In a randomized , double blind , parallel groups design participants received either placebo ( 0mg/day ; n = 16 ) , modafinil ( 200mg/day ; n = 16 ) , escitalopram ( 20mg/day ; n = 17 ) , or modafinil + escitalopram ( 200 +20 mg/day ; n = 15 ) for 5 days .


On day 5 , during separate sessions participants received an intravenous sample of cocaine ( 0 or 20mg ; randomized ) and five $ 1 bills .


Participants rated the subjective effects of the infusions and subsequently made choices to either return $ 1 and receive another infusion or keep $ 1 and receive no infusion .


Compared to saline , cocaine ( 20mg ) significantly ( p0 .008 ) increased most ratings , including `` good effects '' , `` stimulated '' , and `` high '' .


Relative to placebo , modafinil significantly ( p0 .007 ) attenuated subject-rated increases of `` any drug effect '' , `` high '' , `` good effects '' , and `` stimulated '' produced by cocaine .


Compared to saline , participants chose cocaine infusions significantly more ; however , no treatment significantly reduced choices for cocaine infusions .


Escitalopram did not enhance the efficacy of modafinil to reduce any measure .


Modafinil attenuated many positive subjective effects produced by cocaine ; however , escitalopram combined with modafinil did not enhance the efficacy of modafinil to reduce cocaine effects .


To compare polypropylene suture and skin staples for securing mesh in Lichtenstein inguinal hernioplasty in terms of mean operating time and postoperative pain .


Randomized clinical trial .


Surgical Ward , Combined Military Hospital , Kharian , from August 2011 to February 2012 .


All individuals fulfilling inclusion criteria underwent elective Lichtenstein inguinal hernioplasty as admitted patients , under spinal anaesthesia and with aseptic measures .


In group 1 , during the operation , mesh fixation was done with 2/0 polypropylene suture and skin was closed with subcuticular 2/0 polypropylene suture whereas in group 2 , the anchorage of mesh was done with skin staples and skin was closed with staples from the same stapler .


Mean operative time and postoperative pain , assessed on a visual analog score , were compared between the groups .


The overall postoperative pain was lower ( p = 0.026 ) when staples were used to anchor mesh .


Moreover , operative time was also lower ( 37.42 2.69 minutes ) in staple group versus ( 42.44 2.55 minutes in polypropylene group ) .


Mean operating time and postoperative pain is less in securing mesh with skin staples as compared to polypropylene suture in Lichtenstein inguinal hernioplasty .


Endoscopic sphincterotomy ( ES ) is one of the most important advances in the treatment of common bile duct ( CBD ) stones .


However , the use of ES to remove CBD stones in high-risk patients without cholecystectomy is still debatable .


The aim of this study was to compare the efficacy of a wait-and-see policy versus cholecystectomy after ES for CBD stones in high-risk patients with co-existing cholelithiasis .


A total of 162 patients after undergoing ES with the clearance of CBD stones were randomised after informed consent to cholecystectomy or conservative management of their gallbladder stones .


The results indicated that cholecystectomy after ES for CBD stones significantly reduced the biliary complications in high-risk patients .


Every patient who has both CBD stones and gallstones with significant co-morbid illnesses , after clearance of CBD stones by ES , should undergo early cholecystectomy .


Parenterally administered ascorbic acid modulates sepsis-induced inflammation and coagulation in experimental animal models .


The objective of this randomized , double-blind , placebo-controlled , phase I trial was to determine the safety of intravenously infused ascorbic acid in patients with severe sepsis .


Twenty-four patients with severe sepsis in the medical intensive care unit were randomized 1:1:1 to receive intravenous infusions every six hours for four days of ascorbic acid : Lo-AscA ( 50 mg/kg/24 h , n = 8 ) , or Hi-AscA ( 200 mg/kg/24 h , n = 8 ) , or Placebo ( 5 % dextrose/water , n = 8 ) .


The primary end points were ascorbic acid safety and tolerability , assessed as treatment-related adverse-event frequency and severity .


Patients were monitored for worsened arterial hypotension , tachycardia , hypernatremia , and nausea or vomiting .


In addition Sequential Organ Failure Assessment ( SOFA ) scores and plasma levels of ascorbic acid , C-reactive protein , procalcitonin , and thrombomodulin were monitored .


Mean plasma ascorbic acid levels at entry for the entire cohort were 17.9 2.4 M ( normal range 50-70 M ) .


Ascorbic acid infusion rapidly and significantly increased plasma ascorbic acid levels .


No adverse safety events were observed in ascorbic acid-infused patients .


Patients receiving ascorbic acid exhibited prompt reductions in SOFA scores while placebo patients exhibited no such reduction .


Ascorbic acid significantly reduced the proinflammatory biomarkers C-reactive protein and procalcitonin .


Unlike placebo patients , thrombomodulin in ascorbic acid infused patients exhibited no significant rise , suggesting attenuation of vascular endothelial injury .


Intravenous ascorbic acid infusion was safe and well tolerated in this study and may positively impact the extent of multiple organ failure and biomarkers of inflammation and endothelial injury .


ClinicalTrials.gov identifier NCT01434121 .


We sought to test the hypothesis that plasma galectin 3 ( Gal-3 ) is positively associated with the risk of heart failure ( HF ) in male subjects .


While Gal-3 has been reported as prognostic factor in HF patients , limited data are available on the role of Gal-3 in the development of HF .


We used a prospective nested-case control study ( n = 462 cases and 462 controls ) within the Physicians ' Health Study for current analyses .


For each case of HF , we randomly selected one control among subjects that were alive and free of HF at the time of index case occurrence and matched on age , race , and time of blood collection .


Gal-3 was measured using ELISA and we used conditional logistic regression to compute adjusted odds ratios .


Mean age at baseline was 58.3 y and median log-Gal-3 was 1.50 ( IQR : 1.20-1 .73 ) ng/ml .


Cubic splines suggested a non-linear relation between Gal-3 and HF .


Odds ratios ( 95 % CI ) for HF were 1.0 ( ref ) , 0.89 ( 0.58-1 .38 ) , 1.08 ( 0.71-1 .67 ) , and 1.57 ( 1.03-2 .39 ) across consecutive quartiles of Gal-3 after adjustment for body mass index , diabetes , atrial fibrillation , hypertension , C-reactive protein , alcohol , smoking , and exercise .


The Gal-3-HF relation was seen for HF with and without antecedent coronary heart disease .


Our data are consistent with a positive non-linear association between Gal-3 and HF risk in male subjects .


Acetaminophen administration for more than 4 days causes aminotransferase elevation in some subjects .


The objective of this randomized , placebo-controlled trial is to describe the course of alanine aminotransferase ( ALT ) elevation in subjects administered 4 g/day of acetaminophen for at least 16 days .


A randomized , placebo controlled trial of acetaminophen ( 4 g/day ) vs placebo .


Subjects were healthy volunteers with normal liver enzymes .


The primary outcome was the course of ALT during acetaminophen administration .


All subjects were treated for a minimum of 16 days .


Subjects with ALT elevation at day 16 were continued on treatment until these elevations resolved up to a maximum of 40 days .


Subjects were also evaluated for elevation of INR or serum bilirubin as evidence of hepatic dysfunction .


157/205 ( 77 % ) completed acetaminophen subjects had no ALT elevation or transient elevations that resolved by day 16 .


Of the 48 subjects who had ALT elevations at study day 16 , 47 continued on acetaminophen and had resolution by study day 40 .


One acetaminophen subject did not have resolution by study day 40 , and the course of aminotransferase elevation suggests an alternative cause .


One placebo subject had an ALT elevation at day 16 that resolved by day 22 .


The highest observed ALT among all acetaminophen subjects was 191 IU/L .


The mean ALT at day 16 was 4.4 IU/L higher for the acetaminophen than for the placebo group .


No subject developed liver dysfunction .


A minority of subjects treated with 4 g/day of acetaminophen for 16 days will have low-grade aminotransferase elevations that are not accompanied by liver dysfunction and resolve if administration is continued .


Clintrials.gov NCT00743093 registered August 26 , 2008 .


The aim of the present study was to evaluate the effect of oral caffeine ingestion during repeated sets of resistance .


Fourteen moderately resistance-trained men ( 20.9 0.36 years and 77.62 2.07 kg of body weight ) ingested a dose of caffeine ( 5 mg.kg-1 ) or placebo prior to 3 sets of bench press and 3 sets of leg press exercises , respectively .


The study used a double-blind , counterbalanced , crossover design .


Repetitions completed and total weight lifted were recorded in each set .


Readiness to invest in both physical ( RTIPE ) and mental ( RTIME ) effort were assessed prior each set , and rating of perceived exertion ( RPE ) was recorded after each set .


Rest and peak heart rates were determined via telemetry .


Caffeine ingestion result in increased number of repetitions to failure in bench press ( F [ 1,13 ] = 6.16 , P = 0.027 ) and leg press ( F [ 1,13 ] = 9.33 , P = 0.009 ) compared to placebo .


The sum of repetitions performed in the 3 sets was 11.60 % higher in bench press ( 26.86 1.74 ; caffeine : 30.00 1.87 ; P = 0.027 ) and 19.10 % in leg press ( placebo : 40.0 4.22 ; caffeine : 47.64 4.69 ; P = 0.009 ) .


Also , RTIME was increased in the caffeine condition both in bench press ( F [ 1,13 ] = 7.02 , P = 0.02 ) and in leg press ( F [ 1,13 ] = 5.41 , P = 0.03 ) .


There were no differences in RPE , RTIPE and HR ( P > 0.05 ) across conditions .


Acute caffeine ingestion can improve performance in repeated sets to failure and increase RTIME in resistance-trained men .


Little evidence is available for the effect of nebulised magnesium sulphate ( MgSO ( 4 ) ) in acute asthma in children .


We assessed the effect of MgSO ( 4 ) treatment in children with severe acute asthma .


In this randomised placebo-controlled , multi-centre , parallel trial , we enrolled children ( aged 2-16 years ) with severe acute asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK .


Children were randomly allocated ( 1:1 ) to receive nebulised salbutamol and ipratropium bromide with either 25 mL of isotonic MgSO ( 4 ) ( 250 mmol/L ; 151 mg per dose ; MgSO ( 4 ) group ) or 25 mL of isotonic saline ( placebo group ) on three occasions at 20-min intervals .


Randomisation was done with a computer-generated randomisation sequence , with random block sizes of two to four .


Both patients and researchers were masked to treatment allocation .


The primary outcome measure was the Yung Asthma Severity Score ( ASS ) at 60 min post-randomisation .


We used a statistical significance level of p < 005 for a between-group difference , but regarded a between-group difference in ASS of 05 as the minimal clinically significant treatment effect .


Analysis was done by intention to treat .


This trial is registered with controlled-trials .


com , number ISRCTN81456894 .


Between Jan 3 , 2009 , and March 20 , 2011 , we recruited and randomly assigned 508 children to treatment : 252 to MgSO ( 4 ) and 256 to placebo .


Mean ASS at 60 min was lower in the MgSO ( 4 ) group ( 472 [ SD 137 ] ) than it was in the placebo group ( 495 [ SD 140 ] ; adjusted difference -025 , 95 % CI -048 to -002 ; p = 003 ) .


This difference , however , was not clinically significant .


The clinical effect was larger in children with more severe asthma exacerbation ( p = 003 ) and those with symptoms present for less than 6 h ( p = 0049 ) .


We detected no difference in the occurrence of adverse events between groups .


Overall , nebulised isotonic MgSO ( 4 ) , given as an adjuvant to standard treatment , did not show a clinically significant improvement in mean ASS in children with acute severe asthma .


However , the greatest clinical response was seen in children with more severe attacks ( SaO ( 2 ) < 92 % ) at presentation and those with preceding symptoms lasting less than 6 h.


National Institute for Health Research Health Technology Assessment Programme .


To compare the efficacy and patient comfort of a new mode of minute ventilation-targeted adaptive servoventilation ( ASVAuto ) with auto-titrating expiratory positive airway pressure ( EPAP ) versus bilevel with back-up respiratory rate ( bilevel-ST ) in patients with central sleep apnea ( CSA ) associated with chronic use of opioid medications .


Prospective , randomized , crossover polysomnography ( PSG ) study .


Eighteen consecutive patients ( age 18 years ) who had been receiving opioid therapy ( 6 months ) , and had sleep disordered breathing with CSA ( central apnea index [ CAI ] 5 ) diagnosed during an overnight sleep study or positive airway pressure ( PAP ) titration were enrolled to undergo 2 PSG studies-one with ASVAuto and one with bilevel-ST .


Patients completed 2 questionnaires after each PSG ; Morning After Patient Satisfaction Questionnaire and PAP Comfort Questionnaire .


Patients had a mean age of 52.9 15.3 years .


PSG prior to randomization showed an apnea hypopnea index ( AHI ) of 50.3 22.2 and CAI of 13.0 18.7 .


Titration with ASVAuto versus bilevel-ST showed that there were significant differences with respect to AHI and CAI .


The AHI and CAI were significantly lower on ASVAuto than bilevel-ST ( 2.5 3.5 versus 16.3 20.9 [ p = 0.0005 ] , and 0.4 0.8 versus 9.4 18.8 [ p = 0.0002 ] , respectively ) .


Respiratory parameters were normalized in 83.3 % of patients on ASVAuto versus 33.3 % on bilevel-ST .


Patients felt more awake and alert on ASVAuto than bilevel-ST based on scores from Morning After Patient Satisfaction Questionnaire ( p = 0.0337 ) .


The ASVAuto was significantly more effective than bilevel-ST for the treatment of CSA associated with chronic opioid use .


Dementia affects over 4 million people in the US and is frequently unrecognized and underdiagnosed in primary care .


Routine dementia screening in primary care is not recommended by the US Preventive Services Task Force due to lack of empirical data on the benefits and harms of screening .


This trial seeks to fill this gap and contribute information about the benefits , harms , and costs of routine screening for dementia in primary care .


Single-blinded , parallel , randomized controlled clinical trial with 1:1 allocation .


A total of 4,000 individuals aged 65 years without a diagnosis of dementia , cognitive impairment , or serious mental illness receiving care at primary care practices within two cities in Indiana .


Subjects will be randomized to either i ) screening for dementia using the Memory Impairment Screen Telephone version or ii ) no screening for dementia .


Subjects who screen positive for dementia will be referred to the local Aging Brain Care program that delivers an evidence-based collaborative care model for dementia and depression .


Research assistants will administer the 15-item Health Utility Index , Patient Health Questionnaire , Generalized Anxiety Disorder Scale , and Medical Outcomes Study at baseline , 1 , 6 , and 12 months .


Information about advanced care planning will be collected at baseline and 12 months .


All enrollees ' medical records will be reviewed to collect data on health care utilization and costs .


We have two primary hypotheses ; first , in comparison to non-screened subjects , those who are screened and referred to a dementia collaborative care program will have a higher health-related quality of life as measured by the Health Utility Index at 12 months post-screening .


Second , in comparison to non-screened subjects , those who are screened and referred to a dementia collaborative care program will not have higher depression or anxiety at one month post-screening as measured by the Patient Health Questionnaire and Generalized Anxiety Disorder Scale scales .


Our secondary hypothesis is that screened subjects will have an Incremental Cost-Effectiveness Ratio below the maximum acceptable threshold of $ 60,000 per quality adjusted life year saved at 12 months .


Ongoing ; registered on September 19 , 2012 .


ClinicalTrials.gov Identifier : 2012 NCT01699503 .


To evaluate the differences in extubation times in a group of cardiac surgical patients who were anesthetized and sedated with either IV propofol or inhaled volatile anesthetic agents .


This was a prospective randomized controlled trial performed between September 2009 and August 2011 .


Cardiovascular ICU within a tertiary referral university-affiliated teaching hospital .


One hundred forty-one patients undergoing coronary artery bypass graft surgery with normal or mildly reduced left ventricular systolic function .


Participants were randomly assigned to receive anesthesia and postoperative sedation using IV propofol ( n = 74 ) or inhaled volatile ( isoflurane or sevoflurane ) anesthetic agent ( n = 67 ) .


Patients sedated using inhaled volatile agent displayed faster readiness to extubation time at 135 minutes ( 95-200 min ) compared with those receiving IV propofol at 215 minutes ( 150-280 min ) ( p < 0.001 ) .


Extubation times were faster within the volatile group at 182 minutes ( 140-255 min ) in comparison with propofol group at 291 minutes ( 210-420 min ) ( p < 0.001 ) .


The volatile group showed a higher prevalence of vasodilatation with hypotension and higher cardiac outputs necessitating greater use of vasoconstrictors .


There was no difference in postoperative pain scores , opioid consumption , sedation score , ICU or hospital length of stay , or patient mortality .


Inhaled volatile anesthesia and sedation facilitates faster extubation times in comparison with IV propofol for patient undergoing coronary artery bypass graft surgery .


Intraoral elastics are commonly used in orthodontics and require regular changing to be effective .


Unfortunately , poor compliance with elastics is often encountered , especially in adolescents .


Intention for an action and its implementation can be improved using `` if-then '' plans that spell out when , where , and how a set goal , such as elastic wear , can be put into action .


Our aim was to determine the effect of if-then plans on compliance with elastics .


To identify common barriers to compliance with recommendations concerning elastic wear , semistructured interviews were carried out with 14 adolescent orthodontic patients wearing intraoral elastics full time .


Emerging themes were used to develop if-then plans to improve compliance with elastic wear .


A prospective pilot study assessed the effectiveness of if-then planning aimed at overcoming the identified barriers on compliance with elastic wear .


Twelve participants were randomized equally into study and control groups ; the study group received information about if-then planning .


The participants were asked to collect used elastics , and counts of these were used to assess compliance .


A wide range of motivational and volitional factors were described by the interviewed participants , including the perceived benefits of elastics , cues to remember , pain , eating , social situations , sports , loss of elastics , and breakages .


Compliance with elastic wear was highly variable among patients .


The study group returned more used elastics , suggesting increased compliance , but the difference was not significant .


The use of if-then plans might improve compliance with elastic wear when compared with routine clinical instructions .


Fourteen percent ( 43.1 million ) of the population in the United States was 65 years and older in 2012 .


This population is projected to reach 20 % ( 88.5 million ) by 2050 .


Older adults accounted for 17 % of all traffic fatalities and 9 % of all vehicle occupant injuries in 2012 .


We explored the effectiveness of three interventions to help older adults assess their current driving behaviors at a Level 1 trauma center .


During 2010 to 2012 , 1,216 inpatients 70 years and older admitted for surgical and medical services were screened for eligibility , and 120 were enrolled .


Participants completed a driving assessment and preintervention questionnaires and were subsequently randomized to one of the following interventions : ( 1 ) brief negotiated interview plus an educational kit by the American Automobile Association about older driving plus an accompanying list of Web-based resources for older adult drivers ; ( 2 ) American Automobile Association document and a list of Web-based resources ; ( 3 ) online referral sheet of the list of Web-based resources only .


A 3-month postintervention follow-up questionnaire was administered over the telephone to measure changes in ( 1 ) driving-related knowledge , attitudes , and beliefs as well as ( 2 ) driving-related behaviors and intended behaviors .


A total of 113 randomized patients were included in the analysis .


The mean ( SD ) age was 76.8 ( 5.23 ) years ; majority of patients were white ( 64 % ) , followed by black African American ( 33 % ) ; and 51 % were males and 49 % were females .


Multivariate analysis showed that older adults ' driving knowledge , attitudes , and beliefs ( p < 0.0001 , R = 0.37 ) as well as behaviors and intentions ( p < 0.0001 , R = 0.27 ) toward driving were positively correlated , controlling for other predictors in the model .


Intervention assignment did not affect changes in outcomes , although outcomes improved across experimental conditions .


Our pilot study suggests that older adults are likely to make changes in their driving behavior on the basis of minimal hospital-based intervention .


Extending palliative care to those with advanced non-malignant disease is advocated , but the implications in specific conditions are poorly understood .


We piloted a novel nurse-led intervention , HELPing older people with very severe chronic obstructive pulmonary disease ( HELP-COPD ) , undertaken 4 weeks after discharge from hospital , which sought to identify and address the holistic care needs of people with severe COPD .


This 6-month mixed-method feasibility pilot trial randomised ( ratio 3:1 ) patients to HELP-COPD or usual care .


We assessed the feasibility of using validated questionnaires as outcome measures and analysed the needs/actions recorded in the HELP-COPD records .


Semi-structured interviews with a purposive sample of patients , carers and professionals explored the perceptions of HELP-COPD .


Verbatim transcriptions and field notes were analysed using Normalisation Process Theory as a framework .


We randomised 32 patients ( 24 to HELP-COPD ) ; 19 completed the study ( death = 3 , ill-health = 4 , declined = 6 ) .


The HELP-COPD record noted a mean of 1.6 actions/assessment , mostly provision of information or self-help actions : only five referrals were made .


Most patients were positive about HELP-COPD , discussing their concerns and coping strategies in all domains , but the questionnaires were burdensome for some patients .


Adaptation to their slowly progressive disability and a strong preference to rely on family support was reflected in limited acceptance of formal services .


Professionals perceived HELP-COPD as addressing an important aspect of care , although timing overlapped with discharge planning .


The HELP-COPD intervention was well received by patients and the concept resonated with professionals , although delivery post discharge overlapped with existing services .


Integration of brief holistic care assessments in the routine primary care management of COPD may be more appropriate .


The increasing prevalence of resistant bacteria such as fluoroquinolone-resistant or extended-spectrum - lactamase-producing strains in pathogens causing acute uncomplicated cystitis has been of concern in Japan .


Faropenem sodium is a penem antimicrobial that demonstrates a wide antimicrobial spectrum against both aerobic and anaerobic bacteria .


It is stable against a number of - lactamases .


We compared 3 and 7 day administration regimens of faropenem in a multicentre , randomized , open-label , controlled study .


In total , 200 female patients with cystitis were enrolled and randomized into 3 day ( N = 97 ) or 7 day ( N = 103 ) treatment groups .


At the first visit , 161 bacterial strains were isolated from 154 participants , and Escherichia coli accounted for 73.9 % ( 119/161 ) of bacterial strains .


At 5-9 days after the completion of treatment , 73 and 81 patients from the 3 day and 7 day groups , respectively , were evaluated by intention-to-treat analysis ; the microbiological efficacies were 58.9 % eradication ( 43/73 ) , 20.5 % persistence ( 15/73 ) and 8.2 % replaced ( 6/73 ) , and 66.7 % eradication ( 54/81 ) , 6.2 % persistence ( 5/81 ) and 7.4 % replaced ( 6/81 ) , respectively ( P = 0.048 ) .


The clinical efficacies were 76.7 % ( 56/73 ) and 80.2 % ( 65/81 ) , respectively ( P = 0.695 ) .


Adverse events due to faropenem were reported in 9.5 % of participants ( 19/200 ) , and the most common adverse event was diarrhoea .


The 7 day regimen showed a superior rate of microbiological response .


E. coli strains were in general susceptible to faropenem , including fluoroquinolone - and cephalosporin-resistant strains .


Teaching people with epilepsy to identify and manage seizure triggers , implement strategies to remember to take antiepileptic drugs , implement precautions to minimize risks during seizures , tell others what to do during a seizure and learn what to do during recovery may lead to better self-management .


No teaching programme exists for adults with epilepsy in the United Kingdom although a number of surveys have shown patients want more information .


This is a multicentre , pragmatic , parallel group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a two-day Self-Management education for epILEpsy ( SMILE ( UK ) ) , which was originally developed in Germany ( MOSES ) .


Four hundred and twenty eight adult patients who attended specialist epilepsy outpatient clinics at 15 NHS participating sites in the previous 12 months , and who fulfil other eligibility criteria will be randomised to receive the intervention ( SMILE ( UK ) course with treatment as usual - TAU ) or to have TAU only ( control ) .


The primary outcome is the effect on patient reported quality of life ( QoL ) .


Secondary outcomes are seizure frequency and psychological distress ( anxiety and depression ) , perceived impact of epilepsy , adherence to medication , management of adverse effects from medication , and improved self-efficacy in management ( mastery/control ) of epilepsy.Within the trial there will be a nested qualitative study to explore users ' views of the intervention , including barriers to participation and the perceived benefits of the intervention .


The cost-effectiveness of the intervention will also be assessed .


This study will provide quantitative and qualitative evidence of the impact of a structured self management programme on quality of life and other aspects of clinical and cost effectiveness in adults with poorly controlled epilepsy .


Current Controlled Trials : ISRCTN57937389 .


Depression related to interferon-alpha ( IFN - ) is common , may reduce adherence , and can be treatment limiting .


HIV-HCV coinfected persons experience lower sustained virologic response rates and commonly have psychiatric comorbidities , thus they may benefit from prevention of depression .


The aim of the study was to determine whether prophylactic citalopram can increase HCV treatment adherence and reduce the incidence of moderate depression in HIV-HCV coinfected patients initiating PEG-IFN - / ribavirin therapy .


This was an investigator-initiated Canadian multicenter randomized , double-blind placebo-controlled trial .


HIV-HCV coinfected patients were randomized in a 1:1 ratio to receive citalopram or placebo 3 weeks prior to starting PEG-IFN-2b / ribavirin , stratified by study center and HCV genotype .


The protocol design permitted the comparison of prophylaxis with the treatment of emergent depression .


The primary outcomes were adherence ( assessed through questionnaire and returned medication ) and time to moderate depression measured by Beck Depression Inventory-II ( BDI - II ) score greater than 15 , confirmed 2 weeks apart .


Seventy-six patients ( 36 citalopram/40 placebo ) were randomized .


Overall adherence was high , ranging from 95 % ( week 12 ) to 91 % ( week 48 ) .


There was no difference between arms with respect to mean or median adherence at any study time point .


Cumulative incidence of moderate depression did not differ significantly by group ( log rank P = .32 ) .


The hazard ratio for moderate depression was 0.81 ( 95 % CI , 0.26 to 2.54 ) for citalopram compared with placebo when adjusted for baseline BDI-II score .


A strategy of prophylactic citalopram compared to treatment of emergent depression was not associated with higher adherence or a reduction in treatment-limiting depression nor did it significantly reduce depressive symptoms among HIV-HCV coinfected persons during treatment for HCV .


To investigate the impact of continuous blood purification ( CBP ) on T-cell subsets and prognosis in children with severe sepsis .


A total of 42 children with severe sepsis were randomly divided into a control group ( n = 22 ) and a CBP group ( n = 20 ) .


The patients in the control group received conventional treatment , while those in the CBP group underwent continuous veno-venous hemofiltration daily 12-24 hours for 3 days besides conventional treatment .


Changes in clinical variables and in peripheral blood regulatory T cell subsets were assessed 3 and 7 days after treatment .


The pediatric intensive care unit length of stay and duration of mechanical ventilation were significantly shortened and the 28-day mortality rate was significantly lower in the CPB treatment group as compared with the control group ( P < 0.05 ) .


In the CBP treatment group , the percentage of CD3 ( + ) , CD4 ( + ) , CD8 ( + ) T cell populations and PCIS scores were significantly higher at 3 and 7 days after treatment than before treatment ( P < 0.05 ) .


At 7 days after treatment , the percentage of CD3 ( + ) , CD4 ( + ) , CD8 ( + ) T cell populations , CD4 ( + ) / CD8 ( + ) ratio and PCIS scores were significantly higher in the CBP group than in the control group ( P < 0.05 ) .


The CBP treatment may counteract the suppression of immune function and thus improve prognosis in children with severe sepsis .


While living with others has been associated with improved functional outcome after acute stroke , it is unclear if this affects adherence to stroke prevention measures .


We examined the relationship between living arrangements and adherence to antiplatelet therapy assignment and participation status in an international randomized trial for secondary stroke prevention .


Antiplatelet therapy adherence , trial retention outcomes , and baseline characteristics for participants enrolled in the Secondary Prevention of Small Subcortical Strokes study were compared between those who lived alone vs. with others ( n = 2374 ) .


Participant status at end-of-trial was categorized into ( 1 ) on assigned antiplatelet , ( 2 ) off assigned antiplatelet by participant request , or ( 3 ) participant withdrew consent/lost to follow-up .


Multivariable multivariate logistic regression was used to identify patient features at entry predictive of participant status at trial end .


Living arrangement , alone vs. with other ( s ) , was not significantly associated with participant status .


Participants enrolled in the United States/Canada ( odds ratio 3.1 , confidence intervals 2.0-5 .0 , vs. Latin America ) , taking more ( 7 + ) prescription medications ( odds ratio 1.7 , confidence intervals 1.1-2 .7 , vs. 0-2 medications ) , and scoring lower on the Stroke Specific Quality of Life scale ( odds ratio 1.3 , confidence intervals 1.1-1 .5 , per 10 points ) were more likely to withdraw or become lost to follow-up in the study vs. completing the study on assigned antiplatelet therapy .


Participants enrolled in the United States/Canada ( odds ratio 5.0 , confidence intervals 2.4-10 .0 , vs. Latin America ) and taking fewer ( 0-2 ) medications ( odds ratio 1.9 , confidence intervals 1.2-3 .1 vs. 3-6 medications ) were more likely to request discontinuation of assigned antiplatelet medication vs. completing the study .


Living with others was not independently predictive of protocol adherence in this cohort .


Number of medications and Stroke Specific Quality of Life scale score may be more indicative of likelihood of trial participation and acceptance of long-term antiplatelet regimen .


Short sleep duration is a contributing factor for decreased insulin sensitivity and hyperglycemia .


Sleep architecture represents a cyclical pattern of sleep that shifts between sleep Stages N1 , N2 , N3 ( slow wave sleep ) and Stage R ( rapid eye movement sleep ) .


The aim of the present study was to examine the association between sleep architecture and glucose and insulin metabolism in both normal weight and overweight/obese children and adolescents .


A total of 118 subjects participated in the study .


Subjects under-went overnight polysomnography ( PSG ) when the percentage of total sleep time ( % TST ) spent at each sleep stage was recorded and an oral glucose tolerance test together was performed the next morning .


We assessed glucose tolerance , insulin sensitivity and pancreatic - cell function using 2-h glucose levels , the Matsuda index ( IS ( OGTT ) ) , and insulin secretion-sensitivity index-2 ( ISSI-2 ) , respectively .


After adjustment for age , gender , body mass index z-score , pubertal status , and obstructive apnea hypopnea index , Stage N3 ( % TST ) was positively associated with IS ( OGTT ) , whereas Stage N1 ( % TST ) exerted an opposite effect on IS ( OGTT ) .


Higher sleep efficiency and longer TST were independently associated with lower 2-h glucose levels , higher ISSI-2 and/or higher IS ( OGTT ) .


Stage N3 , sleep efficiency and TST were protective factors in maintaining glucose and insulin homeostasis ; however , Stage N1 functioned in the opposite direction .


Although blood donation is allowed every 8 weeks in the United States , recovery of hemoglobin to the currently accepted standard ( 12.5 g/dL ) is frequently delayed , and some donors become anemic .


To determine the effect of oral iron supplementation on hemoglobin recovery time ( days to recovery of 80 % of hemoglobin removed ) and recovery of iron stores in iron-depleted ( `` low ferritin , '' 26 ng/mL ) and iron-replete ( `` higher ferritin , '' > 26 ng/mL ) blood donors .


Randomized , nonblinded clinical trial of blood donors stratified by ferritin level , sex , and age conducted in 4 regional blood centers in the United States in 2012 .


Included were 215 eligible participants aged 18 to 79 years who had not donated whole blood or red blood cells within 4 months .


One tablet of ferrous gluconate ( 37.5 mg of elemental iron ) daily or no iron for 24 weeks ( 168 days ) after donating a unit of whole blood ( 500 mL ) .


Time to recovery of 80 % of the postdonation decrease in hemoglobin and recovery of ferritin level to baseline as a measure of iron stores .


The mean baseline hemoglobin levels were comparable in the iron and no-iron groups and declined from a mean ( SD ) of 13.4 ( 1.1 ) g/dL to 12.0 ( 1.2 ) g/dL after donation in the low-ferritin group and from 14.2 ( 1.1 ) g/dL to 12.9 ( 1.2 ) g/dL in the higher-ferritin group .


Compared with participants who did not receive iron supplementation , those who received iron supplementation had shortened time to 80 % hemoglobin recovery in both the low-ferritin ( mean , 32 days , interquartile range [ IQR ] , 30-34 , vs 158 days , IQR , 126 - > 168 ) and higher-ferritin groups ( 31 days , IQR , 29-33 , vs 78 days , IQR , 66-95 ) .


Median time to recovery to baseline ferritin levels in the low-ferritin group taking iron was 21 days ( IQR , 12-84 ) .


For participants not taking iron , recovery to baseline was longer than 168 days ( IQR , 128 - > 168 ) .


Median time to recovery to baseline in the higher-ferritin group taking iron was 107 days ( IQR , 75-141 ) , and for participants not taking iron , recovery to baseline was longer than 168 days ( IQR , > 168 - > 168 ) .


Recovery of iron stores in all participants who received supplements took a median of 76 days ( IQR , 20-126 ) ; for participants not taking iron , median recovery time was longer than 168 days ( IQR , 147 - > 168 days ; P < .001 ) .


Without iron supplements , 67 % of participants did not recover iron stores by 168 days .


Among blood donors with normal hemoglobin levels , low-dose iron supplementation , compared with no supplementation , reduced time to 80 % recovery of the postdonation decrease in hemoglobin concentration in donors with low ferritin ( 26 ng/mL ) or higher ferritin ( > 26 ng/mL ) .


clinicaltrials.gov Identifier : NCT01555060 .


AZD6280 is a novel - aminobutyric acid A receptor modulator with higher in vitro efficacy at the 2,3 subtypes as compared to the 1 and 5 subtypes .


This study compared the pharmacodynamic effects of single oral dose AZD6280 10 mg and 40 mg on the central nervous system with 2 mg of lorazepam .


Sixteen healthy males were enrolled into the double-blind , randomized , 4-way crossover study .


Two validated central nervous system test batteries , Neurocart and CogState , were administered to measure drug effects on cognition , neurophysiologic function , and psychomotor and subjective feelings .


Statistical analysis was performed using mixed model analysis of variance , with fixed factors of treatment , period , time and treatment by time , and random factors of subject , subject by treatment and subject by time , and the average prevalue as covariate .


Most pharmacodynamic parameters were affected by lorazepam .


AZD6280 induced dose-dependent smaller-than-lorazepam effects on saccadic peak velocity ( SPV ) ( AZD6280 , 10 mg vs. AZD6280 , 40 mg vs. lorazepam [ deg/s ] : -22.6 vs. -50.0 vs. -62.9 , P < 0.001 ) , whereas the impacts on adaptive-tracking , body-sway , smooth-pursuit , and the one-card-learning tests were significant but much smaller than lorazepam .


Thus , the slopes of regression lines for the Log ( Sway ) - SPV , Tracking-SPV , and Smooth-SPV relations were flatter with AZD6280 than with lorazepam .


AZD6280 caused a distinct electroencephalography signature from that of lorazepam .


The SPV responses to AZD6280 suggest potential concentration-related anxiolytic effects , whereas the smaller SPV-normalized effects of AZD6280 on various non-SPV pharmacodynamic parameters suggest a more favorable side effect profile compared to lorazepam .


Overall , the pharmacodynamic profile of AZD6280 matches the pharmacological specificity and selectivity of this compound at the 2,3 - aminobutyric acid A receptor subtypes .


Cross-sectional analysis of long-term follow-up ( LTFU ) data from 4 randomized controlled trials of operative versus nonoperative treatment for chronic low back pain .


To examine the influence of spinal fusion on adjacent segment disc space height as an indicator of disc degeneration at LTFU .


There is ongoing debate as to whether adjacent segment disc degeneration results from the increased mechanical stress of fusion .


Plain standing lateral radiographs were obtained at LTFU ( mean , 13 4 yr postrandomization ) in 229 of 464 ( 49 % ) patients randomized to surgery and 140 of 303 ( 46 % ) , to nonoperative care .


Disc space height and posteroanterior displacement were measured for each lumbar segment using a validated computer-assisted distortion compensated roentgen analysis technique .


Values were reported in units of standard deviations above or below age and sex-adjusted normal values .


Patient-rated outcomes included the Oswestry Disability Index and pain scales .


Radiographs were usable in 355 of 369 ( 96 % ) patients ( 259 fusion and 96 nonoperative treatment ) .


Both treatment groups showed significantly lower values for disc space height of the adjacent segment than norm values .


There was a significant difference between treatment groups for the disc space height of the cranial adjacent segment ( in both as-treated and intention-to-treat analyses ) .


The mean treatment effect of fusion on adjacent segment disc space height was -0.44 SDs ( 95 % CI , -0.77 to -0.11 ; P = 0.01 ; as-treated analysis ) ; there was no group difference for posteroanterior displacement ( 0.18 SDs , 95 % confidence interval , -0.28 to 0.64 , P = 0.45 ) .


Adjacent level disc space height and posteroanterior displacement were not correlated with Oswestry Disability Index or pain scores at LTFU ( r = 0.010-0 .05 ; P > 0.33 ) .


Fusion was associated with lower disc space height at the adjacent segment after an average of 13 years of FU .


The reduced disc space height had no influence on patient self-rated outcomes ( pain or disability ) .


2 .


To demonstrate the efficacy of exenatide versus insulin glargine on endothelial functions and cardiovascular risk markers .


Thirty-four insulin and incretin-naive patients with type 2 diabetes mellitus ( body mass index 25-45 kg/m ( 2 ) ) who received metformin for at least two months were randomized to exenatide or insulin glargine treatment arms and followed-up for 26 weeks .


Measurements of endothelial functions were done by ultrasonography , cardiovascular risk markers by serum enzyme-linked immunosorbent assay , and total body fat mass by bioimpedance .


Levels of high sensitivity-C-reactive protein and endothelin-1 decreased ( 27.5 % and 18.75 % , respectively ) in the exenatide arm .


However , in the insulin glargine arm , fibrinogen , monocyte chemoattractant protein-1 , leptin and endothelin-1 levels ( 13.4 , 30.2 , 47.5 , and 80 % , respectively ) increased .


Post-treatment flow mediated dilatation and endothelium independent vascular responses were significantly higher in both arms ( p = 0.0001 , p = 0.0001 ) .


Positive correlation was observed between the changes in body weight and endothelium-independent vasodilatation , leptin , plasminogen activator inhibitor type 1 and endothelin-1 in both arms ( r = 0.376 , r = 0.507 , r = 0.490 , r = 0.362 , respectively ) .


Insulin glargine improved endothelial functions , without leading to positive changes in cardiovascular risk markers .


Exenatide treatment of 26 weeks resulted in reduced body weight and improvement in certain cardiovascular risk markers and endothelial functions .


Paralytic ileus after laparoscopic-assisted surgery often occurs .


We investigated whether daikenchuto ( DKT ) , a traditional Japanese herbal medicine , improves intestinal motility in patients undergoing laparoscopic-assisted colectomy for colon cancer .


Fifty-four patients who underwent colectomy at Iwate Medical University Hospital between October 2010 and March 2012 were randomized to either the DKT group ( 7.5 g/day , p.o. ) or the control group ( lactobacillus preparation , 3g/day , p.o. ) .


Primary endpoints included time to first flatus , bowel movement , and tolerance of diet after extubation .


Secondary endpoints were WBC count , C-reactive protein ( CRP ) level , length of hospital stay , and postoperative ileus .


Colonic transit time was measured using radiopaque markers and abdominal radiographs .


Fifty-one patients ( DKT , 26 vs. control , 25 ) were included in the per-protocol analysis .


The DKT group had significantly faster time until first flatus ( 67.5 + / - 13.6 h vs. 77.9 + / - 11.8 h , P < 0.01 ) and bowel movement ( 82.9 + / - 17.8 h vs. 99.5 + / - 18.9 h , P < 0.01 ) and colonic transit time ( 91.9 + / - 19.8 h vs. 115.2 + / - 12.8 h , P < 0.05 ) .


There were no significant intergroup differences in secondary endpoints and adverse events .


DKT accelerates colonic motility in patients undergoing laparoscopic-assisted colectomy for colon cancer .


Several epidemiologic studies have suggested a role of tomato products in decreasing the risk of the development of diseases related to oxidative stress ( cancer and other chronic diseases ) .


Oxidative stress may result in periodontal tissue damage either directly or indirectly .


Lycopene , a powerful antioxidant and the main carotenoid in tomato products possesses the greatest quenching ability of singlet oxygen among the various carotenoids and is effective in protecting blood lymphocytes from NOO-radical damage .


Hence , the aim of the present study is to compare the effect of systemically administered lycopene as an adjunct to scaling and root planing in patients with gingivitis and periodontitis .


Twenty systemically healthy patients were involved in a randomized , double-blind , parallel study and based on their clinical signs were divided into two groups of mild to moderate periodontitis ( A ) and moderate gingivitis ( B ) .


The subjects under the groups A and B were randomly distributed between the two treatment groups : test group ( n = 5 ) , 4 mg lycopene/day for 2 weeks with oral prophylaxis ( full mouth scaling and root planing ( SRP ) completed within 24 hours ) and controls ( n = 5 ) , receiving only oral prophylaxis .


Pre - and post-therapeutic periodontal parameters were evaluated .


In group A , statistically significant improvement in CAL was reported in test group as compared to control group .


In group B , the difference between pretreatment and post-treatment bleeding on probing scores was found to be statistically non-significant in both groups .


Results show that lycopene is a promising treatment modality as an adjunct to full mouth SRP of the oral cavity in patients with moderate periodontal disease .


Modulation of the free radical production seems to be essential for the inhibition of tissue destruction , and treatment with antioxidants , like lycopene , which is the most potent among them will block the production of free ROS or its effects might prove to be therapeutically valuable .


To evaluate the humoral immune response to pneumococcal and influenza vaccination in adults with rheumatoid arthritis ( RA ) receiving certolizumab pegol ( CZP ) .


In this 6-week , single-blind , placebo-controlled trial with optional 6-month open-label extension ( NCT00993668 ) , patients were stratified by concomitant methotrexate ( MTX ) use and randomized to receive CZP 400 mg ( loading dose ; according to CZP label ) or placebo at weeks 0 , 2 , and 4 .


Pneumococcal ( polysaccharide 23 ) and influenza vaccines were administered at Week 2 .


Satisfactory humoral immune response , defined as 2-fold titer increase in 3 of 6 pneumococcal antigens and 4-fold titer increase in 2 of 3 influenza antigens , were assessed independently 4 weeks after vaccination .


Following pneumococcal vaccination , 62.5 % of placebo patients and 54.5 % of CZP patients without effective titers at baseline achieved a humoral response ( difference in proportions was -8.0 percentage points ; 95 % CI -22.5 to 6.6 % ) .


Following influenza vaccination , 61.4 % of placebo and 53.5 % of CZP patients without effective titers at baseline achieved a humoral response ( difference in proportions : -8.0 percentage points ; 95 % CI -22.9 to 7.0 % ) .


In all patients , including those with effective titers at baseline , 58.2 % of placebo and 53.3 % of CZP patients developed satisfactory pneumococcal titers , and 54.1 % of placebo and 50.5 % of CZP patients developed satisfactory influenza antibody titers .


Vaccine responses to pneumococcal and influenza antigens were reduced similarly in both treatment groups with concomitant MTX use .


Humoral immune responses to pneumococcal and influenza vaccination are not impaired when given during the loading phase of CZP treatment in patients with RA .


( ClinicalTrials.gov NCT00993668 ) .


The goal of this study was to evaluate the impact of the Active Teen Leaders Avoiding Screen-time ( ATLAS ) intervention for adolescent boys , an obesity prevention intervention using smartphone technology .


ATLAS was a cluster randomized controlled trial conducted in 14 secondary schools in low-income communities in New South Wales , Australia .


Participants were 361 adolescent boys ( aged 12-14 years ) considered at risk of obesity .


The 20-week intervention was guided by self-determination theory and social cognitive theory and involved : teacher professional development , provision of fitness equipment to schools , face-to-face physical activity sessions , lunchtime student mentoring sessions , researcher-led seminars , a smartphone application and Web site , and parental strategies for reducing screen-time .


Outcome measures included BMI and waist circumference , percent body fat , physical activity ( accelerometers ) , screen-time , sugar-sweetened beverage intake , muscular fitness , and resistance training skill competency .


Overall , there were no significant intervention effects for BMI , waist circumference , percent body fat , or physical activity .


Significant intervention effects were found for screen-time ( mean SE : -30 10.08 min/d ; P = .03 ) , sugar-sweetened beverage consumption ( mean : -0.6 0.26 glass/d ; P = .01 ) , muscular fitness ( mean : 0.9 0.49 repetition ; P = .04 ) , and resistance training skills ( mean : 5.7 0.67 units ; P < .001 ) .


This school-based intervention targeting low-income adolescent boys did not result in significant effects on body composition , perhaps due to an insufficient activity dose .


However , the intervention was successful in improving muscular fitness , movement skills , and key weight-related behaviors .


Gemigliptin is approved for the treatment of type II diabetes mellitus .


Sulfonylureas are commonly used in combination with other antidiabetic drugs to improve glycemic control .


The objective of this study was to evaluate the pharmacokinetics , safety , and tolerability of gemigliptin and glimepiride combination therapy compared with those of monotherapies .


A randomized , open-label , crossover study was performed on healthy Korean male volunteers .


Each subject received the following treatments ( A and B ) with a 7-day washout period : treatment A consisted of gemigliptin 50 mg once daily administered orally for 6 days , followed by concomitant oral dosing of glimepiride 4 mg and gemigliptin 50 mg on day 7 ; treatment B consisted of a single dose of glimepiride 4 mg .


Blood samples were collected up to 24-h postdose on day 6 ( gemigliptin ) and day 7 ( gemigliptin and glimepiride ) following treatment A , and on day 1 ( glimepiride ) following treatment B. Concentrations of gemigliptin , glimepiride , and metabolites were determined using validated liquid chromatography-tandem mass spectrometry ( LC-MS/MS ) .


Safety assessments were performed throughout the study .


Twenty-three subjects completed the study .


The geometric mean ratios ( GMRs ) of C max , ss and AUC , ss for gemigliptin were 1.0097 [ 90 % confidence interval ( CI ) 0.924-1 .103 ] and 0.9997 ( 90 % CI 0.976-1 .024 ) , respectively .


For glimepiride , the GMRs of C max and AUClast were 1.031 ( 90 % CI 0.908-1 .172 ) and 0.995 ( 90 % CI 0.902-1 .097 ) , respectively .


Both combination and monotherapy were well tolerated , and no serious adverse events were reported .


Gemigliptin and glimepiride did not alter the pharmacokinetic properties of each other when they were co-administered in healthy volunteers , and were generally tolerated .


It is estimated that more than half of those with serious mental illness smoke tobacco regularly .


Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence , but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy .


To determine whether smokers diagnosed with schizophrenia and bipolar disease have higher rates of prolonged tobacco abstinence with maintenance pharmacotherapy than with standard treatment .


Randomized , double-blind , placebo-controlled , parallel-group , relapse-prevention clinical trial conducted in 10 community mental-health centers .


Of 247 smokers with schizophrenia or bipolar disease recruited from March 2008-April 2012 , 203 received 12-weeks ' open-label varenicline and cognitive behavioral therapy and 87 met abstinence criteria to enter the relapse prevention intervention .


Participants who had 2 weeks or more of continuous abstinence at week 12 of open treatment were randomly assigned to receive cognitive behavioral therapy and double-blind varenicline ( 1 mg , 2 per day ) or placebo from weeks 12 to 52 .


Participants then discontinued study treatment and were followed up to week 76 .


Seven-day rate of continuous abstinence at study week 52 , the end of the relapse-prevention phase , confirmed by exhaled carbon monoxide .


Secondary outcomes were continuous abstinence rates for weeks 12 through 64 based on biochemically verified abstinence and weeks 12 through 76 , based on self-reported smoking behavior .


Sixty-one participants completed the relapse-prevention phase ; 26 discontinued participation ( 7 varenicline , 19 placebo ) and were considered to have relapsed for the analyses ; 18 of these had relapsed prior to dropout .


At week 52 , point-prevalence abstinence rates were 60 % in the varenicline group ( 24 of 40 ) vs 19 % ( 9 of 47 ) in the placebo group ( odds ratio [ OR ] , 6.2 ; 95 % CI , 2.2-19 .2 ; P < .001 ) .


From weeks 12 through 64 , 45 % ( 18 of 40 ) among those in the varenicline group vs 15 % ( 7 of 47 ) in the placebo group were continuously abstinent ( OR , 4.6 ; 95 % CI , 1.5-15 .7 ; P = .004 ) , and from weeks 12 through 76 , 30 % ( 12 of 40 ) in the varenicline group vs 11 % ( 5 of 47 ) in the placebo group were continuously abstinent ( OR , 3.4 ; 95 % CI , 1.02-13 .6 ; P = .03 ) .


There were no significant treatment effects on psychiatric symptom ratings or psychiatric adverse events .


Among smokers with serious mental illness who attained initial abstinence with standard treatment , maintenance pharmacotherapy with varenicline and cognitive behavioral therapy improved prolonged tobacco abstinence rates compared with cognitive behavioral therapy alone after 1 year of treatment and at 6 months after treatment discontinuation .


clinicaltrials.gov Identifier : NCT00621777 .


Insufficient production oferythropoietin ( EPO ) is the primary cause ofanemia in patients with chronic kidney disease ( CKD ) .


The EPO treatment is an established treatment for renal anemia .


The study investigated the therapeutic outcome between lyophilized powder and liquid form of EPO alpha by intravenous ( IV ) administration in hemoglobin maintenance of anemic treatment for CKD patients receiving hemodialysis .


Forty patients were randomly assigned to either lyophilized powder of EPO alpha ( treatment , n = 21 ) or liquidform of EPO alpha ( control , n = 19 ) for 12 weeks by lVadministration .


The hemoglobin was maintained within the target range of 10.0 to 12.0 g/dL by adjusting the dosage of EPO .


The clinical and biochemical profiles including transferrin saturation andferritin were measured .


Adverse events were documented .


The mean hemoglobin ofboth groups at baseline was 11.20.6 g/dL .


Mean hemoglobin and mean hematocrit levels at baseline , and follow-up data of both groups were not statistically different .


The mean weekly dosage of EPO in the treatment and control groups had no statistical significance within the same group and between groups as well .


Stable hemoglobin levels were maintained without EPO dosage adjustment in the majority ofpatients in both groups ( treatment group , 90.5 % , control group , 94.7 % ) .


During the 12-week study period , no serious side effect was detected


The present study demonstrated that the lyophilizedpowder ofEPO alpha was effective and safe as the standard liquid form of EPO alpha when it was administered by IV route in hemoglobin maintenance of anemia treatment .


The objective of this study was to assess the prognostic significance of exercise capacity in patients with ischemic left ventricular ( LV ) dysfunction eligible for coronary artery bypass graft surgery ( CABG ) .


Poor exercise capacity is associated with mortality , but it is not known how this influences the benefits and risks of CABG compared with medical therapy .


In an exploratory analysis , physical activity was assessed by questionnaire and 6-min walk test in 1,212 patients before randomization to CABG ( n = 610 ) or medical management ( n = 602 ) in the STICH ( Surgical Treatment for Ischemic Heart Failure ) trial .


Mortality ( n = 462 ) was compared by treatment allocation during 56 months ( interquartile range : 48 to 68 months ) of follow-up for subjects able ( n = 682 ) and unable ( n = 530 ) to walk 300 m in 6 min and with less ( Physical Ability Score [ PAS ] > 55 , n = 749 ) and more ( PAS 55 , n = 433 ) limitation by dyspnea or fatigue .


Compared with medical therapy , mortality was lower for patients randomized to CABG who walked 300 m ( hazard ratio [ HR ] : 0.77 ; 95 % confidence interval [ CI ] : 0.59 to 0.99 ; p = 0.038 ) and those with a PAS > 55 ( HR : 0.79 ; 95 % CI : 0.62 to 1.01 ; p = 0.061 ) .


Patients unable to walk 300 m or with a PAS 55 had higher mortality during the first 60 days with CABG ( HR : 3.24 ; 95 % CI : 1.64 to 6.83 ; p = 0.002 ) and no significant benefit from CABG during total follow-up ( HR : 0.95 ; 95 % CI : 0.75 to 1.19 ; p = 0.626 ; interaction p = 0.167 ) .


These observations suggest that patients with ischemic left ventricular dysfunction and poor exercise capacity have increased early risk and similar 5-year mortality with CABG compared with medical therapy , whereas those with better exercise capacity have improved survival with CABG .


( Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease [ STICH ] ; NCT00023595 ) .


Physical activity ( PA ) declines dramatically during adolescence , and activity levels are consistently lower among children living in low-income communities .


Competency in a range of fundamental movement skills ( FMS ) may serve as a protective factor against the decline in PA typically observed during adolescence .


The purpose of this study was to evaluate the effect of a 12-month multicomponent PA and FMS intervention on children attending primary schools in low-income communities .


The Supporting Children 's Outcomes using Rewards , Exercise , and Skills intervention was evaluated using a cluster randomized controlled trial .


The sample included 25 classes from eight primary schools located in low-income communities .


Participants were 460 children ( 54.1 % girls ) age 8.5 0.6 yr .


Primary outcomes were objectively measured PA ( ActiGraph GT3X and GT3X + accelerometers ) , FMS competency ( Test of Gross Motor Development 2 , six locomotor and six object control skills ) , and cardiorespiratory fitness ( 20-m multistage fitness test ) assessed at baseline , midprogram ( 6-months ) , and at posttest ( 12 months ) .


Linear mixed models , adjusted for sex , age , body mass index z-score , socioeconomic status , ethnicity , and school class as a random factor , were used to assess the effect of the intervention .


At midprogram , there were no significant intervention effects for any of the outcomes .


At posttest ( study 's primary time point ) , there were intervention effects for daily moderate-to-vigorous PA ( MVPA ) ( adjusted mean difference , 12.7 mind of MVPA ; 95 % confidence interval ( CI ) , 5.0-20 .5 ) , overall FMS competency ( 4.9 units ; 95 % CI , -0.04 to 9.8 ) , and cardiorespiratory fitness ( 5.4 laps ; 95 % CI , 2.3-8 .6 ) .


A school-based multicomponent PA and FMS intervention maintained daily MVPA , improved overall FMS competency , and increased cardiorespiratory fitness among children attending primary schools in low-income communities .


This study determined the effective concentration of ropivacaine required to produce the type of differential block known as sensory block with mobilization , for adequate analgesia after forearm or hand soft tissue surgery by axillary brachial plexus block .


Forty-four patients were enrolled , and ultrasound-guided axillary nerve block with nerve stimulation was achieved using 16 mL of ropivacaine in total .


Postoperative analgesia and sensory/motor function , side effects , the use of rescue analgesics , and the patient satisfaction score were evaluated 24 h after surgery .


The effective concentration of nerve block was calculated by probit analysis .


Eighteen patients achieved differential block and were sufficiently satisfied with the block , which was significantly better than the patient satisfaction obtained with incomplete differential block .


The maximum effective concentration of 6 mL of ropivacaine needed for differential block was calculated as 0.1285 % , which meant that 71 % of the patients experienced both sensory block and maintenance of motor function .


This analysis showed that 16 ml of 0.1285 % ropivacaine is suitable for achieving differential block in ultrasound-guided axillary nerve block for hand and forearm surgery .


Hand osteoarthritis ( OA ) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual 's functioning , health-related quality of life and participation in society .


Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA , with a similar effect suggested for hip OA .


For hand OA , available research is very limited and shows conflicting results , and high-quality randomised controlled trials are warranted.This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA .


Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts : the population-based `` Musculoskeletal pain in Ullensaker Study '' ( MUST ) OA cohort , and the hospital-based Oslo Hand OA cohort .


Participants are randomised into an intervention - or control group .


The control group receives `` usual care '' , whereas the intervention group receives a 12-week exercise intervention .


The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home .


Adherence will be captured using self-report .


During the eight weeks with no group sessions , the intervention group receives a weekly telephone call .


The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital , Oslo .


Outcomes are collected at baseline , and at 3 and 6 months .


The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation , as measured by the Functional Index for Hand Osteoarthritis ( FIHOA ) ; and a patient-generated measure of disability , the Patient-Specific Functional Scale ( PSFS ) .


Secondary outcome measures are self-reported OA symptoms ( e.g. pain , stiffness and fatigue ) , the Patient Global Assessment of disease activity , measured hand function ( e.g. grip strength , thumb web space and hand dexterity ) and health-related quality of life .


Cost-utility and cost-effectiveness analyses will be conducted .


This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA .


The trial is registered at ClinicalTrials.gov with registration number : NCT01245842 .


Investigate the benefit of zinc supplement combined with standard treatment ofidiopathic sudden sensorineural hearing loss ( ISSNHL ) patients .


A prospective , randomized study was designed to evaluate the hearing outcomes in ISSNHL patients treated with zinc supplement .


The patients were randomized into two groups , the study and the control group .


The study group received oral chelated zinc with standard treatment ( oral prednisolone ) , while the control group received standard treatment alone .


Hearing improvement was assessed from pure-tone average ( PTA ) and speech discrimination scores ( SDS ) .


After treatment , significant hearing improvement was noted in both groups regarding PTA value ( p = 0.016 , 0.025 ) .


SDS was also improved in both groups but with no statistical significance ( p > 0.05 ) .


Post-treatment PTA and SDS values between the zinc and control groups were not statistically different ( p > 0.05 ) .


Hearing improvement was documented in eight of 16 patients in the study group and seven of 14 patients in the control group .


This was no significant difference ( p = 1.000 ) .


Zinc supplementation does not have benefit when combined with standard treatment .


Nevertheless , more subjects and well-designed studies are needed to verify the effect of zinc .


To investigate the effectiveness of shared care combined with telecare in type 2 diabetic patients in an underserved community in Asia .


In total , 95 patients with type 2 diabetes who had a glycosylated hemoglobin ( HbA1c ) level of > 7 % were recruited from six community health centers in remote areas in Changhua County , Taiwan .


All patients were randomly divided into intervention ( shared care combined with telecare ) and usual-care groups and followed up for 6 months .


The decrease in HbA1c level was significantly greater in the intervention group than in the usual-care group ( 0.7 1.3 % versus 0.1 1.0 % , p = 0.03 ) .


There were no significant differences in lipid profiles and blood pressure changes between the two groups .


Shared care combined with telecare could significantly reduce HbA1c levels in type 2 diabetic patients with poor glycemic control in underserved rural communities .


Further studies should be conducted to clarify the target users and to develop cost-effective interventions .


Fluticasone furoate nasal spray ( FFNS ) is a glucocorticoid developed for the treatment of allergic rhinitis ( AR ) .


This is the first randomized clinical trial to assess the efficacy and safety of FFNS in Japanese children with perennial AR ( PAR ) .


In this multicentre , randomized , double-blind , placebo-controlled , parallel-group , phase III study , 261 children aged 6 to < 15 years were treated with FFNS 55g , once daily or placebo for two weeks .


Nasal and ocular symptoms were rated by parents/guardians/patients in the patient daily diary .


The primary endpoint was the mean change from baseline in the three total nasal symptom score ( 3TNSS ) .


In addition , rhinoscopic findings were rated by the investigators as an efficacy measure .


As a safety measure , adverse events and clinical chemistry and hematology were evaluated .


Mean change from baseline over the entire treatment period in 3TNSS was greater in the FFNS 55g group compared with placebo , and the difference was statistically significant ( p < 0.001 ) .


Significant improvements in rhinoscopic findings of swelling of inferior turbinate mucosa and quantity of nasal discharge were also observed .


The total ocular symptom score ( TOSS ) was reduced significantly in the FFNS 55g group , compared with placebo , in the second week in a subgroup of patients with baseline TOSS > 0 .


The incidence of adverse events was similar between FFNS 55g ( 18 % ) and placebo ( 19 % ) .


Two-week treatment with FFNS 55g , once daily is effective and tolerable in Japanese children aged 6 to < 15 years with PAR .


Fostering positive school climates and student drug testing have been separately proposed as strategies to reduce student drug use in high schools .


To assess the promise of these strategies , the present research examined whether positive school climates and/or student drug testing successfully predicted changes in youth substance use over a 1-year follow-up .


Two waves of panel data from a sample of 361 high school students , assessed 1 year apart , were analyzed .


Changes in reported initiation and escalation in frequency of alcohol , cigarette , and marijuana use as a function of perceived student drug testing and positive school climates were analyzed , while we held constant prior substance use .


Perceived student drug testing was not associated with changes in substance use , whereas perceived positive school climates were associated with a reduction in cigarette and marijuana initiation and a reduction in escalation of frequency of cigarette use at 1-year follow-up .


However , perceived positive school climates were not associated with a reduction in alcohol use .


Student drug testing appears to be less associated with substance use than positive school climates .


Nevertheless , even favorable school climates may not be able to influence the use of alcohol , which appears to be quite normative in this age group .


More patient-centered programming is essential for endometrial cancer ( EC ) survivors needing to lose weight to reduce cardiovascular disease risk ( CVD ) .


The purpose of this study was to improve self-efficacy ( SE ) and quality of life ( QOL ) using a lifestyle intervention program designed for weight loss .


Overweight and obese early-stage EC survivors , n = 75 , were randomized into two groups : 1 ) Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet ( SUCCEED ) , a six-month lifestyle intervention or 2 ) a usual care group ( UC ) .


Participants completed the Weight Efficacy Lifestyle Questionnaire ( WEL ) to assess SE and the Functional Assessment of Cancer Therapy-General ( FACT-G ) to measure QOL , and their body mass index ( BMI ) was calculated at baseline , 3 , 6 , and 12 months .


Mixed , repeated-measures ANCOVA models with baseline covariates were employed using SPSS 20.0 .


Positive effects in every WEL domain , including the total score , were statistically significant in the SUCCEED group versus the UC group .


A linear regression model demonstrated that , if BMI decreased by 1 unit , the total WEL score increased by 4.49 points .


Significant negative correlations were found in the total WEL score and a change in BMI of R = -0.356 ( p = 0.006 ) .


Between-group differences in the FACT-G were significant from baseline in the fatigue domain at three months ( p = .008 ) and in the physical domain at six months ( p = .048 ) .


No other significant differences were found .


Overall , this study shows promise for targeted interventions to help improve SE , thus improving BMI .


The aim of our study was to determine whether the combination of intratympanic ( IT ) corticosteroid with melatonin could be associated with decreased tinnitus in patients with unilateral acute idiopathic tinnitus developed within 3months .


We evaluated this hypothesis through a prospective , randomized , controlled , double-blinded trial .


Patients included in the study were randomly allocated into two groups : Group A - comprising 30 patients , received melatonin and IT dexamethazone , and Group B - including 30 patients receiving melatonin alone .


After 3 months , improvement in tinnitus was assessed using different outcome measures : tinnitus loudness score , tinnitus awareness score , Tinnitus Handicap Inventory ( THI ) , Pittsburgh Sleep Quality Index ( PSQI ) and Beck Depression Inventory ( BDI ) .


We have demonstrated significant improvements in each of the above mentioned outcomes subsequent to treatment in both groups .


However , patients in the IT dexamathazone and melatonin group attained statistically significant better outcomes .


Besides , the differences in improvement rate and cure rate were highly significant between the two groups , favoring the IT dexamethazone and melatonin group .


Our preliminary study demonstrated that IT dexamethazone plus melatonin is efficient in improvement of idiopathic unilateral tinnitus developed within 3 months .


This study aimed to assess the predictive validity of the Alcohol Use Disorders Identification Test ( AUDIT ) among adult prisoners with respect to hazardous drinking following release , and identify predictors of post-release hazardous drinking among prisoners screening positive for risk of alcohol-related harm on the AUDIT .


Data came from a survey-based longitudinal study of 1325 sentenced adult prisoners in Queensland , Australia .


Baseline interviews were conducted pre-release with follow-up at 3 and 6 months post-release .


We calculated sensitivity , specificity and area under the receiver operating characteristic ( AUROC ) to quantify the predictive validity of the AUDIT administered at baseline with respect to post-release hazardous drinking .


Other potential predictors of hazardous drinking were measured by self-report and their association with the outcome was examined using logistic regression .


At a cut-point of 8 or above , sensitivity of the AUDIT with respect to hazardous drinking at 3-month follow-up was 81.0 % ( 95 % CI : 77.9-84 .6 % ) and specificity was 65.6 % ( 95 % CI : 60.6-70 .3 % ) .


The AUROC was 0.78 ( 95 % CI : 0.75-0 .81 ) , indicating moderate accuracy .


Among those scoring 8 or above , high expectations to drink post-release ( AOR : 2.49 ; 95 % CI : 1.57-3 .94 ) and past amphetamine-type stimulant ( ATS ) use ( AOR : 1.64 ; 95 % CI : 1.06-2 .56 ) were significantly associated with hazardous drinking at 3 months post-release .


Results were similar at 6 months .


Among adult prisoners in our sample , pre-release AUDIT scores predicted hazardous drinking six months after release with acceptable accuracy , sensitivity and specificity .


Among prisoners screening positive on the AUDIT , expectations of post-release drinking and ATS use are potential targets for intervention to reduce future hazardous drinking .


Clinical outcomes and the effects of oral anticoagulants among patients with acute coronary syndrome ( ACS ) and either a history of or acute heart failure ( HF ) are largely unknown .


We aimed to assess the relationship between prior HF or acute HF complicating an index ACS event and subsequent clinical outcomes and the efficacy and safety of apixaban compared with placebo in these populations .


High-risk patients were randomly assigned post-ACS to apixaban 5.0 mg or placebo twice daily .


Median follow-up was 8 ( 4-12 ) months .


The primary outcome was cardiovascular death , myocardial infarction , or stroke .


The main safety outcome was thrombolysis in myocardial infarction major bleeding .


Heart failure was reported in 2,995 patients ( 41 % ) , either as prior HF ( 2,076 [ 28 % ] ) or acute HF ( 2,028 [ 27 % ] ) .


Patients with HF had a very high baseline risk and were more often managed medically .


Heart failure was associated with a higher rate of the primary outcome ( prior HF : adjusted hazard ratio [ HR ] 1.73 , 95 % CI 1.42-2 .10 , P < .0001 , acute HF : adjusted HR 1.65 , 95 % CI 1.35-2 .01 , P < .0001 ) and cardiovascular death ( prior HF : HR 2.54 , 95 % CI 1.82-3 .54 , acute HF : adjusted HR 2.52 , 95 % CI 1.82-3 .50 ) .


Patients with acute HF also had significantly higher rates of thrombolysis in myocardial infarction major bleeding ( prior HF : adjusted HR 1.22 , 95 % CI 0.65-2 .27 , P = .54 , acute HF : adjusted HR 1.78 , 95 % CI 1.03-3 .08 , P = .04 ) .


There was no statistical evidence of a differential effect of apixaban on clinical events or bleeding in patients with or without prior HF ; however , among patients with acute HF , there were numerically fewer events with apixaban than placebo ( 14.8 vs 19.3 , HR 0.76 , 95 % CI 0.57-1 .01 , interaction P = .13 ) , a trend that was not seen in patients with prior HF or no HF .


In high-risk patients post-ACS , both prior and acute HFs are associated with an increased risk of subsequent clinical events .


Apixaban did not significantly reduce clinical events and increased bleeding in patients with and without HF ; however , there was a tendency toward fewer clinical events with apixaban in patients with acute HF .


It was the aim of this study to find an optimal therapeutic regimen of transarterial chemoembolization ( TACE ) by comparing the efficacy of chemoembolization with different anticancer agents in hepatocellular carcinoma ( HCC ) patients .


A single-blind , three-group parallel , randomized trial was conducted in Guangdong General Hospital , Guangzhou , China , with patients with biopsy-confirmed HCC .


Group 1 received single-drug ( doxorubicin ) chemoembolization , while group 2 received double-drug ( doxorubicin and mitomycin C ) chemoembolization .


Patients in group 3 were treated with triple-drug ( doxorubicin , mitomycin C , and gemcitabine ) chemoembolization .


Lipiodol was used as embolization agent in all protocols .


We compared the overall survival ( OS ) , time to progression ( TTP ) , and objective response rate ( ORR ) between groups .


Response assessment was performed according to modified RECIST ( Response Evaluation Criteria In Solid Tumors ) criteria .


Between January 2008 and January 2011 , 162 patients ( group 1 , n = 50 ; group 2 , n = 59 ; group 3 , n = 53 ) were recruited .


The OS and TTP in groups 1 , 2 , and 3 were 14.9 and 6.4 , 13.2 and 6.4 , and 20.5 and 6.8 months , respectively .


OS and TTP were statistically significant among groups ( p = 0.002 and p = 0.037 ) .


The ORR was 22.0 , 40.7 , and 56.6 % , respectively .


The ORR was significantly different across the three groups ( p < 0.002 ) .


TACE with multiple chemotherapeutic agents might significantly increase survival and tumor response ; additionally , gemcitabine was likely to have an advantage in improving the prognosis of HCC patients .


2015 S. Karger AG , Basel .


Many patients with type 2 diabetes mellitus ( T2DM ) on insulin therapy have inadequate glycaemic control .


In such cases , Dutch guidelines recommend unlimited up-titration of insulin , yet in practice many patients never reach their glycaemic target .


Clinical evidence shows that dapagliflozin-a highly selective sodium-glucose cotransporter 2 inhibitor-meets a need for these patients , i.e. by reducing glycated haemoglobin levels and bodyweight .


We estimated the cost effectiveness and cost utility of adding dapagliflozin to insulin compared with not adding dapagliflozin in patients with T2DM who have inadequate glycaemic control while on insulin .


The cost effectiveness of dapagliflozin was estimated using the Cardiff Diabetes Model , using direct comparative efficacy data from a randomized placebo-controlled trial ( ClinicalTrials.gov identifier NCT00673231 ) .


In this trial , up-titration of insulin was allowed in case of severe glycaemic imbalance .


Risk factor progression and the occurrence of future vascular events were estimated using the United Kingdom Prospective Diabetes Study 68 risk equations .


Costs and utilities were derived from the literature .


The analysis was conducted from the societal perspective , simulating the remaining lifetime of the patients .


The overall incidence of macro - and microvascular complications was lower , and life expectancy was greater ( 19.43 versus 19.35 life-years [ LYs ] ) in patients receiving dapagliflozin than in those not receiving dapagliflozin .


Patients in the dapagliflozin arm obtained an incremental benefit of 0.42 quality-adjusted life-years ( QALYs ) .


The lifetime incremental cost per patient in the dapagliflozin arm was 2,293 , resulting in an incremental cost-effectiveness ratio of 27,779 per LY gained and an incremental cost-utility ratio of 5,502 per QALY gained .


Sensitivity and scenario analyses showed that the results were insensitive to variations in modelling assumptions and input variables .


Dapagliflozin in combination with insulin was estimated to be a cost-effective treatment option for patients with T2DM whose insulin treatment regimen does not provide adequate glycaemic control in a Dutch healthcare setting .


The objective of our study was to use proton MR spectroscopy ( MRS ) to quantitatively evaluate bone marrow infiltration by measuring the fat fraction ( FF ) and to compare the FF with semiquantitative bone marrow MRI scores and clinical status in children treated for type 1 Gaucher disease ( GD ) .


Over a 2-year period , we prospectively evaluated 10 treated GD patients ( six males , four females ; median age , 15.1 years ) and 10 healthy age-matched control subjects ( five males , five females ; median age , 15.3 years ) using 3-T proton MRS of L5 and the femoral neck .


Water and lipid AUCs were measured to calculate the FF .


Two blinded pediatric musculoskeletal radiologists performed a semiquantitative analysis of the conventional MR images using the bone marrow burden score and modified Spanish MRI score .


We evaluated symptoms , spleen and liver volumes , platelet levels , hemoglobin levels , and bone complications .


In the femur , the FF was higher in the control subjects ( median , 0.71 ) than the GD patients ( 0.54 ) ( p = 0.02 ) .


In L5 , the difference in FF -- higher FF in control subjects ( 0.37 ) than in GD patients ( 0.26 ) -- was not significant ( p = 0.16 ) .


In both groups and both regions , the FF increased with patient age ( p < 0.02 ) .


Semiquantitative scores showed no differences between control subjects and treated GD patients ( p > 0.11 ) .


Eight of 10 GD patients were asymptomatic and two had chronic bone pain .


The median age of patients at symptom onset was 4.0 years , the median age of patients at the initiation of enzyme replacement therapy was 4.3 years , and the median treatment duration was 10.2 years .


Hemoglobin level , platelet count , and liver volume at MRI were normal .


Mean pretreatment spleen volume ( 15.4-fold above normal ) decreased to 2.8-fold above normal at the time of MRI ( p = 0.01 ) .


Proton MRS detected FF differences that were undetectable using conventional MRI ; for that reason , proton MRS can be used to optimize treatment of GD patients .


Proper bioequivalence studies comparing original with generic immunosuppressive drugs in patients are limited , especially in the increasing population of elderly renal transplant recipients .


We performed an open-label , single-center , prospective , randomized , cross-over study and compared steady-state pharmacokinetics ( PK ) of a generic tacrolimus ( Tacni ) formulation with the original ( Prograf ) in renal transplant recipients older than 60 years .


Twenty-eight patients , with a median age of 69 years ( range , 60 to 78 ) , were randomized at time of transplantation to receive original or generic tacrolimus , and 25 ( 21 men , 4 women ) provided two evaluable 12-hr PK profiles .


The PK investigations were performed in a stable phase approximately 6 and 8 weeks postengraftment .


After the first PK investigation , tacrolimus formulations were switched ( 1:1 dose ratio ) .


Generic tacrolimus did not meet the bioequivalence criteria ; the area under the curve ( 0-12 ) ratio of generic-original tacrolimus formulation was 1.17 ( 90 % confidence interval , 1.10-1 .23 ) and the Cmax ratio was 1.49 ( 90 % confidence interval , 1.35-1 .65 ) .


The generic formulation also showed a shorter time to C ( max ) ( T ( max ) ) ( P = 0.04 ) .


Importantly , the lack of bioequivalence was not reflected in the standard monitoring parameter , trough concentrations ( P = 0.80 ) .


Generic tacrolimus ( Tacni ) was not found to be bioequivalent to the original formulation in elderly renal transplant recipients .


The significantly higher systemic exposure of tacrolimus , despite similar trough concentrations , may in the long run increase the risk of adverse effects .


Autoimmune rheumatic diseases ( ARD ) are characterized by systemic inflammation and may affect multiple organs and cause vascular events such as ischemic stroke and acute myocardial infarction .


However , the association between ARD and increased risk of dementia is uncertain .


This is a retrospective cohort study to investigate and compare the risk of dementia between patients clinically diagnosed with ARD and non-ARD patients during a 5-year follow-up period .


Data were obtained from the Longitudinal Health Insurance Database 2000 ( LHID2000 ) .


We included 1221 patients receiving ambulatory or hospitalization care and 6105 non-ARD patients ; patients were matched by sex , age , and the year of index use of health care .


Each patient was studied for 5 years to identify the subsequent manifestation of dementia .


The data obtained were analyzed by Cox proportional hazard regression .


During the 5-year follow-up period , 30 ARD ( 2.48 % ) and 141 non-ARD patients ( 2.31 % ) developed dementia .


During the 5-year follow-up period , there were no significant differences in the risks of any type of dementia ( adjusted hazard ratio ( HR ) , 1.18 ; 95 % CI , 0.79-1 .76 ) in the ARD group after adjusting for demographics and comorbidities .


Within the 5-year period , patients with and without ARD were found to have similar risks of developing dementia .


The high consumption of low-fat and nonfat dairy products is associated with reduced risk of high blood pressure .


We aimed to investigate whether the solitary addition of nonfat dairy products to the normal routine diet was capable of lowering blood pressure in middle-aged and older adults with elevated blood pressure .


With the use of a randomized , crossover intervention-study design , 49 adults ( 56 % women ) with elevated blood pressure ( mean SEM age : 53 2 y ; systolic blood pressure : 135 1 ; diastolic blood pressure : 80 1 mm Hg ) underwent a high-dairy condition ( +4 servings conventional nonfat dairy products/d ) and isocaloric no-dairy condition ( +4 servings fruit products/d ) in which all dairy products were removed .


Both dietary conditions lasted 4 wk with a 2-wk washout before crossing over into the alternate condition .


The high-dairy condition produced reductions in systolic blood pressure ( 135 1 to 127 1 mm Hg ) and pulse pressure ( 54 1 to 48 1 mm Hg ) ( both P < 0.05 ) .


The hypotensive effects were observed within 3 wk after the initiation of the dietary intervention and in both casual seated and ambulatory ( 24-h ) measurements ( P < 0.05 ) .


Pulse pressure was increased after the removal of all dairy products in the no-dairy condition ( 54 1 to 56 1 mm Hg ; P < 0.05 ) .


There were no changes in diastolic blood pressure after either dietary condition .


We concluded that the solitary manipulation of conventional dairy products in the normal routine diet would modulate blood pressure in middle-aged and older adults with prehypertension and hypertension .


This trial was registered at clinicaltrials.gov as NCT01577030 .


Potent antibody depletion techniques have paved the way to successful ABO-incompatible transplantation .


Considering its efficiency regarding IgG removal , the use of non-antigen-specific semi-selective immunoadsorption ( IA ) has been advocated .


One attractive strategy to overcome the caveat of incomplete IgM depletion and to interfere with complement activation could be the adjunctive use of membrane filtration ( MF ) to enhance the removal of macromolecules .


To investigate the depletion efficiency of semi-selective IA plus MF , we conducted a randomized , controlled , cross-over trial including patients on regular IA treatment for indications outside recipient desensitization .


According to the results of sample size calculation , 14 subjects were enrolled .


Two treatment sequences , a single session of IA plus MF followed by IA alone after 7 days ( and vice versa ) , were analysed .


IA plus MF markedly enhanced the median per cent reduction of ABO-specific IgM determined by flow cytometry ( primary end point ; 59 versus 23 % , P < 0.001 ) and haemagglutination ( 2 versus 1 titre steps , P < 0.001 ) , respectively .


Combined treatment also substantially lowered C1q concentrations ( 86 versus 58 % reduction , P < 0.001 ) and the functionality of classical complement as reflected by impaired in vitro C3 activation capability .


IgG was strongly reduced without any additional effect of MF .


We demonstrate that the innovative strategy of combining MF with semi-selective IA may substantially increase IgM elimination and affect classical complement activation .


Our findings suggest that this new treatment concept could be an efficient strategy for recipient desensitization in ABO - and HLA-incompatible transplantation .


This study examined the effect of brief functional relaxation ( FR ) training on needle anxiety ( NA ) during vaccinations .


From October 2010 through May 2012 , 48 undergraduates were recruited through the psychology research participant pool .


Students ( N = 48 ) were randomly assigned to a 15-minute brief FR session delivered via MP3 player or a standard care condition ( 15 minutes of sitting quietly ) prior to receiving injections at the immunization clinic .


Measures were completed before ( T1 ) and after ( T2 ) the assigned condition , assessing expected NA , state anxiety , blood pressure , and heart rate ; and after the injection ( T3 ) , self-reported NA during the injection .


Unexpectedly , the groups did not differ at T2 .


However , during the injection , brief FR participants indicated lower self-reported NA ( T3 ) than standard care .


Brief FR is a simple , inexpensive technique that may reduce NA in college health settings and help decrease delays in treatment seeking .


Little is known about the relationship between body temperature and outcomes in patients with acute respiratory distress syndrome ( ARDS ) .


A better understanding of this relationship may provide evidence for fever suppression or warming interventions , which are commonly applied in practice .


To examine the relationship between body temperature and mortality in patients with ARDS .


Secondary analysis of body temperature and mortality using data from the ARDS Network Fluid and Catheter Treatment Trial ( n = 969 ) .


Body temperature at baseline and on study day 2 , primary cause of ARDS , severity of illness , and 90-day mortality were analyzed by using multiple logistic regression .


Mean baseline temperature was 37.5 C ( SD , 1.1 C ; range , 27.2C-40 .7 C ) .


At baseline , fever ( 38.3 C ) was present in 23 % and hypothermia ( < 36C ) in 5 % of the patients .


Body temperature was a significant predictor of 90-day mortality after primary cause of ARDS and score on the Acute Physiology and Chronic Health Evaluation III were adjusted for .


Higher temperature was associated with decreased mortality : for every 1C increase in baseline temperature , the odds of death decreased by 15 % ( odds ratio , 0.85 ; 95 % CI , 0.73-0 .98 , P = .03 ) .


When patients were divided into 5 temperature groups , mortality was lower with higher temperature ( P for trend = .02 ) .


Early in ARDS , fever is associated with improved survival rates .


Fever in the acute phase response to lung injury and its relationship to recovery may be an important factor in determining patients ' outcome and warrants further study .


Endoscopic examinations carry a potential risk of cross-infection , and the traditional reprocessing method is time consuming .


We evaluated the safety and efficacy of a novel disposable sheathed gastroscope system in clinical practice in comparison with the conventional gastroscope .


There were two phases in the study .


In phase 1 , 20 patients with hepatitis B were randomized into two groups : the sheathed group was examined with the novel disposable sheathed gastroscope ( n = 10 ) and the conventional group with the conventional gastroscope ( n = 10 ) .


Microbiologic tests were performed on each endoscope afterwards .


In the second phase , 1120 patients were randomized again into the same two groups with 568 and 552 patients in the sheathed group and the conventional group , respectively .


The time duration of the endoscopic procedure and reprocessing were measured .


The pathology detection rate of endoscopic examinations , the patients ' subjective feelings , and problems occurred during procedures were also recorded .


The total instrument turn-around time in the phase 2 sheathed group ( 9.9 1.3 min ) was significantly shorter than the conventional group ( 39.0 1.4 min , P = 0.000 ) .


The mean procedural time was slightly longer in the sheathed group than in the conventional group ( 4.9 1.4 vs 4.1 1.3 min , P = 0.000 ) .


However , the duration of endoscopic reprocessing was much shorter ( 4.9 0.2 vs 35 0.2 min , P = 0.000 ) .


No significant differences were observed in patient discomfort , optical clarity , or pathology detection rate .


There were no complications in either group , and no microbial contamination was detected in phase 1 of the study .


Compared with the conventional gastroscope , the novel disposable sheathed gastroendoscope is safe and more efficient in clinical practice .


To evaluate the outcome of the non-skin thinning technique as compared with the thinning technique 5 years after surgical implantation of bone-anchored hearing `` devices . ''


A single-center , 5-year retrospective follow-up study was designed to evaluate the novel surgical technique without skin thinning as compared to conventional techniques .


Eligible patients were consecutively operated on 5 years earlier in a test group without thinning and in two control groups with thinning .


In the first control group , a flap technique was used , whereas in the second control group a dermatome technique was used and age-matched patients were selected .


Thirty-six patients were operated on with a single-step surgery under local anesthesia .


In the test group ( non-skin thinning technique ) , 12 patients were operated on with a linear incision using an 8.5-mm abutment .


In the control groups ( flap and dermatome techniques , 12 patients in each group ) , the standard protocol with skin thinning was used with a 5.5-mm abutment .


Throughout the 5-year span under review , the non-skin thinning test group exhibited good preservation of tissue with decreased skin reactions and no adverse events .


The time required for surgery without skin thinning was reduced to approximately 10 to 15 minutes and the cosmetic outcome after 5 years was improved .


Numbness and peri-implant infections were minimal in the surrounding skin area for patients who underwent surgery without thinning .


This 5-year follow-up study demonstrates that percutaneous osseointegrated implantation without skin thinning is safe and has a better outcome than implantation with skin thinning .


The two primary residential options for older adults who require supportive care are nursing homes and residential care/assisted living .


More than one-quarter of all deaths in the U.S. occur in these settings .


Although the information available on end of life in long-term care has been growing , the comparative suitability of various measures to guide this work is unknown .


To determine the optimal measures to assess end-of-life care and outcomes in nursing homes and residential care/assisted living .


A total of 264 family members of decedents from 118 settings were interviewed and provided data on 11 instruments that have been used in , but not necessarily developed for , long-term care populations ; Overall , 20 scales and subscales/indices were evaluated .


Measures were compared on their psychometric properties and the extent to which they discriminated among important resident , family , and setting characteristics .


Prioritizing measures that distinguish the assessment of care from the assessment of dying , and secondarily thatexhibit an acceptable factor structure , this study recommends two measures of care-the Family Perceptions of Physician-Family Caregiver Communication and the End of Life in Dementia ( EOLD ) - Satisfaction With Care-and two measures of outcomes-the EOLD-Symptom Management and the EOLD-Comfort Assessment in Dying .


An additional measure to assess outcomes is the Mini-Suffering State Examination ( MSSE ) .


The care measures and the MSSE are especially valuable as they discriminate between decedents who were and were not transferred immediately before death , an important outcome , and whether the family expected the death , a useful target for intervention .


Despite these recommendations , measurement selection should be informed not only on the basis of psychometric properties but also by specific clinical and research needs .


The data in this manuscript will help researchers , clinicians , and administrators understand the implications of choosing various measures for their work .


To explore the effect of Tongfu Jinghua Decoction ( TJD ) on hemodynamics and tissue oxygen metabolism in patients with post-traumatic sepsis shock .


Totally 60 patients were randomly assigned to the treatment group and the control group , 30 in each group .


Patients in the treatment group took TJD or were administered with TJD by nasal feeding in combined with conventional Western medical treatment , while patients in the control group only received conventional Western medical treatment .


Changes of each index in hemodynamics and tissue oxygen metabolism were observed before treatment , and at 6 , 12 , 24 , and 48 h after treatment .


Compared with before treatment in the same group , hemodynamic changes were significantly improved at each time point in the two groups .


All indices of tissue oxygen metabolism at each time point of the two groups were significantly improved , except changes of O2 extraction ratio ( ER ) after treatment in the control group ( P < 0.05 , P < 0.01 ) .


Compared with the control group in the same period , heart rate ( HR ) , systemic vascular resist - ance ( SVR ) , and cardiac output ( CO ) were significantly improved with statistical difference ( P < 0.05 , P < 0.01 ) .


Mean arterial pressure ( MAP ) , central venous pressure ( CVP ) , and cardiac index ( CI ) were significantly improved at 6 , 12 , and 24 h after treatment with statistical difference ( P < 0.05 , P < 0.01 ) .


Each index of tissue oxygen metabolism in the treatment group were all improved at each time point with statistical difference ( P < 0.05 , P < 0.01 ) .