`` Success of fit '' was defined as the ability to correctly don a mask in one try .


There were no statistical differences by training modality for either mask regarding ease of fit or success of fit .


There were no differences among video presentation , small group demonstration , and self-directed slide show just-in-time training modalities for ease of fit or success of fit N-95 respirator mask fitting .


Further study is needed to explore more effective fit training modalities .


In TRITON-TIMI 38 , patients with acute coronary syndromes were treated with prasugrel or clopidogrel , with aspirin , for a median of 14.5 ( maximum of 15 ) months .


Based on this trial , the EU label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroke/transient ischemic attack ( TIA ) .


Furthermore , the EU label recommends the 10mg maintenance dose ( MD ) for patients with body weight 60kg and age < 75 years .


A lower MD of 5mg is recommended for those with body weight < 60kg ; although generally not recommended , 5mg can be prescribed to patients 75 years after individual risk-benefit evaluation .


This paper presents the one-year outcome data for this ' 10mg indicated cohort ' .


From the overall cohort of 13,608 patients in TRITON-TIMI 38 , 10,804 fulfilled inclusion criteria for the 10mg indicated cohort , of whom 22 % had a history of diabetes , 73 % an index diagnosis of unstable angina/non-ST-segment - elevation myocardial infarction ( UA/NSTEMI ) , and 27 % an index diagnosis of ST-segment-elevation myocardial infarction ( STEMI ) .


In this cohort at 12 months , those given prasugrel experienced significantly fewer ischemic events ( cardiovascular death , non-fatal myocardial infarction , or non-fatal stroke , 7.8 % vs 10.5 % , hazard ratio ( HR ) = 0.73 , p < 0.001 , than those given clopidogrel , with a non-significant increase in non-coronary artery bypass graft ( CABG ) TIMI major bleeding , 1.7 % vs 1.5 % , HR = 1.15 , p = 0.40 ; similarly , in the overall cohort these frequencies were 9.4 % vs 11.4 % , HR = 0.81 , p < 0.001 , for cardiovascular death , non-fatal myocardial infarction , or non-fatal stroke , and 2.2 % vs 1.8 % , HR = 1.24 , p = 0.10 , for non-CABG TIMI major bleeding .


There was a significant reduction in stent thrombosis in the prasugrel group , with similar mortality rates and no excess of strokes .


Treatment with prasugrel according to EU label recommendations results in a significant 27 % and 57 % relative risk reduction ( absolute risk reductions of 2.7 % and 1.2 % ) in ischemic events and stent thromboses respectively compared with clopidogrel , with a 15 % relative risk increase ( absolute risk increase of 0.2 % ) for major bleeds ( p = 0.40 ) , and no excess of strokes .


Although restricted to 365 days of follow-up , this analysis encapsulates 1366 of 1424 ( 95.9 % ) of all primary endpoint events and 244 of 257 ( 94.9 % ) of all first non-CABG TIMI major bleeds reported in the pivotal manuscript .


Furthermore , the 10mg indicated cohort was not a pre-specified subgroup in the study protocol , but due to European labeling restrictions , results for all outcomes in this cohort are presented through 12 months .


The aim of this study was to evaluate the usefulness of the APACHE II ( Acute Physiology and Chronic Health Evaluation II ) , SAPS II ( Simplified Acute Physiology Score II ) and SOFA ( Sequential Organ Failure Assessment ) scores compared to simpler models based on age and Glasgow Coma Scale ( GCS ) in predicting long-term outcome of patients with moderate-to-severe traumatic brain injury ( TBI ) treated in the intensive care unit ( ICU ) .


A national ICU database was screened for eligible TBI patients ( age over 15 years , GCS 3-13 ) admitted in 2003-2012 .


Logistic regression was used for customization of APACHE II , SAPS II and SOFA score-based models for six-month mortality prediction .


These models were compared to an adjusted SOFA-based model ( including age ) and a reference model ( age and GCS ) .


Internal validation was performed by a randomized split-sample technique .


Prognostic performance was determined by assessing discrimination , calibration and precision .


In total , 1,625 patients were included .


The overall six-month mortality was 33 % .


The APACHE II and SAPS II-based models showed good discrimination ( area under the curve ( AUC ) 0.79 , 95 % confidence interval ( CI ) 0.75 to 0.82 ; and 0.80 , 95 % CI 0.77 to 0.83 , respectively ) , calibration ( P > 0.05 ) and precision ( Brier score 0.166 to 0.167 ) .


The SOFA-based model showed poor discrimination ( AUC 0.68 , 95 % CI 0.64 to 0.72 ) and precision ( Brier score 0.201 ) but good calibration ( P > 0.05 ) .


The AUC of the SOFA-based model was significantly improved after the insertion of age and GCS ( AUC +0.11 , P < 0.001 ) .


The performance of the reference model was comparable to the APACHE II and SAPS II in terms of discrimination ( AUC 0.77 ; compared to APACHE II , AUC -0.02 , P = 0.425 ; compared to SAPS II , AUC -0.03 , P = 0.218 ) , calibration ( P > 0.05 ) and precision ( Brier score 0.181 ) .


A simple prognostic model , based only on age and GCS , displayed a fairly good prognostic performance in predicting six-month mortality of ICU-treated patients with TBI .


The use of the more complex scoring systems APACHE II , SAPS II and SOFA added little to the prognostic performance .


Pomaglumetad methionil ( LY2140023 monohydrate ) is a potent and highly selective agonist for the metabotropic glutamate mGluR2 and mGluR3 receptors .


We present results of a pivotal clinical study H8Y-MC-HBBM assessing the efficacy of LY2140023 in improving symptoms as a monotherapy in patients with an acute exacerbation of schizophrenia .


Enrolled adult patients ( ages 18-65 ) with schizophrenia who had experienced an exacerbation of symptoms within 2 weeks prior to study entry .


Patients ( N = 1013 ) were randomized 2:2:2:1 to treatment with placebo , LY40 mg twice daily ( BID ) , LY80 mg BID , or risperidone ( RIS ) 2 mg BID for 6 weeks after a one-week blinded placebo lead-in .


The primary outcome assessed change from baseline in the Positive and Negative Syndrome Scale ( PANSS ) total score in an overall schizophrenia population and a predefined subpopulation which excluded non-Hispanic white patients with the A/A genotype at the HTR2A SNP rs7330461 .


Neither LY2140023 dose showed significant improvement compared to placebo on PANSS total in either population ( 1-sided p-value [ significance level ] , overall : LY40 , p = .154 [ 0.01 ] ; LY80 , p = .698 [ 0.01 ] , subpopulation : LY40 , p = .033 [ 0.0025 ] ; LY80 , p = .659 [ 0.0025 ] , MMRM analysis ) .


RIS statistically separated from placebo in both populations ( p < .001 [ 0.05 ] ) .


There were no statistically significant differences in the incidence of serious adverse events , and no seizures on LY2140023 .


LY2140023 treatment did not demonstrate efficacy in populations studied .


Overall , LY2140023 treatment was generally well tolerated with no new adverse safety findings compared to previous trials .


Further understanding of the role of glutamate as a therapeutic target in schizophrenia is needed .


A Phase 2 , Multicenter , Double-Blind , Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia ClinicalTrials.gov identifier : NCT01086748 .


The aim of the present study was to investigate the effects of mindfulness-based cognitive therapy ( MBCT ) on suicidal ideation in an open-label randomised controlled trial of patients with residual depressive symptoms .


Furthermore , this study aimed at examining whether an effect of MBCT on suicidal ideation was dependent on a reduction in depression severity , worry and rumination , or an increase in mindfulness .


One hundred and thirty participants were randomised to a treatment arm ( treatment as usual plus MBCT ) or a wait list arm .


Change in depression , change in worry , change in rumination and change in mindfulness were entered as covariates in a repeated measures ANOVA in order to assess to what degree MBCT-induced changes in suicidal ideation were independent from changes in these parameters .


There was a significant grouptime ( pre vs. post ) interaction on suicidal ideation indicating a significant reduction of suicidal ideation in the MBCT group , but not in the control group .


The interaction remained significant after addition of the above covariates .


Change in worry was the only covariate associated with change in suicidal ideation , causing a moderate reduction in the interaction effect size .


The results suggest that MBCT may affect suicidal ideation in patients with residual depressive symptoms and that this effect may be mediated , in part , by participants ' enhanced capacity to distance themselves from worrying thoughts .


The aim of this study was to show the preliminary outcomes of transplantation in patients treated with the generic formulation of mycophenolate mofetil ( Myfenax , Teva ) .


Over the past 4 years , 60 patients received generic mycophenolate mofetil ( Myfenax ) after renal transplantation at the Gdansk Transplantology Center .


During the same time period , another 273 kidney transplantations were performed in our department , and these patients were treated with other formulations of mycophenolate ( CellCept [ Roche ] , Myfortic , or mycophenolate mofetil-Apotex ) as a part of the immunosuppressive plan .


Thirty of the Myfenax patients received a pair of kidneys from the same donor and received original mycophenolate mofetil CellCept with observation for at least 12 months .


The outcomes of the renal transplantations in both groups ( Myfenax vs pair ) were good , with satisfactory function of grafts .


One case of graft loss was reported in the Myfenax group ( renal vein thrombosis , graftectomy 5 days after transplantation ) .


There was no difference in the incidence of acute renal graft rejection in either group .


Moderate adverse reactions to immunosuppression were observed in both groups .


On the other hand , a comparison between the 60 patients with Myfenax and the 273 other patients with other formulations of mycophenolate revealed no differences in the incidence of acute renal graft rejection , delayed graft function , graft loss , and death .


There were no differences in the incidence of acute renal graft rejection , delayed graft function , graft loss , and death in patients with Myfenax vs original CellCept and other formulations of mycophenolate .


To confirm its complete biological and pharmacokinetic equivalence with the reference medicine , long-term , randomized observations carried out on larger renal transplant patients groups are needed .


To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone .


Randomised controlled trial .


Jos University Teaching Hospital , Jos , Nigeria .


Nigerian children with active rickets treated with calcium carbonate as limestone ( approximately 938 mg elemental calcium twice daily ) were , in addition , randomised to receive either oral vitamin D2 50,000 IU ( Ca + D , n = 44 ) or placebo ( Ca , n = 28 ) monthly for 24weeks .


Achievement of a 10-point radiographic severity score 1.5 and serum alkaline phosphatase 350U/L .


The median ( range ) age of enrolled children was 46 ( 15-102 ) months , and baseline characteristics were similar in the two groups .


Mean ( SD ) 25-hydroxyvitamin D ( 25 ( OH ) D ) was 30.213.2 nmol/L at baseline , and 29 ( 43 % ) had values < 30nmol/L .


Baseline alkaline phosphatase and radiographic scores were unrelated to vitamin D status .


Of the 68 children ( 94 % of original cohort ) who completed 24weeks of treatment , 29 ( 67 % ) in the Ca + D group and 11 ( 44 % ) in the Ca group achieved the primary outcome ( p = 0.06 ) .


Baseline 25 ( OH ) D did not alter treatment group effects ( p = 0.99 for interaction ) .


At the end of 24weeks , 25 ( OH ) D values were 55.417.0 nmol/L and 37.920.0 nmol/L in the Ca + D and Ca groups , respectively , ( p < 0.001 ) .


In the Ca + D and Ca groups , the final 25 ( OH ) D concentration was greater in those who achieved the primary outcome ( 56.417.2 nmol/L ) than in those who did not ( 37.718.5 nmol/L , p < 0.001 ) .


In children with calcium-deficiency rickets , there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone , independent of baseline 25 ( OH ) D concentrations .


ClinicalTrials.gov NCT00949832 .


Patient-reported outcomes are increasingly incorporated in drug evaluation trials .


Whether new immunosuppressive drugs result in an improved health-related quality of life ( HRQoL ) and a reduced side effect experiences remains unknown .


Moreover , the relationship between HRQoL and kidney function has never been investigated in kidney transplant recipients .


Using the BENEFIT and BENEFIT-EXT trials , we investigated the following : ( a ) evolution of HRQoL , assessed by the Medical Outcomes Short Form Health Survey ( SF-36 ) in the first 3 years ( baseline , 12 , 24 , and 36 months ) after kidney transplantation ; ( b ) association among kidney function ( chronic kidney disease stage ) , HRQoL , and patient-reported side effects ( Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R ; BENEFIT trial only ) ; and ( c ) impact of belatacept and cyclosporine on side effect experience and HRQoL .


In the BENEFIT trial , all subjects reported clinically meaningful improvements compared with baseline and returned to general population scores , both for physical composite score ( PCS ) and mental composite score Short Form ( 36 ) Health Survey at 12 to 36 months after transplantation .


In the BENEFIT-EXT trial , this was observed for PCS only .


Belatacept-treated patients reported better absolute PCSs compared with cyclosporine-treated patients .


The differences were small but statistically significant at all times .


Belatacept-treated patients tended to experience less side effects compared with cyclosporine-treated patients , except for dry skin .


Worsening kidney function was associated with a significant decrease in HRQoL .


Worsening in kidney function was associated with lower HRQoL .


Compared with cyclosporine , belatacept was associated with improved HRQoL , suggesting that use of non-nephrotoxic immunosuppressants may affect the patient 's side effect experience and improve their HRQoL .


To examine the impact of prescription on predicted speech intelligibility and loudness for children .


A between-group comparison of speech intelligibility index ( SII ) and loudness , based on hearing aids fitted according to NAL-NL1 , DSL v4 .1 , or DSL m [ i/o ] prescriptions .


A within-group comparison of gains prescribed by DSL m [ i/o ] and NAL-NL2 for children in terms of SII and loudness .


Participants were 200 children , who were randomly assigned to first hearing-aid fitting with either NAL-NL1 , DSL v4 .1 , or DSL m [ i/o ] .


Audiometric data and hearing-aid data at 3 years of age were used .


On average , SII calculated on the basis of hearing-aid gains were higher for DSL than for NAL-NL1 at low input level , equivalent at medium input level , and higher for NAL-NL1 than DSL at high input level .


Greater loudness was associated with DSL than with NAL-NL1 , across a range of input levels .


Comparing NAL-NL2 and DSL m [ i/o ] target gains revealed higher SII for the latter at low input level .


SII was higher for NAL-NL2 than for DSL m [ i/o ] at medium - and high-input levels despite greater loudness for gains prescribed by DSL m [ i/o ] than by NAL-NL2 .


The choice of prescription has minimal effects on speech intelligibility predictions but marked effects on loudness predictions .


Femorotibial knee osteoarthritis is associated with muscle weakness in the lower limbs , particularly in the quadriceps , which results in disease progression .


The interest of having muscular strengthening as part of the therapeutic arsenal for the medical treatment of knee osteoarthritis is now well established.The functional disability induced by knee osteoarthritis manifests itself principally when walking , notably downhill , during which the muscles are called upon to contract eccentrically.We can therefore think that eccentric muscular strengthening could bring a functional benefit that is superior to concentric muscular strengthening .


This is a prospective , randomized , bicenter , parallel-group , international study .


Eighty patients aged from 40 to 75 years old , suffering from medical-stage knee osteoarthritis , will undertake 6 weeks of isokinetic muscular strengthening .


Randomization determines the mode of muscular strengthening : either exclusively eccentric or exclusively concentric.The principal objective is to demonstrate the superiority of the improvement in the quadriceps isokinetic torque after isokinetic muscular strengthening by the eccentric mode compared to the concentric mode.The following parameters are also evaluated : the variations in the level of pain , the parameters of walking ( maximum speed over 10 and 200 meters , analysis on a computerized Gaitrite treadmill ) , static equilibrium ( on a FUSYO force platform ) , and the functional status of the patient using the Western Ontario and MacMaster Universities osteoarthritis index ( WOMAC ) questionnaire after the strengthening period and at 6 months .


A better knowledge of the most effective mode of muscular strengthening is needed to optimize the functional benefits to the patients .


In case of superiority in terms of efficacy of the eccentric mode , the latter could be given priority in the rehabilitation treatment of knee osteoarthritis patients .


Clinical trials.gov number : NCT01586130 .


We developed the iTrainer ( iT ) as a portable laparoscopic trainer , which incorporates the iPad tablet .


We then compared the iT with a standard pelvic trainer ( SPT ) to assess surgical skills as well as its image quality , resolution , brightness , comfort , and overall performance .


We designed and constructed the iT to be compatible with the Apple iPad 3 and standard laparoscopic instruments .


Participants were assigned to perform the thread-the-loops task on both trainers and were prospectively randomized to start on either the iT or the SPT .


Each participant was allowed a 2-minute warm-up before the 2-minute testing period .


We scored participants using the product of skill quality ( 0-4 scale ) and quantity of loops threaded ( 0-10 scale ) .


Participants then rated each trainer on image quality , resolution , brightness , comfort , and overall performance on a 5-point Likert scale .


A total of 45 subjects including 10 undergraduates , 10 medical students , 10 general surgery and urology residents , and 15 experts ( fellows and attending surgeons ) participated in this study .


There was no significant difference between thread-the-loops task scores completed on the iT when compared with the SPT for all groups tested ( p > 0.05 ) with the exception of the medical student group , who performed better on the SPT ( p < 0.05 ) .


On evaluation of each trainer , participants rated the iT as having superior image quality and resolution when compared with the SPT ( p < 0.05 ) but rated the SPT higher in overall performance ( p < 0.05 ) .


Brightness and comfort were rated similarly for both trainers .


We have demonstrated face validity and criterion validity for the thread-the-loops task on the iT .


The iT rated superior in image quality and resolution but inferior in overall performance compared with the SPT .


The iT provides trainees a unique advantage over SPT as an additional resource to laparoscopic training as it is inexpensive , portable , and can be readily available for training .


Simulator sickness causes vestibulo-autonomic responses that increase sympathetic activity and decrease parasympathetic activity .


The purpose of the study was to quantify these responses through electrogastrography and cardiac interbeat intervals during flight simulation .


There were 29 subjects that were randomly assigned to 2 parallel arms : ( 1 ) oculovestibular recoupling , where galvanic vestibular stimulation was synchronous with the visual field ; and ( 2 ) control .


Electrogastrography and interbeat interval data were collected during baseline , simulation , and post-simulation periods .


A simulator sickness questionnaire was administered .


Statistically significant differences were observed in percentage of recording time with the dominant frequency of electrogastrography in normogastric and bradygastric domains between the oculovestibular recoupling and control groups .


Normogastria was dominant during simulation in the oculovestibular recoupling group .


In the control group , the percentage of recording time with the dominant frequency decreased by 22 % in normogastria and increased by 20 % in bradygastria .


The percentage change of the dominant power instability coefficient from baseline to simulation was 26 % in the oculovestibular recoupling group vs. 108 % in the control group .


The power of high-frequency components for interbeat intervals did not change significantly in the oculovestibular recoupling group and was decreased during simulation in the control group .


Electrogastrography and interbeat intervals are sensitive indices of autonomic changes in subjects undergoing flight simulation .


These data demonstrate the potential of oculovestibular recoupling to stabilize gastric activity and cardiac autonomic changes altered during simulator and motion sickness .


The inability of current vaccines to provide effective protection against porcine reproductive and respiratory syndrome virus ( PRRSV ) infection is not fully understood .


One of the reasons might be the presence of anti-idiotypic antibodies ( Ab2s ) to the envelope glycoprotein GP5 induced by PRRSV infection since our previous studies demonstrated the presence of auto-Ab2s ( aAb2s ) in pigs infected with PRRSV .


To test this hypothesis , PRRSV negative piglets were injected with a monoclonal Ab2 ( Mab2-5G2 ) and aAb2s that are specific for anti-GP5 antibody , vaccinated with the attenuated PRRSV vaccine CH-1R and then challenged with the highly pathogenic PRRSV HuN4 strain .


The animals were evaluated for clinical signs , pathological changes of the thymus and lungs , viremia , levels of serum antibodies and cytokines .


The piglets injected with Mab2-5G2 or aAb2 , and who received the attenuated PRRSV vaccine CH-1R before challenge , produced high levels of anti-N antibodies , IL-2 and IL-4 , but low levels of neutralizing antibodies .


After PRRSV HuN4 challenge , the animals showed obvious clinical signs , including lung lesions , severe thymus atrophy and decreased production of IL-4 and higher level of viremia .


When anti-GP5 Ab2s are present , the use of attenuated PRRSV vaccine CH-1R against HP-PRRSV infection is not recommended .


It can result in poor health status with pneumonia and thymus atrophy .


Problems associated with lifelong antiretroviral therapy , such as need for strict adherence , drug-related toxic effects , difficulties with treatment schedules , and cost , mean that simplification strategies should be sought .


We aimed to explore the efficacy and safety of dual treatment with atazanavir-ritonavir plus lamivudine as an option to switch to from standard combination antiretroviral therapy in patients with an HIV-1 infection who are virologically suppressed .


In this randomised , open-label , non-inferiority trial , we recruited patients aged 18 years and older with chronic HIV-1 infection and no previous treatment failure or resistance , and with HIV-1 RNA of less than 50 copies per mL for at least 6 months , negative hepatitis B virus surface antigen , and good general health , from 30 hospitals in Spain .


Exclusion criteria were switch in antiretroviral therapy during the previous 4 months , previous virological failure , pregnancy or breastfeeding , Gilbert 's syndrome , use of contraindicated drugs , grade 4 laboratory abnormalities , and previous intolerance to any of the study drugs .


We randomly assigned patients ( 1:1 ; stratified by active hepatitis C virus infection and previous treatment ; computer-generated random number sequence ) to dual treatment with oral atazanavir ( 300 mg once daily ) and ritonavir ( 100 mg once daily ) plus lamivudine ( 300 mg once daily ) or triple treatment with oral atazanavir ( 300 mg once daily ) and ritonavir ( 100 mg once daily ) plus two nucleos ( t ) ide reverse transcriptase inhibitors at the discretion of the investigators .


The primary endpoint was virological response , defined as HIV-1 RNA of less than 50 copies per mL at week 48 , in the per-protocol population , with a non-inferiority margin of 12 % .


We included patients who received at least one dose of the study drug in the safety analysis .


This study is registered at ClinicalTrials.gov , number NCT01307488 .


Between Sept 29 , 2011 , and May 2 , 2013 , we randomly assigned 286 patients ( 143 [ 50 % ] to each group ) .


At week 48 in the per-protocol population , 112 ( 84 % ) of 133 patients had virological response in the dual-treatment group versus 105 ( 78 % ) of 135 in the triple-treatment group ( difference 6 % [ 95 % CI -5 to 16 % ) , showing non-inferiority at the prespecified level .


14 ( 5 % ) patients developed severe adverse events ( dual treatment six [ 4 % ] ; triple treatment eight [ 6 % ] ) , none of which we deemed related to the study drug .


Grade 3-4 adverse events were similar between groups ( dual treatment 77 [ 55 % ] of 140 ; triple treatment 78 [ 55 % ] of 141 ) .


Treatment discontinuations were less frequent in the dual-treatment group ( three [ 2 % ] ) than in the triple-treatment group ( ten [ 7 % ] ; p = 0047 ) .


In our trial , dual treatment was effective , safe , and non-inferior to triple treatment in patients with an HIV-1 infection who are virologically suppressed who switch antiretroviral therapy because of toxic effects , intolerance , or simplification .


This combination has the potential to suppress some of the long-term toxic effects associated with nucleos ( t ) ide reverse transcriptase inhibitors , preserve future treatment options , and reduce the cost of antiretroviral therapy .


Bristol Myers-Squibb and Fundacin SEIMC-GESIDA .


To observe the efficacy of Jinghuaweikang gelatin pearls plus proton pump inhibitor ( PPI ) - based triple regimen in the treatment of chronic atrophic gastritis ( CAG ) patients with Helicobacter pylori ( H.pylori ) infection .


For this multicenter , randomized , controlled clinical study , 90 patients of endoscopically confirmed CAG with positive H.pylori ( ( 13 ) C or ( 14 ) C-urea breath test ( UBT ) or rapid urease test ) were enrolled .


There were 46 males and 44 females with an age range of ( 54 10 ) years .


None of them had H.pylori eradication background .


They were randomly divided into 2 groups , Group LACJ ( n = 45 ) received lansoprazole 30 mg + amoxicillin 1000 mg + clarithromycin 500 mg + jinghuaweikang gelatin pearls 240 mg , twice daily , for 10 days ( d1-10 ) plus another 14 days ( d11-24 ) only with jinghuaweikang gelatin pearls 240 mg , twice daily .


Group LACB ( n = 45 ) had standard quadruple regimen treatment : lansoprazole 30 mg + amoxicillin 1000 mg + clarithromycin 500 mg + bismuth potassium citrate 220 mg , twice daily for 10 days ( d1-10 ) .


The status of H.pylori was detected by ( 13 ) C-UBT at least 28 days after therapy .


The eradication rates in Groups LACJ and LACB were as follows : per-protocol ( PP ) : 70.5 % ( 31/44 ) and 83.3 % ( 35/42 ) , intention-to-treat ( ITT ) : 68.9 % ( 31/45 ) and 77.8 % ( 35/45 ) ( both P > 0.05 ) .


The symptomatic improvements of bloating in upper abdomen , belching and epigastric pain after treatment in both groups .


And those in Group LACJ was higher than those of Group LACB , but no statistical difference existed between two groups ( all P > 0.05 ) .


The efficacy of LACJ for the treatment of CAG patients with H.pylori infection is similar to LACB .


And the symptomatic improvement of patients is better than LACB .


To determine the independent and combined effects of pain and opioids on the activation of an early marker of inflammation , nuclear factor-B ( NF-B ) .


NF-B activation was compared within-subjects following four randomly ordered experimental sessions of opioid-only ( intravenous fentanyl 1 g/kg ) , painonly ( cold-pressor ) , opioid + pain , and a resting condition .


University General Clinical Research Center .


Twenty-one ( 11 female ) healthy controls .


Following exposure to treatment ( fentanyl administration and/or cold-pressor pain ) , blood samples for NF-B analysis were obtained .


Intracellular levels of activated NF-B , in unstimulated and stimulated peripheral blood mononuclear cells at 15 and 30 minutes .


Neither pain nor opioid administration alone effected NF-B levels in cell populations ; however , the combination of treatments induced significant increases of NF-B in stimulated peripheral blood mononuclear cell , lymphocytes , and monocytes .


The combination of acute pain with opioids , as occurs in clinical situations , activates a key transcription factor involved in proinflammatory responses .


Hemodynamic disturbances are common during continuous epidural anesthesia in elderly patients undergoing total hip arthroplasty .


This study aimed to investigate the effects of methoxamine on the intraoperative hemodynamics in elderly patients undergoing total hip arthroplasty under epidural anesthesia .


This prospective study included 150 elderly patients undergoing elective total hip arthroplasty under epidural anesthesia .


Patients were randomly assigned into 5 groups ( n = 30 per group ) : a control group receiving saline ( Group C ) , a dopamine group receiving 7 g/kg/min dopamine ( Group D ) , and methoxamine groups receiving 1 , 2 , or 3 g/kg/min methoxamine ( Groups M1 , M2 , and M3 , respectively ) .


Hemodynamic parameters were assessed 10 min before anesthesia ( T1 ) ; 10 min ( T2 ) , 20 min , ( T3 ) , 30 min ( T4 ) , and 60 min ( T5 ) after anesthesia ; and at the conclusion of surgery ( T6 ) .


At T2-T6 , the mean arterial pressure , central venous pressure , cardiac output , stroke volume , stroke volume ratio , and pulmonary vascular resistance were higher in Groups D , M2 , and M3 compared to Group C ( p < 0.05 ) .


Compared to Group D , the heart rate and rate pressure product were significantly lower in Groups M1-M3 .


Infusion volume , ephedrine dose , and postoperative 24-h urine volume were significantly lower and intraoperative urine volume was significantly greater in Groups D , M2 , and M3 compared with Group C. Hypertension occurred more frequently in Group M3 than in any other group .


Continuous intravenous infusion of 2 g/kg/min methoxamine is safe and effective in maintaining hemodynamic stability in elderly patients undergoing total hip arthroplasty .


This study aimed at evaluating the safety and efficacy of an improved dosage regimen of sertraline in patients with premature ejaculation ( PE ) and to examine whether the premature ejaculation diagnostic tool ( PEDT ) can be used as a measure of treatment response in these patients .


A total of 218 PE patients were randomized into control ( n = 61 ) and treatment ( n = 157 ) groups to receive mycelium of cordyceps sinensis C4 and sertraline 50mg daily for 8weeks , respectively .


Following this blinded stage , sixty-three patients chose to take sertraline 100mg daily for an additional 4-week period , and 80 other patients continued treatment with sertraline 50mg .


Main outcome measures include intravaginal ejaculatory latency time ( IELT ) , PEDT score and Clinical Global Impression of Change ( CGIC ) score .


At weeks 4 and 8 , mean IELT of patients who subsequently chose to take 100mg of sertraline was significantly lower than that of patients who continued taking 50mg of sertraline , although the IELT value was comparable between the two groups of patients at baseline .


However , with an additional 4-week treatment , the mean IELT increased significantly more in the 100-mg group than in the 50-mg continuation group .


Similar results were also obtained in the analyses of the PEDT and CGIC scores .


Both regimens were well tolerated , and relapse rate did not differ significantly between the two groups .


These findings suggest that PE patients not responding to an 8-week treatment with sertraline 50mg can benefit from an additional 4-week treatment with sertraline 100mg and that the PEDT may be a valid measure of treatment response in PE patients .


The long-acting muscarinic antagonist ( LAMA ) umeclidinium ( UMEC ) and the combination of UMEC with the long-acting 2-agonist ( LABA ) vilanterol ( UMEC/VI ) are approved maintenance treatments for chronic obstructive pulmonary disease ( COPD ) in the US and EU .


They are not indicated for the treatment of asthma .


In this 52-week , double-blind , placebo-controlled , parallel-group safety study ( GSK study DB2113359 ; NCT01316887 ) , patients were randomized 2:2:1 to UMEC/VI 125/25 mcg , UMEC 125 mcg , or placebo .


Study endpoints included adverse events ( AEs ) , clinical chemistry and hematology parameters , vital signs , 12-lead , and 24-hour Holter electrocardiograms .


COPD exacerbations and rescue medication use were assessed as safety parameters ; lung function was also evaluated .


The incidence of on-treatment AEs , serious AEs ( SAEs ) , and drug-related AEs was similar between treatment groups ( AEs : 52-58 % ; SAEs : 6-7 % ; drug-related AEs : 12-13 % ) .


Headache was the most common AE in each treatment group ( 8-11 % ) .


AEs associated with the LAMA and LABA pharmacologic classes occurred at a low incidence across treatment groups .


No clinically meaningful effects on vital signs or laboratory assessments were reported for active treatments versus placebo .


The incidences of atrial arrhythmias with UMEC/VI 125/25 mcg were similar to placebo ; for UMEC 125 mcg , the incidences of ectopic supraventricular beats , sustained supraventricular tachycardia , and ectopic supraventricular rhythm were 2 % greater than placebo .


With active treatments , COPD exacerbations were fewer ( 13-15 % of patients reporting 1 exacerbation ) and on average less rescue medication was required ( 1.6-2 .2 puffs/day ) versus placebo ( 24 % reporting 1 exacerbation , 2.6 puffs/day ) .


Both active treatments improved lung function versus placebo .


UMEC/VI 125/25 mcg and UMEC 125 mcg were well tolerated over 12months in patients with COPD .


Retinoblastoma is a rare malignant intraocular neoplasm .


About 90 % of cases feature a germline mutation in the RB1 gene and these will develop retinoblastoma during their early childhood .


An association between mutations in germline cells and aging has been demonstrated .


This suggests a higher incidence of childhood cancer including retinoblastoma among children of older parents .


In the present study we aimed to determine the association of paternal and maternal age with an increased risk of retinoblastoma in a case-control study in Iranian population .


The study was carried out on 240 persons who were born during 1984-2012 in Mahak and Mofid hospitals in Tehran , Iran .


The statistical analysis included studying the mean age of parents and in order to know whether parental age of patients is different from parental age of control group , ( t-test ) compare averages test is used perfectly .


By binary logistic regression , odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) were calculated .


The results of statistical analysis including the study of mean parental age by the use of ( t-test ) compare averages test showed a significant difference between parental ages of patients and controls .


Logistic regression showed that coefficients were significant for maternal but not paternal age .


Our findings indicate that advanced maternal age can increase the risk of retinoblastoma in offspring , but the paternal age has no significant effect .


To observe the curative effect of acupoint-injection and intramuscular-injection of Bacillus Calmette-Guerin ( BCG ) Polysaccharide Nucleic Acid for bronchial asthma .


Sixty patients with bronchial asthma were equally randomized into acupoint-injection group and intramuscular-injection group .


For patients of the acupoint-injection group , 2 mL of BCG was injected into bilateral Feishu ( BL 13 , 1 mL for one side ) once per day in the first 15 days , and once every other day in the rest 2.5 months except weekends .


Intramuscular-injection was conducted at the lateral sites of the left or right buttock , 2 mL/time for each site , and the injection frequency was the same to that of the acupoint-injection .


The therapeutic effect was assessed according to the standards of Guide Principles for Clinical Research of New Chinese Herbal Drugs ( 2002 ) and Asthma Group of Breathing Diseases of China Medical Association ( 2008 ) .


Changes of FEV 1 ( forced expiratory volume in the first second ) / FVC ( forced vital capacity ) and PEF % ( peak expiratory flow ) were detected using a pulmonary function detector .


Serum IgA , IgM , IgG and IgE contents were assayed by using an autonomic biochemical analyzer .


After 3 months ' treatment , the scores of patients ' symptoms and signs and serum IgE and IgG levels were significantly decreased in both muscular-injection and acupoint-injection groups ( P < 0.01 ) , while asthma controlled test ( ACT ) scores FEV 1/FVC % and PEF % values were considerably increased in both groups compared to pre-treatment in the same one group ( P < 0.01 ) .


The effects of acupoint-injection were markedly superior to those of the intramuscular-injection in reducing clinical symptom-sign score , and serum IgE content , and in up-regulating ACT score , FEV 1/FVC % and PEF % levels ( P < 0.05 , P < 0.01 ) .


There were no significant differences in serum IgG , IgA and IgM levels between the two groups 3 months following the treatment ( P > 0.05 ) .


Acupoint-injection of BCG polysaccharide nucleic acid can effectively improve bronchial asthma patients ' clinical symptoms and sings and pulmonary function , which may be closely associated with its function in down-regulating serum IgE and IgG levels .


Omega-3 fatty acids supplements lower triglyceride ( TG ) levels in adults ; little pediatric information is available .


We evaluated their effect in hypertriglyceridemic adolescents .


Twenty-five patients aged 10 to 19 years with TG levels 150 to 1000 mg/dL were randomized to 6 months double-blind trial of Lovaza ( ~ 3360 mg docosahexaenoic acid + eicosapentaenoic acid per day ) versus placebo .


Baseline mean TG levels were 227 mg/dL ( standard deviation = 49 ) .


TG levels declined at 3 months in the Lovaza group by 54 27 mg/dL ( mean standard error ; P = .02 ) and by 34 26 mg/dL ( P = .16 ) in the placebo group .


The difference in TG lowering between groups was not significant ( P = .52 ) .


There were no between-group differences in endothelial function , blood pressure , body mass index , C-reactive protein , or side effects .


High-dose omega-3 fatty acid supplements are well tolerated in adolescents .


However , declines in TG levels did not differ significantly from Placebo in this small study .


The objective of this study was to ascertain whether clinicians can reliably distinguish between spasmodic dysphonia ( SD ) / vocal tremor and other voice disorders by telephone , despite this modality 's limited frequency response .


Randomized , single-blinded , and prospective study .


Voice-disordered patients with ( n = 22 ) and without ( n = 17 ) SD and/or vocal tremor recorded standardized utterances via landline telephone .


A laryngologist and two speech-language pathologists blinded to the diagnoses rated each recording as `` yes '' or `` no '' to `` SD or tremor present ?


, '' and if `` yes '' categorized into adductor , abductor , tremor only , or adductor with tremor subtypes .


Twenty-one recordings were presented twice at random so intrarater reliability could be assessed .


All ratings were compared with gold standard diagnosis by a second laryngologist who performed a full examination , including videostroboscopy , on each patient .


For the comparison `` SD or tremor '' yes versus no , sensitivity , specificity , positive predictive value , and negative predictive value are 90 % , 95 % , 96 % , and 89 % , respectively .


Interrater reliability ( Cohen kappa ) compared with the gold standard ranged from 0.70 to 0.93 ( substantial to almost perfect agreement ) .


Cronbach alpha among three raters was 0.90 for this comparison .


Intrarater reliability ( number matched/number inspected ) was very high , ranging from0 .97 to 1.0 .


Comparing gold standard and telephone rating of SD/tremor subtypes , kappa ranged from 0.48 to 0.60 ( moderate agreement ) .


Cronbach alpha among three raters was 0.88 for this comparison .


Intrarater reliability ranged from 0.84 to 0.97 .


SD and tremor can be reliably distinguished from other voice disorders over the telephone .


Contrast-induced nephropathy ( CIN ) , an acute kidney injury resulting from the administration of intravascular iodinated contrast media , is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients .


Despite preventative measures intended to mitigate the risk of CIN , there remains a need for an effective intervention .


Remote ischaemic conditioning ( RIC ) , where non-injurious ischaemia is applied to an arm prior to the administration of contrast , has shown promise in attenuating CIN but its effectiveness in preserving long-term renal function is unknown , which will be studied as part of the effect of remote ischaemic conditioning against contrast-induced nephropathy ( ERICCIN ) trial .


( http://Controlled-trials.com Identifier : ISRCTN49645414 . )


The ERICCIN trial is a single-centre , randomised double-blinded placebo-controlled trial which plans to recruit 362 patients who are at risk of CIN , defined by pre-existent renal impairment ( estimated glomerular filtration rate < 60 ml/min/1 .73 m2 ) , over a period of 2 years .


Patients will be randomised to either control or RIC consisting of 4 , 5 min 200 mmHg balloon-cuff inflation/deflations , to the upper arm .


The primary endpoint will be the development of CIN ( > 25 % of eGFR , or rise of creatinine of > 44 mol/l ) at 48 h.


A key secondary endpoint will be whether RIC impacts upon persistent renal impairment over the 3-month follow-up period .


Additional secondary endpoints include the measurement of serum neutrophil gelatinase-associated lipocalin and urinary albumin at 6 , 48 h and 3 months following administration of contrast .


Findings from ERICCIN trial will potentially demonstrate that RIC attenuates contrast-induced acute and chronic kidney injury and influence future clinical practice guidelines in at-risk patients undergoing coronary angiographic procedures .


To investigate the effects of sitagliptin therapy on the kinetics of triglyceride-rich lipoprotein ( TRL ) apolipoprotein ( apo ) B-48 , VLDL apoB-100 , apoE and apoC-III in patients with type 2 diabetes .


Twenty-two subjects with type 2 diabetes were recruited in this double-blind crossover study , during which the subjects received sitagliptin ( 100 mg/day ) or placebo for a 6-week period each .


At the end of each phase of treatment , the in vivo kinetics of the different apolipoproteins were assessed using a primed-constant infusion of l - [ 5,5,5-D3 ] leucine for 12 h , with the participants in a constantly fed state .


Sitagliptin therapy significantly reduced fasting plasma triglyceride ( -15.4 % , p = 0.03 ) , apoB-48 ( -16.3 % , p = 0.03 ) and free fatty acid concentrations ( -9.5 % , p = 0.04 ) , as well as plasma HbA1c ( placebo : 7.0 % 0.8 vs. sitagliptin : 6.6 % 0.7 , p < 0.0001 ) and plasma glucose levels ( -13.5 % , p = 0.001 ) , without any significant effect on insulin levels .


Kinetic results showed that treatment with sitagliptin significantly reduced the pool size of TRL apoB-48 by -20.8 % ( p = 0.03 ) , paralleled by a reduction in the production rate of these particles ( -16.0 % , p = 0.03 ) .


The VLDL apoB-100 pool size was also significantly decreased by sitagliptin therapy ( -9.3 % , p = 0.03 ) , mainly because of a reduction in the hepatic secretion of these lipoproteins , although this difference did not reach statistical significance ( -9.2 % , p = 0.06 ) .


Treatment with sitagliptin for 6 weeks reduced triglyceride-rich apoB-containing lipoprotein levels by reducing the synthesis of these particles .


It has previously been reported that increased level of serum heat shock proteins ( Hsps ) antibody in patients with metabolic syndrome .


It is possible that the expression of Hsp and inflammatory markers can be affected by cupping and traditional Chinese medicine .


There is a little data investigating the effects of cupping on markers of inflammation and Hsp proteins , hence , the objective of this study was evaluation of the effects of wet cupping on serum high-sensitivity C-reactive protein ( hs-CRP ) and Hsp27 antibody titers in patients with metabolic syndrome .


Serum Hs-CRP and Hsp27 antibody titers were assessed in samples from 126 patients with metabolic syndrome ( 18-65 years of age ) at baseline , and after 6 and 12 weeks after treatment .


One hundred and twenty-six patients were randomly divided into the experimental group treated with wet cupping combined with dietary advice , and the control group treated with dietary advice alone using a random number table .


Eight patients in case group and five subjects in control groups were excluded from the study .


Data were analyzed using SPSS 15.0 software and a repeated measure ANCOVA .


Serum hs-CRP titers did not change significantly between groups ( p > 0.05 ) and times ( p = 0.27 ) .


The same result was found for Hsp27 titers ( p > 0.05 ) .


Wet-cupping on the interscapular region has no effect on serum hs-CRP and Hsp27 patients with metabolic syndrome .


The aim of this study was to ascertain if a modified carotid sinus massage ( CSM ) using ultrasonography is superior to the conventional CSM for vagal tone generation .


This was a prospective , crossover , clinical trial including 30 subjects with sinus rhythm .


Participants were paired , and they performed 2 types of CSM to each other .


To perform the conventional technique , pressure was exerted at the point where the maximal impulse of the carotid pulse was palpated .


In the modified technique , participants localized the point of maximal diameter just above the bifurcation of the common carotid artery using ultrasonography and applied pressure to that point .


Mean differences between premaneuver and postmaneuver R-R intervals and heart rates were compared .


The distance from the midline of the neck ( x distance ) to the angle of the mandible ( y distance ) was measured , and the mean distance between the 2 techniques was compared .


The baseline mean premaneuver R-R interval and heart rate did not differ significantly between the 2 techniques .


The postmaneuver R-R interval and heart rate as well as the mean R-R interval and heart rate differences were significantly greater in the modified CSM .


The mean location determined using the modified CSM was located 0.8 cm lateral and 0.8 cm superior to the mean location of the conventional CSM .


The modified CSM using ultrasonography might be more useful than the conventional CSM in reverting episodes of paroxysmal supraventricular tachycardia and may be a suitable alternative for treating the same in the emergency department .


Flumazenil was administered after the completion of endoscopy under sedation to reduce recovery time and increase patient safety .


We evaluated patient satisfaction after endoscopy under sedation according to the timing of a postprocedural flumazenil injection .


In total , 200 subjects undergoing concurrent colonoscopy and upper endoscopy while sedated with midazolam and meperidine were enrolled in our investigation .


We randomly administered 0.3 mg of flumazenil either immediately or 15 minutes after the endoscopic procedure .


A postprocedural questionnaire and next day telephone interview were conducted to assess patient satisfaction .


Flumazenil injection timing did not affect the time spent in the recovery room when comparing the two groups of patients .


However , the subjects in the 15 minutes injection group were more satisfied with undergoing endoscopy under sedation than the patients in the immediate injection group according to the postprocedural survey ( p = 0.019 ) .


However , no difference in overall satisfaction , memory , or willingness to undergo a future endoscopy was observed between the two groups when the telephone survey was conducted on the following day .


This study demonstrated that a delayed flumazenil injection after endoscopic sedation increased patient satisfaction without prolonging recovery time , even though the benefit of the delayed flumazenil injection did not persist into the following day .


The degree of glycemic control in patients with type 2 diabetes mellitus ( T2DM ) may alter lipid levels and may alter the efficacy of lipid-modifying agents .


Evaluate the lipid-modifying efficacy of extended-release niacin/laropiprant ( ERN/LRPT ) in subgroups of patients with T2DM with better or poorer glycemic control .


Post hoc analysis of clinical trial data from patients with T2DM who were randomized 4:3 to double-blind ERN/LRPT or placebo ( n = 796 ) , examining the lipid-modifying effects of ERN/LRPT in patients with glycosylated hemoglobin or fasting plasma glucose levels above and below median baseline levels .


At Week 12 of treatment , ERN/LRPT significantly improved low-density lipoprotein cholesterol , high-density lipoprotein cholesterol ( HDL-C ) , non-high-density lipoprotein cholesterol , triglycerides , and lipoprotein ( a ) , compared with placebo , with equal efficacy in patients above or below median baseline glycemic control .


Compared with placebo , over 36 weeks of treatment more patients treated with ERN/LRPT had worsening of their diabetes and required intensification of antihyperglycemic medication , irrespective of baseline glycemic control .


Incidences of other adverse experiences were generally low in all treatment groups .


The lipid-modifying effects of ERN/LRPT are independent of the degree of baseline glycemic control in patients with T2DM ( NCT00485758 ) .


A combination of scintigraphy and a lymphotropic dye ( patent blue dye ( BD ) ) is the recommended technique to detect the sentinel lymph node ( SLN ) in early breast cancer .


This study determined the effect of clinical factors on SLN identification in the sentinel node biopsy versus axillary clearance ( SNAC ) trial .


A total of 1088 women were registered .


Lymphatic mapping was performed using preoperative lymphoscintigraphy ( LSG ) and gamma probe ( GP ) combined with peritumoural injection of patent BD ( 971 patients ) or BD alone ( 106 patients ) .


SLNs were identified in 1024 women ( 94 % ) , localized with LSG in 779 ( 81.4 % ) , and were identified by GP in 879 ( 91.8 % ) .


The BD identified SLNs in 890 of 1073 ( 82 % ) women .


Three patients had allergic reactions .


BD detected the SLNs in 141 of 178 women with negative LSG mapping and in 44 of 79 women with no hot SLNs detected intraoperatively .


Age , body mass index ( BMI ) and tumour presentation ( screen detected versus symptomatic ) were significantly related to the identification of the SLN .


For BD , the primary tumour location was significantly related to identification rate .


The detection of blue SLN was significantly lower in women with inner quadrant tumours .


The combined technique resulted in a high identification rate .


BD contributed to the identification of the SLNs in patients where LSG and GP failed to identify the sentinel node .


Special attention to these techniques is needed in particular groups of patients such as those with high BMI , screen-detected primary tumours and tumour located in the inner quadrants .


To compare the clinical , analytical and graft maturation effects of two different platelet-rich plasma ( PRP ) preparations applied during anterior cruciate ligament ( ACL ) reconstruction .


A total of 150 patients with ACL disruption were included in the study .


Arthroscopic ACL reconstruction with patellar tendon allograft was conducted on all knees using the same protocol .


One hundred patients were prospectively randomised to either a group to receive double-spinning platelet-enriched gel ( PRP ) with leukocytes ( n = 50 ) or to a non-gel group ( n = 50 ) .


Finally , we included 50 patients treated with a platelet-rich preparation from a single-spinning procedure ( PRGF Endoret ( ) Technology ) without leukocytes .


Inflammatory parameters , including C-reactive protein ( CRP ) and knee perimeters ( PER ) , were measured 24 hours and 10 days after surgery .


Postoperative pain score ( visual analogue score [ VAS ] ) was recorded the day after surgery .


Follow-up visits occurred postoperatively at 3 , 6 , and 12 months .


The International Knee Documentation Committee scale ( IKDC ) was included to compare functional state , and MRI was conducted 6 months after surgery .


The PRGF group showed a statistically significant improvement in swelling and inflammatory parameters compared with the other two groups at 24 hours after surgery ( p < 0.05 ) .


The results did not show any significant differences between groups for MRI and clinical scores .


PRGF used in ACL allograft reconstruction was associated with reduced swelling ; however , the intensity and uniformity of the graft on MRI were similar in the three groups , and there was no clinical or pain improvement compared with the control group .


II .


Despite calls to expand measurement of acute myocardial infarction ( AMI ) outcomes to include symptom burden , little has been done to describe hospital-level variation in this patient-centered outcome , or its association with mortality .


Understanding the relationship between symptoms and longer-term mortality could inform the importance of these outcomes for monitoring quality of care .


Among 4316 patients with AMI treated at 24 hospitals participating in the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients ' Health Status ( TRIUMPH ) study , we assessed risk-standardized 1-year symptom burden as measured by the Seattle Angina Questionnaire Angina Frequency Score and mortality attributed to the hospital that provided AMI care .


Median odds ratios were used to assess outcome variation and reflect the relative odds of an outcome for 2 patients with identical covariates at different , randomly selected , hospitals .


We then evaluated the correlation between hospital-level mortality and angina .


Finally , we determined the extent to which variation in mortality and angina was explained by achievement of AMI performance measures .


We observed hospital variation in risk-adjusted 1-year mortality ( range , 4.9 % -8.6 % ; median odds ratio , 1.30 ; P = 0.01 ) and angina ( range , 17.7 % -29.4 % ; median odds ratio , 1.34 ; P < 0.001 ) .


At the hospital level , mortality and angina at 1 year were weakly correlated ( r = 0.40 ; 95 % confidence interval , 0.00-0 .68 ; P = 0.05 ) .


Accounting for the quality of AMI care did not attenuate variation in risk-adjusted 1-year mortality or angina .


Symptom burden and mortality vary at the hospital level after AMI and are only weakly correlated .


These findings suggest that symptom burden should be considered a separate quality domain that is not well captured by current quality metrics .


Forty to sixty percent of MS patients suffer from cognitive impairments .


Cognitive deficits are a great burden for patients affected .


In particular they may lead to a reduced quality of life , loss of work and problems with the social environment .


The aim of this study was to evaluate a specific neuropsychological rehabilitation program for MS patients according to the ICF to be able to meet more properly individual requirements on the therapy level of function as well as of activities and participation .


Forty patients with MS were randomised in an intervention ( IG ) - and a control group ( CG ) .


The outcome measure of the IG , who started an intensive computer based home training of attention and attended psychological counselling was compared to the untrained CG .


In specific domains of attention ( simple and cued alertness and divided attention ) significant group differences between CG and IG could be found .


The IG reported an improvement of mental fatigue and retardation .


These findings support the idea that a neuropsychological rehabilitation program , which based on the model of ICF , could improve cognitive impairment and could also have a positive influence of activities and participation .


The results of weight maintenance after initial weight loss are reported infrequently , although , when they have been reported , the outcomes are generally poor and weight regain is common .


After an initial 12-week randomised intervention comparing all meal provision against a self-directed energy restriction , participants re-consented to participate in a follow-on study .


Participants were given the option to choose to continue with the same dietary intervention ( either all meal provision ( provided free of charge ) or self-directed diet ) or change to the other diet for a further 12 weeks .


Participants were followed up at 4-weekly intervals during both intervention periods ( a total of 24 weeks ) , with a final follow up at 12 months .


Eighty-five out of 86 individuals who completed the original 12-week randomised phase chose to continue on to the follow-up study .


No significant differences in further weight loss between groups ( P = 0.138 ) [ mean ( SEM ) : -3.4 % ( 1.1 % ) for all meal provision only ; -3.4 % ( 0.6 % ) self-directed then all meal provision ; -1.1 % ( 1.2 % ) all meal provision then self-directed ] were seen after a further 12 weeks .


Meal provision for a total of 24 weeks resulted in 67 % of individuals losing at least 10 % body weight .


The groups switching from self-directed dieting to meal provision ( or vice versa ) were the only groups to have a lower mean weight at 12 months than at the start of the follow-on study .


Structured support for 24 weeks followed by 28 weeks of self-care can result in weight maintenance , with initial weight loss maintained at 12 months from enrolling on a 12-week weight loss intervention , with a 12-week follow-on period .


A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder .


The combined diseases have a wide range of adverse outcomes , such as a lower quality of life , poorer diabetes outcomes and increased healthcare utilisation .


Diabetes patients with depression can be treated effectively with psychotherapy , but access to psychological care is limited .


In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention ( GET.ON Mood Enhancer Diabetes ) for people with diabetes and comorbid depressive symptoms .


A two-arm randomised controlled trial will be conducted .


Adults with diabetes ( type 1 or type 2 ) with increased depression scores ( > 22 on the German version of the Center for Epidemiological Studies Depression Scale ( CES-D ) ) will be included .


Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company .


The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression .


The study will include 260 participants , which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80 % and a significance level of p = 0.05 .


The primary outcome measure will be the level of depression as assessed by the CES-D .


The secondary outcome measures will be : diabetes-specific emotional distress , glycaemic control , self-management behaviour and the participants ' satisfaction with the intervention .


Online self-assessments will be collected at baseline and after a 2 months period , with additional follow-up measurements 6 and 12 months after randomisation .


The data will be analysed on an intention-to-treat basis and per protocol .


In addition , we will conduct an economic evaluation from a societal perspective .


If this intervention is shown to be cost-effective , it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes .


German Clinical Trial Register ( DRKS ) : DRKS00004748 .


Determine efficacy and safety of acetaminophen extended release ( ER ) 1300mg given three times daily compared to placebo for relieving signs and symptoms of hip or knee osteoarthritis .


Sixty investigators at 58 private , ambulatory , primary care sites in the US enrolled 542 outpatient adults 40 years old with moderate to severe idiopathic osteoarthritis pain into a randomized , placebo-controlled , double-blind 12 week clinical trial .


Patients were randomly assigned to treatment given three times daily of acetaminophen 1300mg ( n = 267 ) or placebo ( n = 275 ) .


The three primary endpoints measured through week 12 favored acetaminophen ER as follows : least squares ( LS ) mean change from baseline for WOMAC physical function subscale score was significantly greater for acetaminophen ER than for placebo ( P = 0.011 ) ; LS mean patient 's global assessment of response to therapy was significantly greater for acetaminophen ER than for placebo ( P = 0.010 ) ; and LS mean change from baseline for WOMAC pain subscale score was marginally greater for acetaminophen ER than for placebo ( P = 0.054 ) .


LS mean change from baseline for secondary endpoints through week 12 also favored acetaminophen ER compared with placebo : significantly for WOMAC stiffness subscale score ( P = 0.004 ) , significantly for WOMAC total index score ( P = 0.013 ) , and marginally for Nottingham Health Profile energy subscale score ( P = 0.057 ) .


The percentage of patients with any adverse event was similar for both treatment groups .


Hepatic transaminases exceeded 3ULN in seven acetaminophen ER patients and one placebo patient .


Elevations were attributed to health conditions in three of seven acetaminophen ER patients ; elevations in the remaining four patients returned to or toward normal .


Acetaminophen ER 1300mg , a nonprescription drug , given three times daily , can provide effective relief of signs and symptoms of osteoarthritis of the hip or knee and was well tolerated .


ClinicalTrials.gov registration number : NCT00240799 .


Hypotension is a common complication following spinal anesthesia for cesarean delivery .


Techniques to prevent hypotension include preloading intravenous fluid .


To compare the effect of two preloading regimens : 6 % hydroxyethyl starch ( HES ) and 9 saline solution , to prevent hypotension after spinal anesthesia in cesarean delivery .


105 patients undergoing intrathecal anesthesia for elective cesarean delivery were randomized and allocated to receive a preload of 500 ml HES 130/0 .4 ( HES Group ) or a preload of 1500 ml 9 saline solution ( CR group ) .


Blood pressure and heart rate were recorded at baseline and after spinal anesthesia ( every minute for the first 10 min , every 3 min for the next 10 min , and then every 5 min for the last 20 min ) .


The primary outcome was to compare the incidence of hypotension ( defined as a 20 % reduction in systolic arterial pressure from baseline ) between the two preloading regimens .


Vasopressor requirements ( i.v. bolus of 6 mg ephedrine ) were also compared .


The incidence of hypotension was 87 % in the CR group and 69 % in the HES group ( p = 0.028 ) .


Ephedrine requirement , incidence of nausea , and/or vomiting and neonatal outcome did not significantly differ between the two groups .


The incidence of hypotension was lower after preloading of 500 mL of HES 130/0 .4 than preloading with 1500 mL of 9 saline solution .


Osteoporosis and atherosclerosis are interconnected entities and share also some pathophysiological mechanisms .


Moreover , recent literature data have supported the hypothesis that bisphosphonates ( BPs ) may have some antiatherogenic actions .


This study aimed to evaluate the effects of one year with zoledronate or ibandronate given intravenously on lipid profile and on carotid artery intima-media thickness ( CA-IMT ) .


Sixty postmenopausal osteoporotic women ( mean age : 66.67.8 years ) were randomly assigned to 1-year treatment with zoledronate 5mg i.v. annually or ibandronate 3mg i.v. every 3 months .


In all patients at baseline and after 12months we measured CA-IMT , total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , 25-hydroxyvitamin D ( 25OHD ) , bone alkaline phosphatase ( B-ALP ) , type I collagen carboxy telopeptide ( CTX ) , osteocalcin ( OC ) , fibroblast growth factor 23 ( FGF-23 ) and sclerostin .


The osteoporotic women treated with zoledronate showed a greater reduction in CA-IMT than those treated with ibandronate .


HDL-C and HDL-C/LDL-C ratio showed a significant ( p < 0.01 ) increase in the 2 groups , whereas , LDL-C showed a reduction in the two groups which , however , reached statistical significance ( p < 0.05 ) only in the zoledronate group .


FGF-23 serum levels showed a similar and significant decrease in both the women treated with zoledronate and in those treated with ibandronate .


At the end of the study period sclerostin serum levels showed a higher increase in the patients treated with zoledronate than in those treated with ibandronate .


In osteoporotic women both zoledronate and ibandronate given intravenously resulted in an increase in HDL-C/LDL-C ratio and a reduction of CA-IMT which was significant only for zoledronate .


Further prospective studies are needed to clarify whether the change in FGF-23 and sclerostin levels is a marker or a potential mechanism of the action of BPs at a vascular level .


The current study was performed to report the long-term results of a trial comparing concurrent chemotherapy and radiotherapy ( CCRT ) with surgery and adjuvant radiotherapy ( RT ) in patients with stage III/IV nonmetastatic head and neck squamous cell carcinoma .


Patients with stage III/IV resectable head and neck squamous cell carcinoma were randomized to surgery followed by RT or CCRT .


The trial was halted prematurely due to poor accrual .


Human papillomavirus status was tested on archival material using polymerase chain reaction sequencing .


Of the total of 119 patients , 60 patients were randomized to primary surgery ( S arm ) and 59 patients were randomized to CCRT ( C arm ) .


Human papillomavirus status was tested in 75 patients , and only 3 were found to be positive .


The median follow-up for surviving patients was 13 years .


Analysis of the entire cohort demonstrated no statistically significant difference in overall survival and disease-specific survival ( DSS ) : 5-year rates were 45 % versus 35 % for overall survival ( P = .262 ) and 56 % versus 46 % for DSS ( P = .637 ) for the S arm and C arm , respectively .


Analysis by subsites indicated that this difference favoring the S arm was mainly driven by survival data among patients with cancers of the oral cavity and maxillary sinus .


For patients with oral cavity cancer , survival was significantly better in those who underwent primary surgery compared with CCRT ; the 5-year DSS rate was 68 % versus 12 % for the S arm and C arm , respectively ( P = .038 ) .


For patients with cancers of the maxillary sinus , the 5-year DSS rate was 71 % for patients on the S arm and 0 % for patients on the C arm ( P = .05 ) .


These long-term results demonstrate a significant advantage for primary surgery in patients with cancers of the oral cavity or maxillary sinus , providing strong support for primary surgery as the main modality of treatment for these subsites .


In other subsites , CCRT and surgery with adjuvant RT were found to demonstrate similar efficacy for survival in patients with advanced resectable tumors .


Liver disease is increasingly recognized in HIV-positive individuals , even among those without viral hepatitis , partly as a result of the recent availability of noninvasive methods of liver fibrosis assessment .


The objective of this substudy is to compare the effects of early versus deferred antiretroviral therapy ( ART ) on liver fibrosis progression .


Sites in the Strategic Timing of AntiRetroviral Treatment ( START ) study with access to FibroScan were invited to participate in the Liver Fibrosis Progression Substudy .


All substudy participants underwent FibroScan at baseline , and two noninvasive serum algorithms , APRI and FIB-4 , were calculated .


Demographic and liver-related information was collected for all START participants at baseline .


A total of 230 participants were enrolled in the substudy ( 11.5 % with hepatitis B or C virus coinfection ) , of whom 221 had a valid transient elastography ( TE ) result .


The median TE score was 4.9 kPa [ interquartile range ( IQR ) 4.3-6 .0 kPa ] .


Seventeen patients ( 7.8 % ) [ 95 % confidence interval ( CI ) 5.1-12 .1 % ] had a TE score of > 7.2 kPa , indicating significant liver fibrosis .


Baseline factors associated with higher TE scores in multivariate analysis were higher alanine aminotransferase ( ALT ) per 10 U/L ( P = 0.045 ) , higher log10 HIV RNA ( P < 0.001 ) and Hispanic/Latino ethnicity ( P = 0.01 ) .


TE correlated weakly with noninvasive markers .


At baseline , significant liver fibrosis was observed in approximately 8 % of participants , with higher ALT and HIV RNA the only clinical factors associated with increasing TE score .


TE will be used annually to monitor fibrosis and evaluate the role of ART in further fibrosis progression .


The study aim was to determine the effect of a dietary intervention on growth , body composition and resting energy expenditure ( REE ) in children with cystic fibrosis ( CF ) and pancreatic insufficiency ( PI ) in a randomized , double blind , placebo-controlled trial .


Subjects ( 5 to 17 yrs ) participated in a 12-month trial of the organized lipid matrix LYM-X-SORB ( LXS ) vs. placebo dietary supplements with similar calories , total fat and fatty acids .


Dietary intake was assessed using 3-day weighed food records .


Height ( HAZ ) , weight ( WAZ ) , BMI ( BMIZ ) , mid-upper arm muscle ( UAMAZ ) and fat area ( UAFAZ ) Z-scores were calculated .


Fat mass ( FM ) and fat-free mass ( FFM ) were obtained by whole body DXA .


REE ( kcal/d ) was evaluated by indirect calorimetry at baseline , 3 and 12 months and % REE calculated using Schofield equations .


No growth or REE differences were observed between LXS and placebo groups so data were pooled for analysis .


63 children ( 57 % males , age 10.6 2.9 yr , 43 % receiving LXS ) completed REE measurements .


Caloric intake increased from a median of 2502 [ 1478 , 4909 ] to 2616 [ 1660 , 4125 ] kcal/d at 12 months .


HAZ , WAZ and UAMAZ increased ( p < 0.05 ) over 12 months .


Mean REE was 109 8 % predicted at baseline and 107 9 % at 12 months ( p < 0.05 ) .


REE ( kcal/d ) adjusted for FFM and FM decreased over 12 months ( [ mean SE ] -31 12 kcals , p < 0.01 ) , significant only in males ( -49 16 kcals , p < 0.01 ) .


Over a 12 month nutrition intervention with either LXS or placebo , the growth status , muscle stores and REE improved .


Sustained increased energy intake improved energy metabolism , growth and nutritional status in school age children with CF , PI and mild lung disease .


In a randomized clinical trial , short - and long-term psychodynamic group psychotherapy ( STG and LTG , respectively ) schedules were equally effective for the ` typical ' patient during a 3-year study period .


Although several studies have reported good effects for patients with personality disorders ( PD ) in diverse forms of psychotherapy , the significance of treatment duration is unclear .


Therefore , we tested the hypothesis that PD patients would improve more during and after LTG than STG .


A randomized , longitudinal , prospective study contrasting the outcomes during and after short - and long-term dynamic group psychotherapies .


One hundred and sixty-seven outpatients with mood disorders , anxiety disorders , or PD were randomized to STG or LTG ( respectively , 20 or 80 weekly sessions of 90 min each ) .


Outcome measures are as follows : symptoms ( SCL-90-R ) , interpersonal problems ( IIP-C ) , and psychosocial functioning ( GAF split version : GAF-Symptom and GAF-Function ) .


PD pathology ( number of PD criteria items ) was selected a priori as a putative moderator of treatment effects .


Change during the 3-year study period was assessed using linear mixed models .


The study was registered at ClinicalTrials.gov as NCT 00021417 .


Our hypothesis was supported , as patients with PD improved significantly more regarding all outcome variables in LTG than STG .


For patients without PD , the rate of change was similar across 3 years ; however , the rate of change in symptoms and interpersonal problems was higher in STG during the first 6 months .


The effectiveness of LTG is higher for patients with co-morbid PD .


Patients without PD do not appear to experience additional gain from LTG .


Clinical implications : LTG demonstrates better effectiveness than STG for patients with personality disorder co-morbidity ( PD ) .


Patients without PD do not appear to experience additional gain from attending LTG .


Correct initial allocation to treatment duration may prevent disruptive breaks in relationships and lead to both human and economic cost savings .


Limitations : Trials on mixed diagnostic samples may limit the ability to fully assess change for specific diagnostic groups .


Therapists were unable to select patients and compose their own groups .


Although this condition might increase the generalizability of the results , it may also have restricted the therapists and the clinical situation inadvertently .


Because data on contrast-induced acute kidney injury ( CI-AKI ) in patients undergoing cardiac resynchronization therapy ( CRT-D ) are scarce , we aimed to assess the incidence , natural course and prognostic importance of this syndrome in CRT recipients .


Study population consisted of 100 consecutive patients enrolled into the Triple Site Versus Standard Cardiac Resynchronization ( TRUST CRT ) trial , who were treated with CRT-D .


Two patients were excluded up to 3 months after randomization and not analysed further .


CI-AKI was defined as a rise in serum creatinine of at least 26.5 mol/L ( 0.3 mg/dL ) within 48 h after contrast exposure , or at least 50 % increase from the baseline value during index hospital stay with CRT-D implantation according to KDIGO Clinical Practice Guideline for Acute Kidney Injury .


Among 98 subjects of TRUST CRT trial , 10 patients ( 10.2 % ) developed CI-AKI after CRT-D implantation .


In patients with glomerular filtration rate ( GFR ) < 60 mL/min/1 .73 m ( 2 ) on admission , the incidence of CI-AKI was almost twofold ( 15.4 % ) higher than in subjects with GFR 60 ( 8.3 % ) .


CRT-D recipients with CI-AKI had significantly higher mortality rate ( 50.0 % ) compared to those without CI-AKI ( 17.0 % ) during 30 months of follow-up ( logrank p = 0.012 ) .


Multivariate Cox regression analysis showed CI-AKI as significant and independent risk factor for death in CRT-D recipients ( hazard ratio 5.71 ; 95 % CI 5.16-6 .26 ; p = 0.001 ) .


Contrast-induced acute kidney injury is a serious and frequent procedural complication of CRT-D implantation with a significant negative influence on long-term survival .


The results suggest that clinical evaluation regarding renal function should be considered in CRT-D recipients , both before and after device implantation .


Previous analyses showed that a telephone-based intervention to increase physical activity in individuals with multiple sclerosis ( MS ) and depression resulted in significantly improved depressive symptoms compared to a wait-list control group .


The aim of this study was to test positive affect and negative affect as mediators of the effect of the physical activity counseling on depressive symptoms .


Ninety-two adults with MS , who met diagnostic criteria for either major depression or dysthymia and who reported low levels of physical activity , were randomized 1:1 to a 12-week telephone-based motivational interviewing ( MI ) intervention to improve physical activity ( n = 44 ) or to a 12-week wait-list control group ( n = 48 ) .


Self-reported positive and negative affect , physical activity , and depressive symptoms were gathered at baseline and postintervention .


Path-analysis was used to test whether positive affect and negative affect mediated the positive effects of the intervention on depressive symptoms .


Both positive and negative affect were significant mediators of the effects of the intervention on depressive symptoms ; however , only positive affect mediated the association between changes in physical activity and improved depressive symptoms .


Findings support physical activity and positive affect as key mediators of the MI treatment effect on improved mood .


Decreases in negative affect were also evident in the treatment group , but were not related to improved physical activity .


Findings may suggest the use of exercise-based interventions in conjunction with treatments that specifically target negative affective mechanisms for depression .


Treatment with folic acid and vitamin B12 appears capable of reducing total plasma homocysteine levels ( tHcy ) , but it is unknown whether vitamin B12 alone reduces tHcy values .


In this study we investigate the effects of alternate vitamins supplementation on homocysteine levels in patients treated by diffusive and convective dialysis techniques .


74 patients were randomized blindly into two groups of 37 subjects each .


The first group was treated initially with vitamin B12 for 2 months and with folic acid for the following 2 months .


The second group was treated initially with folic acid .


A wash out period of 2 months followed the treatment in both groups .


Total homocysteine levels decreased in both groups following the alternate vitamins therapy and dialysis , without significant difference between diffusive and convective techniques .


Surprisingly , after the wash-out period , tHcy increased remarkably , regardless of the dialysis procedure used .


At the end of the study , folate levels showed a higher reduction with haemodialysis compared to haemodiafiltration .


In contrast , vitamin B12 levels showed a significant increase using diffusive haemodialysis , confirming a decisive role of membrane performance .


In conclusion we show for the first time that , even if total homocysteine levels decreased in both dialysis procedures , the convective techniques demonstrate a superior capacity on the reduction of tHcy levels compared to the diffusive method .


Moreover , the lower depletion of vitamin B12 by diffusive techniques could determine a higher reduction of folate levels , demonstrating the decisive role of the membrane performance in the treatment of this patients .


Turning is a common activity for older people , and is one of the activities commonly associated with falls during walking .


Falls that occur while walking and turning have also been associated with an increased risk of hip fracture in older people .


Despite the importance of stability during turning , there has been little focus on identifying this impairment in at risk older people , or in evaluating interventions aiming to improve this outcome .


This study will evaluate the effectiveness of a 16 week tailored home based exercise program in older adults aged ( 50 years and above ) who were identified as having unsteadiness during turning .


A single blind randomized controlled trial will be conducted , with assessors blind to group allocation .


Study participants will be aged 50 years and above , living in the community and have been identified as having impaired turning ability [ outside of age and gender normal limits on the Step Quick Turn ( 180 degree turn ) task on the Neurocom Balance Master with long plate ] .


After a comprehensive baseline assessment , those classified as having balance impairment while turning will be randomized to intervention or control group .


The intervention group will receive a 16 week individualized balance and strength home exercise program , based on the Otago Exercise Program with additional exercises focused on improving turning ability .


Intervention group will attend four visit to the assessment centre over 16 weeks period , for provision , monitoring , modification of the exercise and encourage ongoing participation .


Participants in the control group will continue with their usual activities .


All participants will be re-assessed on completion of the 16 week program .


Primary outcome measures will be the Step Quick Turn Test and Timed-Up and Go test .


Secondary outcomes will include other clinical measures of balance , psychological aspects of falls , incidence of falls and falls risk factors .


Results of this study will provide useful information for clinicians on the types of exercises to improve turning ability in older people with increased falls risk and the effectiveness of these exercises in improving outcomes .


ACTRN12613000855729 .


Trauma such as hip fracture initiates a neurohumoral stress response that changes the balance between anabolism and catabolism resulting in muscle breakdown and reduced mobilisation .


Various studies have demonstrated a reduction in catabolism with pre-operative carbohydrate loading but only in an elective setting .


This is a two-centre , randomised double-blinded trial in the United Kingdom .


Sample size will be 30 patients ( approximately 15 from each centre ) .


Randomisation will be web based using computer-generated concealed tables .


Both participants and investigators will be blinded to group allocation .


Participants will be > 70 years of age , cognitively intact ( Abbreviated Mental Score 7 ) , able to give informed consent , and admitted directly through the emergency department with fractured neck of femur requiring hemiarthroplasty .


Intervention will consist of two carbohydrate drinks ( Nutricia pre-Op ) given the night before , and the morning of the surgery .


The control will receive two placebo drinks of equal volume .


All participants will receive standard hospital care at the discretion of the clinical team .


The primary outcome is the difference between groups in insulin resistance calculated by a glucose tolerance test administered pre-operatively and 24 hours postoperatively .


Secondary endpoints will be changes in muscle carbohydrate metabolism ( biopsy ) , mobility ( Cumulative Ambulation Score ) and subjective measures of tolerability .


This is a small-scale pilot study , investigating the benefits and tolerability of carbohydrate loading in an emergency setting in a frail elderly group with known high morbidity and mortality .


Positive findings will provide the basis for a larger scale study .


Current Controlled Trials ISRCTN91109766 ( 7 April 2014 ) ; NRES ref : 13/EM/0214Trial Sponsor : University of Nottingham Ref .13036 .


This study examined the effects of a cardiac rehabilitation ( CR ) program on functional capacity and health status ( HS ) in patients with newly implanted left ventricular assist devices ( LVADs ) .


Reduced functional capacity and HS are independent predictors of mortality in patients with heart failure .


CR improves both , and is related to improved outcomes in patients with heart failure ; however , there is a paucity of data that describe the effects of CR in patients with LVADs .


Enrolled subjects ( n = 26 ; 7 women ; age 55 13 years ; ejection fraction 21 8 % ) completed a symptom-limited cardiopulmonary exercise test , the Kansas City Cardiomyopathy Questionnaire ( KCCQ ) , a 6-min walk test ( 6MW ) , and single-leg isokinetic strength test before 2:1 randomization to CR versus usual care .


Subjects in the CR group underwent 18 visits of aerobic exercise at 60 % to 80 % of heart rate reserve .


Within-group changes from baseline to follow-up were analyzed with a paired t-test , whereas an independent t-test was used to determine differences in the change between groups .


Within-group improvements were observed in the CR group for peak oxygen uptake ( 10 % ) , treadmill time ( 3.1 min ) , KCCQ score ( 14.4 points ) , 6MW distance ( 52.3 m ) , and leg strength ( 17 % ) .


Significant differences among groups were observed for KCCQ , leg strength , and total treadmill time .


Indicators of functional capacity and HS are improved in patients with continuous-flow LVADs who attend CR .


Future trials should examine the mechanisms responsible for these improvements , and if such improvements translate into improved clinical outcomes .


( Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices : Rehab VAD Trial [ RehabVAD ] ; NCT01584895 ) .


Postoperative pain is one of the most important problems that confront surgical patients .


The aim of this work is to compare pain control using intravenous patient controlled analgesia ( PCA ) and patient controlled epidural analgesia ( PCEA ) in cirrhotic patients undergoing elective hepatic resection .


Thirty four adult patients ASAI and II scheduled for liver resection were randomly allocated into two groups-Group ( P ) with I.V ( PCA ) with fentanyl and Group ( E ) ( PCEA ) via epidural catheter using Bubivacaine 0.125 % plus 2 microgram per ml fentanyl .


Coagulation changes were followed and pain score was compared in both groups .


34 child A cirrhotic patients , undergoing liver resection were studied .


The demographic data were comparable in both groups .


There was a significant decrease in pain score in both groups during the follow up period when compared to their initial score .


When comparing average pain score between both groups , the PCEA group had significantly lower values .


The changes in prothrombin time ( PT ) , INR , and hemoglobin ( Hb ) , were significant all over the follow up period compared to their corresponding base line values .


2 cases needed FFP to normalize the INR for epidural removal .


There was no significant difference regarding postoperative nausea and vomiting ( PONV ) in both groups , no clinical manifestation suggesting epidural hematoma , and no cases were recorded to have respiratory depression .


There were no significant differences in patient satisfaction and ICU stay .


The two modalities of pain control seems to be nearly equivalent , but considering the risk of epidural catheter insertion and removal in cirrhotic patients who are further exposed to hepatectomy with subsequent additional coagulopathy , it may be wise to consider IVPCA technique as a policy for pain management in cirrhotic patient undergoing hepatectomy .


We studied the response to high doses of egg yolk containing antisecretory factor ( B221 , Salovum ) in young children with acute diarrhoea , presenting to the Children 's Hospital , Lahore , Pakistan .


In a randomised , placebo-controlled trial , 36 children aged 7 to 60 months with acute diarrhoea of unknown aetiology , with mild-to-moderate dehydration , were randomised to the Salovum or placebo groups .


Initially , 16 grams of Salovum or ordinary egg yolk ( placebo ) mixed in oral rehydration salts was given , followed by 8 g every 5 h until recovery .


The number and consistency of stools were recorded .


The two groups were comparable in age , gender , duration of diarrhoea , hydration and nutritional status , although the proportion with watery stools was higher in the Salovum group ( p = 0.04 ) .


Reduction in the frequency of stools was seen at 7 versus 18 h ( p < 0.0001 ) and normalising of stool consistency was 10 versus 18 h , p < 0.03 ) in the Salovum and placebo groups .


The overall effect was 35 versus 70 h in the two groups ( p = 0.001 ) .


No side effects were reported .


High doses of AF in the form of Salovum effectively and safely reduce childhood diarrhoea of a likely broad aetiology .


An anabolic state can be achieved upon intravenous amino acid administration during the immediate postnatal phase despite a low energy intake .


The optimal dosing of amino acid and energy intake has yet to be established .


The aim was to quantify the efficacy of early initiation of parenteral lipids and increased amounts of amino acids on metabolism and protein accretion in very low birth weight infants .


28 very low birth weight infants were randomized to receive parenteral nutrition with glucose and either 2.4 gamino acids / ( kgd ) ( control group ) , 2.4 gamino acids / ( kgd ) plus 2-3glipid / ( kgd ) ( AA + lipid group ) , or 3.6 gamino acids / ( kgd ) plus 2-3glipid / ( kgd ) ( high AA + lipid group ) from birth onward .


On postnatal day 2 , we performed a stable isotope study with [ 1 - ( 13 ) C ] phenylalanine , [ ring-D4 ] tyrosine , [ U - ( 13 ) C6 , ( 15 ) N ] leucine , and [ methyl-D3 ] - ketoisocaproic acid to quantify intermediate amino acid metabolism .


The addition of lipids only had no effect on phenylalanine metabolism , whereas the addition of both lipids and additional amino acids increased the amount of phenylalanine used for protein synthesis .


In addition , high amino acid intake significantly increased the rate of hydroxylation of phenylalanine to tyrosine , increasing the availability of tyrosine for protein synthesis .


However , it also increased urea concentrations .


Increasing energy intake from 40 to 60kcal / ( kgd ) did not increase protein efficiency as measured by phenylalanine kinetics .


The leucine data were difficult to interpret due to the wide range of results and inconsistency in the data between the phenylalanine and leucine models .


High amino acid and energy intakes from birth onwards result in a more anabolic state in very low birth weight infants , but at the expense of higher urea concentrations , which reflects a higher amino acid oxidation .


Long-term outcome data should reveal whether this policy deserves routine implementation .


This trial was registered at www.trialregister.nl , trial number NTR1445 , name Nutritional Intervention for Preterm Infants-2 .


To characterize the postprandial nutrient profiles of exercise-conditioned dogs fed a supplemental carbohydrate and protein bar with or without astaxanthin from Haematococcus pluvialis immediately after exercise .


34 exercise-conditioned adult Husky-Pointer dogs .


The study had 2 phases .


During phase 1 , postprandial plasma glucose concentration was determined for dogs fed a bar containing 25 % protein and 18.5 % or 37.4 % maltodextrin plus dextrin ( rapidly digestible carbohydrate ; RDC ) , or dry kibble ( 30 % protein and 0 % RDC ) immediately after exercise .


During phase 2 , dogs were exercised for 3 days and fed a bar ( 25 % protein and 37.4 % RDC ) with ( CPA ; n = 8 ) or without ( CP ; 8 ) astaxanthin or no bar ( control ; 8 ) immediately after exercise .


Pre - and postexercise concentrations of plasma biochemical analytes and serum amino acids were determined on days 1 and 3 .


Phase 1 postexercise glucose concentration was increased when dogs were provided the 37.4 % RDC bar , but not 0 % or 18.5 % RDC .


On day 3 of phase 2 , the CPA group had the highest pre-exercise triglyceride concentration and significantly less decline in postexercise glucose concentration than did the CP and control groups .


Mean glucose concentration for the CP and CPA groups was significantly higher than that for the control group between 15 and 60 minutes after bar consumption .


Compared to immediately after exercise , branched-chain amino acid , tryptophan , leucine , and threonine concentrations 15 minutes after exercise were significantly higher for the CP and CPA groups , but were lower for the control group .


Dogs fed a bar with 37.4 % RDCs and 25 % protein immediately after exercise had increased blood nutrient concentrations for glycogen and protein synthesis , compared with control dogs .


Anger and aggression among adults with intellectual disability ( ID ) are associated with a range of adverse consequences for their well-being and that of their family or staff carers .


The aims were to evaluate the effectiveness of an anger management intervention for adults with mild to moderate ID and to evaluate the costs of the intervention and its impact on health and social care resource use .


This paper is concerned with the latter aim .


A cluster-randomised controlled trial was conducted involving day services for adults with ID in Scotland , England and Wales .


Incremental costs of delivering the intervention and its impact on subsequent total health and social care package costs were calculated .


Full data comparing costs between baseline and follow-up 10 months later were collected for 67 participants in the intervention arm and 62 participants in the control arm .


Cost differences between the groups at follow-up , adjusted for baseline levels , were calculated using non-parametric bootstrapping controlling for clustering .


The mean hourly excess cost of intervention over treatment as usual was 12.34 .


A mean adjusted cost difference of 22.46 per person per week in favour of the intervention group was found but this was not statistically significant .


The baseline-adjusted cost difference at follow-up would result in a fairly immediate compensation for the excess costs of intervention , provided the difference is not a statistical artefact .


Further research is needed to clarify the extent to which it might represent a real saving in service support costs .


Data on risk associated with 24-hour ambulatory diastolic ( DBP24 ) versus systolic ( SBP24 ) blood pressure are scarce .


We recorded 24-hour blood pressure and health outcomes in 8341 untreated people ( mean age , 50.8 years ; 46.6 % women ) randomly recruited from 12 populations .


We computed hazard ratios ( HRs ) using multivariable-adjusted Cox regression .


Over 11.2 years ( median ) , 927 ( 11.1 % ) participants died , 356 ( 4.3 % ) from cardiovascular causes , and 744 ( 8.9 % ) experienced a fatal or nonfatal cardiovascular event .


Isolated diastolic hypertension ( DBP2480 mmHg ) did not increase the risk of total mortality , cardiovascular mortality , or stroke ( HRs1 .54 ; P0 .18 ) , but was associated with a higher risk of fatal combined with nonfatal cardiovascular , cardiac , or coronary events ( HRs1 .75 ; P0 .0054 ) .


Isolated systolic hypertension ( SBP24130 mmHg ) and mixed diastolic plus systolic hypertension were associated with increased risks of all aforementioned end points ( P0 .0012 ) .


Below age 50 , DBP24 was the main driver of risk , reaching significance for total ( HR for 1-SD increase , 2.05 ; P = 0.0039 ) and cardiovascular mortality ( HR , 4.07 ; P = 0.0032 ) and for all cardiovascular end points combined ( HR , 1.74 ; P = 0.039 ) with a nonsignificant contribution of SBP24 ( HR0 .92 ; P0 .068 ) ; above age 50 , SBP24 predicted all end points ( HR1 .19 ; P0 .0002 ) with a nonsignificant contribution of DBP24 ( 0.96 HR1 .14 ; P0 .10 ) .


The interactions of age with SBP24 and DBP24 were significant for all cardiovascular and coronary events ( P0 .043 ) .


The risks conferred by DBP24 and SBP24 are age dependent .


DBP24 and isolated diastolic hypertension drive coronary complications below age 50 , whereas above age 50 SBP24 and isolated systolic and mixed hypertension are the predominant risk factors .


To evaluate efficacy and safety of subcutaneous ( SC ) and intravenous ( IV ) abatacept and background methotrexate ( MTX ) in Japanese patients with rheumatoid arthritis ( RA ) and inadequate response to MTX ( MTX-IR ) .


Double-dummy , double-blind study ( NCT01001832 ) ; 118 adults with 10 swollen joints , 12 tender joints and C-reactive protein ( CRP ) 0.8 mg/dL randomized 1:1 to SC abatacept ( 125 mg weekly ) with IV loading ( 10 mg/kg on Day 1 ) , or IV abatacept ( 10 mg/kg monthly ) for 169 days , both also receiving MTX ( 6-8 mg/week ) .


Primary endpoint was Day 169 American College of Rheumatology ( ACR ) 20 response ; other efficacy endpoints , safety and immunogenicity were assessed .


Similar proportions of patients achieved ACR20 responses at Day 169 with SC ( 91.5 % [ 95 % CI 81.3 , 97.2 ] ) and IV abatacept ( 83.1 % [ 71.0 , 91.6 ] ) .


ACR50/70 responses , adjusted mean changes from baseline in Health Assessment Questionnaire-Disability Index scores and remission rates ( 28-joint Disease Activity Score [ CRP ] < 2.6 ) were also comparable between groups .


Serious adverse event frequencies ( 5.1 % vs. 3.4 % ) were similar with both formulations .


One patient per group tested seropositive for immunogenicity .


Weekly SC abatacept dosing achieved mean serum concentrations > 10 g/mL ( minimum therapeutic target ) .


SC abatacept demonstrated comparable efficacy and safety to IV abatacept , with low immunogenicity rates , in MTX-IR Japanese patients with RA .


To measure the change in the minimum alveolar concentration of isoflurane ( EtISO ) associated with epidural nalbuphine and the postoperative analgesic requirements in dogs after ovariohysterectomy .


Twenty four healthy female dogs were randomly assigned to receive saline or nalbuphine at 0.3 or 0.6 mg/kg ( n = 8 for each group ) administered via lumbosacral epidural catheter introduced cranially into the epidural canal .


Changes in heart and respiratory rates and arterial blood pressure during surgery were recorded along with the corresponding EtISO .


Immediately after tracheal extubation , analgesia , sedation , heart rate , respiratory rate , and arterial blood pressure were measured at predetermined intervals and every 60 min thereafter until the first rescue analgesic .