Rosiglitazone or pioglitazone did not improve Emax ( 58.6 % 5.9 % vs 52.3 % 4.6 % [ P = .15 ] and 49.3 % 6.5 % vs 51.9 % 4.5 % [ P = .48 ] , respectively ) .


Glitazones increased the concentration of HDL cholesterol without restoring the ability of HDL particles to protect the endothelium from oxidative stress-induced dysfunction , meaning that HDL remained dysfunctional with impaired antiatherogenic properties .


Osteonecrosis of the femoral head frequently leads to collapse of the necrotic portion and subsequent degenerative joint disease of the hip , which is the most common diagnosis leading to total hip arthroplasty in young adults .


Bisphosphonate therapy has been reported to potentially retard the collapse .


We conducted a two-year prospective , randomized , open-label , multicenter study to determine whether zoledronate prevents the collapse and reduces the need for total hip arthroplasty .


We randomly assigned patients who had Steinberg stage-I or II nontraumatic osteonecrosis of the femoral head with a necrotic area of 30 % to either the zoledronate group or the control group .


Patients in the zoledronate group received 5 mg of zoledronate intravenously per year for two years , while patients in the control group did not receive this medication .


The primary efficacy outcome was the survival rate in terms of the occurrence of collapse ( 2 mm ) .


The patients were observed for a minimum of two years after enrollment .


A total of 110 patients ( 110 hips ) underwent randomization ; fifty-five patients were assigned to the zoledronate group and fifty-five , to the control group .


During the two-year follow-up , twenty-nine femoral heads in the zoledronate group and twenty-two in the control group collapsed ( p > 0.05 ) .


Nineteen hips in the zoledronate group and twenty in the control group underwent total hip arthroplasty ( p > 0.05 ) .


Zoledronate for Steinberg stage-I or II osteonecrosis of the femoral head , with a medium to large necrotic area , did not prevent the collapse of the femoral head or reduce the need for total hip arthroplasty .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Exposure , trauma-focused cognitive therapy and eye-movement desensitisation and re-processing ( EMDR ) are effective treatments for posttraumatic stress disorder ( PTSD ) producing equivalent outcomes .


How might the field advance ?


One way is to base new treatments on PTSD maintenance mechanisms .


A treatment that does this , metacognitive therapy ( MCT ) , underwent preliminary controlled evaluation in this study .


Twenty participants aged 18 to 65 years with chronic PTSD were randomly allocated to either a total of 8 sessions of MCT or a delayed treatment control .


Measures of PTSD , emotional symptoms , and underlying metacognitive variables were obtained at pretreatment and posttreatment .


Patients were followed-up at 3 and 6 months postintervention .


Statistically significant reductions in PTSD symptoms , depression , and anxiety at posttreatment were observed in the MCT group but not in the control group .


Changes were maintained over follow-up .


The average number of sessions delivered was 6.4 .


Eighty percent of patients ( intention to treat ) met clinical significance criteria for recovery based on the IES .


Treatment was well tolerated with only one ( 10 % ) dropout .


Changes in thought control strategy hypothesized to be involved in the maintenance of PTSD were found .


MCT appeared to be a brief treatment producing high recovery rates .


The data add to existing uncontrolled evaluations and provide strong justification for future evaluation of this treatment against existing evidence-based interventions .


Much is to be learned about what implementation strategies are the most beneficial to communities attempting to adopt evidence-based practices .


This paper presents outcomes from a randomized implementation trial of Multidimensional Treatment Foster Care ( MTFC ) in child public service systems in California and Ohio , including child welfare , juvenile justice , and mental health .


Fifty-one counties were assigned randomly to one of two different implementation strategies ( Community Development Teams ( CDT ) or independent county implementation strategy ( IND ) ) across four cohorts after being matched on county characteristics .


We compared these two strategies on implementation process , quality , and milestone achievements using the Stages of Implementation Completion ( SIC ) ( Implement Sci 6 ( 1 ) :1 -8 , 2011 ) .


A composite score for each county , combining the final implementation stage attained , the number of families served , and quality of implementation , was used as the primary outcome .


No significant difference between CDT and IND was found for the composite measure .


Additional analyses showed that there was no evidence that CDT increased the proportion of counties that started-up programs ( i.e. , placed at least one family in MTFC ) .


For counties that did implement MTFC , those in the CDT condition served over twice as many youth during the study period as did IND. .


Of the counties that successfully achieved program start-up , those in the CDT condition completed the implementation process more thoroughly , as measured by the SIC .


We found no significant differences by implementation condition on the time it took for first placement , achieving competency , or number of stages completed .


This trial did not lead to higher rates of implementation or faster implementation but did provide evidence for more robust implementation in the CDT condition compared to IND implementation once the first family received MTFC services .


This trial was successful from a design perspective in that no counties dropped out , even though this study took place during an economic recession .


We believe that this methodologic approach of measurement utilizing the SIC , which is comprised of the three dimensions of quality , quantity , and timing , is appropriate for a wide range of implementation and translational studies .


Trial ID : NCT00880126 ( ClinicalTrials.gov ) .


To evaluate the efficacy of ampicillin versus cefazolin as prophylactic antibiotics prior to cesarean delivery in Rwanda .


In a prospective , randomized , open-label , single-site study conducted between March and May 2012 , the effects of prophylactic ampicillin versus cefazolin were compared among women undergoing cesarean delivery at the Centre Hospitalier Universitaire de Kigali , Rwanda .


Postoperatively , participants were evaluated daily for infectious morbidity while in the hospital .


Follow-up was done by phone and by appointment at the hospital within 2 weeks of delivery .


During the study period , there were 578 total deliveries and 234 cesarean deliveries ( 40.4 % ) .


Overall , 132 women were enrolled in the study and randomized to receive either ampicillin ( n = 66 ) or cefazolin ( n = 66 ) .


No women were lost to follow-up .


The overall infection rate was 15.9 % ( 21/132 ) .


The infection rate in the ampicillin group and the cefazolin group was 25.8 % ( 17/66 ) and 6.1 % ( 4/66 ) , respectively .


Implementing a universal protocol in Rwanda of prophylactic cefazolin prior to cesarean delivery might reduce postoperative febrile morbidity , use of postoperative antibiotics , and number of postoperative days in hospital .


To observe the effect of acupuncture of Neiguan ( PC 6 ) , Sanyinjiao ( SP 6 ) , etc. on plasma lysophosphatidic acid ( LPA ) level in patients with acute cerebral infarction ( ACI ) so as to study its mechanism underlying improvement of ACI .


A total of 160 patients with ACI were randomly divided into four groups : medication ( Aspirin and Panax Notoginseng Saponins for improving blood circulation ) , acupuncture , Tongxinluo , and acupuncture + Tongxinluo groups , with 40 cases being in each group .


Plasma LPA content was measured using biochemical method , and the therapeutic effects of the 4 groups were assessed by neurologic deficit score which were evaluated using the modified standards of the 4Th Session of Chinese National Cerebrovascular Conference issued in 1995 .


Following the treatment , plasma LPA levels and neurological deficit scores were significantly decreased in the medication , acupuncture , Tongxinluo and acupuncture + Tongxinluo groups in com - parison with pre-treatment in each group ( P < 0.01 ) , and LPA level and neurological deficit score of the acupuncture + Tongxinluo group were significantly lower than those of the other three groups ( P < 0.01 ) .


Of the four 40 cases in the medication , acupuncture , Tongxinluo and acupuncture + Tongxinluo groups , 6 , 7 , 7 and 12 patients were basically cured , 9 , 8 , 9 and 18 experienced marked improvement in their symptoms , 14 , 16 , 15 and 6 were improved , 6 , 5 , 4 and 2 were invalid , 5 , 4 , 5 and 2 got worsened , with the effective rates ( basically cured + improvement ) being 37.5 % , 37.5 % , 40.0 % and 75.0 % , respectively .


The therapeutic effect of the acupuncture + Tongxinluo group was significantly superior to those of the other three groups ( P < 0.01 ) .


Acupuncture can accelerate the recovery of neurological function and ameliorate clinical symptoms in ACI patients , which may be related to its effect in lowering plasma PLA .


The therapeutic effect of acupuncture + Tongxinluo is relatively better than simple acupuncture and simple medication .


Generalized Anxiety Disorder ( GAD ) , characterized by excessive and uncontrollable worry , has a negative impact on the health , well-being , and functioning of older adults .


Cognitive behavioral therapy has demonstrated efficacy in reducing anxiety and worry in older adults , but the generalizability of these findings to community-dwelling older adults is unknown .


The aim of the current study is to examine the efficacy of a cognitive-behavioral intervention delivered by telephone in reducing anxiety and worry in rural community-dwelling older adults with GAD .


We propose a randomized controlled trial comparing telephone-delivered cognitive behavioral therapy ( CBT-T ) with nondirective supportive therapy ( NST-T ) .


One hundred seventy six adults 60 years and older diagnosed with GAD will be randomized to one of the two treatment conditions .


The primary outcomes are self-report worry and clinician-rated anxiety .


Secondary outcomes include depressive symptoms , sleep , quality of life , and functional status .


It is hypothesized that CBT-T will be superior to NST-T in reducing anxiety and worry among older adults with GAD .


Further , CBT-T is hypothesized to be superior to NST-T in reducing problems with depressive symptoms , sleep , functional status and quality of life .


If this program is successful , it could be implemented as a low-cost program to treat late-life anxiety , especially in rural areas or in circumstances where older adults may not have access to qualified mental health providers .


clinicaltrials.gov Identifier : NCT01259596 .


To evaluate the ultrasound ( US ) characteristics of peripheral nerves in chronic inflammatory demyelinating polyradiculoneuropathy ( CIDP ) and their correlations with electrodiagnostic ( EDX ) characteristics .


Nineteen patients with CIDP and 19 healthy controls matched by age and body mass index were included in a blind case-control , observational study .


All patients underwent a neurologic examination ( including inflammatory neuropathy cause and treatment [ INCAT ] and Medical Research Council [ MRC ] sum score ) and an EDX study .


Each patient and each control underwent a US study of 14 nerve segments , yielding a total number of 266 segments scanned in each group .


US changes , characterized by an increased nerve cross-sectional area ( NCSA ) , were detected in 53 % of the 266 patient nerve segments .


Mean NCSA was higher in nerve segments of patients than in those of controls ( p < 0.001 ) .


Nerve segments with abnormal US belonged to patients with longer disease duration , lower MRC sum score , higher INCAT score , and progressive disease form ( all p < 0.0001 ) .


All the aforementioned variables were independently associated with the occurrence of US changes .


Motor nerve conduction was significantly lower in nerve segments with increased NCSA than in those with normal NCSA ( p < 0.0001 ) .


NCSA in segments with prevalent myelin damage was higher than that in segments with prevalent axonal damage ( p = 0.001 ) or in segments with normal EDX characteristics ( p < 0.0001 ) .


NCSA and motor nerve conduction velocity were inversely correlated in nerve segments with EDX evidence of myelin damage ( R = 0.599 ; p < 0.0001 ) .


Conduction blocks were associated with increased NCSA ( p = 0.001 ) .


US may , similar to MRI , have a supporting role in the diagnosis of CIDP .


US and EDX changes are correlated .


Vitamin D deficiency is associated with heart failure ( HF ) events , and in animal models vitamin D down-regulates renin-angiotensin-aldosterone system hormones .


Patients with New York Heart Association ( NYHA ) functional class II-IV HF and a 25OH-D level 37.5 ng/mL received 50,000 IU vitamin D3 weekly ( n = 31 ) or placebo ( n = 33 ) for 6 months .


Serum aldosterone , renin , echocardiography , and health status were determined at baseline and 6 months .


Mean age of participants was 65.9 10.4 years , 48 % were women , 64 % were African American , mean ejection fraction was 37.6 13.9 % , 36 % were in NYHA functional class III , and 64 % were in class II .


The vitamin D group increased serum 25OH-D ( 19.1 9.3 to 61.7 20.3 ng/mL ) and the placebo group did not ( 17.8 9.0 to 17.4 9.8 ng/mL ) .


Aldosterone decreased in the vitamin D group ( 10.0 11.9 to 6.2 11.6 ng/dL ) and not in the placebo group ( 8.9 8.6 to 9.0 12.4 ng/dL ; P = .02 ) .


There was no difference between groups in renin , echocardiographic measures , or health status from baseline to 6 months .


Modeling indicated that variables which predicted change in aldosterone included receiving vitamin D , increasing age , African American race , and lower glomerular filtration rate .


Vitamin D3 repletion decreases aldosterone in patients with HF and low serum vitamin D. Vitamin D may be an important adjunct to standard HF therapy .


Further study will assess if vitamin D provides long-term benefit for patients with HF .


The purposes of this study were to identify nocturnal patterns of heart rate ( HR ) in depressed and nondepressed patients after an acute myocardial infarction ( MI ) and to determine which patterns , if any , are associated with all-cause mortality or recurrent infarction .


Functional data analysis and model-based clustering methods were used to identify nocturnal HR patterns in 245 depressed and 247 nondepressed patients with a recent MI .


All-cause mortality and recurrent infarctions were ascertained over a median follow-up of 24 months .


Three HR activity patterns were identified .


In the first , HR gradually declined during the nighttime and increased the next morning .


The second pattern was similar , but with a higher overall HR during the recording interval .


The third showed almost no decrease in HR at night ( ie , `` nondipping '' ) .


All-cause mortality was higher among patients with pattern 3 than pattern 1 ( P = .007 ) , and the combined end point of recurrent MI or all-cause mortality was higher in pattern 3 than pattern 2 ( P = .05 ) .


Patterns 2 and 3 were more common in the depressed than in the nondepressed patients .


The nondipping nocturnal HR independently predicts all-cause mortality and recurrent MI .


Future studies should examine the underlying causes of nondipping nocturnal HR and its association with depression and investigate the effects of treatment on survival .


Endothelial dysfunction is the first , although reversible , sign of atherosclerosis and is present in obese adolescents .


The primary end point of this study was to investigate the influence of a multicomponent treatment on microvascular function .


Additional objectives and end points were a reduced BMI SD score , improvements in body composition , exercise capacity , and cardiovascular risk factors , an increase in endothelial progenitor cells ( EPCs ) , and a decrease in endothelial microparticles ( EMPs ) .


We used a quasi-randomized study with 2 cohorts of obese adolescents : an intervention group ( n = 33 ; 15.4 1.5 years , 24 girls and 9 boys ) treated residentially with supervised diet and exercise and a usual care group ( n = 28 ; 15.1 1.2 years , 22 girls and 6 boys ) , treated ambulantly .


Changes in body mass , body composition , cardiorespiratory fitness , microvascular endothelial function , and circulating EPCs and EMPs were evaluated after 5 months and at the end of the 10-month program .


Residential intervention decreased BMI and body fat percentage , whereas it increased exercise capacity ( P < .001 after 5 and 10 months ) .


Microvascular endothelial function also improved in the intervention group ( P = .04 at 10 months ; + 0.59 0.20 compared with + 0.01 0.12 arbitrary units ) .


Furthermore , intervention produced a significant reduction in traditional cardiovascular risk factors , including high-sensitivity C-reactive protein ( P = .012 at 10 months ) .


EPCs were increased after 5 months ( P = .01 ) , and EMPs decreased after 10 months ( P = .004 ) .


A treatment regimen consisting of supervised diet and exercise training was effective in improving multiple adolescent obesity-related end points .


Quantitative light intensity analysis of the strut core by optical coherence tomography ( OCT ) may enable assessment of changes in the light reflectivity of the bioresorbable polymeric scaffold from polymer to provisional matrix and connective tissues , with full disappearance and integration of the scaffold into the vessel wall .


The aim of this report was to describe the methodology and to apply it to serial human OCT images post procedure and at 6 , 12 , 24 and 36 months in the ABSORB cohort B trial .


In serial frequency-domain OCT pullbacks , corresponding struts at different time points were identified by 3-dimensional foldout view .


The peak and median values of light intensity were measured in the strut core by dedicated software .


A total of 303 corresponding struts were serially analyzed at 3 time points .


In the sequential analysis , peak light intensity increased gradually in the first 24 months after implantation and reached a plateau ( relative difference with respect to baseline [ % Dif ] : 61.4 % at 12 months , 115.0 % at 24 months , 110.7 % at 36 months ) , while the median intensity kept increasing at 36 months ( % Dif : 14.3 % at 12 months , 75.0 % at 24 months , 93.1 % at 36 months ) .


Quantitative light intensity analysis by OCT was capable of detecting subtle changes in the bioresorbable strut appearance over time , and could be used to monitor the bioresorption and integration process of polylactide struts .


Many stroke survivors report participation challenges .


Occupational Performance Coaching for stroke survivors ( OPC-Stroke ) is designed to assist stroke survivors to develop the ability to plan and manage engagement in occupation .


This approach combines emotional support , individualized education , and goal-focused problem solving to promote occupational engagement .


This study will explore the potential efficacy of OPC-Stroke and the feasibility of the research methods for use in a larger trial .


A pilot randomized controlled trial will be undertaken .


Participants will be randomly assigned to receive 10 sessions of OPC-Stroke or usual care .


Participation , perceived goal performance , satisfaction and self-efficacy , emotional well-being , and cognition will be measured at three time points .


This research will test the potential usefulness of OPC-Stroke as well as the study methods , and thereby inform the continuing development of OPC-Stroke and further studies to measure its effectiveness .


The purpose of this study was to assess satisfaction with specific aspects of care for acute neck pain and explore the relationship between satisfaction with care , neck pain , and global satisfaction .


This study was a secondary analysis of patient satisfaction from a randomized trial of spinal manipulation therapy ( SMT ) delivered by doctors of chiropractic , home exercise and advice ( HEA ) delivered by exercise therapists , and medication ( MED ) prescribed by a medical doctors for acute/subacute neck pain .


Differences in satisfaction with specific aspects of care were analyzed using a linear mixed model .


The relationship between specific aspects of care and ( 1 ) change in neck pain ( primary outcome of the randomized trial ) and ( 2 ) global satisfaction were assessed using Pearson 's correlation and multiple linear regression .


Individuals receiving SMT or HEA were more satisfied with the information and general care received than MED group participants .


Spinal manipulation therapy and HEA groups reported similar satisfaction with information provided during treatment ; however , the SMT group was more satisfied with general care .


Satisfaction with general care ( r = -0.75 to -0.77 ; R ( 2 ) = 0.55-0 .56 ) had a stronger relationship with global satisfaction compared with satisfaction with information provided ( r = -0.65 to 0.67 ; R ( 2 ) = 0.39-0 .46 ) .


The relationship between satisfaction with care and neck pain was weak ( r = 0.17-0 .38 ; R ( 2 ) = 0.08-0 .21 ) .


Individuals with acute/subacute neck pain were more satisfied with specific aspects of care received during spinal manipulation therapy or home exercise interventions compared to receiving medication .


The relationship between neck pain and satisfaction with care was weak .


The need for assistance from others is a hallmark concern in Alzheimer 's disease ( AD ) .


The psychometric properties of the Dependence Scale ( DS ) for measuring treatment benefit were investigated in large randomized clinical trials of patients with mild to moderate AD .


Reliability , validity , and responsiveness of the DS were examined .


Path models appraised relationships and distinctiveness of key AD measures .


The responder definition was empirically derived .


Generally acceptable reliability ( .65 ) , significant ( P < .001 ) known-groups tests , and moderate to strong correlations ( r .31 ) confirmed the DS psychometric properties .


Path models supported relationships and distinctiveness of key AD measures .


A DS change of 1 point for patients with limited home care and 2 points for patients with assisted living care best described stability of the level of dependence on caregivers .


The DS is a psychometrically robust measure in mild to moderate AD .


The empirically derived responder definition aids in the interpretation of DS change .


This study compared the oral hygiene and caries risk of patients treated with labial and lingual orthodontic appliances throughout a prospective evaluation of the status of the oral environment before and after bracket placement .


A total of 20 orthodontic patients aged 19 to 23 years were included in the study and were divided into two groups : 10 patients wore Roth labial appliance ( American Orthodontics , Sheboygan , WI , USA ) and 10 patients wore STb lingual appliance ( Ormco Corporation , Glendora , CA , USA ) .


Plaque index ( PI ) , gingival bleeding index ( GBI ) , salivary flow rate , saliva buffer capacity , salivary pH , and Streptococcus mutans and Lactobacillus counts in saliva were determined at three time points : before orthodontic appliance placement ( T0 ) , 4 weeks after bonding ( T1 ) , and 8 weeks after bonding ( T2 ) .


After appliance placement , all patients were periodically educated to the oral hygiene procedures .


Wilcoxon rank and Mann-Whitney U tests were used to determine intragroup and intergroup differences as regards qualitative data .


To compare quantitative data between the groups , chi-square and Fisher 's exact tests were undertaken , while intragroup differences were tested with McNemar test .


The level of statistical significance was set at p < 0.05 .


Statistical analysis of the data obtained revealed a statistically significant difference between the data of T0 and T1 and the data of T0 and T2 of the PI scores and between T0 and T2 of the GBI scores in the group treated with the lingual appliance .


The GBI value increased significantly between T0 and T1 but decreased significantly between T1 and T2 ( p < 0.01 ) in the group treated with labial appliance .


S. mutans counts increased significantly between T0 and T2 in the saliva samples of patients treated with lingual appliance .


No statistically significant differences were found between S. mutans and Lactobacillus counts at the three terms of saliva collection in patients treated with labial appliance .


No statistically significant differences were found between the two groups at the three time points as regards the salivary flow rate and saliva buffer capacity .


Lingual and labial orthodontic appliances showed a different potential in modifying the investigated clinical parameters : patients wearing STb lingual orthodontic appliance had more plaque retention 4 and 8 weeks after bonding , while there were more gingival inflammation and more S. mutans counts 8 weeks after bonding .


No differences were found between the two groups as regards the Lactobacillus counts , the salivary flow rate , and saliva buffer capacity .


Application of an abdominal binder is often part of a standard postoperative regimen after ventral hernia repair to reduce pain and seroma formation .


However , there is lack of evidence of the clinical effects .


The aim of the present study was to investigate the pain - and seroma-reducing effect of an abdominal binder in patients undergoing laparoscopic umbilical or epigastric hernia repair .


Based on power analysis , a minimum of 54 patients undergoing laparoscopic umbilical and epigastric hernia repair were to be included .


Patients were randomized to abdominal binders vs. no abdominal binders during the first postoperative week .


Standardized surgical technique , anaesthesia , and analgesic regimens were used and study observers were blinded towards the intervention .


Postoperative pain ( visual analogue score ) on day 1 was the primary outcome .


In addition , ultrasonographic evaluation of seroma formation and several subjective patient-related parameters were registered .


Furthermore , patients in the abdominal binder group were asked to rate benefits or discomforts of wearing the binder .


Data from 56 patients ( abdominal binder , n = 28 ; no binder , n = 28 ) were available for analysis .


No significant intergroup differences in postoperative pain or any of the other surgical outcomes , including seroma formation , were found .


However , the abdominal binder group reported subjective beneficial effect of wearing the binder in 24 of the 28 patients ( 86 % ) .


No adverse effects of the abdominal binder were found .


There were no effects of an abdominal binder on pain , movement limitation , fatigue , seroma formation , general well-being , or quality of life .


However , most patients claimed a subjective beneficial effect of using their abdominal binder .


This study aimed to examine the association between changes in objectively measured overall physical activity ( PA ) and changes in fasting and postprandial plasma insulin , C-peptide , and glucose concentrations in type 2 diabetes-prone immigrant Pakistani men living in Norway and to examine whether this association is explained by changes in moderate and vigorous PA ( MVPA ) or changes in sedentary time .


The current study is a secondary cohort analysis on data collected from the Physical Activity and Minority Health study , a randomized controlled trial aimed at increasing the PA level , and not sedentary time per se , in a group of sedentary immigrant Pakistani men ( n = 150 ) .


For the present analyses , the two groups were merged and a cohort analysis was performed .


Overall PA ( counts per minute ) and its subcomponents , sedentary time and MVPA , were measured with accelerometry .


Outcome variables were measured after a 2-h standardized glucose tolerance test .


Change in overall PA was significantly associated with postprandial log-transformed plasma insulin ( = -0.002 ; 95 % confidence interval ( CI ) , -0.003 to 0.000 ; P = 0.008 ) , C-peptide ( = -2.7 ; 95 % CI , -4.9 to -0.5 ; P = 0.01 ) , and glucose concentration ( = -0.006 ; 95 % CI , -0.01 to -0.002 ; P = 0.002 ) .


Change in sedentary time was significantly and beneficially associated with changes in postprandial log-transformed plasma insulin ( = 0.002 ; 95 % CI , 0.001-0 .003 ; P = 0.001 ) , C-peptide ( = 3.7 ; 95 % CI , 1.5-6 .0 ; P = 0.001 ) , and glucose concentration ( = 0.006 ; 95 % CI , 0.002-0 .1 ; P = 0.002 ) , independent of changes in MVPA , waist circumference , and other confounders .


Increasing overall PA by reducing sedentary time seems as important as increasing time spent at MVPA in relation to postprandial plasma insulin and glucose levels in diabetes-prone immigrant men .


Exercise treatment is recommended for all patients with hip osteoarthritis ( OA ) , but its effect on the long-term need for total hip replacement ( THR ) is unknown .


We conducted a long-term follow-up of a randomised trial investigating the efficacy of exercise therapy and patient education versus patient education only on the 6-year cumulative survival of the native hip to THR in 109 patients with symptomatic and radiographic hip OA .


Results regarding the primary outcome measure of the trial , self-reported pain at 16months follow-up , have been reported previously .


There were no group differences at baseline .


The response rate at follow-up was 94 % .


22 patients in the group receiving both exercise therapy and patient education and 31 patients in the group receiving patient education only underwent THR during the follow-up period , giving a 6-year cumulative survival of the native hip of 41 % and 25 % , respectively ( p = 0.034 ) .


The HR for survival of the native hip was 0.56 ( CI 0.32 to 0.96 ) for the exercise therapy group compared with the control group .


Median time to THR was 5.4 and 3.5 years , respectively .


The exercise therapy group had better self-reported hip function prior to THR or end of study , but no significant differences were found for pain and stiffness .


Our findings in this explanatory study suggest that exercise therapy in addition to patient education can reduce the need for THR by 44 % in patients with hip OA .


ClinicalTrials.gov number NCT00319423 ( original project protocol ) and NCT01338532 ( additional protocol for long-term follow-up ) .


Previous trials of prenatal iron supplementation had limited measures of maternal or neonatal iron status .


The purpose was to assess effects of prenatal iron-folate supplementation on maternal and neonatal iron status .


Enrollment occurred June 2009 through December 2011 in Hebei , China .


Women with uncomplicated singleton pregnancies at 20 wk gestation , aged 18 y , and with hemoglobin 100 g/L were randomly assigned 1:1 to receive daily iron ( 300 mg ferrous sulfate ) or placebo + 0.40 mg folate from enrollment to birth .


Iron status was assessed in maternal venous blood ( at enrollment and at or near term ) and cord blood .


Primary outcomes were as follows : 1 ) maternal iron deficiency ( ID ) defined in 2 ways as serum ferritin ( SF ) < 15 g/L and body iron ( BI ) < 0 mg/kg ; 2 ) maternal ID anemia [ ID + anemia ( IDA ) ; hemoglobin < 110 g/L ] ; and 3 ) neonatal ID ( cord blood ferritin < 75 g/L or zinc protoporphyrin/heme > 118 mol/mol ) .


A total of 2371 women were randomly assigned , with outcomes for 1632 women or neonates ( 809 placebo/folate , 823 iron/folate ; 1579 mother-newborn pairs , 37 mothers , 16 neonates ) .


Most infants ( 97 % ) were born at term .


At or near term , maternal hemoglobin was significantly higher ( +5.56 g/L ) for iron vs. placebo groups .


Anemia risk was reduced ( RR : 0.53 ; 95 % CI : 0.43 , 0.66 ) , as were risks of ID ( RR : 0.74 ; 95 % CI : 0.69 , 0.79 by SF ; RR : 0.65 ; 95 % CI : 0.59 , 0.71 by BI ) and IDA ( RR : 0.49 ; 95 % CI : 0.38 , 0.62 by SF ; RR : 0.51 ; 95 % CI : 0.40 , 0.65 by BI ) .


Most women still had ID ( 66.8 % by SF , 54.7 % by BI ) .


Adverse effects , all minor , were similar by group .


There were no differences in cord blood iron measures ; > 45 % of neonates in each group had ID .


However , dose-response analyses showed higher cord SF with more maternal iron capsules reported being consumed ( per 10 capsules = 2.60 , P < 0.05 ) .


Prenatal iron supplementation reduced anemia , ID , and IDA in pregnant women in rural China , but most women and > 45 % of neonates had ID , regardless of supplementation .


This trial was registered at clinicaltrials.gov as NCT02221752 .


Noise as a common physical hazard may lead to noise-induced hearing loss , an irreversible but preventable disorder .


Annual audiometric evaluations help detect changes in hearing status before clinically significant hearing loss develops .


This study was designed to track hearing threshold changes during 2-year follow-up among tile and ceramic workers .


This follow-up study was conducted on 555 workers ( totally 1110 ears ) .


Subjects were divided into four groups according to the level of noise exposure .


Hearing threshold in conventional audiometric frequencies was measured and standard threshold shift was calculated for each ear .


Hearing threshold was increased during 2 years of follow-up .


Increased hearing threshold was most frequently observed at 4000 , 6000 , and 3000 Hz .


Standard threshold shift was observed in 13 ( 2.34 % ) , 49 ( 8.83 % ) , 22 ( 3.96 % ) , and 63 ( 11.35 % ) subjects in the first and second years of follow-up in the right and left ears , respectively .


This study has documented a high incidence of noise-induced hearing loss in tile and ceramic workers that would put stress on the importance of using hearing protection devices .


Uruguay is located at the southern border of Aedes aegypti distribution on the South American sub-continent .


The reported dengue cases in the country are all imported from surrounding countries .


One of the cities at higher risk of local dengue transmission is Salto , a border city with heavy traffic from dengue endemic areas .


We completed an intervention study using a cluster randomized trial design in 20 randomly selected ` clusters ' in Salto .


The clusters were located in neighborhoods of differing geography and economic , cultural and social aspects .


Entomological surveys were carried out to measure the impact of the intervention on vector densities .


Through participatory processes of all stakeholders , an appropriate ecosystem management intervention was defined .


Residents collected the abundant small water holding containers and the Ministry of Public Health and the Municipality of Salto were responsible for collecting and eliminating them .


Additional vector breeding places were large water tanks ; they were either altered so that they could not hold water any more or covered so that oviposition by mosquitoes could not take place .


The response from the community and national programme managers was encouraging .


The intervention evidenced opportunities for cost savings and reducing dengue vector densities ( although not to statistically significant levels ) .


The observed low vector density limits the potential reduction due to the intervention .


A larger sample size is needed to obtain a statistically significant difference .


Nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , disrupts PD-1-mediated signaling and may restore antitumor immunity .


In this randomized , open-label , international phase 3 study , we assigned patients with nonsquamous non-small-cell lung cancer ( NSCLC ) that had progressed during or after platinum-based doublet chemotherapy to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks .


The primary end point was overall survival .


Overall survival was longer with nivolumab than with docetaxel .


The median overall survival was 12.2 months ( 95 % confidence interval [ CI ] , 9.7 to 15.0 ) among 292 patients in the nivolumab group and 9.4 months ( 95 % CI , 8.1 to 10.7 ) among 290 patients in the docetaxel group ( hazard ratio for death , 0.73 ; 96 % CI , 0.59 to 0.89 ; P = 0.002 ) .


At 1 year , the overall survival rate was 51 % ( 95 % CI , 45 to 56 ) with nivolumab versus 39 % ( 95 % CI , 33 to 45 ) with docetaxel .


With additional follow-up , the overall survival rate at 18 months was 39 % ( 95 % CI , 34 to 45 ) with nivolumab versus 23 % ( 95 % CI , 19 to 28 ) with docetaxel .


The response rate was 19 % with nivolumab versus 12 % with docetaxel ( P = 0.02 ) .


Although progression-free survival did not favor nivolumab over docetaxel ( median , 2.3 months and 4.2 months , respectively ) , the rate of progression-free survival at 1 year was higher with nivolumab than with docetaxel ( 19 % and 8 % , respectively ) .


Nivolumab was associated with even greater efficacy than docetaxel across all end points in subgroups defined according to prespecified levels of tumor-membrane expression ( 1 % , 5 % , and 10 % ) of the PD-1 ligand .


Treatment-related adverse events of grade 3 or 4 were reported in 10 % of the patients in the nivolumab group , as compared with 54 % of those in the docetaxel group .


Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy , overall survival was longer with nivolumab than with docetaxel .


( Funded by Bristol-Myers Squibb ; CheckMate 057 ClinicalTrials.gov number , NCT01673867 . )


Gross cystic disease fluid protein 15 ( GCDFP-15 ) , which is regulated by the androgen receptor ( AR ) , is a diagnostic marker for mammary differentiation in histopathology .


We determined the expression of GCDFP-15 in breast cancer subtypes , its potential prognostic and predictive value , as well as its relationship to AR expression .


602 pre-therapeutic breast cancer core biopsies from the phase III randomized neoadjuvant GeparTrio trial ( NCT00544765 ) were investigated for GCDFP-15 expression by immunohistochemistry .


Expression data were correlated with disease-free ( DFS ) and overall survival ( OS ) time as well as pathological complete response ( pCR ) to neoadjuvant chemotherapy .


239 tumors ( 39.7 % ) were GCDFP-15 positive .


GCDFP-15 expression was positively linked to hormone receptor ( HR ) and HER2 positive tumor type , while most triple negative carcinomas were negative ( p < 0.0001 ) .


GCDFP-15 was also strongly correlated to AR expression ( p 0.001 ) , and to the so-called molecular apocrine subtype ( HR - / AR + , p < 0.0001 ) .


Higher rates of GCDFP-15 positivity were seen in tumors of lower grade ( < 0.0001 ) and negative nodal status ( p = 0.008 ) .


GCDFP-15 positive tumors tended to have a more favourable prognosis than GCDFP-15 negative tumors ( DFS ( p = 0.052 ) and OS ( p = 0.044 ) ) , which was not independent from other factors in multivariate analysis .


GCDFP-15 expression was not linked to pCR .


Histological apocrine differentiation was frequent in molecular apocrine carcinomas ( 60.7 % ) , and was associated with GCDFP-15 within this group ( p = 0.039 ) .


GCDFP-15 expression is higher in tumors with favorable prognostic features .


GCDFP-15 expression is further a frequent feature of AR positive tumors and the molecular apocrine subtype .


It might have reduced sensitivity as a diagnostic marker for mammary differentiation in triple negative tumors as compared to HR or HER2 positive tumor types .


Owing to mobility limitations , people with lumbar spinal stenosis ( LSS ) are at risk for diseases of inactivity , including obesity .


Therefore , weight management in LSS is critical .


Body mass index is the strongest predictor of function in LSS , suggesting that weight loss may promote physical activity and provide a unique treatment option .


We propose a lifestyle modification approach of physical activity and nutrition education , delivered through an e-health platform .


The purpose of this study was to develop and pilot an e-health intervention aimed at increasing physical activity and decreasing fat mass in people with LSS .


The study design was based on intervention development and pilot .


Ten overweight or obese individuals with LSS were confirmed clinically and on imaging .


Self-reported measures were food record , Short-Form 36 ( SF-36 ) , pain scales , Swiss Spinal Stenosis Symptom and Physical Function Scales , Oswestry Disability Index ( ODI ) , Pain Catastrophizing Questionnaire , Tampa Scale for Kinesiophobia , Center for Epidemiologic Studies ( Depression ) Scale , Behavioral Regular in Exercise Questionnaire , and Regulation for Eating Behavior Scale and physiologic measures were dual-energy X-ray absorptiometry ( DXA ) , blood draw , 7-day accelerometry , self-paced walking test , and balance test .


The e-health platform was developed .


during Week 1 , participants received a pedometer and a personalized consultation with a dietitian and an exercise physiologist .


For 12 weeks , participants logged on to the e-health Web site to access personal step goals , nutrition education videos , and a discussion board .


Follow-up occurred at Week 13 .


Nine participants had a mean age of 67.56.7 years ( 60 % women ) .


Significant improvements were observed for fat mass ( DXA ) , trunk fat mass , symptom severity ( Swiss Symptom Scale ) , energy intake , maximum continuous activity ( accelerometry ) , and mental health ( SF-36 ) ( p < .05 ) .


Nonsignificant improvements were observed for waist circumference , pain , ODI , and obesity biomarkers .


Seventy percent lost weight , 50 % increased walking capacity , and 60 % increased quality of life .


The mean increase in steps was 15 % .


The spinal stenosis pedometer and nutrition lifestyle intervention was shown to be feasible , attractive to participants , and effective in this small sample .


This intervention provides people with LSS the opportunity to participate in their own health management , potentially improving access to care .


Efficacy is currently being assessed in a randomized trial .


Guideline implementation in primary care has proven difficult .


Although external assistance through performance feedback , academic detailing , practice facilitation ( PF ) , and learning collaboratives seems to help , the best combination of interventions has not been determined .


In a cluster randomized trial , we compared the independent and combined effectiveness of PF and local learning collaboratives ( LLCs ) , combined with performance feedback and academic detailing , with performance feedback and academic detailing alone on implementation of the National Heart , Lung and Blood Institute 's Asthma Guidelines .


The study was conducted in 3 primary care practice-based research networks .


Medical records of patients with asthma seen during pre - and postintervention periods were abstracted to determine adherence to 6 guideline recommendations .


McNemar 's test and multivariate modeling were used to evaluate the impact of the interventions .


Across 43 practices , 1,016 patients met inclusion criteria .


Overall , adherence to all 6 recommendations increased ( P .002 ) .


Examination of improvement by study arm in unadjusted analyses showed that practices in the control arm significantly improved adherence to 2 of 6 recommendations , whereas practices in the PF arm improved in 3 , practices in the LLCs improved in 4 , and practices in the PF + LLC arm improved in 5 of 6 recommendations .


In multivariate modeling , PF practices significantly improved assessment of asthma severity ( odds ratio [ OR ] = 2.5 , 95 % CI , 1.7-3 .8 ) and assessment of asthma level of control ( OR = 2.3 , 95 % CI , 1.5-3 .5 ) compared with control practices .


Practices assigned to LLCs did not improve significantly more than control practices for any recommendation .


Addition of PF to performance feedback and academic detailing was helpful to practices attempting to improve adherence to asthma guidelines .


The Single combination budesonide-formoterol inhaler Maintenance And Reliever Therapy ( SMART ) regimen reduces severe asthma exacerbations in patients , but whether the high doses of corticosteroid and agonist increase the risk of adverse effects with both short-term and cumulative exposure is not certain .


Our aim was to investigate whether the SMART regimen would reduce the risk of overuse of agonist , reduce the likelihood of patients to seek medical review when such episodes occurred , and if any reduction in severe asthma exacerbations would be at the cost of a higher burden of systemic corticosteroid .


In this 24-week trial undertaken at four primary health-care practices and one hospital in New Zealand , patients ( aged 16-65 years ) with a recent asthma exacerbation were randomly assigned in a 1:1 ratio to the SMART or standard fixed-dose regimen .


Treatment in the SMART group consisted of two actuations of budesonide-formoterol ( 200 g and 6 g , respectively , per actuation ) twice daily , delivered through a combination metered dose inhaler ( MDI ) , with one extra actuation as needed for relief of symptoms ; treatment in the standard group consisted of two actuations of budesonide-formoterol ( 200 g and 6 g , respectively , per actuation ) twice daily through a combination MDI with one to two actuations of salbutamol ( 100 g per actuation ) by MDI as needed for relief of symptoms .


MDIs were monitored electronically to measure actual use of medication .


The allocation sequence for randomisation was computer generated , with a block size of eight per site .


Participants , investigators , and the statistician were not masked to group assignment .


The primary outcome was the proportion of participants with at least one high-use episode of agonist ( more than eight actuations per day of budesonide-formoterol in addition to the four maintenance doses in the SMART group or more than 16 actuations per day of salbutamol in the standard group ) .


Analysis was by intention to treat .


This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12610000515099 .


303 patients were randomly assigned to the SMART ( n = 151 ) or standard group ( n = 152 ) .


No significant difference was noted between the SMART and standard groups in the proportion of participants with at least one high-use episode of agonist ( 84 [ 56 % ] vs 68 [ 45 % ] , respectively , relative risk 124 [ 95 % CI 099-156 ] ; p = 0058 ) .


There were fewer days of high use in the SMART group ( mean 51 days [ SD 143 ] vs 89 days [ 209 ] , relative rate 058 [ 039-088 ] ; p = 001 ) .


Of the patients who had at least one high-use episode , those in the SMART group had fewer days of high use without medical review ( 85 days [ 178 ] vs 183 days [ 248 ] , 049 [ 031-075 ] ; p = 0001 ) .


The SMART regimen resulted in higher inhaled corticosteroid exposure ( 9435 g budesonide per day [ 15025 ] vs 6843 g budesonide per day [ 3905 ] , respectively ; ratio of means 122 [ 106-141 ] ; p = 0006 ) , but reduced oral corticosteroid exposure ( 775 mg prednisone [ 2405 ] vs 1266 mg prednisone [ 3821 ] , respectively ; p = 0011 ) , with no significant difference in composite systemic corticosteroid exposure ( 7937 mg prednisone equivalent per year [ 8931 ] vs 7721 mg prednisone equivalent per year [ 10627 ] , respectively ; 103 [ 086-122 ] ; p = 076 ) .


Participants in the SMART group had fewer severe asthma exacerbations ( 35 [ weighted mean rate per year 053 ] vs 66 [ 097 ] ; relative rate 054 [ 036-082 ] ; p = 0004 ) .


The SMART regimen has a favourable risk-to-benefit profile and can be recommended for use in adults at risk of severe asthma exacerbations .


Health Research Council of New Zealand .


To evaluate anti-depressive effects of acupuncture on selective serotonin reuptake inhibitors ( SSRIs ) .


Totally 60 patients with depression were randomly assigned to the control group ( 30 cases ) and the treatment group ( 30 cases ) .


All patients took one kind of SSRIs .


Those in the treatment group were additionally treated by acupuncture .


All were treated for 6 weeks .


Patients ' efficacies were evaluated with Hamilton Depression Scale ( HAMD ) , Self-rating Depression Scale ( SDS ) , and Eisenberg antidepressant side effects scale ( Asberg ) .


Compared with the control group after 6 weeks of treatment , the cured-markedly effective rate was improved by 33.4 % in the treatment group ( P < 0.05 ) .


The HAMD was lower in the treatment group .


The tendency of interaction of sleep disorder factor and anxiety/somatization factor was different between at the end of 1-week treatment and at the end of 6-week treatment in the treatment group ( P < 0.05 ) .


The SDS score decreased at the end of 6-week treatment in the treatment group .


The reduction rate was elevated by 19.23 % ( P < 0.05 ) .


By the end of 6-week treatment , the average score of Asberg decreased by 3.77 score in average in the treatment group , while it decreased by 0.07 score in average in the control group ( P < 0.05 ) .


Acupuncture could effectively improve anti-depressive effects of SSRIs and reduce their adverse reactions .


The aim of this study was to assess the long-term prognosis , efficacy , and safety of combination therapy using ursodeoxycholic acid ( UDCA ) and bezafibrate ( BF ) for primary biliary cirrhosis ( PBC ) patients exhibiting dyslipidemia .


We performed a prospective , randomized , controlled , multicenter study to compare the long-term clinical results between combination therapy and UDCA monotherapy for patients refractory to UDCA monotherapy .


Twenty-seven consecutive PBC patients were enrolled .


The median treatment period in the UDCA and UDCA+BF groups was 107 and 110 months , respectively .


The serum alkaline phosphatase ( ALP ) levels and the Mayo risk score in the combination therapy group ( mean 290IU/l and 0.91 , respectively ) were significantly lower than those in the UDCA monotherapy group ( mean 461IU/l and 1.42 , respectively ) at 8 years after the beginning of the study ( P < 0.05 ) .


The serum creatinine levels in the combination therapy group ( mean 0.94 mg/dl ) were significantly higher than those in the UDCA monotherapy group ( mean 0.56 mg/dl ) at 8 years after the beginning of the study ( P < 0.05 ) .


However , the survival rate was not significantly different between the groups .


We observed dose reduction or discontinuation of the administration of BF , but not UDCA , due to renal dysfunction or muscle pain .


Long-term combination therapy significantly improved the serum ALP levels and the Mayo risk score .


In addition , long-term combination therapy significantly increased the serum creatinine levels .


We should pay close attention to adverse events during this long-term combination therapy .


To evaluate the effects of a dexmedetomidine constant rate infusion ( CRI ) and atropine on changes in global perfusion variables induced by hemorrhage and volume replacement ( VR ) in isoflurane-anesthetized dogs .


8 adult dogs .


Each dog was anesthetized twice , with a 2-week interval between anesthetic sessions .


Anesthesia was maintained with 1.3 times the minimum alveolar concentration of isoflurane with and without dexmedetomidine ( 1.6 g/kg , IV bolus , followed by 2 g/kg/h , CRI ) .


Dogs were mechanically ventilated and received an atracurium neuromuscular blockade during both sessions .


During anesthesia with isoflurane and dexmedetomidine , atropine was administered 30 minutes before baseline measurements were obtained .


After baseline data were recorded , 30 % of the total blood volume was progressively withdrawn and VR was achieved with an equal proportion of autologous blood .


Following hemorrhage , cardiac index , oxygen delivery index , and mixed-venous oxygen saturation were significantly decreased and the oxygen extraction ratio was significantly increased from baseline .


The anaerobic threshold was not achieved during either anesthetic session .


When dogs were anesthetized with isoflurane and dexmedetomidine , they had a significantly lower heart rate , cardiac index , and mixed-venous oxygen saturation during VR than they did when anesthetized with isoflurane alone .


Plasma lactate concentration , mixed venous-to-arterial carbon dioxide difference , base excess , and anion gap were unaltered by hemorrhage and VR and did not differ between anesthetic sessions .


Results indicated that the use of a dexmedetomidine CRI combined with atropine in isoflurane-anesthetized dogs that underwent volume-controlled hemorrhage followed by VR did not compromise global perfusion sufficiently to result in anaerobic metabolism .


Daily bathing of critically ill patients with the broad-spectrum , topical antimicrobial agent chlorhexidine is widely performed and may reduce health care-associated infections .


To determine if daily bathing of critically ill patients with chlorhexidine decreases the incidence of health care-associated infections .


A pragmatic cluster randomized , crossover study of 9340 patients admitted to 5 adult intensive care units of a tertiary medical center in Nashville , Tennessee , from July 2012 through July 2013 .


Units performed once-daily bathing of all patients with disposable cloths impregnated with 2 % chlorhexidine or nonantimicrobial cloths as a control .


Bathing treatments were performed for a 10-week period followed by a 2-week washout period during which patients were bathed with nonantimicrobial disposable cloths , before crossover to the alternate bathing treatment for 10 weeks .


Each unit crossed over between bathing assignments 3 times during the study .


The primary prespecified outcome was a composite of central line-associated bloodstream infections ( CLABSIs ) , catheter-associated urinary tract infections ( CAUTIs ) , ventilator-associated pneumonia ( VAP ) , and Clostridium difficile infections .


Secondary outcomes included rates of clinical cultures that tested positive for multidrug-resistant organisms , blood culture contamination , health care-associated bloodstream infections , and rates of the primary outcome by ICU .


During the chlorhexidine bathing period , 55 infections occurred : 4 CLABSI , 21 CAUTI , 17 VAP , and 13 C difficile .


During the control bathing period , 60 infections occurred : 4 CLABSI , 32 CAUTI , 8 VAP , and 16 C difficile .


The primary outcome rate was 2.86 per 1000 patient-days during the chlorhexidine and 2.90 per 1000 patient-days during the control bathing periods ( rate difference , -0.04 ; 95 % CI , -1.10 to 1.01 ; P = .95 ) .


After adjusting for baseline variables , no difference between groups in the rate of the primary outcome was detected .


Chlorhexidine bathing did not change rates of infection-related secondary outcomes including hospital-acquired bloodstream infections , blood culture contamination , or clinical cultures yielding multidrug-resistant organisms .


In a prespecified subgroup analysis , no difference in the primary outcome was detected in any individual intensive care unit .


In this pragmatic trial , daily bathing with chlorhexidine did not reduce the incidence of health care-associated infections including CLABSIs , CAUTIs , VAP , or C difficile .


These findings do not support daily bathing of critically ill patients with chlorhexidine .


clinicaltrials.gov Identifier : NCT02033187 .


Get It & Forget It , an educational video about intrauterine devices ( IUDs ) , was developed and evaluated .


A feasibility study and a pre/post evaluation nested within a randomized trial were conducted to test change in knowledge about IUDs and intention to get an IUD after viewing a theory-driven dramatic video .


Participants ( n = 315 ) completed surveys before and after watching the video .


Knowledge about IUD effectiveness increased significantly ( 33 % to 64 % , p < .001 ) , as did intention to use an IUD ( 18 % to 36 % , p < .001 ) postvideo .


An online theory-driven video intervention can reach young women seeking information about long-acting contraception .


Oxidative stress may contribute to heart failure ( HF ) progression .


Inhibiting xanthine oxidase in hyperuricemic HF patients may improve outcomes .


We randomly assigned 253 patients with symptomatic HF , left ventricular ejection fraction 40 % , and serum uric acid levels 9.5 mg/dL to receive allopurinol ( target dose , 600 mg daily ) or placebo in a double-blind , multicenter trial .


The primary composite end point at 24 weeks was based on survival , worsening HF , and patient global assessment .


Secondary end points included change in quality of life , submaximal exercise capacity , and left ventricular ejection fraction .


Uric acid levels were significantly reduced with allopurinol in comparison with placebo ( treatment difference , -4.2 [ -4.9 , -3.5 ] mg/dL and -3.5 [ -4.2 , -2.7 ] mg/dL at 12 and 24 weeks , respectively , both P < 0.0001 ) .


At 24 weeks , there was no significant difference in clinical status between the allopurinol - and placebo-treated patients ( worsened 45 % versus 46 % , unchanged 42 % versus 34 % , improved 13 % versus 19 % , respectively ; P = 0.68 ) .


At 12 and 24 weeks , there was no significant difference in change in Kansas City Cardiomyopathy Questionnaire scores or 6-minute walk distances between the 2 groups .


At 24 weeks , left ventricular ejection fraction did not change in either group or between groups .


Rash occurred more frequently with allopurinol ( 10 % versus 2 % , P = 0.01 ) , but there was no difference in serious adverse event rates between the groups ( 20 % versus 15 % , P = 0.36 ) .


In high-risk HF patients with reduced ejection fraction and elevated uric acid levels , xanthine oxidase inhibition with allopurinol failed to improve clinical status , exercise capacity , quality of life , or left ventricular ejection fraction at 24 weeks .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00987415 .


Data on gastrointestinal ( GI ) side effects of bariatric surgery are limited because of incomplete reporting , cross-sectional samples , and nonstandardized assessments .


To report on GI side effects over the first 6 months after Roux-en-Y gastric bypass ( RYGB ) and laparoscopic adjustable gastric banding ( LAGB ) .


Academic medical center , United States .


One hundred forty-four patients completed a standardized clinical interview 6 months after operation , including questions on the occurrence and frequency of episodes of dumping syndrome , vomiting , and plugging for each of the past 6 months ; monthly rates were stable , so results were averaged over the entire period .


Although data were collected as part of a randomized controlled trial , randomization group and the interaction of group by surgical procedure were not related to GI side effects .


Thus , results are reported by procedure only ( RYGB , n = 87 ; LAGB , n = 56 ) .


RYGB patients had a higher preoperative body mass index ( BMI ) than LAGB patients ( 46.86.8 versus 43.54.8 kg/m ( 2 ) , respectively ; P = .001 ) , were more likely to report dumping ( 45.7 % versus 4.7 % , P < .0001 ) , and were less likely to report plugging ( 45.7 % versus 79.1 % , P = .0005 ) .


Vomiting did not differ significantly by procedure ( 68.6 % versus 65.1 % , P = .7 ) .


Most patients experienced each GI side effect less than once per week .


Although self-reported GI side effects were common over the first 6 months after operation , the frequency of episodes was relatively low .


Longer-term follow-up is needed to determine whether symptoms worsen or improve over time .


Many people with intellectual disability present with challenging behaviour which often has serious consequences such as the prescription of long term medication , in-patient admissions and disruption of normal daily activities .


Small scale studies of Positive Behaviour Support ( PBS ) delivered by paid carers suggest that it reduces challenging behaviour and costs of care and improves quality of life .


This study aims to investigate whether professionals training in the delivery of PBS as part of routine practice is clinically and cost effective compared to treatment as usual in community intellectual disability services .


The study is a multi-centre cluster randomised controlled trial involving community intellectual disability services in England and service users with mild to severe intellectual disability and challenging behaviour .


The teams will be randomly allocated into one of two conditions , either training and support to deliver PBS or treatment as usual .


We will carry out assessments of challenging behaviour , use of services , quality of life , mental health , and family and paid carer burden at six and 12 months .


We will monitor treatment fidelity and we will interview a sample of paid and family carers , service users , staff and managers about what they think of the treatment and how best we can deliver it in routine care .


The main outcome is reduction in challenging behaviour at one year after randomisation .


We will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS .


The study findings will have significant implications for the delivery of PBS in community based services with the potential for reducing inpatient admissions and out-of-area placements for adults with intellectual disability and challenging behaviour .


This trial is registered with Clinical Trials.gov ( Ref NCT01680276 ) .


Clinical Trials Unit : PRIMENT https://www.ucl.ac.uk/priment/ .


To investigate the effect of physical training combined with growth hormone ( GH ) on muscle thickness and its relationship with muscle strength and motor development in infants with Prader-Willi syndrome ( PWS ) .


In a randomized controlled trial , 22 infants with PWS ( 12.9 7.1 months ) were followed over 2 years to compare a treatment group ( n = 10 ) with a waiting-list control group ( n = 12 ) .


Muscle thickness of 4 muscle groups was measured by using ultrasound .


Muscle strength was evaluated by using the Infant Muscle Strength meter .


Motor performance was measured with the Gross Motor Function Measurement .


Analyses of variance were used to evaluate between-group effects of GH on muscle thickness at 6 months and to compare pre - and posttreatment ( after 12 months of GH ) values .


Multilevel analyses were used to evaluate effects of GH on muscle thickness over time , and multilevel bivariate analyses were used to test relationships between muscle thickness , muscle strength , and motor performance .


A significant positive effect of GH on muscle thickness ( P < .05 ) was found .


Positive relationships were found between muscle thickness and muscle strength ( r = 0.61 , P < .001 ) , muscle thickness and motor performance ( r = 0.81 , P < .001 ) , and muscle strength and motor performance ( r = 0.76 , P < .001 ) .


GH increased muscle thickness , which was related to muscle strength and motor development in infants with PWS .


Catch-up growth was faster in muscles that are most frequently used in early development .


Because this effect was independent of GH , it suggests a training effect .


Vaginal infections are common , frequently recur , and may increase women 's risk for sexually transmitted infections ( STIs ) .


We tested the efficacy of a novel regimen to prevent recurrent vaginal infections .


Human immunodeficiency virus ( HIV ) - negative women 18-45 years old with 1 or more vaginal infections , including bacterial vaginosis ( BV ) , vulvovaginal candidiasis ( VVC ) , or Trichomonas vaginalis ( TV ) , were randomly assigned to receive vaginal suppositories containing metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months .


Primary endpoints , evaluated every 2 months , were BV ( Gram stain ) and VVC ( positive wet mount and culture ) .


Participants ( N = 234 ) were randomly assigned to the intervention ( N = 118 ) or placebo ( N = 116 ) arm .


Two hundred seventeen ( 93 % ) women completed an end-of-study evaluation .


The intervention reduced the proportion of visits with BV compared to placebo ( 21.2 % vs 32.5 % ; relative risk [ RR ] 0.65 , 95 % confidence interval [ CI ] .48 -.87 ) .


In contrast , the proportion of visits with VVC was similar in the intervention ( 10.4 % ) versus placebo ( 11.3 % ) arms ( RR 0.92 , 95 % CI .62 -1.37 ) .


Monthly treatment with intravaginal metronidazole plus miconazole reduced the proportion of visits with BV during 12 months of follow-up .


Further study will be important to determine whether this intervention can reduce women 's risk of STIs .


The aim of this clinical study was to evaluate the retention rate and caries-prevention effect of a flowable composite compared to a conventional resin-based sealant in a young population over a 24-month period .


Thirty-four patients , ranging in age from 16 to 22 years , diagnosed with at least 2 non-cavitated pit-and-fissure caries in the first and second molars were selected for this randomized split-mouth design trial .


A total of 220 sealants , were placed in 117 upper molars and 103 lower molars .


The teeth were sealed with a flowable resin composite ( Tetric Evo Flow ) or a sealant material ( Helioseal F ) .


Each restoration was independently evaluated in terms of retention and the presence of caries at baseline and at 1 , 6 , 12 , and 24 months .


Data were analyzed using non-parametric Mann-Whitney U and Friedman 1-way ANOVA tests at p < 0.05 .


Tetric Evo Flow showed complete retention with 100 % , 95.5 % , 93.8 % , and 88.5 % at 1 , 6 , 12 , and 24-month evaluations , respectively , while Helioseal F retention rates were 98.1 % , 95.5 % , 94.8 % , and 85.4 % , respectively , for the same evaluation periods .


At the 24-month recall , 4 ( 4.2 % ) total losses were observed in subjects treated with Tetric Evo Flow and 2 total losses ( 2.1 % ) for Helioseal F , respectively .


No significant differences were observed between the materials in retention rates or caries incidence for each evaluation period ( p > 0.05 ) .


Placement of flowable composite as fissure sealants in the younger population seems to be as effective as conventional fluoride containing fissure sealants for the prevention of fissure caries .


The use of a flowable composite as a fissure sealant material , in conjunction with a total-etch , single bottle adhesive , yielded better retention than did the conventional fluoride containing resin-based fissure sealant over a 24-month period in young patients .


Total knee arthroplasty ( TKA ) is associated with significant perioperative blood loss and need for transfusion .


This study aimed to evaluate the effectiveness and safety of tranexamic acid ( TXA ) to reduce perioperative blood loss in patients receiving TKA .


A total of 92 patients who accepted unilateral TKA from May 2012 to May 2013 randomly received either 15 mg/kg TXA in 100 mL normal saline solution ( TXA group , n = 46 ) or the same amount of normal saline solution ( placebo group , n = 46 ) at 15 min before the tourniquet was loosened .


The following data were recorded : intraoperative blood loss ; post-operative drainage at 12 h ; total drainage amount ; hidden blood loss ; total blood loss ; transfusion volumes ; number of transfusions ; post-operative hemoglobin at 1 , 3 , and 5 days ; D-dimer ; number of lower limb ecchymoses ; and deep vein thrombosis ( DVT ) .


A total of 81 patients were available for analysis ( TXA group , n = 41 ; placebo group , n = 40 ) .


Post-operative12-h drainage , post-operative 24-h D-dimer values , total drainage volume , hidden blood loss , total blood loss , and the rate of postoperative ecchymosis were lower in the TXA group than in the placebo group ( p < 0.05 ) .


The post-operative 3-day Hgb was higher in the TXA group than in the placebo group ( p = 0.000 ) .


The rate of transfusion and DVT was similar in both groups ( n.s. ) .


Perioperative blood loss could be reduced after TKA by intravenously injecting 15 mg/kg TXA at 15 min before the tourniquet was loosened .


The application of TXA is not associated with increased risk of DVT .


A Knowledge Broker is one approach for facilitating the integration of evidence-informed decision making in public health practice .


In this paper , the findings from two studies investigating a Knowledge Broker intervention as a means of enhancing capacity for evidence-informed decision making are presented .


Contextual factors that facilitate this strategy are also identified .


This paper describes work done through a single mixed-methods study ( randomized controlled trial with a qualitative component ) and a case study .


The Health Evidence team conducted two studies examining Knowledge Broker impact in Canadian public health departments .


The effectiveness of knowledge translation strategies of varying intensities for promoting the use of research evidence in decisions related to child obesity prevention were explored via a randomized controlled trial with a fundamental descriptive component ( 2003-2007 ) .


In a case study ( 2010-2013 ) , the authors partnered with three health departments to develop and implement tailored strategies targeted at the organization .


Knowledge Brokers worked with designated staff in these studies via one-on-one consultations , small group meetings , and/or workshops and presentations .


The Knowledge Broker role was assessed by analysing data from close-ended surveys , interviews , organizational documents , and reflective journals .


In this paper , the authors focus on findings from the qualitative analysis of implementing the Knowledge Broker role in both studies and explore several contextual factors that impacted study outcomes .


Knowledge Brokers were shown to enhance individual capacity by improving knowledge and skill in searching for , critically appraising , and applying research evidence to practice-based issues .


Organizational capacity was also enhanced with strong management support and policies .


Effective Knowledge Broker attributes included both expertise in research methodology and public health , as well as intangible traits such as approachability and patience .


Finally , optimal positioning and ways of working were identified , including the importance of in-person meetings and neutrality of the Knowledge Broker .


Knowledge brokering is a potentially promising knowledge translation strategy for public health , though additional feasibility and cost-effectiveness data are still needed .


The research presented here further highlights the importance of context and adopting a tailored approach to implement a Knowledge Broker strategy .


Open tibial fractures are usually caused by high-energy trauma .


There is no consensus about the best treatment for these fractures .


Biomechanical studies show that fixing on two planes approaches the rigidity of the bone , whereas the use of interlocking intramedullary nailing is widely used and reported to produce better therapeutic results in fracture healing .


To compare bone tissue repair in patients with open diaphyseal tibial fracture treated with biplanar external fixation or reamed locked intramedullary nailing .


Prospective randomised study with 68 patients undergoing two types of surgical treatment : biplanar external fixation or reamed locked intramedullary nailing .


Consolidation , complications ( infection , malunion and non-union ) and quality of life using the SF-36 Health Survey were assessed 12 months after surgery .


Consolidation occurred in 84.6 % of patients who underwent reamed intramedullary nailing , and in 90.3 % of patients who were treated with biplanar external fixation .


In the intramedullary nailing group , there were two cases of non-union , three cases of malunion and two cases of infection .


In the patients treated with biplanar fixation , there were three cases of non-union , five cases of malunion and no cases of infection .


There were no statistically significant differences between the treatment groups for these results .


Patient quality of life was statistically equal for both methods .


Treatment with biplanar external fixation was associated with statistically similar results compared with intramedullary locking .


There are significant burdens associated with providing care for loved ones with cancer .


However , caregiver quality of life ( QOL ) is often overlooked .


With the increasing number of older adults with cancer , it is important to determine whether a patient 's age and QOL have any association with the caregiver 's QOL .


The objective of our study was to describe caregiver QOL and explore whether patient age and other psychosocial factors impact caregiver QOL .


Baseline information from patients with advanced cancer undergoing radiation and their caregivers , who were enrolled in a randomized , controlled clinical trial to test the effectiveness of a structured , multidisciplinary QOL intervention , was analyzed for this study .


Caregivers completed the Caregiver Quality of Life Index-Cancer ( CQOLC ) Scale .


Both patients and caregivers completed the Linear Analogue Self-Assessment ( LASA ) to measure QOL , and Profile of Mood States ( POMS ) to measure mood states .


Overall , 131 patient-caregiver pairs participated in the study .


At baseline , caregivers of older adults ( 65years ) had higher mental ( P = 0.01 ) , emotional ( P = 0.003 ) , spiritual ( P < 0.01 ) , and social support ( P = 0.03 ) LASA QOL scores .


Caregivers of older adults also had higher baseline QOL ( CQOLC , P = 0.003 ) and mood ( POMS , P = 0.04 ) than caregivers of younger adults .


Caregivers of patients with higher LASA QOL scores had higher overall ( P = 0.02 ) , mental ( P = 0.006 ) , physical ( P = 0.02 ) , emotional ( P = 0.002 ) , and spiritual LASA QOL scores ( P = 0.047 ) .


Caregivers of older adults with advanced cancer demonstrated better QOL and fewer mood disturbances compared to caregivers of younger patients .


When patients have good QOL , caregivers also had good QOL .


Cranial nerve injury ( CNI ) is the most common neurologic complication of carotid endarterectomy ( CEA ) and can cause significant chronic disability .


Data from prior randomized trials are limited and provide no health-related quality of life ( HRQOL ) outcomes specific to CNI .


Incidence of CNIs and their outcomes for patients in the Carotid Revascularization Endarterectomy vs Stenting Trial ( CREST ) were examined to identify factors predictive of CNI and their impact on HRQOL .


Incidence of CNIs , baseline and procedural characteristics , outcomes , and HRQOL scores were evaluated in the 1151 patients randomized to CEA and undergoing surgery 30 days .


Patients with CNI were identified and classified using case report forms , adverse event data , and clinical notes .


Baseline and procedural characteristics were compared using descriptive statistics .


Clinical outcomes at 1 and 12 months were analyzed .


All data were adjudicated by two neurologists and a vascular surgeon .


HRQOL was evaluated using the Medical Outcomes Short-Form 36 ( SF-36 ) Health Survey to assess general health and Likert scales for disease-specific outcomes at 2 weeks , 4 weeks , and 12 months after CEA .


The effect of CNI on SF-36 subscales was evaluated using random effects growth curve models , and Likert scale data were compared by ordinal logistic regression .


CNI was identified in 53 patients ( 4.6 % ) .


Cranial nerves injured were VII ( 30.2 % ) , XII ( 24.5 % ) , and IX/X ( 41.5 % ) , and 3.8 % had Horner syndrome .


CNI occurred in 52 of 1040 patients ( 5.0 % ) receiving general anesthesia and in one of 111 patients ( 0.9 % ) operated on under local anesthesia ( P = .05 ) .


No other predictive baseline or procedural factors were identified .


Deficits resolved in 18 patients ( 34 % ) at 1 month and in 42 of 52 patients ( 80.8 % ) by 1 year .


One patient died before the 1-year follow-up visit .


The HRQOL evaluation showed no statistical difference between groups with and without CNI at any interval .


By Likert scale analysis , the group with CNI showed a significant difference in the difficulty eating/swallowing parameter at 2 and 4 weeks ( P < .001 ) but not at 1 year .


In CREST , CNI occurred in 4.6 % of patients undergoing CEA , with 34 % resolution at 30 days and 80.8 % at 1 year .


The incidence of CNI was significantly higher in patients undergoing general anesthesia .


CNI had a small and transient effect on HRQOL , negatively affecting only difficulty eating/swallowing at 2 and 4 weeks but not at 1 year .


On the basis of these findings , we conclude that CNI is not a trivial consequence of CEA but rarely results in significant long-term disability .


Changes in the levels of lipids are associated with breast cancer ( BC ) .


Disease-specific serum free fatty acids ( FFAs ) were quantified using chip-based direct-infusion nanoelectrospray ionization-Fourier transform ion cyclotron resonance mass spectrometry ( CBDInanoESI-FTICR MS ) in the negative ion mode .


Multiple point internal standard calibration curves between the concentration ratios of fatty acids ( i.e. , C16 :1 , C18 :3 , C18 :2 , C18 :1 , C20 :4 , and C22 :6 ) to internal standards ( C17 :1 for C16 :1 , C18 :3 , C18 :2 , and C18 :1 , C21 :0 for C20 :4 and C22 :6 ) and their corresponding intensity ratios were established with a correlation coefficient of greater than 0.986 .


Data from 342 serum samples including 202 healthy controls and 140 BC patients indicate that serum concentrations of FFAs in patients with BC were significantly decreased compared with those in healthy controls .


A panel of C16 :1 , C18 :3 , C18 :2 , C20 :4 , and C22 :6 showed an excellent diagnostic ability to differentiate the patients with early stage BC from healthy controls , with the area under the receiver operating characteristics ( ROC ) curve of 0.953 , a sensitivity of 83.3 % , and a specificity of 87.1 % .


Our findings suggest that these FFAs may be a valuable biomarker panel for the early-stage detection of BC .


Inhaled glucocorticosteroids ( ICS ) are the mainstay of treatment in asthma .


Fluticasone furoate ( FF ) is a novel , once-daily ICS asthma therapy .


This study investigated the efficacy and safety of FF50mcg in patients with mild-to-moderate persistent asthma .


A 24-week , multicenter , randomized , placebo-controlled and active-controlled , double-blind , double-dummy , parallel-group phase III study .


Three hundred and fifty-one patients ( aged 12years ; uncontrolled by non-ICS therapy ) were randomized to treatment ( 1:1:1 ) with once-daily FF50mcg dosed in the evening , twice-daily fluticasone propionate ( FP ) 100mcg or placebo .


The primary endpoint was change from baseline in evening trough forced expiratory volume in 1s ( FEV1 ) at Week24 .


Secondary endpoints were change from baseline in the percentage of rescue-free 24-h periods ( powered endpoint ) , change from baseline in evening and morning peak expiratory flow , change from baseline in the percentage of symptom-free 24-h periods and number of withdrawals due to lack of efficacy .


Evening trough FEV1 at Week 24 was not statistically significantly increased with FF 50mcg once-daily ( 37ml [ 95 % CI : -55 , 128 ] ; P = 0.430 ) , but was with FP 100mcg twice daily ( 102ml [ 10 , 194 ] ; P = 0.030 ) , vs placebo .


No consistent trends were observed across other endpoints , including the powered secondary endpoint .


No safety concerns were raised for either active treatment .


FP 100mcg twice daily improved evening trough FEV1 in patients with mild-to-moderate persistent asthma , but FF 50mcg once daily did not demonstrate a significant effect .


Secondary endpoints showed variable results .


No safety concerns were identified for FF or FP .


A prophylactic antibiotic is recommended in open cholecystectomy surgeries , but in laparoscopic cholecystectomies such prophylaxis is controversial .


Recent reviews have not found conclusive evidence that routine prophylaxis , especially in low risk patients , is effective .


This clinical trial was undertaken to evaluate the efficacy of cefazolin in reducing surgical site infection SSI in laparoscopic cholecystectomies in a sample not screened for high or low risk patients .


A randomized double-blind controlled trial was conducted in a single university hospital .


Scheduled cholecystectomy patients without selection for patient risk factors were randomized into two groups .


Pre-operatively , group A patients received a placebo of 10ml isotonic sodium chloride , and group B patients received 1g of cefazolin as a prophylactic antibiotic .


All patients underwent a standard laparoscopic cholecystectomy , and were followed up for at least 30days .


Two hundred ninety-nine patients were randomized ( 149 in group A and 150 in group B ) .


SSI occurred in seven patients ( 2.34 % ) , five ( 1.67 % ) in the placebo group , and two ( 0.67 % ) in the prophylactic antibiotic group .


The difference was not statistically significant ( p value = 0.512 ) , and no specific risk factors for post-operative infection were identified .


A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy .


Whether or not to use a prophylactic depends on the individual patient , and the consideration of the attending surgeon .


The purpose of this study was to test the effectiveness of an online problem-based learning ( e-PBL ) program that offers multimedia scenarios to develop sexual health care competencies .


A pretestposttest control group design was used with two randomized groups in one Korean tertiary hospital .


The sample included 32 RNs who cared for oncology patients .


The intervention group completed an e-PBL cycle consisting of eight tutorials .


Nurses in the intervention group scored significantly higher on knowledge than did those in the control group .


The intervention group exhibited no significant differences in attitude and practices following the intervention .


The results show the potential of e-PBL to enhance traditional PBL by offering multimedia scenarios in an interactive and flexible learning environment .


To determine whether children with type 1 diabetes mellitus ( T1DM ) have evidence of increased aortic stiffness or early atherosclerosis as measured by magnetic resonance imaging ( MRI ) .


T1DM increases risk for cardiovascular disease in adults but whether this process starts in childhood is unknown .


A total of 54 T1DM patients ( 15.4 2.6 yr ) and 30 age-matched controls ( 14.8 2.7 yr ) participated .


MRI was performed to assess aortic arch pulse wave velocity ( PWV ) , strain , and distensibility of the ascending and descending thoracic aorta and measures of atherosclerosis .


Groups were well-matched for age , pulse pressure , and gender .


Low-density lipoprotein-cholesterol ( LDL-C ) was higher in T1DM ( 119.3 50 vs. 76.1 13.5 mg/dL , p < 0.0001 ) .


There was a trend toward decreased strain and distensibility in T1DM vs. controls in the ascending ( distensibility : T1DM 62.2 19.9 kPa 10 , control 71.6 26.4 kPa 10 , p = 0.08 ) and descending aorta ( strain : T1DM 25.8 6.2 % vs. control 28.3 6.8 % , p = 0.09 ) .


There was no difference in arch PWV .


Advancing age and male gender was negatively associated with aortic stiffness .


Hemoglobin A1c ( HbA1c ) was inversely related to descending aorta strain and distensibility ( p < 0.05 ) .


Children with diabetes in the lowest two tertiles of insulin sensitivity demonstrated thoracic descending aortas with significantly lower strain ( p = 0.027 ) and distensibility ( p = 0.039 ) and increased measures of wall irregularity ( p = 0.005 ) .


There were no differences in measurements of atherosclerosis between the two groups .


Adolescents with T1DM , especially those with lower insulin sensitivity , demonstrated a trend toward stiffer , less compliant thoracic aortas , which was inversely associated with diabetes control .


These data suggest large vessel aortopathy starts early in T1DM .


The homeostatic mechanisms of iron metabolism and erythropoiesis in infants are unclear .


Infants synthesize both fetal hemoglobin ( HbF ) and adult hemoglobin ( HbA ) , and it is not known how the hemoglobin switch is regulated .


We hypothesized that iron supplements to infants affect the disappearance of HbF .


We randomized 285 low-birth-weight infants ( 2,000-2 ,500 g ) into three intervention groups receiving 0 , 1 , or 2mg/kg/d of iron supplements from 6wk to 6 mo of age .


In the present secondary analysis , we analyzed iron status , total hemoglobin ( Hb ) , and HbF fraction at 6wk , 12wk , and at 6 mo and calculated absolute levels of HbF .


We observed dose-dependent increased levels of Hb in iron-supplemented groups at 6 mo of age .


However , for absolute HbF concentration , there was no similar effect of intervention .


Mean ( SD ) HbF was 81.2 ( 16.8 ) , 37.0 ( 13.8 ) , and 8.1 ( 5.6 ) g/l at 6wk , 12wk , and 6 mo , respectively , similar in all groups .


In linear regression analyses , postconceptional age turned out as the major predictor of HbF , independent of gestational age at birth .


Our hypothesis was rejected .


Instead , we confirmed a close correlation to postconceptional age , supporting a genetically programmed switch , insensitive to most environmental factors including birth .


Dose-dense sequential chemotherapy including anthracyclines and taxanes has been established in the adjuvant setting of high-risk operable breast cancer .


However , the preferable taxane and optimal schedule of administration in a dose-dense regimen have not been defined yet .


From July 2005 to November 2008 , 1001 patients ( 990 eligible ) were randomized to receive , every 2 weeks , 3 cycles of epirubicin 110 mg/m2 followed by 3 cycles of paclitaxel 200 mg/m2 followed by 3 cycles of intensified CMF ( Arm A ; 333 patients ) , or 3 cycles of epirubicin followed by 3 cycles of CMF , as in Arm A , followed 3 weeks later by 9 weekly cycles of docetaxel 35 mg/m2 ( Arm B ; 331 ) , or 9 weekly cycles of paclitaxel 80 mg/m2 ( Arm C ; 326 ) .


Trastuzumab was administered for one year to HER2-positive patients post-radiation .


At a median follow-up of 60.5 months , the 3-year disease-free survival ( DFS ) rate was 86 % , 90 % and 88 % , for Arms A , B and C , respectively , while the 3-year overall survival ( OS ) rate was 96 % in all arms .


No differences were found in DFS or OS between the combined B and C Arms versus Arm A ( DFS : HR = 0.81 , 95 % CI : 0.59-1 .11 , P = 0.20 ; OS : HR = 0.84 , 95 % CI : 0.55-1 .30 , P = 0.43 ) .


Among the 255 patients who received trastuzumab , 189 patients ( 74 % ) completed 1 year of treatment uneventfully .


In all arms , the most frequently reported severe adverse events were neutropenia ( 30 % vs. 27 % vs. 26 % ) and leucopenia ( 12 % vs. 13 % vs. 12 % ) , while febrile neutropenia occurred in fifty-one patients ( 6 % vs. 4 % vs. 5 % ) .


Patients in Arm A experienced more often severe pain ( P = 0.002 ) , neurological complications ( P = 0.004 ) and allergic reactions ( P = 0.004 ) , while patients in Arm B suffered more often from severe skin reactions ( P = 0.020 ) .


No significant differences in survival between the regimens were found in the present phase III trial .


Taxane scheduling influenced the type of severe toxicities .


HER2-positive patients demonstrated comparable 3-year DFS and OS rates with those reported in other similar studies .


Australian New Zealand Clinical Trials Registry ACTRN12610000151033 .


Protein-rich supplements are used widely for the prevention and management of undernutrition in older people .


The use of protein supplements in older people could , however , be counterproductive by reducing appetite and overall energy intake .


The objective was to determine whether aging influences the effects of protein loads , administered directly into the small intestine , on energy intake , antropyloroduodenal motility , and appetite .


Intraduodenal infusions ( 240 mL , 60 min ) of saline ( 0 kcal , control ) and protein ( hydrolyzed whey ) loads of 30 , 90 , and 180 kcal were followed by an ad libitum buffet meal in 10 young ( 19-29 y ) and 10 healthy older ( 68-81 y ) men .


Suppression of energy intake ( kcal ) at the meal by protein infusion compared with control was calculated .


In young subjects , a dose-responsive suppression ( SEM ) of energy intake was found at the buffet meal by protein ( suppression at 30 kcal : 7 8 % , P = 0.189 ; 90 kcal : 17 8 % , P = 0.054 ; 180 kcal : 33 7 % , P = 0.002 ) , whereas suppression was observed only after the 180-kcal load in older subjects ( 30 kcal : 7 4 % increase , P = 0.126 ; 90 kcal : 6 7 % increase , P = 0.291 ; 180 kcal : 17 6 % suppression , P = 0.016 ) .


Suppression of energy intake by protein was less in older than in young subjects ( P < 0.005 ) .


In young subjects , total energy intake ( meal + infusion ) on the 180-kcal protein-infusion day was lower than that on the control day ( P = 0.041 ) , whereas in older subjects it was greater on the 30-kcal ( P = 0.033 ) and 90-kcal ( P = 0.016 ) infusion days .


Energy intake was inversely related to isolated pyloric pressure waves ( r = -0.32 , P = 0.013 ) and positively related to antral ( r = 0.30 , P = 0.021 ) and duodenal ( r = 0.35 , P = 0.006 ) pressure waves .


Suppression of energy intake by protein was inversely related to the change in isolated pyloric pressure waves ( r = -0.35 , P = 0.027 ) and positively related to duodenal pressure waves ( r = 0.32 , P = 0.044 ) .


Intraduodenal protein suppresses appetite and energy intake less in healthy older than in young adults .


In older subjects , intraduodenal protein at low doses increased overall energy intake , which supports the use of protein supplements in undernourished older people .


This trial was registered at www.anzctr.org.au as 12612000906853 .


To determine whether internet-delivered cognitive behaviour therapy ( iCBT ) for depression and anxiety reduces self-reported absenteeism in employed individuals .


We reanalysed data from five randomised controlled trials of iCBT : two for depression ( conducted from September 2008 to February 2009 and from June 2009 to January 2010 ) , two for generalised anxiety disorder ( conducted from March 2009 to June 2009 and from July 2009 to January 2010 ) and one for social phobia ( conducted from May 2008 to July 2008 ) .


Participants across Australia were recruited via a website .


The inclusion criteria were : ( i ) meets criteria for the disorder of interest ; ( ii ) aged 18 years or over ; ( iii ) no previous history of a psychotic disorder or drug or alcohol misuse ; ( iv ) not actively suicidal .


The iCBT courses each consisted of six online lessons ( to be completed within 11 weeks ) , homework assignments , automatic emails and resource documents .


The number of days absent ( self-reported absenteeism ) in the previous week .


We included 284 participants in our analysis .


When data for the three disorders were combined , participants who received iCBT had significant reductions in self-reported absenteeism compared with those in the control groups ( who were on a waitlist ) ( P = 0.03 ) .


When data for the three disorders were analysed separately , reductions in self-reported absenteeism for participants who received iCBT were not significantly different to those for participants in the control groups .


Using data from five RCTs , we showed that iCBT was associated with reductions in self-reported absenteeism .


Future research should focus on replicating these findings in other contexts , such as other disorders and other iCBT courses .


To compare the combination spironolactone-norgestimate-ethinyl estradiol in hirsutism with other protocols including the same dose of estrogen .


In this open prospective study , 167 women with hirsutism due to polycystic ovary syndrome ( PCOS ) were randomly assigned to the following treatment protocols : Group A ( n = 72 ) : spironolactone 100 mg-norgestimate 250 mcg-ethinyl estradiol 35 microg ; Group B ( n = 70 ) : cyproterone acetate 12 mg-ethinyl estradiol 35 microg ; Group C ( n = 25 ) : norgestimate 250 microg-ethinyl estradiol 35 microg .


The decrease in the hirsutism score was higher in group A than in the other groups ( p < 0.001 ) and comparable in groups B and C.


The decrease in acne score , androgen and estradiol levels , and ovary volume was similar in groups A and B. C-reactive protein increase was similar in all groups , but the augmentation of fibrinogen ( p = 0.04 ) , triglycerides ( p < 0.01 ) , monocyte count ( p = 0.04 ) , platelet number ( p < 0.001 ) and mean volume ( p = 0.01 ) was more pronounced in group B than in group A. Low-density lipoprotein/high-density lipoprotein cholesterol ratio decreased in groups A and C.


Spironolactone-norgestimate-ethinyl estradiol is an effective and well-tolerated combination for the treatment of hirsutism in PCOS , with a favorable influence on lipids and indices of low-grade inflammation .


Lowering dietary sodium and adhering to medication regimens are difficult for persons with heart failure ( HF ) .


Because these behaviors often occur within the family context , this study evaluated the effects of family education and partnership interventions on dietary sodium ( Na ) intake and medication adherence ( MA ) .


HF patient and family member ( FM ) dyads ( n = 117 ) were randomized to : usual care ( UC ) , patient-FM education ( PFE ) , or family partnership intervention ( FPI ) .


Dietary Na ( 3-day food record ) , urinary Na ( 24-hour urine ) , and MA ( Medication Events Monitoring System ) were measured at baseline ( BL ) before randomization , and at 4 and 8 months .


FPI and PFE reduced urinary Na at 4 months , and FPI differed from UC at 8 months ( P = .016 ) .


Dietary Na decreased from BL to 4 months , with both PFE ( P = .04 ) and FPI ( P = .018 ) lower than UC .


The proportion of subjects adherent to Na intake ( 2,500 mg/d ) was higher at 8 months in PFE and FPI than in UC ( ( 2 ) ( 2 ) = 7.076 ; P = .029 ) .


MA did not differ among groups across time .


Both FPI and PFE groups increased HF knowledge immediately after intervention .


Dietary Na intake , but not MA , was improved by PFE and FPI compared with UC .


The UC group was less likely to be adherent with dietary Na .


Greater efforts to study and incorporate family-focused education and support interventions into HF care are warranted .


To evaluate preexposure prophylaxis ( PrEP ) efficacy for HIV-1 prevention among women using depot medroxyprogesterone acetate ( DMPA ) for contraception and men whose HIV-1-infected partners use DMPA .


Secondary analysis of data from a randomized placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among heterosexual Kenyan and Ugandan HIV-1 serodiscordant couples .


PrEP efficacy for HIV-1 prevention was compared among HIV-1-uninfected women using DMPA versus no hormonal contraception and among HIV-1 uninfected men whose HIV-1-infected female partners used DMPA versus no hormonal contraception .


Of 4747 HIV-1 serodiscordant couples , 901 HIV-1-uninfected women used DMPA at some point during follow-up , 1422 HIV-1-uninfected women used no hormonal contraception , 1568 HIV-1-uninfected men had female partners who used DMPA , and 2626 men had female partners who used no hormonal contraception .


PrEP efficacy estimates for HIV-1 prevention , compared with placebo , were similar among women using DMPA and those using no hormonal contraception ( 64.7 and 75.5 % , adjusted interaction P = 0.65 ) .


Similarly , for men whose female partners used DMPA , PrEP efficacy did not differ from men whose partners used no hormonal contraception ( 90.0 versus 81.7 % , adjusted interaction P = 0.52 ) .


PrEP is efficacious for HIV-1 prevention among women using DMPA and men whose partners use DMPA , suggesting PrEP could mitigate the potential increased HIV-1 acquisition and transmission risks that have been associated with DMPA use .


Women at risk for HIV-1 choosing DMPA could maintain this contraceptive method and add PrEP to achieve prevention of unintended pregnancy and HIV-1 .


The Verband Deutscher Rentenversicherungstrger ( VDR ) required the intense focus on vocational rehabilitation of medical problems since the early 1990s .


By integrating elements of the working environment in the structures and processes of medical rehabilitation , vocational problems can be identified early in order to take appropriate countermeasures .


Posttreatment proposals off er a way to provide a reliable long-term success .


The intention of this study is the implementation and the investigation of effectiveness of an intensified vocational program that integrates besides the in-patient rehabilitation post-treatment proposals as well .


Cardiac rehabilitation patient occurring special vocational problems participe .


The recruited patients were randomized to either the vocational program or the common cardiac rehabilitation.Primary outcome was the vocational reintegration 12 months after the end of rehabilitation.The database was collected through a query of the pension insurance accounts and questionnaires .


306 people were included to the study at the beginning of rehabilitation .


Rates of response :95 % of the survey to the end of rehabilitation ,77 % of the survey 6 months and 73 % of the survey 12 months after the end of rehabilitation.The sample was characterized by great interferences of their professional involvement and a high demand for vocational treatments .


At the beginning of the rehabilitation 50 % of study participants intended to make an application for reduction-pension .


Nevertheless , one year after the end of rehabilitation a surprisingly high rate of vocational reintegration by over 70 % in both groups ( IG : 72 % , KG : 75 % , p < 0.929 ) was indicated.The majority of the unemployed patients at the beginning of rehabilitation remained in the unemployment ( IG : 69 % , KG : 65 % , p < 0.757 ) .


The participation rate at the post-treatment proposals was 42 % .