher in @S anastomosis group as compared to traditional group .


Jejunal interposition is a better method of digestive tract reconstruction in proximal gastrectomy for early gastroesophageal junction carcinoma .


A brief psychodynamic interpersonal therapy ( PIT ) in patients with multisomatoform disorder has been recently shown to improve health-related quality of life .


To assess cost-effectiveness of PIT compared to enhanced medical care in patients with multisomatoform disorder .


An economic evaluation alongside a randomised controlled trial ( International Standard Randomised Controlled Trial Number ISRCTN@ ) conducted in @ German academic outpatient centres was performed .


Incremental cost-effectiveness ratio ( ICER ) was calculated from the statutory health insurance perspective on the basis of quality adjusted life years ( QALYs ) gained at @ months .


Uncertainty surrounding the cost-effectiveness of PIT was presented by means of a cost-effectiveness acceptability curve .


Based on the complete-case analysis ICER was @ Euro per QALY .


The results did not change greatly with the use of multiple imputation ( ICER = @ ) and last observation carried forward ( LOCF ) approach to missing data ( ICER = @ ) .


The probability of PIT being cost-effective exceeded @ % for thresholds of willingness to pay over @ thousand Euros per QALY .


Cost-effectiveness of PIT is highly uncertain for thresholds of willingness to pay under @ thousand Euros per QALY .


To analyze the effect of biological maturation on training-induced strength and endurance adaptations in the prepubertal growth spurt .


One hundred and twenty-five healthy children ( @ boys , @ girls ) , aged @-@ years old ( @ @ years ) , who were self-assessed as belonging to Tanner stages I and II , were randomly divided into two experimental groups , a strength training group ( @ boys , @ girls ) and an endurance training group ( @ boys , @ girls ) that would train twice a week for @ weeks , as well as a control group ( @ boys , @ girls ; no training program ) .


After @ weeks of training , there were improvements in all strength and endurance measures ( P < @ ) for both groups of Tanner stage I and II children .


No significant differences in training response were observed relative to biological maturity or gender ( P > @ ) .


These data suggest that more biologically mature prepubescent children seem to have no advantage in training-induced strength and endurance adaptations compared with their less mature peers .


Additionally , gender did not affect the training-induced changes in strength or aerobic fitness .


These results are meaningful for the development of optimized well-rounded training programs in prepubertal children .


Am .


J. Hum .


Biol .


@:@ -@ , @ Wiley Periodicals , Inc. .


@,@-Dihydroxyvitamin D -LSB- @,@ ( OH ) @D -RSB- in serum may be both a nuisance and nutritionally valuable .


We investigated the impact of @,@ ( OH ) @D@ on the performance of commercially available immunoassays for serum total @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- using ( a ) serum from a nationally representative sample of adults , ( b ) serum from a spiking experiment , and ( c ) data from the UK Vitamin D External Quality Assurance Scheme ( DEQAS ) .


We also investigated the utility of the serum ratio of @,@ ( OH ) @D@ to @ ( OH ) D as an index of inactivation and of response to vitamin D supplementation using randomized controlled trial ( RCT ) data .


Measurement of @,@ ( OH ) @D in sera by a LC-MS/MS method allowed for an investigation of its impact on immunoassay-derived serum @ ( OH ) D values as well as its clinical utility .


We report data from a nationally representative sample of adults , a recent vitamin D RCT in older adults , and DEQAS .


@,@ ( OH ) @D@ contributed to the positive bias observed in some immunoassays relative to LC-MS/MS-derived estimates for total @ ( OH ) D.


A spiking experiment showed that the degree of cross-reactivity with @,@ ( OH ) @D was high and may underpin this positive bias .


Adjustment for @,@ ( OH ) @D@ concentration brought estimates closer to true values .


Data from the vitamin D RCT showed that the ratio of @,@ ( OH ) @D@ to @ ( OH ) D was associated with serum @ ( OH ) D@ and with response of serum @ ( OH ) D to vitamin D supplementation .


Our findings highlight that the effect of @,@ ( OH ) @D@ in serum is a double-edged sword-an interferent for some immunoassays , yet potentially informative of nutritional status .


The progressive nature of heart failure ( HF ) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management .


Limited evidence exists from randomized , controlled trials supporting the use of interdisciplinary palliative care in HF .


PAL-HF is a prospective , controlled , unblinded , single-center study of an interdisciplinary palliative care intervention in @ patients with advanced HF estimated to have a high likelihood of mortality or rehospitalization in the ensuing @ months .


The @-month PAL-HF intervention focuses on physical and psychosocial symptom relief , attention to spiritual concerns , and advanced care planning .


The primary end point is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at @ months .


Secondary end points include changes in anxiety/depression , spiritual well-being , caregiver satisfaction , cost and resource utilization , and a composite of death , HF hospitalization , and quality of life .


PAL-HF is a randomized , controlled clinical trial that will help evaluate the efficacy and cost effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic end points .


There is a need to find simple cost effective weight loss interventions that can be used in primary care .


There is evidence that self-monitoring is an effective intervention for problem drinking and self-weighing might be an effective intervention for weight loss .


To examine the efficacy of daily self-weighing as an intervention for weight loss .


A randomised controlled trial of @ obese adults , follow-up three months .


The intervention group were given a set of weighing scales and instructed to weigh themselves daily and record their weight .


Both groups received two weight loss consultations which were known to be ineffective .


@ participants were randomised to the intervention group and @ to the control group .


The intervention group lost @ kg ( @ % CI @ to @ kg ) more than the control group , but this was not significant .


There was no evidence that self-weighing frequency was associated with more weight loss .


As an intervention for weight loss , instruction to weigh daily is ineffective .


Unlike other studies , there was no evidence that greater frequency of self-weighing is associated with greater weight loss .


Cardiac surgery can be complicated by postoperative cognitive decline ( POCD ) , which is characterized by impaired memory function and intellectual ability .


The systemic inflammatory response that is induced by major surgery and cardiopulmonary bypass may play an important role in the etiology of POCD .


Prophylactic corticosteroids to attenuate the inflammatory response may therefore reduce the risk of POCD .


The authors investigated the effect of intraoperative high-dose dexamethasone on the incidence of POCD at @ month and @ months after cardiac surgery .


This multicenter , randomized , double-blind , placebo-controlled trial is a preplanned substudy of the DExamethasone for Cardiac Surgery trial .


A total of @ adult patients undergoing cardiac surgery with cardiopulmonary bypass were recruited in three hospitals and randomized to receive dexamethasone @ mg/kg ( n = @ ) or placebo ( n = @ ) .


The main outcome measures were incidence of POCD at @ - and @-month follow-up , defined as a decline in neuropsychological test performance beyond natural variability , as measured in a control group .


At @-month follow-up , @ of @ patients in the dexamethasone group ( @ % ) and @ of @ patients in the placebo group ( @ % ) fulfilled the diagnostic criteria for POCD ( relative risk , @ ; @ % CI , @ to @ ; P = @ ) .


At @-month follow-up , @ of @ patients in the dexamethasone group ( @ % ) and @ of @ patients ( @ % ) in the placebo group had POCD ( relative risk , @ ; @ % CI , @ to @ ; P = @ ) .


Intraoperative high-dose dexamethasone did not reduce the risk of POCD after cardiac surgery .


As glycaemia and the incidence of microvascular diabetes complications follow a log-linear relationship , it becomes increasingly difficult to demonstrate a microvascular benefit of glucose-lowering when the HbA@c level is close to normal .


The Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial randomised @,@ people with diabetes , impaired glucose tolerance or impaired fasting glucose to receive standard glycaemic care or standard care with the addition of basal insulin glargine ( A@Gly , B@Arg , B@Arg human insulin ) , targeting a fasting plasma glucose level @ mmol/l .


Microvascular outcomes during a median follow-up of @ years were examined in participants whose baseline HbA@c was above or below the median of @ % ( @ mmol/mol ) .


Allocation to the insulin glargine group reduced the incidence of the primary microvascular composite outcome of kidney and eye disease in participants whose baseline HbA@c level was @ % ( @ mmol/mol ; HR @ -LSB- @ % CI @ , @ -RSB- ) but not in participants with a lower baseline HbA@c ( HR @ -LSB- @ % CI @ , @ -RSB- ; p value for interaction @ ) .


In people whose baseline HbA@c level was @ % ( @ mmol/mol ) , the median post-randomisation change in HbA@c was -@ % ( interquartile range -@ , -@ % ) after allocation to insulin glargine and -@ % ( -@ , @ % ) after allocation to standard care ( median HbA@c difference @ % ; p < @ ) .


A smaller median difference of @ % was noted in people whose baseline HbA@c was < @ % ( p < @ ) .


In patients with dysglycaemia , intervention targeting normal fasting glucose levels reduced HbA@c and attenuated the risk of microvascular outcomes in participants with a baseline HbA@c level @ % ( @ mmol/mol ) .


A neutral effect was seen in those with a lower baseline HbA@c level .


Effective reduction of albuminuria and blood pressure in patients with type @ diabetes who have nephropathy is seldom achieved with available treatments .


We tested the effects of treatment of such patients with daglutril , a combined endothelin-converting enzyme and neutral endopeptidase inhibitor .


We did this randomised , crossover trial in two hospitals in Italy .


Eligibility criteria were : age @ years or older , urinary albumin excretion @-@ g/min , systolic blood pressure ( BP ) less than @ mm Hg , and diastolic BP less than @ mm Hg .


Patients were randomly assigned ( @:@ ) with a computer-generated randomised sequence to receive either daglutril ( @ mg/day ) then placebo for @ weeks each or vice versa , with a @-week washout period .


Patients also took losartan throughout .


Participants and investigators were masked to treatment allocation .


The primary endpoint was @-h urinary albumin excretion in the intention-to-treat population .


Secondary endpoints were median office and ambulatory ( @ h , daytime , and night-time ) BP , renal haemodynamics and sieving function , and metabolic and laboratory test results .


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


We screened @ patients , of whom @ were enrolled ( @ assigned to daglutril then placebo , @ to placebo then daglutril ; enrolment from May , @ , to December , @ ) and @ ( @ vs @ ) were included in the primary analysis .


Daglutril did not significantly affect @-h urinary albumin excretion compared with placebo ( difference in change -@ g/min , IQR -@ to @ ; p = @ ) .


@ patients had complete @-h BP readings ; compared with placebo , daglutril significantly reduced @-h systolic ( difference -@ mm Hg , SD @ ; p = @ ) , diastolic ( -@ , @ ; p = @ ) , pulse ( -@ , @ ; p = @ ) , and mean ( -@ , @ ; p = @ ) BP , as well as all night-time BP readings and daytime systolic , pulse , and mean BP , but not diastolic BP .


Compared with placebo , daglutril also significantly reduced office systolic BP ( -@ , @ ; p = @ ) , but not diastolic ( -@ , @ ; p = @ ) , pulse ( -@ , @ ; p = @ ) , or mean ( -@ , @ ; p = @ ) BP , and increased big endothelin serum concentration .


Other secondary outcomes did not differ significantly between treatment periods .


Three patients taking placebo and six patients taking daglutril had mild treatment-related adverse events -- the most common was facial or peripheral oedema ( in four patients taking daglutril ) .


Daglutril improved control of BP in hypertensive patients with type @ diabetes and nephropathy and had an acceptable safety profile .


Combined endothelin-converting enzyme and neutral endopeptidase inhibition could provide a new approach to hypertension in this high-risk population .


To compare the effects of body weight-supported treadmill training and overground walking training when matched for task and dose ( duration/frequency/intensity ) on improving walking function , activity , and participation after stroke .


Single-blind , pilot randomized controlled trial with three-month follow-up .


University and community settings .


A convenience sample of participants ( N = @ ) at least six months post-stroke and able to walk independently were recruited .


Thirty-minute walking interventions ( body weight-supported treadmill training or overground walking training ) were administered five times a week for two weeks .


Intensity was monitored with the Borg Rating of Perceived Exertion Scale at five-minute increments to maintain a moderate training intensity .


Walking speed ( comfortable/fast @-meter walk ) , walking endurance ( @-minute walk ) , spatiotemporal symmetry , and the ICF Measure of Participation and ACTivity were assessed before , immediately after , and three months following the intervention .


The overground walking training group demonstrated significantly greater improvements in comfortable walking speed compared with the body weight-supported treadmill training group immediately ( change of @ m/s vs. @ m/s , respectively ; p = @ ) and three months ( change of @ m/s vs. @ m/s , respectively ; p = @ ) after training .


Only the overground walking training group significantly improved comfortable walking speed ( p = @ ) , aspects of gait symmetry ( p = @ ) , and activity ( p = @ ) immediately after training .


Gains were maintained at the three-month follow-up ( p < @ ) for all measures except activity .


Improvements in participation were not demonstrated .


Overgound walking training was more beneficial than body weight-supported treadmill training at improving self-selected walking speed for the participants in this study .


To assess the influence of simulated oral erosive/abrasive challenges on the bond strength of an etch-and-rinse two-step bonding system to enamel using an in situ/ex vivo protocol .


Bovine enamel blocks were prepared and randomly assigned to four groups : CONT - control ( no challenge ) , ABR - @x/day -@ minute toothbrushing ; ERO - @x/day - @ minutes extraoral immersion into regular Coca Cola ; and ERO+ABR - erosive protocol followed by a @-minute toothbrushing .


Eight blocks were placed into an acrylic palatal appliance for each volunteer ( n = @ ) , who wore the appliance for @ days .


Two blocks were subjected to each of the four challenges .


Subsequently , all the blocks were washed with tap water and Adper Single Bond @/Filtek Z@ were placed .


After @ hours , @ mm@ beams were obtained from each block to be tested with the microtensile bond strength test ( @ N load at @ mm/minute ) .


The data were statistically analyzed by one-way RM-ANOVA and Tukey 's tests ( alpha = @ ) .


No difference was detected among the ABR , ERO , and CONT groups ( P > @ ) .


ERO+ABR group yielded lower bond strengths than either the ABR and ERO groups ( P < @ ) .


To investigate the effect of enhanced nutritional therapy on wound healing after endoscopic therapy in patients with liver cirrhosis and esophageal varices .


Fifty patients with liver cirrhosis and esophageal varices were randomly divided into an enhanced nutritional therapy group ( n = @ ) and a control group ( n = @ ) .


The enhanced nutritional therapy group received one week of enhanced nutritional supplementation , including liver nutritional elements , prior to routine endoscopic therapy .


The routine without any change to their diet .


The rate of transformation and status of wound healing of esophageal varices were compared between the two groups .


The ratio of ulcers occurring at the injection site was lower in the enhanced nutrition group than in the control group ( @/@ vs. @/@ ; x@ = @ , P = @ ) .


The enhanced nutrition group had only one case of minimal bleeding occurring during endoscopy as compared to the seven cases of bleeding in the control group ( x@ = @ , P = @ ) .


On average , the enhanced nutrition group required less sessions of endoscopic treatment to achieve eradication of esophageal varices than the control group ( @ vs. @ ; t = @ , P = @ ) .


Pre-endoscopic enhanced nutritional therapy may benefit patients with liver cirrhosis and esophageal varices by promoting recovery of procedure-related local tissue injury and occlusion of varices .


Most adolescents relapse within @ days of discharge from residential substance use treatment .


We hypothesized that contingency management ( CM ) , assertive continuing care ( ACC ) , and their combination ( CM + ACC ) would each be more effective than usual continuing care ( UCC ) .


Following residential treatment , @ adolescents were randomized to @ continuing care conditions : UCC alone , CM , ACC , or CM + ACC .


UCC was available across all conditions .


Outcome measures over @ months included percentage of days abstinent from alcohol , heavy alcohol , marijuana , and any alcohol or other drugs ( AOD ) using self-reports and toxicology testing and remission status at @ months .


CM had significantly higher rates of abstinence than UCC for heavy alcohol use , t ( @ ) = @ , p < @ , d = @ ; any alcohol use , t ( @ ) = @ , p < @ , d = @ ; or any AOD use , t ( @ ) = @ , p = @ , d = @ ; and had a higher rate in remission , odds ratio ( OR ) = @ , @ % confidence interval ( CI ) -LSB- @ , @ -RSB- , p = @ .


ACC had significantly higher rates of abstinence than UCC from heavy alcohol use , t ( @ ) = @ , p < @ , d = @ ; any alcohol use , t ( @ ) = @ , p < @ , d = @ ; any marijuana use , t ( @ ) = @ , p = @ , d = @ ; or any AOD use , t ( @ ) = @ , p = @ , d = @ ; and had higher rates in remission , OR = @ , @ % CI -LSB- @ , @ -RSB- , p = @ .


The ACC + CM condition was not significantly different from UCC on any outcomes .


CM and ACC are promising continuing care approaches after residential treatment .


Future research should seek to further improve their effectiveness .


A randomized controlled trial ( RCT ) and an extension trial of qigong ( Chaoyi Fanhuan qigong -LSB- CFQ -RSB- ) in patients with fibromyalgia were recently completed .


In the present study , a qualitative analysis of comments from the RCT was undertaken using motivation and amount of practice to determine whether initial experiences provided information relevant to outcomes .


Participants in the RCT received instruction in qigong ( level @ CFQ ) , practiced @min/day for @ weeks and continued practice to @ months ; open-ended qualitative comments on experiences were invited at @ weeks and @ and @ months .


Extension trial participants received further instruction ( level @ CFQ ) and practiced regularly for @ weeks-@ months .


Comments from the original RCT were considered as narratives for the extension trial subgroup ( n = @ ) and thematically , according to amount of practice , for all participants who completed the RCT ( n = @ ) .


Narrative comments from the RCT for those who completed the extension trial ( n = @ ) and those who withdrew from that trial ( n = @ ) were considered separately .


Participants reporting benefits within the first @ weeks were more likely to maintain practice and report continued benefits at @-@ months than those who withdrew from the trial .


Thematic comments for all who completed the RCT ( n = @ ) were considered in relation to amount of practice ( per protocol , intermediate , minimal ) .


Participants who practiced per protocol during the initial @ weeks ( @ hours/wk ) were more likely to maintain practice over @-@ months and to report beneficial health effects from qigong .


This retrospective qualitative analysis of information collected in an RCT of qigong for fibromyalgia indicates that favorable initial experiences with the practice over @ weeks predispose to continued practice and more health effects .


Future individual trials and meta-analyses of qigong will need to attend to the amount , and potentially quality , of practice undertaken in considering trial outcomes .


The aim of the present study was to evaluate the efficacy and tolerability of vandetanib plus gemcitabine ( V/G ) compared with gemcitabine alone in elderly patients with untreated advanced non-small-cell lung cancer .


This was a phase II , randomized , double-blind study .


A total of @ elderly patients ( mean age , @ yr ; age range , @-@ yr ; @ % men ) received V/G ( n = @ ) or placebo plus gemcitabine ( n = @ ) .


Progression-free survival ( PFS ) was the primary endpoint .


Secondary endpoints were overall survival , objective response rate , duration of response , disease control rate , time to deterioration of performance status , and safety outcomes .


PFS was significantly prolonged with V/G ( median , @ days ; @ % confidence interval , @-@ ) compared with placebo plus gemcitabine ( median , @ days ; @ % confidence interval , @-@ ; p = @ ) .


No statistically significant differences between arms were observed in all secondary endpoints , including overall survival .


The addition of vandetanib to gemcitabine was well tolerated .


The rate of patients with @ treatment-related adverse event was comparable in the two arms , pyrexia , dyspnea , and neutropenia being the most common adverse events .


V/G combination was associated with a statistically significant prolongation of PFS compared with gemcitabine alone in untreated elderly patients with advanced non-small-cell lung cancer , with an acceptable safety profile .


Research has shown that obese individuals have cognitive deficiencies in executive function , leading to poor planning and impulse control , and decision-making difficulties .


An intervention that could help reduce these deficits and in turn help weight loss maintenance is Cognitive Remediation Therapy for Obesity ( CRT-O ) .


We aim to examine the efficacy of manualised CRT-O , which is intended to improve executive function , enhance reflective practice and help weight loss maintenance .


A randomised controlled trial ( registered with the Australian New Zealand Clinical Trials Registry ) will be conducted .


First , @ obese adults ( body mass index > @ kg/m@ ) in the community will receive three weekly sessions of a group Behaviour Weight Loss Treatment ( BWLT ) , and then will be randomised either to receive CRT-O or to enter a no-treatment control group .


CRT-O training will comprise twice-weekly sessions of @ minutes over a @ to @ week period , for a total of eight sessions .


Measurement points will be at baseline , post CRT-O ( or @ to @ weeks after BWLT for the no-treatment control ) , @ months post treatment and @ year post treatment .


The primary outcome will be executive function and secondary outcome measures will include participants ' body mass index , hip to waist ratio , eating behaviours and quality of life .


This is the first study of its kind to examine the efficacy of Cognitive Remediation Therapy for obese adults through a randomised controlled trial .


The systematic pro-inflammatory responses after percutaneous coronary intervention with drug-eluting stents ( DES ) remain poorly defined .


Therefore , we compared the systematic pro-inflammatory state of circulating mononuclear cells ( MNCs ) between DES and bare metal stent ( BMS ) implantation .


Patients with indications for treatment with stents were randomized in a @:@ ratio to placement of DES or BMS .


The primary endpoint was a change of pro-inflammatory state at @ weeks post-procedure .


Thirty-six consecutive patients received DES or BMS .


At @ weeks after stent implantation , the lipid profile and high-sensitivity C-reactive protein ( hs-CRP ) improved significantly in both groups .


The mRNA levels and plasma concentrations of interleukin-@ , tumor necrosis factor - and matrix metalloproteinase-@ were significantly elevated in the DES group , which was not observed in the BMS group .


An increase in NF-B binding activity and a decrease in PPAR - expression in MNCs were observed in the DES group , along with increases in IB phosphorylation and p@ expression .


However , similar changes were not observed in the BMS group .


Systematic inflammatory responses were accentuated after the patients were treated percutaneously with DES , despite their improved lipid profile and hs-CRP .


These data may provide fundamental information for optimizing therapeutic strategy in the era of DES .


The aim of this randomized clinical trial ( RCT ) was to compare the clinical performance of the tunnel technique with subepithelial connective tissue graft ( TUN ) versus a coronally advanced flap with enamel matrix derivative ( CAF ) in the treatment of gingival recession defects .


The use of innovative @D digital measuring methods allowed to study healing dynamics at connective tissue ( CT ) - grafted sites and to evaluate the influence of the thickness of the root covering soft tissues on the outcome of surgical root coverage .


Twenty-four patients contributed a total of @ Miller class I or II recessions for scientific evaluation .


Precise study models collected at baseline and follow-up examinations were optically scanned and virtually superimposed for digital evaluation of clinical outcome measures including mean marginal soft tissue thickness ( THK ) .


Healing dynamics were measured in a defined region of interest at CT-grafted sites where volume differences between time points were calculated .


At @months , recession reduction as well as mean root coverage were significantly better at CT-grafted sites treated in the TUN group ( @ mm and @ % respectively ) compared to the non-augmented sites of the CAF group ( @ mm and @ % respectively ) and statistical analysis revealed a positive correlation of THK ( @ mm TUN versus @ mm CAF , p < @ ) to both these variables .


Soft tissue healing following surgical root coverage with CT-grafting was mainly accomplished after @months , with around two-thirds of the augmented volume being maintained after @months .


The TUN resulted in thicker gingiva and better clinical outcomes compared to CAF .


Increased gingival thickness was associated with better surgical outcomes in terms of recession reduction and root coverage .


Pazopanib is an oral , multikinase inhibitor of vascular endothelial growth factor receptor ( VEGFR ) -@ / -@ / -@ , platelet-derived growth factor receptor ( PDGFR ) - / - , and c-Kit .


Preclinical and clinical studies support VEGFR and PDGFR as targets for advanced ovarian cancer treatment .


This study evaluated the role of pazopanib maintenance therapy in patients with ovarian cancer whose disease did not progress during first-line chemotherapy .


Nine hundred forty patients with histologically confirmed cancer of the ovary , fallopian tube , or peritoneum , International Federation Gynecology Obstetrics ( FIGO ) stages II-IV , no evidence of progression after primary therapy consisting of surgery and at least five cycles of platinum-taxane chemotherapy were randomized @:@ to receive pazopanib @ mg once per day or placebo for up to @ months .


The primary end point was progression-free survival by RECIST @ assessed by the investigators .


Maintenance pazopanib prolonged progression-free survival compared with placebo ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; P = @ ; median , @ v @ months , respectively ) .


Interim survival analysis based on events in @ % of the population did not show any significant difference .


Grade @ or @ adverse events of hypertension ( @ % ) , neutropenia ( @ % ) , liver-related toxicity ( @ % ) , diarrhea ( @ % ) , fatigue ( @ % ) , thrombocytopenia ( @ % ) , and palmar-plantar erythrodysesthesia ( @ % ) were significantly higher in the pazopanib arm .


Treatment discontinuation related to adverse events was higher among patients treated with pazopanib ( @ % ) compared with placebo ( @ % ) .


Pazopanib maintenance therapy provided a median improvement of @ months ( HR , @ ) in progression-free survival in patients with advanced ovarian cancer who have not progressed after first-line chemotherapy .


Overall survival data to this point did not suggest any benefit .


Additional analysis should help to identify subgroups of patients in whom improved efficacy may balance toxicity ( NCT@ ) .


Large prospective studies in patients with type @ diabetes mellitus have demonstrated that metformin treatment improves cardiovascular prognosis , independent of glycemic control .


Administration of metformin potently limits infarct size in murine models of myocardial infarction .


This study examined , for the first time in humans , whether metformin limits ischemia-reperfusion ( IR ) injury in vivo using a well-validated forearm model of endothelial IR-injury .


Twenty-eight healthy volunteers ( age @ years , @ male/@ female ) were randomized between pretreatment with metformin ( @ mg three times a day for @ days ) or no treatment in a Prospective Randomized Open Blinded Endpoint study .


Brachial artery flow mediated dilation ( FMD ) was measured before and after @ minutes of forearm ischemia and @ minutes of reperfusion .


FMD analysis was performed offline by investigators blinded for the treatment arm .


Baseline FMD did not differ between metformin pretreatment and no pretreatment ( @ % and @ % , respectively , p = @ , n = @ ) .


FMD was significantly lower after forearm IR in both treatment arms ( @ % and @ % , respectively , P < @ in both conditions ) .


A linear mixed model analysis revealed that metformin treatment did not prevent the decrease in FMD by IR .


A @ day treatment with metformin in healthy , middle-aged subjects does not protect against endothelial IR-injury , measured with brachial artery FMD after forearm ischemia .


Further studies are needed to clarify what mechanism underlies the cardiovascular benefit of metformin treatment .


Dietary fibers are associated with enhanced satiety .


However , the mechanism of different dietary fibers contributing to satiety-related gastrointestinal ( GI ) peptide release , especially in an obese population , is still poorly understood .


Polydextrose ( PDX ) , a water-soluble glucose polymer , has demonstrated its ability to reduce energy intake at a subsequent meal , but its mechanism of action requires further research .


Also , there is limited evidence on its capacity to regulate subjective feelings of appetite .


This study examines the effects of PDX on postprandial secretion of satiety-related GI peptides , short chain fatty acids ( SCFAs ) , lactic acid , and subjective appetite ratings in obese participants .


@ non-diabetic , obese participants ( @ y , @ kg/m@ ) consumed a high-fat meal ( @ kJ , @ % from fat ) with or without PDX ( @ g ) in an acute , multicenter , randomized , double-blind , placebo-controlled and crossover trial .


Postprandial plasma concentrations of satiety-related peptides , namely ghrelin , cholecystokinin ( CCK ) , glucagon-like peptide @ ( GLP-@ ) , and peptide YY ( PYY ) , as well as SCFAs and lactic acid were assessed .


GI peptide , SCFA and lactate concentrations were then modeled using a linear mixed-effects model.The subjective feelings of hunger , satisfaction , and desire to eat were evaluated using visual analogue scales ( VAS ) , which were analyzed as incremental areas under the curve ( iAUC ) during the satiation and satiety periods .


We found that PDX supplementation increased plasma GLP-@ levels more than the placebo treatment ( P = @ ) .


In the whole group , GLP-@ concentrations found in participants older than @ years old were significantly lower ( P = @ ) as compared to those aged @ years or less .


There were no statistically significant differences in postprandial ghrelin , CCK , or PYY responses .


The lactic acid concentrations were significantly ( P = @ ) decreased in the PDX group , while no significant changes in SCFAs were found .


PDX reduced iAUC for hunger by @ % ( P = @ ) and marginally increased satisfaction by @ % ( P = @ ) during the post-meal satiety period .


Polydextrose increased the postprandial secretion of the satiety hormone GLP-@ and reduced hunger after a high-fat meal .


PDX also reduced the elevated postprandial lactic acid levels in plasma .


Therefore , PDX may offer an additional means to regulate inter-meal satiety and improve postprandial metabolism in obese participants .


To evaluate the effect of sustained American College of Rheumatology ( ACR ) / European League Against Rheumatism ( EULAR ) Boolean remission on residual joint inflammation assessed by magnetic resonance imaging ( MRI ) and to secondarily evaluate other clinical definitions of remission , within an early seropositive rheumatoid arthritis ( RA ) cohort .


A subcohort of @ RA patients was enrolled from patients who completed the @-year , double-blind randomized Treatment of Early Aggressive Rheumatoid Arthritis ( TEAR ) trial .


Patients received a single contrast-enhanced @ T MRI of their most involved wrist .


Two readers scored MRIs for synovitis , osteitis , tenosynovitis , and erosions .


Clinical assessments were performed every @ months during the trial and at time of MRI .


The subcohort was @ % seropositive with mean age @ years , duration @ months , and Disease Activity Score in @ joints using the erythrocyte sedimentation rate @ at TEAR entry .


Total MRI inflammatory scores ( tenosynovitis + synovitis + osteitis ) were lower among patients in clinical remission .


Lower MRI scores were correlated with longer duration of Clinical Disease Activity Index ( CDAI ) remission ( = @ , P = @ ) .


At the time of MRI , @ patients had no wrist pain/tenderness/swelling ; however , all @ patients had MRI evidence of residual joint inflammation after @ years .


No statistically significant differences in damage or MRI inflammatory scores were observed across treatment groups .


This is the first detailed appraisal describing the relationship between clinical remission cut points and MRI inflammatory scores within an RA randomized controlled trial .


The most stringent remission criteria ( @ ACR/EULAR and CDAI ) best differentiate the total MRI inflammatory scores .


These results document that @ years of triple therapy or tumor necrosis factor plus methotrexate treatment in early RA does not eliminate MRI evidence of joint inflammation .


To assess the efficacy , safety and tolerability of sodium valproate ( @mg/die ) compared with placebo in medication-overuse headache patients with a history of migraine without aura .


This is a multicenter , randomized , double-blind , placebo-controlled study enrolled medication-overuse headache patients for a @-month treatment period with sodium valproate ( @mg/day ) or placebo after a @ day outpatient detoxification regimen , followed by a @-month follow-up .


Primary outcome was defined by the proportion of patients achieving @ % reduction in the number of days with headache per month ( responders ) from the baseline to the last @ weeks of the @-month treatment .


Multivariate logistic regression models were used on the primary endpoint , adjusting for age , sex , disease duration , comorbidity and surgery .


The last-observation-carried-forward method was used to adjust for missing values .


Nine sites enrolled @ patients and , after a @-day detoxification phase , randomized @ eligible patients .


The @-month responder rate was higher in the sodium valproate ( @ % ) than in the placebo arm ( @ % ) with an absolute difference of about @ % ( p = @ ) .


Sodium valproate had safety and tolerability profiles comparable to placebo .


The present study supports the efficacy and safety of sodium valproate in the treatment of medication overuse headache with history of migraine after detoxification .


Internet-based guided self-help has been successfully used in the general population , but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias .


The aim was to assess the clinical effectiveness of Phobias Under Control , an Internet-based intervention based on exposure therapy with weekly guidance .


We conducted a randomized controlled trial , recruiting @ outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic .


Participants suffering from at least @ DSM-IV or ICD-@ classified phobia ( social phobia , agoraphobia with or without panic disorder , and/or specific phobia as ascertained by a telephone interview at baseline ) were randomly allocated to either a @-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy ( n = @ ) or a wait-list control group followed by face-to-face psychotherapy ( n = @ ) .


Primary outcome was the Fear Questionnaire ( FQ ) .


Secondary outcomes were the Beck Anxiety Inventory ( BAI ) and Center of Epidemiological Studies-Depression scale ( CES-D ) .


Assessments took place by telephone at baseline ( T@ ) and on the Internet at posttest ( T@ , self-assessment at @ weeks after baseline ) .


Missing data at T@ were imputed .


At posttest , analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ ( d = @ , P = @ ) , CES-D ( d = @ , P = @ ) , and a nonsignificant effect size on the BAI ( d = @ .


P = @ ) .


Although initial acceptance was good , high nonresponse was observed , with @ of @ participants ( @ % ) lost to follow-up at T@ and only @ of @ ( @ % ) intervention participants finishing all @ weeks .


Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice .


Non-invasive characterization of a tumor 's molecular features could enhance treatment management .


Quantitative computed tomography ( CT ) based texture analysis ( QTA ) has been used to derive tumor heterogeneity information , and the appearance of the tumors has been shown to relate to patient outcome in non-small cell lung cancer ( NSCLC ) and other cancers .


In this study , we examined the potential of tumoral QTA to differentiate K-ras mutant from pan-wildtype tumors and its prognostic potential using baseline pre-treatment non-contrast CT imaging in NSCLC .


Tumor DNA from patients with early-stage NSCLC was analyzed on the LungCarta Panel .


Cases with a K-ras mutation or pan-wildtype for @ oncogenes and tumor suppressor genes were selected for QTA .


QTA was applied to regions of interest in the primary tumor .


Non-parametric Mann Whitney test assessed the ability of the QTA , clinical and patient characteristics to differentiate between K-ras mutation from pan-wildtype .


A recursive decision tree was developed to determine whether the differentiation of K-ras mutant from pan-wildtype tumors could be improved by sequential application of QTA parameters .


Kaplan-Meier survival analysis assessed the ability of these markers to predict survival .


QTA was applied to @ cases identified , @ had a K-ras mutation and @ cases were pan-wildtype .


Positive skewness and lower kurtosis were significantly associated with the presence of a K-ras mutation .


A five node decision tree had sensitivity , specificity , and accuracy values ( @ % CI ) of @ % ( @-@ ) , @ % ( @-@ @ ) , and @ % ( @-@ @ ) ; respectively .


Kurtosis was a significant predictor of OS and DFS , with a lower kurtosis value linked with poorer survival .


Lower kurtosis and positive skewness are significantly associated with K-ras mutations .


A QTA feature such as kurtosis is prognostic for OS and DFS .


Non-invasive QTA can differentiate the presence of K-ras mutation from pan-wildtype NSCLC and is associated with patient survival .


Edentulism and sleep disturbance are chronic conditions that are common in older people and have serious adverse consequences for their functioning and quality of life .


Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue .


However , the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood .


The objectives of this study are to test whether nocturnal denture wear affects sleep quality , daytime sleepiness , and the oral health related quality of life of edentate older people with moderate to severe sleep apnea , and to identify modifiers of effect of nocturnal denture wear .


We will carry out a single-blind randomized cross-over trial .


Seventy edentate older people with moderate to severe obstructive sleep apnea will be enrolled .


The study participants will be assigned to wear and not wear their dentures on alternate periods of @ days .


The outcome measures will be sleep quality ( assessed by portable polysomnography ) , daytime sleepiness ( assessed by the Epworth Sleepiness Scale ) , and oral health related quality of life ( assessed by validated questionnaire ) .


A number of characteristics ( sociodemographic , oropharyngeal morphology , oral and prosthesis characteristics , and perceived general health quality of life ) will be assessed by means of clinical examination , @D imaging of the craniofacial structure , and validated questionnaires at baseline .


Linear mixed effects regression models for repeated measures will be fitted to test the study hypotheses .


The main analyses will be based on the intention-to-treat principle .


To assess the robustness of the findings to potential incomplete adherence , sensitivity analyses will be conducted while applying the per-protocol principle .


This practice-relevant evidence could represent a preventive approach to improve sleep characteristics of the older population and improve their well-being and quality of life .


To study the efficacy and safety of certolizumab pegol ( CZP ) in patients with active rheumatoid arthritis ( RA ) who had discontinued an initially effective TNF inhibitor ( TNF-IR ) .


A randomised @-week double-blind trial with CZP ( n = @ ) or placebo ( n = @ ) followed by an open-label @ week extension period with CZP .


Baseline characteristics of the @ groups were similar .


ACR@ response ( primary end point ) at week @ was achieved in @ % , and none of CZP and placebo-treated patients , respectively .


Weeks @-@ showed a maximum effect for CZP at @ weeks , and that placebo patients switched blindly to CZP attained similar results seen with CZP in weeks @-@ .


Since this result was highly significant , study inclusion was terminated after entry of @ % of the originally planned @ patients .


Adverse events occurred in @/@ ( @ % ) CZP subjects and @/@ ( @ % ) placebo subjects .


There were no serious adverse events , neoplasms , opportunistic , or serious infections .


This first , prospective , blinded trial of CZP in secondary TNF-IR shows that the ACR@ response rate observed with CZP was higher than that reported in most previous studies of TNF-IR .


Additionally , CZP demonstrated good safety and tolerability .


This study supports the use of CZP in RA patients who are secondary non-responders to anti-TNF therapies .


To compare two thoracotomy closure techniques ( pericostal and transcostal suture ) in terms of postoperative pain and pulmonary function .


This was a prospective , randomized , double-blind study carried out in the Department of Thoracic Surgery of the Luzia de Pinho Melo Hospital das Clnicas and at the University of Mogi das Cruzes , both located in the city of Mogi das Cruzes , Brazil .


We included @ patients ( @-@ years of age ) undergoing posterolateral or anterolateral thoracotomy .


The patients were randomized into two groups by the type of thoracotomy closure : pericostal suture ( PS ; n = @ ) and transcostal suture ( TS ; n = @ ) .


Pain intensity during the immediate and late postoperative periods was assessed by a visual analogic scale and the McGill Pain Questionnaire .


Spirometry variables ( FEV@ , FVC , FEV@/FVC ratio , and PEF ) were determined in the preoperative period and on postoperative days @ and @ .


Pain intensity was significantly greater in the PS group than in the TS group .


Between the preoperative and postoperative periods , there were decreases in the spirometry variables studied .


Those decreases were significant in the PS group but not in the TS group .


The patients in the TS group experienced less immediate and late post-thoracotomy pain than did those in the PS group , as well as showing smaller reductions in the spirometry parameters .


Therefore , transcostal suture is recommended over pericostal suture as the thoracotomy closure technique of choice .


Botulinum toxin type A has been widely used to correct unwanted hyperfunctional facial lines .


Most forms of botulinum toxin type A currently used require reconstitution , which is very inconvenient for users .


The authors compared the efficacy and safety of a newly developed liquid-type botulinum toxin type A ( MT@L ) and onabotulinumtoxinA ( Botox ) for moderate to severe glabellar lines .


A double-blind , randomized , active drug-controlled , phase III study with @ enrolled subjects was performed .


The primary efficacy endpoint was the improvement rate at maximum frown at week @ by the investigators ' live assessment .


The secondary efficacy endpoint included the improvement rate at maximum frown at week @ and at rest at weeks @ and @ by live assessment , and the improvement rate at maximum frown and at rest based on photographic assessment at week @ .


Self-assessment and self-satisfaction with glabellar line improvement were also evaluated .


The improvement rate at maximum frown by live assessment was not significantly different between the MT@L and Botox groups .


In addition , the improvement rate of glabellar lines at rest based on the investigators ' live assessment and photographic assessment was similar in both treatment groups .


However , the improvement rate at maximum frown by live assessment at week @ was significantly higher in the MT@L group compared with the Botox group .


There were no severe adverse events .


The efficacy and safety of MT@L were comparable to those of Botox for the management of glabellar frown lines .


MT@L provides greater convenience because it does not require dilution and has long-lasting effects .


Therapeutic , II .


This prospective , randomized , multicenter trial evaluated the @-month success rate of sacral neuromodulation ( SNM ) with InterStim Therapy versus standard medical therapy ( SMT ) for overactive bladder ( OAB ) .


Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized @:@ to SNM or SMT .


Subjects had bothersome symptoms of overactive bladder ( OAB ) including urinary urge incontinence ( @ leaks/@hr ) and/or urgency-frequency ( @voids/day ) .


Subjects failed at least one anticholinergic medication , and had at least one medication not yet attempted .


The primary objective was to compare OAB therapeutic success rate at @ months between SNM and SMT .


Overall , @ subjects were randomized ( @ to SNM and @ to SMT ) ; @ % were female and mean age was @ .


The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group ( @ % ) than the SMT group ( @ % ; P = @ ) .


In the as treated analysis , OAB therapeutic success was @ % for SNM and @ % for SMT ( P = @ ) .


The SNM group showed significant improvements in quality of life versus the SMT group ( all P < @ ) and @ % of SNM subjects reported improved or greatly improved urinary symptom interference score at @ months , compared to @ % for SMT subjects .


The device-related adverse event rate was @ % and the medication-related adverse event rate was @ % .


This study demonstrates superior objective and subjective success of SNM compared to SMT .


SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms .


Neurourol .


Urodynam .


@:@ -@ , @ Wiley Periodicals , Inc. .


Isolation of the pulmonary veins ( PVs ) for the treatment of atrial fibrillation ( AF ) is often supplemented with linear lesions within the left atrium ( LA ) .


However , there are conflicting data on the effects of creating a roof line ( RL ) joining the superior PVs in paroxysmal atrial fibrillation ( PAF ) .


A cohort of @ patients with drug-refractory PAF referred for ablation were prospectively randomized into @ strategies : ( @ ) PV isolation in combination with RL ablation ( LA roof ablation -LSB- LARA -RSB- -@ : @ patients ) or ( @ ) PV isolation ( LARA-@ : @ patients ) .


Follow-up was performed at @ , @ , and @ months after the procedure and every @ months thereafter .


After a @-month blanking period , recurrence was defined as the ocurrence of any atrial tachyarrhythmia lasting @ seconds .


PV isolation was achieved in @ % and complete RL block in @ % .


RF duration , fluoroscopy , and procedural times were slightly , but not significantly , longer in the LARA-@ group .


After @ months , there was no difference in the arrhythmia-free survival after a single AF ablation procedure ( LARA-@ : @ % vs. LARA-@ : @ % at @ months ; log rank P = @ ) .


The achievement of complete RL block did not influence the results .


The incidence of LA macroreentrant tachycardias was @ % in the LARA-@ group ( n = @ ) versus @ % in the LARA-@ ( n = @ ) ( P = ns ) .


Univariate analysis only identified AF duration as a covariate associated with arrhythmia recurrence ( hazard ratio , @ -LSB- @ % confidence interval , @ to @ -RSB- ; P < @ ) .


The linear block at the LA roof is not associated with an improved clinical outcome compared with PV isolation alone .


It is estimated that @ in @ children in the United States is affected by chronic pain .


Increasing adaptive coping strategies and decreasing stress may be important in treatment .


Research has suggested that mindfulness can help alleviate symptoms associated with medical illnesses and increase quality of life .


Little is known about the effectiveness of mindfulness-based stress reduction ( MBSR ) in youth , partly due to insufficient methodological rigor in related studies .


The primary purpose of the present study was to examine the feasibility , acceptability , and effectiveness of MBSR for a treatment-seeking sample of youth with chronic pain .


The current study was the first randomized , controlled pilot study of MBSR for pediatric chronic pain .


The research team had intended to use block randomization involving a total of five recruitment waves , with each wave consisting of one MBSR group and one psychoeducation group .


Due to difficulties with recruitment and attrition before the start of either group , however , only MBSR was conducted at each wave after the first wave .


Participants were recruited from a multidisciplinary pain clinic in a large , Midwestern children 's hospital .


The final sample included six adolescents between the ages of @ and @ y , four in the MBSR group and two in the psychoeducation group .


Weekly sessions for the MBSR group were @ min in length and followed a structured protocol .


Sessions included a review of homework , an introduction to and practice of meditation , discussion of the session , and a review of the home practice assignment .


The psychoeducation group participated in six group sessions , which were based on a cognitive-behavioral model of pain , and discussion topics included the nature of chronic pain and stress management .


Health-related quality of life , pain catastrophizing , anxiety , functional disability , mindfulness , and treatment acceptability were all assessed pre - and postintervention as well as at follow-up .


Recruitment and retention difficulties were experienced .


Qualitative examination of participants ' scores suggested increased mindfulness but inconsistent patterns on other outcome measures .


The research team highlighted critical challenges faced by potential researchers aiming to investigate MBSR for pediatric chronic pain , and the study provides recommendations for research and implications for clinical practice .


The use of opioid analgesics in prehospital trauma care has been reported to have negative side effects on the airway and circulation .


Several studies of urban trauma management have recommend ketamine as a safe and efficient analgesic .


To date , however , no controlled trials of prehospital opioid analgesics versus ketamine in rural trauma management have been published .


This study aimed to compare the analgesic effects and side effects of ketamine and morphine in a prehospital , low-resource setting .


The study was conducted with a prospective , cluster-randomized design .


The Quang Tri province of Vietnam was divided into two sectors that alternated monthly between ketamine and morphine treatments .


A total of @ trauma patients were treated outside hospital settings with ketamine , while @ patients were treated with morphine .


The treatment effects were measured by comparing the Visual Analogue Scale ( VAS ) ratings in the field to those upon on admission .


The analgesic effects were positive and similar for the two drugs .


The rate of vomiting was significantly lower in the ketamine group ( @ % ) than in the morphine group ( @ % , @ % CI for difference @-@ % ) .


The rate of hallucinations and agitation was higher in ketamine-treated patients ( @ % ) than in the morphine-treated patients ( @ % , @ % CI for difference @-@ % ) .


In this study , patients with head trauma ( n = @ ) showed no adverse effects on consciousness level after being treated with ketamine .


Ketamine had an analgesic effect similar to morphine and carried a lower risk of airway problems .


The risk of hallucinations and agitation was increased in the ketamine group .


These findings are of medical significance , particularly in rough and low-resource scenarios .


Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications , yet the benefits and risks of treatment beyond @ year are uncertain .


Patients were enrolled after they had undergone a coronary stent procedure in which a drug-eluting stent was placed .


After @ months of treatment with a thienopyridine drug ( clopidogrel or prasugrel ) and aspirin , patients were randomly assigned to continue receiving thienopyridine treatment or to receive placebo for another @ months ; all patients continued receiving aspirin .


The coprimary efficacy end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events ( a composite of death , myocardial infarction , or stroke ) during the period from @ to @ months .


The primary safety end point was moderate or severe bleeding .


A total of @ patients were randomly assigned to continue thienopyridine treatment or to receive placebo .


Continued treatment with thienopyridine , as compared with placebo , reduced the rates of stent thrombosis ( @ % vs. @ % ; hazard ratio , @ -LSB- @ % confidence interval -LCB- CI -RCB- , @ to @ -RSB- ; P < @ ) and major adverse cardiovascular and cerebrovascular events ( @ % vs. @ % ; hazard ratio , @ -LSB- @ % CI , @ to @ -RSB- ; P < @ ) .


The rate of myocardial infarction was lower with thienopyridine treatment than with placebo ( @ % vs. @ % ; hazard ratio , @ ; P < @ ) .


The rate of death from any cause was @ % in the group that continued thienopyridine therapy and @ % in the placebo group ( hazard ratio , @ -LSB- @ % CI , @ to @ -RSB- ; P = @ ) .


The rate of moderate or severe bleeding was increased with continued thienopyridine treatment ( @ % vs. @ % , P = @ ) .


An elevated risk of stent thrombosis and myocardial infarction was observed in both groups during the @ months after discontinuation of thienopyridine treatment .


Dual antiplatelet therapy beyond @ year after placement of a drug-eluting stent , as compared with aspirin therapy alone , significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but was associated with an increased risk of bleeding .


( Funded by a consortium of eight device and drug manufacturers and others ; DAPT ClinicalTrials.gov number , NCT@ . )


Ivabradine is a pure heart rate-lowering agent that acts by inhibiting I ( f ) , an important ionic current involved in pacemaker activity in the cells of the sinoatrial node .


In the @ European Society of Cardiology Guidelines on Heart Failure , it was recommended that patients with a persistently high heart rate , despite treatment with an evidence-based dose of a - blocker , should be considered for treatment with ivabradine .


The aim of this study was to explore the pharmacokinetic/pharmacodynamic properties and safety profile of ivabradine in healthy Chinese men .


This Phase I , randomized , open-label , parallel-arm , single - and multiple-dose study was conducted at the Clinical Pharmacology Center of the Cardiovascular Institute and Fu Wai Hospital at the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing , People 's Republic of China .


Healthy , nonsmoking volunteers were randomly assigned to @ of @ treatment groups based on treatment with @ , @ or @ mg of ivabradine .


After a single dose , the subjects assigned to the @ dose groups received repeated oral doses of ivabradine BID for @ days .


The plasma concentrations of ivabradine were determined by using a HPLC-MS/MS method .


Systolic and diastolic blood pressure and heart rate measurements were taken , and ECG and Holter monitoring was performed .


Tolerability was assessed throughout the study by physical and ophthalmologic examinations , vital signs measurement , laboratory analyses , and monitoring of adverse effects .


A total of @ healthy Chinese men were enrolled in the study .


After the single dose , plasma ivabradine Cmax and AUC increased approximately linearly with dosage , no statistically significant differences were found in t or Tmax between the dose groups .


After multiple doses , there was no significant change in Tmax compared with the results after a single dose .


After repeated doses , t , Cmax , and AUC increased significantly ( P < @ ) .


After a single dose , a significant reduction in heart rate at @ hours ' postdose was observed in the highest dose group , whereas after repeated doses , a significant reduction in heart rate was observed from @ to @ hours ' postdose for all @ groups .


The mean ( SD ) heart rate after repeated doses decreased @ ( @ ) , @ ( @ ) , and @ ( @ ) beats/min for the @ - , @ - , and @-mg dose groups , respectively .


No clear trend in the changes in QTc , systolic and diastolic blood pressures , or respiration rate was observed .


Ivabradine was well tolerated in these healthy Chinese men .


The results of the study in a small population of healthy Chinese men suggest that the PK properties of ivabradine are linear with respect to dosing .


After single and repeated oral administration of ivabradine , a significant decrease in heart rate was observed .


Ivabradine appeared well tolerated in the population studied .


Trial identifier : ACTRN@ .


This study sought to compare paclitaxel-eluting balloon ( PEB ) with conventional percutaneous transluminal angioplasty ( PTA ) , followed by systematic implantation of a self-expanding nitinol bare-metal stent ( BMS ) in patients at risk for restenosis .


PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis ( FPA ) .


Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions , it is unknown whether these results are applicable to complex degrees of FPA atheroma .


A total of @ patients ( @ FPA lesions in @ limbs ) were randomly assigned to either PEB + BMS or PTA + BMS .


The primary endpoint was @-month binary restenosis .


Secondary endpoints were freedom from target lesion revascularization and major amputation .


Post hoc subanalyses were performed for the comparison of long ( @ mm ) versus short lesions and true lumen versus subintimal approach .


Mean lesion length was @ @ versus @ @ mm in the PEB + BMS and PTA + BMS groups ( p = @ ) , respectively .


The primary endpoint occurred in @ ( @ % ) versus @ ( @ % ) of lesions in the PEB + BMS and PTA + BMS groups ( p = @ ) , respectively .


A near-significant ( p = @ ) @-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group .


No major amputation occurred .


No significant difference was observed according to lesion characteristics or technical approach .


Pre-dilation with PEB angioplasty prior to BMS implantation , as compared to PTA + BMS in complex FPA lesions , reduces restenosis and target lesion revascularization at @-month follow-up .


Restenosis reduction is maintained irrespective of lesion length and recanalization technique .


( DrugEluting Balloon in Peripheral Intervention for the Superficial Femoral Artery -LSB- DEBATE-SFA -RSB- ; NCT@ ) .


Organizational and wider health system factors influence the implementation and success of interventions .


Clinical Pathways in Acute Coronary Syndromes @ is a cluster randomized trial of a clinical pathway-based intervention to improve acute coronary syndrome care in hospitals in China .


We performed a qualitative evaluation to examine the system-level barriers to implementing clinical pathways in the dynamic healthcare environment of China .


A qualitative descriptive analysis of @ in-depth interviews with health professionals conducted in a sample of @ hospitals purposively selected to explore barriers to implementation of the intervention .


Qualitative data were analyzed using the Framework method .


In-depth interviews identified @ key system-level barriers to effective implementation : ( @ ) leadership support for implementing quality improvement , ( @ ) variation in the capacity of clinical services and quality improvement resources , ( @ ) fears of patient disputes and litigation , ( @ ) healthcare funding constraints and high out-of-pocket expenses , and ( @ ) patient-related factors .


System-level barriers affect the ability of acute coronary syndrome clinical pathways to change practice .


Addressing these barriers in the context of current and planned national health system reform will be critical for future improvements in the management of acute coronary syndromes , and potentially other hospitalized conditions , in China .


Clinical Trial Registration - URL : http://www.anzctr.org.au/default.aspx .


Register .


Unique identifier : ACTRN@ .


Fractional flow reserve ( FFR ) - guided percutaneous coronary intervention ( PCI ) improved outcomes compared with an angiography-guided strategy in patients with multivessel coronary artery disease ( CAD ) .


However , the effect of age on FFR has not been well-studied .


We aimed to evaluate the impact of age on the favorable results of routine FFR-guided PCI for multivessel CAD .


We compared @ year outcomes between FFR-guided PCI and angiography-guided PCI in the @ patients enrolled in the FAME study < @ years old compared to the @ patients @ years old .


We also evaluated the effect of age on the FFR result of varying degrees of visually estimated coronary stenosis .


The @-year rate of death , myocardial infarction or repeat revascularization in the angiography-guided group tended to be higher than in the FFR-guided group for both those patients < @ ( @ % vs. @ % , P = @ ) and those @ years old ( @ % vs. @ % , P = @ ) with no significant interaction based on age ( P = @ ) .


Older patients had higher FFR in vessels with @ % to @ % stenosis ( @ @ vs. @ @ , P = @ ) and in vessels with @ % to @ % stenosis ( @ @ vs. @ @ , P = @ ) .


The proportion of functionally significant lesions ( FFR @ ) in vessels with @ % to @ % stenosis was significantly lower in elderly compared to younger patients ( @ % vs. @ % , P = @ ) .


FFR-guided PCI is beneficial regardless of age , however , older patients have fewer functionally significant lesions , despite a similar angiographic appearance .


To evaluate the efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease ( HFMD ) .


A randomized , double-blind , placebo-controlled trial was performed .


A total of @ children with mild HFMD were randomly divided into an observed group ( n = @ ) and a control group ( n = @ ) .


In the observed group , ribavirin aerosol was given four times within the first hour , followed by once every other hour for the remaining time of the day and day @ ; from days @ to @ , it was given @ times per day , with @-@ sprays every time , for @ days .


In the control group , placebo was given in the same way as in the observed group .


Additionally , both groups used oral antiviral liquid .


The scores of clinical symptoms including oral ulcer , skin rash , nasal congestion , runny nose , sneezing , cough , and fever before and after treatment were recorded to evaluate treatment outcomes .


Throat swabs were taken before treatment and @-@ days after treatment to measure viral load by RT-PCR and to compare the negative conversion rate between the two groups .


Fifty-seven patients in the observed group and @ patients in the control group were tested according to the original research design .


After @-@ days of treatment , the observed group had a significantly higher overall negative conversion rate of enterovirus than the control group ( P < @ ) .


The overall marked response rate and overall response rate of the observed group were @ % and @ % , respectively , significantly higher than those of the control group ( @ % and @ % ) .


During treatment , there were no adverse reactions such as dizziness , vomiting , and notable decreases in hemoglobin , white blood cells , and platelets in the two groups .


Ribavirin aerosol can be effectively and safely used for treating mild HFMD .


With low dosage and few adverse reactions , it holds promise for clinical application .


Lowering blood pressure ( BP ) and reducing diurnal variation are important for the prevention of stroke in patients with hypertension .


This study was conducted to compare the BP-lowering and diurnal BP variation effects of amlodipine and losartan on acute stroke patients .


Seventy-seven hypertensive patients with acute stroke were enrolled in this randomized , double-blind , single-center clinical trial .


They were randomly assigned to receive either amlodipine or losartan daily .


To evaluate whether amlodipine was noninferior to losartan , ambulatory BP monitoring was performed before the drugs were first administered and at the end of week @ .


BP variables analyzed included the mean awake , sleep , morning , evening , and prewake BP values ; the nocturnal dipping status ; and the morning surge .


Thirty-nine patients in the amlodipine group and @ patients in the losartan group completed the follow-up .


In the baseline characteristics , mean age was @ years , and @ % were male .


In the intention-to-treat analysis , the mean ( SD ) systolic BP decreased @ ( @ ) mm Hg in the amlodipine group and @ ( @ ) mm Hg in the losartan group , and amlodipine proved noninferior to losartan ( mean difference , @ mm Hg -LSB- @ % CI , -@ to @ -RSB- ) .


However , in the per-protocol analysis , noninferiority was not proven ( BP reduction , @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- mm Hg ; mean difference , -@ mm Hg -LSB- @ % CI , -@ to @ -RSB- ) .


Amlodipine had a greater tendency than losartan to produce a blunt morning surge .


The noninferiority of amlodipine was not confirmed by the per-protocol analysis .


However , amlodipine showed a favorable effect on the morning surge .


ClinicalTrials.gov identifier : NCT@ .


The objective of this study was to evaluate short term and long term efficacy of a transurethral injection ( TUI ) using bulking agent Bulkamid for female stress ( SUI ) and mixed urinary incontinence by women with ISD or where anti-incontinence surgery has failed .


Retrospective clinical study .


Gynecological and Obstetric Dpt .


@st Medical Faculty UK and VFN , Prague .


A retrospective study was performed on @ women with urinary incontinence ( stress , @ ; mixed @ ) .


One patient died during study .


Forty patients had previously undergone anti-incontinence surgery .


The efficacy of TUI was evaluated @ months ( @ week ) and an average of @ months after surgery .


Subjective assessment of the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short form ( ICIQ-UI SF ) filled in before , three and - on average - @ months after the surgery ( minimum time after surgery was @ months ) .


Improvement in urinary incontinence was defined as a drop in the score of more than @ % .


Objective assessment of leakage of urine was assessed by cough test .


The cure effect was evaluated by VAS ( Visual Analogue Scale ) score and by using the five-point Likert score .


Ethical committee approval was obtained , and all subjects gave written informed consent to participate in the study .


Mean age of patients was @ years , mean body mass index ( BMI ) @ , and mean parity was @ .


The cough test showed that @/@ ( @ % ) of patients had negative results for this test @ months and @/@ ( @ % ) @ months after the operation .


The ICIQ-UI SF questionnaire showed that @/@ ( @ % ) of our patients were completely dry @ months after the operation and @/@ ( @ % ) @ months after the operation .


@/@ ( @ % ) of patients were dry or improved @ months after the operation and @/@ ( @ % ) @ months after the operation .


The mean cure effect evaluated by VAS score @ months after the operation was @ and @ months after the operation it was @ .


The Likert score was @ or @ ( cured or improved ) three and @ months after operation by @ % / @ % patients .


The cure effect of Bulkamid operation decreases in correlation with the time that elapses after the operation , although this procedure is minimally invasive and is an option in cases where anti-incontinence surgery has failed .


The purpose of this single blind , prospective , parallel randomized trial study was to compare the effects of face mask and fixed tongue appliance in treatment of Class III malocclusion with maxillary deficiency in growing patients .


@ patients with maxillary deficiency were selected .


@ fulfilled the study requirements .


The patients were randomly assigned to @ groups by computer generated tables .


One group was treated with removable face mask and the other group was treated by fixed tongue appliance .


@ of the patients dropped out of study leaving a final number of @ patients .


Thus , the face mask group included @ patients ( @ males , @ females ) with the mean age of @ ( SD @ ) years and the fixed tongue appliance group included @ patients ( @ males , @ females ) with the mean age of @ ( SD @ ) years .


The patients Lateral cephalograms obtained at the beginning and end of the study were analyzed .


Paired t-tests showed that SNA increased by @ ( SD @ ) in face mask group ( P < @ ) and it increased by @ ( SD @ ) in fixed tongue appliance group ( P < @ ) .


T-test showed that there were no statistically significant differences between the two groups except for SNB .


IMPA decreased significantly in both groups .


Both treatment modalities were successful in moving the maxilla forward and improving the profile of the patients ; however , the bulky size of face masks might reduce patients ' compliance and make them less favorite choice of treatment .


Although combination pharmacotherapy is common in child and adolescent psychiatry , there has been little research evaluating it .


The value of adding risperidone to concurrent psychostimulant and parent training ( PT ) in behavior management for children with severe aggression was tested .


One hundred sixty-eight children @ to @ years old ( mean age @ @ years ) with severe physical aggression were randomized to a @-week trial of PT , stimulant ( STIM ) , and placebo ( Basic treatment ; n = @ ) or PT , STIM , and risperidone ( Augmented treatment ; n = @ ) .


All had diagnoses of attention-deficit/hyperactivity disorder and oppositional-defiant disorder ( n = @ ) or conduct disorder ( n = @ ) .


Children received psychostimulant ( usually Osmotic Release Oral System methylphenidate ) for @ weeks , titrated for optimal effect , while parents received PT .


If there was room for improvement at the end of week @ , placebo or risperidone was added .


Assessments included parent ratings on the Nisonger Child Behavior Rating Form ( Disruptive-Total subscale was the primary outcome ) and Antisocial Behavior Scale ; blinded clinicians rated change on the Clinical Global Impressions scale .


Compared with Basic treatment ( PT + STIM -LSB- @ @ mg/day -RSB- + placebo -LSB- @ mg/day @ -RSB- ) , Augmented treatment ( PT + STIM -LSB- @ @ mg/day -RSB- + risperidone -LSB- @ mg/day @ -RSB- ) showed statistically significant improvement onthe Nisonger Child Behavior Rating Form Disruptive-Total subscale ( treatment-by-time interaction , p = @ ) , the Nisonger Child Behavior Rating Form Social Competence subscale ( p = @ ) , and Antisocial Behavior Scale Reactive Aggression subscale ( p = @ ) .


Clinical Global Impressions scores weresubstantially improved for the @ groups but did not discriminate between treatments ( Clinical Global Impressions-Improvement score@ , @ % forBasic treatment versus @ % for Augmented treatment ) .


Prolactin elevations and gastrointestinal upset occurred more with Augmented treatment ; other adverse events differed modestly from Basic treatment ; weight gain in the Augmented treatment group was minor .


Risperidone provided moderate butvariable improvement in aggressive and other seriously disruptive child behaviorswhenadded to PT and optimized stimulant treatment .


Clinical trial registration information-Treatment of Severe Childhood Aggression ( The TOSCA Study ) , URL : http://clinicaltrials.gov , unique identifier : NCT@ .


To test the hypothesis that early enteral supplementing fat and fish oil decreases the duration of parenteral nutrition ( PN ) and increases enteral nutrition ( EN ) before bowel reanastomosis in premature infants with an enterostomy .


Premature infants ( < @ months old ) who had an enterostomy and tolerated enteral feeding at @ mL/kg/day were randomized to usual care ( control = @ ) or early supplementing enteral fat supplement and fish oil ( treatment = @ ) .


Intravenous lipid was decreased as enteral fat intake was increased .


Daily weight , clinical and nutrition data , and weekly length and head circumference were recorded .


The primary outcomes were the duration of PN and volume of EN intake , and the secondary outcomes were weight gain ( g/day ) , ostomy output ( mL/kg/d ) , and serum conjugated bilirubin level ( mg/dL ) from initiating feeding to reanastomosis .


Data were analyzed by Student t test or Wilcoxon rank sum test .


There were no differences in the duration of PN , ostomy output , and weight gain between the @ groups before reanastomosis .


However , supplemented infants received less intravenous lipid , had greater EN intake , and lower conjugated bilirubin before reanastomosis , and they also received greater total calorie , had fewer sepsis evaluations and less exposure to antibiotics and central venous catheters before reanastomosis , and had greater weight and length gain after reanastomosis ( all P < @ ) .


Early enteral feeding of a fat supplement and fish oil was associated with decreased exposure to intravenous lipid , increased EN intake , and reduced conjugated bilirubin before reanastomosis and improved weight and length gain after reanastomosis in premature infants with an enterostomy .


Noise-induced hearing loss ( NIHL ) is one of the most common occupational diseases and the second most common cause of workers ' claims for occupational injuries .


Due to high prevalence of NIHL and several reports of improper use of hearing protective devices ( HPDs ) , we conducted this study to compare the effect of face-to-face training in effective use of earplugs with appropriate NRR to overprotection of workers by using earplugs with higher than necessary noise reduction rating ( NRR ) .


In a randomized clinical trial , @ workers referred to occupational medicine clinic were randomly allocated to three arms -- a group wearing earplugs with an NRR of @ with no training in appropriate use of the device ; a group wearing earplugs with an NRR of @ with training ; another group wearing earplugs with an NRR of @ , with no training .


Hearing threshold was measured in the study groups by real ear attenuation at threshold ( REAT ) method .


This trial is registered with Australian New Zealand clinical trials Registry , number ACTRN@ .


The mean SD age of the participants was @ @ ( range : @-@ ) years .


@ % of participants were female .


The mean noise attenuation in the group with training was @ dB , significantly higher than those observed in other groups .


The highest attenuation was observed in high frequencies ( @ , @ , and @ kHz ) in the group with training .


Training in appropriate use of earplugs significantly affects the efficacy of earplugs -- even more than using an earplug with higher NRR .


The PARAMOUNT phase III trial demonstrated that pemetrexed continuation maintenance significantly reduced the risk of disease progression ( hazard ratio = @ ) and death ( hazard ratio = @ ) versus placebo in patients with advanced nonsquamous non-small-cell lung cancer .


To further understand the survival data , descriptive subgroup analyses were undertaken .


Nine hundred thirty-nine patients received induction therapy ( four @-day cycles pemetrexed @ mg/m and cisplatin @ mg/m ) , after which @ nonprogressing patients with an Eastern Cooperative Oncology Group performance status ( PS ) of @/@ were randomized ( @:@ ) to maintenance pemetrexed ( @ mg/m ) cycles or placebo until disease progression .


Baseline characteristics of patients surviving for longer periods were comparable to patients surviving shorter periods , suggesting overall survival ( OS ) benefit for all subgroups of patients on maintenance therapy .


An examination of type and severity of induction adverse events also found no association with survival duration .


Response to induction ( tumor response versus stable disease ) was not determinate of pemetrexed maintenance OS outcome as assessed by waterfall plot and scattergrams and by the distribution of patients among various OS intervals .


The length of the interval before beginning maintenance therapy ( < @ days versus @/@ days ) also did not impact the survival results .


PS , a known prognostic factor , was the only baseline characteristic associated with improved OS ; however , both PS @ and PS @ patients exhibited a survival benefit from pemetrexed maintenance .


In PARAMOUNT , the OS benefit was seen across all subgroups .


Other than PS , no baseline or clinical parameter clearly identified a subgroup more likely to benefit .


Maintenance treatment decisions should be made on an individual basis .


To compare the clinical effects and safety of transepithelial corneal cross-linking ( CXL ) to epithelium-off ( epi-off ) CXL in progressive keratoconus .


Randomized clinical trial ( noninferiority ) .


Patients received either transepithelial CXL with Ricrolin TE ( n = @ ) or epi-off CXL with isotonic riboflavin ( n = @ ) in @ academic treatment center , using a simple unrestricted randomization procedure .


The main outcome measure was clinical stabilization of keratoconus after @ year , defined as a maximal keratometry ( Kmax ) increase < @ diopter ( D ) .


Average Kmax was stable at all visits in the transepithelial group , while after epi-off CXL a significant flattening of @-@ @ D was demonstrated from the @-month follow-up onwards .


The trend over time in Kmax flattening was significantly different between the groups ( P = @ ) .


Eight eyes ( @ % ) in the transepithelial group showed a Kmax increase of > @ D after @ year ( range @-@ @ D ) vs none in the epi-off group ( P = @ ) .


There was significant different trend in corrected distance visual acuity ( CDVA ) , with a more favorable outcome in the transepithelial group ( P = @ ) .


In the transepithelial group , no complications occurred and in the epi-off group , @ eyes ( @ % ) developed complications owing to healing problems ( sterile infiltrate , herpes keratitis , central haze , and stromal scar ) .


This study showed that although transepithelial CXL was a safe procedure without epithelial healing problems , @ % of cases showed a continued keratoconus progression after @ year .


Therefore , at this time , we do not recommend replacing epi-off CXL by transepithelial CXL for treatment of progressive keratoconus .


Cognitive behavioral therapy for insomnia ( CBT-I ) is well-validated in the western countries .


However , it has not been widely adopted or disseminated in China .


One possibility is that therapeutic approaches drawn from traditional Chinese medicine ( TCM ) will be more widely accepted .


This study aimed to evaluate the efficacy of medication in combination with a therapeutic approach drawn from TCM , Low Resistance Thought Induction Sleep-regulating Technique ( TIP@-@ ) , for acute treatment of insomnia .


A randomized controlled trial was conducted .


Ninety primary insomnia patients were randomly assigned to receive TIP@-@ combined with medication ( n = @ ) or medication only ( n = @ ) for @ weeks .


Medication consisted of @-@ mg Estazolam nightly .


On the basis of taking Estazolam , TIP@-@ combined with medication group was given Low Resistance Thought Induction Sleep-regulating Technique ( TIP@-@ ) treatment twice a week .


Outcomes were assessed with the Pittsburgh sleep quality index ( PSQI ) and polysomnography ( PSG ) before and after treatment .


Both groups demonstrated significant improvements in the PSQI and polysomnography indices .


The TIP@-@ + medication group demonstrated a significant difference between the two groups in PSQI total score , sleep medication use , daytime dysfunction , subjective sleep quality , as well as polysomnography indices of sleep efficiency and awakening times ( P < @ ) .


Among patients with primary insomnia , the addition of TIP@-@ provided benefits above and beyond the role of medication alone .


Excessive alcohol consumption on single occasions among undergraduate students is a major health issue as research has shown this pattern of drinking to be related to maladaptive health and psychosocial outcomes .


Brief , theory-based interventions targeting motivation and self-control as behavior-change techniques have been identified as effective means to reduce alcohol consumption , but few studies have examined the interactive effects of these components .


The aim of the present study is to develop a brief theory-based intervention using motivational and self-control intervention techniques to reduce alcohol consumption in undergraduate students .


The intervention will adopt a factorial design to test the main and interactive effects of the techniques on alcohol consumption .