Multifarious immunotherapeutic approaches in the context of fully suppressive cART further reduce immune activation , and improve both CD4 T-lymphocyte counts and HIV-1-specific T-cell responses ( NCT01130376 ) .


To investigate the analgesic and sedative effects of inhaling a mixture of nitrous oxide and oxygen on burn patient during and after dressing change .


A total of 240 burn patients hospitalized in the Institute of Burn Research of Changhai Hospital Affiliated to the Second Military Medical University , Department of Burns of the First People 's Hospital in Zhengzhou , and Department of Burns and Plastic Surgery of General Hospital of Ningxia Medical University from October 2011 to September 2012 were enrolled in our study , and they were all in accordance with the inclusion criteria .


The 240 patients were divided into control group ( n = 60 , treated with inhalation of oxygen during dressing change ) and treatment group ( n = 180 , treated with inhalation of a mixture of 65 % nitrous oxide and oxygen during dressing change ) according to the computer-generated list of random number .


The other treatments in control group and treatment group were the same .


Before , during , and after dressing change , heart rate ( HR ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , oxygen saturation ( SO2 ) , and adverse effects were observed .


The degree of pain and anxiety felt by the patients were respectively evaluated with the visual analogue scale ( VAS ) and Chinese version of the burn specific pain anxiety scale ( C-BSPAS ) at the same time points as above .


Data were processed with analysis of covariance , chi-square test , analysis of variance , and rank sum test .


There were no significant differences between control group and treatment group in the levels of HR , SBP , DBP , and SO2 before dressing change ( with F values respectively 0.76 , 0.06 , 1.11 , 0.70 , P values all above 0.05 ) .


Compared with those of control group , the levels of HR , SBP , DBP , and SO2 in treatment group were significantly ameliorated during dressing change ( with F values respectively 81.78 , 146.36 , 226.44 , 205.62 , P values all below 0.01 ) .


After dressing change , the levels of DBP in the two groups were close ( F = 0.31 , P > 0.05 ) , but the levels of HR , SBP , and SO2 showed statistical differences ( with F values respectively 7.02 , 8.69 , 12.23 , P < 0.05 or P < 0.01 ) .


Before dressing change , the VAS scores were approximate between control group and treatment group ( Z = 0.21 , P > 0.05 ) .


Compared with those in control group ( 9.4 0.7 , 1.7 2.5 ) , the VAS scores were significantly lowered in treatment group during and after dressing change ( 1.6 1.3 , 0.7 1.1 , with Z values respectively 11.84 , 3.35 , P values all below 0.01 ) .


There was no significant difference in C-BSPAS score between control group and treatment group before dressing change ( Z = 0.62 , P > 0.05 ) .


Compared with those in control group ( 75 13 , 73 12 ) , the C-BSPAS scores in treatment group were decreased during and after dressing change ( 9 15 , 9 14 , with Z values respectively 11.91 , 12.28 , P values all below 0.01 ) .


There were no obvious adverse effects in two groups before , during , and after dressing change .


A mixture of nitrous oxide and oxygen seems to have obvious analgesic and sedative effects on burn patients during dressing change , and it can be widely used .


Although postmenopausal combined hormone replacement therapy reduces the risk of hip fracture , long-term use may be associated with an increased risk of breast cancer , and in women more than 10 years after menopause it is associated with an increased risk of cardiovascular disease .


Isoflavones , because of preferential binding to estrogen receptor beta , may retain the beneficial effects on bone but lessen the adverse effects on the breast .


The objective of this study was to study the effects of an isoflavone obtained from red clover ( Rimostil ) on bone mineral density , and on low-density lipoprotein ( LDL ) cholesterol .


In a double-blind , randomized , placebo-controlled trial , 50 mg of Rimostil was given to women who were menopausal for at least 1 year .


Bone mineral density of the spine , femoral neck and forearm and serum LDL cholesterol were measured at baseline and at 6-month intervals .


The duration of follow-up was 2 years .


There was no beneficial effect of Rimostil on bone density at any site .


There was a 12 % fall in serum LDL cholesterol in the Rimostil-treated arm , which was significantly greater than the 2 % drop seen in the control arm ( P = 0.005 ) .


Patellofemoral pain syndrome ( PFPS ) is a frequent cause of anterior knee pain predominantly affecting young female patients who do not have significant chondral damage .


Development of PFPS is probably multifactorial , involving various knee , hip , and foot kinematic factors .


Biomechanical studies have described patellar maltracking and dynamic valgus ( functional malalignment ) in patients with patellofemoral pain syndrome .


The literature provides evidence for short-term use of nonsteroidal anti-inflammatory drugs ; short-term medially directed taping ; and exercise programs focusing on the lower extremity , hip , and trunk muscles .


Evidence supporting the use of patellar braces is limited because previous studies have been low quality .


The aim of this article is to publish the design of a prospective randomized trial that examines the outcomes of patients with PFPS after treatment with a new patellar brace ( Patella Pro ) that applies medially directed force on the patella .


For this multicenter trial , 156 patients ( adolescents and young adults ) with PFPS were recruited from orthopedic practices and orthopedic hospitals and randomly allocated to 3 months of supervised physiotherapy in combination with the Patella Pro brace or supervised physiotherapy alone .


The primary outcome measures are pain ( numerical analog scale ) ; knee function ( Kujala score and Knee Injury and Osteoarthritis Outcome Score ) ; and self-reported perception of recovery at baseline , 6 weeks , 3 months , and 1 year .


Only limited evidence for the use of a patellar brace for the treatment of PFPS exists in the literature .


Disputable evidence for the use of orthoses for PFPS patients has been presented in one meta-analysis , in which only one of three studies found the effect of a medially directed patellar brace to be significant .


Because of these low-quality studies , the authors concluded that this evidence should be regarded as limited , and we feel there is a need for further well-designed studies to evaluate the effect of patellar bracing on PFPS-related pain .


The Patella Pro study is a prospective randomized trial in which supervised physiotherapy in combination with a patellar brace is compared with supervised physiotherapy alone .


This trial started in April 2012 and finished in October 2013 .


DRKS-ID : DRKS00003291 , January 3rd , 2012 .


To compare the use of fluorine 18 fluorodeoxyglucose ( FDG ) positron emission tomography ( PET ) / computed tomography ( CT ) with the use of a combination of ultrasonography ( US ) and chest radiography for systematic follow-up of patients with high-risk Hodgkin lymphoma .


Institutional review board approval and informed consent were obtained .


In a single center between January 2001 and December 2009 , patients with advanced-stage Hodgkin lymphoma who had responded completely to first-line treatment were randomly assigned ( 1:1 ) to follow-up with either PET/CT or US/chest radiography .


Follow-up included clinical and imaging procedures at 4 , 8 , 12 , 16 , 20 , 24 , 30 , 36 , 48 , 60 , 84 , and 108 months after treatment discontinuation .


When clinical and/or imaging results were positive , recurrence was confirmed histologically .


The primary endpoint was to compare the sensitivity of the two follow-up imaging approaches .


Secondary endpoints were their specificity , positive and negative predictive values , time to recurrence detection , radiation risks , and costs .


A total of 300 patients were randomized into the two arms .


The study was closed after a median follow-up time of 60 months , with a relapse rate of 27 % .


Sensitivity for detection of Hodgkin lymphoma was similar for the two follow-up approaches .


All of the relapses ( 40 of 40 ) were identified with FDG PET/CT ( 100 % ) and 39 of 40 relapses were identified with US/chest radiography ( 97.5 % ; P = .0001 for the equivalence test ) .


US/chest radiography showed significantly higher specificity and positive predictive value than did PET/CT ( 96 % [ 106 of 110 ] vs 86 % [ 95 of 110 ] , respectively ; P = .02 ; and 91 % [ 39 of 43 ] vs 73 % [ 40 of 55 ] , respectively ; P = .01 ) .


Exposure to ionizing radiation was estimated to be 14.5 mSv for one PET/CT examination versus 0.1 mSv for one chest radiographic examination .


Estimated cost per relapse diagnosed with routine PET/CT was 10-fold higher compared with that diagnosed with routine US/chest radiography .


US and chest radiography are diagnostic tools that enable effective , safe , and low-cost routine surveillance imaging for patients at high risk of Hodgkin lymphoma relapse .


Laparoscopic gastric plication ( LGP ) is emerging as a safe and effective bariatric procedure .


However , there are no reports on the comparison between the efficacy and complications of LGP and laparoscopic mini-gastric bypass ( LMGB ) , which is still an investigational bariatric procedure .


The objective of this study was to compare safety and efficacy of LGP and LMGB in the treatment of morbid obesity in a one-year follow-up study .


Forty patients met the National Institutes of Health criteria and were randomly assigned to receive either LGP ( n = 20 ) or LMGB ( n = 20 ) by a block randomization method .


Early and late complications , body mass index ( BMI ) , excess weight loss , and obesity-related co-morbidities were determined at the 1-year follow-up .


Operative time and mean length of hospitalization were shorter in the LGP group ( 71.0 minutes versus 125.0 minutes , P < .001 , and 1.6 days versus 5.2 days ; P < .001 , respectively ) .


The mean percentage of excess weight loss ( % EWL ) at 12 months follow-up was 66.9 % in the LMGB group and 60.8 % in the LGP group ( P = .34 ) .


Improvement was observed in all co-morbidities in both groups , with the exception of hyperlipidemia , which remained unresolved in 4 patients .


Lower incidence of iron deficiency occurred in the LGP group ( P = .035 ) .


Rehospitalization and reoperation were not required in any cases .


Considering the cost of instruments used in the LMGB procedure and operative time , LGP saved approximately $ 2,500 per case compared with LMGB .


Both LGP and LMGB are effective weight loss procedures .


LGP proved to be a simpler and less costly procedure compared with LMGB with a lower risk of iron deficiency during a 1-year follow-up study .


Individuals involved in the early stages of a passionate romantic relationship can be consumed by the experience and report emotional dependence and constant focus on their romantic partner .


A few studies have shown that viewing pictures of a romantic partner can significantly reduce experimental pain .


The strength of the effect , however , varies substantially between individuals .


To study why some individuals experience significant pain reduction when looking at a picture of their partner , we examined partner preoccupation .


We hypothesized that a greater degree of preoccupation in the early stages of a romantic relationship would be associated with greater analgesia during a pain induction task .


Participants were shown pictures of their romantic partner or an equally attractive and familiar acquaintance while exposed to low , moderate , or high levels of thermal pain .


Participants were also asked to rate how much time they spent thinking about their romantic partner during an average day .


Degree of preoccupation was defined as the percentage of time participants spent thinking about their partner on an average day .


In two separate experiments , viewing pictures of a romantic partner produced an analgesic effect .


The degree of pain relief was positively correlated with partner preoccupation .


The results suggest that preoccupation with a romantic partner during early stage romantic love is a predictor of pain relief when viewing pictures of the beloved .


To compare the relative gentleness of a silicone tape to a paper tape in healthy infants and children .


A randomized , grader-blinded , comparative study .


The sample group comprised 24 healthy infants and children 9.1 to 46.7 months of age ( mean SEM , 34.0 2.21 ) .


The study was conducted at a dermatological research facility ( cyberDERM , Inc ) located in Broomall , Pennsylvania .


All volunteers were recruited from the surrounding community .


Tapes measuring 1 1.5 inches were randomly applied to the left and right intrascapular regions of the upper back .


Tapes were removed in a standardized fashion after 24 hours .


The primary study outcome , gentleness , was based on visual assessments of skin damage , discomfort , and quantification of keratin removal .


Four-point scales were used to assess skin damage , and a 10-point Faces , Legs , Activity , Cry , and Consolability instrument was used to assess discomfort .


Secondary assessments included hair removal , tape edge-lift assessments , and parent preference for either tape .


There was a significantly lower mean SEM erythema response for the silicone tape ( 0.93 0.14 vs 1.35 0.11 , P = .0129 ) than for the paper tape .


No measurable epidermal stripping occurred with the silicone tape compared to a mean SEM response of 0.29 0.11 for the paper tape ( P = .0039 ) .


Discomfort was significantly lower ( P = .0002 ) for the silicone tape as compared to the paper tape ( Faces , Legs , Activity , Cry , and Consolability score mean difference from baseline 0.5 vs 3.3 , P = .0002 ) .


Keratin removal was significantly less with the silicone as compared to paper tape ( 8.7 0.5 g/mL vs 15.2 1.3 g/mL , P < .0001 ) .


Few hairs were removed with either tape .


There was significantly less ( P < .0001 ) edge-lift with the paper tape than the silicone tape ; no statistically significant differences in parent preferences for silicone versus paper tapes were measured ( P = .3359 ) .


Gentleness assessments favored the silicone tape compared to a paper tape and warrant further clinical investigation in the neonatal intensive care unit .


The surgical management of symptomatic giant hiatus hernia ( GHH ) aims to improve quality of life ( QoL ) and reduce the risk of life threatening complications .


Previous reports are predominantly those with small sample sizes and short follow-up periods .


The present study sought to assess a large cohort of patients for recurrence and QoL over a longer time period .


This was a follow-up study of a prospectively collected database of 455 consecutive patients .


Primary repair of GHH was evaluated by endoscopy/barium meal for recurrence and a standardised symptom questionnaire for QoL .


Recurrence was assessed for size , elapsed time , oesophagitis and symptoms .


Objective and subjective review was achieved in 91.9 % and 68.6 % of patients .


The median age was 69 years ( range : 15-93 years ) and 64 % were female .


Laparoscopic repair was completed in 95 % ( mesh in 6 % and Collis gastroplasty in 7 % ) .


The 30-day mortality rate was 0.9 % .


The proportion of patients alive at five and ten years were 90 % and 75 % respectively .


Postoperative QoL scores improved from a mean of 95 to 111 ( p < 0.01 ) and were stable over time ( 112 at 10 years ) .


The overall recurrence rate was 35.6 % ( 149/418 ) at 42 months ; this was 11.5 % ( 48/418 ) for hernias > 2cm and 24.2 % ( 101/418 ) for < 2cm .


The rate of new recurrence at 0-1 years was 13.7 % ( > 2cm = 3.4 % , < 2cm = 10.3 % ) , at 1-5 years it was 30.8 % ( > 2cm = 9.5 % , < 2cm = 21.3 % ) , at 5-10 years it was 40.1 % ( > 2cm = 13.8 % , < 2cm = 26.3 % ) and at over 10 years it was 50.0 % ( > 2cm = 25.0 % , < 2cm = 25.0 % ) .


Recurrence was associated with oesophagitis but not decreased QoL .


Revision surgery was required in 4.8 % of cases ( 14.8 % with recurrence ) .


There were no interval major GHH complications .


Surgery has provided sustained QoL improvements irrespective of recurrence .


Recurrence occurred progressively over ten years and may predispose to oesophagitis .


To assess the clinical effect of the ` prostatic urethral lift ' ( PUL ) on lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) through a crossover design study .


Men aged 50 years with an International Prostate Symptom Score of 13 , a maximum urinary flow rate ( Qmax ) of 12 mL/s , and a prostate of 30-80 mL were enrolled into a crossover study after completing a prospective , randomised , controlled , ` blinded ' pivotal study in which they were control subjects receiving a sham procedure .


Patients were followed for 1 year after crossover PUL at 19 centres in the USA , Canada and Australia .


The sham procedure involved rigid cystoscopy with simulated active treatment sounds .


PUL involved placing permanent UroLift ( NeoTract , Inc. , Pleasanton , CA , USA ) implants into the lateral lobes of the prostate to enlarge the urethral lumen .


Urinary symptom relief , health-related quality of life ( HRQL ) impact , urinary flow parameters , sexual function , and adverse events were assessed and compared between the sham and PUL using paired statistical analysis .


Symptom , flow , HRQL and sexual function assessments showed response improvements from baseline results , similar to results from other published studies , and most parameters were markedly improved after PUL vs the sham procedure in the same patients .


Symptom , flow , and HRQL improvements were durable over the 12 months of the study .


Adverse events associated with the procedure were typically transient and mild to moderate ; one patient ( 2 % ) required re-intervention with transurethral resection of the prostate in the first year .


There were no occurrences of de novo , sustained ejaculatory or erectile dysfunction .


The PUL can be performed under local anaesthesia , causes minimal associated perioperative complications , allows patients to quickly return to normal activity , provides rapid and durable improvement in symptoms , and preserves sexual function .


People with atherosclerotic renal artery stenosis may benefit from renin-angiotensin inhibitors , angiotensin-converting enzyme inhibitors , and angiotensin-receptor blockers , but little is known about the factors associated with their use .


The Cardiovascular Outcomes in Renal Atherosclerotic Lesions study ( ClinicalTrials.gov identified : NCT00081731 ) is a prospective , international , multicenter clinical trial that randomly assigned participants with atherosclerotic renal artery stenosis who received optimal medical therapy to stenting versus no stenting from May 2005 through January 2010 .


At baseline , medication information was available from 853 of 931 randomly assigned participants .


Kidney function was measured by serum creatinine-based eGFR at a core laboratory .


Before randomization , renin-angiotensin inhibitors were used in 419 ( 49 % ) of the 853 participants .


Renin-angiotensin inhibitor use was lower in those with CKD ( eGFR < 60 ml/min per 1.73 m ( 2 ) ) ( 58 % versus 68 % ; P = 0.004 ) and higher in individuals with diabetes ( 41 % versus 27 % ; P < 0.001 ) .


Presence of bilateral renal artery stenosis or congestive heart failure was not associated with renin-angiotensin inhibitor use .


Although therapy with renin-angiotensin inhibitors varied by study site , differences in rates of use were not related to the characteristics of the site participants .


Participants receiving a renin-angiotensin inhibitor had lower systolic BP ( mean SD , 148 23 versus 152 23 mmHg ; P = 0.003 ) and more often had BP at goal ( 30 % versus 22 % ; P = 0.01 ) .


Kidney function and diabetes were associated with renin-angiotensin inhibitor use .


However , these or other clinical characteristics did not explain variability among study sites .


Patients with renal artery stenosis who received renin-angiotensin inhibitor treatment had lower BP and were more likely to be at treatment goal .


This study was designed to investigate whether patients with stable coronary artery disease ( CAD ) receiving chronic statin treatment who are undergoing noncardiac emergency surgery benefit from acute atorvastatin reload .


A total of 500 patients with stable CAD and regular administration of statin before noncardiac emergency surgery were randomized to atorvastatin reload ( n = 250 ) or placebo ( n = 250 ) .


All patients received atorvastatin treatment thereafter .


The primary end point was a 30-day incidence of major adverse cardiac events ( MACE ) .


Secondary end points were the incidence of atrial fibrillation ( AF ) during hospitalization and length of hospital stay .


The primary end point occurred in 2.4 % of patients treated with atorvastatin reload and in 8 % in the placebo arm ( p = 0.0088 ) .


The incidence of AF during hospitalization was 6.8 % in patients treated with atorvastatin reload and 17 % in the placebo arm ( p = 0.0003 ) .


Compared with the placebo arm , the atorvastatin reload arm shortened the length of stay ( 9.8 3.3 vs. 10.6 3.5 days , p = 0.009 ) .


Multivariable analysis suggested that atorvastatin reload conferred a 65 % risk reduction of 30-day MACE ( odds ratio 0.35 , 95 % confidence interval 0.18-0 .86 ; p = 0.005 ) .


The trial suggests that atorvastatin reload may improve the clinical outcome of patients with stable CAD receiving chronic statin treatment who are undergoing noncardiac emergency surgery .


It is commonly known that ultrasonography ( US ) transducers function as both a reservoir and means of transfer for hospital infections .


The current study aimed to compare the antimicrobial effectiveness of using > 80 C water versus antiseptic wipes to disinfect US transducers .


Subsequent to abdominal inspections in three groups of 20 patients , a swab culture was taken from the transducer in each case .


Neither a mechanical nor chemical disinfection was applied to the transducer in the first group .


As for the second group , the transducer was placed in > 80 C hot water for five minutes .


In the third group , the transducer was wiped clean using antiseptic wipes .


Of the 60 swab samples collected , 40 did not produce any growth .


The number of samples exhibiting growth in the first group involved 18 cases of coagulase-negative staphylococcus ( CNS ) , as well as 15 cases of Listeria spp. , one case of Corynebacterium spp .


and one case of Bacillus spp. , while only one case of CNS was observed in the second and third groups , respectively .


The culture growth and colony forming units rate were significantly higher in the samples obtained from the first group than in those obtained from the other groups ( p < 0.01 ) .


As for the second and third groups , no significant differences were found in terms of the amount of colonization and growth ( p = 1.00 ) .


Being a practical and a simple method for particular use in developing and underdeveloped countries , where it is hard to access relatively costly transducer disinfection materials , such as antiseptic wipes , hot water disinfection may play an active role in fighting hospital infections .


To study the effect of 2 weeks of prophylactic zinc supplementation on incidence and duration of acute respiratory infections .


Randomized double blind controlled trial .


Community based ; urban resettlement area in North-East Delhi , India .


272 children aged 6-11 months with acute respiratory infections .


Children receiving zinc supplement within the past 3 months , severely malnourished , immuno-deficient , on steroid therapy , with severe illness requiring hospitalization , or children of families likely to migrate from the study area were excluded .


Placebo ( syrup base ) or zinc ( 20 mg/5 mL elemental zinc as zinc sulfate ) orally given for a period of 2 weeks .


Incidence , type and duration of acute respiratory infections , and adverse effects .


No effect on incidence of acute respiratory infections was noted .


A decrease of 15 % ( 0.78-0 .94 ) in days and 12 % ( 0.78-0 .94 ) in duration of episode in acute respiratory infections was observed .


Incidence of acute lower respiratory infections decreased by 62 % ( 0.26-0 .36 ) and the effect remained for full five months of follow up .


There were no drop outs due to side effects .


Prophylactic zinc supplementation for two weeks may reduce the morbidity due to acute lower respiratory infections but not overall rate of acute respiratory infections in infants aged 6-11 months in similar populations .


The purpose of this study was to compare the outcome of primary tooth pulpotomies using two different white mineral trioxide aggregate ( MTA ) cements and calcium hydroxide ( CH ) .


Primary molars ( N = 139 ) from three - to nine-year-old children were randomly assigned to be treated using either ProRoot MTA ( N = 46 ) , MTA Angelus ( N = 45 ) , or CH paste ( N = 48 ) as pulpotomy medicaments .


All pulpotomized teeth received a Class I amalgam as a final restoration .


Recall examinations were carried out at one , three , six , 12 , 18 , and 24 months .


The 24-month cumulative clinical success rates for ProRoot MTA , MTA Angelus , and CH were approximately 98 percent , 96 percent , and 77 percent , respectively .


The cumulative radiographic success rates for ProRoot MTA , MTA Angelus , and CH were approximately 98 percent , 91 percent , and 45 percent , respectively .


For all parameters evaluated , the MTA cements showed similar clinical and radiographic outcomes ( P > .05 ) , which were significantly better than those of CH ( P < .05 ) .


The two-year clinical and radiographic survival probabilities for ProRoot MTA and MTA Angelus were comparable ( P = .62 and P = .20 , respectively ) and superior to calcium hydroxide ( all P > .05 ) .


ProRoot MTA and MTA Angelus showed similar and favorable success rates as pulpotomy materials in primary molars .


To compare the difference in clinical efficacy on chronic obstructive pulmonary disease ( COPD ) at stable stage in the patients among the combined therapy of cutting method and western medication ( combined therapy ) , simple cutting method and simple western medication .


One hundred and twenty cases of COPD were randomized into three groups , 40 cases in each one .


In the cutting method group , for excessive phlegm pattern/syndrome , Feishu ( BL 13 ) , Danzhong ( CV 17 ) , Dingchuan ( EX-B 1 ) and Yuji ( LU 10 ) were selected as the main acupoints , and Lieque ( LU 7 ) and Pianli ( LI 6 ) were as the supplementary acupoints .


For the pattern/syndrome of failure to consolidate kidney primary , Shenshu ( BL 23 ) , Pishu ( BL 20 ) , Guanyuan ( CV 4 ) and Yuji ( LU 10 ) were selected as main acupoints , and Jueyinshu ( BL 14 ) and Zusanli ( ST 36 ) were as the supplementary acupoint .


Three acupoints were selected alternatively in each treatment and the cutting method was applied once every 10 days .


Three treatments made one session .


Two sessions of treatment were required .


In the western medication group , salbutamol sulfate aerosol , one press ( 200 g/press ) was used each night , as well as salmeterol xinafoate and fluticasone propionate powder for inhalation , one inhalation each night .


The treatment of 1 month made one session .


Two sessions were required .


In the combined therapy group , the cutting method and western medication were applied in combination .


The results of clinical symptom score , lung function test , arterial blood gas analysis , degree of inflation as well as clinical efficacy were observed before and after treatment in each group .


Except the degree of lung inflation , the clinical symptom score , indices of lung function test , partial pressure of arterial blood gas ( PaO2 ) and partial pressure of carbon dioxide ( PaCO2 ) were all obviously improved after treatment as compared with those before treatment in each group ( all P < 0.05 ) .


They were apparently improved after treatment in the combined therapy group and the cutting method group as compared with those in the western medication group ( all P < 0.05 ) .


The total effective rate was 77.5 % ( 31/40 ) in the combined therapy group and was 75.0 % ( 30/40 ) in the cutting method group , both better than 60.0 % ( 24/40 ) in the western medication group ( both P < 0.05 ) .


The simple cutting method based on syndrome differentiation and the combined therapy with western medication achieve the superior efficacy on COPD at stable stage as compared with the simple western medication .


The effect mechanism is possibly related to the improvement of bronchial airway function through constant acupoint stimulation .


All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks .


Subsequent support is available on request from staff in community clinics and from a telephone helpline .


The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0-6 months versus a single home-visit together with subsequent standard services ( the latter support was available to mothers in both study groups ) .


The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups .


Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide .


Mothers were excluded if they did not have internet access , required an interpreter , or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse .


Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units ( this was done by administrative staff who had no involvement in recruiting mothers , delivering the intervention , or analyzing results for the study ) .


Consistent with design and power calculations , 819 mothers were recruited to the trial .


The primary outcomes for the trial are parents ' sense of competence and self-efficacy measured using standard self-report questionnaires .


Secondary outcomes include the quality of mother-infant relationships , maternal social support , role satisfaction and maternal mental health , infant social-emotional and language development , and patterns of service utilisation .


Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged < 2 months ( pre-intervention ) , 9 , 15 , and 21 months .


We know of no previous study that has evaluated an intervention that combines the capacity of nurse and internet-based services to improve outcomes for mothers and infants .


The knowledge gained from this study will inform the design and conduct of community-based postnatal mother and child support programs .


Australian New Zealand Clinical Trials Registry ACTRN12613000204741 .


House dust contains mite allergens as well as bacterial products such as lipopolysaccharide ( LPS ) .


Asthma exacerbations are associated with the level of exposure to allergens and LPS .


LPS can potentiate allergen effects in steroid-nave patients .


Long-acting 2-agonists ( LABA ) were shown to inhibit LPS-induced bronchial inflammation in healthy volunteers .


The aim of this study was to assess the effect of LPS on the allergen-induced eosinophilic inflammation [ primary endpoints : eosinophil counts and eosinophil cationic protein ( ECP ) ] induced by bronchial instillation of house dust mite ( HDM ) in patients with asthma on maintenance treatment with inhaled corticosteroids ( ICS ) .


Thirty-two nonsmoking asthmatics with HDM allergy were treated with run-in medication ( fluticasone propionate 100 g bid ) during 2 weeks before the study day .


All patients underwent bronchial challenge with HDM , and half of them were randomized to receive additional LPS .


Both groups were randomized to receive pretreatment with a single inhalation of 100 g salmeterol 30 min before bronchial segmental challenge .


Six hours later , bronchoalveolar lavage ( BAL ) was collected for leukocyte cell count , differentials , and cellular activation markers .


Challenge with HDM/LPS induced a significant increase in eosinophil cationic protein ( P = 0.036 ) and a trend toward an increase in BALF eosinophils as compared to HDM challenge .


Lipopolysaccharide promotes eosinophilic airway inflammation in patients with asthma despite being on maintenance treatment with ICS .


Various positive psychology interventions have been experimentally tested , but only few studies addressed the effects of such activities in participants aged 50 and above .


We tested the impact of four self-administered positive psychology interventions in an online setting ( i.e. , gratitude visit , three good things , three funny things , and using signature strengths in a new way ) on happiness and depressive symptoms in comparison with a placebo control exercise ( i.e. , early memories ) .


A total of 163 females aged 50-79 tried the assigned interventions or the placebo control exercise for one week and completed measures on happiness and depressive symptoms at five times ( pre - and post-test , 1 , 3 , and 6 months ) .


Three out of the four interventions ( i.e. , gratitude visit , three good things , and using signature strengths in a new way ) increased happiness , whereas two interventions ( three funny things and using signature strengths in a new way ) led to a reduction of depressive symptoms on at one post-measure .


Positive psychology interventions yield similar results for people aged 50 and above as for younger people .


The dissemination of such interventions via the Internet offers a valuable opportunity for older age groups as well .


This prospective randomized pilot study sought to determine whether fixation with Sonoma CRx intramedullary pin is a comparable alternative to minimally invasive plating fixation in patients with displaced clavicle fractures .


A total of 45 consecutive patients ( Robinson class B1 or B2 ) were randomly allocated into two groups ; intramedullary pin ( IMP ) group ( n = 24 , mean age ; 33.178.60 years , 14 males 58.3 % ) received Sonoma CRx Collarbone pin ( Sonoma , USA ) whereas locking midshaft superior plating ( MIPPO ) group ( n = 21 , 32.388.41 years , 12 males ) patients received minimally invasive locking midshaft superior plating ( Acumed , USA ) .


Patients were followed up with a mean time of 11.824.22 and 14.456.43 months , respectively .


Functional status , as the primary outcome measure , was assessed using quick disability of the arm , shoulder and hand ( DASH ) scores .


Mean time of operation and mean time of fluoroscopy were significantly shorter in the IMP group than those in MIPPO group ( p < 0.001 and p = 0.03 , respectively ) .


Time of hospital stay was significantly shorter in IMP group ( p < 0.001 ) .


Complications were rare in the early postoperative period .


Time until bony union was significantly shorter in IMP group .


Mean quick DASH scores were not significantly different between two groups .


Implant failure occurred in one patient from each group .


Cosmetic dissatisfaction was more common in MIPPO group .


Given the shorter operative times and better cosmetic appearance , Sonoma CRx intramedullary pin may be an alternative to minimally invasive plating .


Further safety studies are warranted .


A randomized intervention study , `` Preventive consultations for 20 - to 40-year-old young adults '' , investigated whether preventive consultations with a general practitioner could help young adults with multiple psychosocial and lifestyle problems to change health behavior .


To optimize the response rate of questionnaires at 1year post-intervention , the non-responders were reminded by telephone .


The aim of this study was to examine potential selection bias induced by non-response by comparing responder and non-responder populations at baseline , and to examine the impact on outcomes by comparing initial respondents to respondents after telephone reminding .


Non-responders were compared with primary responders using logistic regression models that included socio-demographic factors , health-related factors , and variables related to the intervention study .


In order to describe the impact of including responders after telephone reminding on the intervention 's effect on different health , resource , and lifestyle outcomes , we compared results in models including and excluding responders after telephone reminding .


Telephone contact raised the response by 10 % from 316 ( 64 % ) to 364 ( 74 % ) among young adults with multiple problems .


Being male was the only factor that significantly predicted non-response in the model after adjustment for other variables .


The responders after telephone reminding tended to improve health and lifestyle more than the primary responders , but not significantly so .


Although the additional responses did not change the estimates of the 1-year effect on health and lifestyle changes , it contributed to increased precision of the results .


Even though the population of primary non-responders had to some degree a different composition than the primary responders , inclusion of responders after telephone reminding did not significantly change the estimates for effect at the 1-year follow-up ; however , the additional responses increased the precision of the estimates .


ClinicalTrials.gov : NCT01231256 .


Echocardiogram reports , but not images , are usually available for the evaluation of potential donor hearts .


To assess the reliability of local reports of potential pediatric heart donors , we compared echocardiographic measurements of left ventricular ( LV ) systolic function between local hospitals and a central echocardiography laboratory .


We identified all potential donors aged < 18 years managed by the California Transplant Donor Network from 2009 to 2013 .


Echocardiograms and reports were obtained from local hospitals .


All studies were reviewed in a central laboratory by an experienced pediatric cardiologist blinded to local reports .


Local and central measurements of fractional shortening ( FS ) were compared using the Bland-Altman method ( mean difference 2 standard deviations ) .


LV function was categorized based on FS as normal or mild , moderately , or severely depressed .


There were 70 studies from 59 donors with local and central measurements of FS .


The mean difference between local and central FS was 3.9 9.0 .


The limits of agreement ranged from -14.2 to 22 .


Twenty-five studies had discordant measurements of LV function , with 17 discordant by 1 category and 8 by 2 or more categories .


Of 55 studies categorized as normal by local measurement , 6 were moderately to severely depressed by central review .


Of 15 studies categorized as depressed by local measurement , 3 were normal by central review .


Local and central measurements of LV systolic function were discordant in 36 % of studies .


Given such discordance , efforts to obtain and view actual echocardiographic images should be part of the standard evaluation of potential pediatric heart donors .


We have shown that a low glutathione concentration and synthesis rate in erythrocytes are associated with a shortage of protein-derived cysteine in children with edematous severe acute malnutrition ( SAM ) .


We tested the hypothesis that methionine supplementation may increase protein-derived cysteine and upregulate cysteine synthesis , thereby improving glutathione synthesis during the early treatment of edematous SAM .


The cysteine flux , its de novo synthesis and release from protein breakdown , and erythrocyte glutathione synthesis rate were measured in 12 children with edematous SAM in the fed state by using stable isotope tracers at 3 clinical phases as follows : 3 1 d ( SE ) [ clinical phase 1 ( CP1 ) ] , 8 1 d [ clinical phase 2 ( CP2 ) ] , and 14 2 d ( clinical phase 3 ) after admission .


Subjects were randomly assigned to receive equimolar supplements ( 0.5 mmol kg ( -1 ) d ( -1 ) ) of methionine or alanine ( control ) immediately after CP1 .


In the methionine compared with the alanine group , cysteine flux derived from protein breakdown was faster at CP2 than CP1 ( P < 0.05 ) , and the change in plasma cysteine concentration from CP1 to CP2 was greater ( P < 0.05 ) .


However , there was no evidence of a difference in cysteine de novo synthesis and its total flux or erythrocyte glutathione synthesis rate and concentration between groups .


Methionine supplementation increased cysteine flux from body protein but had no significant effect on glutathione synthesis rates .


Although cysteine is made from methionine , increased dietary cysteine may be necessary to partially fulfill its demand in edematous SAM because glutathione synthesis rates and concentrations were less than previous values shown at full recovery .


This study was registered at clinicaltrials.gov as NCT00473031 .


Trauma stress and neuro-inflammation caused by surgery/anaesthesia releases cytokines .


This study analysed impact of Auditory Evoked Potential Index ( AAI ) depth-of-anaesthesia titration on the early plasma IL-6 release after eye surgery under general anaesthesia .


This is a subgroup analysis of a prospective randomized study on the effect of auditory evoked potential guided anaesthesia for eye surgery .


Plasma IL-6 levels taken before , 5 and 24 h after end of surgery from 450 patients undergoing elective ophthalmic surgery under desflurane anaesthesia were analysed .


Minimal mental state examination ( MMSE ) was also tested at 24-h .


IL - 6 increased significantly at both 5 and further at 24 h after surgery ( 3.2 , 4.5 and 5.1 base-line , 5 and 24-h respectively ) , the IL-6 increase showed different patterns between the 2 groups ; IL-6 was significantly increased in the control group of patients between preoperative baseline and 24 h after surgery ( p = 0.008 ) also between 5 h and 24 h , ( p = 0.006 ) after surgery while the AAI-group had only minor non-significant changes .


The 18 patients that showed a 24-h MMSE score less than 25 had a significant higher 24-h IL-6 compared to the 390 patients with a MMSE score > 24 ( p = 0.002 ) .


The IL-6 increase after surgery was less pronounced in patients where anaesthesia was titrated by AAI compared to anaesthesia adjusted on clinical signs only .


IL-6 were also found to be higher in patients with a MMSE < 25 at 24-h .


Further studies are warranted evaluating the role of depth of anaesthesia monitoring on the risk for early cognitive impairment and neuro-inflammation .


Clinicaltrials.gov identifier : NA/study were conducted between January 2005-April 2008 .


To detect early changes in the metabolic profile of pregnant ewes subject to acute feed restriction at 130 days of gestation , and to establish indicators of risk for ovine pregnancy toxaemia ( OPT ) for diagnostic purposes .


Twenty Corriedale ewes with known mating dates , carrying a single fetus , were used .


Ewes were maintained on meadow grasslands and at 130 days of gestation were randomly divided in two groups of 10 ewes .


The control group had ad libitum access to pasture .


Ewes in the restricted group were subjected to an acute feed restriction for a maximum of 144 hours ( 6 days ) , with free access to water .


From the start ( 0 hours ) until the end of feed restriction , blood samples were collected from all ewes to monitor concentrations of cortisol , non-esterified fatty acids ( NEFA ) , - hydroxybutyrate ( BOHB ) daily , and glucose in plasma every 6 hours ; urinary pH was also measured .


Every 6 hours the food restricted ewes were observed to detect clinical signs of OPT e.g. apathy , grinding teeth , empty chewing movements , head leaning against the wall , tachypnea and not drinking water .


In food-restricted ewes , concentrations of glucose decreased and differed from control ewes from 54 to 90 hours ( p < 0.001 ) , and 96 to 102 hours ( p < 0.05 ) .


Concentrations of BOHB , cortisol and NEFA increased following feed restriction and differed from control ewes after 48 to 144 hours ( p < 0.01 ) .


Eight of the 10 restricted ewes showed clinical signs of OPT after 102-132 hours .


Mean concentrations of glucose , BOHB and cortisol differed between control and restricted ewes prior to the onset of clinical signs of OPT , after 48-96 hours of feed restriction ( p < 0.01 ) .


Mean gestational length , and time from birth to placental expulsion was not affected by the feed restriction .


Our results suggest that concentrations of glucose , BOHB and cortisol in plasma may provide a precocious diagnosis of subclinical OPT , using values of 1.59 ( SD 0.24 ) mmol/L , 2.26 ( SD 1.03 ) mmol/L and 15.09 ( SD 7.75 ) nmol/L , respectively .


The identification of a potentially harmful metabolic imbalance could lead to the improvement of treatment success .


Recurrence of tuberculosis after treatment makes management difficult and is a key factor for determining treatment efficacy .


Two processes can cause recurrence : relapse of the primary infection or re-infection with an exogenous strain .


Although re-infection can and does occur , its importance to tuberculosis epidemiology and its biological basis is still debated .


We used whole-genome sequencing-which is more accurate than conventional typing used to date-to assess the frequency of recurrence and to gain insight into the biological basis of re-infection .


We assessed patients from the REMoxTB trial-a randomised controlled trial of tuberculosis treatment that enrolled previously untreated participants with Mycobacterium tuberculosis infection from Malaysia , South Africa , and Thailand .


We did whole-genome sequencing and mycobacterial interspersed repetitive unit-variable number of tandem repeat ( MIRU-VNTR ) typing of pairs of isolates taken by sputum sampling : one from before treatment and another from either the end of failed treatment at 17 weeks or later or from a recurrent infection .


We compared the number and location of SNPs between isolates collected at baseline and recurrence .


We assessed 47 pairs of isolates .


Whole-genome sequencing identified 33 cases with little genetic distance ( 0-6 SNPs ) between strains , deemed relapses , and three cases for which the genetic distance ranged from 1306 to 1419 SNPs , deemed re-infections .


Six cases of relapse and six cases of mixed infection were classified differently by whole-genome sequencing and MIRU-VNTR .


We detected five single positive isolates ( positive culture followed by at least two negative cultures ) without clinical evidence of disease .


Whole-genome sequencing enables the differentiation of relapse and re-infection cases with greater resolution than do genotyping methods used at present , such as MIRU-VNTR , and provides insights into the biology of recurrence .


The additional clarity provided by whole-genome sequencing might have a role in defining endpoints for clinical trials .


Wellcome Trust , European Union , Medical Research Council , Global Alliance for TB Drug Development , European and Developing Country Clinical Trials Partnership .


Cardiac rehabilitation programs aim to improve health status and to decrease the risk of further cardiac events .


Persons undergoing rehabilitation often have difficulties transferring the learned health behaviors into their daily routine after returning home and maybe to work .


This includes physical activity as well as fruit and vegetable consumption .


Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption .


The aim of this study is , to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation .


The study will have a randomized controlled design and will be conducted among German and Dutch people who participated in cardiac rehabilitation .


The study will consist of one intervention group which will be compared to a waiting list control group .


During the eight week duration of the intervention , participants will be invited to participate in the online after-care program once per week .


The intervention encourages participants to define individual health behavior goals as well as action , and coping plans to reach these self-determined goals .


The effectiveness of the program will be compared between the intervention condition and the control group in terms of behavior change , antecedents of behavior change ( e.g. , self-efficacy ) , ability to return to work and increased well-being .


Further , subgroup-differences will be assessed including differences between the two countries , socioeconomic inequalities and across age groups .


The present study will make a contribution to understanding how such an online-based tailored interventions enables study participants to adopt and maintain a healthy lifestyle .


Implications can include how such an online program could enrich cardiac rehabilitation aftercare further .


NTR 3706 , NCT01909349 .


An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3-9 years .


In this follow-up of the Phase II study , we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3-9 years .


The randomized , open-label study assessed two doses of H5N1 A/Vietnam/1194 / 2004 influenza vaccine ( 19 g or 375 g hemagglutinin antigen ) formulated with AS03A or AS03B ( 1189 mg or 593 mg tocopherol , respectively ) .


Control groups received seasonal trivalent influenza vaccine .


Safety was assessed prospectively and included potential immune-mediated diseases ( pIMDs ) .


Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination ; cross-reactivity and cell-mediated responses were also assessed .


( NCT00502593 ) .


The safety population included 405 children .


Over 24 months , five events fulfilled the criteria for pIMDs , of which four occurred in H5N1 vaccine recipients , including uveitis ( n = 1 ) and autoimmune hepatitis ( n = 1 ) , which were considered to be vaccine-related .


Overall , safety profiles of the vaccines were clinically acceptable .


Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine , although still within the range of those observed after the first dose .


Persistence of cell-mediated immunity was strong , and CD4 ( + ) T cells with a TH 1 profile were observed .


Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity , with clinically acceptable safety profiles up to 24 months following first vaccination .


To compare the efficacy and safety of recombinant human interferon -2 b ( INF-2b ) monotherapy and combined therapy with entecavir ( ETV ) plus adefovir dipivoxil ( ADV ) in chronic hepatitis B patients with poor response to combined therapy with lamivudine and ADV.


A total of 161 patients with chronic hepatitis B refractory to to combined therapy with lamivudine ( LAM ) and ADV were randomized to receive INF-2b monotherapy ( 510 ( 6 ) , three times a week ) ( group A ) or combined therapy with entecavir ( 0.5 mg/day ) plus adefovir ( 10 mg/day ) ( group B ) .


Serum levels of HBsAg , HBeAg and HBV viral load were analyzed at 48 weeks using chemiluminescence assay and by real-time PCR as appropriate .


The drug resistance genes in HBV was tested by direct DNA sequencing .


At 48 weeks of treatment , HBV DNA decreased significantly in groups A and B to 2.061.15 log10 copies/ml and 1.771.28 log10 copies/ml , respectively .


The rates of viral response , serological response , and biochemical response in groups A and B were 48.15 % ( 39/81 ) vs 53.75 % ( 43/80 ) , 61.70 % ( 50/81 ) vs 53.75 % ( 43/80 ) , and 49.38 % ( 40/81 ) vs 60.00 % ( 48/80 ) , showing no significant differences between the two groups ( P > 0.05 ) .


The drug resistance gene mutation rate was significanty higher in group B ( 64.86 % , 24/37 ) than in group A ( 30.95 % , 13/42 , P < 0.05 ) .


Chronic hepatitis B patients refractory to lamivudine combined with ADV have a good response to INF-2b monotherapy and combined therapy with entecavir and ADV , and interferon treatment is preferred to reduce potential drug resistance gene mutations .


Cryptococcal meningitis accounts for 20 to 25 % of acquired immunodeficiency syndrome-related deaths in Africa .


Antiretroviral therapy ( ART ) is essential for survival ; however , the question of when ART should be initiated after diagnosis of cryptococcal meningitis remains unanswered .


We assessed survival at 26 weeks among 177 human immunodeficiency virus-infected adults in Uganda and South Africa who had cryptococcal meningitis and had not previously received ART .


We randomly assigned study participants to undergo either earlier ART initiation ( 1 to 2 weeks after diagnosis ) or deferred ART initiation ( 5 weeks after diagnosis ) .


Participants received amphotericin B ( 0.7 to 1.0 mg per kilogram of body weight per day ) and fluconazole ( 800 mg per day ) for 14 days , followed by consolidation therapy with fluconazole .


The 26-week mortality with earlier ART initiation was significantly higher than with deferred ART initiation ( 45 % [ 40 of 88 patients ] vs. 30 % [ 27 of 89 patients ] ; hazard ratio for death , 1.73 ; 95 % confidence interval [ CI ] , 1.06 to 2.82 ; P = 0.03 ) .


The excess deaths associated with earlier ART initiation occurred 2 to 5 weeks after diagnosis ( P = 0.007 for the comparison between groups ) ; mortality was similar in the two groups thereafter .


Among patients with few white cells in their cerebrospinal fluid ( < 5 per cubic millimeter ) at randomization , mortality was particularly elevated with earlier ART as compared with deferred ART ( hazard ratio , 3.87 ; 95 % CI , 1.41 to 10.58 ; P = 0.008 ) .


The incidence of recognized cryptococcal immune reconstitution inflammatory syndrome did not differ significantly between the earlier-ART group and the deferred-ART group ( 20 % and 13 % , respectively ; P = 0.32 ) .


All other clinical , immunologic , virologic , and microbiologic outcomes , as well as adverse events , were similar between the groups .


Deferring ART for 5 weeks after the diagnosis of cryptococcal meningitis was associated with significantly improved survival , as compared with initiating ART at 1 to 2 weeks , especially among patients with a paucity of white cells in cerebrospinal fluid .


( Funded by the National Institute of Allergy and Infectious Diseases and others ; COAT ClinicalTrials.gov number , NCT01075152 . )


Glucagon delivery in closed-loop control of type 1 diabetes is effective in minimizing hypoglycemia .


However , high insulin concentration lowers the hyperglycemic effect of glucagon , and small doses of glucagon in this setting are ineffective .


There are no studies clearly defining the relationship between insulin levels , subcutaneous glucagon , and blood glucose .


Using a euglycemic clamp technique in 11 subjects with type 1 diabetes , we examined endogenous glucose production ( EGP ) of glucagon ( 25 , 75 , 125 , and 175 g ) at three insulin infusion rates ( 0.016 , 0.032 , and 0.05 units/kg/h ) in a randomized , crossover study .


Infused 6,6-dideuterated glucose was measured every 10 min , and EGP was determined using a validated glucoregulatory model .


Area under the curve ( AUC ) for glucose production was the primary outcome , estimated over 60 min .


At low insulin levels , EGP rose proportionately with glucagon dose , from 5 68 to 112 152 mg/kg ( P = 0.038 linear trend ) , whereas at high levels , there was no increase in glucose output ( 19 53 to 26 38 mg/kg , P = NS ) .


Peak glucagon serum levels and AUC correlated well with dose ( r2 = 0.63 , P < 0.001 ) , as did insulin levels with insulin infusion rates ( r2 = 0.59 , P < 0.001 ) .


EGP increases steeply with glucagon doses between 25 and 175 g at lower insulin infusion rates .


However , high insulin infusion rates prevent these doses of glucagon from significantly increasing glucose output and may reduce glucagon effectiveness in preventing hypoglycemia when used in the artificial pancreas .


The aim of our study was to evaluate renal function assessed by serum creatinine as well as novel biomarkers in 142 patients with stable coronary heart disease and normal serum creatinine undergoing percutaneous coronary interventions ( PCI ) depending on the type of hydration : physiological saline vs. sodium bicarbonate ( 1:1 randomization ) .


Serum and urinary NGAL were evaluated before and after 8-12 , and 24 hours after PCI .


Serum cystatin C , serum creatinine , estimated glomerular filtration rate using different formulae were assessed before PCI , and 24 hours after the procedure .


Only 2 patients ( 2.8 % ) from the saline-hydrated group fulfilled the criteria for CI-AKI .


In patients hydrated with sodium bicarbonate serum creatinine declined significantly ( p < 0.01 ) .


In patients hydrated with sodium bicarbonate a significant fall in serum NGAL after 8-12 hours was found .


In sodium bicarbonate group cystatin C decreased non significantly after 8-12 hours , then returned to the baseline values .


In patients hydrated with physiological saline serum NGAL before PCI and after 24 hours correlated positively with cystatin C and eGFR by CKD-EPI .


In patients hydrated with sodium bicarbonate baseline serum NGAL correlated with NGAL baseline cystatin C and eGFR by CKD-EPI , similarly serum NGAL after 24 hours correlated with cystatin C.


We suggest to rather use sodium bicarbonate in a hydration protocol in patients undergoing PCI .


However , the value of NGAL in this setting remains to be elucidated and volume expansion remain the unquestionable prevention methods of CI-AKI .


To evaluate the sustainability of dedicated education units ( DEUs ) within an academic-service partnership .


A two-year , multisite , mixed-methods study with a randomized control trial was designed to isolate the effects of the DEU innovation on clinical education quality , teaching capacity , work life , and productivity .


Interview data from 34 participants were analyzed for interactions and behaviors that indicated sustainability .


Seven themes portrayed successful participant interactions , revealing shifting roles based on mutual respect and collaboration among engaged partners working within complex adaptive systems .


Relationship building and partnership achievements were confirmed as key components in DEU sustainability .


Sustainable , mature clinical education partnerships depend on implementing routinizing , reinforcing , recognizing , and rewarding activities .


Unit level success relies on foundational structures that support the ongoing development of DEU clinical instructors .


DEU sustainability will depend on the continual creation of new meaning for participants and the generation of new resources and results .


There is wide interindividual variation in response to morphine for cancer-related pain ; 30 % of patients do not have a good therapeutic outcome .


Alternative opioids such as oxycodone are increasingly being used , and opioid switching has become common clinical practice .


To compare clinical response to oral morphine vs. oral oxycodone when used as first-line or second-line ( after switching ) treatment in patients with cancer-related pain .


In this prospective , open-label , randomized , controlled trial ( ISRCTN65155201 ) with a selected crossover phase , patients with cancer-related pain were randomized to receive either oral morphine or oxycodone as first-line treatment .


Dose was individually titrated until the patient reported adequate pain control .


Patients who did not respond to the first-line opioid ( either because of inadequate analgesia or unacceptable adverse effects ) were switched to the alternative opioid .


Two hundred patients were recruited .


On intention-to-treat analysis ( n = 198 , morphine 98 , oxycodone 100 ) , there was no significant difference between the numbers of patients responding to morphine ( 61/98 = 62 % ) or oxycodone ( 67/100 = 67 % ) when used as a first-line opioid .


Similarly , there was no significant difference in subsequent response when patients were switched to either morphine ( 8/12 = 67 % ) or oxycodone ( 11/21 = 52 % ) .


Per-protocol analysis demonstrated a 95 % response rate when both opioids were available .


There was no difference in adverse reaction scores between morphine and oxycodone either in first-line responders or nonresponders .


In this population , there was no difference between analgesic response or adverse reactions to oral morphine and oxycodone when used as a first - or second-line opioid .


These data provide evidence to support opioid switching to improve outcomes .


New York City ( NYC ) is currently home to the largest Bangladeshi population in the United States ( US ) at approximately 62,000 individuals .


The high prevalence of Type 2 diabetes mellitus ( T2DM ) among Bangladeshis has been well documented in Bangladesh , as well as in Canada and the United Kingdom ( UK ) .


However , little is known about the diabetes prevalence and management practices of US Bangladeshis .


This paper describes the protocol for a Community Health Worker ( CHW ) intervention to improve diabetic management and control among Bangladeshis with diabetes in NYC .


For a two-arm , randomized controlled trial ( RCT ) , investigators will recruit a sample of 256 participants , all of whom are 1 ) of Bangladeshi descent , 2 ) residing in NYC , 3 ) diagnosed with T2DM and a recent Hemoglobin A1c ( HbA1c ) of6 .5 , and 4 ) between the ages of 21-85 .


The treatment group receives a six-month CHW-led intervention consisting of five monthly group educational sessions , two one-on-one visits , and follow-up phone calls as needed from a CHW .


The control group receives an introductory educational session only .


Primary and secondary outcomes include clinical and behavioral measures , such as HbA1c and weight change , access to and utilization of care ( i.e. appointment keeping and use of specialty care ) , and knowledge and practice of physical activity and healthful eating .


Additionally , information regarding CHW characteristics , the processes and mechanisms for influencing healthful behavior change , and fidelity of the intervention are collected .


Outcomes are measured at Baseline , 3-Months , 6-Months for both groups , and at 12-Months for the treatment group .


To our knowledge , this study represents the first attempt to document the efficacy of T2DM management strategies in the NYC Bangladeshi population .


Thus , future qualitative and quantitative findings of the submitted protocol will fill an important gap in the health disparities literature .


NCT02041598 .


Greater than 70 % of patients with cancer experience chemotherapy-induced nausea and vomiting .


In the current study , the authors examined the effects of electrostimulation of the K1 acupoint located on the sole of the foot because it is believed to have the potential to control chemotherapy-induced nausea and vomiting .


In this trial , 103 patients diagnosed with primary or metastatic liver cancer were recruited before transcatheter arterial infusion ( TAI ) of cisplatin or oxaliplatin and randomized to either group A ( 51 patients who were treated with the antiemetic tropisetron and acustimulation at the K1 acupoint for 20 minutes approximately 1 to 2 hours before TAI on the first day and then daily for the subsequent 5 days ) or group B ( 52 patients who were treated with tropisetron and electrostimulation at a placebo point on the heel ) .


The rate , intensity , and duration of nausea and vomiting were collected at baseline and then daily for 5 days after TAI .


Quality of life was assessed daily using the MD Anderson Symptom Inventory and the EuroQoL scale .


No differences were found between groups A and B with regard to the incidence and degree of nausea or vomiting on day 1 or the following 5 days .


Patients in group A had better EuroQoL scores compared with patients in group B ( 72.83 in group A vs 65.94 in group B ; P = .04 ) on day 4 but not on the other days .


No group differences were noted at any time point for MD Anderson Symptom Inventory scores .


Electrostimulation of K1 combined with antiemetics did not result in initial prevention of cisplatin-induced or oxaliplatin-induced nausea or vomiting .


Health-related quality of life in adults , who in adolescence participated in a scoliosis-specific exercise program , was not previously studied .


Design .


Cross-sectional study , with retrospective data collection .


Homogenous groups of 68 persons ( 43 women ) aged 30.10 ( 25-39 ) years , with mild or moderate scoliosis , and 76 ( 38 women ) able-bodied persons , aged 30.11 ( 24-38 ) years , who 16.5 ( 12-26 ) years earlier had completed scoliosis-specific exercise or observation regimes , participated .


Their respiratory characteristics did not differ from predicted values .


The WHOQOL-BREF questionnaire , Oswestry Disability Questionnaire , and pain scale ( VAS ) were applied .


The transformed WHOQOL-BREF scores ranged from 54.6 11.19 in the physical domain in the mild scoliotic subgroup to 77.1 16.05 in the social domain in the able-bodied subgroup .


The ODQ values did not generally exceed 5.3 7.53 .


Inter - and intragroup differences were nonsignificant .


Age , marital status , education , and gender were significantly associated with the ODQ scores .


Significant association between the ODQ and WHOQOL-BREF social relationships domain scores with the participation in exercise treatment was found .


Participants with the history of exercise treatment generally did not differ significantly from their peers who were only under observation .


This study can not conclude that scoliosis-specific exercise treatment in adolescence alters quality of life in adulthood .


To determine the safety and efficacy of an automated unified safety system ( USS ) in providing overnight closed-loop ( OCL ) control in children and adolescents with type 1 diabetes attending diabetes summer camps .


The Diabetes Assistant ( DIAS ) USS used the Dexcom G4 Platinum glucose sensor ( Dexcom ) and t : slim insulin pump ( Tandem Diabetes Care ) .


An initial inpatient study was completed for 12 participants to evaluate safety .


For the main camp study , 20 participants with type 1 diabetes were randomized to either OCL or sensor-augmented therapy ( control conditions ) per night over the course of a 5 - to 6-day diabetes camp .


Subjects completed 54 OCL nights and 52 control nights .


On an intention-to-treat basis , with glucose data analyzed regardless of system status , the median percent time in range , from 70-150 mg/dL , was 62 % ( 29 , 87 ) for OCL nights versus 55 % ( 25 , 80 ) for sensor-augmented pump therapy ( P = 0.233 ) .


A per-protocol analysis allowed for assessment of algorithm performance .


The median percent time in range , from 70-150 mg/dL , was 73 % ( 50 , 89 ) for OCL nights ( n = 41 ) versus 52 % ( 24 , 83 ) for control conditions ( n = 39 ) ( P = 0.037 ) .


There was less time spent in the hypoglycemic range < 50 , < 60 , and < 70 mg/dL during OCL compared with the control period ( P = 0.019 , P = 0.009 , and P = 0.023 , respectively ) .


The DIAS USS algorithm is effective in improving time spent in range as well as reducing nocturnal hypoglycemia during the overnight period in children and adolescents with type 1 diabetes in a diabetes camp setting .


To our knowledge there has been no study investigating the impact of freeze-dried strawberry ( FDS ) supplementation on metabolic biomarkers of atherosclerosis in subjects with type 2 diabetes ( T2D ) .


This study was carried out to determine the effects of FDS supplementation on glycemic control , biomarkers of oxidative stress , inflammation and serum total antioxidant status in subjects with T2D compared to matched control subjects .


Thirty-six subjects with T2D ( 23 females ; mean body mass index 27.90 3.7 ; mean age 51.57 10 years ) were randomly divided into two groups .


The treatment group consumed 2 cups of FDS beverage ( 50 g of FDS is equivalent to 500 g of fresh strawberries ) or macronutrient matched placebo powder with strawberry flavor daily for 6 weeks in a randomized double-blind controlled trial .


Anthropometric measurements , dietary intakes , hemoglobin ( Hb ) A1c , antioxidant status , C-reactive protein and malondialdehyde ( MDA ) levels were assessed at baseline and 6 weeks post-intervention .


FDS supplementation significantly decreased C-reactive protein levels as a biomarker of inflammation ( 2.5 vs. 2.04 mg/l , p < 0.05 ) and lipid peroxidation in the form of MDA ( 3.36 vs. 2.7 nmol/ml , p < 0.05 ) at 6 weeks compared to the baseline .


Moreover , supplementation led to a decreasing trend in HbA1c ( -5.7 % , p < 0.05 ) and significant increase in total antioxidant status in the FDS group ( 1.44 vs. 1.26 mmol/l , p < 0.01 ) compared to the placebo group .


No significant changes were observed in serum glucose concentrations and anthropometric indices .


FDS improved glycemic control and antioxidant status , and reduced lipid peroxidation and inflammatory response in patients with T2D .


Supplementation with freeze-dried berry products , as natural sources of antioxidants with low glycemic index , could be considered as an adjunctive therapy in ameliorating metabolic complications of T2D .


To assess the 1-year efficacy and safety of a regimen of tocilizumab plus methotrexate or placebo , which was augmented by a treat-to-target strategy from week 24 .


ACT-RAY was a double-blind , 3-year trial .


Adults with active rheumatoid arthritis despite methotrexate were randomised to add tocilizumab to ongoing methotrexate ( add-on strategy ) or to switch to tocilizumab plus placebo ( switch strategy ) .


Tocilizumab 8 mg/kg was administered every 4 weeks .


Conventional open-label disease-modifying antirheumatic drugs ( DMARDs ) other than methotrexate were added at week 24 or later in patients with DAS28 > 3.2 .


556 patients were randomised ; 85 % completed 52 weeks .


The proportion of patients receiving open-label DMARDs was comparable in the add-on ( 29 % ) and switch ( 33 % ) arms .


Overall , week 24 results were maintained or further improved at week 52 in both arms .


Some endpoints favoured the add-on strategy .


Mean changes in Genant-modified Sharp scores were small ; more add-on ( 92.8 % ) than switch patients ( 86.1 % ) had no radiographic progression .


At week 52 , comparable numbers of patients had antidrug antibodies ( ADAs ; 1.5 % and 2.2 % of add-on and switch patients , respectively ) and neutralising ADAs ( 0.7 % and 1.8 % ) .


Rates of serious adverse events and serious infections per 100 patient-year ( PY ) were 11.3 and 4.5 in add-on and 16.8 and 5.5 in switch patients .


In patients with normal baseline values , alanine aminotransferase elevations > 3 upper limit of normal were observed in 11 % of add-on and 3 % of switch patients .


Despite a trend favouring the add-on strategy , these data suggest that both tocilizumab add-on and switch strategies led to meaningful clinical and radiographic responses .


Depression is the most prevalent psychiatric disorder in persons with epilepsy ( PWEs ) .


Despite its major impact on quality of life and risk of suicide , most PWEs are not treated for depression .


A current challenge in mental health care is how to close this treatment gap and increase access to psychological services .


Psychological online interventions ( POIs ) have shown efficacy in improving depression among individuals without neurologic disorders .


This pilot study aimed to assess the feasibility and efficacy of a psychological online intervention for depression ( Deprexis ) in PWEs who have symptoms of depression .


Participants with self-reported epilepsy and subjective complaints of depressive symptoms were randomized to an intervention condition ( Deprexis ) or to a waiting list control ( WLC ) condition .


After 9weeks , participants were invited to complete an online reassessment .


Relative to the waiting list group , program users experienced a significant symptom decline on the Beck Depression Inventory - I ( BDI-I , primary outcome ) with a moderate effect size in the complete observations analysis and a small effect size in the intention-to-treat analysis .


Furthermore , there was a significant improvement with a moderate effect size on the `` energy/fatigue '' subscale of the Quality of Life In Epilepsy Inventory - 31 ( QOLIE-31 ) .


The results of this trial suggest that POIs may be a feasible and beneficial tool for PWEs who have comorbid depressive symptoms .


This study investigates the effect of photodynamic therapy ( PDT ) as monotherapy during supportive periodontal therapy .


A split-mouth , randomized controlled trial was conducted in patients with chronic periodontitis ( N = 22 ) presenting at least three residual pockets ( probing depth [ PD ] 5 mm with bleeding on probing [ BOP ] ) .


The selected sites randomly received the following : 1 ) PDT ; 2 ) photosensitizer ( PS ) ; or 3 ) scaling and root planing ( SRP ) .


At baseline and 3 and 6 months , clinical , microbiologic ( real-time polymerase chain reaction analyses ) , cytokine pattern ( multiplexed bead immunoassay ) , and patient-centered ( regarding morbidity ) evaluations were performed .


All therapies promoted similar improvements in clinical parameters throughout the study ( P < 0.05 ) , except that BOP was not reduced in the PS protocol ( P > 0.05 ) .


Lower levels of Aggregatibacter actinomycetemcomitans were observed in the PDT and SRP protocols at 3 months when compared with the PS protocol ( P < 0.05 ) .


An inferior frequency detection of Porphyromonas gingivalis was observed in the PDT protocol at 3 and 6 months and in the SRP protocol at 6 months from baseline ( P < 0.05 ) .


In addition , PDT protocol presented inferior frequency of P. gingivalis at 3 months when compared with the other therapies ( P < 0.05 ) .


Only patients in the PDT protocol exhibited augmented levels of anti-inflammatory interleukin ( IL ) -4 and reduced proinflammatory IL-1 and IL-6 throughout the study ( P < 0.05 ) .


Intergroup analyses showed reduced IL-10 and increased interferon - and IL-1 levels in the PS protocol when compared with the other therapies during follow-ups ( P < 0.05 ) .


No differences in morbidity were observed between the therapies ( P > 0.05 ) , although the need for anesthesia was higher in SRP-treated sites ( P < 0.05 ) .


PDT as an exclusive therapy may be considered a non-invasive alternative for treating residual pockets , offering advantages in the modulation of cytokines .


Functional dyspepsia ( FD ) is a common health problem currently without any optimal treatments .


Acupuncture has been traditionally sought as a treatment for FD .


The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD .


A two-center , randomized , waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms .


Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals .


They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group .


The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks .


The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period .


The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index , EQ-5D , FD-related quality of life , Beck 's depression inventory , state-trait anxiety inventory questionnaire , and level of ghrelin hormone .


The protocol was approved by the participating centers ' Institutional Review Boards .


Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work .


ClinicalTrials.gov Identifier : NCT01921504 .


An examination of the effects of up to 260 weeks of growth hormone ( GH ) therapy on metabolic parameters in Japanese children born small for gestational age ( SGA ) .


Data were analysed from a 156-week extension of a 104-week multicentre , randomised , double-blind , parallel-group trial .


Sixty-five children born SGA ( age 3 - < 8 years ) received 33 g/kg/day ( n = 31 , 64.5 % male ) or 67 g/kg/day ( n = 34 , 58.8 % male ) GH for 260 weeks .


Changes in metabolic parameters - glucose , insulin , total cholesterol , low-density lipoprotein cholesterol and high-density lipoprotein cholesterol - were recorded .


Alterations in weight , body mass index standard deviation score ( BMI SDS ) and vital signs were also evaluated .


Over 260 weeks of GH treatment , a positive correlation between height SDS and insulin-like growth factor-I SDS was observed .


Insulin and glucose levels were generally unaffected .


Favourable changes in lipid profiles were recorded , which were maintained for the study duration .


No adverse alterations in weight , BMI SDS or vital signs were noted .


Long-term , continuous GH treatment in children born SGA appears to be efficacious , associated with potential benefits for several metabolic parameters and associated with no long-term safety concerns .


To investigate whether a footbath inhibits spasticity in the hemiplegic lower limbs of post-stroke patients .


Randomized , controlled study .


Rehabilitation education and research hospital .


Twenty-two post-stroke patients were randomly allocated to control or experimental groups .


After relaxing in a supine posture for 30min , the experimental group subject 's legs were immersed in 41C water below the knee joint for 15min , while the control group remained in a resting posture .


Modified Ashworth Scale ( MAS ) scores of the affected triceps surae muscle and F-wave parameters ( i.e. , F-wave amplitude , F/M ratio , and F-wave persistence ) were recorded before , immediately after , and 30min after each intervention .


Physiological parameters were simultaneously monitored to determine the thermo-therapeutic mechanisms and side effects of footbath usage .


At the time immediately after the intervention , F-wave amplitudes decreased significantly in the experimental group , compared to the control group ( p < 0.01 , difference : -106.8 ; 95 % CI ; -181.58 to -32.09 ) .


F-wave amplitudes decreased significantly after 30-min intervention in the experimental group , with a total reduction of 161.2 V being recorded compared to 8.8 V increase in the control group ( p < 0.01 , difference : -170.0 ; 95 % CI ; -252.73 to -87.33 ) .


There were also significant differences between the experimental and control group for both F/M ratio and F-wave persistence , immediately after and 30min after the intervention .


Further , there were significant differences between the experimental and control group for the MAS scores immediately after the intervention ( p < 0.05 , difference : -0.72 ; 95 % CI ; -1.262 to -0.193 ) , and 30min after the intervention ( p < 0.05 , difference : -0.73 ; 95 % CI ; -1.162 to -0.293 ) .


These findings demonstrate that the use of footbaths is an effective non-pharmacological anti-spastic treatment for use in stroke rehabilitation .


Advancements in mobile phone technology offer huge potential for enhancing the timely delivery of health behavior change interventions .


The development of smartphone-based health interventions ( apps ) is a rapidly growing field of research , yet there have been few longitudinal examinations of how people experience and use these apps within their day-to-day routines , particularly within the context of a hybrid Web - and app-based intervention .


This study used an in-depth mixed-methods design to examine individual variation in ( 1 ) impact on self-reported goal engagement ( ie , motivation , self-efficacy , awareness , effort , achievement ) of access to a weight management app ( POWeR Tracker ) when provided alongside a Web-based weight management intervention ( POWeR ) and ( 2 ) usage and views of POWeR Tracker .


Thirteen adults were provided access to POWeR and were monitored over a 4-week period .


Access to POWeR Tracker was provided in 2 alternate weeks ( ie , weeks 1 and 3 or weeks 2 and 4 ) .


Participants ' goal engagement was measured daily via self-report .


Mixed effects models were used to examine change in goal engagement between the weeks when POWeR Tracker was and was not available and whether the extent of change in goal engagement varied between individual participants .


Usage of POWeR and POWeR Tracker was automatically recorded for each participant .


Telephone interviews were conducted and analyzed using inductive thematic analysis to further explore participants ' experiences using POWeR and POWeR Tracker .


Access to POWeR Tracker was associated with a significant increase in participants ' awareness of their eating ( 1 = 0.31 , P = .04 ) and physical activity goals ( 1 = 0.28 , P = .03 ) .


The level of increase varied between individual participants .


Usage data showed that participants used the POWeR website for similar amounts of time during the weeks when POWeR Tracker was ( mean 29 minutes , SD 31 minutes ) and was not available ( mean 27 minutes , SD 33 minutes ) .


POWeR Tracker was mostly accessed in short bursts ( mean 3 minutes , SD 2 minutes ) during convenient moments or moments when participants deemed the intervention content most relevant .


The qualitative data indicated that nearly all participants agreed that it was more convenient to access information on-the-go via their mobiles compared to a computer .


However , participants varied in their views and usage of the Web - versus app-based components and the informational versus tracking tools provided by POWeR Tracker .


This study provides evidence that smartphones have the potential to improve individuals ' engagement with their health-related goals when used as a supplement to an existing online intervention .


The perceived convenience of mobile access to information does not appear to deter use of Web-based interventions or strengthen the impact of app access on goal engagement .


A mixed-methods design enabled exploration of individual variation in daily usage of the app-based tools .


Though theoretically superior to standard 2D visualization , 3D video systems have not yet achieved a breakthrough in laparoscopy .


The latest 3D monitors , including autostereoscopic displays and high-definition ( HD ) resolution , are designed to overcome the existing limitations .


We performed a randomized study on 48 individuals with different experience levels in laparoscopy .


Three different 3D displays ( glasses-based 3D monitor , autostereoscopic display , and a mirror-based theoretically ideal 3D display ) were compared to a 2D HD display by assessing multiple performance and mental workload parameters and rating the subjects during a laparoscopic suturing task .


Electromagnetic tracking provided information on the instruments ' pathlength , movement velocity , and economy .


The usability , the perception of visual discomfort , and the quality of image transmission of each monitor were subjectively rated .


Almost all performance parameters were superior with the conventional glasses-based 3D display compared to the 2D display and the autostereoscopic display , but were often significantly exceeded by the mirror-based 3D display .


Subjects performed a task faster and with greater precision when visualization was achieved with the 3D and the mirror-based display .


Instrument pathlength was shortened by improved depth perception .


Workload parameters ( NASA TLX ) did not show significant differences .


Test persons complained of impaired vision while using the autostereoscopic monitor .


The 3D and 2D displays were rated user-friendly and applicable in daily work .


Experienced and inexperienced laparoscopists profited equally from using a 3D display , with an improvement in task performance about 20 % .


Novel 3D displays improve laparoscopic interventions as a result of faster performance and higher precision without causing a higher mental workload .


Therefore , they have the potential to significantly impact the further development of minimally invasive surgery .


However , as shown by the custom-built 3D mirror display , this effect can be improved , thus stimulating further research .


Magnesium sulfate is neuroprotective in preclinical models of stroke and has shown signals of potential efficacy with an acceptable safety profile when delivered early after stroke onset in humans .


Delayed initiation of neuroprotective agents has hindered earlier phase 3 trials of neuroprotective agents .


We randomly assigned patients with suspected stroke to receive either intravenous magnesium sulfate or placebo , beginning within 2 hours after symptom onset .


A loading dose was initiated by paramedics before the patient arrived at the hospital , and a 24-hour maintenance infusion was started on the patient 's arrival at the hospital .


The primary outcome was the degree of disability at 90 days , as measured by scores on the modified Rankin scale ( range , 0 to 6 , with higher scores indicating greater disability ) .


Among the 1700 enrolled patients ( 857 in the magnesium group and 843 in the placebo group ) , the mean ( SD ) age was 6913 years , 42.6 % were women , and the mean pretreatment score on the Los Angeles Motor Scale of stroke severity ( range , 0 to 10 , with higher scores indicating greater motor deficits ) was 3.71.3 .


The final diagnosis of the qualifying event was cerebral ischemia in 73.3 % of patients , intracranial hemorrhage in 22.8 % , and a stroke-mimicking condition in 3.9 % .


The median interval between the time the patient was last known to be free of stroke symptoms and the start of the study-drug infusion was 45 minutes ( interquartile range , 35 to 62 ) , and 74.3 % of patients received the study-drug infusion within the first hour after symptom onset .


There was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the magnesium group and those in the placebo group ( P = 0.28 by the Cochran-Mantel-Haenszel test ) ; mean scores at 90 days did not differ between the magnesium group and the placebo group ( 2.7 in each group , P = 1.00 ) .


No significant between-group differences were noted with respect to mortality ( 15.4 % in the magnesium group and 15.5 % in the placebo group , P = 0.95 ) or all serious adverse events .


Prehospital initiation of magnesium sulfate therapy was safe and allowed the start of therapy within 2 hours after the onset of stroke symptoms , but it did not improve disability outcomes at 90 days .


( Funded by the National Institute of Neurological Disorders and Stroke ; FAST-MAG ClinicalTrials.gov number , NCT00059332 . )


To compare left ventricular function after a long-term His or para-His pacing ( HP ) and right ventricular septal pacing ( RVSP ) in patients with atrioventricular block ( AVB ) .


We included consecutive patients with AVB , a narrow QRS < 120 ms , and a preserved left ventricular ejection fraction ( LVEF ) > 0.40 , in a prospective , randomized , double-blinded , crossover design .


All patients were treated with 12 months HP and 12 months RVSP .


A total of 38 patients [ mean age , 67 10 years ; 30 ( 79 % ) men ] were included .


The primary endpoint was LVEF , which was significantly lower after a 12 months RVSP ( 0.50 0.11 ) than after 12 months of HP ( 0.55 0.10 ) , P = 0.005 .


We measured the difference in time-to-peak systolic velocity between opposite basal segments in the apical views by using tissue Doppler imaging .


In the four-chamber view , the difference was 58 ( 7 ) ms after RVSP and 49 ( 7 ) ms after HP , P = 0.27 ; in the two-chamber view , the difference was 45 ( 5 ) ms after RVSP and 31 ( 4 ) ms after HP , P = 0.02 , and in the apical long-axis view , the difference was 63 ( 6 ) after RVSP and 44 ( 7 ) after HP , P = 0.03 .


There was no difference in New York Heart Association class , 6-min hall walk test , quality-of-life assessments , or device-related complications .


The mean threshold was significantly higher in HP leads than in RVSP leads .


His or para-His pacing preserves LVEF and mechanical synchrony as compared with RVSP after 12 months pacing in patients with AVB , narrow QRS , and LVEF > 0.40 .


People with psychosis often experience weight gain , which places them at risk of cardiovascular disease , diabetes , and early death .


To determine the uptake , adherence , and clinical effectiveness of a healthy living intervention designed to reduce weight gain .


An exploratory randomized controlled trial , comparing the intervention with treatment as usual ( TAU ) in 2 early intervention services for psychosis in England .


DSM-IV classification was the diagnostic criteria used to assign the psychiatric diagnoses .


The primary outcome was change in body mass index ( BMI ) from baseline to 12-month follow-up .


The study was conducted between February 2009 and October 2012 .


105 service users , with a BMI of 25 ( 24 in South Asians ) , were randomized to intervention ( n = 54 ) or TAU ( n = 51 ) after stratification by recent commencement of antipsychotic medication .


Ninety-three service users ( 89 % ) were followed up at 12 months .


Between-group difference in change in BMI was not significant ( effect size = 0.11 ) .


The effect of the intervention was larger ( effect size = 0.54 , not significant ) in 15 intervention ( 28 % ) and 10 TAU ( 20 % ) participants who were taking olanzapine or clozapine at randomization .


The healthy living intervention did not show a significant difference in BMI reduction compared to the TAU group .


www.isrctn.org identifier : ISRCTN22581937 .


Prader-Willi syndrome is a neurogenetic disorder , with characteristics such as obesity , short stature , muscular weakness , intellectual deficiencies and deviant social behaviour .


This study evaluated whether growth hormone treatment of children with Prader-Willi syndrome resulted in possible and lasting effects on their cognition and behaviour .


We randomised six girls and 13 boys to either a treatment group or a control group .


The treatment group received growth hormone ( Genotropin ( ) 0.033 mg/kg/day ) for 2 years , while the control group did not receive treatment in the first year and then received a double dose in the second year .


Treatment was then stopped in both groups for 6 months .


Both groups showed the same intellectual disabilities at the start of the study , and no difference was found after the first and second years .


The parents reported that the children showed increased vitality during treatment .


When treatment was stopped , the children showed a marked exacerbation of behavioural problems , a significant increase in body fat and a decrease in insulin-like growth factor 1 levels .


We believe this is the first study to show that abrupt-ceasing growth hormone treatment led to a successive deterioration in behavioural problems in children with Prader-Willi syndrome .


Aside from the multikinase inhibitor sorafenib , there are no effective systemic therapies for the treatment of advanced hepatocellular carcinoma .


To assess the efficacy of everolimus in patients with advanced hepatocellular carcinoma for whom sorafenib treatment failed .


EVOLVE-1 was a randomized , double-blind , phase 3 study conducted among 546 adults with Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma and Child-Pugh A liver function whose disease progressed during or after sorafenib or who were intolerant of sorafenib .


Patients were enrolled from 17 countries between May 2010 and March 2012 .


Randomization was stratified by region ( Asia vs rest of world ) and macrovascular invasion ( present vs absent ) .


Everolimus , 7.5 mg/d , or matching placebo , both given in combination with best supportive care and continued until disease progression or intolerable toxicity .


Per the 2:1 randomization scheme , 362 patients were randomized to the everolimus group and 184 patients to the placebo group .


The primary end point was overall survival .


Secondary end points included time to progression and the disease control rate ( the percentage of patients with a best overall response of complete or partial response or stable disease ) .


No significant difference in overall survival was seen between treatment groups , with 303 deaths ( 83.7 % ) in the everolimus group and 151 deaths ( 82.1 % ) in the placebo group ( hazard ratio [ HR ] , 1.05 ; 95 % CI , 0.86-1 .27 ; P = .68 ; median overall survival , 7.6 months with everolimus , 7.3 months with placebo ) .


Median time to progression with everolimus and placebo was 3.0 months and 2.6 months , respectively ( HR , 0.93 ; 95 % CI , 0.75-1 .15 ) , and disease control rate was 56.1 % and 45.1 % , respectively ( P = .01 ) .


The most common grade 3/4 adverse events for everolimus vs placebo were anemia ( 7.8 % vs 3.3 % , respectively ) , asthenia ( 7.8 % vs 5.5 % , respectively ) , and decreased appetite ( 6.1 % vs 0.5 % , respectively ) .


No patients experienced hepatitis C viral flare .


Based on central laboratory results , hepatitis B viral reactivation was experienced by 39 patients ( 29 everolimus , 10 placebo ) ; all cases were asymptomatic , but 3 everolimus recipients discontinued therapy .


Everolimus did not improve overall survival in patients with advanced hepatocellular carcinoma whose disease progressed during or after receiving sorafenib or who were intolerant of sorafenib .


clinicaltrials.gov Identifier : NCT01035229 .


Right - and left-sided colon cancers ( RC , LC ) differ with respect to biology , pathology and epidemiology .


Previous data suggest a mortality difference between RC and LC .


We examined if primary tumour side also predicts for outcome in chemotherapy refractory , metastatic colon cancer ( MCC ) .


We also compared RC versus LC as a predictor of efficacy of epidermal growth factor receptor ( EGFR ) inhibition with cetuximab .


Reanalyzing NCIC CO. 17 trial ( cetuximab versus best supportive care [ BSC ] ) , we coded the primary tumour side as RC ( caecum to transverse colon ) or LC ( splenic flexure to rectosigmoid ) .


The association between tumour side and baseline characteristics was assessed .


Cox regression models determined factors affecting overall survival ( OS ) and progression free survival ( PFS ) .


Patients with RC ( 150/399 ) had more poorly differentiated , mutant KRAS , mutated PIK3CA and wild-type BRAF tumours , fewer liver and lung metastases , and shorter interval between diagnosis and study entry .


Among BSC patients , tumour side was not prognostic for PFS ( hazard ratios ( HR ) 1.07 [ 0.79-1 .44 ] , p = 0.67 ) or OS ( HR 0.96 [ 0.70-1 .31 ] , p = 0.78 ) .


Among wild-type KRAS patients , those with LC had significantly improved PFS when treated with cetuximab compared to BSC ( median 5.4 versus 1.8 months , HR 0.28 [ 0.18-0 .45 ] , p < 0.0001 ) , whereas those with RC did not ( median 1.9 versus 1.9 months , HR 0.73 [ 0.42-1 .27 ] , p = 0.26 ) , [ interaction p = 0.002 ] .


In refractory MCC , tumour location within the colon is not prognostic , but is strongly predictive of PFS benefit from cetuximab therapy .


Additional research is needed to understand the molecular differences between RC and LC and their interaction with EGFR inhibition .


There is evidence of an association between pulmonary function and various nutrients , although no association has been observed in our setting between the Mediterranean Diet ( MD ) eating pattern and improved lung function .


The objective of this study is to evaluate the effect of an intervention designed to increase MD adherence on lung function in smokers with no previous respiratory disease .


Randomized , controlled , parallel clinical trial .


primary health care centers in Catalonia ( Spain ) .


Current smokers ( cumulative > 10 pack-years ) aged 35-70 years , with Internet access , who provide signed informed consent to participate .


A nutritionist will conduct a 2-year multicomponent intervention to increase MD adherence , based on : 1 ) a personalized dietary-nutritional education intervention , 2 ) a Web 2.0 approach , the DIET Blog of nutritional information , and 3 ) group sessions to increase motivation to increase MD adherence and motivation to make changes in eating habits .


Annually , an office visit and one group session will reinforce the nutritional intervention .


The control group will follow their usual diet , with general nutritional counselling .


In both groups , a 14-item questionnaire will evaluate individual MD dietary patterns and forced spirometry will assess lung function .


Intention to treat .


The unit of analysis will be the individual smoker .


Primary outcome is lung function indicated by spirometry , FVC , FEV1 and FEV1/FVC % .


Lung function parameters in both groups will be compared by adherence to the MD pattern .


The DIET study could contribute data on a protective action of the MD pattern on lung function in smokers .


If so , this population may benefit from a nutritional intervention , along with the fundamental recommendation to stop smoking .


ClinicalTrials.gov : NCT02151669 .


Registered 26 May 2014 .


The effects of opioid medication on cognitive functioning in patients with cancer and non-cancer pain remain unclear .