However , miniperc resulted in more complications , greater operative time and radiation exposure , and a longer hospital stay .


Blood biomarkers are increasingly used to diagnose , guide therapy in , and risk-stratify community-acquired pneumonia ( CAP ) patients in emergency departments ( EDs ) .


How pre-analytic factors affect these markers ' initial levels in this population is unknown .


In this secondary analysis of consecutive ED patients with CAP from a large multicentre antibiotic stewardship trial , we used adjusted multivariate regression models to determine the magnitude and statistical significance of differences in mean baseline concentrations of five biomarkers ( procalcitonin [ PCT ] , C-reactive protein [ CRP ] , white blood cells count [ WBC ] , proadrenomedullin [ ProADM ] , copeptin ) associated with six pre-analytic factors ( antibiotic or corticosteroid pretreatment , age , gender , chronic renal failure or chronic liver insufficiency ) .


Of 925 CAP patients ( median age 73 years , 58.8 % male ) , 25.5 % had antibiotic pretreatment , 2.4 % , corticosteroid pretreatment , 22.3 % , chronic renal failure , 2.4 % chronic liver insufficiency .


Differences associated with pre-analytic factors averaged 6.1 % 4.6 % ; the three largest statistically significant changes ( 95 % confidence interval ) were : PCT , +14.2 % ( +2.1 % to +26.4 % , p = 0.02 ) with liver insufficiency ; ProADM , +13.2 % ( +10.2 % to +16.1 % , p < 0.01 ) with age above median ; CRP , -12.8 % ( -25.4 % to -0.2 % , p = 0.05 ) with steroid pretreatment .


In post hoc sensitivity analyses , reclassification statistics showed that these factors did not result in significant changes of biomarker levels across clinically used cut-off ranges .


Despite statistically significant associations of some pre-analytic factors and biomarker levels , a clinically relevant influence seems unlikely .


Our observations reinforce the concept of using biomarkers in algorithms with widely-separated cut-offs and overruling criteria considering the entire clinical picture .


Identifier ISRCTN95122877 .


Malaria prophylaxis is recommended for persons with sickle cell disease ( SCD ) , but the value of this has been questioned .


The aim of this study was to find out whether intermittent preventive treatment ( IPT ) with a fixed-dose combination of mefloquine-artesunate ( MQAS ) or sulfadoxine-pyrimethamine plus amodiaquine ( SPAQ ) was more effective than daily proguanil for malaria prevention in subjects with SCD .


Patients with SCD were randomized to receive daily treatment with proguanil or IPT with either MQAS or SPAQ once every 2 months at routine clinic visits .


Patients were followed up for 14 months .


A total of 270 patients with SCD were studied , with 90 in each group .


Adherence to the IPT regimens was excellent , but 57 % of patients took < 75 % of their daily doses of proguanil .


IPT was well tolerated ; the most common side effects were vomiting and abdominal pain .


Protective efficacy against malaria , compared with daily proguanil , was 61 % ( 95 % confidence interval , 3 % -84 % ) for MQAS and 36 % ( 40 % -70 % ) for SPAQ .


There were fewer outpatient illness episodes in children who received IPT than those who received proguanil .


IPT with MQAS administered to patients with SCD during routine clinic visits was well tolerated and more effective in preventing malaria than daily prophylaxis with proguanil .


NCT01319448 and ISRCTN46158146 .


To compare the clinical effectiveness of a newly developed cognitive behavioural self-management manual delivered by specialist heart failure nurses or the same programme followed by the patient on their own , in terms of readmissions/admissions to hospital for any reason within a 12 month period , patient health related quality of life , self-management and carer quality of life .


Pragmatic , open parallel group , randomised controlled trial .


Open access heart failure diagnostic clinics and primary care .


260 patients with a definitive diagnosis of symptomatic heart failure ( LVSD ) as defined by ECHO , clinical diagnosis or coronary angiography were eligible for the study .


A newly developed nurse facilitated , cognitive behavioural self-management programme was developed and was delivered either by a heart failure nurse or by the patient on their own .


Patient admission/readmission to hospital for any reason within a 12 month period following randomisation .


Secondary outcomes were : participant health related quality of life as measured by the Minnesota Living with Heart Failure questionnaire , the Hospital , Anxiety and Depression Scale , the European self-care form .


There was no evidence of a difference between the groups in whether or not a patient was re-admitted to hospital during the 12 month follow-up period ( p = 0.66 ) .


There was no evidence of a difference between the treatment groups in the mean MLHF scores over time ( p = 0.768 ) , the European self-care questionnaire ( p = 0.340 ) or the mean HAD anxiety score ( p = 0.786 ) .


However , when adjusted for baseline scores the self-management group had a statistically significant higher HADS depression score at 12 months ( p = 0.003 ) .


There was no evidence of a difference in admissions/readmission to hospital between patients who undertook a brief heart failure self-management programme facilitated by a specialist heart failure nurse and those also receiving care from a specialist nurse who followed the programme on their own .


This trial is registered as ISRCTN84692046 .


For advanced gastrointestinal stromal tumour ( GIST ) patients who are responding to imatinib mesylate , the role of surgery has not been formally demonstrated .


This multicenter randomised controlled trial was designed to assess whether surgery to treat residual disease for patients with recurrent/metastatic GISTs responding to imatinib mesylate ( IM ) improved progression free survival ( PFS ) compared with IM treatment alone .


Between 3 and 12months after starting IM for recurrent/metastatic GISTs , eligible patients were randomised to two arms : Arm A ( surgery for residual disease ) and Arm B ( IM treatment alone ) .


In Arm A ( 19pts ) , surgery was performed to remove residual macroscopic lesions as completely as possible , and IM treatment continued after surgery .


In Arm B ( 22pts ) , IM was given alone at a dose of 400mg per day until disease progression .


The primary end-point was PFS measured from the date IM started .


This study was registered in the ChiCTR registry with the ID number ChiCTR-TRC-00000244 .


This randomised trial was closed early due to poor accrual .


Only 41 patients were enrolled as opposed to 210 patients planned .


2-year PFS was 88.4 % in the surgery arm and 57.7 % in the IM-alone arm ( P = 0.089 ) .


Median overall survival ( mOS ) was not reached in the surgery arm and 49months in patients with IM-alone arm ( P = 0.024 ) .


While no significant differences were observed in the two arms , this study suggests that surgical removal of the metastatic lesion may improve the outcome of advanced GIST patients and should stimulate additional research on this topic .


The aim of this study was to compare the effects of low-volume , high-intensity aerobic interval training ( HAIT ) on maximal oxygen consumption ( VOmax ) , left ventricular ( LV ) mass , and heart rate recovery ( HRR ) with high-volume , moderate-intensity continuous aerobic training ( CAT ) in sedentary adults .


Twenty-four healthy but sedentary male adults ( aged 29.2 7.2 years ) participated in an 8-week , 3-day a week , supervised exercise intervention .


They were randomly assigned to either HAIT ( 18 min , 180 kcal per exercise session ) or CAT ( 45 min , 360 kcal ) .


VOmax , LV mass ( 3T-MRI ) , and HRR at 1 min ( HRR-1 ) and 2 min ( HRR-2 ) after maximal exercise were measured pre - and post-intervention .


Changes in VOmax during the 8-week intervention were significant ( P < 0.01 ) in both groups ( HAIT , 8.7 3.2 ml kg ( -1 ) min ( -1 ) , 22.4 8.9 % ; CAT , 5.5 2.8 ml kg ( -1 ) min ( -1 ) , 14.7 9.5 % ) , while the VOmax improvement in HAIT was greater ( P = 0.02 ) than in CAT .


LV mass in HAIT increased ( 5.1 8.4 g , 5.7 9.1 % , P = 0.05 ) , but not in CAT ( 0.9 7.8 g , 1.1 8.4 % , P = 0.71 ) .


While changes in HRR-1 were not significant in either group , change in HRR-2 for HAIT ( 9.5 6.4 bpm , 19.0 16.0 % , P < 0.01 ) was greater ( P = 0.03 ) than for CAT ( 1.6 10.9 bpm , 3.9 16.2 % , P = 0.42 ) .


This study suggests that HAIT has potential as a time-efficient training mode to improve cardiorespiratory capacity and autonomic nervous system function in sedentary adults .


To investigate short - and long-term effects of real-time monitoring medication use combined with short message service ( SMS ) reminders for missed doses on refill adherence to oral anti-diabetic medication .


A randomized controlled trial with two intervention groups and one control group involving 161 participants with Type2 diabetes with suboptimal adherence .


For 6months , participants in the SMS group ( n = 56 ) were monitored and received SMS reminders if they missed their medication .


Participants in the non-SMS group ( n = 48 ) were only monitored .


The control group ( n = 57 ) was not exposed to any intervention .


Primary outcome measure was refill adherence to oral anti-diabetic medication .


Multi-level regression analyses were performed to examine intervention effects on adherence between and within groups after 1 and 2years of follow-up .


At baseline , mean refill adherence was comparable between the groups .


After 1year , adherence in the SMS group was significantly higher than in the control group ( 79.5 % vs. 64.5 % ; P < 0.001 ) and showed a significant improvement from baseline ( +16.3 % ; P < 0.001 ) .


Mean adherence in the non-SMS group reached 73.1 % ( +7.3 % ; P < 0.05 ) , but did not differ from the control group ( P = 0.06 ) .


After 2years , the improved adherence in the SMS group persisted and remained significantly higher than in the control group ( 80.4 % vs. 68.4 % ; P < .01 ) , contrary to the non-SMS group whose adherence approached baseline level again ( 65.5 % ) .


This study shows the long-term effectiveness of real-time medication monitoring combined with SMS reminders in improving refill adherence .


This new reminder system can strengthen the self-management of people with diabetes .


Rheumatoid arthritis ( RA ) , as a common systemic inflammatory autoimmune disease , affects approximately 1 in 100 individuals .


Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA .


Xinfeng Capsule , a patent Chinese herbal medicine , has been used in the treatment of RA in recent years .


Despite its reported clinical efficacy , there are no large-sample , multicenter , randomized trials that support the use of Xinfeng Capsule for RA .


Therefore , we designed a randomized , double-blind , multicenter , placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA .


This is a 12-week , randomized , placebo-controlled , double-blind , multicenter trial on the treatment of RA .


The participants will be randomly assigned to the experimental group and the control group at a ratio of 1:1 .


Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo ( imitation leflunomide ) .


The control group will receive leflunomide and an herbal placebo ( imitation Xinfeng Capsule ) .


The American College of Rheumatology ( ACR ) Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule .


The primary outcome measure will be the percentage of study participants who achieve an ACR 20 % response rate ( ACR20 ) , which will be measured every 4 weeks after randomization .


Secondary outcomes will include the ACR50 and ACR70 responses , the side effects of the medications , the Disease Activity Score 28 , RA biomarkers , quality of life , and X-rays of the hands and wrists .


The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment .


The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA .


This trial has been registered in ClinicalTrials.gov .


The identifier is NCT01774877 .


Despite rehabilitation programmes offered to all patients with newly diagnosed type 2 diabetes in Denmark , a number of patients either never accomplish good diabetes regulation or the regulation deteriorates with time .


Therefore , new approaches are needed .


The aim of the present study is to examine whether telemedicine conferences with a nurse can contribute to achieving good diabetes control among patients with poorly regulated type 2 diabetes .


A total of 165 patients with type 2 diabetes who have formerly undergone a rehabilitation programme are randomized to either telemedicine intervention or usual care .


The intervention lasts for 32 weeks and consists of monthly videoconferences with a nurse from a health-care centre as an add-on to usual care .


Blood sugar , blood pressure and weight are regularly self-monitored and measurements are automatically transferred to a database .


Glycaemic control ( HbA1c level ) is examined at baseline , 16 weeks , 32 weeks and 58 weeks ( six months post intervention ) .


Blood pressure , weight , waist/hip ratio , quality of life , physical activity , lipids , creatinine and haemoglobin are examined at baseline and after 32 weeks .


The study will examine whether telemedicine technology can contribute to achieving good diabetes regulation .


The City of Copenhagen and the Prevention Fund of the Capital Region of Denmark funded the project .


Also `` Smedemester Niels Hansen og Hustru Johanne F. Frederiksens Legat '' has supported the study .


ClinicalTrials.gov registration number : NCT01688778 .


Different aspiration techniques to retrieve bronchoalveolar lavage fluid ( BALF ) affect sample quality in healthy dogs .


Studies evaluating these techniques in dogs with respiratory disease are lacking .


To compare sample quality of BALF acquired by manual aspiration ( MA ) and suction pump aspiration ( SPA ) .


Eighteen client-owned dogs with respiratory disease .


Randomized , blinded prospective clinical trial .


Manual aspiration was performed with a 35-mL syringe attached directly to the bronchoscope biopsy channel and SPA was performed with a maximum of 50 mmHg negative pressure applied to the bronchoscope suction valve using the suction trap connection .


Both aspiration techniques were performed in each dog on contralateral lung lobes , utilizing 2 mL/kg lavage volumes per site .


Samples of BALF were analyzed by percentage of retrieved infusate , total nucleated cell count ( TNCC ) , differential cell count , semiquantitative assessment of slide quality , and diagnosis score .


Data were compared by paired Student 's t-test , Wilcoxon signed-rank test , chi-squared test , and ANOVA .


Cohen 's kappa coefficient was used to assess agreement .


The percentage of retrieved BALF ( P = .001 ) was significantly higher for SPA than MA .


Substantial agreement was found between cytologic classification of BALF obtained with MA and SPA ( kappa = 0.615 ) .


There was no significant difference in rate of definitive diagnosis achieved with cytologic assessment between techniques ( P = .78 ) .


Suction pump aspiration , compared to MA , improved BALF retrieval , but did not significantly affect the rate of diagnostic success of bronchoalveolar lavage ( BAL ) in dogs with pulmonary disease .


As a Chinese Traditional Medicine product , Kuntai capsule could improve the peri-menopausal symptoms in postmenopausal women .


But it is still not clear whether Kuntai capsule has a good effect on alleviating peri-menopausal symptoms induced by gonadotropin releasing hormone agonist ( GnRH-a ) treatment .


The purpose of this study was to investigate the clinical effectiveness and safety of Kuntai capsule , on peri-menopausal symptoms in endometriosis ( EMS ) patients , with postoperative GnRH-a treatment .


Ninety EMS ovarian cyst women with postoperative GnRH-a administration were enrolled in the study , and were randomly divided into Kuntai group , Tibolone group , or blank Control group .


The therapeutic strategy in Kuntai group was 4 Kuntai capsules tid , po for 12 weeks after the first GnRH-a injection , while Tibolone 2.5 mg qd , po for 12 weeks in Tibolone group .


There was no drug addition in Control group .


Climacteric complaints were evaluated by Kupperman menopausal index ( KMI ) and hot flash/sweating score .


Liver and renal functions , lipid profile , serum sex hormone levels and endometrial thickness were measured , and the frequency of adverse events in Kuntai and Tibolone groups was recorded .


( 1 ) Before GnRH-a therapy , the baseline parameter results were comparable in the three groups ( P > 0.05 ) .


( 2 ) After GnRH-a therapy , KMI and hot flash/sweating scores in all the three groups increased significantly ( P < 0.05 ) .


At the 4 th week after GnRH-a therapy , KMI and hot flash/sweating score results were as follows : Control group > Kuntai group > Tibolone group ( P < 0.05 ) ; at the 8 th and 12 th week after GnRH-a therapy , KMI and hot flash/sweating score in Control group were significantly higher than the other two groups ( P < 0.05 ) , and no significant difference was identified between Kuntai and Tibolone group ( P > 0.05 ) .


( 3 ) No statistical change took place in the liver and renal functions and lipid profile in all the three groups after the treatment ( P > 0.05 ) .


( 4 ) The posttherapeutic serum follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) and estradiol ( E2 ) level and endometrial thickness decreased significantly in all the three groups ( P < 0.05 ) .


After therapy , serum E2 level in Tibolone group was obviously higher than the other two groups ( P < 0.05 ) , while FSH and LH levels were obviously lower ( P < 0.05 ) .


( 5 ) The incidence of vaginal bleeding , breast distending pain in Tibolne group was obviously higher than Kuntai group ( P < 0.05 ) .


Kuntai capsule is effective on the peri-menopausal symptoms induced by postoperative GnRH-a administration to EMS patients , although its clinical effect might be a few weeks later than Tibolone .


Kuntai capsule might be a little safer than Tibolone tablet .


The purpose of this clinical investigation was to evaluate the effectiveness of a marketed whitening chewing gum compared to a no-gum control in preventing the formation of extrinsic stains on the teeth of stain-forming subjects when chewed over a 12-week period of regular unsupervised use in conjunction with daily tooth brushing .


This was a single-center , examiner-blind , randomized , 12-week crossover clinical trial .


Stain-forming ( after smoking or drinking coffee or tea ) adults , starting with a stain-free baseline , either chewed the test gum ( Orbit White ) unsupervised four times per day , 15 minutes/chew , or used no gum along with daily brushing with a commercially available toothbrush and dentifrice for 12 weeks .


At the crossover , all procedures were repeated with subjects assigned the opposite treatment .


Extrinsic stain was measured at six and 12 weeks by both the Lobene Stain Index ( LSI ) and the Modified Lobene Stain Index ( MLSI ) using separate experienced examiners .


After 12 weeks , LSI stain scores showed a significant 25 % reduction ( p = 0.0008 ) in new stain formation for subjects using the test chewing gum along with tooth brushing versus tooth brushing alone ( no-gum control ) .


The corresponding MLSI stain scores demonstrated a 36 % reduction ( p < 0.0001 ) in the formation of extrinsic stain on the teeth .


The overall findings of this clinical study demonstrated that regular use of Orbit White chewing gum , soon after smoking or drinking coffee or tea , will supplement daily tooth brushing in preventing unsightly stains from forming on the anterior teeth compared to brushing alone .


To evaluate the effectiveness and safety of cervical arthroplasty and anterior cervical discectomy fusion methods .


The randomised clinical trial was conducted at the neurosurgical clinic of University of Harran , Turkey , between February 2009 and January 2010 .


The patients had single level disc disorder between C4-C7 levels .


Before surgery , all of the patients had taken medical treatment with no improvement .


Surgery was conducted with anterior approach , and disc prosthesis or polyetheretherketone cage for fusion were applied after patients were randomly divided into two groups .


For preoperative and postoperative clinical evaluations Neck Disability Index and Visual Analogue Scale were used .


Surgical results were evaluated according to Odom 's criterion , and ` excellent ' and ` good ' results were accepted as successful .


P < 0.05 was taken as statistically significant .


Of the 42 patients in the study , 23 ( 54.76 % ) were treated with Anterior Cervical Discectomy and Fusion , and 19 ( 45.23 % ) with Cervical Disc Arthroplasty .


There were no statistical differences between postoperative mean Visual Analogue Scale score ( p < 0.86 ) and Neck Disability Index scores ( p < 0.11 ) in the two groups .


Average decrease in lordosis angle was 1.2 degree in Arthroplasty group , while it was 1 degree in the Fusion group .


Postoperative adjacent segment degeneration was not detected in either group .


Anterior Cervical Discectomy and Fusion , and Cervical Disc Arthroplasty are safe and successful methods for the treatment of single level cervical disc disease .


Although the latter is a relatively new technique performed with increased frequency , but its superiority is still uncertain .


The objective of study was to develop an accurate and reproducible HPLC method for determination of piracetam in human plasma and to evaluate pharmacokinetic parameters of 800 mg piracetam .


A simple , rapid , accurate , precise and sensitive high pressure liquid chromatography method has been developed and subsequently validated for determination of piracetam .


This study represents the results of a randomized , single-dose and single-period in 18 healthy male volunteers to assess pharmacokinetic parameters of 800 mg piracetam tablets .


Various pharmacokinetic parameters were determined from plasma for piracetam and found to be in good agreement with previous reported values .


The data was analyzed by using Kinetica version 4.4 according to non-compartment model of pharmacokinetic analysis and after comparison with previous studies , no significant differences were found in present study of tested product .


The major pharmacokinetic parameters for piracetam were as follows : t1/2 was ( 4.40 0.179 ) h ; Tmax value was ( 2.33 0.105 ) h ; Cmax was ( 14.53 0.282 ) g/mL ; the AUC ( 0 - ) was ( 59.19 4.402 ) gh/mL .


AUMC ( 0 - ) was ( 367.23 38.96 ) g. ( h ) ( 2 ) / mL ; Ke was ( 0.16 0.006 ) h ; MRT was ( 5.80 0.227 ) h ; Vd was ( 96.36 8.917 L ) .


A rapid , accurate and precise high pressure liquid chromatography method was developed and validated before the study .


It is concluded that this method is very useful for the analysis of pharmacokinetic parameters , in human plasma and assured the safety and efficacy of piracetam , can be effectively used in medical practice .


To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia .


Three-arm , single-site , randomized controlled trial .


Academic medical center .


Fifty-four adults with chronic insomnia .


Participants were randomized to either mindfulness-based stress reduction ( MBSR ) , mindfulness-based therapy for insomnia ( MBTI ) , or an eight-week self-monitoring ( SM ) condition .


Patient-reported outcome measures were total wake time ( TWT ) from sleep diaries , the pre-sleep arousal scale ( PSAS ) , measuring a prominent waking correlate of insomnia , and the Insomnia Severity Index ( ISI ) to determine remission and response as clinical endpoints .


Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy .


Linear mixed models showed that those receiving a meditation-based intervention ( MBSR or MBTI ) had significantly greater reductions on TWT minutes ( 43.75 vs 1.09 ) , PSAS ( 7.13 vs 0.16 ) , and ISI ( 4.56 vs 0.06 ) from baseline-to-post compared to SM .


Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures , but no significant differences were found when comparing MBSR to MBTI from baseline-to-post .


From baseline to 6-month follow-up , MBTI had greater reductions in ISI scores than MBSR ( P < 0.05 ) , with the largest difference occurring at the 3-month follow-up .


Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up , with MBTI showing the highest rates of treatment remission ( 50 % ) and response ( 78.6 % ) at the 6-month follow-up .


Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia .


Mindfulness-Based Approaches to Insomnia : clinicaltrials.gov , identifier : NCT00768781 .


To determine the effect of nurse-implemented transitional care ( TC ) on readmission and mortality rates in Chinese individuals with chronic heart failure ( CHF ) in Hong Kong .


Single-center randomized controlled trial of TC versus usual care ( UC ) .


University-affiliated hospital in Hong Kong .


Hospitalized Chinese individuals with CHF ( N = 178 ; aged 78.6 6.9 , 45 % male ) .


The TC group received a predischarge visit , two home visits , and then regular telephone calls over 9 months to provide self-care education and support , optimized health surveillance , and facilitation in use of community services .


Primary endpoints were event-free survival , all-cause hospital readmission , and mortality during the 9-month follow-up .


Secondary endpoints were length of hospital stay , self-care , and health-related quality of life ( HRQL ) .


Data were analyzed using survival analysis and generalized estimating equations , following an intention-to-treat principle .


Survival analysis indicated no significant differences in event-free survival , hospital readmission , or mortality between the TC and UC groups , although the TC group had a lower hospital readmission rate at 6 weeks ( 8.1 % vs 16.3 % , P = .048 ) and lower mortality at 9 months ( 4.1 % vs 13.8 % , P = .03 ) .


The TC group also had a shorter hospital stay ( P = .006 ) and significantly better self-care and HRQL .


Because of attrition , sensitivity analyses were conducted to examine whether the intention-to-treat assumption affected the results .


Per-protocol population analyses ( hazard ratio ( HR ) = 0.40 , 95 % confidence interval ( CI ) = 0.17-0 .93 ) and worst-case-scenario analysis ( HR = 0.44 , 95 % CI = 0.25-0 .77 ) suggested a lower mortality risk in the TC group .


The translation of individual-centered nurse-implemented TC to the Chinese culture and healthcare context of Hong Kong appears beneficial .


To investigate the mechanism of action of tranexamic acid ( TXA ) in bleeding trauma patients , we examined the timing of its effect on mortality .


We hypothesised that if TXA reduces mortality by decreasing blood loss , its effect should be greatest on the day of the injury when bleeding is most profuse .


However , if TXA reduces mortality via an anti-inflammatory mechanism its effect should be greater over the subsequent days .


Exploratory analysis , including per-protocol analyses , of data from the CRASH-2 trial , a randomised placebo controlled trial of the effect of TXA on mortality in 20,211 trauma patients with , or at risk of , significant bleeding .


We examined hazard ratios ( HR ) and 95 % confidence intervals for all-cause mortality , deaths due to bleeding and non-bleeding deaths , according to the day since injury .


The CRASH-2 trial is registered as ISRCTN86750102 and ClinicalTrials.gov NCT00375258 .


The effect of TXA on mortality is greatest for deaths occurring on the day of the injury ( HR all-cause mortality = 0.83 , 0.73 to 0.93 ) .


This survival benefit is only evident in patients in whom treatment is initiated within 3 hours of their injury ( HR 3 hours = 0.78 , 0.68 to 0.90 ; HR > 3 hours = 1.02 , 0.76 to 1.36 ) .


Initiation of TXA treatment within 3 hours of injury reduced the hazard of death due to bleeding on the day of the injury by 28 % ( HR = 0.72 , 0.60 to 0.86 ) .


TXA treatment initiated beyond 3 hours of injury appeared to increase the hazard of death due to bleeding , although the estimates were imprecise .


Early administration of tranexamic acid appears to reduce mortality primarily by preventing exsanguination on the day of the injury .


Photoperiod is known to cause physiological changes in seasonal mammals , including changes in body weight , physical activity , reproductive status , and adipose tissue gene expression in several species .


The objective of this study was to determine the effects of day length on the adipose transcriptome of cats as assessed by RNA sequencing .


Ten healthy adult neutered male domestic shorthair cats were used in a randomized crossover design study .


During two 12-wk periods , cats were exposed to either short days ( 8 hr light :16 hr dark ) or long days ( 16 hr light :8 hr dark ) .


Cats were fed a commercial diet to maintain baseline body weight to avoid weight-related bias .


Subcutaneous adipose biopsies were collected at wk 12 of each period for RNA isolation and sequencing .


A total of 578 million sequences ( 28.9 million/sample ) were generated by Illumina sequencing .


A total of 170 mRNA transcripts were differentially expressed between short day - and long day-housed cats .


89 annotated transcripts were up-regulated by short days , while 24 annotated transcripts were down-regulated by short days .


Another 57 un-annotated transcripts were also different between groups .


Adipose tissue of short day-housed cats had greater expression of genes involved with cell growth and differentiation ( e.g. , myostatin ; frizzled-related protein ) , cell development and structure ( e.g. , cytokeratins ) , and protein processing and ubiquitination ( e.g. , kelch-like proteins ) .


In contrast , short day-housed cats had decreased expression of genes involved with immune function ( e.g. , plasminogen activator inhibitor 1 ; chemokine ( C-C motif ) ligand 2 ; C-C motif chemokine 5 ; T-cell activators ) , and altered expression of genes associated with carbohydrate and lipid metabolism .


Collectively , these gene expression changes suggest that short day housing may promote adipogenesis , minimize inflammation and oxidative stress , and alter nutrient metabolism in feline adipose tissue , even when fed to maintain body weight .


Although this study has highlighted molecular mechanisms contributing to the seasonal metabolic changes observed in cats , future research that specifically targets and studies these biological pathways , and the physiological outcomes that are affected by them , is justified .


The purpose of this study was to investigate the effect of lutein on systemic complement activation in elderly individuals .


Seventy patients with signs of early age-related macular degeneration ( AMD ) were included in this study .


All subjects were randomly assigned to receive a 10 mg daily dose of lutein or a placebo for a time period of 1 year .


EDTA blood was collected before and at various time-points during the study ( 0 , 4 , 8 and 12 months ) .


The plasma level of the soluble complement membrane attack complex sC5b-9 was measured by ELISA .


We found a significant 1.1 ng/ml monthly decrease in the plasma sC5b-9 concentration in the lutein group ( p < 0.001 ) , resulting in a decrease from 60.3 ng/ml at baseline to 46.3 ng/ml at 12 months .


For the placebo group , we found a significant 0.6 ng/ml monthly increase in plasma sC5b-9 concentration ( p = 0.001 ) , resulting in an increase from 51.6 ng/ml at baseline to 58.4 ng/ml at 12 months .


Lutein supplementation inhibits the systemic activation of the complement system , which provides further functional evidence for the reported beneficial effects of this carotenoid in the management of AMD .


Tuberculosis ( TB ) is common among HIV-infected individuals in many resource-limited countries and has been associated with poor survival .


We evaluated morbidity and mortality among individuals first starting antiretroviral therapy ( ART ) with concurrent active TB or other AIDS-defining disease using data from the `` Prospective Evaluation of Antiretrovirals in Resource-Limited Settings '' ( PEARLS ) study .


PARTICIPANTS WERE CATEGORIZED RETROSPECTIVELY INTO THREE GROUPS ACCORDING TO PRESENCE OF ACTIVE CONFIRMED OR PRESUMPTIVE DISEASE AT ART INITIATION : those with pulmonary and/or extrapulmonary TB ( `` TB '' group ) , those with other non-TB AIDS-defining disease ( `` other disease '' ) , or those without concurrent TB or other AIDS-defining disease ( `` no disease '' ) .


Primary outcome was time to the first of virologic failure , HIV disease progression or death .


Since the groups differed in characteristics , proportional hazard models were used to compare the hazard of the primary outcome among study groups , adjusting for age , sex , country , screening CD4 count , baseline viral load and ART regimen .


31 of 102 participants ( 30 % ) in the `` TB '' group , 11 of 56 ( 20 % ) in the `` other disease '' group , and 287 of 1413 ( 20 % ) in the `` no disease '' group experienced a primary outcome event ( p = 0.042 ) .


This difference reflected higher mortality in the TB group : 15 ( 15 % ) , 0 ( 0 % ) and 41 ( 3 % ) participants died , respectively ( p < 0.001 ) .


The adjusted hazard ratio comparing the `` TB '' and `` no disease '' groups was 1.39 ( 95 % confidence interval : 0.93-2 .10 ; p = 0.11 ) for the primary outcome and 3.41 ( 1.72-6 .75 ; p < 0.001 ) for death .


Active TB at ART initiation was associated with increased risk of mortality in HIV-1 infected patients .


To compare the clinical efficacy in the treatment of post-stroke shoulder-hand syndrome between floating-needle therapy and conventional acupuncture on the basis of rehabilitation training .


One hundred cases of post-stroke shoulder-hand syndrome were randomized into a floating-needle group and an acupuncture group , 50 cases in each one .


The passive and positive rehabilitation training was adopted in the two groups .


Additionally , in the floating-needle group , the floating-needle therapy was used .


The needle was inserted at the site 5 to 10 cm away from myofasical trigger point ( MTrP ) , manipulated and scattered subcutaneously , for 2 min continuously .


In the acupuncture group , the conventional acupuncture was applied at Jianqian ( EX-UE ) , Jianyu ( LI 15 ) , Jianliao ( TE 14 ) , etc. .


The treatment was given once every two days , 3 times a week , and 14 days of treatment were required .


The shoulder hand syndrome scale ( SHSS ) , the short form McGill pain scale ( SF-MPQ ) and the modified Fugl-Meyer motor function scale ( FMA ) were used to evaluate the damage severity , pain and motor function of the upper limbs before and after treatment in the two groups .


The clinical efficacy was compared between the two groups .


SHSS score , SF-MPQ score and FMA score were improved significantly after treatment in the two groups ( all P < 0.01 ) , and the improvements in the floating-needle group were superior to those in the acupuncture group ( all P < 0.05 ) .


The total effective rate was 94.0 % ( 47/50 ) in the floating-needle group , which was better than 90.0 % ( 45/50 ) in the acupuncture group ( P < 0.05 ) .


The floating-needle therapy combined with rehabilitation training achieves a satisfactory efficacy on post-stroke shoulder-hand syndrome , which is better than the combined therapy of conventional acupuncture and rehabilitation training .


To prospectively determine the feasibility of low-iodine-load and low-tube-voltage computed tomographic ( CT ) angiographic imaging of the kidney and to evaluate the opacification and image quality compared with moderate-iodine-load and high-iodine-load techniques .


Institutional review board approval and written informed consent was obtained .


One hundred thirteen consecutive patients randomly underwent three protocols for dual-phase renal CT angiographic imaging : high-iodine-load ( 600 mg iodine per kilogram of body weight at 120 kVp ) ; moderate-iodine-load ( 400 mg iodine per kilogram of body weight at 80 kVp ) ; and low-iodine-load ( contrast agent injection initially prepared at 400 mg iodine per kilogram of body weight but stopped immediately after bolus-tracking trigger at 80 kVp ) scanning .


CT numbers of vessels and kidneys were measured .


CT numbers and signal-to-noise ratio ( SNR ) were compared with one-way analysis of variance and posthoc Tukey-Kramer test and depiction of vessels and image noise , with Kruskal-Wallis test and pair-wise Mann-Whitney test with Bonferroni correction .


Mean iodine weight administered was significantly reduced in order of low - ( 16.4 g ) , moderate - ( 23.5 g ) , and high-iodine-load ( 33.7 g ) protocols ( P < .001 ) .


Mean CT numbers of abdominal aorta , renal artery , and renal cortex in first phase were significantly lower with high-iodine-load protocol ( 308 , 274 , and 132 HU , respectively ) than with moderate - ( 347 , 334 , and 156 HU , respectively ; P = .001 -.006 ) or low-iodine-load ( 362 , 316 , and 161 HU , respectively ; P = .001 -.003 ) protocol .


Mean CT number of renal vein in second phase was significantly lower with low-iodine-load protocol ( 223 HU ) than with moderate - ( 299 HU ; P < .001 ) or high-iodine-load ( 258 HU ; P = .020 ) .


Mean SNR of renal medulla in second phase was significantly lower ( P = .019 ) with moderate-iodine-load protocol ( mean SNR , 7.2 ) than with high-iodine-load protocol ( mean SNR , 10.0 ) .


No significant difference in image quality grades was found between high-iodine-load ( mean grade , 2.6-2 .9 ) , moderate-iodine-load ( mean grade , 2.6-3 .0 ) , and low-iodine-load ( mean grade , 2.6-2 .9 ) protocols ( P = .018 -.31 ) .


Combined application of low-iodine-load , bolus tracking with saline flushing , and low-tube-voltage scanning is feasible and resulted in substantial reduction of iodine dose for renal CT angiographic imaging without compromising image quality .


Transendocardial stem cell injection ( TESI ) with mesenchymal stem cells improves remodeling in chronic ischemic cardiomyopathy , but the effect of the injection site remains unknown .


To address whether TESI exerts its effects at the site of injection only or also in remote areas , we hypothesized that segmental myocardial scar and segmental ejection fraction improve to a greater extent in injected than in noninjected segments .


Biplane ventriculographic and endocardial tracings were recorded .


TESI was guided to 10 sites in infarct-border zones .


Sites were mapped according to the 17-myocardial segment model .


As a result , 510 segments were analyzed in 30 patients before and 13 months after TESI .


Segmental early enhancement defect ( a measure of scar size ) was reduced by TESI in both injected ( -43.7 4.4 % ; n = 95 ; P < 0.01 ) and noninjected segments ( -25.1 7.8 % ; n = 148 ; P < 0.001 ; between-group comparison P < 0.05 ) .


Conversely , segmental ejection fraction ( a measure of contractile performance ) improved in injected scar segments ( 19.9 3.3-26 .3 3.5 % ; P = 0.003 ) but not in noninjected scar segments ( 21.3 2.6-23 .5 3.2 % ; P = 0.20 ; between-group comparison P < 0.05 ) .


Furthermore , segmental ejection fraction in injected scar segments improved to a greater degree in patients with baseline segmental ejection fraction < 20 % ( 12.1 1.2-19 .9 2.7 % ; n = 18 ; P = 0.003 ) , versus < 20 % ( 31.7 3.4-35 .5 3.3 % ; n = 12 ; P = 0.33 , between-group comparison P < 0.0001 ) .


These findings illustrate a dichotomy in regional responses to TESI .


Although scar size reduction was evident in all scar segments , scar size reduction and ventricular functional responses preferentially occurred at the sites of TESI versus non-TESI sites .


Furthermore , improvement was greatest when segmental left ventricular dysfunction was severe .


To assess the effectiveness of recombinant human ( rh ) IL-11 to increase platelets count in patients suffering from Dengue fever ( DF ) .


Randomized double blind placebo control study .


Farooq Hospital , Lahore , from July to October 2011 .


Forty hospitalized patients suffering from Dengue fever having platelets count 30000 per micro liter were randomly categorized into two groups , rhIL-11 ( test ) and distilled water ( placebo ) groups .


The efficacy outcomes ( as indicated by step up in platelets count at 48 hours ) for the treatment group were compared with the outcomes for the placebo group .


The data revealed that the increase in platelet response with recombinant human interleukin 11 , 1.5 mg subcutaneously is significantly more brisk than the placebo group .


The platelets response in patients with severe thrombocytopenia was greater in the treatment group ( 50 % ) at 48 hours as compared to the placebo group ( 20 % ) ( p = 0.047 ) .


Response rate was slightly greater among males ( 6/10 , 60 % ) than females ( 8/16 , 50 % ) ; moreover , three-fourth ( 75 % ) female responders were in the placebo group , compared to half ( 50 % ) male responders in the treatment group .


Results of the study suggest that treatment of severe thrombocytopenia accompanying DF with recombinant human interleukin11 may be a useful therapeutic option .


People with chronic obstructive pulmonary disease lead sedentary lives and could benefit from increasing their physical activity .


The purpose of this study was to determine if an exercise-specific self-efficacy enhancing intervention could increase physical activity and functional performance when delivered in the context of 4 months of upper body resistance training with a 12-month follow-up .


IN THIS RANDOMIZED CONTROLLED TRIAL , SUBJECTS WERE ASSIGNED TO : exercise-specific self-efficacy enhancing intervention with upper body resistance training ( SE-UBR ) , health education with upper body resistance training ( ED-UBR ) , or health education with gentle chair exercises ( ED-Chair ) .


Physical activity was measured with an accelerometer and functional performance was measured with the Functional Performance Inventory .


Forty-nine people with moderate to severe chronic obstructive pulmonary disease completed 4 months of training and provided valid accelerometry data , and 34 also provided accelerometry data at 12 months of follow-up .


The self-efficacy enhancing intervention emphasized meeting physical activity guidelines and increasing moderate-to-vigorous physical activity .


Differences were observed in light physical activity ( LPA ) after 4 months of training , time by group interaction effect ( P = 0.045 ) .


The SE-UBR group increased time spent in LPA by +20.6829.30 minutes/day and the other groups decreased time spent in LPA by -22.4347.88 minutes/day and -25.7351.76 minutes/day .


Changes in LPA were not sustained at 12-month follow-up .


There were no significant changes in moderate-to-vigorous physical activity , sedentary time , or functional performance .


Subjects spent most of their waking hours sedentary : 72 % 9 % for SE-UBR , 68 % 10 % for ED-UBR , and 74 % 9 % for ED-Chair .


The self-efficacy enhancing intervention produced a modest short-term increase in LPA .


Further work is needed to increase the magnitude and duration of effect , possibly by targeting LPA .


Inhaled endotoxin induces airways ` neutrophilia , in human .


TNF-a being a key cytokine in the response to endotoxin , the effect of anti-TNF on the endotoxin-induced neutrophilic response was evaluated among healthy volunteers .


Among a population of 30 healthy subjects , an induced-sputum was collected 2 weeks before , and 24 hours after an inhalation of 20 mcg endotoxin ( E. coli 026 : B6 ) .


Then , the subjects were randomized into 3 parallel groups treated with control , oral methylprednisolone 20 mg/day during 7 days or anti-TNF ( adalimumab , Humira , Abbott ) 40 mg s.c. .


One week later , an induced-sputum was sampled , 24 hours after an inhalation of endotoxin .


After endotoxin inhalation , the number of total cells , neutrophils and macrophages was significantly increased ( p < 0.001 ) .


Compared to the response to endotoxin among the control group , anti-TNF inhibited the endotoxin-induced neutrophil influx , both in relative ( 51.3 ( 6.4 ) % versus 26.2 ( 5.3 ) % , p < 0.002 ) and in absolute values ( 1321 ( 443-3935 ) cells/mcL versus 247 ( 68-906 ) cells/mcL , p < 0.02 ) .


The endotoxin-induced neutrophilic response was not significantly modified among the control group and oral corticosteroid group .


While oral corticosteroid had no effect , anti-TNF inhibited the neutrophil influx in sputum , induced by inhalation of endotoxin , in human subject .


The endotoxin model could be an early predictor of clinical efficacy of novel therapeutics .


ClinicalTrials.gov NCT02252809 ( EudraCT2008-005526-37 ) .


A previously published study demonstrated a pharmacogenetic association between the minor alleles of 2 VEGFR2 single nucleotide polymorphisms ( SNPs ) and greater improvement in visual acuity ( VA ) to treatment with ranibizumab , an anti-vascular endothelial growth factor ( VEGF ) drug , in patients with neovascular age-related macular degeneration ( AMD ) .


We evaluated whether this association was replicated among patients who participated in the Comparison of AMD Treatments Trials ( CATT ) or the Alternative Treatments to Inhibit VEGF in Patients with Age-Related Choroidal Neovascularisation ( IVAN ) trial .


Cohort studies within randomized clinical trials .


Eight hundred thirty-five patients participating in CATT and 512 patients participating in IVAN .


Each patient was genotyped for the SNPs rs4576072 and rs6828477 in the VEGFR2 gene .


Mean change in VA from baseline to 1 year after initiation of treatment with ranibizumab or bevacizumab .


Differences in VA response between the patient group homozygous for the minor allele of each SNP and the other genotype groups were evaluated with analysis of variance .


Differences in VA response by the number of minor alleles present for either SNP or both combined were evaluated with tests of linear trend .


Analyses were conducted separately for CATT and IVAN participants and with both the studies combined .


No statistically significant difference in mean change in VA was identified between genotypes of either SNP ( P 0.05 ) .


Furthermore , a stepwise analysis failed to show a significant interaction for either SNP based on the number of minor alleles present .


The lack of association was similar in both the CATT and IVAN cohorts and whether the analysis combined patients treated with either ranibizumab or bevacizumab or when restricted to patients treated with ranibizumab only .


The CATT and IVAN data do not support a pharmacogenetic association between the 2VEGFR2 SNPs , rs4576072 and rs6828477 , and change in VA in response to anti-VEGF therapy in patients with neovascular AMD .


Amiodarone is used commonly for pharmacological cardioversion of atrial fibrillation ( AF ) , but it is limited by moderate efficacy and delayed action .


Ranolazine and amiodarone are markedly synergistic in suppressing experimental AF in vitro , yet the clinical efficacy of ranolazine combined with amiodarone for AF conversion has only undergone minimal investigation .


This prospective , single-blinded , randomized study compared the safety and efficacy of ranolazine added to amiodarone vs. amiodarone alone for conversion of recent-onset AF .


We enroled 121 patients ( 64 10 years , 45 % male ) with recent-onset ( < 48 h duration ) AF who were eligible for pharmacological cardioversion .


Patients received either 24 h amiodarone infusion ( loading dose 5 mg/kg followed by maintenance dose of 50 mg/h ; n = 60 ) , or amiodarone infusion at the same dosage plus a single oral dose of ranolazine 1500 mg ( n = 61 ) .


Patients in the amiodarone plus ranolazine group compared with the amiodarone-only group showed significantly higher conversion rates at 24 h ( 87 vs. 70 % , respectively ; P = 0.024 ) and at 12 h ( 52 vs. 32 % ; P = 0.021 ) , and shorter time to conversion ( 10.2 3.3 vs. 13.3 4.1 h ; P = 0.001 ) .


Subgroup analysis identified higher 24 h conversion in patients with left atrial ( LA ) diameter > 46 mm who received the combination treatment vs. amiodarone alone ( 81 vs. 54 % ; P = 0.02 ) , whereas the efficacy of the two interventions did not differ among patients with LA diameter 46 mm ( P = 0.77 ) .


There was modest QT prolongation in both the groups , no serious adverse reactions , and no pro-arrhythmic events .


Addition of ranolazine to amiodarone was safe and well tolerated in this study , and it demonstrated efficacy superior to amiodarone alone for conversion of recent-onset AF .


These findings may have clinical implications by offering a simple therapeutic manoeuvre to enhance amiodarone 's effectiveness for conversion of AF .


QVA149 is an inhaled fixed-dose combination therapy under development for the treatment of chronic obstructive pulmonary disease ( COPD ) .


It combines indacaterol ( a longacting 2-agonist ) with glycopyrronium ( a longacting muscarinic antagonist ) as a dual bronchodilator .


We aimed to compare the efficacy , safety , and tolerability of QVA149 versus salmeterol-fluticasone ( SFC ) over 26 weeks in patients with moderate-to-severe COPD .


In this multicentre double-blind , double-dummy , parallel-group study , 523 patients ( age 40 years or older , Global Initiative for Chronic Obstructive Lung Disease [ GOLD ] stages II-III , without exacerbations in the previous year ) were randomly assigned ( 1:1 ; via automated , interactive response technology and stratified for smoking status ) to once-daily QVA149 110/50 g or twice-daily SFC 50/500 g for 26 weeks .


Efficacy was assessed in the full analysis set ( randomised patients who received at least one dose of study drug ) ; safety was assessed in all patients who received at least one dose of study drug .


The primary endpoint was to demonstrate the superiority of QVA149 compared with SFC for the standardised area under the curve from 0 to 12 h post dose for forced expiratory volume in 1 second ( FEV1 AUC0-12h ) after 26 weeks of treatment .


This trial was registered at ClinicalTrial.gov , NCT01315249 .


Between March 25 , 2011 , and March 12 , 2012 , 259 patients were randomly assigned to receive QVA149 and 264 to receive SFC. At week 26 , FEV1 AUC0-12h was significantly higher with QVA149 than with SFC ( treatment difference 0138 L ; 95 % CI 0100-0176 ; p < 00001 ) .


Overall incidence of adverse events ( including COPD exacerbations ) was 554 % ( 143 of 258 ) for the QVA149 group and 602 % ( 159 of 264 ) for the SFC group .


Incidence of serious adverse events was similar between treatment groups ( QVA149 , 13 of 258 [ 50 % ] ; SFC 14 of 264 [ 53 % ] ) ; COPD worsening was the most frequent serious adverse event ( one of 13 [ 04 % ] and three of 14 [ 11 % ] , respectively ) .


Once-daily QVA149 provides significant , sustained , and clinically meaningful improvements in lung function versus twice-daily SFC , with significant symptomatic benefit .


These results indicate the potential of dual bronchodilation as a treatment option for non-exacerbating symptomatic COPD patients .


Novartis Pharma AG .


Though current hospital paging systems are neither efficient ( callbacks disrupt workflow ) , nor secure ( pagers are not Health Insurance Portability and Accountability Act [ HIPAA ] - compliant ) , they are routinely used to communicate patient information .


Smartphone-based text messaging is a potentially more convenient and efficient mobile alternative ; however , commercial cellular networks are also not secure .


To determine if augmenting one-way pagers with Medigram , a secure , HIPAA-compliant group messaging ( HCGM ) application for smartphones , could improve hospital team communication .


Eight-week prospective , cluster-randomized , controlled trial


Stanford Hospital


Three inpatient medicine teams used the HCGM application in addition to paging , while two inpatient medicine teams used paging only for intra-team communication .


Baseline and post-study surveys were collected from 22 control and 41 HCGM team members .


When compared with paging , HCGM was rated significantly ( P < 0.05 ) more effective in : ( 1 ) allowing users to communicate thoughts clearly ( P = 0.010 ) and efficiently ( P = 0.009 ) and ( 2 ) integrating into workflow during rounds ( P = 0.018 ) and patient discharge ( P = 0.012 ) .


Overall satisfaction with HCGM was significantly higher ( P = 0.003 ) .


85 % of HCGM team respondents said they would recommend using an HCGM system on the wards .


Smartphone-based , HIPAA-compliant group messaging applications improve provider perception of in-hospital communication , while providing the information security that paging and commercial cellular networks do not .


Evidence of a beneficial effect of exercise training on mediators of vascular disease is accumulating in chronic kidney disease ( CKD ) , but its effect on vascular function in vivo still has to be established .


The present study was designed to investigate whether a formal aerobic exercise training program improves peripheral endothelial function in patients with CKD stages 3 to 4 .


Randomized controlled trial with a parallel-group design .


48 patients with CKD stages 3 to 4 without established cardiovascular disease were randomly assigned to either an exercise training program or usual care .


40 patients completed the study ( exercise training , 19 ; usual care , 21 ) .


The 3-month home-based aerobic training program consisted of 4 daily cycling sessions of 10 minutes each at a target heart rate , calculated as 90 % of the heart rate achieved at the anaerobic threshold .


Patients in the usual-care group were given standard therapy .


The primary outcome was peripheral endothelial function .


Secondary outcomes were aerobic capacity , arterial stiffness , numbers of endothelial ( EPCs ) and osteogenic progenitor cells ( OPCs ) , migratory function of circulatory angiogenic cells , and health-related quality of life .


Endothelial function was assessed with flow-mediated dilation of the brachial artery , aerobic capacity by peak oxygen uptake ( VO ( 2peak ) ) , arterial stiffness by carotid-femoral pulse wave velocity , numbers of EPCs and OPCs by flow cytometry , circulatory angiogenic cell function by an in vitro migratory assay , and quality of life by the Kidney Disease Quality of Life-Short Form questionnaire .


Exercise training significantly improved VO ( 2peak ) and quality of life , but not in vivo vascular function ( flow-mediated dilation and carotid-femoral pulse wave velocity ) or cellular markers for vascular function ( EPC and OPC count and circulatory angiogenic cell migratory function ) .


Short duration and intermittent nature of the exercise intervention .


In patients with CKD stages 3 to 4 without overt cardiovascular disease , 3 months of aerobic exercise training improved VO ( 2peak ) and quality of life , without altering endothelial function or arterial stiffness .


To determine the most efficient route and timing of oxytocin administration for active management of the third stage of labor .


A prospective randomized study was done at one center in Ankara , Turkey , between January and October 2010 .


Women with a singleton pregnancy ( > 37 weeks ) who had a live vaginal birth were randomly allocated to four groups : iv-A ( intravenous oxytocin after delivery of the fetus ) , iv-B ( when anterior shoulder seen ) , im-A ( intramuscular oxytocin after delivery ) , and im-B ( when anterior shoulder seen ) .


Postpartum blood loss within the first hour , hemoglobin , hematocrit , and duration of the third stage were compared .


A total of 600 eligible women were recruited ; 150 were assigned to each group .


Postpartum blood loss , prepartum and postpartum hemoglobin and hematocrit , and need for additional uterotonics were similar among groups ( P > 0.05 ) .


The duration of the third stage of labor and changes in hemoglobin and hematocrit were significantly reduced in group iv-B ( P < 0.05 ) .


Among women not exposed to oxytocin before delivery , postpartum blood loss was significantly lower in group iv-B ( P = 0.019 ) .


Labor augmentation was related to significantly increased postpartum blood loss in all groups except iv-A .


Although postpartum blood loss was similar in all groups , early intravenous administration seemed to have beneficial effects .


ClinicalTrials.gov : NCT01954186 .


Stroke is the second-leading cause of death in low - and middle-income countries , but use of evidence-based therapies for stroke prevention in such countries , especially those in Africa , is extremely poor .


This study is designed to enhance the implementation and sustainability of secondary stroke-preventive services following hospital discharge .


The primary study aim is to test whether a Chronic Care Model-based initiative entitled the Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke ( THRIVES ) significantly improves blood pressure control after stroke .


This prospective triple-blind randomized controlled trial will include a cohort of 400 patients with a recent stroke discharged from four medical care facilities in Nigeria .


The culturally sensitive , system-appropriate intervention comprises patient report cards , phone text messaging , an educational video , and coordination of posthospitalization care .


The primary outcome is improvement of blood pressure control .


Secondary endpoints include control of other stroke risk factors , medication adherence , functional status , and quality of life .


We will also perform a cost analysis of THRIVES from the viewpoint of government policy-makers .


We anticipate that a successful intervention will serve as a scalable model of effective postdischarge chronic blood pressure management for stroke in sub-Saharan Africa and possibly for other symptomatic cardiovascular disease entities in the region .


Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery , and triclosan-coated sutures were developed to reduce their occurrence .


The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure , compared with non-coated PDS II sutures , in the prevention of surgical site infections .


This multicentre , randomised controlled group-sequential superiority trial was done in 24 German hospitals .


Adult patients ( aged 18 years ) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion .


Exclusion criteria were impaired mental state , language problems , and participation in another intervention trial that interfered with the intervention or outcome of this trial .


A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures ( PDS Plus ) or uncoated sutures ( PDS II ) for abdominal fascia closure .


The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation .


Patients , surgeons , and the outcome assessors were masked to group assignment .


Interim and final analyses were by modified intention to treat .


This trial is registered with the German Clinical Trials Register , number DRKS00000390 .


Between April 7 , 2010 , and Oct 19 , 2012 , 1224 patients were randomly assigned to intervention groups ( 607 to PDS Plus , and 617 to PDS II ) , of whom 1185 ( 587 PDS Plus and 598 PDS II ) were analysed by intention to treat .


The study groups were well balanced in terms of patient and procedure characteristics .


The occurrence of surgical site infections did not differ between the PDS Plus group ( 87 [ 148 % ] of 587 ) and the PDS II group ( 96 [ 161 % ] of 598 ; OR 091 , 95 % CI 066-125 ; p = 064 ) .


Serious adverse events also did not differ between the groups-146 of 583 ( 250 % ) patients treated with PDS Plus had at least one serious adverse event , compared with 138 of 602 ( 229 % ) patients treated with PDS II ; p = 039 ) .


Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy .


Innovative , multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections .


Johnson & Johnson Medical Limited .


Tonsillectomy is the oldest and most frequently performed surgical procedure practiced by ear , nose , and throat physicians .


In this study , our aim was to compare the analgesic effects of peritonsillar , rectal , as well as intravenous infiltration of ketamine and intravenous tramadol hydrochloride infiltration for postoperative pain relief and sedation after tonsillectomy in children .


This randomized controlled study evaluated the effects of peritonsillar , intravenous , and rectal infiltration of ketamine in children undergoing adenotonsillectomy .


One hundred twenty children who were categorized under American Society of Anesthesiologists classes I to II were randomized to 4 groups of 30 members each .


Group 1 received intravenous ( IV ) ketamine ( 0.5 mg/kg ) , group 2 received rectal ketamine ( 0.5 mg/kg ) , group 3 received local peritonsillar ketamine ( 2 mg/kg ) , and the control group received IV tramadol hydrochloride infiltration ( 2 mg/kg ) .


Children 's Hospital of Eastern Ontario Pain Scale scores and Wilson sedation scale were recorded at minutes 1 , 15 , 30 , 60 as well as hours 2 , 12 , and 24 postoperatively .


The patients were interviewed on the day after the surgery to assess the postoperative pain and sedation .


All the routes of infiltration of ketamine were as effective as those of tramadol hydrochloride ( P > 0.05 ) .


A statistically significant difference was observed between IV infiltrations and all groups during the assessments at hours 6 and 24 .


The analgesic efficacy of IV ketamine was found especially higher at hours 6 and 24 ( P ( 6 ) = 0.045 , P ( 24 ) = 0.011 ) .


Perioperative , low-dose IV , rectal , or peritonsillar ketamine infiltration provides efficient pain relief without any adverse effects in children who would undergo adenotonsillectomy .


To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour ( E-ZES ) vs. Cypher ( C-SES ) Stenting Trial ( PROTECT ) .


At 3 years , there was no difference in the primary outcome of definite or probable stent thrombosis or in the other main secondary clinical outcomes consisting of the composite of death or myocardial infarction ( MI ) .


Prespecified 4-year clinical follow-up was analysed .


Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial was a prospective , open-label randomized-controlled superiority trial powered to look at differences in long-term clinical safety , including stent thrombosis .


Dual antiplatelet therapy ( DAPT ) was prescribed for 3 months and up to 12 months based on current guidelines .


Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial enrolled 8791 patients undergoing elective or emergency PCI to E-ZES or C-SES .


There was no difference in DAPT usage between the two groups up to 4 years .


At 4-year follow-up , the primary outcome occurred in 1.6 % of E-ZES vs. 2.6 % of C-SES patients [ HR 0.63 ( 95 % CI 0.46-0 .85 ) , P = 0.003 ] .


The composite of all-cause death or large MI occurred in 6.7 % of E-ZES vs. 8.0 % of C-SES-treated patients [ HR 0.84 ( 95 % CI 0.71-0 .98 ) , P = 0.024 ] .


Drug-eluting coronary stents with different healing characteristics demonstrated different late safety profiles : after 4 years , compared with C-SES , E-ZES reduced the risk of stent thrombosis and the risk of the composite endpoints of death or MI .


Appropriately powered large-scale trials with long-term follow-up are critical to determine clinical safety and efficacy of permanently implanted coronary stents .


This trial is registered with ClinicalTrials.gov , number NCT00476957 .


This 2-arm crossover study compared the relative bioavailability of two dovitinib ( TKI258 ) formulations [ anhydrate clinical service form ( CSF ) capsule and monohydrate final market image ( FMI ) tablet ; Arm 1 ] and determined the effect of food on dovitinib exposure ( Arm 2 ) .


Patients with advanced solid tumors , excluding breast cancer , were enrolled in 1 of the 2 arms of the study .


Patients in Arm 1 were randomized to a single 500-mg dose of CSF capsule or FMI tablet followed by 7 days of rest and 500 mg of the other formulation .


Patients in Arm 2 received 300 mg of FMI tablet daily and were randomized to follow 1 of 6 meal sequences , each with 3 prandial conditions : low fat ( LF ) , high fat ( HF ) , or no meal ( NM ) .


In Arm 1 ( n = 21 ) , 17 patients were evaluable .


FMI tablet compared with CSF capsule showed only slight reductions in the adjusted geometric means for area under the plasma concentration-time curve ( AUClast ; 3 % ) and maximum plasma concentration ( C max ; 1 % ) .


In Arm 2 ( n = 42 ) , 19 patients were evaluable .


HF meal versus NM showed a 9 % decrease in the adjusted geometric mean for AUClast and an 18 % decrease for C max .


Comparison of LF meal versus NM showed a 1 % decrease for AUClast and a 10 % decrease for C max .


Common adverse events suspected to be study drug related included vomiting , diarrhea , nausea , and fatigue .


Dovitinib FMI tablet had similar systemic exposure to the CSF capsule and was not affected by food .


In a published study on cervical cancer , 5-beam IMRT was inferior to single arc VMAT .


Here we compare 9 , 12 , and 20 beam IMRT with single and dual arc VMAT .


For each of 10 patients , automated plan generation with the in-house Erasmus-iCycle optimizer was used to assist an expert planner in generating the five plans with the clinical TPS .


For each patient , all plans were clinically acceptable with a high and similar PTV coverage .


OAR sparing increased when going from 9 to 12 to 20 IMRT beams , and from single to dual arc VMAT .


For all patients , 12 and 20 beam IMRT were superior to single and dual arc VMAT , with substantial variations in gain among the study patients .


As expected , delivery of VMAT plans was significantly faster than delivery of IMRT plans .


Often reported increased plan quality for VMAT compared to IMRT has not been observed for cervical cancer .


Twenty and 12 beam IMRT plans had a higher quality than single and dual arc VMAT .


For individual patients , the optimal delivery technique depends on a complex trade-off between plan quality and treatment time that may change with introduction of faster delivery systems .


Depression is common in heart failure ( HF ) and associated with adverse outcomes .


Randomized comparisons of the effectiveness of HF care strategies by patients ' mood are scarce .


We therefore investigated in a randomized trial a structured collaborative disease management programme ( HeartNetCare-HF ; HNC ) recording mortality , morbidity , and symptoms in patients enrolled after hospitalization for decompensated systolic HF according to their responses to the 9-item Patient Health Questionnaire ( PHQ-9 ) during an observation period of 180 days .


Subjects scoring < 12/12 were categorized as non-depressed/depressed , and those ignoring the questionnaire as PHQ-deniers .


Amongst 715 participants ( 6912years , 29 % female ) , 141 ( 20 % ) were depressed , 466 ( 65 % ) non-depressed , and 108 ( 15 % ) PHQ-deniers .


The composite endpoint of mortality and re-hospitalization was neutral overall and in all subgroups .


However , HNC reduced mortality risk in both depressed and non-depressed patients [ adjusted hazard ratios ( HRs ) 0.12 , 95 % confidence interval ( CI ) 0.03-0 .56 , P = 0.006 , and 0.49 , 95 % CI 0.25-0 .93 , P = 0.03 , respectively ] , but not in PHQ-deniers ( HR 1.74 , 95 % CI 0.77-3 .96 , P = 0.19 ; P = 0.006 for homogeneity of HRs ) .


Average frequencies of patient contacts in the HNC arm were 12.87.9 in non-depressed patients , 12.47.1 in depressed patients , and 5.57.2 in PHQ-deniers ( P < 0.001 ) .


Early after decompensation , HNC reduced mortality risk in non-depressed and even more in depressed subjects , but not in PHQ-deniers .


This suggests that differential acceptability and chance of success of care strategies such as HNC might be predicted by appropriate assessment of patients ' baseline characteristics including psychological disposition .


These post-hoc results should be reassessed by prospective evaluation of HNC in larger HF populations .


Generalized anxiety and panic disorders are a burden on the society because they are costly and have a significant adverse effect on quality of life .


The aim of this study was to evaluate the cost-utility of a collaborative stepped care intervention for panic disorder and generalized anxiety disorder in primary care compared to care as usual from a societal perspective .


The design of the study was a two armed cluster randomized controlled trial .


In total 43 primary care practices in the Netherlands participated in the study .


Eventually , 180 patients were included ( 114 collaborative stepped care , 66 care as usual ) .


Baseline measures and follow-up measures ( 3 , 6 , 9 and 12 months ) were assessed using questionnaires .


We applied the TiC-P , the SF-HQL and the EQ-5D respectively measuring health care utilization , production losses and health related quality of life .


The average annual direct medical costs in the collaborative stepped care group were 1854 Euro ( 95 % C.I. , 1726 to 1986 ) compared to 1503 ( 95 % C.I. , 1374 to 1664 ) in the care as usual group .


The average quality of life years ( QALYs ) gained was 0.05 higher in the collaborative stepped care group , leading to an incremental cost effectiveness ratio ( ICER ) of 6965 Euro per QALY .


Inclusion of the productivity costs , consequently reflecting the full societal costs , decreased the ratio even more .


The study showed that collaborative stepped care was a cost effective intervention for panic disorder and generalized anxiety disorder and was even dominant when a societal perspective was taken .


trialregister.nl , Netherlands Trial Register NTR107 .


Despite anecdotal reports of voice impairment in quadriplegia , the exact nature of these impairments is not well described in the literature .


This article details objective and subjective voice assessments for people with quadriplegia at baseline and after a respiratory-targeted singing intervention .


Randomized controlled trial .


Twenty-four participants with quadriplegia were randomly assigned to a 12-week program of either a singing intervention or active music therapy control .


Recordings of singing and speech were made at baseline , 6 weeks , 12weeks , and 6 months postintervention .


These deidentified recordings were used to measure sound pressure levels and assess voice quality using the Multidimensional Voice Profile and the Perceptual Voice Profile .


Baseline voice quality data indicated deviation from normality in the areas of breathiness , strain , and roughness .


A greater percentage of intervention participants moved toward more normal voice quality in terms of jitter , shimmer , and noise-to-harmonic ratio ; however , the improvements failed to achieve statistical significance .


Subjective and objective assessments of voice quality indicate that quadriplegia may have a detrimental effect on voice quality ; in particular , causing a perception of roughness and breathiness in the voice .


The results of this study suggest that singing training may have a role in ameliorating these voice impairments .


Medications to control intraocular pressure ( IOP ) are frequently preserved using benzalkonium chloride ( BAK ) , which can negatively affect the ocular surface .


Data are needed to assess efficacy and safety of prostaglandin drugs preserved with and without BAK .


The present study compared the efficacy and safety of BAK-free travoprost 0.004 % ( TRAV ) and BAK 0.02 % - preserved bimatoprost 0.01 % ( BIM ) during late-day time points in patients with open-angle glaucoma or ocular hypertension .


This was a 12-week , phase 4 , randomized , investigator-masked , crossover study .


84 patients with IOP 24 and < 36 mmHg were randomized 1:1 to receive once-daily TRAV or BIM for 6 weeks followed by an additional 6-week crossover period .


IOP was measured at the end of each treatment period at 4 , 6 , and 8 pm .


TRAV was considered noninferior to BIM if the upper limit of the 95 % CI of the between-group difference in mean IOP was 1.5 mmHg .


Adverse events were assessed throughout the study .


One patient discontinued due to allergic conjunctivitis , and 2 patients with missing data were excluded ; 81 patients were included in the per-protocol population ( mean SD age , 58.3 11.4 years ; TRAV/BIM , n = 41 ; BIM/TRAV , n = 40 ) .


After 6 weeks , mean IOP with TRAV ( 17.4 2.7 mmHg ; change from baseline , -6.0 mmHg ) was similar to BIM ( 17.2 2.6 mmHg ; change from baseline , -6.3 mmHg ) ; the between-group difference was 0.22 mmHg ( 95 % CI , -0.22 to 0.67 ) .


Thus , noninferiority of TRAV versus BIM was demonstrated .


Mean IOP at each time point and mean and percentage IOP change from baseline were not significantly different between treatments .


All treatment-emergent adverse events were mild to moderate .


The incidences of mild ocular hyperemia with TRAV and BIM were 31 % and 39 % , respectively ; moderate hyperemia was observed in 2 % of patients receiving BIM .


Late-day IOP-lowering efficacy of BAK-free TRAV was noninferior to that of BAK 0.02 % - preserved BIM ; both reduced baseline IOP by 25 % .


Both treatments were well tolerated , although a higher incidence of moderate ocular hyperemia was observed with BIM .


ClinicalTrials.gov identifier , NCT01464424 ; registered November 1 , 2011 .


Most electronic health record ( EHR ) systems have the capability of generating a printed after-visit summary ( AVS ) , but there has been little research on optimal content .


We conducted a qualitative study and a randomized trial to understand the effect of AVS content on patient recall and satisfaction .


Adult primary care patients ( n = 272 ) with at least 1 chronic condition were randomly assigned to 4 AVS content conditions : minimum , intermediate , maximum , or standard AVS .


Demographics and health literacy were measured at an index clinic visit .


Recall and satisfaction were measured by telephone 2 days and 2 to 3 weeks after the clinic visit .


Average age was 52 years ; 75 % of patients were female , 61 % were Hispanic , and 21 % were African American , and 64 % had adequate health literacy .


Average medication recall accuracy was 53 % at 2 days and 52 % at 3 weeks , with no significant difference among groups at either time .


Satisfaction with AVS content was high and did not differ among groups .


Recall of specific content categories was low and unrelated to group assignment .


Health literacy was unrelated to recall and satisfaction .


Primary care patients like to receive an AVS , but the amount of information included does not affect content recall or satisfaction with the information .


Adequate serum 25-hydroxyvitamin D concentrations , [ 25 ( OH ) D ] , are required for optimal bone health , and low levels are associated with chronic diseases .


We investigated whether 41 candidate single nucleotide polymorphisms ( SNPs ) in vitamin D and calcium pathway genes ( GC , DHCR7 , CYP2R1 , CYP27B1 , CYP24A1 , VDR , and CASR ) are associated with [ 25 ( OH ) D ] or modify the increase in [ 25 ( OH ) D ] from vitamin D3 supplementation .


Baseline and year 1 [ 25 ( OH ) D ] measurements from a randomized controlled trial conducted at 11 clinical centers in the United States .


A total of 1787 healthy non-Hispanic white participants aged 45-75 years .


Vitamin D3 ( 1000 IU/d ) , calcium carbonate ( 1200 mg/d elemental ) , both , or placebo .


Genotype main effects and interactions with vitamin D3 treatment estimated using multiple linear regression .


The baseline serum [ 25 ( OH ) D ] was 25.4 8.7 ng/mL ( mean SD ) .


Associations with baseline levels were discovered for SNPs in CYP24A1 ( rs2209314 , rs2762939 ) and confirmed for SNPs in GC and CYP2R1 .


After 1 year , [ 25 ( OH ) D ] increased on average by 6.1 8.9 ng/mL on vitamin D3 treatment and decreased by 1.1 8.4 ng/mL on placebo .


The increase in [ 25 ( OH ) D ] due to vitamin D3 supplementation was modified by genotypes at rs10766197 near CYP2R1 , rs6013897 near CYP24A1 , and rs7968585 near VDR .


The increase in [ 25 ( OH ) D ] attributable to vitamin D3 supplementation may vary according to common genetic differences in vitamin D 25-hydroxylase ( CYP2R1 ) , 24-hydroxylase ( CYP24A1 ) , and the vitamin D receptor ( VDR ) genes .


These findings have implications for achieving optimal vitamin D status and potentially for vitamin D-related health outcomes .


The purpose of this study was to evaluate postoperative pain levels after arthroscopic elbow surgery under general anesthesia and to determine whether an axillary nerve block provides additional pain management benefits compared with a portal site injection of local anesthetic .


Thirty-six patients undergoing arthroscopic elbow surgery under general anesthesia were randomized to either a study group receiving axillary nerve block ( Ax group ) or a control group receiving portal site injections of local anesthetic ( Lo group ) .


During the first 48 hours after surgery , pain visual analog scale ( VAS ) scores ( 0-100 ) , total amount of oral analgesics required , and patient satisfaction were assessed .


Among all 36 patients , mean pain VAS scores at rest were 37 , 18 , and 9 for the first 12-hour period and at 24 and 48 hours after surgery , respectively .


The mean pain VAS scores during physiotherapy were 47 and 33 at 24 and 48 hours postoperatively , respectively .


No intergroup differences were observed between the Ax and Lo groups at any time point after surgery ( P value range , .41 to .87 ) .


The mean number of loxoprofen tablets required during the 48-hour study period was 5.1 in the Ax group and 4.5 in the Lo group ( P = .90 ) .


The Ax and Lo groups had mean overall patient satisfaction scores of 91 and 91 , respectively ( P = .98 ) .


Postoperative pain levels after arthroscopic elbow surgery could be well managed with oral analgesics and local anesthetic .


An axillary nerve block was not found to provide any postoperative pain control benefits .


To evaluate the benefit of aerobic exercise on colonic transit time ( CTT ) for psychiatric inpatients in a closed ward .


Sixty consecutive adult inpatients of the Somang Hospital Psychiatry Unit ( Eumsung-gun , South Korea ) , without CTT-related diseases or drug therapies , were recruited for study from March to June of 2012 .


Upon enrollment , the patients were randomly assigned to partake in a 12-wk instructor-led group aerobic exercise program ( exercise group ; n = 30 ) or to maintain their ordinary daily activities ( control group ; n = 30 ) .


The exercise program was structured as 10 min warm-up ( stretching ) , 40 min exercise , and 10 min cool-down ( stretching ) for three days each week .


The exercise sessions consisted of walking only in week one and aerobics from weeks two to 12 , with increasing intensity ( 50 % heart rate reserve ( HRR ) for weeks one to four , 60 % HRR for weeks five to eight , and 70 % HRR for weeks nine to 12 ) .


CTT was measured before ( baseline ) and after ( week 12 ) the exercise program , in duplicate ( on days four and seven ) , using abdominal radiography and the multiple radio-opaque marker technique .


Changes in the exercising patients ' CTT and weight - , cardiovascular - and fitness-related parameters were statistically assessed .


The study dropout rate was 30.0 % , with 23 patients in the exercise group and 19 patients in the control group completing the study .


At week 12 , the exercise group showed decreases in body weight ( mean SE ) baseline : 69.4 2.8 vs study-end : 67.6 2.7 ; P < 0.635 ) and body mass index ( BMI ) ( 25.2 1.1 vs 24.9 0.8 ; P < 0.810 ) , but the extent of change was not significantly different from that experienced by the control group ( body weight : 68.8 4.0 vs 68.8 3.9 ; BMI : 24.3 1.1 vs 24.4 1.2 ) .


However , the exercise group showed significant improvements in leg muscle strength ( baseline : 41.7 4.3 vs study-end : 64.1 5.0 ; P < 0.001 ) , cardio-respiratory endurance ( 120.5 4.5 vs 105.4 2.8 ; P < 0.004 ) , and leg muscle elasticity and power output ( 21.5 2.6 vs 30.6 2.8 ; P < 0.001 ) .


The exercise group showed an exercise-induced reduction in total CTT ( baseline : 54.2 8.0 vs 30.3 6.1 ) , which was significantly different from that experienced by the control group over the 12-wk period ( 48.6 9.3 vs 48.3 12.3 ; P = 0.027 ) ; however , the exercise-induced decreases in CTT involving the three colonic segments examined ( right , left and recto-sigmoid ) showed no significant differences from the control group .


A 12-wk aerobic exercise program can benefit psychiatric inpatients by increasing intestinal motility , possibly decreasing risk of metabolic - and cardiovascular-related disease .


Reported rates of hypoglycemia in patients with type 2 diabetes mellitus are lower with glimepiride as compared to glyburide .


The aim of this study was to determine whether physiologic differences in counterregulatory neuroendocrine and metabolic mechanisms during hypoglycemia provide a basis for the observed clinical differences between glimepiride and glyburide .


Non-diabetic volunteers ( age 382years , BMI 261kg/m ( 2 ) ) were studied in a single-blind fashion during separate 2day randomized protocols consisting of 2h hyperinsulinemic ( 9pmol/kg/min ) euglycemic ( 4.90.1 mmol ) and hypoglycemic ( 2.90.1 mmol/L ) clamps .


Individuals received biologically equivalent doses of glimepiride ( 4mg ) or glyburide ( 10mg ) 1h prior to each glucose clamp ( n = 11 ) as well as a control group of placebo studies .


Glucose kinetics were calculated using D-Glucose-6-6d2 .


Insulin and C-peptide levels were increased ( p < 0.05 ) during euglycemia in both sulfonylurea groups as compared to placebo .


However , despite equivalent hypoglycemia , insulin and C-peptide levels were higher ( p < 0.05 ) only after glyburide .


Glucagon responses and endogenous glucose production ( EGP ) were decreased ( p < 0.05 ) during hypoglycemia following glyburide administration as compared to glimepiride .


Glyburide reduced ( p < 0.05 ) norepinephrine responses during euglycemic clamps .


In addition combined epinephrine and norepinephrine responses during hypoglycemia were reduced ( p < 0.05 ) following glyburide as compared to placebo .


Leptin levels fell by a greater amount ( p < 0.05 ) during hypoglycemia with both sulfonylureas as compared to placebo .


In summary , glimepiride and glyburide can both similarly increase insulin and C-peptide levels during hyperinsulinemic euglycemia .


However , during moderate hyperinsulinemic hypoglycemia ( 2.9 mmol/L ) glyburide resulted in increased C-peptide and insulin , but blunted glucagon , sympathetic nervous system and EGP responses .


We conclude that glyburide can acutely reduce key neuroendocrine and metabolic counterregulatory defenses during hypoglycemia in healthy individuals .


Tobramycin inhalation is an accepted treatment of chronic pseudomonal infection in cystic fibrosis ( CF ) patients .


Twice daily inhalation is efficacious , but time-consuming .


In this randomized , open-label , multicentre , two-period , crossover study , 58 patients with CF and chronic Pseudomonas aeruginosa ( PA ) infection received two tobramycin nebuliser solutions : T100/eFlow or TNS/PARI LC PLUS .


The primary objective was to demonstrate the equivalence of both treatments with respect to pharmacokinetics ( area under the concentration-time curve and maximum concentration in plasma ) .


Secondary endpoints were tobramycin sputum pharmacokinetics , reduction in PA colony forming units , improvement of lung function , incidence of adverse drug reactions and reduction of inhalation times .


Tobramycin plasma AUC and Cmax were lower after administration of T100 than after TNS .


The study failed to demonstrate systemic bioequivalence of the two treatments .


After T100 administration , tobramycin sputum AUC and Cmax achieved higher values than after TNS .


Changes in efficacy parameters from baseline were similar .


Safety profiles were not different or unexpected .


Inhalation time per inhalation was shorter during treatment with T100 .


The lower systemic drug burden and the higher local drug deposition together with a comparable efficacy/safety profile and a shorter inhalation time render T100/eFlow an attractive treatment option for CF patients .


( www.controlled-trials.com/ISRCTN85410458 ) .


Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for type 2 diabetes mellitus ( T2DM ) treatment .


An exploratory Phase II study was conducted to assess the efficacy and safety of several doses of luseogliflozin in Japanese T2DM patients .


Japanese T2DM patients aged 20-74 years with hemoglobin A1c ( HbA1c ) of 6.9-10 .5 % , fasting plasma glucose ( FPG ) 126mg/dL and on diet therapy were randomized in a double-blind manner to receive luseogliflozin ( 0.5 , 2.5 , or 5mg ) or placebo once daily for 12 weeks ( n = 61 , 61 , 61 , and 56 , respectively ) .


The primary endpoint was the change in HbA1c from baseline to end of treatment .


Other endpoints included FPG , 2h postprandial plasma glucose ( PPG ) in a meal tolerance test ( MTT ) , and body weight .


Drug safety was also assessed .


Japan Pharmaceutical Information Center ( identifier : JapicCTI-090908 ) .


Changes in HbA1c from baseline to end of treatment were -0.36 , -0.62 , and -0.75 % in the 0.5 , 2.5 , and 5mg luseogliflozin groups , respectively , versus +0.06 % in the placebo group ( all P < 0.001 ) .


The reductions in FPG and 2h-PPG in the MTT were also significantly greater in the luseogliflozin groups ( all P < 0.01 ) without increases in insulin levels from baseline .


Luseogliflozin reduced body weight at all doses .


There were no significant differences in the incidences of adverse events among groups .


Most adverse events were mild in severity .


There were no serious adverse events .


Although this was a small-scale study with a short duration , all tested doses of luseogliflozin significantly improved glycemic control , reduced body weight , and were well tolerated in Japanese T2DM patients over the 12-week treatment period .


Short-term blood pressure variability ( BPV ) may predict outcome in acute stroke .


We undertook a post hoc analysis of data from 2 randomized controlled trials to determine the effect of short-term BPV on 2-week outcome .


Controlling Hypertension and Hypotension Immediately Post Stroke ( CHHIPS ) was a trial of BP-lowering , enrolling 179 acute stroke patients ( onset < 36 hours ) .


Continue or Stop Post-Stroke Antihypertensives Collaborative Study ( COSSACS ) compared a strategy of continuation versus temporarily stopping prestroke antihypertensive therapy in 763 acute stroke patients ( onset < 48 hours ) .


BPV at baseline ( defined as SD , coefficient of variation , variation independent of the mean , and average real variability ) was derived from standardized casual cuff BP measures ( 6 readings < 30 minutes ) .


Adjusted logistic regression models were used to assess the relation between BPV and death and disability ( modified Rankin scale > 3 ) at 2 weeks .


Seven hundred six ( 92.5 % ) and 171 ( 95.5 % ) participants were included in the analysis for the COSSACS and CHHIPS data sets , respectively .


Adjusted logistic regression analyses revealed no statistically significant associations between any of the included BPV parameters with 2-week death or disability in either study data set : COSSACS , odds ratio SD systolic BP 0.98 ( 0.78-1 .23 ) ; CHHIPS , odds ratio SD systolic BP 0.97 ( 0.90-1 .11 ) .


When derived from casual cuff BP measures , short-term BPV is not a useful predictor of early ( 2 weeks ) outcome after acute stroke .


Differing methodology may account for the discordance with previous studies indicating long-term ( casual BPV ) and short-term ( beat-to-beat BPV ) prognostic value .


COSSACS was registered on the International Standard Randomised Controlled Trial Register ; URL : http://www.isrctn.com .


Unique identifier : ISRCTN89712435 .


CHHIPS was registered on the National Research Register ; URL : http://public.ukcrn.org.uk .


Unique identifier : N0484128008 .


Stroke is a major cause of morbidity and mortality during open-heart surgery .


Up to 60 % of intraoperative cerebral events are emboli induced .


This randomized , controlled , multicenter trial is the first human study evaluating the safety and efficacy of a novel aortic cannula producing simultaneous forward flow and backward suction for extracting solid and gaseous emboli from the ascending aorta and aortic arch upon their intraoperative release .


Sixty-six patients ( 25 females ; 6810 years ) undergoing elective aortic valve replacement surgery , with or without coronary artery bypass graft surgery , were randomized to the use of the CardioGard ( CardioGard Medical , Or-Yehuda , Israel ) Emboli Protection cannula ( `` treatment '' ) or a standard ( `` control '' ) aortic cannula .


The primary endpoint was the volume of new brain lesions measured by diffusion-weighted magnetic resonance imaging ( DW-MRI ) , performed preoperatively and postoperatively .


Device safety was investigated by comparisons of complications rate , namely neurologic events , stroke , renal insufficiency and death .


Of 66 patients ( 34 in the treatment group ) , 51 completed the presurgery and postsurgery MRI ( 27 in the treatment group ) .


The volume of new brain lesion for the treatment group was ( meanstandard error of the mean ) 44.0064.00 versus 126.5628.74 mm3 in the control group ( p = 0.004 ) .


Of the treatment group , 41 % demonstrated new postoperative lesions versus 66 % in the control group ( p = 0.03 ) .


The complication rate was comparable in both groups .


The CardioGard cannula is safe and efficient in use during open-heart surgery .


Efficacy was demonstrated by the removal of a substantial amount of emboli , a significant reduction in the volume of new brain lesions , and the percentage of patients experiencing new brain lesions .


The skills and knowledge that residents have to master has increased , yet the amount of hours that the residents are allowed to work has been reduced .


There is a strong need to improve training techniques to compensate for these changes .


One approach is to use simulation-training methods to shorten the learning curve for surgeons in training .


To analyze the effect of surgical training using three-dimensional ( 3D ) simulation on the placement of lateral mass screws in the cervical spine on either cadavers or sawbones .


A blinded randomized control study .


Fifteen orthopedic residents , postgraduate year ( PGY ) 1 to 6 , were asked to simulate Magerl lateral mass screw trajectories from C3-C7 on cadavers using a navigated drill guide , but with no feedback as to the actual trajectory within the bone ( Baseline 1 ) .


This was repeated to determine baseline accuracy ( Baseline 2 ) .


They were then randomized into three groups : Group 1 , control , did not receive any training , whereas Groups 2 and 3 received 3D navigational feedback as to the intended drill trajectory on sawbones and cadavers , respectively .


All three groups then performed final simulated drilling ( final test ) .


All 3D images were deidentified and reviewed by a blinded single fellowship-trained orthopedic spine surgeon .


Each image/screw was measured for the starting site , caudad/cephalad angle , and medial/lateral angle to determine trajectory accuracy .


The aggregate mean difference from a perfect screw was compiled for each session for each group .


A negative difference shows improvement , whereas a positive difference shows regression .


The difference between final test and Baseline 1 in the control group was 2.4 , suggesting regression .


In contrast , the differences for groups sawbone and cadaver were -8.2 and -7.2 , respectively , suggesting improvement .


When comparing the difference in aggregate sum angle for the sawbones and cadaver groups with the control group , the difference was statistically significant ( p < .0001 ) .


Training with 3D navigation significantly improved the ability of orthopedic residents to properly drill simulated lateral mass screws .


As such , training with 3D navigation may be a useful adjunct in resident surgical education .


Anti-inflammatory therapeutic approaches are considered for the management of type 2 diabetes and for the prevention of its complications .


There is limited evidence regarding the effects of prebiotics on inflammation , especially in patients with type 2 diabetes .


This trial aims to examine the effects of oligofructose-enriched inulin on glycemic status , inflammation markers , and metabolic endotoxemia in female patients .


Over a period of 8 wk , 52 women with body mass indices of > 25 kg/m ( 2 ) but < 35 kg/m ( 2 ) with type 2 diabetes were randomly assigned to either an intervention group , in which participants were given oligofructose-enriched inulin ( n = 27 , consuming 10 g/d of oligofructose-enriched inulin ) , or to a control group , in which participants were given maltodextrin ( n = 25 , consuming 10 g/d of maltodextrin ) .


Fasting plasma glucose , glycosylated hemoglobin , high-sensitivity C-reactive protein , interleukin-6 , tumor necrosis factor - , interferon - , interleukin-10 , and plasma lipopolysaccharide were measured before and after the intervention .


Data were analyzed with the use of SPSS software version 13 .


Paired and unpaired Student t tests and analysis of covariance were used to compare quantitative variables .


Oligofructose-enriched inulin caused a significant decrease in the levels of fasting plasma glucose ( 19.2 mg/dL ; 9.50 % ) , glycosylated hemoglobin ( 1.0 % ; 8.40 % ) , interleukin-6 ( 1.3 pg/mL ; 8.15 % ) , tumor necrosis factor - ( 3.0 pg/mL ; 19.80 % ) and plasma lipopolysaccharide ( 6.0 EU/mL ; 21.95 % ) as compared with maltodextrin ( P < 0.05 ) .


Decreases in levels of interferon - ( 0.3 pg/mL ; 16.50 % ) and high-sensitivity C-reactive protein ( 3.9 ng/mL ; 31.70 % ) and an increase in the level of interleukin-10 ( 0.4 pg/mL , 11.50 % ) were not significant in the oligofructose-enriched inulin group as compared with the maltodextrin group .


In women with type 2 diabetes and suboptimal daily dietary fiber intake , oligofructose-enriched inulin may help to modulate some inflammatory markers .


Interventions that make extensive use of theory tend to have larger effects on behaviour .


The Intervention Mapping ( IM ) framework incorporates theory into intervention design , implementation and evaluation , and was applied to the development of a community-based childhood obesity prevention intervention for a multi-ethnic population .


IM was applied as follows : 1 ) Needs assessment of the community and culture ; consideration of evidence-base , policy and practice ; 2 ) Identification of desired outcomes and change objectives following identification of barriers to behaviour change mapped alongside psychological determinants ( e.g. knowledge , self-efficacy , intention ) ; 3 ) Selection of theory-based methods and practical applications to address barriers to behaviour change ( e.g. , strategies for responsive feeding ) ; 4 ) Design of the intervention by developing evidence-based interactive activities and resources ( e.g. , visual aids to show babies stomach size ) .


The activities were integrated into an existing parenting programme ; 5 ) Adoption and implementation : parenting practitioners were trained by healthcare professionals to deliver the programme within Children Centres .


HAPPY ( Healthy and Active Parenting Programme for Early Years ) is aimed at overweight and obese pregnant women ( BMI > 25 ) ; consists of 12 2.5 hr .


sessions ( 6 ante-natal from 24weeks ; 6 postnatal up to 9months ) ; it addresses mother 's diet and physical activity , breast or bottle feeding , infant diet and parental feeding practices , and infant physical activity .


We have demonstrated that IM is a feasible and helpful method for providing an evidence based and theoretical structure to a complex health behaviour change intervention .


The next stage will be to assess the impact of the intervention on behaviour change and clinical factors associated with childhood obesity .


The HAPPY programme is currently being tested as part of a randomised controlled feasibility trial .


Glycerol preserved acellular dermis ( Glyaderm ( ) ) consists of collagen and elastin fibers and is the first non-profit dermal substitute derived from glycerol-preserved , human allogeneic skin .


It is indicated for bi-layered skin reconstruction of full thickness wounds .


A protocol for clinical application and optimal interval before autografting with split thickness skin graft ( STSG ) was developed in a pilot study .


A phase III randomized , controlled , paired , intra-individual study compared full thickness defects engrafted with Glyaderm ( ) and STSG versus STSG alone .


Outcome measures included percentage of Glyaderm ( ) take , STSG take , and scar quality assessment .


Pilot study ( 27 patients ) : Mean take rates equaled 91.55 % for Glyaderm ( ) and 96.67 % for STSG .


The optimal autografting interval was 6 days ( 1 day ) .


Randomized trial ( 28 patients ) : Mean Glyaderm ( ) take rate was 88.17 % .