The maintenance program consisted of one monthly supervised high intensity interval training session , a written exercise program and exercise diary , and a maximum exercise test every third month during follow-up .


Forty-nine patients ( 15 women ) on optimal medical treatment were included following discharge from cardiac rehabilitation .


The primary endpoint was change in peak oxygen uptake at follow-up ; secondary endpoints were physical activity level , quality of life and blood markers of cardiovascular risk .


There was no change in peak oxygen uptake from baseline to follow-up in either group ( intervention group 27.9 ( 4.7 ) to 28.8 ( 5.6 ) mLkg ( -1 ) min ( -1 ) , control group 32.0 ( 6.2 ) to 32.8 ( 5.8 ) mLkg ( -1 ) min ( -1 ) , with no between-group difference , p = 0.22 ) .


Quality of life and blood biomarkers remained essentially unchanged , and both self-reported and measured physical activity levels were similar between groups after 12 months .


A maintenance exercise program for 12 months did not improve adherence to exercise or peak oxygen uptake in CAD patients after discharge from cardiac rehabilitation compared to usual care .


This suggests that infrequent supervised high intensity interval training sessions are inadequate to improve peak oxygen uptake in this patient group .


ClinicalTrials.gov NCT01246570 .


Early , goal-directed therapy ( EGDT ) is recommended in international guidelines for the resuscitation of patients presenting with early septic shock .


However , adoption has been limited , and uncertainty about its effectiveness remains .


We conducted a pragmatic randomized trial with an integrated cost-effectiveness analysis in 56 hospitals in England .


Patients were randomly assigned to receive either EGDT ( a 6-hour resuscitation protocol ) or usual care .


The primary clinical outcome was all-cause mortality at 90 days .


We enrolled 1260 patients , with 630 assigned to EGDT and 630 to usual care .


By 90 days , 184 of 623 patients ( 29.5 % ) in the EGDT group and 181 of 620 patients ( 29.2 % ) in the usual-care group had died ( relative risk in the EGDT group , 1.01 ; 95 % confidence interval [ CI ] , 0.85 to 1.20 ; P = 0.90 ) , for an absolute risk reduction in the EGDT group of -0.3 percentage points ( 95 % CI , -5.4 to 4.7 ) .


Increased treatment intensity in the EGDT group was indicated by increased use of intravenous fluids , vasoactive drugs , and red-cell transfusions and reflected by significantly worse organ-failure scores , more days receiving advanced cardiovascular support , and longer stays in the intensive care unit .


There were no significant differences in any other secondary outcomes , including health-related quality of life , or in rates of serious adverse events .


On average , EGDT increased costs , and the probability that it was cost-effective was below 20 % .


In patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation , hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome .


( Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme ; ProMISe Current Controlled Trials number , ISRCTN36307479 . )


To identify characteristics of hemodialysis patients most likely to experience difficulty adhering to sodium restrictions associated with their dietary regimen .


Secondary analysis using baseline data from an ongoing randomized clinical trial examining the effects of a technology-supported behavioral intervention on dietary sodium intake in hemodialysis patients .


Thirteen dialysis centers in southwestern Pennsylvania .


We included 122 participants ( 61 % women ; 48 % African American ) aged 61 14 years undergoing maintenance , intermittent hemodialysis for end-stage renal disease .


Normalized dietary sodium intake , adjusted interdialytic weight gain , perceived problems , and self-efficacy for restricting dietary sodium .


Younger participants were more likely to report problems managing their hemodialysis diet and low self-efficacy for restricting sodium intake .


Consistent with these findings , younger participants had a higher median sodium intake and higher average adjusted interdialytic weight gain .


Females reported more problems managing their diet .


Race , time on dialysis , and perceived income adequacy did not seem to influence outcome measures .


Our findings suggest that patients who are younger and female encounter more difficulty adhering to the hemodialysis regimen .


Hence , there may be a need to individualize counseling and interventions for these individuals .


Further investigation is needed to understand the independent effects of age and gender on adherence to hemodialysis dietary recommendations and perceived self-efficacy .


Ventricular and supraventricular premature complexes ( PC ) are frequent and usually symptomatic .


According to a previous study , magnesium pidolate ( MgP ) administration to symptomatic patients can improve the PC density and symptoms .


To assess the late follow-up of that clinical intervention in patients treated with MgP or placebo .


In the first phase of the study , 90 symptomatic and consecutive patients with PC were randomized ( double-blind ) to receive either MgP or placebo for 30 days .


Monthly follow-up visits were conducted for 15 months to assess symptoms and control electrolytes .


24-hour Holter was performed twice , regardless of symptoms , or whenever symptoms were present .


In the second phase of the study , relapsing patients , who had received MgP or placebo ( crossing-over ) in the first phase , were treated with MgP according to the same protocol .


Of the 45 patients initially treated with MgP , 17 ( 37.8 % ) relapsed during the 15-month follow-up , and the relapse time varied .


Relapsing patients treated again had a statistically significant reduction in the PC density of 138.25 / hour ( p < 0.001 ) .


The crossing-over patients reduced it by 247/hour ( p < 0.001 ) .


Patients who did not relapse , had a low PC frequency ( 3 PC/hour ) .


Retreated patients had a 76.5 % improvement in symptom , and crossing-over patients , 71.4 % .


Some patients on MgP had relapse of symptoms and PC , indicating that MgP is neither a definitive nor a curative treatment for late follow-up .


However , improvement in the PC frequency and symptoms was observed in the second phase of treatment , similar to the response in the first phase of treatment .


To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles ( Oral-B Pro 7000 SmartSeries and Oral-B CrossAction brush head ) versus a marketed sonic toothbrush ( Colgate ProClinical A1500 with the Triple Clean brush head ) in the reduction of gingivitis and plaque over a 6-week period .


This was a single center , randomized , open label , examiner-blind , 2-treatment , parallel group study .


Study participants who met the entrance criteria were enrolled in the study and randomly assigned to one of the two toothbrush groups .


Study participants brushed with their assigned toothbrush and a marketed fluoride dentifrice for 2 minutes twice daily at home for 6 weeks .


Gingivitis and plaque were evaluated at baseline and Week 6 .


Gingivitis was assessed using the Modified Gingival Index ( MGI ) and Gingival Bleeding Index ( GBI ) and plaque was assessed using the Rustogi Modified Navy Plaque Index ( RMNPI ) .


Data was analyzed using the ANCOVA with baseline as the covariate .


In total , 130 study participants were randomized to treatment resulting in 64 study participants per group completing the study .


Both brushes produced statistically significant ( P < 0.001 ) reductions in gingivitis and plaque measures relative to baseline .


The oscillating-rotating , brush with the novel brush head demonstrated statistically significantly ( P < 0.05 ) greater reductions in all gingivitis measures , as well as whole mouth and interproximal plaque measures , compared to the sonic toothbrush .


The benefit for the oscillating - rotating brush over the sonic brush was 21.3 % for gingivitis , 35.7 % for gingival bleeding , 34.7 % for number of bleeding sites , 17.4 % for whole mouth plaque , and 21.2 % for interproximal plaque .


There were no adverse events reported or observed for either brush .


Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach , which is based on type I and type II errors , in determining sample sizes for randomized clinical trials .


However , in addition to sample size calculation , value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times , by considering trial designs that maximize the expected net benefit of research , which is the difference between the expected cost of the trial and the expected value of additional information .


To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial .


An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices : standard polyurethane , tissue adhesive , bordered polyurethane and sutureless securement device .


Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information .


To guide the optimal future trial design , the expected costs and benefits of the alternative trial designs were estimated and compared .


Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile .


Among the possible designs for the future trial , a four-arm study with 220 patients/arm would provide the highest expected net benefit corresponding to 130 % return-on-investment .


The initially considered design of 388 patients/arm , based on hypothesis testing calculations , would provide lower net benefit with return-on-investment of 79 % .


Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation .


Another limitation was that different follow-up durations for the larger trial were not evaluated .


The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research .


This approach should be considered early in the design of randomized clinical trials .


To conduct a cost-effectiveness analysis comparing two different tooth replacement strategies for partially dentate older patients , namely partial removable dental prostheses ( RDP ) and functionally orientated treatment based on the shortened dental arch concept ( SDA ) .


Ninety-two partially dentate older patients completed a randomized controlled clinical trial .


Patients were randomly allocated to two treatment groups : the RDP group and the SDA group .


Treatment effect was measured using impact on oral health-related quality of life ( OHrQOL ) , and the costs involved in providing and maintaining care were recorded for all patients .


Patients were followed for 12 months after treatment intervention .


All treatment was provided by a single operator .


The total cost of achieving the minimally important clinical difference ( MID ) in OHrQOL for an average patient in the RDP group was 464.64 .


For the SDA group , the cost of achieving the MID for an average patient was 252.00 .


The cost-effectiveness ratio was therefore 1:1.84 in favour of SDA treatment .


With an increasingly ageing population , many patients will continue to benefit from removable prostheses to replace their missing natural teeth .


From a purely economic standpoint , the results from this analysis suggest that the treatment of partially dentate older adults should be focused on functionally orientated treatment because it is simply more cost-effective .


Previous reports suggest that adherence to patching is a major issue in amblyopia treatment .


We tested with an unmasked randomised controlled clinical trial whether an intense educational/motivational intervention improves adherence when a high-dose regime is prescribed .


62 children with newly diagnosed amblyopia were randomly allocated into two treatment arms with and without educational/motivational intervention material .


Both were prescribed patching 10 h/day , 6 days/week for a fixed period of 12 weeks .


The intervention arm received an educational/motivational intervention before patching which included information booklets , video , a cartoon story book , sticker charts and a dedicated session with a researcher .


The control arm received the usual clinical information .


The primary outcome measure was adherence measured using electronic occlusion dose monitors where a success/failure binary outcome was used to account for participants who dropped out of the study defined as patching > 4 h/day .


Visual outcome , expressed as percentage visual deficit , was measured as secondary outcome .


The intervention increased adherence success rate from 45.2 % in the control group to 80.6 % in the intervention group ( p = 0.0027 ) .


However , visual outcome was not significantly better in the intervention group ( p = 0.190 ) .


Our study shows that an intense educational/motivational intervention can improve adherence to patching to high prescribed doses although no significant improvement in visual outcome was observed .


TRIALS REGISTRATION NUMBER : ISRCTN05346737 ( International Standard Randomised Controlled Trial Number Register ) .


Currently , there is an increased prevalence of diabetes mellitus among the elderly .


To minimize adverse effects on glycemic control , prevention and management of general and oral complications in diabetic patients is essential .


The purpose of the present study is to assess the effectiveness of a Lifestyle Change plus Dental Care ( LCDC ) program to improve glycemic and periodontal status in the elderly with type 2 diabetes .


A quasi-experimental study was conducted in Health Centers 54 ( intervention ) and 59 ( control ) from October 2013 to January 2014.66 diabetic patients per health center were included .


At baseline , the intervention group attended a 20 minute lifestyle and oral health education program , individual lifestyle counseling using motivational interviewing ( MI ) , application of self regulation manual , and individual oral hygiene instruction .


The intervention group received booster education every visit by viewing a 15 minute educational video .


The control group received a routine program .


Participants were assessed at baseline and 3 month follow up for glycosylated hemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) , body mass index ( BMI ) , periodontal status , knowledge , attitude and practice of oral health and diabetes mellitus .


Data were analyzed by using descriptive statistic , Chi-square test , Fisher 's exact test , t-test , and multiple linear regression .


After the 3 month follow up , a multiple linear regression analysis showed that the intervention group was significantly negatively correlated in both glycemic and periodontal status .


Participants in the intervention group had significantly lower glycosylated hemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) , plaque index score , gingival index score , pocket depth , clinical attachment level ( CAL ) , and percentage of bleeding on probing ( BOP ) when compared to the control group .


The combination of lifestyle change and dental care in one program improved both glycemic and periodontal status in the elderly with type 2 diabetes .


ClinicalTrials.in.th : TCTR20140602001 .


The aim of this study is to evaluate the effects of hormone replacement therapy using dienogest and medroxyprogesterone acetate on psychological symptoms in perimenopausal and postmenopausal women .


A total of 73 patients who sought treatment at the menopause units of the authors ' gynecology and obstetrics clinics between of November 2003 and October 2004 complaining of vasomotor symptoms were included in the study prospectively .


The cases were divided into two groups : Group I ( 37 patients ) was given 2 mg estradiol valerate and 2 mg dienogest , and Group II ( 36 patients ) was given 2 mg estradiol valerate and 10 mg medroxyprogesterone acetate .


The groups ' results in months 0 and 6 were compared through the evaluation of vasomotor and psychological symptom levels .


No significant difference was found between the groups when the initial levels of vasomotor and psychological symptom subtypes were compared ( p = 0.16 ) .


It was observed that all the psychological symptoms decreased in the 6th month in the group using dienogest in comparison with the initial situation , and that psychological symptoms increased in the group using medroxyprogesterone acetate in the evaluation performed in the 6th month compared with the initial levels .


It was also found out that there was a statistically significant difference between the two groups when compared in terms of these symptoms ( p < 0.0001 ) .


While the use of dienogest normalizes the general psychological situation and sleep , it was observed that the use of medroxyprogesterone acetate ( MPA ) worsens the general psychological situation .


Cross-sectional and retrospective studies have associated major depressive disorder with glial activation and injury as well as blood-brain barrier disruption , but these associations have not been assessed prospectively .


Here , we aimed to determine the relationship between changes in depressive symptom severity and in blood levels of S-100 calcium-binding protein B ( S-100B ) , high-sensitivity C-reactive protein , and interleukin-6 following an inflammatory challenge .


Fifty unselected participants were recruited from a randomized , controlled trial comparing coronary artery bypass grafting procedures performed with versus without cardiopulmonary bypass for the risk of neurocognitive decline .


Depressive symptom severity was measured at baseline , discharge , and six-month follow-up using the Beck Depression Inventory II ( BDI-II ) .


The primary outcome of the present biomarker study was acute change in depressive symptom severity , defined as the intra-subject difference between baseline and discharge BDI-II scores .


Blood biomarker levels were determined at baseline and 2 days postoperative .


Changes in S-100B levels correlated positively with acute changes in depressive symptom severity ( Spearman , 0.62 ; P = 0.0004 ) and accounted for about one-fourth of their observed variance ( R2 , 0.23 ; P = 0.0105 ) .


This association remained statistically significant after adjusting for baseline S-100B levels , age , weight , body-mass index , or - blocker use , but not baseline BDI-II scores ( P = 0.064 ) .


There was no statistically significant association between the primary outcome and baseline S-100B levels , baseline high-sensitivity C-reactive protein or interleukin-6 levels , or changes in high-sensitivity C-reactive protein or interleukin-6 levels .


Among most participants , levels of all three biomarkers were normal at baseline and markedly elevated at 2 days postoperative .


Acute changes in depressive symptom severity were specifically associated with incremental changes in S-100B blood levels , largely independent of covariates associated with either .


These findings support the hypothesis that glial activation and injury and blood-brain barrier disruption can be mechanistically linked to acute exacerbation of depressive symptoms in some individuals .


We hypothesized that untreated severe obstructive sleep apnea ( OSA ) is associated with elevated ambulatory blood pressure ( BP ) in subjects with high cardiovascular disease ( CVD ) risk despite medical management .


Data from the baseline examination of the Heart Biomarker Evaluation in Apnea Treatment ( HeartBEAT ) study , a 4-site randomized controlled trial were analyzed .


Individuals with moderate-severe OSA ( apnea hypopnea index , AHI = 15-50 ) and cardiovascular risk were recruited from cardiology practices .


Those with hypertension were included .


Intensive antihypertensive regimen ( IAR ) was defined as 3 antihypertensives including a diuretic .


Definitions were : controlled BP ( BP < 130/80 ) , uncontrolled elevated BP ( BP 130/80 not on IAR ) and resistant elevated BP ( BP 130/80 mm Hg despite IAR ) .


Associations of untreated severe OSA ( AHI 30 ) and uncontrolled and resistant elevated BP were evaluated using logistic regression analyses adjusted for age , sex , race , body mass index , smoking status , diabetes , and CVD .


Among the 284 participants ( mean age 63.1 7.2 years , 23.6 % with severe OSA ) , 61.6 % had controlled BP , 28.5 % had uncontrolled elevated BP , and 9.9 % had resistant elevated BP .


Among participants prescribed IAR , resistant elevated BP was more prevalent in those with severe compared to moderate OSA ( 58.3 % vs. 28.6 % , p = 0.01 ) .


Participants with severe OSA had a 4-fold higher adjusted odds of resistant elevated BP ( OR 4.1 , 95 % CI : 1.7-10 .2 ) , a finding not reproduced in the absence of IAR use .


Among patients with increased cardiovascular risk and moderate to severe OSA , untreated severe compared to moderate OSA was associated with elevated BP despite IAR suggesting untreated severe OSA contributes to poor BP control despite aggressive medication use .


A commentary on this article appears in this issue on page 845 .


The aim of this study is to explore the efficacy and safety of the combination of autologous transplantation of granulocyte colony-stimulating factor ( G-CSF ) - mobilized peripheral blood mononuclear cells ( PBMNCs ) and Panax notoginseng saponins ( PNS ) in the treatment of unreconstructable critical limb ischemia ( CLI ) .


We performed an open-label , parallel-group , single-center , randomized clinical trial in this study .


A total of 52 patients were enrolled and randomly divided into 2 groups ( the PBMNC + PNS group and the PBMNC group ) in a 1:1 ratio .


Evaluation variables , including changes in the ankle-brachial index ( ABI ) of ischemic limbs , ulcer area , severity of rest pain , transcutaneous oxygen pressure ( T ( C ) PO2 ) , and 6-min walk distance from baseline to week 8 and 16 , as well as angiographic scores for new collateral vessel formation at week 16 , were used to compare the benefits of these 2 treatment approaches .


After 16 weeks of treatment , improvement in ABI , T ( C ) PO2 , and 6-min walk distance was significantly better in the PBMNC + PNS group .


In addition , the combination of PBMNC transplantation and PNS administration yielded a greater reduction in ulcer area and severity of rest pain than did PBMNC transplantation alone .


The proportion of patients experiencing any adverse event was similar between both treatment groups .


Adverse events caused by PBMNC transplantation or PNS were generally mild and no serious adverse events occurred throughout the entire period of study .


A combination of PNS and PBMNC transplantation appears to be a safe and effective treatment for patients with unreconstructable CLI .


This combination may have great potential advantages in comparison with PBMNC transplantation alone and might constitute a novel therapeutic option for unreconstructable CLI .


Bone marrow ( BM ) dysfunction is common in severely injured trauma patients , resulting from elevated catecholamines and plasma granulocyte colony-stimulating factor ( G-CSF ) as well as prolonged mobilization of hematopoietic progenitor cells ( HPCs ) .


We have previously shown that propranolol ( - blocker [ BB ] ) reduces HPC mobilization in a rodent model of injury and hemorrhagic shock .


We hypothesize that BB would prevent BM dysfunction in humans following severe injury .


Forty-five severely injured trauma patients were studied in a prospective , randomized pilot trial .


Twenty-five patients received BB , and 20 served as untreated controls .


The dose of propranolol was adjusted to decrease the heart rate by 10 % to 20 % from baseline .


Blood was analyzed for the presence of HPC ( blast-forming unit erythroid cells [ BFU-E ] and colony-forming unit erythroid cells ) and G-CSF .


Demographic data , Injury Severity Score ( ISS ) , hemoglobin , reticulocyte number , and outcome data were obtained .


The mean age of the study population was 33 years ; 87 % were male , with a mean ISS of 29 .


There is a significant increase in BFU-E in peripheral blood immediately following traumatic injury , and this mobilization persists for 30 days .


The use of BB significantly decreases BFU-E and colony-forming unit erythroid cells at all time points .


G-CSF is significantly elevated in both groups on admission ; the use of BB decreases G-CSF levels by 51 % as compared with 37 % for controls .


The average hemoglobin is nearly 1 g higher on the day of discharge with propranolol treatment ( BB , 9.9 0.4 g/dL vs. no BB , 9.1 0.6 g/dL ) .


Following severe trauma , early treatment with propranolol following resuscitation is safe .


The use of propranolol blunts early tachycardia , reduces HPC mobilization , and results in a faster return to baseline of the G-CSF peak seen after injury .


There is also a trend toward faster recovery and resolution of anemia .


Propranolol may be the first therapeutic agent to show improved BM function after severe injury .


Therapeutic study , level III .


Despite evidence for the effectiveness of structured psychological therapies for bipolar disorder no psychological interventions have been specifically designed to enhance personal recovery for individuals with recent-onset bipolar disorder .


A pilot study to assess the feasibility and effectiveness of a new intervention , recovery-focused cognitive-behavioural therapy ( CBT ) , designed in collaboration with individuals with recent-onset bipolar disorder intended to improve clinical and personal recovery outcomes .


A single , blind randomised controlled trial compared treatment as usual ( TAU ) with recovery-focused CBT plus TAU ( n = 67 ) .


Recruitment and follow-up rates within 10 % of pre-planned targets to 12-month follow-up were achieved .


An average of 14.15 h ( s.d. = 4.21 ) of recovery-focused CBT were attended out of a potential maximum of 18 h. Compared with TAU , recovery-focused CBT significantly improved personal recovery up to 12-month follow-up ( Bipolar Recovery Questionnaire mean score 310.87 , 95 % CI 75.00-546 .74 ( s.e. = 120.34 ) , P = 0.010 , d = 0.62 ) and increased time to any mood relapse during up to 15 months follow-up ( 2 = 7.64 , P < 0.006 , estimated hazard ratio ( HR ) = 0.38 , 95 % CI 0.18-0 .78 ) .


Groups did not differ with respect to medication adherence .


Recovery-focused CBT seems promising with respect to feasibility and potential clinical effectiveness .


Clinical - and cost-effectiveness now need to be reliably estimated in a definitive trial .


Tofacitinib is a novel , oral Janus kinase inhibitor being investigated for psoriasis .


This study assessed the relationship between pruritus and clinical signs of psoriasis ( assessed by Physician 's Global Assessment [ PGA ] ) in patients with moderate-to-severe chronic plaque psoriasis receiving tofacitinib .


In this 16-week ( 12-week treatment period , 4-week observation period ) , double-blind , placebo-controlled , phase IIb study ( NCT00678210 ) , 197 patients were randomized to tofacitinib 2 , 5 or 15 mg BID , or placebo .


Pruritus was patient assessed using the Itch Severity Score ( ISS ) , a 0-10 ( 10 = worst itching ) rating scale recorded daily from baseline to week 2 and at study visits .


Mediation modeling was used to determine relationships between ISS ( average score weeks 2-12 ) , PGA ( average score weeks 2-12 ) and treatment groups .


Mediation analysis showed that 70.2-80 .5 % ( p < 0.001 versus placebo ) of tofacitinib 's effect on pruritus was direct , and mostly independent of improvements in erythema , induration and scaling .


ISS measurements had acceptable test-retest reliability .


Correlation analyses with clinical outcomes supported the validity of the ISS as a pruritus measure .


Tofacitinib has a direct , beneficial effect on patient-reported pruritus independent from improvements in clinician-reported psoriasis severity signs .


The ISS demonstrated favorable psychometric characteristics , supporting its use as a pruritus assessment tool .


Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child , there is no intervention proven to reduce the risk of these complications .


The primary aim of this randomised controlled trial is to assess in obese pregnant women , whether a complex behavioural intervention , based on changing diet ( to foods with a lower glycemic index ) and physical activity , will reduce the risk of gestational diabetes ( GDM ) and delivery of a large for gestational age ( LGA ) infant .


A secondary aim is to determine whether the intervention lowers the long term risk of obesity in the offspring .


Multicentre randomised controlled trial comparing a behavioural intervention designed to improve glycemic control with standard antenatal care in obese pregnant women.Inclusion criteria ; women with a BMI 30 kg/m2 and a singleton pregnancy between 15 +0 weeks and 18 +6 weeks ' gestation .


Exclusion criteria ; pre-defined , pre-existing diseases and multiple pregnancy .


Randomisation is on-line by a computer generated programme and is minimised by BMI category , maternal age , ethnicity , parity and centre .


Intervention ; this is delivered by a health trainer over 8 sessions .


Based on control theory , with elements of social cognitive theory , the intervention is designed to improve maternal glycemic control .


Women randomised to the control arm receive standard antenatal care until delivery according to local guidelines .


All women have a 75 g oral glucose tolerance test at 27 +0 - 28 +6 weeks ' gestation.Primary outcome ; Maternal : diagnosis of GDM , according to the International Association of Diabetes in Pregnancy Study Group ( IADPSG ) criteria .


Neonatal ; infant LGA defined as > 90th customised birth weight centile.Sample size ; 1546 women to provide 80 % power to detect a 25 % reduction in the incidence of GDM and a 30 % reduction in infants large for gestational age .


All aspects of this protocol have been evaluated in a pilot randomised controlled trial , with subsequent optimisation of the intervention .


The findings of this trial will inform whether lifestyle mediated improvement of glycemic control in obese pregnant women can minimise the risk of pregnancy complications .


Current controlled trials ; ISRCTN89971375 .


Animal-assisted therapy ( AAT ) , most frequently used with dogs , is being used increasingly as an adjunctive alternative treatment for psychiatric patients .


AAT with larger animals , such as horses , may have unique benefits .


In this randomized controlled study , equine and canine forms of AAT were compared with standard treatments for hospitalized psychiatric patients to determine AAT effects on violent behavior and related measures .


The study included 90 patients with recent in-hospital violent behavior or highly regressed behavior .


Hospitalization at the 500-bed state psychiatric hospital was two months or longer ( mean 5.4 years ) .


Participants were randomly selected to receive ten weekly group therapy sessions of standardized equine-assisted psychotherapy ( EAP ) , canine-assisted psychotherapy ( CAP ) , enhanced social skills psychotherapy , or regular hospital care .


Participants ' mean age was 44 , 37 % were female , 76 % had diagnoses of schizophrenia or schizoaffective disorder , and 56 % had been committed involuntarily for civil or forensic reasons .


Violence-related incident reports filed by staff in the three months after study intake were compared with reports two months preintake .


Interventions were well tolerated .


Analyses revealed an intervention group effect ( F = 3.00 , df = 3 and 86 , p = .035 ) ; post hoc tests showed specific benefits of EAP ( p < .05 ) .


Similar AAT effects were found for the incidence of 1:1 clinical observation ( F = 2.70 , df = 3 and 86 , p = .051 ) ; post hoc tests suggested benefits of CAP ( p = .058 ) as well as EAP ( p = .082 ) .


Covariance analyses indicated that staff can predict which patients are likely to benefit from EAP ( p = .01 ) .


AAT , and perhaps EAP uniquely , may be an effective therapeutic modality for long-term psychiatric patients at risk of violence .


Knowledge about the inhibition of centrally located angiotensin-I ( AT-I ) receptors by highly lipophilic AT-I receptor blockers and its ' effect are limited with experimental studies .


Thus , we aimed to investigate the effect of Telmisartan on Inter-dialytic weight gain ( IDWG ) % and echocardiographic measurements in anuric hemodialysis ( HD ) patients .


A total of forty-one anuric HD patients with 6 months maintenance on HD were included in this prospective , randomized and self-controlled study .


Four weeks prior the study , angiotensin converting enzyme blockers and AT-I receptor blocker drugs were stopped .


Patients were assessed three times during the study protocol .


These are baseline , three months later ( without Telmisartan period ) and three months after Telmisartan therapy .


IDWG % was significantly decreased in the period of with Telmisartan compared to period without Telmisartan ( 5.6 1.0 % vs 5.3 1.0 % , p = 0.03 ) .


After the administration of Telmisartan left ventricule end-diastolic diameter ( LVEDD ) ( p = 0.001 ) and inferior vena cava diameter ( IVCD ) ( 19.1 3.8 mm vs 17.3 4.2 mm , p = 0.001 ) were significantly decreased compared to the period of without Telmisartan .


Despite of significantly changes observed in IVCD and LVEDD measurements in a period without Telmisartan , there was no significantly difference in left ventricular mass index ( LVMI ) measurements in this period .


However , LVMI was significantly regressed after the administration of Telmisartan ( 269.3 82.7 g vs 256.3 70.3 g , p = 0.003 respectively ) .


Treatment of anuric HD patients with Telmisartan at a dose of 40 mg a day reduces IDWG % , LVEDD and IVCD measurements .


Further studies investigating the long-term effect of these beneficial effects on clinical outcomes are necessary .


There are currently no serum biomarkers capable of distinguishing elevations in serum alanine aminotransferase ( ALT ) that portend serious liver injury potential from benign elevations such as those occurring during cholestyramine treatment .


The aim of the research was to test the hypothesis that newly proposed biomarkers of hepatotoxicity would not significantly rise in serum during elevations in serum ALT associated with cholestyramine treatment , which has never been associated with clinically relevant liver injury .


In a double-blind placebo-controlled trial , cholestyramine ( 8g ) was administered for 11 days to healthy adult volunteers .


Serum from subjects with elevations in alanine aminotransferase ( ALT ) exceeding three-fold the upper limit of normal ( ULN ) were utilized for biomarker quantification .


In 11 of 67 subjects , cholestyramine treatment resulted in ALT elevation by > 3x ULN ( mean 6.9 fold ; range 3-28 fold ) .


In these 11 subjects , there was a 22.4-fold mean increase in serum levels of miR-122 relative to baseline , supporting a liver origin of the serum ALT .


Significant elevations were noted in mean levels of necrosis biomarkers sorbitol dehydrogenase ( 8.1 fold ) , cytokeratin 18 ( 2.1 fold ) and HMGB1 ( 1.7 fold ) .


Caspase-cleaved cytokeratin 18 , a biomarker of apoptosis was also significantly elevated ( 1.7 fold ) .


A rise in glutamate dehydrogenase ( 7.3 fold ) may support mitochondrial dysfunction .


All toxicity biomarkers measured in this study were elevated along with ALT , confirming the liver origin and reflecting both hepatocyte necrosis and apoptosis .


Since cholestyramine treatment has no clinical liver safety concerns , we conclude that interpretation of the biomarkers studied may not be straightforward in the context of assessing liver safety of new drugs .


Type 2 diabetes can often be prevented by lifestyle modification ; however , successful lifestyle intervention programmes are labour intensive .


Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification .


We aimed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type 2 diabetes in Indian Asian men with impaired glucose tolerance .


We did a prospective , parallel-group , randomised controlled trial between Aug 10 , 2009 , and Nov 30 , 2012 , at ten sites in southeast India .


Working Indian men ( aged 35-55 years ) with impaired glucose tolerance were randomly assigned ( 1:1 ) with a computer-generated randomisation sequence to a mobile phone messaging intervention or standard care ( control group ) .


Participants in the intervention group received frequent mobile phone messages compared with controls who received standard lifestyle modification advice at baseline only .


Field staff and participants were , by necessity , not masked to study group assignment , but allocation was concealed from laboratory personnel as well as principal and co-investigators .


The primary outcome was incidence of type 2 diabetes , analysed by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT00819455 .


We assessed 8741 participants for eligibility .


537 patients were randomly assigned to either the mobile phone messaging intervention ( n = 271 ) or standard care ( n = 266 ) .


The cumulative incidence of type 2 diabetes was lower in those who received mobile phone messages than in controls : 50 ( 18 % ) participants in the intervention group developed type 2 diabetes compared with 73 ( 27 % ) in the control group ( hazard ratio 064 , 95 % CI 045-092 ; p = 0015 ) .


The number needed to treat to prevent one case of type 2 diabetes was 11 ( 95 % CI 6-55 ) .


One patient in the control group died suddenly at the end of the first year .


We recorded no other serious adverse events .


Mobile phone messaging is an effective and acceptable method to deliver advice and support towards lifestyle modification to prevent type 2 diabetes in men at high risk .


The UK India Education and Research Initiative , the World Diabetes Foundation .


We studied the unclear question whether blood pressure ( BP ) lowering reduces cardiovascular disease ( CVD ) in elderly individuals with systolic BP < 160 mm Hg .


We initiated a randomized placebo-controlled stratified 2 2 factorial clinical trial evaluating the effects of BP lowering in 11 000 elderly individuals with systolic blood pressure ( SBP ) between 130 and 159 mm Hg , for 5 years .


Following 5-week active run-in , participants were randomized to aliskiren ( 300 mg ) or placebo , and to an additional antihypertensive [ hydrochlorothiazide ( 25 mg ) or amlodipine ( 5 mg ) ] , or their respective placeboes .


Study was terminated by sponsor after 1759 subjects ( age 72.1 5.2 years , 88 % receiving at least one antihypertensive ) were randomized and followed for 0.6 year .


Study drugs were well tolerated with few serious adverse events during run-in and after randomization , with no significant differences between treatment groups .


By design , three levels of BP reductions were achieved , adjusted mean BP reductions of 3.5 / 1.7 mm Hg ( P < 0.001 ) by aliskiren , 6.8 / 3.3 mm Hg ( P < 0.001 ) by hydrochlorothiazide or amlodipine , and 10.3 / 5.0 mm Hg ( P < 0.001 ) by double therapy compared with placebo .


Twenty-five major CVD events occurred .


Non-significant trends towards fewer CVD events with greater BP reductions are evident : hazard ratios ( HR ) 0.82 [ 95 % confidence interval ( CI ) : 0.37-1 .81 ] for 3.5 mm Hg SBP reduction ; HR 0.45 ( 95 % CI : 0.19-1 .04 ) for 6.8 mm Hg ; and HR 0.25 ( 0.05-1 .18 ) for 10.3 mm Hg reduction for primary composite of CV death , MI , stroke , or significant heart failure .


Sizeable reductions in BP , with potential for substantial CVD reduction , can be safely achieved using combinations of BP drugs in the elderly with normal high and Stage 1 hypertension .


NCT01259297 .


As a result of research suggesting increased health risk with low serum 25-hydroxycholecalciferol ( 25 ( OH ) D ) , health care providers are measuring it frequently .


Providers and patients are faced with treatment choices when low status is identified .


To compare the safety and efficacy of three vitamin D3 dietary supplements with different delivery matrices .


A 12-week , parallel group , single-masked , clinical trial was conducted in Seattle , Washington and Kailua Kona , Hawaii .


Sixty-six healthy adults with ( 25 ( OH ) D ) < 33 ng/mL were randomly assigned to take one of three D3 supplements , ie , a chewable tablet ( TAB ) , an oil-emulsified drop ( DROP ) , or an encapsulated powder ( CAP ) at a label-claimed dose of 10,000 IU/day .


Actual D3 content was assessed by a third party and the results adjusted based on the actual D3 content administered .


Mean change in 25 ( OH ) D/mcg D3 administered ; difference in the proportion of D3 insufficient participants ( ie , 25 ( OH ) D 30 ng/mL ) reaching sufficiency ( ie , 25 ( OH ) D 30 ng/mL ) ; and mean change in serum 1 , 25-dihydroxycholecalciferol were measured .


In two of the three products tested , the measured vitamin D3 content varied considerably from the label-claimed dose .


Differences in 25 ( OH ) D/mcg D3 administered were significantly different between groups ( P = .04 ; n = 55 ) .


Pairwise comparisons demonstrated DROP resulted in a greater increase than TAB ( P < .05 ) but not than CAP .


TAB was not different from CAP .


The proportions reaching sufficiency were : 100 % ( TAB and CAP ) and 80 % ( DROP ) ( P = .03 between groups ; n = 55 ) .


1 , 25-Dihydroxycholecalciferol did not change significantly in any group .


Oil-emulsified vitamin D3 supplements resulted in a greater mean change in serum 25 ( OH ) D concentration , but fewer patients reaching vitamin D sufficiency , than chewable or encapsulated supplements .


In the REPAIR-AMI trial , intracoronary infusion of bone marrow-derived cells ( BMCs ) was associated with a significantly greater recovery of contractile function in patients with acute myocardial infarction ( AMI ) at 4-month follow-up than placebo infusion .


The current analysis investigates clinical outcome and predictors of event-free survival at 5 years .


In the multicentre , placebo-controlled , double-blind REPAIR-AMI trial , 204 patients received intracoronary infusion of BMCs ( n = 101 ) or placebo ( n = 103 ) into the infarct vessel 3-7 days following successful percutaneous coronary intervention .


Fifteen patients died in the placebo group compared with seven patients in the BMC group ( P = 0.08 ) .


Nine placebo-treated patients and five BMC-treated patients required rehospitalization for chronic heart failure ( P = 0.23 ) .


The combined endpoint cardiac/cardiovascular/unknown death or rehospitalisation for heart failure was more frequent in the placebo compared with the BMC group ( 18 vs. 10 events ; P = 0.10 ) .


Univariate predictors of adverse outcomes were age , the CADILLAC risk score , aldosterone antagonist and diuretic treatment , changes in left ventricular ejection fraction , left ventricular end-systolic volume , and N-terminal pro-Brain Natriuretic Peptide ( all P < 0.01 ) at 4 months in the entire cohort and in the placebo group .


In contrast , in the BMC group , only the basal ( P = 0.02 ) and the stromal cell-derived factor-1-induced ( P = 0.05 ) migratory capacity of the administered BMC were associated with improved clinical outcome .


In patients of the REPAIR-AMI trial , established clinical parameters are associated with adverse outcome at 5 years exclusively in the placebo group , whereas the migratory capacity of the administered BMC determines event-free survival in the BMC-treated patients .


These data disclose a potency-effect relationship between cell therapy and long-term outcome in patients with AMI .


Xpert MTB/RIF is approved for use in tuberculosis ( TB ) and rifampicin-resistance diagnosis .


However , data are limited on the impact of Xpert under routine conditions in settings with high TB burden .


A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive ( symptomatic ) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic .


The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by 3 mo after presentation .


Secondary outcomes included time to TB treatment and mortality .


Unblinded randomisation occurred on a weekly basis .


Xpert and smear microscopy were performed on site .


Analysis was both by intention to treat ( ITT ) and per protocol .


Between 7 September 2010 and 28 October 2011 , 1,985 participants were assigned to the Xpert ( n = 982 ) and routine ( n = 1,003 ) diagnostic algorithms ( ITT analysis ) ; 882 received Xpert and 1,063 routine ( per protocol analysis ) .


13 % ( 32/257 ) of individuals with bacteriologically confirmed TB ( smear , culture , or Xpert ) did not initiate treatment by 3 mo after presentation in the Xpert arm , compared to 25 % ( 41/167 ) in the routine arm ( ITT analysis , risk ratio 0.51 , 95 % CI 0.33-0 .77 , p = 0.0052 ) .


The yield of bacteriologically confirmed TB cases among patients with presumptive TB was 17 % ( 167/1 ,003 ) with routine diagnosis and 26 % ( 257/982 ) with Xpert diagnosis ( ITT analysis , risk ratio 1.57 , 95 % CI 1.32-1 .87 , p < 0.001 ) .


This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm : 23 % ( 229/1 ,003 ) and 28 % ( 277/982 ) in the routine and Xpert arms , respectively ( ITT analysis , risk ratio 1.24 , 95 % CI 1.06-1 .44 , p = 0.013 ) .


Time to treatment initiation was improved overall ( ITT analysis , hazard ratio 0.76 , 95 % CI 0.63-0 .92 , p = 0.005 ) and among HIV-infected participants ( ITT analysis , hazard ratio 0.67 , 95 % CI 0.53-0 .85 , p = 0.001 ) .


There was no difference in 6-mo mortality with Xpert versus routine diagnosis .


Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic .


These data suggest that in this routine primary care setting , use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by 3 mo and reduced time to treatment initiation , particularly among HIV-infected participants .


Pan African Clinical Trials Registry PACTR201010000255244 .


Please see later in the article for the Editors ' Summary .


Circumsporozoite protein ( CS ) is the antigenic target for RTS , S , the most advanced malaria vaccine to date .


Heterologous prime-boost with the viral vectors simian adenovirus 63 ( ChAd63 ) - modified vaccinia virus Ankara ( MVA ) is the most potent inducer of T-cells in humans , demonstrating significant efficacy when expressing the preerythrocytic antigen insert multiple epitope-thrombospondin-related adhesion protein ( ME-TRAP ) .


We hypothesized that ChAd63-MVA containing CS may result in a significant clinical protective efficacy .


We conducted an open-label , 2-site , partially randomized Plasmodium falciparum sporozoite controlled human malaria infection ( CHMI ) study to compare the clinical efficacy of ChAd63-MVA CS with ChAd63-MVA ME-TRAP .


One of 15 vaccinees ( 7 % ) receiving ChAd63-MVA CS and 2 of 15 ( 13 % ) receiving ChAd63-MVA ME-TRAP achieved sterile protection after CHMI .


Three of 15 vaccinees ( 20 % ) receiving ChAd63-MVA CS and 5 of 15 ( 33 % ) receiving ChAd63-MVA ME-TRAP demonstrated a delay in time to treatment , compared with unvaccinated controls .


In quantitative polymerase chain reaction analyses , ChAd63-MVA CS was estimated to reduce the liver parasite burden by 69 % -79 % , compared with 79 % -84 % for ChAd63-MVA ME-TRAP .


ChAd63-MVA CS does reduce the liver parasite burden , but ChAd63-MVA ME-TRAP remains the most promising antigenic insert for a vectored liver-stage vaccine .


Detailed analyses of parasite kinetics may allow detection of smaller but biologically important differences in vaccine efficacy that can influence future vaccine development .


NCT01623557 .


The purpose of the study was to compare behavioral outcomes ( physical activity , sedentary behavior , smoking cessation , diet ) between the intervention and usual care conditions from the TEAMcare trial .


TEAMcare was a randomized trial among 214 adults with depression and poorly controlled diabetes and/or coronary heart disease that promoted health behavior change and pharmacotherapy to improve health .


Behavioral outcomes were measured with the International Physical Activity Questionnaire ( physical activity , sitting time ) and the Summary of Diabetes Self-Care Activities Measure ( smoking , diet , exercise ) .


Poisson regression models among completers ( N = 185 ) were conducted adjusting for age , education , smoking status and depression .


Intervention participants had more days/week following a healthy eating plan [ relative rate = 1.2 , 95 % confidence interval ( CI ) = 1.1-1 .4 ] and more days of participation in 30 min of physical activity ( relative rate = 1.2 , 95 % CI = 1.1-2 .0 ) compared to usual care .


Intervention participants were more likely to meet physical activity guidelines ( 7.5 % increase ) compared to usual care ( 12 % decrease ; P = .053 ) .


Diet and activity generally improved for those receiving the intervention , while there were no differences in some aspects of diet ( fruit and vegetable and high-fat food intake ) , smoking status and sitting time between conditions in the TEAMcare trial .


The 2010 American Heart Association guidelines suggested an increase in cardiopulmonary resuscitation compression depth with a target > 50 mm and no upper limit .


This target is based on limited evidence , and we sought to determine the optimal compression depth range .


We studied emergency medical services-treated out-of-hospital cardiac arrest patients from the Resuscitation Outcomes Consortium Prehospital Resuscitation Impedance Valve and Early Versus Delayed Analysis clinical trial and the Epistry-Cardiac Arrest database .


We calculated adjusted odds ratios for survival to hospital discharge , 1-day survival , and any return of circulation .


We included 9136 adult patients from 9 US and Canadian cities with a mean age of 67.5 years , mean compression depth of 41.9 mm , and a return of circulation of 31.3 % , 1-day survival of 22.8 % , and survival to hospital discharge of 7.3 % .


For survival to discharge , the adjusted odds ratios were 1.04 ( 95 % CI , 1.00-1 .08 ) for each 5-mm increment in compression depth , 1.45 ( 95 % CI , 1.20-1 .76 ) for cases within 2005 depth range ( > 38 mm ) , and 1.05 ( 95 % CI , 1.03-1 .08 ) for percentage of minutes in depth range ( 10 % change ) .


Covariate-adjusted spline curves revealed that the maximum survival is at a depth of 45.6 mm ( 15-mm interval with highest survival between 40.3 and 55.3 mm ) with no differences between men and women .


This large study of out-of-hospital cardiac arrest patients demonstrated that increased cardiopulmonary resuscitation compression depth is strongly associated with better survival .


Our adjusted analyses , however , found that maximum survival was in the depth interval of 40.3 to 55.3 mm ( peak , 45.6 mm ) , suggesting that the 2010 American Heart Association cardiopulmonary resuscitation guideline target may be too high .


http://www.clinicaltrials.gov .


Unique identifier : NCT00394706 .


To compare the efficacy differences between acupuncture combined with auricular point sticking therapy and clomiphene oral administration in the treatment of polycystic ovary syndrome ( PCOS ) .


One hundred cases of PCOS were randomized into two groups , 50 cases in each one .


Acupuncture com bined with auricular point sticking group ( group A ) : acupuncture was applied at Guanyuan ( CV 4 ) , Zhongji ( CV 3 ) and Zigong ( EX-CA 1 ) , once daily ; auricular point sticking was applied at Spleen ( pi , CO13 ) , Endocrine ( neifenmi , CO18 ) , Unterus and Kidney ( shen , CO10 ) , t he plaster was changed once a week .


Clomiphene grou p ( group B ) : oral clomiphene was prescribed at the 5th day of the menstrual , for 5 consecutive days , totally 3 menstrual cycles was needed .


The ovulation induction , pregnancy and menstruation resuming of patients in the two ' , The totally effective rate was 90.00 % ( 45/50 ) in group A , which was group were observed and compared .


The totally effective rate was 90.0 % ( 45/50 ) in group A , which was superior to 86.0 % ( 43/50 ) in group B ( P < 0.05 ) ; the ovulation rate and pregnancy rate were 68.0 % ( 34/50 ) and 64.0 % ( 32/50 ) in group A , whiche were superior to that of group B ( all P < 0.05 ) ; the menstruation resuming rate was 94.00 ( 47/50 ) in group A , which was superior to 88.00 ( 44/50 ) in group B ( P < 0.05 ) .


No adverse effect was observed in group A , while in group B , varying degrees of nausea , vomiting , headache and dermatitis were observed in 29 cases , ovarian hyperstimulation syndrome ( OHSS ) like polycystic ovary was observed in 14 cases under the B ultrasound .


Acupuncture combined with auricular point sticking therapy has a better effect than clomiphene in the treatment of PCOS without any adverse effect .


Former sleep studies among non-treatment seeking chronic cocaine users had captured polysomnographic changes for as long as three weeks of abstinence .


20 cocaine dependent participants , randomized to placebo in an ongoing clinical trial , received 12 days of inpatient substance abuse treatment followed by 6 weeks of outpatient cognitive behavioral therapy .


Polysomnographic recording was performed on consecutive nights during the 1st and 2nd inpatient and 3rd and 6th outpatient weeks .


Number of days abstinent was determined from thrice weekly urine toxicology and self-report .


Polysomnographic sleep was compared between study week 1 and 2 , using paired t-tests .


Trajectory of total sleep time ( TST ) was modeled both as a linear and a quadratic function of days abstinent .


Despite reporting an improvement in overall sleep quality , polysomnographic sleep worsened from week 1 to 2 .


Among all participants , TST and stage 2 sleep time decreased , while REM sleep latency increased .


Among participants who began the study with a positive urine test , there was also a decrease in REM and a trend for decreased slow wave sleep .


TST compared to number of days abstinent ( up to 54 days ) was best fit with a quadratic model ( p = 0.002 ) , suggesting the possibility of an improvement in total sleep time with extended abstinence .


This is the first polysomnographic characterization of sleep in a large sample of cocaine users in treatment .


Present findings confirm earlier results of poor and deteriorating sleep early in abstinence , and raise the possibility of improvement after an extended abstinence .


Assessment of differences in soft tissue healing and long-term issues between two techniques for bone-anchored hearing implant ( BAHI ) surgery .


Single-center , randomized , nonblinded study using balanced randomization ( 1:1 ) .


Tertiary referral center in the Central Denmark Region .


Forty-seven adults with normal skin quality .


Operation with a BAHI system with randomization to 1 ) dermatome technique with soft tissue removal and 2 ) linear incision with no soft tissue reduction .


Holgers ' score , pain , and sensibility loss assessed at 0 , 3 , 7 , 10 , 14 , and 21 days and 1 , 3 , 6 , and 12 months postoperatively .


Implant loss .


Forty-nine patients were randomized ( linear incision , n = 25 ; dermatome , n = 24 ) .


Forty-seven patients were analyzed ( linear incision , n = 25 ; dermatome , n = 22 ) .


Differences in proportions for grouped data ( outcome 0 and outcome > 0 ) for the total of all visits were Holgers ' Index : 0.13 ( p = 0.0004 ; 95 % confidence interval [ 95 % CI ] , 0.058-0 .21 ) ; sensibility loss : 0.50 ( p = 2.2 10 ; 95 % CI , 0.42-0 .58 ) ; pain : 0.096 ( p = 0.006 ; 95 % CI , 0.026-0 .17 ) .


Soft tissue reactions and pain were most prominent in the early postoperative period , whereas issues with sensibility loss subsided throughout the 1-year follow-up period .


No implants were lost .


In a randomized trial for BAHI surgery , the linear incision with no subcutaneous reduction had a faster healing time and inflicted less pain and sensibility loss than the dermatome technique .


The long-term soft tissue problems were similar in the two groups , thus favoring the linear incision , which is less invasive .


The combined IVGTT-hyperinsulinaemic-euglycaemic clamp ( Botnia clamp ) allows the assessment of insulin secretion and sensitivity in one experiment .


It remains unclear whether this clamp yields results comparable with those of the standard hyperinsulinaemic-euglycaemic clamp ( SHEC ) in diabetes patients .


We hypothesised that the IVGTT induces responses affecting insulin sensitivity assessment .


Of 22 randomised diet - or metformin-treated patients with well-controlled type 2 diabetes , 19 randomly underwent a Botnia clamp and an SHEC , spaced by 2 weeks , in one clinical research centre in a crossover study .


The main outcomes were whole-body and hepatic insulin sensitivity as measured by the clamp and [ 6,6 - ( 2 ) H2 ] glucose .


Substrate utilisation was assessed from indirect calorimetry and beta cell function from insulin dynamics during IVGTT .


The values of whole-body insulin sensitivity obtained from Botnia clamp and SHEC were correlated ( r = 0.87 , p < 0.001 ) , but also revealed intra-individual variations .


Hepatic insulin sensitivity did not differ between experiments during the clamp , but differed after IVGTT .


The contribution of glucose oxidation to glucose disposal increased by 2.2 0.3 and 1.2 0.4 mg kg fat-free mass ( FFM ) ( -1 ) min ( -1 ) ( Botnia and SHEC , p < 0.05 ) , whereas lipid oxidation decreased by 0.8 0.1 and 0.4 0.1 mg kg FFM ( -1 ) min ( -1 ) ( p < 0.05 ) from baseline .


Differences in NEFA ( r = -0.60 , p < 0.01 ) , but not C-peptide ( r = -0.16 , p = 0.52 ) or hepatic insulin sensitivity between IVGTT and placebo before the clamps correlated with individual variations of insulin sensitivity .


The Botnia clamp provides similar estimates of insulin sensitivity as SHEC in patients with type 2 diabetes , but changes in NEFA during IVGTT may affect insulin sensitivity and thereby the discrimination between insulin-sensitive and insulin-resistant individuals .


ClinicalTrials.gov NCT01397279 FUNDING : The study was funded by the Ministry of Science and Research of the State of North Rhine-Westphalia and the German Federal Ministry of Health , and supported in part by grants from the Federal Ministry for Research to the Centers for Diabetes Research , Helmholtz Alliance Imaging and Curing Environmental Metabolic Diseases and the Schmutzler-Stiftung .


Clinical studies of recent years have shown that hyperuricemia is associated with poor outcomes such as cardiovascular mortality and dialysis inadequacy in patients undergoing hemodialysis .


Our study investigated the effect of vitamin C supplementation on serum uric acid levels in hemodialysis patients .


This randomized placebo-controlled trial was conducted on 172 hemodialysis patients .


They were randomly divided into the intervention group , to receive 250 mg of vitamin C , three times per week , for 8 weeks , and control groups 1 and 2 , to receive placebo injection ( saline ) and no intervention , respectively .


Serum levels of uric acid and creatinine were measured at the start of the study and also after 8 weeks .


The mean of serum levels of uric acid was 6.02 1.08 mg/dL ( reference range , 2.6 mg/dL to 6 mg/dL ) .


Nearly , half of the patients ( 46.7 % ) had a serum level of uric acid greater than 6 mg/dL .


The median baseline serum levels of uric acid were 6.2 mg/dL , 5.9 mg/dL , and 6 mg/dL in the intervention , control 1 , and control 2 groups , respectively ( P = .19 ) .


After 2 months , median levels reduced significantly in the vitamin C group to 5.8 mg/dL as compared to 6.4 mg/dL and 6.3 mg/dL in control groups ( P = .02 ) .


The mean serum creatinine level had no significant changes during the study .


Our results demonstrated the existence of a significant negative relationship between vitamin C and serum uric acid levels .


Detailed investigations with larger sample sizes and longer-term use of vitamin C are recommended .


This prospective long-term follow-up study evaluated the effects of half-dose etanercept ( 25 mg weekly ) on clinical remission and radiographic progression in a large cohort of patients with rheumatoid arthritis ( RA ) in clinical remission after etanercept 25 mg bi-weekly .


524 biologic-nave RA patients were treated with etanercept 25 mg bi-weekly after failure of conventional drugs .


Patients achieving remission ( DAS28 < 2.6 ) for 12 months were randomised to receive etanercept 25 mg weekly or 25 mg bi-weekly .


Patients were assessed at baseline and every 12 weeks .


Remission rates , radiographic progression , incidence of infections and costs of the regimens were compared .


After a mean follow-up of 1811 months , 347 patients ( 66.2 % ) achieved DAS28 remission ; 323 were randomised to one of two dose regimens : etanercept 25 weekly ( group A , 159 patients ) and etanercept 25 mg bi-weekly ( group B , 164 patients ) .


At the end of follow-up , 81.8 % patients of group A maintained remission for a mean of 3.61.5 years .


Radiographic progression occurred in a small number of patients of group A and the rate of radiographic progression ( TSS > 0 ) was not significantly different in the two groups ( 18.85 % vs. 19.0 % after the first year and 16.9 % vs. 21.6 % after the second year , respectively ) .


The incidence ratio of severe infections was 2.3 / 1.000 patient-years in group A. Etanercept half-dose regimen resulted in a saving of 3.190.545 with a cost saving up to 827.318 per year .


Clinical remission and arrest of radiographic progression persisted in a substantial percentage of patients with RA even after reduction of standard-dose etanercept .


Acute appendicitis is the most common reason for abdominal surgery in young adults and children .


Open appendectomy is still the treatment often chosen because it is simple , safe , and effective .


Our aim was to study whether cosmetic results of appendectomy wounds are better after using continuous absorbable intradermal ( A ) sutures compared with wound closure with interrupted nonabsorbable ( NA ) sutures .


A total of 206 adult patients with clinically suspected appendicitis were allocated to the study and prospectively randomized into two wound-closure groups : the interrupted NA suture group and the A suture group .


Of these , 193 patients with sufficient data were invited to the outpatient clinic for cosmetic analysis .


Cosmetic results were evaluated after a median of 14 months .


For subjective scar assessment , the Vancouver scar scale , the patient and observer scar assessment scale ( POSAS ) , and a visual analog scale ( VAS ) were used .


Objective evaluation was carried out by measuring surface area , average width , and estimated concentration change ( ECC ) of hemoglobin and melanin in the scar using spectrocutometry .


For statistical analyses we used the Mann-Whitney test and Student 's t test .


Both objective and subjective analyses showed better cosmetic results for absorbable intradermal suturing .


The difference between the two groups was statistically significant as regards POSAS in both patient ( p = 0.032 ) and observer scales ( p = 0.001 ) , and VAS ( p = 0.002 ) .


Scar surface area was significantly smaller in group A than in group NA ( p = 0.002 ) .


ECC measurements showed higher values for melanin in group NA than in group A ( p = 0.034 ) .


Continuous intradermal absorbable suturing yields a better cosmetic result than interrupted nonabsorbable suturing in lower abdominal transverse appendectomy .


We investigated 3 approaches for implementing the Chronic Care Model to improve diabetes care : ( 1 ) practice facilitation over 6 months using a reflective adaptive process ( RAP ) approach ; ( 2 ) practice facilitation for up to 18 months using a continuous quality improvement ( CQI ) approach ; and ( 3 ) providing self-directed ( SD ) practices with model information and resources , without facilitation .


We conducted a cluster-randomized trial , called Enhancing Practice , Improving Care ( EPIC ) , that compared these approaches among 40 small to midsized primary care practices .


At baseline and 9 months and 18 months after enrollment , we assessed practice diabetes quality measures from chart audits and Practice Culture Assessment scores from clinician and staff surveys .


Although measures of the quality of diabetes care improved in all 3 groups ( all P < .05 ) , improvement was greater in CQI practices compared with both SD practices ( P < .0001 ) and RAP practices ( P < .0001 ) ; additionally , improvement was greater in SD practices compared with RAP practices ( P < .05 ) .


In RAP practices , Change Culture scores showed a trend toward improvement at 9 months ( P = .07 ) but decreased below baseline at 18 months ( P < .05 ) , while Work Culture scores decreased from 9 to 18 months ( P < .05 ) .


Both scores were stable over time in SD and CQI practices .


Traditional CQI interventions are effective at improving measures of the quality of diabetes care , but may not improve practice change and work culture .


Short-term practice facilitation based on RAP principles produced less improvement in quality measures than CQI or SD interventions and also did not produce sustained improvements in practice culture .


Intracoronary thrombus is disrupted by stent deployment and confounded by the development of intrastent plaque prolapse .


This study aims at investigating the feasibility and repeatability of thrombus quantification prior to stent implantation using optical coherence tomography ( OCT ) in ST-segment elevation myocardial infarction ( STEMI ) patients .


Patients were enrolled in an OCT substudy of the TOTAL trial ( a randomized trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI undergoing primary PCI ) of aspiration thrombectomy or percutaneous coronary intervention ( PCI ) alone in primary PCI ( PPCI ) of STEMI .


Using OCT , thrombus burden ( TB ) and other measures of pre - and post-stent atherothrombus were analysed over the arterial segment defined by the final stent length .


Feasibility was 86.2 % ( 25/29 patients ) for both pre - and post-stent OCT imaging .


Altogether , 8111 OCT cross-sections were analysed .


In Bland-Altman analyses of inter-observer variation ( n = 25 ) , the mean pre-stent TB was 8.76 % for Observer 1 and 8.97 % for Observer 2 ( limits of agreement -2.6 to 2.2 % ) .


In Bland-Altman analyses of intra-observer variation ( n = 15 ) , the mean pre-stent TB was 8.06 % for the first and 7.35 % for the second round of analysis by Observer 1 ( limits of agreement -1.72 to 3.15 % ) .


There was a good correlation between pre-stent TB and pre-stent quadrants with thrombus/mm ( r = 0.97 ) , but only modest correlation between pre-stent TB and post-stent atherothrombotic burden ( ATB ; r = 0.54 ) .


Measurement of pre-stent TB by OCT during the PPCI of STEMI is feasible and highly repeatable .


Pre-stent TB is only modestly correlated with post-stent ATB , which indicates that pre-stent measurements might be of additional value when assessing the TB in STEMI .


The aim of this study was to investigate the degree of correlation between the Pelvic Organ Quantification system ( POP-Q ) measurements and symptom questionnaire scores before and after surgery .


This was a part of a randomized controlled study comparing conventional colporrhaphy with mesh repair surgery .


The correlation between POP-Q measurements and Pelvic Floor Impact Questionnaire ( PFIQ-7 ) and Pelvic Floor Distress Inventory ( PFDI-20 ) scores was investigated in 164 women 55 years or older scheduled for primary anterior vaginal wall prolapse surgery at baseline and the correlation between the change in point Ba and scores following surgery .


Statistical analyses used McNemar 's and Wilcoxon signed-rank tests , Spearman 's rank-order correlation , and multiple linear regression .


Surgery significantly improved POP-Q , PFIQ-7 , and PFDI-20 scores , including subscales .


We observed weak correlations between POP-Q and PFIQ-7 , including subscales ( r 0.173-0 .324 , p < 0.05 ) , and PFDI-20 , including the Pelvic Organ Prolapse Distress Inventory ( POPDI ) subscale ( r 0.180-0 .211 , p < 0.05 ) .


Regression analysis demonstrated a significant relationship between point Ba and PFIQ-7 ( p = 0.001 ) and PFDI-20 ( p = 0.04 ) , respectively .


Furthermore , we observed a significant relationship between the change in point Ba ( following surgery ) and change in scores ; point Ba following surgery was significantly correlated with symptoms of bulging ( r = 0.303 , p < 0.01 ) and bladder-emptying problems ( r = 0.213 , p < 0.01 ) .


The weak correlation between POP-Q and urogenital symptoms based on questionnaire scores suggests that neither scoring system is optimal .


Pressure ulcers are one of the most common health complaints , which often take months or years to heal , and affect patients ' morbidity and quality of life .


Medical options for pressure ulcers are limited .


Electroacupuncture ( EA ) has been employed to relieve the symptoms for patients with pressure ulcers , but there is limited clinical evidence for its effectiveness .


This study consists of a randomized controlled trial ( RCT ) with two parallel arms : a control group and an EA group .


Both groups will receive standard wound care ( including changing position , using mattresses and cushions , and a good diet ) of five sessions per week for a total of 40 sessions during the 8-week treatment period .


In addition , the EA group will receive the EA intervention .


The following outcome measurements will be used in examination of participants : wound surface area ( WSA ) , visual analogue scale ( VAS ) , and the proportion of ulcers healed within trial period ( PUHTP ) .


All the outcomes will be evaluated at the start of the study , at the end of the fourth week , at 8 weeks after randomization , and 1 month after treatment cessation .


The aim of this study is to evaluate the effectiveness of EA for the treatment of patients with pressure ulcers .


Chinese Clinical Trial Register : ChiCTR-TRC-11001693 .


Although statins can induce coronary atheroma regression , this benefit has yet to be demonstrated in diabetic individuals .


We tested the hypothesis that high-intensity statin therapy may promote coronary atheroma regression in patients with diabetes .


The Study of Coronary Atheroma by Intravascular Ultrasound : Effect of Rosuvastatin Versus Atorvastatin ( SATURN ) used serial intravascular ultrasound measures of coronary atheroma volume in patients treated with rosuvastatin 40 mg or atorvastatin 80 mg for 24 months .


This analysis compared changes in biochemistry and coronary percent atheroma volume ( PAV ) in patients with ( n = 159 ) and without ( n = 880 ) diabetes .


At baseline , patients with diabetes had lower LDL cholesterol ( LDL-C ) and HDL cholesterol ( HDL-C ) levels but higher triglyceride and CRP levels compared with patients without diabetes .


At follow-up , diabetic patients had lower levels of LDL-C ( 61.0 20.5 vs. 66.4 22.9 mg/dL , P = 0.01 ) and HDL-C ( 46.3 10.6 vs. 49.9 12.0 mg/dL , P < 0.001 ) but higher levels of triglycerides ( 127.6 [ 98.8 , 163.0 ] vs. 113.0 mg/dL [ 87.6 , 151.9 ] , P = 0.001 ) and CRP ( 1.4 [ 0.7 , 3.3 ] vs. 1.0 [ 0.5 , 2.1 ] mg/L , P = 0.001 ) .


Both patients with and without diabetes demonstrated regression of coronary atheroma as measured by change in PAV ( -0.83 0.13 vs. -1.15 0.13 % , P = 0.08 ) .


PAV regression was less in diabetic compared with nondiabetic patients when on-treatment LDL-C levels were > 70 mg/dL ( -0.31 0.23 vs. -1.01 0.21 % , P = 0.03 ) but similar when LDL-C levels were 70 mg/dL ( -1.09 0.16 vs. -1.24 0.16 % , P = 0.50 ) .


High-intensity statin therapy alters the progressive nature of diabetic coronary atherosclerosis , yielding regression of disease in diabetic and nondiabetic patients .


To evaluate the effects of different intracorporeal ligation techniques with titanium clips , Plasma Trisector ( Gyrus , USA ) ( PTG ) , and surgical silk on bilateral laparoscopic varicocelectomy ( LPVx ) .


Between May 2009 and August 2012 , 100 patients who underwent bilateral LPVx were evaluated .


The demographic parameters of patients , preoperative radiological findings , semen analysis , operative data , and follow-up were recorded .


All of the patients were divided into 3 groups , randomized prospectively .


The patients whose veins were ligated by 5-mm titanium clips were included in group I , those whose veins were ligated by PTG were included in group II , and those whose veins were ligated by surgical silk were included in group III .


The recorded data of the groups were analyzed .


Mean follow-up time was 18.8 + 1.1 months .


According to the demographics of age , body mass index , spermiogram , and diameter of veins before surgery , there were no statistical differences between any of the groups ( P > 0.05 ) .


However , operation time was longer in group III ( P < 0.0001 ) , while total numbers ofligated veins did not differ among the groups ( P > 0.05 ) .


Additionally , hospital stay , oral intake , and complications were not different among the groups ( P > 0.05 ) .


In follow-up the sperm count analysis was higher than the preoperative count analysis for all of the groups ( P < 0.05 ) .


PTG may provide a shorter operation time than using titanium clips and/or surgical silk in LPVx .


Additionally , PTG may increase sperm count with fewer complications than the other ligation techniques in LPVx .


Therefore , PTG may be the new candidate electrosurgical standard device for LPVx in the nearby future .


To compare the level of anxiety and performance of nursing students when performing a clinical simulation through the traditional method of assessment with the presence of an evaluator and through a filmed assessment without the presence of an evaluator .


Controlled trial with the participation of Brazilian public university 20 students who were randomly assigned to one of two groups : a ) assessment through the traditional method with the presence of an evaluator ; or b ) filmed assessment .


The level of anxiety was assessed using the Zung test and performance was measured based on the number of correct answers .


Averages of 32 and 27 were obtained on the anxiety scale by the group assessed through the traditional method before and after the simulation , respectively , while the filmed group obtained averages of 33 and 26 ; the final scores correspond to mild anxiety .


Even though there was a statistically significant reduction in the intra-groups scores before and after the simulation , there was no difference between the groups .


As for the performance assessments in the clinical simulation , the groups obtained similar percentages of correct answers ( 83 % in the traditional assessment and 84 % in the filmed assessment ) without statistically significant differences .


Filming can be used and encouraged as a strategy to assess nursing undergraduate students .


We aimed to evaluate whether oral anticoagulants ( OACs ) alter faecal immunochemical test ( FIT ) performance in average-risk colorectal cancer ( CRC ) screening .


Individuals aged 50-69 years were invited to receive one FIT sample ( cutoff 75 ng ml ( -1 ) ) between November 2008 and June 2011 .


Faecal immunochemical test was positive in 9.3 % ( 21 out of 224 ) of users of OAC and 6.2 % ( 365 out of 5821 ) of non-users ( P-trend = 0.07 ) .


The positive predictive value ( PPV ) for advanced neoplasia ( AN ) in non-users was 50.4 % vs 47.6 % in users ( odds ratio , 0.70 ; 95 % CI , 0.3-1 .8 ; P = 0.5 ) .


The PPV for AN in OAC more antiplatelets ( aspirin or clopidogrel ) was 75 % ( odds ratio , 2 ; 95 % CI , 0.4-10 .8 ; P = 0.4 ) .


Oral anticoagulant did not significantly modify the PPV for AN in this population-based colorectal screening program .


The detection rate of advanced adenoma was higher in the combination OAC more antiplatelets .


Virtual patients ( VPs ) offer valuable alternative encounters when live patients with rare conditions , such as cranial nerve ( CN ) palsies , are unavailable ; however , little is known regarding simulation and optimal social learning context .


Compare learning outcomes and perspectives between students interacting with VPs in individual and team contexts .


Seventy-eight medical students were randomly assigned to interview and examine four VPs with possible CN damage either as individuals or in three-person teams , using Neurological Examination Rehearsal Virtual Environment ( NERVE ) .


Learning was measured through diagnosis accuracy and pre - / post-simulation knowledge scores .


Perspectives of learning context were collected post-simulation .


Students in teams submitted correct diagnoses significantly more often than students as individuals for CN-IV ( p = 0.04 ; team = 86.1 % ; individual = 65.9 % ) and CN-VI ( p = 0.03 ; team = 97.2 % ; individual = 80.5 % ) .


Knowledge scores increased significantly in both contexts ( p < 0.001 ) ; however , a significant aptitude-treatment interaction effect was observed ( p = 0.04 ) .


At pre-test scores 25.8 % , students in teams scored significantly higher ( 66.7 % ) than students as individuals ( 43.1 % ) at post-test ( p = 0.03 ) .


Students recommended implementing future NERVE exercises in teams over five other modality-timing combinations .


Results allow us to define best practices for integrating VP simulators into medical education .


Implementing NERVE experiences in team environments with medical students in the future may be preferable .


Exercise-induced cough ( EIC ) is frequently reported by winter athletes , but this symptom is not always associated with exercise-induced bronchoconstriction ( EIB ) .


The aims of this study were to determine if EIC can be inhibited or reduced with the inhalation of ipratropium , and if EIC in winter athletes is associated with EIB .


On 2 visits , 24 cross-country skiers ( 10 males and 12 females , mean age 17 3 years ) performed an outdoor exercise in the winter ( 30-minute warm-up , followed by a 3-minute sprint ) , randomly preceded by the inhalation of ipratropium or a placebo .


A spirometry was done at baseline and 20 minutes after inhalation of ipratropium or placebo .


Exercise was then performed , followed by the measurement of forced expiratory volume in 1 second and the recording of the number of coughs until 60 minutes after exercise .


Before and after exercise , the perception of cough intensity was evaluated using a modified Borg scale .


Twelve of 16 athletes who completed the study ( 75 % ) were symptomatic following exercise with placebo ( number of coughs 5 ) , but none developed EIB .


For these athletes , the number of coughs after exercise ( mean number of coughs standard deviation : placebo , 26 14 ; ipratropium , 25 23 ; P value , nonsignificant ) and the maximal perception score for cough intensity ( mean Borg score standard deviation : placebo , 1.9 1.2 ; ipratropium , 2.0 1.1 ; P value , nonsignificant ) were not significantly different between ipratropium and placebo .


A decrease in the number of coughs was observed in 6 of the symptomatic athletes and an increase was observed in the other 6 , resulting in a nonsignificant mean effect .


Ipratropium does not appear to significantly influence the number and the perception of cough following exercise .


Moreover , these results suggest that EIC is not mainly associated with EIB .


However , a subgroup of athletes seems to show a beneficial response to ipratropium , suggesting different cough responses in this population .


The Avosentan on Time to Doubling of Serum Creatinine , End Stage Renal Disease or Death ( ASCEND ) trial tested the renoprotective effect of the endothelin receptor antagonist avosentan in patients with diabetes and nephropathy , but the study was terminated due to an excess of congestive heart failure ( CHF ) events in the avosentan arms , likely due to fluid retention .


The aim of this study was to identify risk markers of CHF after treatment with avosentan .


In a post hoc analysis of the ASCEND trial ( N = 1392 participants ) , we assessed which baseline characteristics predicted CHF risk during avosentan treatment .


Furthermore , postrandomization changes between baseline and the first available measurement of body weight and hemoglobin were examined as potential clinical indicators of fluid retention for their relationship with CHF development .


Relative to placebo , avosentan increased CHF risk ( hazard ratio , 2.76 ; 95 % confidence interval , 1.68 to 4.54 ) .


The avosentan-related CHF risk was higher with lower baseline cholesterol levels ( P interaction = 0.003 ) and concomitant statin use ( P interaction = 0.06 ) , whereas it was lower with a lower estimated GFR ( P interaction = 0.04 ) .


Patients allocated to avosentan had a median body weight increase of 0.6 kg ( interquartile range , 0.0 to 2.0 kg ) and a median hemoglobin decrease of 1.4 g/dl ( interquartile range , -2.1 to -0.7 g/dl ) at the first postrandomization measurement .


The body weight increase induced by avosentan was associated with CHF development ( P interaction = 0.04 ) , whereas hemoglobin decrease was not ( P interaction = 0.64 ) .


The increase in body weight was particularly pronounced in patients with a cardiovascular disease history and in patients using statins .


In avosentan-treated patients , body weight increase , but not hemoglobin decrease , was associated with CHF development , indicating that close body weight monitoring could provide an early signal of CHF development in future trials with endothelin receptor antagonists .


The aim of this study was to measure round window ( RW ) diameters in patients with congenital aural atresia ( CAA ) or sensorineural hearing loss ( SNHL ) and a normal control group and to analyze whether differences exist between these groups .


Temporal bone computed tomographic scans of 12 patients with CAA ( 5 males , 7 females ) aged 1 to 50 years ( median age , 6 years ) , 12 patients with SNHL ( 8 males , 4 females ) aged 2 to 32 years ( median age , 5 years ) , and 11 patients ( 3 males , 7 females ) aged 2 months to 53 years ( median age , 8 years ) randomly selected from a pool of patients with unilateral chronic otitis media or cholesteatoma were reviewed .


We measured RW diameter on oblique reconstruction planes .


To prevent possible individual differences , skull width was measured .


There were no statistically significant differences between all groups for skull width .


Both RW diameter and RW membrane width were found smaller in the CAA group than both SNHL group and control group with statistical significance , whereas there were no statistically significant differences between the SNHL group and the control group .


We found that both the RW diameter and RW membrane width in CAA were smaller than those in the control group .


If this finding is supported in future studies , the production of floating mass transducer with different sizes may be useful .


We suggest that RW diameter should be measured in each patient before operation and thus a floating mass transducer with the appropriate caliber should be chosen .


New topical treatments studied in adults have been published to be potentially effective in the treatment of hypertrophic scar and keloids .


There is still no study in Thai children .


To study the efficacy of 10 % onion extract in silicone derivative gel for the prevention of hypertrophic scar and keloid in median sternotomy wound from open heart surgery in pediatric patients .


Thirty-nine pediatric patients who had median sternotomy were recruited in this prospective randomized , double-blinded , placebo-controlled split-scar experimental study .


The wound in each patient was divided into upper and lower parts , and the treatment with , either onion extract gel or placebo was randomly applied by block randomization onto each part of the wound twice daily after the seventh day postoperatively for six months .


The incidence of scars , serial photographs of the wound , Vancouver Scar Scale ( VSS ) , and adverse effect were assessed at each visit .


Thirty patients with the mean age of 4.3 years completed the 6-month study period .


Six patients ( 20 % ) in onion extract gel group had no scar compared to one patient ( 3.3 % ) in placebo group ( p = 0.04 ) .


Of the 27 patients with hypertrophic scar nine were from onion extract gel group and 18 from the placebo group ( p = 0.02 ) .


Keloid was not statistically significant diferent in both groups ( p = 0.29 ) .


VSS was not statistically significant different in all visits .


One case had a pustule on the part of the onion extract in silicone derivative application at the sixth month .


Onion extract in silicone derivative gel can significantly decreased the incidence of hypertrophic scar from median sternotomy wound in pediatric patients .


Keloid did not show statistically significant differences in both groups .


To investigate the characteristics of residual symptoms and to evaluate the effects of adjuvant vestibular suppressants on residual symptoms after successful canalith repositioning procedures ( CRPs ) .


Individual randomized controlled trial .


One hundred fifty patients with idiopathic benign paroxysmal positional vertigo who achieved successful CRPs on initial visit participated in this study .


Dizziness Handicap Inventory ( DHI ) questionnaires were completed before CRPs .


All study populations were divided into three groups after successful CRPs on the initial visit day : the medication ( V ) group ( treated with a vestibular suppressant [ dimenhydrinate 50 mg per day ] ) , the placebo ( P ) group , and the no medication ( N ) group .


One week after successful CRPs , residual symptoms were checked and repeated DHI questionnaires were completed to compare residual symptoms .


Among the 138 patients who did not show positional nystagmus at follow-up , 67 ( 48.5 % ) complained of residual symptoms .


The presence of residual symptoms was more prevalent in the P and N group compared with the V group ( P = .035 , P = .017 , respectively ) .


The most frequent residual symptom was lightheadedness ( n = 42 ) .


Moreover , in the V group , lightheadedness was significantly reduced compared with the P group ( P = .029 ) .


However , in the analysis of DHI , total and subscale scores did not differ across the three groups before or after successful CRP .


Vestibular suppressants significantly reduced residual symptoms compared to both placebo and no medication after CRP .


However , there was no significant reduction in DHI score compared with the control group , suggesting that the residual symptoms could not be evaluated by DHI score alone .


To study the effect of perioperative immunomodulatory therapy on postoperative recurrence of rectal cancer .


This prospective study was conducted among 238 rectal/anal cancer patients undergoing intersphincteric resection at our center between January , 2010 and January , 2011 , among whom 150 were eligible to be included and completed the study .


The 150 patients were randomized in a double-blinded fashion into 3 equal groups to receive immunomodulatory therapy with 8 mg/kg celecoxib ( group A ) , 0.4 mg/kg Sou-Medrol ( group B ) , or placebo ( group C ) , given daily from 5 days before surgery to 5 days after surgery , and the postoperative cancer recurrence were compared .


At 3 days after the operation , the 3 groups showed significantly different C-reactive protein ( CRP ) levels , which decreased obviously in all the 3 groups compared with those at 1 day following the operation ( P = 0.022 ) , especially in group B.


The levels of interleukin-6 ( IL-6 ) at 3 days after the operation also differed significantly between the 3 groups but were lower in all the 3 groups than those at 1 day after the operation ( P = 0.046 ) , and this reduction was the most obvious in group A. COX-2 expression differed significantly between the 3 groups ( P = 0.017 ) , among which group A showed the most obvious suppression of COX-2 expression .


During the follow-up for a mean of 45 months , no significant difference in the recurrence rate was found between the 3 groups ( P = 0.549 ) .


With a lower efficacy than Sou-Medrol in decreasing postoperative inflammation , celecoxib produces a better effect in inhibiting COX-2 expression , but it does not lower postoperative recurrence rate of rectal cancer .


In trials of behavioural interventions , the individuals who deliver the intervention are in a position of key influence on the success of the trial .


Their fidelity to the intervention is crucial .


Yet little is understood about the experiences of this group of trial personnel .


This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes , which incorporated training in self-monitoring of either blood glucose ( SMBG ) or urine glucose ( SMUG ) as part of a randomized controlled trial ( RCT ) .


Educators ' views were explored through focus groups before and after training ( N = 18 ) and approximately 1 year into the trial ( N = 14 ) , and semi-structured telephone interviews at approximately 2 years ( N = 7 ) .


Analysis was based on the constant comparative method .


Educators held preferences regarding the intervention variants ; thus , they were not in individual equipoise .


Training raised awareness of preferences and their potential to impact on delivery .


Educators were confident in their unbiased delivery , but acknowledged the challenges involved .


Concealing their preferences was helped by a sense of professionalism , the patient-centred nature of the intervention , and concessions in the trial protocol ( enabling participants to swap monitoring methods if needed ) .


Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG .


The findings provide insight into a previously unexplored group of trial personnel -- intervention deliverers in trials of behavioural interventions -- which will be useful to those designing and running similar trials .


Rather than individual equipoise , it is intervention deliverers ' awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery .


Further , awareness of community equipoise , the need for evidence , and relevance to the individual enhance commitment to the RCT .


ISRCTN95696668 .


The purpose of this study is to determine whether varying the format used to present prognostic data alters the perception of risk among surrogate decision makers in the intensive care unit ( ICU ) .


This was a prospective randomized comparative trial conducted in a 23-bed adult tertiary ICU .


Enrolled surrogate decision makers were randomized to 1 of 2 questionnaires , which presented hypothetical ICU scenarios , identical other than the format in which prognostic data were presented ( eg , frequencies vs percentages ) .


Participants were asked to rate the risk associated with each prognostic statement .


We enrolled 141 surrogate decision makers .


The perception of risk varied significantly dependent on the presentation format .


For `` quantitative data , '' risks were consistently perceived as higher , when presented as frequencies ( eg , 1 in 50 ) compared with equivalent percentages ( eg , 2 % ) .


Framing `` qualitative data '' in terms of chance of `` death '' rather than `` survival '' led to a statistically significant increase in perceived risks .


Framing `` quantitative '' data in this way did not significantly affect risk perception .


Data format had a significant effect on how surrogate decision makers interpreted risk .


Qualitative statements are interpreted widely and affected by framing .


Where possible , multiple quantitative formats should be used for presenting prognostic information .


The training response of an intensified period of high-intensity exercise is not clear .


Therefore , we compared the cardiovascular adaptations of completing 24 high-intensity aerobic interval training sessions carried out for either three or eight weeks , respectively .


Twenty-one healthy subjects ( 23.02.1 years , 10 females ) completed 24 high-intensity training sessions throughout a time-period of either eight weeks ( moderate frequency , MF ) or three weeks ( high frequency , HF ) followed by a detraining period of nine weeks without any training .


In both groups , maximal oxygen uptake ( VO2max ) was evaluated before training , at the 9 ( th ) and 17 ( th ) session and four days after the final 24 ( th ) training session .


In the detraining phase VO2max was evaluated after 12 days and thereafter every second week for eight weeks .


Left ventricular echocardiography , carbon monoxide lung diffusion transfer factor , brachial artery flow mediated dilatation and vastus lateralis citrate maximal synthase activity was tested before and after training .


The cardiovascular adaptation after HF training was delayed compared to training with MF .


Four days after ending training the HF group showed no improvement ( +3.0 % , p = 0.126 ) , whereas the MF group reached their highest VO2max with a 10.7 % improvement ( p < 0.001 : group difference p = 0.035 ) .


The HF group reached their highest VO2max ( 6.1 % increase , p = 0.026 ) twelve days into the detraining period , compared to a concomitant reduction to 7.9 % of VO2max ( p < 0.001 ) above baseline in the MF group ( group difference p = 0.609 ) .


Both HF and MF training of high-intensity aerobic exercise improves VO2max .


The cardiovascular adaptation following a HF programme of high-intensity exercise is however delayed compared to MF training .


ClinicalTrials.gov NCT00733941 .


Impaired arterial function has been implicated in diabetes-related atherosclerosis , but its determinants in high-risk adults have not been well characterised .


We investigated factors associated with impaired arterial function in adults with type 2 diabetes .


Flow-mediated dilatation ( a marker of endothelial function ) and dilator response to glyceryl trinitrate ( to assess smooth muscle function ) of the brachial artery were assessed at baseline in 193 patients with type 2 diabetes from the Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) study .


Traditional risk factors were assessed and a multivariable model was constructed to identify factors independently associated with impaired arterial function .


Median age was 64 years ( interquartile range , 58-69 ; 61 % male ) and duration of diabetes was 4 years ( interquartile range , 2-9 ) .


Flow-mediated dilatation ( 3.06 0.25 % , mean SEM ) was severely impaired but not significantly associated with other risk factors .


Dilator responses to glyceryl trinitrate ( 10.56 0.52 % ) were significantly and independently impaired in past and present cigarette smokers ( P = 0.005 ) and in subjects with increased urinary albumin/creatinine ratio ( P = 0.01 ) .


In adults with type 2 diabetes and known or suspected atherosclerosis , arterial smooth muscle-dependent dilatation was shown to be significantly impaired in cigarette smokers and those with elevated urinary albumin levels .


To determine whether a home-based care coordination program focused on medication self-management would affect the cost of care to the Medicare program and whether the addition of technology , a medication-dispensing machine , would further reduce cost .


Randomized , controlled , three-arm longitudinal study .


Participant homes in a large Midwestern urban area .


Older adults identified as having difficulty managing their medications at discharge from Medicare Home Health Care ( N = 414 ) .


A team consisting of advanced practice nurses ( APNs ) and registered nurses ( RNs ) coordinated care for two groups : home-based nurse care coordination ( NCC ) plus a pill organizer group and NCC plus a medication-dispensing machine group .


To measure cost , participant claims data from 2005 to 2011 were retrieved from Medicare Part A and B Standard Analytical Files .


Ordinary least squares regression with covariate adjustment was used to estimate monthly dollar savings .


Total Medicare costs were $ 447 per month lower in the NCC plus pill organizer group ( P = .11 ) than in a control group that received usual care .


For participants in the study at least 3 months , total Medicare costs were $ 491 lower per month in the NCC plus pill organizer group ( P = .06 ) than in the control group .


The cost of the NCC plus pill organizer intervention was $ 151 per month , yielding a net savings of $ 296 per month or $ 3,552 per year .


The cost of the NCC plus medication-dispensing machine intervention was $ 251 per month , and total Medicare costs were $ 409 higher per month than in the NCC plus pill organizer group .


Nurse care coordination plus a pill organizer is a cost-effective intervention for frail elderly Medicare beneficiaries .


The addition of the medication machine did not enhance the cost effectiveness of the intervention .


Numerous animal studies and clinical trials have demonstrated that erythropoietin ( EPO ) has therapeutic effects in ischemic and degenerative diseases .


However , few clinical trials have investigated the effect of EPO in Parkinson 's disease ( PD ) patients .