Although education , income , and marital status are important sociodemographic contributors to cohort disparity trends , future studies should investigate individual behavioral health determinants and cohort-specific characteristics that explain the cohort-based racial difference in ADL and IADL disabilities .


Randomized trials have not shown major survival benefits when induction chemotherapy plus standard therapy is compared with standard therapy alone in patients with oral squamous cell carcinoma ( OSCC ) .


Induction chemotherapy is likely to be effective for biologically distinct subgroups and biomarker development may lead to identification of patients whose tumors are likely to respond to a particular treatment .


We evaluated immunohistochemical staining for GDF15 in pretreatment biopsy specimens of 230 of 256 OSCC patients who were treated in a prospective , randomized , phase III trial on induction chemotherapy including docetaxel , cisplatin and 5-fluorouracil ( TPF ) .


Relationship between GDF15 intervention and cell proliferation , migration , invasion , colony formation and tumorigenicity was analyzed using in vitro and in vivo OSCC models .


Low GDF15 expression predicted a better survival in OSCC patients , especially overall survival [ P = 0.049 , hazard ratio ( HR ) = 0.597 ] and distant metastasis-free survival ( DMFS ; P = 0.031 , HR = 0.562 ) .


cN + patients with low GDF15 expression benefitted from induction TPF in overall survival ( P = 0.039 , HR = 0.247 ) and DMFS ( P = 0.039 , HR = 0.247 ) , cN - patients with high GDF15 expression benefitted from induction TPF in overall survival ( P = 0.019 , HR = 0.231 ) , disease-free survival ( P = 0.011 , HR = 0.281 ) , locoregional recurrence-free survival ( P = 0.035 , HR = 0.347 ) and DMFS ( P = 0.009 , HR = 0.197 ) .


Decreased GDF15 expression in OSCC lines significantly inhibited cell proliferation , migration , invasion , colony formation and tumorigenesis through increased phosphorylation of AKT and ERK1/2 ( P < 0.05 ) .


Likewise , overexpression of GDF15 significantly promoted cell proliferation , migration , invasion and colony formation through decreased phosphorylation of AKT and ERK1/2 ( P < 0.05 ) .


GDF15 expression can be used as a prognostic biomarker for OSCC , and as a predictive biomarker for benefitting from TPF induction chemotherapy .


GDF15 promotes tumorigenesis and progression through phosphorylation of AKT and ERK1/2 in OSCC .


The clinical trial in this study was registered with www.ClinicalTrials.gov ( NCT01542931 ) .


The continued use of angiotensin-converting enzyme inhibitors ( ACEIs ) and angiotensin II subtype I receptor antagonists ( ARBs ) medications in the preoperative period has been reported to be associated with intraoperative hypotension that can be unresponsive to pressor drugs .


As a result , several investigators suggested discontinuation of these medications before scheduled surgery but did not report on unintended consequences that might result from discontinuation .


We conducted a prospective , single-blind , randomized trial to observe the effect of the medications on preoperative arterial blood pressure recordings in patients presenting for ambulatory and same-day surgery .


Six hundred forty-four patients presenting for ambulatory and same-day surgery were enrolled prospectively between 2006 and 2011 and randomly assigned to 2 groups based on continuation or discontinuation of ACEIs and ARBs .


An intention-to-treat analysis was performed .


The primary outcome was presence of hypertension ( HTN ) immediately before surgery .


Secondary outcomes included surgical cancellations due to HTN , prolongation of hospitalization , adverse clinical events , and HTN in the postoperative period .


Data for 526 patients were analyzed .


There were 262 patients in the discontinuation group and 264 patients in the continuation group .


Discontinuation of ACEIs and ARBs on the day of surgery was not associated with increased prevalence of preoperative HTN ( P = 0.775 ) .


The upper bound of a 95 % confidence interval for the difference in prevalence of Stage 1 and 2 HTN between study arms indicates that discontinuation of study medication is unlikely to be associated with an increase in Stage 1 HTN of > 4.8 percentage points and in Stage 2 HTN of no > 5.8 percentage points .


Discontinuation was not associated with an increase in postoperative HTN , with prolongation of hospitalization or with adverse clinical events .


Discontinuing ACEIs and ARBs in patients on the day of surgery did not result in a substantively increased incidence of pre - or postoperative HTN compared with patients who continued these medications on the day of surgery .


The results provide an evidentiary basis for the safety of discontinuing ACEIs and ARBs on the day of surgery without increasing adverse hemodynamic outcomes .


To evaluate efficacy and safety of superior hypogastric plexus neurolysis ( SHN ) for treatment of interstitial cystitis ( IC ) - bladder pain syndrome ( BPS ) in comparison with bladder hydrodistention ( HD ) .


In a prospective study , 24 female patients were randomly allocated to receive either SHN or HD .


Patients were evaluated by recording the O'Leary-Sant IC symptom indices , IC problem indices , pain visual analog scale ( VAS ) , number of daytime frequency , and nocturia .


Pressure flow study was conducted for all patients .


Intraoperative and postoperative changes and adverse events were recorded .


Basal IC symptom indices , IC problem indices , and VAS scores were comparable between both groups ( P = .31 , .63 , and .94 , respectively ) .


There was no statistically significant difference between both groups with respect to urodynamic parameters .


Only pain VAS at first week was improved in SHN in comparison with HD ( P = .012 ) .


Thereafter , all parameters were significantly improved in favor of the HD group at 2 - and 4-week visits .


Adverse events in both groups were ranked as Grade 1 Clavien-Dindo classification including transient hematuria in the HD group and transient back ache in the SHN group .


Despite effective pain control in cases with IC-BPS after SHN , it lacks durability .


It seems that SHN in its current form is not to be a suitable line of treatment for IC-BPS .


Multimodality treatment would be needed for proper control of patients ' symptoms .


Recent studies show that cerebral - amyloid ( A ) deposition is associated with blood pressure and measures of arterial stiffness in nondemented individuals .


To examine the association between measures of arterial stiffness and change in A deposition over time .


Deposition of A was determined in a longitudinal observational study of aging by positron emission tomography using the Pittsburgh compound B twice 2 years apart in 81 nondemented individuals 83 years and older .


Arterial stiffness was measured with a noninvasive and automated waveform analyzer at the time closest to the second positron emission tomography scan .


All measures were performed under standardized conditions .


Pulse wave velocity ( PWV ) was measured in the central ( carotid-femoral and heart-femoral PWV ) , peripheral ( femoral-ankle PWV ) , and mixed ( brachial-ankle PWV ) vascular beds .


The change in A deposition over 2 years was calculated from the 81 individuals with repeat A-positron emission tomography .


The proportion of A-positive individuals increased from 48 % at baseline to 75 % at follow-up .


Brachial-ankle PWV was significantly higher among A-positive participants at baseline and follow-up .


Femoral-ankle PWV was only higher among A-positive participants at follow-up .


Measures of central stiffness and blood pressure were not associated with A status at baseline or follow-up , but central stiffness was associated with a change in A deposition over time .


Each standard deviation increase in central stiffness ( carotid-femoral PWV , P = .001 ; heart-femoral PWV , P = .004 ) was linked with increases in A deposition over 2 years .


This study showed that A deposition increases with age in nondemented individuals and that arterial stiffness is strongly associated with the progressive deposition of A in the brain , especially in this age group .


The association between A deposition changes over time and generalized arterial stiffness indicated a relationship between the severity of subclinical vascular disease and progressive cerebral A deposition .


This study investigates measures of mindfulness meditation ( MM ) as a mental practice , in which a resting but alert state of mind is maintained .


A population of older people with high stress level participated in this study , while electroencephalographic ( EEG ) and respiration signals were recorded during a MM intervention .


The physiological signals during meditation and control conditions were analyzed with signal processing .


EEG and respiration data were collected and analyzed on 34 novice meditators after a 6-week meditation intervention .


Collected data were analyzed with spectral analysis , phase analysis and classification to evaluate an objective marker for meditation .


Different frequency bands showed differences in meditation and control conditions .


Furthermore , we established a classifier using EEG and respiration signals with a higher accuracy ( 85 % ) at discriminating between meditation and control conditions than a classifier using the EEG signal only ( 78 % ) .


Support vector machine ( SVM ) classifier with EEG and respiration feature vector is a viable objective marker for meditation ability .


This classifier should be able to quantify different levels of meditation depth and meditation experience in future studies .


This randomised phase II trial aimed to compare efficacy of the irreversible ErbB family blocker , afatinib , with cetuximab in patients with KRAS wild-type metastatic colorectal adenocarcinoma ( mCRC ) with progression following oxaliplatin - and irinotecan-based regimens .


Efficacy in patients with KRAS mutations was also evaluated .


Patients with KRAS wild-type tumours were randomised 2:1 to afatinib ( 40 mg/day , increasing to 50 mg/day if minimal toxicity ) or cetuximab weekly ( 400 mg/m2 loading dose , then 250 mg/m2/week ) according to number of previous chemotherapy lines .


All patients with KRAS-mutated tumours received afatinib .


Primary end-points were objective response ( OR ) for the wild-type group and disease control for the KRAS-mutated group .


Secondary end-points were progression-free survival ( PFS ) and overall survival ( OS ) .


Patients with KRAS wild-type tumours ( n = 50 ) received afatinib ( n = 36 ) or cetuximab ( n = 14 ) .


Unconfirmed and confirmed ORs were 3 % and 0 % for afatinib versus 20 % and 13 % for cetuximab ( odds ratio : 0.122 [ P = 0.0735 ] and < 0.001 , respectively ) .


Median PFS was 46.0 and 144.5 days for afatinib and cetuximab , respectively .


Median OS was 355 days with afatinib but not reached for cetuximab .


In the KRAS-mutated group ( n = 41 ) , five ( 12 % ) patients achieved confirmed disease control ( stable disease ; P = 0.6394 [ comparison versus 10 % ] ) ; no ORs were reported .


Median PFS and OS were 41.0 and 173days , respectively .


Most frequent treatment-related adverse events were diarrhoea and rash across groups .


The efficacy of afatinib was inferior to cetuximab in patients with KRAS wild-type mCRC .


In patients with KRAS-mutated tumours , disease control was modest with afatinib .


Afatinib had a manageable safety profile .


Heart failure and left ventricular systolic dysfunction ( LVSD ) are common in patients with permanent pacemakers , but whether right ventricular ( RV ) pacing is contributory or merely a bystander in patients with more severe cardiac disease is controversial .


The aim of the present study was to determine whether reprogramming of existing pacemakers to reduce RV pacing is safe and leads to improvements in cardiac function .


This was a prospective service evaluation of the effects of optimising pacemaker programming to avoid RV pacing in 66 consecutive attendees of a teaching hospital pacemaker clinic without complete heart block .


The main outcome measures were left ventricular ejection fraction ( LVEF ) , N-terminal pro-B-type natriuretic peptide ( NT-pro-BNP ) levels , quality of life and cardiopulmonary exercise testing at baseline and after 6 months .


At 6 months , the protocol reduced absolute RV pacing by a mean of 49 % ( 95 % CI 41 % to 57 % ) ( p < 0.0001 from baseline ) and resulted in a mean absolute improvement in LVEF of 6 % ( 4 % to 8 % ) ( p < 0.0001 from baseline ) but no reduction in exercise capacity , NT-pro-BNP or quality of life .


There was a relationship between the magnitude of change in EF and the reduction in RV pacing ( p = 0.04 ) and changes in NT-pro-BNP seemed to relate to change in RV pacing ( p = 0.07 ) .


Programming standard pacemakers to avoid RV pacing is safe , does not adversely affect patients ' symptoms or quality of life and is associated with improved LV function , related to the reductions in RV pacing percentage .


New technologies could facilitate changes in lifestyle and improve public health .


However , no large randomized , controlled studies providing scientific evidence of the benefits of their use have been made .


The aims of this study are to develop and validate a smartphone application , and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity .


An evaluation is also made of the effect of modifying habits upon vascular structure and function , and therefore on arterial aging .


A randomized , double-blind , multicenter , parallel group clinical trial will be carried out .


A total of 1215 subjects under 70years of age from the EVIDENT trial will be included .


Counseling common to both groups ( control and intervention ) will be provided on adaptation to the Mediterranean diet and on physical activity .


The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity , and will use the application for three months .


The main study endpoints will be the changes in physical activity , assessed by accelerometer and the 7-day Physical Activity Recall ( PAR ) interview , and adaptation to the Mediterranean diet , as evaluated by an adherence questionnaire and a food frequency questionnaire ( FFQ ) .


Evaluation also will be made of vascular structure and function based on central arterial pressure , the radial augmentation index , pulse velocity , the cardio-ankle vascular index , and carotid intima-media thickness .


Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications , and may contribute to generalize their application in favor of improved population health .


Clinical Trials.gov Identifier : NCT02016014 .


To investigate the safety , feasibility and preliminary efficacy of low-frequency repetitive transcranial magnetic stimulation ( rTMS ) over the cerebellum in ataxic patients with acute posterior circulation stroke .


Randomized , double-blind , sham-controlled pilot study .


Thirty-two ataxic patients with posterior circulation stroke were randomized to real ( n = 22 ) and sham ( n = 10 ) rTMS groups .


Patients received 5 15-min sessions of 1 Hz cerebellar rTMS over 5 consecutive days .


Compliance and adverse events for the rTMS sessions were checked .


The 10-m walk test ( 10MWT ) and Berg Balance Scale ( BBS ) were completed before rTMS , immediately and 1 month after the last rTMS session .


Compliance with the rTMS was 100 % and no adverse events were reported in either group .


10MWT and BBS of real rTMS group improved significantly ( p < 0.01 ) .


Percentage changes immediately after the last rTMS session for time and steps in the 10MWT and BBS in the real vs sham group were : -16.7 35.1 % vs -8.4 72.5 % , -8.5 23.0 % vs -0.3 28.4 % and 46.4 100.2 % vs 36.6 71.6 % , respectively .


This study demonstrated that 1 Hz rTMS over the cerebellum is safe , feasible and may have a beneficial effect in ataxic patients with posterior circulation stroke .


Because of its contribution to dietary diversity and to favorable intakes of micronutrients , including iron and zinc , meat is hypothesized to be a valuable complementary food for the infant and young child .


However , the evidence base remains limited .


To compare the difference in anthropometric measurements of rural Chinese infants and toddlers 6 to 18 months of age who received a daily supplement of meat or cereal for 12 months .


This cluster-randomized , controlled study provided a daily supplement of either meat ( n = 514 , 20 clusters ) or cereal ( n = 957 , 40 clusters ) starting as a first complementary food at 6 months of age .


Anthropometric measurements were assessed longitudinally .


After 12 months of intervention , the meat group ( 13.01 1.9 cm ) had greater ( p = .01 ) linear growth than the cereal group ( 12.75 1.8 cm ) and a smaller decrease in length-for-age z-score ( LAZ ) over time ( -0.43 0.72 in the meat group vs. -0.54 0.67 in the cereal group ) , after adjustment for baseline length , LAZ , maternal education , work status , and maternal height and weight .


Linear growth was modestly greater in the meat group than in the cereal group .


LAZ was substantially negative at 6 months , and the intervention did not prevent ongoing decline over the course of the study .


Poor sleep is prevalent in patients with systemic inflammatory disorders , including rheumatoid arthritis , and , in addition to fatigue , pain , depression and inflammation , is associated with an increased risk of co-morbidity and all-cause mortality .


Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue , no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis .


The aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep , assessed both objectively and subjectively in patients with rheumatoid arthritis .


A randomized controlled trial including 44 patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group .


The intervention consists of 18 session intermittent aerobic exercise training on a bicycle ergometer three times a week .


Patients are evaluated according to objective changes in sleep as measured by polysomnography ( primary outcome ) .


Secondary outcomes include changes in subjective sleep quality and sleep disturbances , fatigue , pain , depressive symptoms , physical function , health-related quality of life and cardiorespiratory fitness .


This trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis , which is considered important in promotion of health and well-being .


As such , the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis .


ClinicalTrials.gov Identifier : NCT01966835 .


Syncope is a cause of significant morbidity in sick sinus syndrome ( SSS ) which may not be resolved with permanent pacemaker therapy .


We aimed to determine the incidence , predictors and prognostic implication of syncope in paced patients with SSS .


We studied 1415 patients ( mean age 72.9 years , SD 11.1 ) with SSS who were randomised in the DANPACE study to either rate-responsive single chamber pacing ( n = 707 ) or rate-responsive dual chamber pacing ( n = 708 ) .


Main outcome measures were patient-reported syncope after pacemaker implantation and mortality .


Mean follow-up was 5.4 years ( SD 2.6 ) .


A total of 247 ( 17.5 % ) patients experienced syncope after pacemaker implantation ( 135 ( 19 % ) from the rate-responsive single chamber pacing group , and 112 ( 15.8 % ) from the rate-responsive dual chamber pacing group .


Predictors of syncope post pacemaker implantation included : age 0-39 years ( HR 2.9 , 95 % CI 1.4 to 6.3 , p = 0.01 ; reference range 60-79 years ) , age 80 years ( HR 1.4 , 95 % CI 1.0 to 1.8 , p = 0.03 ) , syncope prior to pacemaker implant ( HR 1.8 , 95 % CI 1.4 to 2.3 , p < 0.001 ) , previous myocardial infarction ( HR 1.5 , 95 % CI 1.1 to 2.1 , p = 0.03 ) , heart failure ( HR 1.4 , 95 % CI 1.0 to 1.9 , p = 0.046 ) , and high Charlson comorbidity index ( HR 1.6 , 95 % CI 1.1 to 2.2 , p = 0.01 ) .


Patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not ( adjusted HR 1.6 , 95 % CI 1.3 to 2.1 , p < 0.001 ) .


Syncope in paced patients with SSS is common , and is associated with higher mortality .


The predictors identified in this study suggest a multifactorial aetiology of syncope .


Surgery remains the dominant treatment for large-bowel obstruction , with emerging data on self-expanding metallic stents .


The aim of this study was to assess whether stent insertion improves quality of life and survival in comparison with surgical decompression .


This study reports on a randomized control trial ( registry number ACTRN012606000199516 ) .


This study was conducted at Royal Prince Alfred Hospital , Sydney , and Western Hospital , Melbourne .


Patients with malignant incurable large-bowel obstruction were randomly assigned to surgical decompression or stent insertion .


The primary end point was differences in EuroQOL EQ-5D quality of life .


Secondary end points included overall survival , 30-day mortality , stoma rates , postoperative recovery , complications , and readmissions .


Fifty-two patients of 58 needed to reach the calculated sample size were evaluated .


Stent insertion was successful in 19 of 26 ( 73 % ) patients .


The remaining 7 patients required a stoma compared with 24 of 26 ( 92 % ) surgery group patients ( p < 0.001 ) .


There were no stent-related perforations or deaths .


The surgery group had significantly reduced quality of life compared with the stent group from baseline to 1 and 2 weeks ( p = 0.001 and p = 0.012 ) , and from baseline to 12 months ( p = 0.01 ) in favor of the stent group , whereas both reported reduced quality of life .


The stent group had an 8 % 30-day mortality compared with 15 % for the surgery group ( p = 0.668 ) .


Median survival was 5.2 and 5.5 months for the groups ( p = 0.613 ) .


The stent group had significantly reduced procedure time ( p = 0.014 ) , postprocedure stay ( p = 0.027 ) , days nothing by mouth ( p = 0.002 ) , and days before free access to solids ( p = 0.022 ) .


This study was limited by the lack of an EQ-5D Australian-based population set .


Stent use in patients with incurable large-bowel obstruction has a number of advantages with faster return to diet , decreased stoma rates , reduced postprocedure stay , and some quality-of-life benefits .


To identify risk factors for headache and migraine in children with sickle cell disease and test the hypothesis that either or both are independently associated with silent cerebral infarcts .


In this cross-sectional study , we evaluated the health history , laboratory values , and brain magnetic resonance imaging findings of participants with sickle cell disease ( hemoglobinSS or hemoglobinS-thalassemia ) with no history of overt stroke or seizures .


Participants characterized headache severity and quality .


Migraine was defined by International Headache Society criteria modified for increased sensitivity in children .


Neuroradiology and neurology committees adjudicated the presence of silent cerebral infarction by review of magnetic resonance imaging and standardized examination by pediatric neurologists .


The cohort included 872 children ( 51.1 % males ) , ranging in age from 5 to 15 years ( mean age , 9.1 years ) .


Of these children , 317 ( 36.4 % ) reported recurrent headaches , and 132 ( 15.1 % ) reported migraines .


In multivariable logistic regression analyses , both were associated with lower steady-state hemoglobin ( P = .01 for headaches ; P < .01 for migraines ) and higher pain rate ( P < .01 for headaches ; P < .01 for migraines ) , defined as the number of admissions requiring opioids in the previous 3 years .


The presence of silent cerebral infarction was not associated with recurrent headaches or migraines .


Only 1.9 % ( 6 of 317 ) of children with recurrent headaches received medication for headache prophylaxis .


Recurrent headaches and migraines are common and undertreated in children with sickle cell disease .


Low hemoglobin levels and high pain rates are associated with recurrent headaches and migraines ; whereas , silent cerebral infarction is not .


Roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease .


Its effect in patients using fixed combinations of inhaled corticosteroids and longacting 2 agonists is unknown .


We postulated that roflumilast would reduce exacerbations in patients with severe chronic obstructive pulmonary disease at risk for exacerbations , even in combination with inhaled corticosteroid and longacting 2 agonist treatment .


For this 1-year double-blind , placebo-controlled , parallel group , multicentre , phase 3-4 trial , the Roflumilast and Exacerbations in patients receiving Appropriate Combination Therapy ( REACT ) study , we enrolled patients with severe chronic obstructive pulmonary disease from 203 centres ( outpatient clinics , hospitals , specialised pulmonologists , and family doctors ) in 21 countries .


Eligible patients were 40 years of age or older with a smoking history of at least 20 pack-years and a diagnosis of chronic obstructive pulmonary disease with severe airflow limitation , symptoms of chronic bronchitis , and at least two exacerbations in the previous year .


We used a computerised central randomisation system to randomly assign patients in a 1:1 ratio to the two treatment groups : roflumilast 500 g or placebo given orally once daily together with a fixed inhaled corticosteroid and longacting 2 agonist combination .


Background tiotropium treatment was allowed .


All patients and investigators were masked to group assignment .


The primary outcome was the rate of moderate to severe chronic obstructive pulmonary disease exacerbations per patient per year , analysed by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT01329029 .


Between April 3 , 2011 , and May 27 , 2014 , we enrolled 1945 eligible participants and randomly assigned 973 to the roflumilast group and 972 to the placebo group .


The rate of moderate-to-severe chronic obstructive pulmonary disease exacerbations was 132 % lower in the roflumilast group than in the placebo group according to a Poisson regression analysis ( roflumilast 0805 vs placebo 0927 ; rate ratio [ RR ] 0868 [ 95 % CI 0753-1002 ] , p = 00529 ) , and 142 % lower according to a predefined sensitivity analysis using negative binomial regression ( 0823 vs 0959 ; 0858 [ 0740-0995 ] , p = 00424 ) .


Adverse events were reported by 648 ( 67 % ) of 968 patients receiving roflumilast and by 572 ( 59 % ) of 967 patients in the placebo group ; adverse event-associated patient withdrawal from the study was also more common in the roflumilast group ( 104/968 [ 11 % ] ) than in the placebo group ( 52/967 [ 5 % ] ) .


The most frequently reported serious adverse events were chronic obstructive pulmonary disease exacerbations and pneumonia , and 17 ( 18 % ) deaths occurred in the roflumilast group compared with 18 ( 19 % ) in the placebo group .


Our findings suggest that roflumilast reduces exacerbations and hospital admissions in patients with severe chronic obstructive pulmonary disease and chronic bronchitis who are at risk of frequent and severe exacerbations despite inhaled corticosteroid and longacting 2 agonist therapy , even in combination with tiotropium .


Takeda .


To test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait .


Single-blinded randomized clinical trial .


University research laboratory .


Adults ( N = 40 ) aged 65 years with gait speed > 1.0 m/s and impaired motor skill ( figure-of-8 walk time > 8s ) .


The 2 interventions included a task-oriented motor learning and a standard exercise program ; both interventions included strength training .


Both lasted 12 weeks , with twice-weekly , 1-hour , physical therapist-supervised sessions .


Two measures of the motor control of gait , gait variability and smoothness of walking , were assessed pre - and postintervention by assessors masked to the treatment arm .


Of 40 randomized subjects , 38 completed the trial ( mean age SD , 77.16.0 y ) .


The motor learning group improved more than the standard group in double-support time variability ( .13 m/s vs .05 m/s ; adjusted difference [ AD ] = .006 , P = .03 ) .


Smoothness of walking in the anteroposterior direction improved more in the motor learning than standard group for all conditions ( usual : AD = .53 , P = .05 ; narrow : AD = .56 , P = .01 ; dual task : AD = .57 , P = .04 ) .


Smoothness of walking in the vertical direction also improved more in the motor learning than standard group for the narrow-path ( AD = .71 , P = .01 ) and dual-task ( AD = .89 , P = .01 ) conditions .


Among older adults with subclinical walking difficulty , there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking , while standard exercise does not .


Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults , and needs to be evaluated in a definitive larger trial .


In an attempt to investigate new strategies aimed at reducing inflammation in osteoarthritis , the anti-inflammatory effect of Elaeagnus angustifolia L. as a complementary treatment was evaluated in females with knee osteoarthritis .


In this clinical trial , 90 females with mild to moderate osteoarthritis were assigned to two intervention and one placebo groups .


In addition to the conventional therapy , the patients in intervention groups received 15g/day of E. angustifolia L. medulla and whole fruit powders respectively for 8 weeks .


The levels of tumor necrosis factor-alpha ( TNF - ) , interleukine-1 ( IL-1 ) , interleukine-10 ( IL-10 ) , matrix metalloproteinase-1 ( MMP-1 ) and -13 ( MMP-13 ) were measured with human ELISA kits .


Paired t-test and ANOVA were used for statistical analysis .


The statistically significant decrease was observed in the mean levels of serum TNF - in the medulla ( 0.004 ) and whole fruit ( 0.001 ) groups after 8 weeks of supplementation .


In contrast to the placebo group , there was a significant rise in the mean levels of serum IL-10 in medulla ( p-value = 0.01 ) and whole fruit groups ( p-value = 0.009 ) at the end of study .


The interventions resulted in significant decrease in the mean levels of serum MMP-1 in the medulla ( 0.001 ) and whole fruit ( 0.002 ) groups .


After the interventions , no significant changes were observed in the serum IL-1 and MMP-13 levels .


Daily supplementation with E. angustifolia L. in both forms of medulla and whole fruit powders appeared to be effective for decreasing inflammatory cytokines ( TNF - and MMP-1 ) and enhancing anti-inflammatory cytokines ( IL-10 ) .


We investigated whether objectively measured sedentary time was associated with markers of inflammation in adults with newly diagnosed type 2 diabetes .


We studied 285 adults ( 184 men , 101 women , mean age 59.0 9.7 ) who had been recruited to the Early ACTivity in Diabetes ( Early ACTID ) randomised controlled trial .


C-reactive protein ( CRP ) , adiponectin , soluble intracellular adhesion molecule-1 ( sICAM-1 ) , interleukin-6 ( IL-6 ) , and accelerometer-determined sedentary time and moderate-vigorous physical activity ( MVPA ) were measured at baseline and after six-months .


Linear regression analysis was used to investigate the independent cross-sectional and longitudinal associations of sedentary time with markers of inflammation .


At baseline , associations between sedentary time and IL-6 were observed in men and women , an association that was attenuated following adjustment for waist circumference .


After 6 months of follow-up , sedentary time was reduced by 0.4 1.2 h per day in women , with the change in sedentary time predicting CRP at follow-up .


Every hour decrease in sedentary time between baseline and six-months was associated with 24 % ( 1 , 48 ) lower CRP .


No changes in sedentary time between baseline and 6 months were seen in men .


Higher sedentary time is associated with IL-6 in men and women with type 2 diabetes , and reducing sedentary time is associated with improved levels of CRP in women .


Interventions to reduce sedentary time may help to reduce inflammation in women with type 2 diabetes .


To investigate the lipid-regulating effect and safety of combined statin and bezafibrate therapy in acute coronary syndrome ( ACS ) patients complicating with dyslipedemia .


One hundred and four hospitalized patients with established ACS and increased serum triglycerides ( TG ) levels and/or low serum levels of high density lipoprotein cholesterol ( HDL-C ) were selected .


Except for conventional therapy , the patients were randomly divided into 2 groups : control group ( n = 52 ) , treated with atorvastatin 20 mg qn or other statin equivalent to 20 mg atorvastatin ; treatment group ( n = 52 ) , treated with the same dose statin plus bezafibrate 200 mg bid .


The serum levels of total cholesterol ( TC ) , TG , low-density lipoprotein cholesterol ( LDL-C ) and HDL-C were assessed before and after 6 and 12 weeks treatment , side effects and adverse events were recorded .


After 6 weeks treatment , the serum levels of TC , TG and LDL-C in two groups were significantly reduced compared to baseline ( all P < 0.05 ) , which were further declined after 12 weeks treatment , and the reduction was more significant in treatment group ( 29.8 % , 38.0 % and 36.1 % , respectively ) than in control group ( 14.7 % , 9.8 % and 26.7 % , respectively ) ( all P < 0.05 ) .


After treatment , the serum levels of HDL-C in the two groups were significantly higher than the baseline levels , especially after 12 weeks treatment ( all P < 0.05 ) , and the elevations of HDL-C levels in control group and in treatment group were 19.3 % and 24.2 % , respectively , but there were no significant difference between the two groups ( P > 0.05 ) .


After 12 weeks , the rates reaching to target goals of LDL-C , TG , HDL-C , and non-HDL-C levels in the treatment group ( 69.2 % , 88.5 % , 92.3 % , 46.2 % and 65.4 % , respectively ) were significantly higher than those in the control group ( 34.6 % , 65.4 % , 46.2 % , 7.7 % and 42.3 % , respectively , all P < 0.05 ) .


No serious side effects were observed in the two groups during the treatment period .


The combined statin and bezafibrate treatment is safe and could increase the ratios of reaching target lipid levels in ACS patients complicating with increased TG and ( or ) decreased HDL-C .


Low-fluence Q-switched neodymium-doped yttrium-aluminum-garnet 1,064-nm laser ( LFQS ) and glycolic acid ( GA ) peeling have been reported as a treatment option for melasma .


However , there are limited data on their efficacy in men .


To compare the efficacy and safety of LFQS monotherapy with combined LFQS and 30 % GA peeling in male patients with melasma .


Fifteen males with mixed type melasma were randomized to receive 5 weekly sessions of LFQS on one side of the face and LFQS plus 30 % GA peeling on the contralateral side and were followed for 12 weeks .


Twelve patients completed the protocol .


Mean relative lightness index ( RL * I ) of the combined treatment side was lowered throughout the study period , with the maximal improvement of 52.3 % reduction at the fourth week follow-up ( p = .023 ) .


Patient self-assessment was favorable in the combined treatment .


However , the mean RL * I increased at 8 and 12 weeks of follow-up .


One subject ( 8.3 % ) developed guttate hypopigmentation , which did not resolve by the 12-week follow-up .


Low-fluence Q-switched neodymium-doped yttrium-aluminum-garnet 1,064-nm laser combined with GA peeling temporarily reduced melasma in men , but the incidence of side effects does not justify the short-lived benefits of this procedure .


This technique requires further study .


While physical exercise as adjunctive treatment for major depression has received considerable attention in recent years , the evidence is conflicting .


This study evaluates the effects of two different add-on treatments : exercise and basic body awareness therapy .


Randomized controlled trial with two intervention groups and one control , including 62 adults on antidepressant medication , who fulfilled criteria for current major depression as determined by the Mini International Neuropsychiatric Interview .


Interventions ( 10 weeks ) were aerobic exercise or basic body awareness therapy ( BBAT ) , compared to a single consultation with advice on physical activity .


Primary outcome was depression severity , rated by a blinded assessor using the Montgomery Asberg Rating Scale ( MADRS ) .


Secondary outcomes were global function , cardiovascular fitness , self-rated depression , anxiety and body awareness .


Improvements in MADRS score ( mean change = -10.3 , 95 % CI ( -13.5 to -7.1 ) , p = 0.038 ) and cardiovascular fitness ( mean change = 2.4 ml oxygen/kg/min , 95 % CI ( 1.5 to 3.3 ) , p = 0.017 ) were observed in the exercise group .


Per-protocol analysis confirmed the effects of exercise , and indicated that BBAT has an effect on self-rated depression .


The small sample size and the challenge of missing data .


Participants positive expectations regarding the exercise intervention need to be considered .


Exercise in a physical therapy setting seems to have effect on depression severity and fitness , in major depression .


Our findings suggest that physical therapy can be a viable clinical strategy to inspire and guide persons with major depression to exercise .


More research is needed to clarify the effects of basic body awareness therapy .


Interest in online positive psychology interventions ( OPPIs ) continues to grow .


The empirical literature has identified design factors ( e.g. , variety and duration of activities ) and moderators ( e.g. , personality traits ) that can influence their effectiveness .


A randomized controlled trial tested an empirically informed OPPI designed to promote self-efficacy and an optimistic outlook .


Pessimism was included as a trait moderator .


Participants ( N = 466 ) were English-speaking adults interested in becoming happier .


They were randomly assigned to complete either an OPPI cultivating optimism or a control condition writing about daily activities for 3 weeks .


Follow-up assessments occurred 1 and 2 months following the exercise period .


A hierarchical linear model analysis indicated that the optimism intervention increased the pursuit of engagement-related happiness in the short term and reduced dysfunctional attitudes across follow-ups .


Pessimistic individuals had more to gain and reported fewer depressive symptoms at post-test .


These findings support the conclusion that empirically informed online interventions can improve psychological well-being , at least in the short run , and may be particularly helpful when tailored to the needs of the individual .


Despite their independent cardiovascular disease ( CVD ) advantages , effects of - linolenic acid ( ALA ) , monounsaturated fatty acid ( MUFA ) , and low-glycemic-load ( GL ) diets have not been assessed in combination .


We therefore determined the combined effect of ALA , MUFA , and low GL on glycemic control and CVD risk factors in type 2 diabetes .


The study was a parallel design , randomized trial wherein each 3-month treatment was conducted in a Canadian academic center between March 2011 and September 2012 and involved 141 participants with type 2 diabetes ( HbA1c 6.5 % -8.5 % [ 48-69 mmol/mol ] ) treated with oral antihyperglycemic agents .


Participants were provided with dietary advice on either a low-GL diet with ALA and MUFA given as a canola oil-enriched bread supplement ( 31 g canola oil per 2,000 kcal ) ( test ) or a whole-grain diet with a whole-wheat bread supplement ( control ) .


The primary outcome was HbA1c change .


Secondary outcomes included calculated Framingham CVD risk score and reactive hyperemia index ( RHI ) ratio .


Seventy-nine percent of the test group and 90 % of the control group completed the trial .


The test diet reduction in HbA1c units of -0.47 % ( -5.15 mmol/mol ) ( 95 % CI -0.54 % to -0.40 % [ -5.92 to -4.38 mmol/mol ] ) was greater than that for the control diet ( -0.31 % [ -3.44 mmol/mol ] [ 95 % CI -0.38 % to -0.25 % ( -4.17 to -2.71 mmol/mol ) ] , P = 0.002 ) , with the greatest benefit observed in those with higher systolic blood pressure ( SBP ) .


Greater reductions were seen in CVD risk score for the test diet , whereas the RHI ratio increased for the control diet .


A canola oil-enriched low-GL diet improved glycemic control in type 2 diabetes , particularly in participants with raised SBP , whereas whole grains improved vascular reactivity .


Different types of exercises can help manage chronic neck pain .


Supervised exercise interventions are widely used , but these protocols require substantial resources .


The aim of this trial , which focused on adherence , was to evaluate two home exercise interventions .


This parallel group randomized controlled trial included 57 women randomly allocated into two groups - a strength training group ( STRENGTH , 34 subjects ) and a stretching group ( STRETCH , 23 subjects ) .


The interventions focused on the neck and shoulder muscles and lasted for 12 months .


The STRENGTH group performed weight training and ended each session with stretching exercises .


These stretching exercises constituted the entirety of the STRETCH group 's training session .


Both groups were instructed to exercise three times per week .


All the participants kept an exercise diary .


In addition , all participants were offered support via phone and e-mail .


The primary outcomes were pain intensity and function .


The trial included a four - to six-month and a twelve-month follow-up .


A completer in this study exercised at least 1,5 times per week during eight unbroken weeks .


A responder in this study reported clinically significant improvements on pain and function .


The statistical analyses used the Mann Whitney U-test , Wilcoxon signed-rank test , and X2 test .


At four - to six-months , the numbers of completers were 19 in the STRENGTH group and 17 in the STRETCH group .


At twelve months , the corresponding numbers were 11 ( STRENGTH ) and 10 ( STRETCH ) .


At four - to six-months , the proportions of subjects reporting clinically important changes ( STRENGTH and STRETCH ) were for neck pain : 47 % and 41 % , shoulder pain : 47 % and 47 % , function : 37 % and 29 % .


At twelve months , the corresponding numbers were for neck pain : 45 % and 40 % , shoulder pain : 55 % and 50 % , function : 55 % and 20 % .


No differences in the two primary outcomes between the two interventions were found , a finding that may be due to the insufficient statistical power of the study .


Both interventions based on home exercises improved the two primary outcomes , but the adherences were relatively low .


Future studies should investigate ways to improve adherence to home exercise treatments .


ClinicalTrials.gov Id : NCT01876680 .


We conducted a randomised , double blind , placebo controlled trial to assess the efficacy and safety of cilostazol , a selective inhibitor of phosphodiesterase 3 , in patients with vasospastic angina ( VSA ) .


Cilostazol has been shown to induce vascular dilatation , but its efficacy in patients with VSA is unknown .


Between October 2011 and July 2012 , 50 patients with confirmed VSA who had 1 angina episodes/week despite amlodipine therapy ( 5mg/day ) were randomly assigned to receive either cilostazol ( up to 200mg/day ) or placebo for 4weeks .


All patients were given diaries to record the frequency and severity of chest pain ( 0-10 grading ) .


The primary endpoint was the relative reduction of the weekly incidence of chest pain .


Baseline characteristics were similar between the two groups .


Among 49 evaluable patients ( 25 in the cilostazol group , 24 in the placebo group ) , the primary endpoint was significantly greater in the cilostazol group compared with the placebo group ( -66.588.6 % vs -17.6140.1 % , respectively , p = 0.009 ) .


The secondary endpoints , including a change in the frequency of chest pain ( -3.70.5 vs -1.90.6 , respectively , p = 0.029 ) , a change in the chest pain severity scale ( -2.80.4 vs -1.10.4 , respectively , p = 0.003 ) , and the proportion of chest pain-free patients ( 76.0 % vs 33.3 % , respectively , p = 0.003 ) also significantly favoured cilostazol .


Headache was the most common adverse event in both groups ( 40.0 % vs 20.8 % , respectively , p = 0.217 ) .


Cilostazol is an effective therapy for patients with VSA uncontrolled by conventional amlodipine therapy , and has no serious side effects .


NCT01444885 .


To study the clinical effect of development theory based acupuncture on early cerebral palsy ( CP ) infants with parafunctional sitting position .


Totally 120 early CP infants were randomly assigned to two groups equally , the treatment group and the control group .


All received acupuncture combined with training rehabilitation .


Patients in the treatment group adopted acupuncture based on infants development theory , while those in the control group were treated by head acupuncture .


Sitting functional points in Gross motor function measure ( GMFM ) 88 were observed in different groups and infant patients of various types before and after treatment .


Root mean square ( RMS ) signals of sitting correlated muscles ( latissimus dorsi , erector spinae , rectus abdominis ) were recorded by surface electromyography ( sEMG ) .


The effective rate was evaluated by Nimodipine method .


Compared with before treatment , sitting functional points were significantly improved in the two groups ( P < 0.01 ) .


After treatment , it was higher in the treatment group than in the control group ( P < 0.01 ) .


The advance amplitude was higher in CP infants of the spastic type and the hypotonic type than other types ( P < 0.01 ) .


Along with sitting process , latissimus dorsi RMS signals were gradually tapered , erector spinae RMS signals were gradually enhanced , and rectus abdominis RMS signals were slightly weakened .


Compared with the control group , latissimus dorsi RMS signals obviously decreased , and erector spinae RMS signals obviously increased in the treatment group after treatment ( all P < 0.01 ) .


The total effective rate was higher in the treatment group than in the control group ( 89.29 % vs. 77.78 % , P < 0.05 ) .


Infants development theory based acupuncture could effectively elevate dorsi-extensor muscles force , improve sitting position of 8 months to 1 year old CP infants with parafunctional sitting position .


Patients who underwent primary inguinal hernia repair still report a high rate of postoperative pain after operation due to the effect of mesh fixation by suture.An alternative is the use of human fibrin glue .


We compared the two techniques .


468 patients randomly underwent primary inguinal hernia Lichtenstein repair fixing the mesh by suture or by human fibrin glue ( HFG ) ; in both cases the mesh was fixed to the posterior wall of the inguinal canal and to the inguinal ligament .


No significant differences were recorded between the two groups in terms of complications , while the sutureless technique reduces the operative time and the postoperative pain .


A widespread technique for the treatment of inguinal hernia is the application of a mesh using Lichtenstein procedure .


The prosthesis can be fixed by traditional suture or using a new method of sutureless fixation with adhesive materials that shows an excellent local tolerability and lack of adverse effects and contraindications .


Uremic pruritus as a symptom that affects hemodialysis ( HD ) patients can decrease the quality of life and increase morbidity in these patients .


The aim of this study was to evaluate the effects of turmeric on uremic pruritus in HD patients .


This was a double-blind placebo-controlled trial conducted on 100 HD patients suffering from pruritus .


Patients ( mean age 53.3 15.8 years ) were randomized into two groups : turmeric and placebo .


The pruritus score and biochemical determinants including high-sensitivity C-reactive protein ( hs-CRP ) were compared before and at the end of the study between the two groups .


The mean decrease in hs-CRP was significantly higher in the turmeric than the placebo group ( -0.8 2.6 vs. 0.4 8.7 mg/l , p = 0.012 ) .


Also reduction of pruritus scores was greater in the turmeric than the placebo group ( 13.6 2.6 vs. 7.2 2.6 , p = 0.001 ) .


No side effect was observed during the study due to the use of turmeric .


This study demonstrates the possible efficacy of turmeric in decreasing hs-CRP and uremic pruritus in end stage renal disease patients .


Future studies are needed to further evaluate the efficacy and safety of turmeric .


Measurement of mixed venous oxygen saturation helps determine whether cardiac output and oxygen delivery are sufficient for metabolic needs .


As recommended by the American Association of Critical-Care Nurses guideline , blood samples for determining mixed venous oxygen saturation are obtained by slowly , in 1 to 2 minutes , withdrawing 1.5 mL of blood from the distal port of the pulmonary artery catheter .


In theory , the negative force of rapid withdrawal could pull oxygenated blood from the pulmonary capillary bed , causing falsely elevated saturation values .


To determine if the speed of withdrawal affects oxygen content in blood samples used to measure mixed venous oxygen saturation .


The sample consisted of heart failure patients with pulmonary artery catheters admitted to a cardiac intensive care unit .


A prospective , randomized , 2 2 crossover design was used to compare mixed venous oxygen saturation in blood samples obtained quickly or slowly .


A total of 50 sets of saturation values were analyzed .


Each set included 1 blood sample obtained slowly , in 1 to 2 minutes , and 1 obtained rapidly , in 5 seconds .


The mean difference in saturation values between the fast and the slow groups was -0.3 ( CI , -1.5 to 0.8 ; P = .55 ) , indicating that no meaningful systematic bias is attributable to fast withdrawal of blood .


Rapid blood sampling does not falsely elevate measurements of mixed venous oxygen saturation .


While many researchers often use a theoretical framework for mammogram repeat interventions , it seems they do not apply an identified mediation analysis method .


The aim of this study was to determine the mediators of mammogram replication behavior in two tailored interventions for non-adherent Iranian women .


A sample population of 184 women over 50 years old in Sanandaj , Iran , was selected for an experiment .


Participants were randomly allocated into one of the three conditions : 1 ) an intervention based on the Health Belief Model ( HBM ) 2 ) an intervention based on an integration of the HBM and selected constructs from the Theory of Planned Behavior ( TPB ) , and 3 ) a control group .


Constructs were measured before the intervention , and after a 6-month follow-up .


Perceived self-efficacy , behavioral control , and subjective norms were recognized as mediators in the HBM and selected constructs from the TPB intervention .


Perceived susceptibility , severity , barriers , self-efficacy and behavioral control met the criteria for mediation in the HBM intervention .


This study was successful in establishing mediation in a sample of women .


Our findings enrich the literature on mammography repeat , indicating key intervention factors , and relegating redundant ones in the Iranian populations .


The use of strategies to increase mammography repeat , such HBM and TPB constructs is suggested to be important for maintaining a screening behavior , once the behavior has been adopted .


The study examined the efficacy of family-based and adolescent-only HIV prevention programs in decreasing HIV risk and improving parental monitoring and sexual communication among youths in mental health treatment .


A randomized controlled trial ( RCT ) with 721 adolescents ( ages 13-18 years ) and their caregivers from mental health settings in three U.S. cities were randomly assigned to one of three theory-based , structured group interventions : family-based HIV prevention , adolescent-only HIV prevention , and adolescent-only health promotion .


Interventions were delivered during an all-day workshop .


Assessments were completed at baseline and three months postintervention .


Compared with those in the health intervention , adolescents in the HIV prevention interventions reported fewer unsafe sex acts ( adjusted rate ratio = .49 , p = .01 ) , greater condom use ( adjusted relative change = 59 % , p = .01 ) , and greater likelihood of avoiding sex ( adjusted odds ratio = 1.44 , p = .05 ) .


They also showed improved HIV knowledge ( p < .01 ) and self-efficacy ( p < .05 ) .


The family-based intervention , compared with the other interventions , produced significant improvements in parent-teen sexual communication ( p < .01 ) , parental monitoring ( p < .01 ) , and parental permissiveness ( p = .05 ) .


This RCT found that the HIV prevention interventions reduced sexual risk behavior over three months in a large , diverse sample of youths in mental health treatment and that the family-based intervention improved parental monitoring and communication with teens about sex .


These interventions show promise .


Structured educational programmes for patients at risk for anaphylaxis have not yet been established .


Patients and caregivers often lack adequate skills in managing the disease .


To investigate effects of structured patient education intervention on knowledge , emergency management skills and psychological parameters in patients with previous episodes of anaphylaxis and caregivers of affected children 95 caregivers ( 11 male , 84 female , mean age 37years ) of affected children and 98 patients ( 32 male , 66 female , mean age 47.5 years ) were randomly assigned to an intervention ( IG ) or control group ( CG ) in a multicentre randomized controlled trial .


The IG received two 3-h schooling modules of group education ; the CG received standard auto-injector training only .


Knowledge of anaphylaxis and emergency management competence in a validated training anaphylaxis situation as main outcome measures as well as secondary psychological parameters were assessed at baseline and 3months after intervention .


In comparison with controls , the intervention led to significant improvement of knowledge from baseline to 3-month follow-up ( caregivers : IG 3.2 / 13.2 improvement/baseline vs CG 0.7 / 12.6 ; P < 0.001 ; patients : IG 3.9 / 10.8 vs 1.3 / 12.6 ; P < 0.001 ) .


Moreover , emergency management competence was increased after intervention as compared to controls ( caregivers : IG 8.6 / 11.2 vs CG 1.2 / 10.8 ; P < 0.001 ; patients : 7.1 / 11.0 vs 1.1 / 11.1 ; P < 0.001 ) .


Intervention showed significant reduction of caregiver anxiety ( -1.9 / 8.4 vs -0.7 / 7.5 ; P < 0.05 ) .


There were no significant changes in the depression scores .


Structured patient education programmes may be beneficial in the management of anaphylaxis by increasing patients ' empowerment to prevent and treat the disease .


Postoperative atrial fibrillation ( POAF ) is considered to be a transient arrhythmia in the first week after cardiac surgery .


To determine the 30-day incidence and predictors of POAF and the value of postoperative overdrive biatrial pacing in the prevention of POAF .


Patients ( n = 148 ) without a history of atrial fibrillation undergoing aortic valve replacement or coronary artery bypass graft ( CABG ) were randomized into a pacing group ( n = 75 ) and a control group .


Patients were treated with standardized sotalol postoperatively .


Rhythm was continuously monitored for 30 days by a transtelephonic event recorder .


POAF occurred in 73 ( 49.3 % ) patients , of whom 60 ( 40.5 % ) patients showed POAF during postoperative days ( PODs ) 0-5 and 37 ( 25 % ) patients during PODs 6-30 .


Prolonged aortic cross-clamp time was an important univariate predictor of 30-day and of late POAF ( PODs 6-30 ; P = .017 and P = .03 , respectively ) .


Best-fit model analysis using 15 predetermined risk factors for POAF showed different positive interactive effects for early POAF ( ie , baseline C-reactive protein levels with a history of myocardial infarction or low body mass index ) and late POAF ( ie , high body mass index , diabetes mellitus , baseline C-reactive protein , early POAF , creatinine levels , type of operation , smoking , and male gender ) .


Biatrial pacing reduced the late POAF incidence in patients with aortic cross-clamp time > 50 minutes ( P = .006 ) .


POAF is not limited to the first week after cardiac surgery but also occurs frequently in the postoperative month .


It is desirable to regularly follow patients with POAF for atrial fibrillation recurrences after discharge .


Only about a third of patients with an episode of major depressive disorder remit with a given treatment and few remissions occur within the first weeks of treatment .


This study tested whether combining escitalopram and bupropion as initial treatment would result in quicker remission and a higher remission rate than monotherapy with either drug .


Two hundred forty-five outpatients aged 18-65 having non-psychotic , non-bipolar major depression were randomly assigned to double-blind treatment with bupropion or escitalopram or the combination dosed to a maximum of bupropion 450 mg/d and/or escitalopram 40 mg/d for 12 weeks .


A Montgomery-Asberg Depression Rating Scale score of 22 was required for randomization , while a Hamilton Rating Scale for Depression score 7 defined remission .


We hypothesized that bupropion plus escitalopram would outperform both monotherapies in both earlier onset of remission and higher rate of remission .


Primary analyses did not demonstrate that dual therapy outperformed both monotherapies in either timing of remission or remission rate .


All three treatments were well tolerated .


These results do not support initial use of bupropion plus escitalopram to speed or enhance antidepressant response .


NCT00519428 .


Atrial fibrillation ( AF ) often occurs after coronary artery bypass grafting ( CABG ) and can result in increased morbidity and mortality due to complications .


In the present study , our goal was to investigate whether the use of levosimendan can reduce the frequency of AF after coronary artery bypass grafting in patients with poor left ventricle function .


To investigate the effectiveness of levosimendan in the prophylaxis of AF , we conducted a prospective , randomized , placebo-controlled clinical study on 200 consecutive patients in whom we performed elective CABG operations .


Baseline characteristics were similar in both groups .


A control group of 100 patients were treated with placebo ( 500 mL saline solution ) , whereas the levosimendan group ( n = 100 patients ) was treated with levosimendan .


High-sensitivity C-reactive protein , cardiac troponin , and creatine kinaseMB levels were measured before surgery and 5 days postoperatively .


AF occurred in 12 % of the levosimendan group and 36 % of the control group .


The occurrence of AF was significantly lower in the levosimendan group ( P < 0.05 ) .


The duration of AF in the levosimendan group was significantly shorter than that in the control group ( 4.83 1.12 and 6.50 1.55 hours , respectively ; P = 0.028 ) .


Our research showed that C-reactive protein was higher postoperatively in the control group than in the levosimendan group ( P < 0.05 ) .


The incidence of postoperative AF in the levosimendan group was reduced significantly in patients with poor left ventricle function after CABG operations .


In lung cancer screening , the prevalence of chronic respiratory symptoms is high among heavy smokers .


The purpose of this study was to compare CT-derived airway wall measurements between male smokers with and those without chronic respiratory symptoms .


Fifty male heavy smokers with chronic respiratory symptoms ( cough , excessive mucus secretion , dyspnea , and wheezing ) and 50 without any respiratory symptom were randomly selected from the Dutch-Belgian Randomized Lung Cancer Screening Trial .


Thin-slice low-dose CT images were evaluated with dedicated software for airway measurements .


Wall area percentage and airway wall thickness were measured from trachea to bronchi in five different pulmonary lobes of airways with a luminal diameter of 5 mm or greater .


Association between airway wall measurements and respiratory symptoms was analyzed by multiple linear regression adjusted for age , body mass index , smoking status , emphysema , and pulmonary function .


After adjustment for relevant factors , a significant positive association between airway wall measurements and respiratory symptoms was found in airways with a luminal diameter between 5 to 10 mm ( p < 0.01 ) , but not in airways measuring 10 mm or greater ( p > 0.05 ) .


At the airway level between 5 to 10 mm , the mean wall area percentages were 51.5 % 7.9 % .


Airway wall thicknesses were 1.54 0.39 mm and 1.37 0.35 mm ( p < 0.001 ) .


Male heavy smokers with chronic respiratory symptoms in lung cancer screening , who are at high-risk of chronic bronchitis , have bronchial wall thickening in airways with a luminal diameter of 5-10 mm but not in larger airways .


Medical abortion with mifepristone and prostaglandins is well established .


We compared clinical assessment with self-assessment of abortion outcome .


This randomised , controlled , non-inferiority trial was done in four clinics in Austria , Finland , Norway , and Sweden , between Aug 16 , 2011 , and Jan 31 , 2013 .


Women aged 18 years and older who had requested medical termination of a pregnancy up to 63 days of gestation were eligible .


Computer-generated block randomisation ( block size ten ) assigned women in a 1:1 ratio to attend routine clinical follow-up or to self-assess outcome at home with a semiquantitative urine human chorionic gonadotropin ( hCG ) test 1-3 weeks after abortion .


The primary outcome was the percentage of women with complete abortion not requiring further medical or surgical intervention within 3 months .


Analysis was per protocol and by intention to treat .


The non-inferiority margin was five percentage points .


This trial is registered with ClinicalTrials.gov , number NCT01487213 .


924 women were assigned routine follow-up ( n = 466 ) or self-assessment ( n = 458 ) and included in the intention-to-treat analysis .


901 were included in the per-protocol analysis ( n = 446 and n = 455 , respectively ) .


Complete abortion was reported in 432 ( 95 % ) of 455 in the routine follow-up group and 419 ( 94 % ) of 446 women in the self-assessment group ( crude difference -10 , 95 % CI -40 to 20 ) .


20 ( 4 % ) women in the routine follow-up group and 17 ( 4 % ) in the self-assessment group required surgery .


No women in the routine follow-up group versus three in the self-assessment group had undetected continuing pregnancies .


Eight ( 18 % ) and one ( 02 % ) women , respectively , had infections ( p = 0038 ) .


Self-assessment was non-inferior to routine follow-up and could save resources .


Nordic Federation of Obstetrics and Gynaecology , European Society of Contraception , Helsinki University Central Hospital , Helse Finnmark , Swedish Research Council , and Stockholm County Council and Karolinska University Hospital .


A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries .


We report the results of long-term follow-up interim analyses and integrated efficacy analyses .


We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials , CYD14 and CYD15 , and a phase 2b trial , CYD23/57 .


We estimated vaccine efficacy using pooled data from the first 25 months of CYD14 and CYD15 .


Follow-up data were available for 10,165 of 10,275 participants ( 99 % ) in CYD14 and 19,898 of 20,869 participants ( 95 % ) in CYD15 .


Data were available for 3203 of the 4002 participants ( 80 % ) in the CYD23 trial included in CYD57 .


During year 3 in the CYD14 , CYD15 , and CYD57 trials combined , hospitalization for virologically confirmed dengue occurred in 65 of 22,177 participants in the vaccine group and 39 of 11,089 participants in the control group .


Pooled relative risks of hospitalization for dengue were 0.84 ( 95 % confidence interval [ CI ] , 0.56 to 1.24 ) among all participants , 1.58 ( 95 % CI , 0.83 to 3.02 ) among those under the age of 9 years , and 0.50 ( 95 % CI , 0.29 to 0.86 ) among those 9 years of age or older .


During year 3 , hospitalization for severe dengue , as defined by the independent data monitoring committee criteria , occurred in 18 of 22,177 participants in the vaccine group and 6 of 11,089 participants in the control group .


Pooled rates of efficacy for symptomatic dengue during the first 25 months were 60.3 % ( 95 % CI , 55.7 to 64.5 ) for all participants , 65.6 % ( 95 % CI , 60.7 to 69.9 ) for those 9 years of age or older , and 44.6 % ( 95 % CI , 31.6 to 55.0 ) for those younger than 9 years of age .


Although the unexplained higher incidence of hospitalization for dengue in year 3 among children younger than 9 years of age needs to be carefully monitored during long-term follow-up , the risk among children 2 to 16 years of age was lower in the vaccine group than in the control group .


( Funded by Sanofi Pasteur ; ClinicalTrials.gov numbers , NCT00842530 , NCT01983553 , NCT01373281 , and NCT01374516 . )


With regard to clinicopathological findings and disease prognosis , breast cancer in young women is different from that in older women .


However , few studies have investigated magnetic resonance imaging ( MRI ) characteristics of young age-onset breast cancer .


To retrospectively evaluate and compare the MR images and clinicopathological characteristics of invasive breast cancer in young women ( aged < 35 years ) with those of breast cancers in older premenopausal women ( 35-45 years ) .


A total of 270 invasive breast cancers in 266 premenopausal women aged 45 years and younger who underwent preoperative breast MRI and curative surgery were identified between 2009 and 2013 .


The subjects were divided into a young group ( < 35 years , n = 56 ) and an older group ( 35-45 years , n = 214 ) .


MRI features and clinicopathological data were compared between the two groups .


The young group had more positive axillary lymph nodes , higher histologic grade , negative estrogen receptor ( ER ) , negative progesterone receptor ( PR ) , and higher p53 and Ki-67 expression compared to the older group .


Using MRI , the young group was more likely to display a round/oval or lobular mass shape , a smooth mass margin , and a high signal intensity on T2-weighted images when compared to the older group .


In multivariate analysis , positive axillary nodal status ( adjusted odds ratio [ OR ] , 4.070 ; P = 0.002 ) , higher expression of p53 ( adjusted OR , 2.902 ; P = 0.038 ) , lobular mass shape ( adjusted OR , 4.979 ; P = 0.028 ) , and smooth mass margin ( adjusted OR , 5.123 ; P = 0.048 ) were independently associated with the young group .


MR morphologic features , including lobular mass shape and smooth mass margin , were independently associated with breast cancer in young women , in addition to positive axillary nodal status and higher p53 expression status .


Cisplatin plus 5-fluorouracil has been globally accepted as a standard regimen for the treatment for advanced gastric cancer .


However , cisplatin has several disadvantages , including renal toxicity and the need for admission .


S-1 plus cisplatin has become a standard treatment for advanced gastric cancer in East Asia .


This phase III study was designed to evaluate the potential benefits of adding docetaxel to S-1 without a platinum compound in patients with advanced gastric cancer .


Patients were randomly assigned to receive docetaxel plus S-1 or S-1 alone .


The docetaxel plus S-1 group received docetaxel on day 1 and oral S-1 on days 1-14 of a 21-day cycle .


The S-1 alone group received oral S-1 on days 1-28 of a 42-day cycle .


The primary end point was overall survival .


Of the 639 patients enrolled , 635 were eligible for analysis .


The median overall survival was 12.5 months in the docetaxel plus S-1 group and 10.8 months in the S-1 alone group ( p = 0.032 ) .


The median progression-free survival was 5.3 months in the docetaxel plus S-1 group and 4.2 months in the S-1 alone group ( p = 0.001 ) .


As for adverse events , neutropenia was more frequent in the docetaxel plus S-1 group , but remained manageable .


As first-line treatment for advanced gastric cancer , docetaxel plus S-1 significantly improves median overall and progression-free survival as compared with S-1 alone .


( ClinicalTrials.gov number : NCT00287768 ) .


Clinical skills expertise can be advanced through accessible and cost-effective video-based observational practice activities .


Previous findings suggest that the observation of performances of skills that include flaws can be beneficial to trainees .


Observing the scope of variability within a skilled movement allows learners to develop strategies to manage the potential for and consequences associated with errors .


This study tests this observational learning approach on the development of the skills of central line insertion ( CLI ) .


Medical trainees with no CLI experience ( n = 39 ) were randomised to three observational practice groups : a group which viewed and assessed videos of an expert performing a CLI without any errors ( F ) ; a group which viewed and assessed videos that contained a mix of flawless and errorful performances ( E ) , and a group which viewed the same videos as the E group but were also given information concerning the correctness of their assessments ( FA ) .


All participants interacted with their observational videos each day for 4 days .


Following this period , participants returned to the laboratory and performed a simulation-based insertion , which was assessed using a standard checklist and a global rating scale for the skill .


These ratings served as the dependent measures for analysis .


The checklist analysis revealed no differences between observational learning groups ( grand mean standard error : [ 20.3 0.7 ] / 25 ) .


However , the global rating analysis revealed a main effect of group ( d.f. 2,36 = 4.51 , p = 0.018 ) , which describes better CLI performance in the FA group , compared with the F and E groups .


Observational practice that includes errors improves the global performance aspects of clinical skill learning as long as learners are given confirmation that what they are observing is errorful .


These findings provide a refined perspective on the optimal organisation of skill education programmes that combine physical and observational practice activities .


To examine the association between individual drug use and peer leaders use .


Analysis of drug use behaviors of 525 students randomized into three arms-control , standard , and networked where peers serve as group leaders .


Among the combined male and female group , there was no association between peer leader and individual use .


Among males , peer leader use at baseline was positively associated with individual alcohol use at post-test .


Among females , peer leader use at post-test was negatively associated with marijuana and cigarette use .


Having peer leaders in the network condition decreased the odds of marijuana and cigarette use among females .


The opposite effect was found in males .


Pylorus-preserving pancreatoduodenectomy ( PPPD ) has been associated with a high incidence of delayed gastric emptying ( DGE ) .


There are few studies comparing DGE associated with PPPD and subtotal stomach-preserving pancreatoduodenectomy ( SSPPD ) .


Moreover , differences between the procedures with respect to long-term results have not been reported .


A prospective randomized study was conducted to compare perioperative complications and long-term nutritional status with PPPD and SSPPD .


One hundred patients with periampullary lesions were randomized to receive either PPPD ( n = 50 ) or SSPPD ( n = 50 ) .


All patients were followed up for 3 years after surgery or to the time of recurrence to evaluate nutritional status for the study .


The effects of the procedure , age , and malignancy on changes in nutritional indicators were estimated with linear mixed models .


This study was registered at UMIN Clinical Trials Registry ( UMIN 000012337 ) .


The incidence of DGE assessed by the International Study Group of Pancreatic Surgery was 20 % with PPPD and 12 % with SSPPD ( P = 0.414 ) .


There were no significant differences between the two procedures on postoperative serum albumin levels , serum total cholesterol levels , and body mass index during the 3-year follow-up period .


SSPPD is equally effective in DGE occurrence rate and long-term nutritional status comparing to PPPD .


To evaluate the effectiveness of two subsequent intervention components ( motivational and self-regulatory components ) , placed in different order , to promote fruit and vegetable ( FV ) intake .


After baseline assessment , university students ( N = 205 , aged 18-26 years ) were allocated to two groups .


One group received a motivational intervention ( outcome expectancies , risk perception , and task self-efficacy ) followed by a self-regulatory intervention ( planning and dietary self-efficacy ) after 17 days .


The second group received the same intervention conditions in the opposite order .


Follow-up assessments were done after another 17 days .


Both intervention sequences yielded gains in terms of FV intake and self-efficacy .


However , this gain was only due to the self-regulatory component whereas the motivational component did not contribute to the changes .


Moreover , changes in intention and self-efficacy mediated between intervention sequence and follow-up behavior , suggesting that improving these proximal predictors of FV intake was responsible for the behavioral gains .


Findings highlight the superiority of a self-regulatory intervention over a motivational intervention when it comes to dietary changes in this sample of young adults .


Moreover , changes in dietary self-efficacy may drive nutritional changes .


To assess the relative impact of an intensive lifestyle intervention ( ILI ) on use and costs of health care within the Look AHEAD trial .


A total of 5,121 overweight or obese adults with type 2 diabetes were randomly assigned to an ILI that promoted weight loss or to a comparison condition of diabetes support and education ( DSE ) .


Use and costs of health-care services were recorded across an average of 10 years .


ILI led to reductions in annual hospitalizations ( 11 % , P = 0.004 ) , hospital days ( 15 % , P = 0.01 ) , and number of medications ( 6 % , P < 0.001 ) , resulting in cost savings for hospitalization ( 10 % , P = 0.04 ) and medication ( 7 % , P < 0.001 ) .


ILI produced a mean relative per-person 10-year cost savings of $ 5,280 ( 95 % CI 3,385-7 ,175 ) ; however , these were not evident among individuals with a history of cardiovascular disease .


Compared with DSE over 10 years , ILI participants had fewer hospitalizations , fewer medications , and lower health-care costs .


To compare tidal breathing on different continuous positive airway pressure ( CPAP ) devices and pressures and to serially measure tidal breathing during weaning off CPAP using electromagnetic inductive plethysmography .


Using electromagnetic inductive plethysmography , tidal breathing was measured in 29 preterm infants receiving CPAP , gestational age 28 2 weeks .


Variable-flow nasal CPAP ( nCPAP ) , bubble CPAP ( bCPAP ) at pressures of 5 , 7 , and 9 cmH2O , nasal bi-level positive airway pressure ( nBiPAP ) system at pressures of 5 , 7/5 , and 9/5 cmH2O , and unsupported breathing were studied .


Twenty-one infants had weekly tidal breathing measurements on and off nCPAP .


Minute volume ( MV/kg ) was similar between all devices ( 0.30-0 .33 L/kg/min ) .


On bCPAP , weight corrected tidal volume ( VT/kg ) was the least , changing little with increasing pressures .


On nCPAP and nBiPAP , VT/kg increased with increasing pressure and the respiratory rate ( fR ) decreased .


The delivered pressure varied slightly from the set pressure being most dissimilar on nBiPAP and similar on bCPAP .


Compared with unsupported breathing , all devices decreased VT/kg , MV/kg , and phase angle , but did not alter fR .


Serial tidal breathing measurements showed decreasing difference for VT/kg over time on and off nCPAP .


At different pressure settings , on all CPAP devices the measured MV/kg was similar either through increasing VT/kg and decreasing fR ( nCPAP and nBiPAP ) or maintaining both ( bCPAP ) .


Serial tidal breathing measurements may aid weaning from CPAP .


Epidemiologic data suggest that low serum 25-hydroxyvitamin D [ 25 ( OH ) D ] increases insulin resistance and the risk of type 2 diabetes .


Few interventional trials have assessed the effect of vitamin D on insulin metabolism , and published results are discordant .


The goal of this study was to perform a detailed assessment of the effect of ergocalciferol administration on glucose and insulin metabolism in healthy people with low total 25 ( OH ) D ( total ) .


This was a 12-wk , double-blinded , randomized controlled trial .


We enrolled 90 healthy volunteers aged 18-45 y with serum 25 ( OH ) D 20 ng/mL ( by immunoassay ) and administered 50,000 IU ergocalciferol/wk or placebo for 12 wk .


Primary endpoints were change in first-phase insulin response and insulin sensitivity as measured by intravenous glucose tolerance test .


Secondary endpoints included change in homeostasis model assessment of insulin resistance ; fasting glucose , insulin , and lipids ; body mass index ( BMI ) ; and blood pressure .


On-study 25 ( OH ) D ( total ) was assessed by liquid chromatography-tandem mass spectrometry .


In the treated group , 25 ( OH ) D ( total ) rose from 18 7 to 43 12 ng/mL ( P < 0.001 ) with no change in the placebo group .


Despite this increase , at 12 wk , there were no between-group differences in either insulin response or insulin sensitivity ; nor were there differences in any measured secondary endpoints .


There was no evidence of effect modification by sex , race , glucose tolerance status , baseline 25 ( OH ) D ( total ) , or BMI .


In healthy persons with low 25 ( OH ) D ( total ) , ergocalciferol administration for 12 wk normalizes 25 ( OH ) D ( total ) but does not improve insulin secretion , insulin sensitivity , or other markers of metabolic health .


The high prevalence of physical inactivity has led to a search for novel and feasible interventions that will enhance physical activity , especially among the least physically active individuals .


This randomized controlled trial aimed to determine the effectiveness of a value-based intervention to promote a physically more active lifestyle among physically inactive adults .


The framework of the study was based on Acceptance and Commitment Therapy ( ACT ) .


Physically inactive participants aged 30 to 50years ( n = 138 ) were randomly allocated to a feedback ( FB , n = 69 ) or an acceptance - and commitment-based group ( ACT+FB , n = 69 ) .


Both groups received written feedback about their objectively measured physical activity and were offered a body composition analysis .


In addition , the participants in the ACT+FB group attended six group sessions and were given a pedometer for self-monitoring their physical activity during the nine-week intervention .


The primary outcome was physical activity .


In addition , participants ' cognitions related to exercise and physical activity were evaluated at baseline and at three - and six-month follow-ups .


The changes in mean physical activity level were analysed using multilevel random regression and rank order stability , using the structural equation model .


Participants in both groups increased their objectively measured and self-reported physical activity with high individual differences .


No difference was observed in the change of physical activity level between the FB and ACT+FB groups over time .


However , the cognitions related to physical activity and exercise improved more in the ACT+FB group than in the FB group .


In addition , after re-analyzing the data among the non-depressive participants , higher stability was observed in objectively measured physical activity at the individual level between the three - and six-month follow-ups in the ACT+FB group as compared to FB group .


Acceptance - and commitment-based group intervention , combined with the self-monitoring of physical activity , was beneficial in supporting the cognition related to exercise and physical activity , and brought more stability to the individual level physical activity behaviour change , especially among the non-depressive participants .


ClinicalTrials.gov , number NCT01796990 .


Registered in February 2013 .


We investigated cardiac proinflammatory , mitogenic , and apoptotic signaling events , and plasma biomarkers of inflammation and oxidative stress in de novo adult cardiac transplant ( CTX ) patients receiving tacrolimus ( TAC ) or cyclosporine A ( CsA ) .


One hundred CTX recipients were randomized 1:1 to TAC/CsA in a prospective , randomized open-label multicenter study .


Biomarkers of inflammation , immunity , oxidative stress , and cardiac signaling underlying growth and inflammation ( extracellular signal-related kinase 1/2 , p38 mitogen-activated protein kinase , mitogen-activated protein kinase kinases [ MEK ] 1/2 and 3/6 , c-Src ) , and apoptosis and survival ( c-Jun NH2-terminal kinases [ JNK ] , Bax/Bcl2 , Akt ) were assessed at 2 , 4 , 12 , 26 , and 52 weeks post-CTX .


Plasma from healthy controls ( n = 30 ) and tissue from explanted non-failing hearts ( n = 6 ) were used as controls .


Biomarkers of inflammation/immunity ( interleukin -6 and -18 , soluble intercellular adhesion molecule , E-selectin , monocyte chemoattractant protein-1 , osteopontin , fibrinogen , N-terminal prohormone brain natriuretic peptide , high-sensitive C-reactive protein ) and oxidative stress ( thiobarbituric acid reactive substances , nitrotyrosine ) were increased , and antioxidant capacity was ( glutathione/glutathione disulfide ) decreased in patients vs healthy controls ( p < 0.05 ) .


Phosphorylation of mitogen-activated protein kinases and Akt was increased , and Bax/Bcl was decreased in transplanted vs non-transplanted hearts .


Except for plasma fibrinogen , which was lower in TAC vs. CsA , ( p = 0.01 ) , there were no significant differences in parameters studied between TAC vs CsA immunoprophylaxis .


De novo CTX recipients exhibit significant sub-clinical inflammation and oxidative stress that persists 12 months after transplantation .


Associated with this is activation of myocardial growth and inflammatory signaling and decreased apoptosis .


Our findings suggest that CTX is an inflammatory condition associated with oxidative stress and myocardial growth regardless of CsA or TAC immunoprophylaxis and independently of rejection status .


To test whether a prolonged 3-hour infusion of meropenem 500mg achieves an equivalent proportion of time above the minimal inhibitory concentration ( MIC ) ( % TMIC ) to that of meropenem 1000mg given over 30 minutes .


A randomised crossover study in 10 critically ill patients .


We administered meropenem as a 1000mg , 30-minute infusion or as a 500mg , 3-hour infusion .


We determined serial plasma concentrations for each dosing episode and performed comparisons of % TMIC at different MICs .


The percentage of time that meropenem was above its MIC .


For low MICs ( 2 mg/L ) , both regimens attained a % TMIC > 40 % in all patients .


For an MIC of 4mg/L , this target was attained in all but one patient , but with an MIC of 8mg/L , three patients in each group had a % TMIC < 40 % .


There was no difference in target attainment between the two regimens for MICs up to 8mg/L .


There was marked variability in the pharmacokinetic and hence the pharmacokinetic-pharmacodynamic parameters between individuals .


Several patients had elevated creatinine clearances and , with both regimens , their target attainment was poor .


Meropenem at 1000mg over 30 minutes achieved a similar % TMIC to meropenem at 500mg given over 3 hours .


Meropenem pharmacokinetics were highly variable from individual to individual .


Probiotic bacteria have been shown to have various effects on the microbiota ; this may also affect appetite and may help promote weight loss and maintenance .


This study was conducted to investigate the effect of Lactobacillus paracasei subsp paracasei L. casei W8 ( L. casei W8 ) on glucagon-like peptide-1 ( GLP-1 ) responses in an isolated pig intestine , in piglets and postprandially in humans .


Additionally , the effect on subjective appetite , ad libitum energy intake , and glucose and insulin responses in humans was investigated .


Piglets were fed with probiotics for 2 weeks and the effect on glucagon encoding gene ( GCG ) was investigated .


An isolated pig intestine was perfused with L. casei W8 and the GLP-1 response was measured .


Twenty-one subjects completed a randomized , controlled , crossover study with three arms .


Each participant completed 3 test days testing the effect of low dose ( LD ) ( 10 ( 9 ) CFU ) , high dose ( HD ) ( 10 ( 10 ) CFU ) L. casei W8 or placebo capsule .


Subjective appetite was assessed before an ad libitum lunch was served .


GLP-1 , insulin and glucose concentrations were analyzed .


Two weeks of treatment of piglets with L. casei W8 resulted in an increase in GCG expression compared to control animals ( P < .05 ) .


L. casei W8 increased the GLP-1 response in the isolated pig intestine .


In humans , L. casei W8 had an overall effect on energy intake ( P = 0.03 ) , but no effects on subjective appetite sensation , overall glucose and insulin response and on GLP-1 release were observed ( P > 0.1 ) .


The probiotic bacteria L. casei W8 appears to lower food intake acutely , but the underlying mechanisms are not understood .


This study was designed to evaluate the role of maintenance therapy with partially hydrolyzed guar gum ( PHGG ) after topical application of glyceryl trinitrate ( GTN ) in the conservative treatment of chronic anal fissure ( CAF ) .


From all the patients with CAF observed during the study period , 165 subjects with healed CAF after standard therapy with topical GTN 0.4 % ointment were randomized to receive ( group II ) or not ( group I ) maintenance therapy with PHGG for 10 months .


Clinical and manometric followup was carried out 6 and 12 months after treatment .


At six-month followup , median visual analogue scale score was significantly higher in group I if compared with group II .


The success and recurrence rate at 12-month followup were , respectively , 38.3 % ( 28/73 ) in group I versus 58.5 % ( 41/70 ) in group II ( P = 0.019 ; Fisher 's exact test ) and 30.2 % ( 13/43 ) in group I versus 14.5 % ( 7/48 ) in group II ( P = 0.0047 ; Fisher 's exact test ) .


The maintenance therapy with PHGG in patients with healed CAF after chemical sphincterotomy by topical application of GTN 0.4 % ointment seems associated with a significant reduction of recurrence rate and with a significant increase of success rate at 12-month followup .


To determine the effects of an intensive lifestyle intervention versus a comparison group on body composition in obese or overweight persons with type 2 diabetes at baseline and at 1 , 4 , and 8 years .


Body composition was measured by dual-energy X-ray absorptiometry in a subset of 1019 Look AHEAD study volunteers randomized to intervention or comparison groups .


The intervention was designed to achieve and maintain 7 % weight loss through increased physical activity and reduced caloric intake .


The comparison group received social support and diabetes education .


At 1 year , the intervention group lost fat ( 5.60.2 kg ) and lean mass ( 2.30.1 kg ) but regained fat ( 100 % ) and lost lean mass between years 1 and 8 .


Between baseline and year 8 , weight loss was greater in intervention versus comparison groups ( 4.00.4 vs. 2.30.4 kg ) ; comparison group weight loss was mostly lean mass ( 2.10.17 kg ) .


Fat mass in the intervention group was lower than that of the comparison group at all post-baseline time points .


Reduced fat mass may place the intervention group at a lower risk of obesity-linked sequelae , a hypothesis that can be tested by future studies of this cohort .


Relations between fibroblast growth factor-23 ( FGF-23 ) , soluble - klotho ( s -- klotho ) , and kidney function in chronic kidney disease ( CKD ) are still unclear .


Especially the role of s -- klotho requires further study .


Our objectives were to analyze the relation of s -- klotho to estimated glomerular filtration rate ( eGFR ) , FGF-23 , and other parameters of calcium-phosphate metabolism and to investigate the response of s -- klotho to cholecalciferol .


Twenty-four CKD ( stage 1-5 ) patients participated in this 8-week randomized controlled trial ( vitamin D and chronic renal insufficiency ) .


Interventions included 40 000 IU cholecalciferol or placebo weekly .


S -- klotho was determined by ELISA with antihuman klotho antibodies 67G3 and 91F1 .


For all patients , s -- klotho concentrations did not differ between CKD stages .


When patients were subdivided based on FGF-23 concentrations , a positive association of s -- klotho with eGFR became apparent in patients with lower than median FGF-23 concentrations but not in those above median value .


Patients with s -- klotho below 204 pg/mL showed higher age , lower phosphate clearance , and lower bone-specific alkaline phosphatase compared with patients with higher s -- klotho .


Treatment with cholecalciferol significantly increased 1,25-dihydroxyvitamin D.


The increase of FGF-23 had only borderline significance .


There was no significant effect of high-dose cholecalciferol administration for 8 weeks on plasma s -- klotho .


CKD patients with s -- klotho below 204 pg/mL had higher age , lower phosphate clearance , and lower bone-specific alkaline phosphatase .


An association of s -- klotho with eGFR was observed only in the presence of close to normal , but not high , FGF-23 concentrations .


Cholecalciferol treatment did not change s -- klotho concentrations .


The purpose of this study was to evaluate a traditional herbal preparation , Jobelyn , for its effects on anemia and CD4 + T-cell counts in human immunodeficiency virus-positive ( HIV + ) patients in Nigeria .


An open-label pilot study involving 10 confirmed ( HIV + ) patients who were not receiving antiretroviral therapy ( ARVT ) was performed , in which the patients consumed Jobelyn for 8 weeks , at a dose of 500mg twice daily .


The pilot study was followed by a controlled trial involving 51 patients , all confirmed HIV + , where the patients with CD4 + T-cell counts below 350 cells/L were receiving ARVT .


The eight patients with baseline CD4 + T-cell counts above 350 cells/L received Jobelyn .


The remaining patients who all received ARVT were randomized to ARVT alone versus ARVT+J obelyn for 12 weeks .


Patients receiving ARVT showed a statistically significant improvement in their CD4 + T-cell counts across the 12-week study period ( p < 0.01 ) .


Patients receiving ARVT+J obelyn showed a faster improvement , reaching a high level of statistical significance compared to baseline already at 6 weeks ( p < 0.001 ) , and remained highly significant at 12 weeks ( p < 0.001 ) .


This is the first controlled study conducted to evaluate efficacy of Jobelyn on immune status in HIV + patients .


The data suggest that consumption of Jobelyn contributed to improved hemoglobin levels and increased CD4 + T-cell counts in Nigerian HIV + patients .


Further studies are needed to examine similar effects in other populations , and to elaborate on the underlying mechanisms , specifically , whether the consumption of Jobelyn supported multiple aspects of bone marrow function .


This study aims to evaluate the immediate effect of a global pelvic manipulation ( GPM ) technique , bilaterally applied , on low back pelvic pain in women with primary dysmenorrhea ( PD ) .


A prospective , randomized , double-blind , controlled trial .


Faculty of Nursing , Physiotherapy and Podiatry .


University of Sevilla , Spain .


The sample group included 40 women ( 30 6.10 years ) that were divided into an experimental group ( EG ) ( N = 20 ) who underwent a bilateral GPM technique and a control group ( CG ) ( N = 20 ) who underwent a sham ( placebo ) intervention .


Evaluations were made of self-reported low back pelvic pain ( visual analog scale ) , pressure pain threshold ( PPT ) in sacroiliac joints ( SIJs ) , and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels .


The intragroup comparison showed a significant improvement in the EG in the self-perceived low back pelvic pain ( P = 0.003 ) and in the mechanosensitivity in both SIJs ( P = 0.001 ) .


In the between-group comparison , there was a decrease in pain perception ( P = 0.004 ; F ( 1,38 ) = 9.62 ; R ( 2 ) = 0.20 ) and an increase in the PPT of both SIJs , in the right side ( P = 0.001 ; F ( 1,38 ) = 21.29 ; R ( 2 ) = 0.35 ) and in the left side ( P = 0.001 ; F ( 1,38 ) = 20.63 ; R ( 2 ) = 0.35 ) .


There were no intergroup differences for catecholamines plasma levels ( adrenaline P = 0.123 ; noradrenaline P = 0.281 ; dopamine P = 0.173 ) , but there were for serotonin levels ( P = 0.045 ; F ( 1,38 ) = 4.296 ; R ( 2 ) = 0.10 ) .


The bilateral GPM technique improves in a short term the self-perceived low back pelvic pain , the PPT in both SIJs , and the serotonin levels in women with PD .


It shows no significant differences with a sham intervention in catecholamines plasma levels .


To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis ( ERA ) , and whether adalimumab provides an additional effect .


In a double-blind , placebo-controlled trial , 85 disease-modifying antirheumatic drug-nave patients with ERA were randomised to receive methotrexate , intra-articular glucocorticosteroid injections and placebo/adalimumab ( 43/42 ) .


Contrast-enhanced MRI of the right hand was performed at months 0 , 6 and 12 .


Synovitis , osteitis , tenosynovitis , MRI bone erosion and joint space narrowing ( JSN ) were scored with validated methods .


Dynamic contrast-enhanced MRI ( DCE-MRI ) was carried out in 14 patients .


Synovitis , osteitis and tenosynovitis scores decreased highly significantly ( p < 0.0001 ) during the 12-months ' follow-up , with mean change scores of -3.7 ( median -3.0 ) , -2.2 ( -1 ) and -5.3 ( -4.0 ) , respectively .


No overall change in MRI bone erosion and JSN scores was seen , with change scores of 0.1 ( 0 ) and 0.2 ( 0 ) .


The tenosynovitis score at month 6 was significantly lower in the adalimumab group , 1.3 ( 0 ) , than in the placebo group , 3.9 ( 2 ) , Mann-Whitney : p < 0.035 .


Furthermore , the osteitis score decreased significantly during the 12-months ' follow-up in the adalimumab group , but not in the placebo group , Wilcoxon : p = 0.001-0 .002 and p = 0.062-0 .146 .


DCE-MRI parameters correlated closely with conventional MRI inflammatory parameters .


Clinical measures decreased highly significantly during follow-up .


A treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with ERA effectively decreased synovitis , osteitis and tenosynovitis and halted structural damage progression as judged by MRI .


The findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis .


This report describes the result of prospective randomized trial to assess effectiveness and safety of neoadjuvant photodynamic therapy ( PDT ) and chemotherapy as well as possibility for further surgery for locally advanced NSCLC .


Patients with stage IIIA and IIIB central NSCLC ( main bronchus/distal trachea involvement ) who were not initially eligible for surgery but might be considered as surgery candidates after neoadjuvant therapy were enrolled in the study .


They were randomized to either neoadjuvant chemotherapy and endobronchial PDT or chemotherapy alone followed by surgical resection .


PDT was done with photosensitizer agent chlorine E6 and 662nm laser light before each of the three courses of chemotherapy .


From January 2008 to December 2011 , 42 patients were assigned to PDT arm ( n = 21 ) and No-PDT arm ( n = 21 ) .


Groups were similar with respect to age , sex , tumor stage , and histology .


No PDT major complications were observed .


After neoadjuvant treatment partial response revealed in 19pts ( 90 % ) in PDT arm and 16pts ( 76 % ) in No-PDT arm ( p = 0.460 ) , these patients underwent thoracotomy .


After thoracotomy tumor was unresectable in 3pts of No-PDT arm ( 19 % ) .


There were 14 pneumonectomies and 5 lobectomies in PDT arm vs. 10 pneumonectomies and 3 lobectomies in No-PDT arm .