No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release , the duration of mechanical ventilation , the length of stay in the intensive care unit or the hospital , new onset of atrial fibrillation , and the incidence of postoperative delirium .


No RIPC-related adverse events were observed .


Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery .


( Funded by the German Research Foundation ; RIPHeart ClinicalTrials.gov number , NCT01067703 . )


An estimated 366 million people are living with diabetes worldwide and it is predicted that its prevalence will increase to 552 million by 2030 .


Management of this disease and its complications is a challenge for many countries .


Optimal glycaemic control is necessary to minimize complications , but less than 70 % of diabetic patients achieve target levels of blood glucose , partly due to poor access to qualified health care providers .


Telemedicine has the potential to improve access to health care , especially for rural and remote residents .


Video teleconsultation , a real-time ( or synchronous ) mode of telemedicine , is gaining more popularity around the world through recent improvements in digital telecommunications .


If video consultation is to be offered as an alternative to face-to-face consultation in diabetes assessment and management , then it is important to demonstrate that this can be achieved without loss of clinical fidelity .


This paper describes the protocol of a randomised controlled trail for assessing the reliability of remote video consultation for people with diabetes .


A total of 160 people with diabetes will be randomised into either a Telemedicine or a Reference group .


Participants in the Reference group will receive two sequential face-to-face consultations whereas in the Telemedicine group one consultation will be conducted face-to-face and the other via videoconference .


The primary outcome measure will be a change in the patient 's medication .


Secondary outcome measures will be findings in physical examination , detecting complications , and patient satisfaction .


A difference of less than 20 % in the aggregated level of agreement between the two study groups will be used to identify if videoconference is non-inferior to traditional mode of clinical care ( face-to-face ) .


Despite rapid growth in application of telemedicine in a variety of medical specialties , little is known about the reliability of videoconferencing for remote consultation of people with diabetes .


Results of this proposed study will provide evidence of the reliability of specialist consultation offered by videoconference for people with diabetes .


Australian New Zealand Clinical Trials Registry ACTRN12612000315819 .


The relationship of hormones adiponectin , leptin and tumor necrosis factor-alpha in adipose tissue on the atherogenic process is one of the most promising models in preventive medicine .


The numerous tests performed to identify the effect of exercise on these hormones have not been clear on the type of exercise routine and physical effort calculated to contribute to changing plasma concentrations in obese women .


Analyze controlledcardiovascular exercise effect on serum level of adiponectin , leptin , and tumournecrosis factor-alpha in obese young women .


A simple blind clinical essay .


The intervention covered a 10-week controlled , cardiovascular exercise program by 34 women ( cases n = 17 , controls n = 17 ) with a body mass index > 27kg/m ( 2 ) .


Molecular analysis was performed by immune-fluorescence .


Following the intervention , cases and controls means were as follows : adiponectin 19.0 vs. 12.2 / ml ( P = .008 ) ; leptin 20.0 vs. 28.0 / L ( P = .02 ) ; and tumour necrosis factor-alpha 4.7 vs. 5.1 pg/ml ( P = .05 ) .


The established exercise ( 5 sessions a week of exercise of 40min each for 10 weeks with a heart rate reserve of 40 to 80 % ) improved plasma concentrations of these hormones in the expected direction .


This finding highlights an unpublished amount of exercise , controlled by the reserve cardiac frequency that might contribute the cardiovascular and metabolic protection to obese women .


To determine the feasibility and pilot a sleep education program in New Zealand high school students .


A parallel , two-arm randomized controlled pilot trial was conducted .


High school students ( 13 to 16 years ) were randomly allocated to either a classroom-based sleep education program intervention ( n = 15 ) or to a usual curriculum control group ( n = 14 ) .


The sleep education program involved four 50-minute classroom-based education sessions with interactive groups .


Students completed a 7-day sleep diary , a sleep questionnaire ( including sleep hygiene , knowledge and problems ) at baseline , post-intervention ( 4 weeks ) and 10 weeks follow-up .


An overall treatment effect was observed for weekend sleep duration ( F 1,24 = 5.21 , p = 0.03 ) .


Participants in the intervention group slept longer during weekend nights at 5 weeks ( 1:37 h : min , p = 0.01 ) and 10 weeks : ( 1:32 h : min , p = 0.03 ) compared to those in the control group .


No differences were found between groups for sleep duration on weekday nights .


No significant differences were observed between groups for any of the secondary outcomes ( sleep hygiene , sleep problems , or sleep knowledge ) .


A sleep education program appears to increase weekend sleep duration in the short term .


Although this program was feasible , most schools are under time and resource pressure , thus alternative methods of delivery should be assessed for feasibility and efficacy .


Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes .


A commentary on this article appears in this issue on page 793 .


X-linked hypophosphatemia ( XLH ) is the most common heritable form of rickets and osteomalacia .


XLH-associated mutations in phosphate-regulating endopeptidase ( PHEX ) result in elevated serum FGF23 , decreased renal phosphate reabsorption , and low serum concentrations of phosphate ( inorganic phosphorus , Pi ) and 1,25-dihydroxyvitamin D [ 1,25 ( OH ) 2D ] .


KRN23 is a human anti-FGF23 antibody developed as a potential treatment for XLH .


Here , we have assessed the safety , tolerability , pharmacokinetics ( PK ) , pharmacodynamics ( PD ) , and immunogenicity of KRN23 following a single i.v. or s.c. dose of KRN23 in adults with XLH .


Thirty-eight XLH patients were randomized to receive a single dose of KRN23 ( 0.003-0 .3 mg/kg i.v. or 0.1-1 mg/kg s.c. ) or placebo .


PK , PD , immunogenicity , safety , and tolerability were assessed for up to 50 days .


KRN23 significantly increased the maximum renal tubular threshold for phosphate reabsorption ( TmP/GFR ) , serum Pi , and 1,25 ( OH ) 2D compared with that of placebo ( P < 0.01 ) .


The maximum serum Pi concentration occurred later following s.c. dosing ( 8-15 days ) compared with that seen with i.v. dosing ( 0.5-4 days ) .


The effect duration was dose related and persisted longer in patients who received s.c. administration .


Changes from baseline in TmP/GFR , serum Pi , and serum 1,25 ( OH ) 2D correlated with serum KRN23 concentrations .


The mean t1/2 of KRN23 was 8-12 days after i.v. administration and 13-19 days after s.c. administration .


Patients did not exhibit increased nephrocalcinosis or develop hypercalciuria , hypercalcemia , anti-KRN23 antibodies , or elevated serum parathyroid hormone ( PTH ) or creatinine .


KRN23 increased TmP/GFR , serum Pi , and serum 1,25 ( OH ) 2D .


The positive effect of KR23 on serum Pi and its favorable safety profile suggest utility for KRN23 in XLH patients .


Trial registration .


Clinicaltrials.gov NCT00830674 .


Funding .


Kyowa Hakko Kirin Pharma , Inc. .


The PREDIMED ( Prevencin con Dieta Mediterrnea ) randomized primary prevention trial showed that a Mediterranean diet enriched with either extravirgin olive oil or mixed nuts reduces the incidence of stroke , myocardial infarction , and cardiovascular mortality .


We assessed the effect of these diets on the incidence of atrial fibrillation in the PREDIMED trial .


Participants were randomly assigned to 1 of 3 diets : Mediterranean diet supplemented with extravirgin olive oil , Mediterranean diet supplemented with mixed nuts , or advice to follow a low-fat diet ( control group ) .


Incident atrial fibrillation was adjudicated during follow-up by an events committee blinded to dietary group allocation .


Among 6705 participants without prevalent atrial fibrillation at randomization , we observed 72 new cases of atrial fibrillation in the Mediterranean diet with extravirgin olive oil group , 82 in the Mediterranean diet with mixed nuts group , and 92 in the control group after median follow-up of 4.7 years .


The Mediterranean diet with extravirgin olive oil significantly reduced the risk of atrial fibrillation ( hazard ratio , 0.62 ; 95 % confidence interval , 0.45-0 .85 compared with the control group ) .


No effect was found for the Mediterranean diet with nuts ( hazard ratio , 0.89 ; 95 % confidence interval , 0.65-1 .20 ) .


In the absence of proven interventions for the primary prevention of atrial fibrillation , this post hoc analysis of the PREDIMED trial suggests that extravirgin olive oil in the context of a Mediterranean dietary pattern may reduce the risk of atrial fibrillation .


http://www.controlled-trials.com .


Unique identifier : ISRCTN35739639 .


To evaluate the analgesic effect of music and audiobooks in children undergoing major surgical procedures when compared to a control ( silence ) group .


The study was a prospective and randomized trial .


Children undergoing major surgeries were randomized to one of the three groups : music , audiobook or control ( silence ) .


The primary outcome was the pain burden reduction by two treatments within 48h postoperatively .


Pain burden was measured using the area under the pain scale versus the 30min interval for each treatment .


60 patients were recruited and 56 completed the study .


Pain burden was reduced in the music and audiobook groups compared to control , median ( IQR ) of -60 ( -90 to 0 ) , -45 ( -90 to 0 ) and 0 ( -30 to 90 ) ( minpain score ) , respectively , P = 0.04 .


A linear regression analysis demonstrated an independent group effect on pain reduction even after adjusting for the mean pain scores recorded at the beginning of the treatment , slope of regression line -56.824 goodness of fit r ( 2 ) = 0.25 and slope significantly different from 0 ( P = 0.02 ) .


Audio therapy is an efficacious adjunct method to decrease post-surgical pain in children undergoing major surgeries .


Audio therapy should be considered as an important strategy to minimize pain in children undergoing major surgery .


Low birth weight ( LBW ) is an important public health problem in undernourished populations .


We tested whether improving women 's dietary micronutrient quality before conception and throughout pregnancy increases birth weight in a high-risk Indian population .


The study was a nonblinded , individually randomized controlled trial .


The intervention was a daily snack made from green leafy vegetables , fruit , and milk ( treatment group ) or low-micronutrient vegetables ( potato and onion ) ( control group ) from 90 d before pregnancy until delivery in addition to the usual diet .


Treatment snacks contained 0.69 MJ of energy ( controls : 0.37 MJ ) and 10-23 % of WHO Reference Nutrient Intakes of - carotene , riboflavin , folate , vitamin B-12 , calcium , and iron ( controls : 0-7 % ) .


The primary outcome was birth weight .


Of 6513 women randomly assigned , 2291 women became pregnant , 1962 women delivered live singleton newborns , and 1360 newborns were measured .


In an intention-to-treat analysis , there was no overall increase in birth weight in the treatment group ( +26 g ; 95 % CI : -15 , 68 g ; P = 0.22 ) .


There was an interaction ( P < 0.001 ) between the allocation group and maternal prepregnant body mass index ( BMI ; in kg/m ( 2 ) ) [ birth-weight effect : -23 , +34 , and +96 g in lowest ( < 18.6 ) , middle ( 18.6-21 .8 ) , and highest ( > 21.8 ) thirds of BMI , respectively ] .


In 1094 newborns whose mothers started supplementation 90 d before pregnancy ( per-protocol analysis ) , birth weight was higher in the treatment group ( +48 g ; 95 % CI : 1 , 96 g ; P = 0.046 ) .


Again , the effect increased with maternal BMI ( -8 , +79 , and +113 g ; P-interaction = 0.001 ) .


There were similar results for LBW ( intention-to-treat OR : 0.83 ; 95 % CI : 0.66 , 1.05 ; P = 0.10 ; per-protocol OR = 0.76 ; 95 % CI : 0.59 , 0.98 ; P = 0.03 ) but no effect on gestational age in either analysis .


A daily snack providing additional green leafy vegetables , fruit , and milk before conception and throughout pregnancy had no overall effect on birth weight .


Per-protocol and subgroup analyses indicated a possible increase in birth weight if the mother was supplemented 3 mo before conception and was not underweight .


This trial was registered at www.controlled-trials.com/isrctn/ as ISRCTN62811278 .


It is unclear whether thiazide diuretics ( TZs ) or calcium channel blockers ( CCBs ) are more effective as add-on therapy to angiotensin receptor blockers ( ARBs ) in controlling hypertension .


Because TZs are a rational choice in salt-sensitive hypertension , patients with high salt intake might preferentially benefit from ARB/TZ over ARB/CCB combination therapy .


Hypertensive patients who failed to reach blood pressure goals despite treatment with ARBs alone were randomly assigned to receive either ARB/TZ or ARB/CCB combination therapy .


Estimated daily sodium intake was calculated from spot urine values of sodium and creatinine .


Blood pressure was measured at baseline , and at 4 , 8 and 12 weeks after starting combination therapy .


For all study patients ( n = 87 ) , diastolic blood pressure reduction was greater in patients receiving ARB/CCB treatment .


However , in the 37 patients with a baseline estimated daily salt intake greater than 10 g and baseline systolic blood pressure ( SBP ) ranging from 150 to 200 mm Hg , SBP was lower ( P < 0.05 ) and SBP reduction was greater ( P < 0.05 ) 4 weeks after starting combination therapy in those receiving ARB/TZ treatment .


In the 31 patients whose estimated daily salt intake increased at 12 weeks compared with baseline , SBP at 12 weeks was lower in those receiving ARB/TZ treatment ( P < 0.05 ) .


Estimated daily salt intake is a useful tool for guiding antihypertensive therapy and should be measured repeatedly during the therapeutic course .


To evaluate the effects of preservative-free 0.45 % ketorolac tromethamine and artificial tears ( carboxymethylcellulose ) compared with those of preservative-free artificial tears alone on the symptoms and signs of acute viral conjunctivitis .


This was a randomized , double-masked clinical trial that included 50 patients who were diagnosed with acute viral conjunctivitis and distributed into two groups ( Group 0 : artificial tears and Group 1 : 0.45 % ketorolac tromethamine + carboxymethylcellulose ) .


The patients were instructed to use the medication 4 times daily .


Signs ( conjunctival hyperemia , chemosis , follicles , and secretion ) and symptoms ( general ocular discomfort , itching , foreign body sensation , tearing , redness , and swelling of the eyelids ) were scored at baseline and on the third and seventh days of treatment using a standardized questionnaire and slitlamp anterior segment examination .


Both groups showed an improvement in the signs and symptoms of conjunctivitis in their follow-up visits .


There was no significant difference in symptom and sign scores between Group 0 and Group 1 in the study visits ( p > 0.05 ) .


The frequency of side effects during treatment was similar between groups ( p > 0.05 ) .


Our findings indicate that 0.45 % ketorolac tromethamine was not superior to the use of artificial tears in relieving the signs and symptoms of viral conjunctivitis .


To apply role - play simulation in pre-clinical practice of the fourth grade students in department of endodontics .


Thirty-two students were randomly divided into 2 groups , there were 16 students in each group .


Students in one group were taught with role-play simulation while the other group with lecture-based learning method .


The teaching effect was measured with examination and questionnaire survey .


The data was analyzed by using SPSS 17.0 software package .


There were no significant differences in basic knowledge , case analysis and oral examination between 2 groups ( P > 0.05 ) , but there was significant difference in history taking and medical records writing , practical examination and total scores between 2 groups ( P < 0.05 ) .


The role-play simulation was generally approved by both teachers and students in experimental group .


The abilities of the fourth grade students can be developed by role-play simulation in different aspects .


Role-play simulation can be applied in pre-clinical practice of the fourth grade students in department of endodontics .


The purpose of this 2-phase project was to conduct a formative evaluation and to test the preliminary efficacy of a newly developed Web-based Tailored Intervention for Preparation of parents and children undergoing Surgery ( WebTIPS ) .


Phase 1 enrolled 13 children 2 to 7 years of age undergoing outpatient elective surgery and their parents for formative evaluation of WebTIPS .


Parent participation focus groups are common in qualitative research and are a method of asking research participants about their perceptions and attitudes regarding a product or concept .


In phase 2 , children 2 to 7 years of age in 2 medical centers were assigned randomly to receive the WebTIPS program ( n = 38 ) compared with children receiving the standard of care ( n = 44 ) .


The primary outcome of phase II was child and parent preoperative anxiety .


In phase 2 , parents reported WebTIPS to be both helpful ( P < 0.001 ) and easy to use ( P < 0.001 ) .


In phase 2 , children in the WebTIPS group ( 36.2 14.1 ) were less anxious than children in the standard of care group ( 46.0 19.0 ) at entrance to the operating room ( P = 0.02 ; Cohen d = 0.59 ) and introduction of the anesthesia mask ( 43.5 21.7 vs 57.0 21.2 , respectively , P = 0.01 ; Cohen d = 0.63 ) .


Parents in the WebTIPS group ( 32.1 7.4 ) also experienced less anxiety compared with parents in the control group ( 36.8 7.1 ) in the preoperative holding area ( P = 0.004 ; Cohen d = 0.65 ) .


WebTIPS was well received by parents and children and led to reductions in preoperative anxiety .


To investigate the efficacy of a standard triple therapy ( comprising rabeprazole , clarithromycin , and amoxicillin ) for Helicobacter pylori ( H. pylori ) eradication , noting factors that influence the outcome and documenting any adverse events .


Following institutional ethical approval , fifty consecutive and consenting symptomatic patients with evidence of H. pylori infection by either a positive urea breath test ( UBT ) and/or a campylobacter-like organism test who presented to the Gastroenterology clinic of Lagos State University Teaching Hospital between 2012 and 2013 were recruited into the study .


Patients were openly randomized to either a 7-d or a 10-d regimen of amoxicillin 1 g , clarithromycin 500 mg and rabeprazole 20 mg twice daily .


The extent of symptom resolution was noted following the treatment , and at the end of one month after the completion of treatment , a repeat UBT was performed in each patient to document the eradication of the infection .


All data ( demographics , symptoms , and eradication rates ) were collated and analyzed with SPSS version 18 .


Forty-seven patients completed the study ( three were excluded from the analysis for breaching the study protocol ) .


The patients included 18 males and 29 females within the age range of 13-80 years ( mean 43.7 , SD 16.8 ) .


The clinical features of the study subjects were dyspepsia , reflux symptoms and features of gastrointestinal bleeding .


The average eradication rate was 87.2 % .


Eighteen subjects were enrolled in the 7-d arm , while 29 were in the 10-d arm .


There was no statistically significant difference in the age or sex distributions of the two arms .


There was no significant advantage of the 10-d treatment duration over the 7-d duration ( P = 0.78 ) , and the eradication outcomes were not influenced by the gender or age of the subjects .


No adverse effects were reported in either arm .


The triple therapy regime , employing a combination of amoxicillin , clarithromycin and rabeprazole , showed great efficacy and safety in the eradication of H. pylori , and this outcome was not influenced by gender or age .


No difference was observed between the 7-d and 10-d regimens .


Traditional Chinese medicine ( TCM ) has accumulated some experience in curing stable angina pectoris ( SAP ) and efficacy has been demonstrated .


Chinese patent medicines , known as modern dosage forms of TCM , can attain the desired effect in clinical application only with the guidance of TCM syndrome theory .


However , due to their use by a large number of persons with little knowledge of TCM theories and practices , their efficacy and reputation have been seriously affected .


Two common syndrome types of SAP in TCM , ` qi deficiency and blood stasis ' and ` qi stagnation and blood stasis ' , will be studied in 144 subjects from four TCM hospitals in Tianjin in China using a partial crossover design .


The two syndromes will be broken down into six symptom combinations ; patients will select a combination of the most distressing to them , and then will be randomised into two groups .


Each group , on the basis of routine medication , will be administered one kind of Chinese patent drug : Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills .


The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team .


This protocol has been approved by the medical ethics committee of Tianjin University of TCM ( registration number TJUTCM-EC20130005 ) .


The study is safe and reliable .


Chinese clinical trials register ChiCTR-TTRCC-14004406 .


Oral appliances that move the mandible forward during sleep are suggested as treatment for mild to moderate obstructive sleep apnea .


To test whether an adjustable , custom-made oral appliance improves daytime sleepiness and quality of life in patients with daytime sleepiness and snoring or mild to moderate obstructive sleep apnea .


Ninety-six patients with daytime sleepiness and an apnea-hypopnea index ( AHI ) lower than 30 were included in a randomized , placebo-controlled , parallel trial in Ume , Sweden , from May 2007 through August 2011 .


Four months ' intervention with an oral appliance or a placebo device .


Daytime sleepiness was measured with the Epworth Sleepiness Scale , the Karolinska Sleepiness Scale , and the Oxford Sleep Resistance ( OSLER ) test .


Quality of life was assessed with the Short-Form 36-Item Health Survey ( SF-36 ) and the Functional Outcomes of Sleep Questionnaire ( FOSQ ) .


Secondary outcomes included the apnea-hypopnea index , headaches , symptoms of restless legs , and insomnia .


Oral appliance therapy was not associated with improvements in daytime sleepiness from baseline to 4-month follow-up when compared with the placebo device ; Epworth score > 10 : 53 % at baseline to 24 % at follow-up for the oral appliance group vs 54 % at baseline to 40 % at follow-up for the placebo device group , P = .11 ; median ( IQR ) for Karolinska score 7/wk : 10 ( 8 to 14 ) at baseline to 7 ( 4 to 9 ) at follow-up for the oral appliance group vs 12 ( 6 to 15 ) at baseline to 8 ( 5 to 12 ) at follow-up for the placebo device group , P = .11 ; mean between-group difference in OSLER test , -2.4 min ( 95 % CI , -6.3 to 1.4 ) .


The mean between-group difference for the total FOSQ score was insignificant ( -1.2 [ 95 % CI , -2.5 to 0.1 ] ) .


No domain of the SF-36 differed significantly between the groups .


The AHI was below 5 in 49 % of patients using the active appliance and in 11 % using placebo , with an odds ratio of 7.8 ( 95 % CI , 2.6-23 .5 ) and a number needed to treat of 3 .


Snoring ( P < .001 ) and symptoms of restless legs ( P = .02 ) were less frequent when using the oral appliance vs placebo , but this did not apply to headache or insomnia .


A custom-made , adjustable oral appliance reduces obstructive sleep apnea , snoring , and possibly restless legs without effects on daytime sleepiness and quality of life among patients with daytime sleepiness and snoring or mild to moderate sleep apnea .


clinicaltrials.gov Identifier : NCT00477009 .


Non-invasive brain stimulation with transcranial direct current stimulation ( tDCS ) modulates cortical excitability and improves upper limb motor performance when applied to chronic stroke patients .


The objective was to evaluate whether tDCS can influence gait function in sub-acute stroke patients .


We assessed the effect of single session , bi-cephalic tDCS on gait performance in 14 subacute patients with stroke involving the cerebral hemisphere ( 2-8 weeks post-stroke ) in a double-blinded , sham-controlled study .


Patients were randomly allocated to receive either active ( n = 7 ) or sham ( n = 7 ) tDCS .


The anodal electrode was placed on the scalp over the ipsilesional lower limb primary motor cortex and the cathode was placed over the contralesional leg motor cortex .


Gait performance was measured using the Timed Up and Go test and the Performance Oriented Mobility Assessment before and after active or sham tDCS .


The tDCS group was significantly quicker in the Timed Up and Go test in the tDCS group , compared to the sham group ( p = 0.018 ) .


The Performance Oriented Mobility Assessment was not different between groups ( p = 0.897 ) .


This is the first study to examine the effects of tDCS on gait in stroke patients in the sub-acute stage .


Active tDCS improved gait performance ( Timed Up and Go ) in stroke patients , despite no changes to limb biomechanics of the hemiparetic side ( Performance Oriented Mobility Assessment ) , as compared to sham stimulation .


These results suggest that tDCS could be used as a therapeutic adjunct for gait rehabilitation following stroke .


The Paliperidone Palmitate Research in Demonstrating Effectiveness ( PRIDE ) study compared the effects of once-monthly paliperidone palmitate with daily oral antipsychotics on treatment failure in adults with schizophrenia .


The PRIDE study is a 15-month , randomized , multicenter study ( May 5 , 2010 , to December 9 , 2013 ) of adult subjects with a DSM-IV diagnosis of schizophrenia and a history of incarceration .


Subjects were randomly assigned to once-monthly paliperidone palmitate injections or daily oral antipsychotics ( randomly assigned from 7 acceptable , prespecified oral antipsychotics ) for 15 months .


The primary end point was time to first treatment failure , defined as arrest/incarceration ; psychiatric hospitalization ; suicide ; treatment discontinuation or supplementation due to inadequate efficacy , safety , or tolerability ; or increased psychiatric services to prevent hospitalization .


Time to first treatment failure was determined by a blinded event-monitoring board and analyzed with the Kaplan-Meier method .


In this study , 450 patients were randomly assigned , and 444 were included in the intent-to-treat population .


Paliperidone palmitate was associated with significant delay in time to first treatment failure versus oral antipsychotics ( hazard ratio , 1.43 ; 95 % CI , 1.09-1 .88 ; log rank P = .011 ) .


Observed treatment failure rates over 15 months were 39.8 % and 53.7 % , respectively .


Arrest/incarceration and psychiatric hospitalization were the most common reasons for treatment failure in the paliperidone palmitate and oral antipsychotic groups ( 21.2 % vs 29.4 % and 8.0 % vs 11.9 % , respectively ) .


The 5 most common treatment-emergent adverse events for the paliperidone palmitate treatment group were injection site pain ( 18.6 % of subjects ) , insomnia ( 16.8 % ) , weight increased ( 11.9 % ) , akathisia ( 11.1 % ) , and anxiety ( 10.6 % ) .


In a trial designed to reflect real-world management of schizophrenia , once-monthly paliperidone palmitate demonstrated superiority compared to oral antipsychotics in delaying time to treatment failure .


Clinicaltrials.gov Identifier : NCT01157351 .


Booster sessions as a means of maintaining the benefits of psycho-educational programs have received little attention in caregiving research .


Caregivers were offered a booster session following participation in a program entitled Learning to Become a Family Caregiver ( LBFC ) intended to facilitate transition to the caregiver role after diagnostic disclosure of dementia in a relative .


The 90-minute booster session served to review program content and afforded the opportunity to discuss and practice learned skills .


This study sought to test the efficacy of the booster session in maintaining or recovering program effects at six months post-program .


Participants in the program were randomly assigned to a group that received the booster session ( n = 31 ) or a group that did not ( n = 29 ) .


A third control group was also formed , which continued to receive only the usual care provided in memory clinics .


Eligible participants - French-speaking primary caregivers of a relative diagnosed with Alzheimer 's in the past nine months - were recruited in memory clinics in Quebec ( Canada ) .


Participants were blindly assessed before randomization and six months after the booster session on outcomes associated with a healthy role transition .


Prediction analyses revealed one significant positive effect of the booster session : emergence of preparedness to provide care .


Moreover , with or without the booster session , the program continued to have a positive effect on psychological distress and contributed to the emergence of self-efficacy in dealing with caregiving situations .


The booster session had no significant effect on knowledge of services , planning for future care needs , use of reframing as a coping strategy , perceived informal support , and family conflicts .


The limited effect observed is discussed in terms of the booster session 's content and intensity .


Recommendations are made for designing future research on the effect of booster sessions , including the importance of including a placebo booster group .


The aim of this study was to compare the effect of a 12-wk exercise therapy program and arthroscopic partial meniscectomy on knee strength and functional performance in middle-aged patients with degenerative meniscus tears .


A total of 82 patients ( mean age , 49 yrs ; 35 % women ) with a symptomatic , unilateral , magnetic resonance imaging-verified degenerative meniscus tear and no or mild radiographic osteoarthritis were randomly assigned to a supervised neuromuscular and strength exercise program or arthroscopic partial meniscectomy .


Outcomes assessed 3 mos after intervention initiation were isokinetic knee muscle strength , lower extremity performance , and self-reported global rating of change .


Mean difference in isokinetic knee extension peak torque between the two groups was 16 % ( 95 % confidence interval , 7.1-24 .0 ) ( P < 0.0001 ) , favoring the exercise group .


Patients in the exercise group improved isokinetic knee extension peak by a mean of 25 Nm ( range , 18-33 Nm ) from baseline to follow-up .


Furthermore , patients assigned to exercise therapy showed statistically significant improvements ( P 0.002 ) in all other measured variables , with moderate to large effect sizes ( 0.5-1 .3 ) .


Patients reported a similar and positive effect of both interventions .


A 12-wk supervised exercise therapy program yielded clinically relevant and statistically significant improvement in isokinetic quadriceps strength immediately after completion of the program , as compared with treatment with arthroscopic partial meniscectomy .


Cervical dystonia is managed mainly by repeated botulinum toxin injections .


We aimed to establish whether pallidal neurostimulation could improve symptoms in patients not adequately responding to chemodenervation or oral drug treatment .


In this randomised , sham-controlled trial , we recruited patients with cervical dystonia from centres in Germany , Norway , and Austria .


Eligible patients ( ie , those aged 18-75 years , disease duration 3 years , Toronto Western Spasmodic Torticollis Rating Scale [ TWSTRS ] severity score 15 points ) were randomly assigned ( 1:1 ) to receive active neurostimulation ( frequency 180 Hz ; pulse width 120 s ; amplitude 05 V below adverse event threshold ) or sham stimulation ( amplitude 0 V ) by computer-generated randomisation lists with randomly permuted block lengths stratified by centre .


All patients , masked to treatment assignment , were implanted with a deep brain stimulation device and received their assigned treatment for 3 months .


Neurostimulation was activated in the sham group at 3 months and outcomes were reassessed in all patients after 6 months of active treatment .


Treating physicians were not masked .


The primary endpoint was the change in the TWSTRS severity score from baseline to 3 months , assessed by two masked dystonia experts using standardised videos , analysed by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT00148889 .


Between Jan 19 , 2006 , and May 29 , 2008 , we recruited 62 patients , of whom 32 were randomly assigned to neurostimulation and 30 to sham stimulation .


Outcome data were recorded in 60 ( 97 % ) patients at 3 months and 56 ( 90 % ) patients at 6 months .


At 3 months , the reduction in dystonia severity was significantly greater with neurostimulation ( -51 points [ SD 51 ] , 95 % CI -70 to -35 ) than with sham stimulation ( -13 [ 24 ] , -22 to -04 , p = 00024 ; mean between-group difference 38 points , 18 to 58 ) in the intention-to-treat population .


Over the course of the study , 21 adverse events ( five serious ) were reported in 11 ( 34 % ) of 32 patients in the neurostimulation group compared with 20 ( 11 serious ) in nine ( 30 % ) of 30 patients in the sham-stimulation group .


Serious adverse events were typically related to the implant procedure or the implanted device , and 11 of 16 resolved without sequelae .


Dysarthria ( in four patients assigned to neurostimulation vs three patients assigned to sham stimulation ) , involuntary movements ( ie , dyskinesia or worsening of dystonia ; five vs one ) , and depression ( one vs two ) were the most common non-serious adverse events reported during the course of the study .


Pallidal neurostimulation for 3 months is more effective than sham stimulation at reducing symptoms of cervical dystonia .


Extended follow-up is needed to ascertain the magnitude and stability of chronic neurostimulation effects before this treatment can be recommended as routine for patients who are not responding to conventional medical therapy .


Medtronic .


The 42 nicotinic acetylcholine receptor partial agonist varenicline has been reported to reduce drinking among both heavy-drinking smokers and primary alcoholics , and this effect may be related to varenicline-mediated reduction of alcohol craving .


Among smokers , varenicline has been reported to modulate cigarette cue-elicited brain activation in several reward-related areas .


This pilot study tested varenicline 's effects on drinking , alcohol craving , and alcohol cue-elicited activation of reward-related brain areas among non-treatment-seeking alcohol-dependent individuals .


Thirty-five such individuals ( mean age = 30 , 57 % male , 76 % heavy drinking days in the past month , 15 smokers ) were randomized to either varenicline ( titrated to 2 mg ) or placebo for 14 days , and were administered an alcohol cue reactivity fMRI task on day 14 .


A priori regions of interest ( ROIs ) were bilateral and medial orbitofrontal cortex ( OFC ) , right ventral striatum ( VS ) , and medial prefrontal cortex ( mPFC ) .


Despite good medication adherence , varenicline did not reduce heavy drinking days or other drinking parameters .


It did , however , increase self-reported control over alcohol-related thoughts and reduced cue-elicited activation bilaterally in the OFC , but not in other brain areas .


These data indicate that varenicline reduces alcohol craving and some of the neural substrates of alcohol cue reactivity .


However , varenicline effects on drinking mediated by cue-elicited brain activation and craving might be best observed among treatment-seekers motivated to reduce their alcohol consumption .


Methotrexate ( MTX ) remains the gold standard disease-modifying antirheumatic drug for the treatment of rheumatoid arthritis ( RA ) .


Few studies have compared different starting doses of MTX in RA .


We hypothesized that starting with a higher MTX dose may be more effective but associated with more adverse effects .


We compared a starting dose of 7.5 versus 15 mg per week of MTX followed by similar fast escalation .


This was an open-label ( blinded assessor ) , parallel-group , randomized controlled trial that included RA patients aged 18 to 65 years , not on MTX , and having active disease ( Disease Activity Score for 28 joints using 3 variables [ DAS28 ( 3 ) ] 5.1 ) .


Patients were randomized to receive MTX at a starting dose of 7.5 mg ( group 1 ) or 15 mg ( group 2 ) per week .


The dose of MTX was escalated by 2.5 mg every 2 weeks to a maximum of 25 mg .


Patients were seen every 4 weeks , and dose escalation was continued if DAS28 ( 3 ) was > 2.6 and there were no laboratory abnormalities ( transaminitis [ > 2 upper limit of normal ] or cytopenia ) .


The primary endpoint was change in disease activity at 12 weeks ( assessed by using the DAS28 [ 3 ] ) .


Secondary endpoints were patient withdrawals and episodes ofcytopenia or transaminitis .


Adverse effects were ascertained by using a questionnaire .


Both intention-to-treat and per-protocol analyses were performed .


We enrolled 100 patients ( female : male ratio , 78:22 ) with a mean ( SD ) age of 43.6 ( 10.8 ) years and a disease duration of 4.7 ( 4.8 ) years .


At baseline , patients had a mean DAS28 ( 3 ) of 6.2 ( 0.7 ) and a Health Assessment Questionnaire score of 1.3 ( 0.6 ) .


Group 1 ( 7.5 mg ) and group 2 ( 15 mg ) included 47 and 53 patients , respectively , with no significant differences in baseline characteristics .


At 12 weeks , the mean dose of MTX reached was 17.3 ( 4.6 ) mg in group 1 and 23.6 ( 3.0 ) mg in group 2 ( P < 0.001 ) .


The 2 groups had a similar number of patient withdrawals .


The mean change in DAS28 ( 3 ) at 12 weeks in group 1 ( -0.47 [ 0.86 ] ) and group 2 ( -0.55 [ 0.79 ] ) was not significantly different ( P = 0.60 ) .


The change in the Health Assessment Questionnaire score was also similar in the groups .


The frequency of episodes of transaminitis ( 6 and 7 ; P = 0.8 ) and cytopenia ( 1 and 2 ; P = 0.9 ) did not differ significantly between groups 1 and 2 , respectively .


Results remained the same according to the per-protocol analysis .


Among adverse effects , nausea was more common in group 2 compared with group 1 ( relative risk , 1.6 [ 95 % CI , 1.1-2 .2 ] ) .


There were no significant differences in efficacy between the 2 starting doses of MTX .


The fast escalation of dose in both groups may have blunted any advantage of starting at a higher dose .


Nausea occurred more commonly in patients started on 15 mg of MTX .


We suggest longer trials to confirm our findings .


ClinicalTrials.gov identifier : NCT01404429 .


To determine the effects of Anshendingzhi decoction ( ASDZD ) on depression , to compare ASDZD with Danzhixiaoyao pill ( DZXYP ) , and to provide evidence for the clinical treatment of depression with Traditional Chinese Medicine .


Seventy-eight patients with depression were enrolled from 2011 to 2013 in this double-blinded study .


Patients were randomly divided into two groups : ASDZD ( treatment group , n = 39 ) and DZXYP ( control group , n = 39 ) .


Hamilton Depressive Scale and TCM Syndrome Differentiation Scale were used to assess depression and efficacy before treatment and 2 , 4 , and 6 weeks after treatment .


The Treatment Emergent Symptoms Scale ( TESS ) was used to evaluate adverse reactions , observe , and record treatment outcomes .


ASDZD was significantly more effective than DZXYP .


There were significant differences between the two groups in terms of recovered patients , overall response rate , and TESS score ( all P < 0.05 ) .


ASDZD is an effective treatment for depression .


ASDZD could improve clinical symptoms and warrants further clinical research and application .


We studied the relationship between heart rate and renal function and the effects of heart rate reduction with ivabradine in heart failure patients with and without renal dysfunction .


From the 6505 patients who were randomized in SHIFT , baseline creatinine and at least one follow-up measurement were available in 6160 patients .


Median follow-up was 22.9 months .


Worsening renal function ( WRF ) was defined as a creatinine increase of 0.3 mg/dL and 25 % from the baseline value .


WRF developed in 1029 ( 17 % ) patients and was directly related to baseline heart rate , with an incremental risk of 5 % for every 5 b.p.m. heart rate increment ( P = 0.003 ) .


WRF was associated with an increased risk of the primary composite endpoint of hospitalization for worsening heart failure or cardiovascular death [ hazard ratio ( HR ) 1.38 , P < 0.001 ] and of all-cause mortality ( HR 1.42 , P < 0.001 ) .


Ivabradine use was associated with a reduction of the primary composite endpoint in patients both with ( HR 0.82 , P = 0.023 ) and without renal dysfunction ( HR 0.81 , P < 0.001 ) at baseline ( P for interaction = 0.89 ) , and tolerability of ivabradine was comparable in the two groups .


No differences were found in changes in renal function over time between ivabradine - and placebo-treated patients .


In chronic stable systolic heart failure patients , heart rate is directly and independently associated with the risk of WRF , but reduction in heart rate by ivabradine had a neutral effect on renal function during 2 years of follow-up .


The beneficial cardiovascular effects and safety of ivabradine were similar in patients with and without renal dysfunction .


To compare the effect of bimatoprost and the fixed combination latanoprost-timolol ( LTFC ) on 24-hour systolic ( SBP ) and diastolic ( DBP ) blood pressure and on 24-hour ocular perfusion pressure ( OPP ) .


200 patients with glaucoma or ocular hypertension , controlled on the unfixed combination of latanoprost and timolol or eligible for dual therapy being not being fully controlled on monotherapy were enrolled in a randomized , double-masked , placebo-controlled , multicentre clinical trial .


They were randomized to LTFC ( 8 a.m. ) or bimatoprost ( 8 p.m. ) and received 24-hour IOP curve at baseline , 6 and 12 weeks ( supine and sitting position IOPs were recorded at 8 p.m. , midnight , 5 a.m. , 8a .


m. , noon and 4 p.m. ) .


Holter 24-hour blood pressure curve was obtained between weeks 2 and 12 .


SBP , DBP , OPP were calculated and compared with ANOVA .


Rates of diastolic OPP ( DPP ) 50 , 40 , 30 mmHg in the 2 groups were calculated and compared using Fisher 's test .


Mean baseline SBP and DBP were 136.518.3 vs 134.220.1 mmHg ( p = 0.1 ) and 79.110.2 vs 78.210.1 mmHg ( p = 0.4 ) in the bimatoprost and LTFC groups respectively .


Holter SBP was significantly higher for bimatoprost ( 135.1 mmHg vs 128.1 mmHg , p = 0.04 ) , while no statistically significant difference in DBP was found .


DPP was similar in the 2 groups , and proportions of patients with at least one value of the 24-hour curve50 , 40 , 30 mmHg were 94 % , 86 % , 41 % respectively .


Bimatoprost and LTFC had similar DBPs and OPPs ; SBP was significantly lower with LTFC .


In this study , the percentage of `` dippers '' was considerably higher than the one described in previous studies on the role of perfusion pressure in glaucoma .


NCT02154217 , May 21 , 2014 .


Primary percutaneous coronary intervention ( PCI ) is the most common method of reperfusion in patients with ST-segment elevation myocardial infarction ( STEMI ) in the United States .


The intersection between processes of care and performance measures such as door-to-balloon ( D2B ) times and clinical trials evaluating novel therapies for STEMI has not been fully investigated .


Processes of STEMI care , incorporating clinical trial enrollment and randomization , in patients undergoing reperfusion with primary PCI in the Counterpulsation Reduces Infarct Size Pre-Percutaneous Coronary Intervention Acute Myocardial Infarction trial ( CRISP-AMI ) will conform to current standards of care .


Patients enrolled in CRISP-AMI were included in the current analysis .


Processes of care during reperfusion were recorded prospectively and compared between groups .


A total of 337 patients with anterior STEMI without cardiogenic shock were randomized in CRISP-AMI .


Complete processes-of-care data were available for 303 patients ( 89.9 % ) .


In this cohort , 68.0 % of patients underwent reperfusion within 90 minutes of hospital contact , and the median D2B time was 71 minutes .


Time from hospital contact to informed consent was significantly different across different regions ( North America , 45 minutes ; India , 35 minutes ; Europe , 20 minutes ) .


In CRISP-AMI , reperfusion was accomplished in a timely fashion while incorporating informed consent and randomization among patients with anterior myocardial infarction .


Further study of patients ' comprehension and preferences during the informed-consent process in STEMI patients is warranted so that innovative drugs and devices can be safely and ethically tested .


To compare the epithelial wound healing response of two preservative-free fluoroquinolones , moxifloxacin and levofloxacin , in patients who underwent cataract surgery .


In this prospective , evaluator-masked , randomized clinical trial , 59 eyes of 50 patients who underwent cataract surgery were enrolled .


Patients were randomized to receive moxifloxacin 0.5 % ( n = 32 eyes ) or levofloxacin 0.5 % ( n = 27 eyes ) .


All patients instilled moxifloxacin or levofloxain four times daily for 1 week prior to surgery and 2 weeks after surgery .


The epithelial wound healing status in the corneal incision site was scanned with a raster scan mode of fourier-domain optical coherence tomography ( FD-OCT ) .


The number of eyes showing epithelial defect images and average number of corneal epithelial defect cuts per eye were compared between groups .


All patients were evaluated on postoperative days 1 , 2 , 3 , and 10 .


On postoperative days 1 , 2 , and 3 , the number of eyes showing epithelial defects in FD-OCT was not statistically different ( all p > 0.05 ) .


The average number of corneal epithelial defect cuts was also not statistically different between the two groups ( all p > 0.05 ) .


No eyes showed epithelial defects on postoperative day 10 in either group .


There were no differences on epithelial wound healing comparing these two different fluoroquinolones at the incision site of cataract surgery .


This Phase 3 , international , randomized , single-blind , controlled trial ( FINISH-3 ) compared the efficacy and safety of Fibrocaps , a ready-to-use , dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen , vs gelatin sponge alone for use as a hemostat for surgical bleeding in 4 indications ( ie , spinal , hepatic , vascular , soft tissue dissection ) .


Adults with mild to moderate surgical bleeding ( randomized 2:1 ; Fibrocaps vs gelatin sponge ) were treated at a single bleeding site ( day 1 ) .


Time to hemostasis ( TTH ) during 5 minutes was compared ( log-rank statistic ) within each indication .


Safety follow-up continued to day29 .


Patients were treated ( Fibrocaps , n = 480 ; gelatin sponge , n = 239 ) when undergoing spinal ( n = 183 ) , vascular ( n = 175 ) , hepatic ( n = 180 ) , or soft-tissue ( n = 181 ) procedures .


Fibrocaps was applied by spray device in 53 % of all procedures ( 94 % of hepatic and soft-tissue procedures ) .


Fibrocaps significantly reduced TTH compared with gelatin sponge ; estimated hazard ratios were 3.3 , 2.1 , 2.3 , and 3.4 for the 4 surgical indications , respectively ( each p < 0.001 ; primary end point ) .


Fibrocaps significantly reduced median TTH for each indication ( p < 0.001 ) and was superior for secondary efficacy end points of restricted mean TTH ( p < 0.001 ) and probability of hemostasis at 3 ( p < 0.001 ) and 5 ( p 0.002 ) minutes .


Adverse event incidences were generally similar between treatment arms .


Non-neutralizing , anti-thrombin antibodies developed in 2 % of Fibrocaps-treated and 3 % of gelatin sponge-treated patients .


Fibrocaps was well tolerated and significantly reduced TTH relative to gelatin sponge alone in all 4 surgical indications .


These findings demonstrate the broad utility of Fibrocaps as a hemostatic agent for mild to moderate surgical bleeding .


High-dose therapy followed by autologous stem-cell transplantation is standard of care for patients with relapsed or primary refractory Hodgkin 's lymphoma .


Roughly 50 % of patients might be cured after autologous stem-cell transplantation ; however , most patients with unfavourable risk factors progress after transplantation .


We aimed to assess whether brentuximab vedotin improves progression-free survival when given as early consolidation after autologous stem-cell transplantation .


We did this randomised , double-blind , placebo-controlled , phase 3 trial at 78 sites in North America and Europe .


Patients with unfavourable-risk relapsed or primary refractory classic Hodgkin 's lymphoma who had undergone autologous stem-cell transplantation were randomly assigned , by fixed-block randomisation with a computer-generated random number sequence , to receive 16 cycles of 18 mg/kg brentuximab vedotin or placebo intravenously every 3 weeks , starting 30-45 days after transplantation .


Randomisation was stratified by best clinical response after completion of salvage chemotherapy ( complete response vs partial response vs stable disease ) and primary refractory Hodgkin 's lymphoma versus relapsed disease less than 12 months after completion of frontline therapy versus relapse 12 months or more after treatment completion .


Patients and study investigators were masked to treatment assignment .


The primary endpoint was progression-free survival by independent review , defined as the time from randomisation to the first documentation of tumour progression or death .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT01100502 .


Between April 6 , 2010 , and Sept 21 , 2012 , we randomly assigned 329 patients to the brentuximab vedotin group ( n = 165 ) or the placebo group ( n = 164 ) .


Progression-free survival by independent review was significantly improved in patients in the brentuximab vedotin group compared with those in the placebo group ( hazard ratio [ HR ] 057 , 95 % CI 040-081 ; p = 00013 ) .


Median progression-free survival by independent review was 429 months ( 95 % CI 304-429 ) for patients in the brentuximab vedotin group compared with 241 months ( 115-not estimable ) for those in the placebo group .


We recorded consistent benefit ( HR < 1 ) of brentuximab vedotin consolidation across subgroups .


The most frequent adverse events in the brentuximab vedotin group were peripheral sensory neuropathy ( 94 [ 56 % ] of 167 patients vs 25 [ 16 % ] of 160 patients in the placebo group ) and neutropenia ( 58 [ 35 % ] vs 19 [ 12 % ] patients ) .


At time of analysis , 28 ( 17 % ) of 167 patients had died in the brentuximab vedotin group compared with 25 ( 16 % ) of 160 patients in the placebo group .


Early consolidation with brentuximab vedotin after autologous stem-cell transplantation improved progression-free survival in patients with Hodgkin 's lymphoma with risk factors for relapse or progression after transplantation .


This treatment provides an important therapeutic option for patients undergoing autologous stem-cell transplantation .


Seattle Genetics and Takeda Pharmaceuticals International .


The aim of this study was to evaluate the effects of losartan on left ventricular ( LV ) hypertrophy and fibrosis in patients with nonobstructive hypertrophic cardiomyopathy ( HCM ) .


Despite evidence that myocardial hypertrophy and fibrosis are mediated by angiotensin II and are important determinants of morbidity and mortality in patients with HCM , no prior studies have evaluated the effects of angiotensin receptor blockers on LV hypertrophy and fibrosis with cardiac magnetic resonance imaging .


In double-blind fashion , 20 patients ( 3 women , 17 men ; age : 51 13 years ) with HCM were randomly assigned to receive placebo ( n = 9 ) or losartan 50 mg twice a day ( n = 11 ) for 1 year .


Cardiac magnetic resonance imaging was performed at baseline and 1 year to measure LV mass and extent of fibrosis as assessed by late gadolinium enhancement .


There was a trend toward a significant difference in the percent change in LV mass ( median [ interquartile range ] : +5 % [ -4 % to +21 % ] with placebo vs.-5 % [ -11 % to-0 .9 % ] with losartan ; p = 0.06 ) .


There was a significant difference in the percent change in extent of late gadolinium enhancement , with the placebo group experiencing a larger increase ( +31 % 26 % with placebo vs.-23 % 45 % with losartan ; p = 0.03 ) .


This pilot study suggests attenuation of progression of myocardial hypertrophy and fibrosis with losartan in patients with nonobstructive HCM .


Confirmation of these results in a larger trial is required to confirm a place for angiotensin receptor blockers in the management of patients with HCM .


( Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy ; NCT01150461 ) .


This study sought to test whether the newly developed platinum chromium ( PtCr ) - based everolimus-eluting stent ( EES ) is noninferior to the cobalt chromium ( CoCr ) - based zotarolimus-eluting stent ( ZES ) in all-comers receiving percutaneous coronary intervention ( PCI ) .


PtCr provides improved radial strength , conformability , and visibility compared with the CoCr alloy , but PtCr-based stents have not been tested in a wide range of patients receiving PCI .


Also , recent case series have raised the issue of longitudinal stent deformation ( LSD ) with newer drug-eluting stents .


We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES .


The primary outcome was target lesion failure ( TLF ) at 1-year post-PCI , defined as the composite of cardiac death , nonfatal target vessel-related myocardial infarction , and ischemia-driven target lesion revascularization .


Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD .


At 1 year , TLF occurred in 2.9 % and 2.9 % of the population in the PtCr-EES and CoCr-ZES groups , respectively ( superiority p = 0.98 , noninferiority p = 0.0247 ) .


There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome .


Of 5,010 stents analyzed , LSD occurred in 0.2 % and 0 % in the PtCr-EES and CoCr-ZES groups , respectively ( p = 0.104 ) .


There was no significant difference in post-deployment stent length ratio between the 2 stents ( p = 0.352 ) .


At 1 year , PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI .


Although LSD was observed only in PtCr-EES , both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types , and PtCr-EES was not associated with adverse clinical outcomes .


( Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [ HOST-ASSURE ] ; NCT01267734 ) .


Prospective long-term analyses of the role of drug-induced mydriasis and laser peripheral iridotomy ( LPI ) are needed to identify and manage the eyes of patients with pigment dispersion syndrome ( PDS ) at risk for progressing to ocular hypertension .


To assess the 10-year incidence of increased intraocular pressure ( IOP ) in the 2 eyes of patients with PDS , with 1 eye that underwent LPI and the other that did not .


In a randomized clinical trial in the glaucoma research unit at the University Hospital of Parma , Italy , 72 patients with PDS underwent phenylephrine testing .


Of these 72 patients , 29 ( 58 eyes ) tested positive for succeeding IOP elevation , and 43 ( 59 eyes ) tested negative .


For the 29 high-risk patients ( all in both eyes ) , one eye was randomly assigned to LPI , and the fellow eye was left untreated .


For the 43 low-risk patients , the affected eyes were left untreated .


An IOP elevation of 5 mm Hg or higher vs baseline ( daily phasing ) was considered to be a significant increase ( ie , an event ) .


In the high-risk group , 3 of 21 eyes that underwent LPI ( 14.3 % ) and 13 of 21 untreated eyes ( 61.9 % ) showed an increase in IOP of 5 mm Hg or higher during the follow-up period ; 4 of 35 low-risk eyes ( 11.4 % ) showed a similar increase .


Event-free mean ( SD ) time was 7.99 ( 0.43 ) years for high-risk treated eyes , 3.89 ( 0.68 ) years for high-risk untreated eyes , and 7.16 ( 0.23 ) years for low-risk eyes .


The log-rank test showed the following : P < .001 for treated high-risk eyes vs untreated high-risk eyes , P = .74 for treated high-risk eyes vs low-risk eyes , and P < .001 for untreated high-risk eyes vs low-risk eyes .


At the end of the 10-year follow-up , ( 1 ) approximately one-third of the whole PDS patient population showed an IOP increase of 5 mm Hg or higher in at least 1 eye ; ( 2 ) phenylephrine testing identified eyes at high risk for developing IOP elevation ; and ( 3 ) LPI , when performed on high-risk eyes , reduced the rate of IOP elevation to the same level as the low-risk eyes .


clinicaltrials.gov Identifier : NCT01053416 .


Compared with a dry environment with talcum powder , a wet , alkaline environment with NaHCO3 solution is better for hair removal , as it can soften and expand the hair , decrease the friction and shear forces on the skin , and make hair removal easier and more efficient .


The purpose of this study was to compare the effects of a preoperative skin preparation of 5 % NaHCO3 with that of talcum powder for softening hair in patients undergoing coronary artery bypass graft ( CABG ) surgery with the saphenous vein .


A prospective randomized , single-blinded , controlled study was established .


Between March 2012 and June 2013 , 120 patients who met the inclusion and exclusion criteria underwent elective CABG surgery with the saphenous vein in our hospital .


The same doctor obtained the saphenous vein of each patient by a uniform method .


CABG surgery was performed through an open or endoscopic technique , according to each patient 's condition .


Patients were divided into two groups of 60 patients each , according to whether the preoperative skin preparation procedure was performed with a 5 % solution of NaHCO3 at 45-50C ( experimental group ) or with talcum powder ( control group ) .


Main outcome measures were the incision inflammation rate , skin preparation time , presence of shaving-induced macroscopic haemorrhagic spots , verbal rating scale ( VRS ) pain score and satisfaction .


Neither group had any evidence of incision inflammation .


The average ( mean standard deviation ) skin preparation time of the experimental group was shorter than that of the control group ( 5.58 1.52 vs 9.74 1.23 min , P < 0.001 ) .


Three patients in the experimental group and 17 in the control group had shaving-induced macroscopic haemorrhagic spots after skin preparation ( P = 0.001 ) .


The VRS pain scores were different between the two groups ( P < 0.001 ) .


In the control group , 40 % of patients and 37 % of nurses were satisfied with the skin preparation procedure , compared with 95 and 90 % , respectively , in the experimental group ( both P < 0.001 ) .


Hair softening with a 5 % NaHCO3 solution protected the skin integrity , alleviated pain and improved patient satisfaction to a greater extent than talcum powder .


Nurses found the 5 % NaHCO3 solution to be more convenient and less time-consuming to use .


The Coronary Psychosocial Evaluation Studies trial demonstrated promising results for enhanced depression treatment to reduce cardiovascular risk of patients with acute coronary syndrome and comorbid depression , but the long-term effectiveness of this intervention is unclear .


A total of 157 participants with persistent depression after hospitalization for acute coronary syndromes were enrolled in the Coronary Psychosocial Evaluation Studies trial .


A total of 80 participants were allocated to 6 months of enhanced depression treatment , and 77 participants were allocated to usual care .


We report on an additional 12 months of observational follow-up for the composite outcome of death or first hospitalization for myocardial infarction or unstable angina .


Although the intervention was previously shown to have favorable cardiovascular effects during the treatment period , we observed a significant time-by-treatment group interaction during extended follow-up ( P = .008 ) .


Specifically , during the 6-month treatment period , death or hospitalization for myocardial infarction/unstable angina occurred in 3 participants ( 4 % ) in the treatment group compared with 11 participants ( 14 % ) in the usual care group ( hazard ratio , 0.25 ; 95 % confidence interval , 0.07-0 .90 ; P = .03 ) .


In contrast , during 12 months of additional observational follow-up , 11 participants ( 14 % ) in the treatment group experienced the composite outcome of deathorhospitalization for myocardial infarction/unstable angina compared with 3 participants ( 4 % ) in the usual caregroup ( hazard ratio , 2.91 ; 95 % confidence interval , 0.80-10 .56 ; P = .10 ) .


Enhanced depression treatment was associated with a reduced risk of death or hospitalization for myocardial infarction/unstable angina during active treatment , but this effect did not persist after treatment ceased .


Future research is needed to confirm our findings and to determine the optimal duration of depression treatment in patients with depression after acute coronary syndromes .


A complication of long-term use of tunneled cuffed catheters for hemodialysis is the high rate of infection and thrombus-related dysfunction .


Specific mechanical features of tunneled cuffed catheters may improve hemodynamic performance and decrease thrombosis and infection rates .


However , there currently is no proven advantage of one design over another .


Single-center randomized clinical trial .


302 hemodialysis patients who required a tunneled cuffed catheter as temporary or definite vascular access .


Palindrome Symmetric Tip Dialysis Catheter or HemoStar Long-Term Hemodialysis Catheter .


The primary end point was primary assisted patency .


Secondary end points were incidence of catheter-related bloodstream infections ( CRBSIs ) , thrombosis , and 2 indicators of rheologic function : mean effective blood flow rate and urokinase use .


Mean primary assisted patency was 135.9 days for Palindrome and 136.5 days for HemoStar ( P = 0.8 ) .


Definite CRBSI occurred in 0.24 and 0.10 / 1,000 catheter-days for Palindrome and HemoStar , respectively ( P = 0.3 ) .


Removal rates for thrombosis that could not be resolved with thrombolysis were 0.53 and 0.43 / 1,000 catheter-days for Palindrome and HemoStar , respectively ( P = 0.7 ) .


Urokinase use was lower for Palindrome than for HemoStar , as evidenced by a lower number of urokinase infusions/1 ,000 catheter-days ( 17 and 35 ; P < 0.001 ) and higher number of catheters that never required thrombolysis ( 58 % and 45 % ; P = 0.03 ) .


Mean effective blood flow rate was higher for Palindrome than for HemoStar ( 333 and 304mL/min ; P < 0.001 ) .


Single-center nonblinded trial .


Primary assisted patency and incidence of infection and thrombosis were similar for both catheter types .


The Palindrome catheter required less thrombolysis and achieved higher blood flow rates than the HemoStar catheter .


These findings suggest that mechanical catheter design may improve catheter rheology , but does not affect risks for thrombosis and infection and hence catheter survival .


To assess whether the addition of a peer testimonial to an informational mailing increases conversion rates from brand name prescription medications to lower-cost therapeutic equivalents , and whether the testimonial 's efficacy increases when information is added about an affiliation the quoted individual shares with the recipient .


A total of 5498 union members were randomly assigned to receive 1 of 3 different informational letters : 1 without a testimonial ( No Testimonial Group ) , 1 with a testimonial from a person whose shared union affiliation with the recipient was not disclosed ( Unaffiliated Testimonial Group ) , and 1 with a testimonial from a person whose shared union affiliation with the recipient was disclosed ( Affiliated Testimonial Group ) .


The conversion rate for the No Testimonial Group was 12.2 % , which is higher than the Unaffiliated Testimonial Group rate of 11.3 % and the Affiliated Testimonial Group rate of 11.7 % .


The differences between the groups are not statistically significant .


Short peer testimonials do not increase the impact of a mailed communication on conversion rates to lower-cost , therapeutically equivalent medications , even when the testimonial is presented as coming from a more socially proximate peer


Chronic systemic inflammation is common in patients with chronic kidney disease on dialysis ( CKD5D ) and has been considered a key mediator of the increased cardiovascular risk in this patient population .


In this study , we tested the hypothesis that supplementation of omega-3 polyunsaturated fatty acids ( -3 PUFAs ) will attenuate the systemic inflammatory process in CKD5D patients .


The design was a randomized , double-blinded , placebo controlled pilot trial ( NCT00655525 ) .


Thirty-eight patients were randomly assigned in a 1 : 1 fashion to receive 2.9 g of eicosapentaenoic acid ( C20 :5 , n-3 ) plus docosahexaenoic acid ( C22 :6 , n-3 ) versus placebo for 12 weeks .


The primary outcome was change in pro-inflammatory chemokines measured by lipopolysaccharide ( LPS ) - stimulated peripheral blood mononuclear cells ( PBMCs ) .


Secondary outcomes were changes in systemic inflammatory markers .


Analysis of covariance was used to compare percent change from baseline to 12 weeks .


Thirty-one patients completed 12 weeks and three patients completed 6 weeks of the study .


Median age was 52 ( interquartile range 45 , 60 ) years , 74 % were African-American and 79 % were male .


Supplementation of -3 PUFAs effectively decreased the LPS-induced PBMC expression of RANTES ( Regulated upon Activation , Normal T cell Expressed and Secreted ) and MCP-1 ( Monocyte Chemotactic Protein-1 ; unadjusted P = 0.04 and 0.06 ; adjusted for demographics P = 0.02 and 0.05 , respectively ) .


There was no significant effect of the intervention on serum inflammatory markers ( C-reactive protein , interleukin-6 and procalcitonin ) .


The results of this pilot study suggest that supplementation of -3 PUFAs is beneficial in decreasing the levels of endothelial chemokines , RANTES and MCP-1 .


Studies of larger sample size and longer duration are required to further evaluate effects of -3 PUFAs on systemic markers of inflammation , other metabolic parameters and clinical outcomes , particularly cardiovascular outcomes in CKD5D patients .


This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography ( MRA ) using digital subtraction angiography ( DSA ) as the reference standard in patients with peripheral arterial occlusive disease ( PAOD ) .


In this prospective international randomized double-blind phase IV trial , 189 patients were enrolled .


Of them , 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings .


Subjects underwent peripheral MRA , after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol , and DSA within 30 days .


The diagnostic accuracy was evaluated and compared using a noninferiority analysis .


Secondary endpoints included sensitivity , specificity , diagnostic confidence , contrast-to-noise ratio , and signal-to-noise ratio evaluations .


The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups ( mean SD , 80.6 % 16.1 % with gadoterate meglumine vs 77.1 % 19.6 % with gadobutrol ; 3.5 % difference ) , and the same was true for off-site readings ( 73.9 % 16.9 % with gadoterate meglumine vs 75.1 % 13.8 % with gadobutrol ; 1.1 % difference ) .


The noninferiority of gadoterate meglumine to gadobutrol was shown for both on - and off-site readings .


Sensitivity in detecting significant stenosis ( > 50 % ) was 72.3 % for gadoterate meglumine versus 70.6 % for gadobutrol , whereas specificity ( 92.6 % vs 92.3 % ) , diagnostic confidence ( 87.0 % vs 86.0 % ) , signal-to-noise ratio ( 165.5 vs 161.0 ) , and contrast-to-noise ratio ( 159.5 vs 155.3 ) did not differ statistically significantly between the two groups .


Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA .


No statistically significant differences were detected between the two MRA groups .


The Scandinavian Candesartan Acute Stroke Trial ( SCAST ) found no benefits of blood pressure-lowering treatment with candesartan in acute stroke .


We have investigated whether the effect of treatment is different in different subtypes of ischemic stroke .


SCAST was a randomized - and placebo-controlled trial of candesartan in 2029 patients presenting within 30 hours of ischemic or hemorrhagic stroke and systolic blood pressure 140 mm Hg .


Ischemic stroke subtype was categorized by the Oxfordshire Community Stroke Project classification .


There were 2 primary effect variables : the composite vascular end point of vascular death , myocardial infarction , or stroke during the first 6 months and functional outcome at 6 months .


A total of 1733 patients with ischemic stroke were included : total anterior circulation infarcts in 129 , partial anterior in 850 , posterior in 236 , and lacunar in 510 patients .


For functional outcome there was a significant trend toward a better effect of candesartan in patients with larger infarcts ( total anterior circulation or partial anterior circulation ) than in patients with smaller infarcts ( lacunar infarction ; P = 0.02 ) .


For the composite vascular end point , there were no differences in treatment effect .


The results suggest that the effect of blood pressure-lowering treatment with candesartan may differ according to different types of acute ischemic stroke , but this needs to be confirmed in future trials .


http://www.clinicaltrials.gov .


Unique identifier : NCT00120003 .


To evaluate the efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation ( OIC ) in patients with chronic noncancer pain .


Prospective , randomized , double-blind , placebo-controlled trial .


Seventy-nine US and Canadian centers .


Patients aged 18 years with OIC , defined as < 3 spontaneous bowel movements ( SBMs ) per week .


Patients received lubiprostone 24 mcg or placebo twice daily for 12 weeks .


The primary endpoint was change from baseline in SBM frequency at week 8 .


Among randomized patients ( N = 418 ; lubiprostone , N = 210 ; placebo , N = 208 ) , most completed the study ( lubiprostone , 67.1 % ; placebo , 69.7 % ) .


The safety and efficacy ( intent-to-treat ) populations included 414 ( lubiprostone , N = 208 ; placebo , N = 206 ) and 413 ( lubiprostone , N = 209 ; placebo , N = 204 ) patients , respectively .


The mean ( standard deviation ) age was 50.4 ( 10.9 ) years ; most patients were female ( 64.4 % ) and white ( 77.7 % ) .


Changes from baseline in SBM frequency rates were significantly higher at week 8 ( P = 0.005 ) and overall ( P = 0.004 ) in patients treated with lubiprostone compared with placebo .


Pairwise comparisons showed significantly greater overall improvement for abdominal discomfort ( P = 0.047 ) , straining ( P < 0.001 ) , constipation severity ( P = 0.007 ) , and stool consistency ( P < 0.001 ) with lubiprostone compared with placebo .


Moreover , patients rated the effectiveness of lubiprostone as significantly ( P < 0.05 ) better than placebo for 11 of 12 weeks .


The most common treatment-related adverse events ( AEs ) with lubiprostone and placebo were nausea ( 16.8 % vs 5.8 % , respectively ) , diarrhea ( 9.6 % vs 2.9 % ) , and abdominal distention ( 8.2 % vs 2.4 % ) .


No lubiprostone-related serious AEs occurred .


Lubiprostone effectively relieved OIC and associated signs and symptoms and was well tolerated in patients with chronic noncancer pain ( http://clinicaltrials.gov/ct2/show/NCT00595946 ) .


Despite the efforts of the healthcare community to improve the quality of diabetes care , about 50 % of people with type 2 diabetes do not reach their treatment targets , increasing the risk of future micro-and macro-vascular complications .


Diabetes self-management education has been shown to contribute to better disease control .


However , it is not known which strategies involving educational programs are cost-effective .


Telehealth applications might support chronic disease management .


Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality .


`` The COACH Program '' was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions .


It proved to be effective in patients with coronary heart disease after hospitalization .


Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed .


Randomized controlled trial in patients with type 2 diabetes .


Patients were selected based on their medication consumption data and were recruited by their sickness fund .


They were randomized to receive either usual care plus `` The COACH Program '' or usual care alone .


The study will assess the difference in outcomes between groups .


The primary outcome measure is the level of HbA1c .


The secondary outcomes are : Total Cholesterol , LDL-Cholesterol , HDL-Cholesterol , Triglycerides , Blood Pressure , body mass index , smoking status ; proportion of people at target for HbA1c , LDL-Cholesterol and Blood Pressure ; self-perceived health status , diabetes-specific emotional distress and satisfaction with diabetes care .


The follow-up period is 18 months .


Within-trial and modeled cost-utility analyses , to project effects over life-time horizon beyond the trial duration , will be undertaken from the perspective of the health care system if the intervention is effective .


The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium .


Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions .


Diet and exercise interventions for cancer survivors result in health benefits ; however , few studies have examined health outcomes in relation to adherence .


We examined associations between adherence to components of a diet-exercise intervention and survivors ' physical and mental health .


A randomized controlled trial tested a telephone and mailed print intervention among 641 older , overweight , long-term survivors of breast , prostate , and colorectal cancer .


Dietary and exercise behaviors were assessed at 14 time points throughout the year-long intervention ; health outcomes were examined postintervention .


Telephone session attendance had significant indirect relationships with health outcomes through intervention-period exercise and dietary behavior .


Attendance showed positive indirect relationships with physical function ( = 0.11 , p < 0.05 ) , basic and advanced lower extremity function ( = 0.10 , p < 0.05 / = 0.09 , p < 0.05 ) , and mental health ( = 0.05 , p < 0.05 ) , and a negative indirect relationship with body mass index ( = -0.06 , p < 0.05 ) .


Session attendance is vital in facilitating improvement in health behaviors and attendant outcomes ( Clinicaltrials.gov number NCT00303875 ) .


To investigate the putative modifying effect of dual antiplatelet therapy ( DAPT ) use on the incidence of stent thrombosis at 3 years in patients randomized to Endeavor zotarolimus-eluting stent ( E-ZES ) or Cypher sirolimus-eluting stent ( C-SES ) .


Of 8709 patients in PROTECT , 4357 were randomized to E-ZES and 4352 to C-SES .


Aspirin was to be given indefinitely , and clopidogrel/ticlopidine for 3 months or up to 12 months after implantation .


Main outcome measures were definite or probable stent thrombosis at 3 years .


Multivariable Cox regression analysis was applied , with stent type , DAPT , and their interaction as the main outcome determinants .


Dual antiplatelet therapy adherence remained the same in the E-ZES and C-SES groups ( 79.6 % at 1 year , 32.8 % at 2 years , and 21.6 % at 3 years ) .


We observed a statistically significant ( P = 0.0052 ) heterogeneity in treatment effect of stent type in relation to DAPT .


In the absence of DAPT , stent thrombosis was lower with E-ZES vs. C-SES ( adjusted hazard ratio 0.38 , 95 % confidence interval 0.19 , 0.75 ; P = 0.0056 ) .


In the presence of DAPT , no difference was found ( 1.18 ; 0.79 , 1.77 ; P = 0.43 ) .


A strong interaction was observed between drug-eluting stent type and DAPT use , most likely prompted by the vascular healing response induced by the implanted DES system .


These results suggest that the incidence of stent thrombosis in DES trials should not be evaluated independently of DAPT use , and the optimal duration of DAPT will likely depend upon stent type ( Clinicaltrials.gov number NCT00476957 ) .


Safe venepuncture technique is a critical skill for health care professionals , to avoid accidental occupational injury .


This study investigates whether watching an instructional video improves medical students ' ability to perform venepuncture safely .


This was a randomised , controlled , assessor-blinded trial that evaluated the utility of an instructional video , with the primary outcome of the ability to perform venepuncture safely .


Forty-two second-year medical students were recruited and randomised to receive either video instruction ( group A , n = 20 ) or no intervention ( group B , n = 22 ) .


Prior to the study , all students attended an instructor-led workshop on venepuncture .


During the study , students were paired and instructed to perform venepuncture on a partner .


Performance was assessed using a points-based checklist .


Pre - and post-study surveys were conducted to assess confidence with technique .


The mean total checklist score was higher in group A than in group B , with values of 14.15 and 9.18 , respectively ( p < 0.0001 , maximum 18 points ) .


Mean scores were also higher in group A than in group B among students who performed first ( p = 0.008 ) and students who performed second ( p = 0.005 ) within the pair .


From the post-procedure survey , only group A rated increased confidence in performing venepuncture after the study ( p = 0.008 ) .


Students who watched an instructional video performed venepuncture more effectively and reported greater confidence with the technique .


Medical students can benefit from having access to an instructional video on venepuncture as an adjunct to the standard curriculum .


Safe venepuncture technique is a critical skill for health care professionals .


Hospital admissions may provide an opportunity to discontinue potentially inappropriate medications ( PIMs ) in older patients .


Little is known about the effect of using the Screening Tool of Older People 's potentially inappropriate Prescriptions ( STOPP ) in this context .


This study aimed to test the hypothesis that specific STOPP recommendations from an inpatient geriatric consultation team ( IGCT ) to the hospital physician leads to reductions in PIMs for patients at discharge .


This was a randomised controlled study in 146 frail inpatients ( in 2011 ) .


The intervention consisted of STOPP recommendations made by the IGCT to ward physicians to discontinue PIMs , in addition to the standard geriatric advice .


Intervention ( n = 74 ) and control ( n = 72 ) groups were similar in terms of patient characteristics ( median age 85years ; median number of daily drugs , seven ) and PIM distribution ( 68 and 57 PIMs in 53 and 51 % of patients , respectively ) .


At discharge , the reduction in PIMs was twice as high for the intervention group as for the control group ( 39.7 and 19.3 % , respectively ; p = 0.013 ) .


The proportion of patients who still had one or more PIM at discharge did not differ between groups .


In the 50 patients followed-up a year later , the majority of PIMs that had been stopped during hospitalisation had not been restarted after discharge ( 17/28 ; 61 % ) .


The clinical relevance of PIMs identified at baseline in those patients was considered major ( 29 % ) , moderate ( 37 % ) , minor ( 5 % ) , deleterious ( 8 % ) , or not assessed ( 11 % ) .


Discontinuation rate was not associated with clinical importance .


Specific STOPP recommendations provided to hospital physicians doubled the reduction of PIMs at discharge in frail older inpatients .


To further improve the appropriateness of prescribing in older patients , clinicians should focus on the STOPP criteria that are of major clinical importance , and general practitioners should be actively involved .


We investigated induction of - secretase A disintegrin and metalloprotease 10 ( ADAM10 ) by the synthetic retinoid acitretin ( Neotigason ; Actavis , Mnchen-Riem , Germany ) in patients with mild to moderate Alzheimer disease ( AD ) via measurement of CSF content of - secretase-derived amyloid precursor protein ( APPs - ) .


Twenty-one patients clinically diagnosed with mild to moderate AD received acitretin ( 30 mg per day ) or placebo in a 4-week double-blind study .


Primary endpoint was the difference of CSF APPs - ratios calculated from the APPs - levels after treatment and at baseline .


We monitored safety and tolerability of the treatment .


In addition , we assessed biomarkers such as - amyloid 42 ( A42 ) under treatment conditions .


The acitretin group showed a significant increase in CSF APPs - levels compared with the placebo group ( difference 0.38 , 95 % confidence interval 0.03-0 .72 , p = 0.035 ) within this rather short treatment period .


The synthetic retinoid acitretin was overall safe and well tolerated .


Our pilot study highlights that acitretin is able to enhance the nonamyloidogenic APP processing in human patients .


Clinical consequences of this regulation should be investigated in larger and longer trials in patients with AD to evaluate acitretin 's potential to serve as a novel therapeutic drug .


This study provides Class III evidence that in patients with AD , oral acitretin increases CSF APPs - levels .


H.P. Acthar ( ) Gel is currently the only Food and Drug Administration therapy approved for the treatment of nephrotic syndrome .


Active drug ingredients include structurally related melanocortin peptides that bind to cell surface G-protein-coupled receptors known as melanocortin receptors , which are expressed in glomerular podocytes .


In animal models of membranous nephropathy , stimulation has been demonstrated to reduce podocyte injury and loss .


We hypothesized that H.P. Acthar ( ) Gel would improve symptoms of the nephrotic syndrome in patients with idiopathic membranous nephropathy .


Twenty patients received a subcutaneous dose of 40 or 80 IU twice weekly .


Changes in proteinuria , albumin , cholesterol profile , estimated glomerular filtration rate and serum anti-PLA2R antibodies were assessed at baseline and in response to treatment along with tolerance and safety .


Baseline characteristics included mean proteinuria ( 9.1 3.4 g/day ) , albumin ( 2.7 0.8 g/dL ) , estimated glomerular filtration rate ( 77 30 mL/min ) along with elevated total and low-density lipoprotein ( LDL ) cholesterol .


By 12 months of follow-up , there was a significant improvement in proteinuria in the entire cohort , decreasing to 3.87 4.24 g/day ( P < 0.001 ) with significant improvements in serum albumin , total and LDL cholesterol .


A > 50 % decrease in proteinuria was noted in 65 % of the patients with a trend toward better outcomes among patients who received greater cumulative doses .


No significant adverse effects were documented .


Clearing of serum anti-PLA2R antibodies prior to or in parallel with proteinuria improvement was noted in some , but not all patients .


H.P. Acthar ( ) Gel is a potential therapy for nephrotic syndrome secondary to idiopathic membranous nephropathy that deserves further study .


The capsular polysaccharide of Salmonella enterica serovar Typhi , Vi antigen , is an essential virulence factor and a protective antigen .


Similar to other polysaccharide vaccines , the protective action of Vi , both to the polysaccharide alone or when presented as a conjugate , is mediated by serum IgG Vi antibodies .


The evaluation of Vi capsular polysaccharide based vaccines to prevent typhoid fever would be significantly facilitated by the identification of a `` protective level '' of serum antibodies to Vi antigen .


The protective level of anti-Vi IgG against typhoid fever was derived from the protective efficacy and immune response of a Vi-rEPA conjugate vaccine efficacy trial .


The estimation was derived by two methods : correlation of the percent efficacy and the antibody distribution profile in the vaccine group at a given period of observation , and use of the relative ratio of anti-Vi IgG levels between the vaccine and placebo groups greater or equal to the Relative Risk of typhoid fever used in the efficacy determination .


Both methods predicted a similar range of a minimum protective level of anti-Vi IgG between 1.4 and 2.0 g/ml ( short term threshold ) .


When applying a protective threshold of 10g/ml at 6 months post immunization , an IgG level in excess of 1.4 g/ml was achieved by 90 % of children at 46 months post immunization , consistent with an 89 % level of protection over the duration of the study .


We thus suggest that the proportion of children with Vi IgG > 10g/ml ( long term threshold ) 6 months after immunization may reflect the proportion protected over at least a 4 year period .


The current assignment of an anti-Vi IgG protective level may be of value when evaluating vaccine performance of future Vi conjugate vaccines .


Reducing LDL cholesterol ( LDL-C ) with statin-based therapy reduces the risk of major atherosclerotic events among patients with CKD , including dialysis patients , but the effect of lowering LDL-C on vascular access patency is unclear .


The Study of Heart and Renal Protection ( SHARP ) randomized patients with CKD to 20 mg simvastatin plus 10 mg ezetimibe daily versus matching placebo .


This study aimed to explore the effects of treatment on vascular access occlusive events , defined as any access revision procedure , access thrombosis , removal of an old dialysis access , or formation of new permanent dialysis access .


Among 2353 SHARP participants who had functioning vascular access at randomization , allocation to simvastatin plus ezetimibe resulted in a 13 % proportional reduction in vascular access occlusive events ( 355 [ 29.7 % ] for simvastatin/ezetimibe versus 388 [ 33.5 % ] for placebo ; risk ratio [ RR ] , 0.87 ; 95 % confidence interval [ 95 % CI ] , 0.75 to 1.00 ; P = 0.05 ) .


There was no evidence that the effects of treatment differed for any of the separate components of this outcome .


To test the hypothesis raised by SHARP , comparable analyses were performed using the AURORA ( A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis : An Assessment of Survival and Cardiovascular Events ) trial cohort .


AURORA did not provide independent confirmation ( vascular access occlusive events : 352 [ 28.9 % ] for rosuvastatin versus 337 [ 27.6 % ] for placebo ; RR , 1.06 , 95 % CI , 0.91 to 1.23 ; P = 0.44 ) .


After combining the two trials , the overall effect of reducing LDL-C with a statin-based regimen on vascular access occlusive events was not statistically significant ( 707 [ 29.3 % ] with any LDL-C-lowering therapy versus 725 [ 30.5 % ] with placebo ; RR , 0.95 , 95 % CI , 0.85 to 1.05 ; P = 0.29 ) .


Exploratory analyses from SHARP suggest that lowering LDL-C with statin-based therapy may improve vascular access patency , but there was no evidence of benefit in AURORA .


Taken together , the available evidence suggests that any benefits of lowering LDL-C on vascular access patency are likely to be modest .


Mobile smartphones are rapidly emerging as an effective means of communicating with many Americans .


Using mobile applications ( apps ) , they can access remote databases , track time and location , and integrate user input to provide tailored health information .


A smartphone mobile app providing personalized , real-time sun protection advice was evaluated in a randomized clinical trial .


The trial was conducted in 2012 and had a randomized pretest-posttest controlled design with a 10-week follow-up .


Data were collected from a nationwide population-based survey panel .


A sample of 604 non-Hispanic and Hispanic adults from the Knowledge Panel 18 years or older who owned an Android smartphone were enrolled .


The mobile app provided advice on sun protection ( ie , protection practices and risk of sunburn ) and alerts ( to apply or reapply sunscreen and get out of the sun ) , hourly UV Index , and vitamin D production based on the forecast UV Index , the phone 's time and location , and user input .


Percentage of days using sun protection and time spent outdoors ( days and minutes ) in the midday sun and number of sunburns in the past 3 months were collected .


Individuals in the treatment group reported more shade use ( mean days staying in the shade , 41.0 % vs 33.7 % ; P = .03 ) but less sunscreen use ( mean days , 28.6 % vs 34.5 % ; P = .048 ) than controls .


There was no significant difference in number of sunburns in the past 3 months ( mean , 0.60 in the treatment group vs 0.62 for controls ; P = .87 ) .


Those who used the mobile app reported spending less time in the sun ( mean days keeping time in the sun to a minimum , 60.4 % for app users vs 49.3 % for nonusers ; P = .04 ) and using all protection behaviors combined more ( mean days , 39.4 % vs 33.8 % ; P = .04 ) .


The mobile app improved some sun protection .


Use of the mobile app was lower than expected but associated with increased sun protection .


Providing personalized advice when and where people are in the sun may help reduce sun exposure .


This study was carried out to examine the difference in effects between rosuvastatin and pravastatin on neointimal formation after the placement of a drug-eluting stent ( DES ) .


Forty patients who underwent placement of a DES in our hospital were prospectively randomized to receive rosuvastatin ( n = 20 ) or pravastatin ( n = 20 ) , and analyzed by optical coherence tomography at the chronic stage .


The main outcome measure was comparison of neointimal coverage analyzed at a strut level .


A significant reduction in total cholesterol , low-density lipoprotein , and white blood cell count was observed during the study in the rosuvastatin group ( total cholesterol , from 4.820.90 to 4.430.77 mmol/l , P = 0.038 ; low-density lipoprotein , from 2.850.76 to 2.340.57 mmol/l , P = 0.006 ; white blood cell count , from 58101399 to 53551257/l , P = 0.048 ) , but not in the pravastatin group .


Although not statistically significant , C-reactive protein was lower in the rosuvastatin than in the pravastatin group at the chronic stage ( 1.141.21 vs. 7.6713.67 mg/l , P = 0.051 ) .


Malapposed and uncovered struts were significantly less frequent in the rosuvastatin group than in the pravastatin group ( malapposed , 0.06 vs. 0.60 % , P < 0.001 ; uncovered , 6.49 vs. 11.29 % , P < 0.001 ) .


The difference in uncovered struts was maintained even when stent types were analyzed separately ( everolimus-eluting stent , 4.81 vs. 6.21 % , P = 0.007 ; sirolimus-eluting stent , 14.40 vs. 20.86 % , P < 0.001 ) .


Comparison of neointimal thickness between the rosuvastatin and the pravastatin groups showed inconsistent results depending on the stent types analyzed .


Compared with pravastatin , the use of rosuvastatin resulted in lower frequency of uncovered and malapposed struts after the placement of a DES , which might be mediated through improved inflammatory and lipid profiles .


The purpose of this study was to describe the unique characteristics of informal hospice cancer caregiving .


Researchers conducted a secondary analysis of data drawn from a randomized clinical trial of an informal hospice caregiving intervention ( N = 348 ) .


Demographic characteristics and measures of the informal caregiving experience of hospice patients and their informal caregivers were compared based on the patient 's diagnosis using chi-square tests for association of categorical variables and t tests for continuous variables .


Informal caregivers of cancer patients differed from their non-cancer counterparts in a number of respects including patient age , caregiver age , patient residence , relationship between patient and caregiver , amount and duration of care provided , likelihood to incur out-of-pocket expenses related to patient care , caregiver problem-solving style , and impact on caregiver daily schedule .


There were no statistically significant differences between cancer and non-cancer caregivers in terms of gender , race , employment status , anxiety , and quality of life .


While cancer and non-cancer caregivers are similar in many respects , a number of unique features characterize the informal hospice cancer caregiving experience .


Attention to these unique features will allow hospice providers to tailor supportive care interventions to better address cancer caregivers ' needs .


Interest in improving care for the growing number of individuals with chronic conditions is rising .


However , access to care is limited by distance , disability , and distribution of doctors .


Small-scale studies in Parkinson disease , a prototypical chronic condition , have suggested that delivering care using video house calls is feasible , offers similar clinical outcomes to in-person care , and reduces travel burden .


We are conducting a randomized comparative effectiveness study ( Connect.Parkinson ) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist .


Recruitment is completed centrally using online advertisements and emails and by contacting physicians , support groups , and allied health professionals .


Efforts target areas with a high proportion of individuals not receiving care from neurologists .


Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year .


Participants receive educational materials , then are randomized in a 1:1 ratio to continue their usual care ( control arm ) or usual care and specialty care delivered virtually ( intervention arm ) .


Care partners are surveyed about their time and travel burden and their perceived caregiver burden .


Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months .


All study activities are completed remotely.The primary outcomes are : ( 1 ) feasibility , as measured by the proportion of visits completed , and ( 2 ) quality of life , as measured by the 39-item Parkinson 's Disease Questionnaire .


Secondary outcomes include measures of clinical benefit , quality of care , time and travel burden , and caregiver burden .


Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease .


The trial may serve as a model for increasing access and delivering patient-centered care at home for individuals with chronic conditions .


This trial was registered on clinicaltrials.gov on January 8 , 2014 [ NCT02038959 ] .


Nitrous oxide anesthesia increases postoperative homocysteine concentrations .


Renal transplantation candidates present with higher homocysteine levels than patients with no renal disease .


We designed this study to investigate if homocysteine levels are higher in subjects receiving nitrous oxide for renal transplantation compared with subjects undergoing nitrous oxide free anesthesia .


Data from 59 patients scheduled for living-related donor renal transplantation surgery were analyzed in this randomized , controlled , blinded , parallel-group , longitudinal trial .


Patients were assigned to receive general anesthesia with ( flowmeter was set at 2 L/min nitrous oxide and 1 L/min oxygen ) or without nitrous oxide ( 2 L/min air and 1 L/min oxygen ) .


We evaluated levels of total homocysteine and known determinants , including creatinine , folate , vitamin B12 , albumin , and lipids .