Ocular itching and conjunctival hyperemia of allergic conjunctivitis were assessed after the conjunctival allergen challenge test .


For the primary end point , epinastine showed superiority to placebo for the inhibition of ocular itching and conjunctival hyperemia induced at 4 hours after the dose ( equivalent to 4-times-daily dosing ) .


For the secondary end points , epinastine significantly inhibited itching and conjunctival hyperemia induced at 15 minutes and 8 hours after the dose ( equivalent to 2-times-daily dosing ) compared with placebo .


In addition , epinastine demonstrated noninferiority to olopatadine for ocular itching and conjunctival hyperemia .


No adverse drug reactions or serious adverse events were reported throughout the study , indicating that epinastine has a good safety profile .


Epinastine is effective and safe for the treatment of allergic conjunctivitis .


Clinicaltrials.gov identifier NCT01363700 .


Sarcopenia is a defining feature of cancer cachexia associated with physical decline , poor quality of life and poor prognosis .


Thus , maintaining muscle mass is an important aim of cachexia treatment .


Many patients at risk for developing cachexia or with cachexia experience side effects of chemotherapy that might aggravate the development of cachexia .


However , achieving tumor control might reverse the catabolic processes causing cachexia .


There is limited knowledge about muscle mass changes during chemotherapy or whether changes in muscle mass are associated with response to chemotherapy .


In this pilot study , patients with advanced non-small cell lung cancer ( NSCLC ) receiving three courses of palliative chemotherapy were analyzed .


Muscle mass was measured as skeletal muscle cross sectional area ( SMCA ) at the level of the third lumbar vertebrae using CT images taken before and after chemotherapy .


In total 35 patients , 48 % women , mean age 67 years ( range 56-86 ) , participated ; 83 % had stage IV disease and 71 % were sarcopenic at baseline .


Mean reduction in SMCA from pre - to post-chemotherapy was 4.6 cm2 ( CI 95 % -7.3 -- 1.9 ; p < 0.002 ) , corresponding to a 1.4 kg loss of whole body muscle mass .


Sixteen patients remained stable or gained SMCA .


Of these , 14 ( 56 % ) responded to chemotherapy , while two progressed ( p = 0.071 ) .


Maintaining or gaining SMCA resulted in longer median overall survival ( loss : 5.8 months , stable/gain : 10.7 months ; p = 0.073 ) .


Stage of disease ( p = 0.003 ) , treatment regimen ( p = 0.023 ) , response to chemotherapy ( p = 0.007 ) and SMCA change ( p = 0.040 ) , but not sarcopenia at baseline , were significant prognostic factors in the multivariate survival analyses .


Almost half of the patients had stable or increased muscle mass during chemotherapy without receiving any cachexia treatment .


Nearly all of these patients responded to the chemotherapy .


Increase in muscle mass , but not sarcopenia at baseline , was a significant prognostic factor .


The effectiveness of commonly suggested public health interventions to control childhood iron-deficiency anemia has been low .


To determine whether iron provided in Sprinkles daily or in a higher dose once weekly affected hemoglobin , serum ferritin levels , and serum transferrin receptor levels , and to determine whether there were differences in the effects of the two regimens .


In this cluster-randomized , community-based trial conducted in rural areas of Bangladesh , 136 children aged 12 to 24 months with mild to moderate anemia ( hemoglobin 70-109 g/L ) were randomly allocated to receive Sprinkles daily ( 12.5 mg of elemental iron , n = 79 ) or once weekly ( 30 mg of elemental iron , n = 73 ) for 8 weeks .


Hemoglobin , serum ferritin , and serum transferrin receptor were assessed at the start and end of the intervention .


In both groups , there were significant increases in hemoglobin and serum ferritin and a significant decrease in serum transferrin receptor ( p < .01 ) .


There were no significant differences between the groups in the increases in hemoglobin ( 16.1 + / - 13.2 g/L for the group receiving Sprinkles daily and 12.3 + / - 13.3 g/L for the group receiving Sprinkles once weekly ) and serum ferritin ( 10.6 and 5.7 microg/L , respectively ) .


The decrease in serum transferrin receptor also did not significantly differ between the groups ( median , -2.5 and -1.8 mg/L , respectively ) .


The prevalence rates of iron-deficiency anemia , depleted iron stores , and tissue iron deficiency decreased significantly within each group ( p < .01 ) , with no significant differences between the groups .


Home fortification of complementary foods with Sprinkles given either daily or once weekly improved iron-deficiency anemia and iron status among young children .


Refinements in stent design affecting strut thickness , surface polymer , and drug release have improved clinical outcomes of drug-eluting stents .


We aimed to compare the safety and efficacy of a novel , ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent .


We did a randomised , single-blind , non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland .


We randomly assigned ( 1:1 ) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents .


Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction .


Patients and outcome assessors were masked to treatment allocation , but treating physicians were not .


The primary endpoint , target lesion failure , was a composite of cardiac death , target vessel myocardial infarction , and clinically-indicated target lesion revascularisation at 12 months .


A margin of 35 % was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent .


Analysis was by intention to treat .


The trial is registered with ClinicalTrials.gov , number NCT01443104 .


Between Feb 24 , 2012 , and May 22 , 2013 , we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents ( 1063 patients , 1594 lesions ) or everolimus-eluting stents ( 1056 patients , 1545 lesions ) .


407 ( 19 % ) patients presented with ST-segment elevation myocardial infarction .


Target lesion failure with biodegradable polymer sirolimus-eluting stents ( 69 cases ; 65 % ) was non-inferior to durable polymer everolimus-eluting stents ( 70 cases ; 66 % ) at 12 months ( absolute risk difference -014 % , upper limit of one-sided 95 % CI 197 % , p for non-inferiority < 00004 ) .


No significant differences were noted in rates of definite stent thrombosis ( 9 [ 09 % ] vs 4 [ 04 % ] , rate ratio [ RR ] 226 , 95 % CI 070-733 , p = 016 ) .


In pre-specified stratified analyses of the primary endpoint , biodegradable polymer sirolimus-eluting stents were associated with improved outcome compared with durable polymer everolimus-eluting stents in the subgroup of patients with ST-segment elevation myocardial infarction ( 7 [ 33 % ] vs 17 [ 87 % ] , RR 038 , 95 % CI 016-091 , p = 0024 , p for interaction = 0014 ) .


In a patient population with minimum exclusion criteria and high adherence to dual antiplatelet therapy , biodegradable polymer sirolimus-eluting stents were non-inferior to durable polymer everolimus-eluting stents for the combined safety and efficacy outcome target lesion failure at 12 months .


The noted benefit in the subgroup of patients with ST-segment elevation myocardial infarction needs further study .


Clinical Trials Unit , University of Bern , and Biotronik , Blach , Switzerland .


Besides the classical role of vitamin D on calcium and bone homeostasis , vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus .


However , it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus .


There are limited clinical trials carried out which measured the effect of vitamin D supplementation on glycaemic control.The objective of this study is to investigate the effect of vitamin D supplementation on glycaemic control and quality of life in patients with type 2 diabetes mellitus .


In a randomised double-blind placebo-controlled trial conducted in five general practices in the Netherlands three hundred patients with type 2 diabetes mellitus treated with lifestyle advises or metformin or sulphonylurea-derivatives are randomised to receive either placebo or 50,000 IU Vitamin D3 at monthly intervals .


The primary outcome measure is the change in glycated haemoglobin level between baseline and six months .


Secondary outcome measures include blood pressure , anthropometric parameters , lipid profile , insulin resistance , quality of life , advanced glycation end products and safety profiles .


Quality of life will be measured by The Short Form ( SF-36 ) Health Survey questionnaire .


Advanced glycation end products are measured by an AGE-reader .


This trial will be the first study exploring the effect of vitamin D supplementation on both glycaemic control and quality of life in patients with type 2 diabetes mellitus .


Our findings will contribute to the knowledge of the relationship between vitamin D status and insulin resistance in patients with type 2 diabetes mellitus .


The Netherlands trial register : NTR3154 .


While performing a lateral nasal wall osteotomy during a rhinoplasty , an intentional fracture is produced and the fractured segments are medialized to narrow a wide nasal base .


The purpose of this study was to investigate the effect of size , shape , and extension of the external nasal splint on the osteotomy , brow lines , and long-term results of rhinoplasty .


The authors designed a randomized prospective clinical trial .


The study population was composed entirely of patients who were voluntarily referred to the authors ' department from May 2012 to May 2013 .


They were randomly divided into 2 equal groups .


The primary predictor variable was splint type .


For group 1 , the external splint was extended beyond the osteotomy lines laterally and covered the overlying skin of the frontal process of the maxillary bone .


For group 2 , the external splint was trimmed above the osteotomy lines .


The primary outcome variables were the levels of satisfaction with the dorsal esthetic lines , brow lines , and distinct osteotomy lines at 12 months after the operation .


Demographic variables were gender and age .


Mann-Whitney U test , ( 2 ) test , and t test were used to analyze the data .


Results with a P value less than .05 were considered significant .


Forty healthy patients ( American Society of Anesthesiologists status I and II ; 18 men and 22 women ; age range , 19 to 41 yr ; mean , 31.4 yr ) were selected .


Although the level of satisfaction with the dorsal esthetic lines was higher in group 2 , it was not significantly different from group 1 ( P > .05 ) .


The levels of satisfaction with the brow lines and the distinct osteotomy lines were significantly higher in group 2 ( P < .05 ) .


The results of this study showed that when a nasal splint is extended beyond the frontal process of the maxilla rather than the base of the nasal bones , positioning of the bones and long-term results are unpredictable .


The complex relationship between left atrial ( LA ) structure and function , electrical burden of atrial fibrillation ( AF ) and stroke risk is not well understood .


We aimed to describe LA structure and function in AF .


Left atrial structure and function was assessed in 971 subjects enrolled in the echocardiographic substudy of ENGAGE AF-TIMI 48 .


Left atrial size , emptying fraction ( LAEF ) , and contractile function were compared across AF types ( paroxysmal , persistent , or permanent ) and CHADS2 scores as an estimate of stroke risk .


The majority of AF patients ( 55 % ) had both LA enlargement and reduced LAEF , with an inverse relationship between LA size and LAEF ( R = -0.57 , P < 0.001 ) .


With an increasing electrical burden of AF and higher CHADS2 scores , LA size increased and LAEF declined .


Moreover , 19 % of AF subjects had impaired LAEF despite normal LA size , and LA contractile dysfunction was present even among the subset of AF subjects in sinus rhythm at the time of echocardiography .


In a contemporary AF population , LA structure and function were increasingly abnormal with a greater electrical burden of AF and higher stroke risk estimated by the CHADS2 score .


Moreover , LA dysfunction was present despite normal LA size and sinus rhythm , suggesting that the assessment of LA function may add important incremental information in the evaluation of AF patients .


http://www.clinicaltrials.gov; ID = NCT00781391 .


Mammography is considered the best imaging technique for breast cancer screening , and the radiographer plays an important role in its performance .


Therefore , continuing education is critical to improving the performance of these professionals and thus providing better health care services .


Our goal was to develop an e-learning course on breast imaging for radiographers , assessing its efficacy , effectiveness , and user satisfaction .


A stratified randomized controlled trial was performed with radiographers and radiology students who already had mammography training , using pre - and post-knowledge tests , and satisfaction questionnaires .


The primary outcome was the improvement in test results ( percentage of correct answers ) , using intention-to-treat and per-protocol analysis .


A total of 54 participants were assigned to the intervention ( 20 students plus 34 radiographers ) with 53 controls ( 19 +34 ) .


The intervention was completed by 40 participants ( 11 +29 ) , with 4 ( 2 +2 ) discontinued interventions , and 10 ( 7 +3 ) lost to follow-up .


Differences in the primary outcome were found between intervention and control : 21 versus 4 percentage points ( pp ) , P < .001 .


Stratified analysis showed effect in radiographers ( 23 pp vs 4 pp ; P = .004 ) but was unclear in students ( 18 pp vs 5 pp ; P = .098 ) .


Nonetheless , differences in students ' posttest results were found ( 88 % vs 63 % ; P = .003 ) , which were absent in pretest ( 63 % vs 63 % ; P = .106 ) .


The per-protocol analysis showed a higher effect ( 26 pp vs 2 pp ; P < .001 ) , both in students ( 25 pp vs 3 pp ; P = .004 ) and radiographers ( 27 pp vs 2 pp ; P < .001 ) .


Overall , 85 % were satisfied with the course , and 88 % considered it successful .


This e-learning course is effective , especially for radiographers , which highlights the need for continuing education .


The Internet is used to deliver information on many psychiatric disorders such as bipolar disorder .


This paper reports on the results of a 12-months randomised controlled trial , which examined the efficacy of an Internet-based preventive program for bipolar disorder , adjunctive to usual pharmacological management .


Participants were recruited by completing an online screening questionnaire accessed through the Black Dog Institute and Sentiens websites based in Australia .


The treatment was predominantly psycho-educational with cognitive behavioral therapy optional elements .


The attention control treatment comprised directing subjects to a variety of websites focused on ` healthy living ' .


Time to recurrence was determined using Kaplan-Meier survival analysis .


The main outcome measures were recurrence as defined by : ( i ) depressive and/or hypomanic symptomatology and functional capacity ( using Beck Depression Inventory , Internal State Scale and Sheehan Disability Scale ) and ( ii ) hospitalization .


Two-hundred-and-thirty-three subjects were randomized to the active or control treatment groups .


There were no significant differences between the active and control treatment groups on any of the definitions of recurrence .


Reliance on an online self-report tool to confirm diagnosis and hospitalization rates may have potentially allowed for inclusion of individuals with other diagnoses such as borderline personality disorder .


The ` attention control ' treatment may have included more ` active ' components than intended .


This is the first report examining the efficacy of a randomized controlled web-based psychological intervention in a large sample of subjects with bipolar disorder .


The potential reasons for failing to demonstrate a significant difference compared to the active control are discussed .


Early enteral fat supplementation and fish oil ( FO ) stimulates post-resection intestinal adaptation in rats and increases fat absorption in premature infants with bowel resection and an enterostomy .


To test the hypothesis that early fat supplement and FO increases post-resection protein absorption , intestinal RNA , protein without decreasing intestinal arachidonic acid ( AA ) in premature infants with an enterostomy .


36 premature infants ( < 2 months old ) with an enterostomy after surgical treatment for necrotizing enterocolitis or spontaneous intestinal perforation who tolerated enteral feeding at 20 ml/kg/day were randomized to usual care ( control , n = 18 ) or early supplementing enteral Microlipid ( ML ) and FO ( treatment , n = 18 ) .


Intralipid was decreased as the dose of enteral fat was increased .


Daily weight , ostomy output and nutritional intake were recorded .


Weekly 24-hour ostomy effluent was collected to measure fecal protein .


Protein absorption was calculated by subtracting fecal protein from dietary protein .


Tissue samples from the functional stoma and the nonfunctional distal diverted end were collected during bowel reanastomosis to measure RNA , protein , and fatty acid ( FA ) profile .


Compared to controls , the treatment group had higher protein absorption ( g/kg/day ) and intestinal RNA and protein ( g/mg tissue ) proximal to the ostomy .


The two groups had similar FA profiles except that the treatment group had higher n-3 eicosapentaenoic acid ( EPA , g/mg tissue ) proximal to the ostomy .


Early supplementation of enteral ML and FO to premature infants with an enterostomy increased dietary protein absorption , intestinal RNA , protein and n-3 EPA content without altering other FA content .


We studied the effect of maternal HIV-exposure and timing of antiretroviral treatment ( ART ) in HIV-infected infants on antibody responses to combined diphtheria-toxoid-tetanus-toxoid-whole cell pertussis and Haemophilus influenzae type b conjugate vaccine ( HibCV ) and monovalent hepatitis B vaccine ( HBV ) .


HIV-uninfected infants born to HIV-infected ( HEU ) or HIV-uninfected ( HUU ) mothers were enrolled in parallel with HIV-infected children with CD4 25 % , who were randomized to initiate ART immediately upon confirmation of HIV-infection ( ART-Immed ) or when clinically and/or immunologically indicated ( ART-Def ) .


Infants received three doses of diphtheria-toxoid-tetanus-toxoid - wP-HibC/HBV at 7.3 , 11.4 and 15.4 weeks of age .


Antibody to diphtheria-toxoid , tetanus-toxoid , pertussis toxin , filamentous hemagglutinin ( FHA ) and hepatitis B surface antigen ( HBsAg ) were measured by Luminex multiplex-immunoassay and polyribosyl-ribitol phosphate ( PRP ) antibodies by standard ELISA and bactericidal assay .


Prevaccination antibody geometric mean concentrations ( GMCs ) were higher in HUU than HEU infants for tetanus-toxoid , but lower for HBsAg , diphtheria-toxoid and FHA .


Postvaccination GMCs and proportion with seroprotective antibody levels or sero-conversion rates were similar between HUU and HEU infants for all vaccines .


Postvaccination GMCs were higher in HUU for tetanus-toxoid , diphtheria-toxoid , HBsAg and FHA than ART-Immed infants ; and for tetanus-toxoid , HBsAg and pertussis-toxoid than ART-Def infants .


Nevertheless , there was no difference in proportion of HUU and HIV-infected infants who developed sero-protective vaccine-specific antibody levels postvaccination .


The timing of ART initiation generally did not affect immune responses to vaccines between HIV-infected groups .


Vaccination with DTwP-HibCV/HBV of HEU and HIV-infected infants initiated on early-ART confers similar immunity compared with HUU children .


Previous analyses of the International Subarachnoid Aneurysm Trial ( ISAT ) cohort have reported on the risks of recurrent subarachnoid haemorrhage and death or dependency for a minimum of 5 years and up to a maximum of 14 years after treatment of a ruptured intracranial aneurysm with either neurosurgical clipping or endovascular coiling .


At 1 year there was a 7 % absolute and a 24 % relative risk reduction of death and dependency in the coiling group compared with the clipping group , but the medium-term results showed the increased need for re-treatment of the target aneurysm in the patients given coiling .


We report the long-term follow-up of patients in this UK cohort .


In ISAT , patients were randomly allocated to either neurosurgical clipping or endovascular coiling after a subarachnoid haemorrhage , assuming treatment equipoise , between Sept 12 , 1994 , and May 1 , 2002 .


We followed up 1644 patients in 22 UK neurosurgical centres for death and clinical outcomes for 100-185 years .


We assessed dependency as self-reported modified Rankin scale score obtained through yearly questionnaires .


Data for recurrent aneurysms and rebleeding events were collected from questionnaires and from hospital and general practitioner records .


The Office for National Statistics supplied data on deaths .


This study is registered , number ISRCTN49866681 .


At 10 years , 674 ( 83 % ) of 809 patients allocated endovascular coiling and 657 ( 79 % ) of 835 patients allocated neurosurgical clipping were alive ( odds ratio [ OR ] 135 , 95 % CI 106-173 ) .


Of 1003 individuals who returned a questionnaire at 10 years , 435 ( 82 % ) patients treated with endovascular coiling and 370 ( 78 % ) patients treated with neurosurgical clipping were independent ( modified Rankin scale score 0-2 ; OR 125 ; 95 % CI 092-171 ) .


Patients in the endovascular treatment group were more likely to be alive and independent at 10 years than were patients in the neurosurgery group ( OR 134 , 95 % CI 107-167 ) .


33 patients had a recurrent subarachnoid haemorrhage more than 1 year after their initial haemorrhage ( 17 from the target aneurysm ) .


Although rates of increased dependency alone did not differ between groups , the probability of death or dependency was significantly greater in the neurosurgical group than in the endovascular group .


Rebleeding was more likely after endovascular coiling than after neurosurgical clipping , but the risk was small and the probability of disability-free survival was significantly greater in the endovascular group than in the neurosurgical group at 10 years .


UK Medical Research Council .


HIV and other STIs are major public health concerns for women , and risky sexual behaviors increase the risk of transmission .


Risky sexual behaviors include sexual abdication , that is , willingness to let a partner decide how far to go sexually .


Alcohol intoxication is a risk factor for risky sexual behavior , and the Inhibition Conflict Model of Alcohol Myopia may help explain this relationship .


This model suggests that in order for intoxication to influence behavior there must be high conflict , meaning the strength of the instigatory cues and inhibitory cues are both high .


Recent research indicates that the degree to which cues are experienced as high in instigation or inhibition is subject to individual difference factors .


One individual difference factor associated with alcohol-related sexual risk taking is child sexual abuse ( CSA ) history .


The current study examined the influence of acute alcohol intoxication , CSA , and inhibition conflict on sexual abdication with 131 women ( mean age 25 ) randomized into a 2 ( alcohol , control ) 2 ( high conflict , low conflict ) experimental design .


Regression analyses yielded a significant 3-way interaction , F ( 1,122 ) = 8.15 , R ( 2 ) = .14 , p < .01 .


When there was high conflict , intoxicated CSA women were more likely to abdicate than sober CSA women , however , sober CSA women were less likely to abdicate than sober NSA women , when there was low conflict , CSA history and alcohol intoxication had no influence on abdication .


These results may help explain the association between alcohol and risky sexual decision making among women with CSA .


To test the efficacy of a Stress Management and Resiliency Training ( SMART ) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians .


The study was approved by the institutional review board .


A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks .


The program involved a single 90-min group session in the SMART training with two follow-up phone calls .


Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale , Linear Analog Self-Assessment Scale , Mindful Attention Awareness Scale , and Connor-Davidson Resilience Scale .


A total of 22 physicians completed the study .


A statistically significant improvement in perceived stress , anxiety , quality of life , and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm ; resilience also improved in the active arm , but the changes were not statistically significant when compared to the control arm .


A single session to decrease stress among radiologists using the SMART program is feasible .


Furthermore , the intervention afforded statistically significant and clinically meaningful improvement in anxiety , stress , quality of life , and mindful attention .


Further studies including larger sample size and longer follow-up are warranted .


Colorectal cancer ( CRC ) is the second most common malignancy in Europe and a leading cause of cancer-related death .


Almost 50 % of patients with CRC develop liver metastases , which heralds a poor prognosis unless metastases can be downsized to surgical resection or ablation .


The FOXFIRE trial examines the hypothesis that combining radiosensitising chemotherapy ( OxMdG : oxaliplatin , 5-fluorouracil and folic acid ) with Selective Internal Radiation Therapy ( SIRT or radioembolisation ) using yttrium-90 resin microspheres ( SIR-Spheres ; Sirtex Medical Limited , North Sydney , Australia ) as a first-line treatment for liver-dominant metastatic CRC will improve clinical outcomes when compared to OxMdG chemotherapy alone .


FOXFIRE is an open-label , multicentre , randomised controlled trial of OxMdG with or without the addition of SIRT ( 1:1 randomisation ) .


Eligible adult patients have histologically confirmed colorectal adenocarcinoma , liver metastases measurable on computed tomography scan and untreatable by either surgical resection or local ablation , and they may have limited extra-hepatic disease , defined as 5 nodules in the lung and/or one other metastatic site which is amenable to future definitive treatment .


Eligible patients may have received adjuvant chemotherapy following resection of the primary tumour , but are not permitted to have previously received chemotherapy for metastatic disease , and must have a life expectancy of 3 months and a WHO performance status of 0-1 .


The primary outcome is overall survival .


Secondary outcomes include progression free survival ( PFS ) , liver-specific PFS , patient-reported outcomes , safety , response rate , resection rate and cost-effectiveness .


FOXFIRE shares a combined statistical analysis plan with an international sister trial called SIRFLOX .


This trial is establishing a network of SIRT centres and ` feeder ' chemotherapy-only centres to standardise the delivery of SIRT across the whole of the UK and to provide greater equity of access to this highly specialised liver-directed therapy .


The FOXFIRE trial will establish the potential role of adding SIRT to first-line chemotherapy for unresectable liver metastatic colorectal cancer , and the impact on current treatment paradigms for metastatic CRC .


ISRCTN83867919 .


To compare adipose tissue concentration among obese women receiving 2 g compared with 3 g of precesarean cefazolin prophylaxis .


This was a double-blind randomized controlled trial of women with singleton gestations and body mass indexes ( BMIs ) of 30 or greater at their first prenatal visit undergoing cesarean delivery at term .


Women were randomly allocated , stratified by BMI , to receive 2 g or 3 g of cefazolin .


Subcutaneous adipose tissue was harvested twice : before ( opening ) fascial incision and after ( closing ) fascial closure .


The primary outcome was opening adipose tissue cefazolin concentration , measured by high-pressure liquid chromatography .


From April 2013 to July 2014 , 58 women were enrolled , 57 included in the analysis : 28 in the 2-g group and 29 in the 3-g group .


Baseline characteristics were similar between groups .


Median opening adipose tissue concentration was similar between the 2-g and 3-g groups ( 9.4 [ interquartile range 5.1-13 .4 ] compared with 11.7 [ interquartile range 7-18 .3 ] micrograms/g , P = .12 ) .


The percentage of women with opening concentrations above 8 micrograms/g , the minimally inhibitory concentration of cefazolin for Staphylococcus species , was similar ( 61 % compared with 72 % , P = .35 ) .


All samples were above 2 micrograms/g , the minimally inhibitory concentration for Enterobacteriaceae .


Closing adipose tissue concentrations and stratified analyses were consistent with the overall analysis .


In obese women undergoing cesarean delivery , prophylaxis with 3 g of cefazolin did not significantly increase adipose tissue concentration .


Thus , our data do not support recommendations for 3-g dosing .


I.


Liraglutide can modulate insulin secretion by directly stimulating beta cells or indirectly through weight loss and enhanced insulin sensitivity .


Recently , we showed that liraglutide treatment in overweight individuals with prediabetes ( impaired fasting glucose and/or impaired glucose tolerance ) led to greater weight loss ( -7.7 % vs -3.9 % ) and improvement in insulin resistance compared with placebo .


The current study evaluates the effects on beta cell function of weight loss augmented by liraglutide compared with weight loss alone .


This was a parallel , randomised study conducted in a single academic centre .


Both participants and study administrators were blinded to treatment assignment .


Individuals who were 40-70 years old , overweight ( BMI 27-40 kg/m ( 2 ) ) and with prediabetes were randomised ( via a computerised system ) to receive liraglutide ( n = 35 ) or matching placebo ( n = 33 ) , and 49 participants were analysed .


All were instructed to follow an energy-restricted diet .


Primary outcome was insulin secretory function , which was evaluated in response to graded infusions of glucose and day-long mixed meals .


Liraglutide treatment ( n = 24 ) significantly ( p0 .03 ) increased the insulin secretion rate ( % mean change [ 95 % CI ] ; 21 % [ 12 , 31 ] vs -4 % [ -11 , 3 ] ) and pancreatic beta cell sensitivity to intravenous glucose ( 229 % [ 161 , 276 ] vs -0.5 % ( -15 , 14 ] ) , and decreased insulin clearance rate ( -3.5 % [ -11 , 4 ] vs 8.2 [ 0.2 , 16 ] ) as compared with placebo ( n = 25 ) .


The liraglutide-treated group also had significantly ( p0 .03 ) lower day-long glucose ( -8.2 % [ -11 , -6 ] vs -0.1 [ -3 , 2 ] ) and NEFA concentrations ( -14 [ -20 , -8 ] vs -2.1 [ -10 , 6 ] ) following mixed meals , whereas day-long insulin concentrations did not significantly differ as compared with placebo .


In a multivariate regression analysis , weight loss was associated with a decrease in insulin secretion rate and day-long glucose and insulin concentrations in the placebo group ( p0 .05 ) , but there was no association with weight loss in the liraglutide group .


The most common side effect of liraglutide was nausea .


A direct stimulatory effect on beta cell function was the predominant change in liraglutide-augmented weight loss .


These changes appear to be independent of weight loss .


ClinicalTrials.gov NCT01784965 FUNDING : The study was funded by the ADA .


The purpose of this study was to compare the performance of a 20-gauge fenestrated catheter with an 18-gauge nonfenestrated catheter for i.v. contrast infusion during MDCT .


Two hundred five adult outpatients imaged on a dual-source 128-MDCT scanner with arterial phase body CT ( flow rates , 5.0-7 .5 mL/s ) were randomized to either an 18-gauge nonfenestrated or 20-gauge fenestrated catheter .


After randomization , any 18-gauge nonfenestrated subjects whose veins were deemed insufficient for that catheter gauge were assigned to a third cohort for placement of a 20-gauge fenestrated catheter .


Catheter placement success , infusion rate , contrast volume , maximum pressure , complications , and aortic enhancement levels were recorded .


Catheters were placed on the first attempt in 97 % ( 100/103 ) for 18-gauge nonfenestrated and 94 % ( 96/102 ) for 20-gauge fenestrated placements and in two or fewer attempts in 99 % of both groups .


Mean infusion rates ( 5.74 mL/s for 18-gauge nonfenestrated and 5.58 mL/s for 20-gauge fenestrated placements ) and aortic enhancement levels were not significantly different .


Maximum pressure was higher with 20-gauge fenestrated catheters ( mean SD , 230.5 27.6 pounds per square inch [ psi ] ) than 18-gauge nonfenestrated catheters ( mean SD 215.6 32.8 psi ) ( p = 0.002 ) .


One subject with an 18-gauge nonfenestrated catheter had a high-pressure alarm .


In the third cohort , a 20-gauge fenestrated catheter was successfully placed in two or fewer attempts in 85 % ( 28/33 ) , with one minor extravasation attributed to vein insufficiency .


A 20-gauge fenestrated catheter performs similarly to an 18-gauge nonfenestrated catheter with respect to i.v. contrast infusion rates and aortic enhancement levels and can be placed in most subjects whose veins are deemed insufficient for an 18-gauge catheter .


Patient blood management is introduced as a new concept that involves the combined use of transfusion alternatives .


In elective adult total hip - or knee-replacement surgery patients , the authors conducted a large randomized study on the integrated use of erythropoietin , cell saver , and/or postoperative drain reinfusion devices ( DRAIN ) to evaluate allogeneic erythrocyte use , while applying a restrictive transfusion threshold .


Patients with a preoperative hemoglobin level greater than 13 g/dl were ineligible for erythropoietin and evaluated for the effect of autologous blood reinfusion .


Patients were randomized between autologous reinfusion by cell saver or DRAIN or no blood salvage device .


Primary outcomes were mean intra - and postoperative erythrocyte use and proportion of transfused patients ( transfusion rate ) .


Secondary outcome was cost-effectiveness .


In 1,759 evaluated total hip - and knee-replacement surgery patients , the mean erythrocyte use was 0.19 ( SD , 0.9 ) erythrocyte units/patient in the autologous group ( n = 1,061 ) and 0.22 ( 0.9 ) erythrocyte units/patient in the control group ( n = 698 ) ( P = 0.64 ) .


The transfusion rate was 7.7 % in the autologous group compared with 8.3 % in the control group ( P = 0.19 ) .


No difference in erythrocyte use was found between cell saver and DRAIN groups .


Costs were increased by 298 per patient ( 95 % CI , 76 to 520 ) .


In patients with preoperative hemoglobin levels greater than 13 g/dl , autologous intra - and postoperative blood salvage devices were not effective as transfusion alternatives : use of these devices did not reduce erythrocyte use and increased costs .


Patient chart review is the gold standard for detection of potential patient hazards ( i.e. medication errors or failure to follow up actionable results ) in both routine clinical care and patient safety research .


However , advanced medical students ' ability to read patient charts and to identify patient hazards is rather poor .


We therefore investigated whether it is possible to teach advanced medical students how to identify patient hazards independent of context ( i.e. cancer versus cardiac failure ) in patient charts .


All fifth-year medical students in one semester ( n = 123 ) were randomized into two groups .


One group ( IC ) received a patient chart review-training first and then a control-intervention and the other group ( CI ) received the control-intervention first and then the patient chart review-training .


Before and after the teaching sessions , students reviewed different scenarios with standardized fictional patient charts containing 12 common patient hazards .


Two blinded raters rated the students ' notes for any patient hazard addressed in the notes using a checklist .


The students were blinded to the study question and design .


There was no external funding and no harm for the participating students .


A total of 35 data sets had to be excluded because of missing data .


Overall , the students identified 17 % ( IQR 8-29 % ) of the patient hazards before the training and 56 % ( IQR 41-66 % ) of the patient hazards after the training .


At the second assessment students identified more patient hazards than at the first .


They identified even more in the third .


The effect was most pronounced after the patient chart review training ( all p < .01 ) .


Patient chart review exercises and problem-based patient chart review training improve students ' abilities to recognize patient hazards independent of context during patient chart review .


To investigate homoarginine and asymmetric dimethylarginine ( ADMA ) in controls compared to children with type 1 diabetes ( T1D ) and if homoarginine and ADMA are affected by atorvastatin .


Homoarginine and ADMA levels of 28 T1D patients were compared to levels of 41 controls .


In T1D patients , homoarginine and ADMA were determined at baseline , 1 year , and 2 years at daily 10 mg atorvastatin or placebo within a double-blind study .


At baseline , both homoarginine and ADMA were lower ( p < 0.001 ) in T1D patients compared to controls .


In T1D patients , homoarginine and ADMA were not influenced by atorvastatin .


Inverse correlations between homoarginine and HbA1c ( p < 0.001 ) and between ADMA and systolic blood pressure ( p = 0.005 ) and pulse pressure ( p = 0.003 ) were shown .


Homoarginine and ADMA levels are decreased and associated with cardiovascular risk factors in children with T1D without being affected by atorvastatin .


To evaluate the effect of note-taking skills training on the achievement motivation in learning .


The experimental study comprised graduate students of the 2010-11 batch at Kerman 's Bahonar University and Kerman 's Medical Sciences University , Iran .


The study sample included 110 people ; 55 in the test group , and 55 in the control group .


They were randomly selected and replaced through the single-stage cluster sampling .


To collect the data , a questionnaire was used .


Pre-test was performed before the training session in two groups .


After training course , a post-test was taken .


For data analysis , the independent t-test , was used .


The average pre-test score of the test group was 182 + / - 34.15 , while for the control group it was 191 + / - 30.37 ( p < 0.089 ) .


After the training , the post-test showed statistically significant change .


The test group scored 220 + / - 20.94 against the controls who scored 195 + / - 27.26 ( p < 0.001 ) .


The findings showed that achievement motivation in learning increased significantly after imparting training in note-taking skills .


Authorities in the educational system should invest more for promotion of such skills .


The present clinical trial was designed to investigate the effectiveness of subgingivally delivered satranidazole ( SZ ) gel as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis .


Sixty-four subjects with probing depth ( PD ) 5 mm and who were diagnosed with type 2 diabetes were selected .


Thirty-two subjects each were randomly assigned to SRP + placebo ( Group 1 ) and SRP + SZ ( Group 2 ) .


The clinical outcomes evaluated were plaque index ( PI ) , gingival index ( GI ) , clinical attachment level ( CAL ) and PD at baseline , 1 month , 3-months and 6 months .


At 6 months , Group 2 had greater mean reduction ( 4.73 mm ) in PD as compared to Group 1 ( 2.09 mm ; p < 0.05 ) and also a greater mean CAL gain ( 3.92 mm versus 1.64 mm ; p < 0.05 ) .


The use of 3 % SZ gel , when used as an adjunct to non-surgical periodontal therapy in subjects with periodontitis , achieves significantly better clinical results than initial periodontal treatment alone .


Although highly porous metals have demonstrated excellent bone ingrowth properties and so are an intriguing option for fixation in total knee arthroplasty ( TKA ) , some surgeons are skeptical about the durability of uncemented tibial fixation and the potential for soft tissues to adhere to these porous metals and perhaps cause knee stiffness or pain .


The purpose of this study was to compare , in the context of a randomized clinical trial , a highly porous metal tibia compared with a traditional modular cemented tibia in terms of survivorship , Knee Society scores , range of motion ( ROM ) , and complications .


From 2003 to 2006 , 397 patients ( age 67.88.7 years ; 54 % female ) were randomized to three groups : ( 1 ) traditional modular cemented tibia ; ( 2 ) cemented highly porous metal tibia ; and ( 3 ) uncemented highly porous metal tibia .


The same posterior-stabilized femoral component and patella component were cemented in every case .


Stratified randomization was done for surgeon , patient 's age , sex , and body mass index .


Survivorship at 5years was compared between the groups , as were Knee Society scores , ROM , and complications .


Radiographic assessment included alignment , radiolucency , and implant migration/loosening .


Patients were followed until death , revision , or for a minimum of 2years ( mean , 5years ; range , 2-9years ) .


Four patients were lost to followup before 2years .


Highly porous metal tibias ( both uncemented and cemented ) were no different from traditional cemented modular tibial modular components in terms of survivorship at 5years using a intention-to-treat analysis ( 96.8 % [ 1 ] ; 97.6 % [ 2 ] ; 96.7 % [ 3 ] ; p = 0.59 ) .


A per-protocol analysis revealed that no highly porous metal tibia was revised for aseptic loosening .


Highly porous metal tibias performed comparably to traditional cemented modular tibias in terms of Knee Society scores , ROM , and the frequency of complications .


At 5years this randomized clinical trial demonstrated that highly porous metal tibias provided comparably durable fixation and reliable pain relief and restoration of function when compared with a traditional cemented modular tibia in TKA .


Level I , therapeutic study .


See Guidelines for Authors for a complete description of levels of evidence .


In The Netherlands , screening for chlamydia ( the most prevalent sexually transmitted infection worldwide ) is a relatively simple and free procedure .


Via an invitation letter sent by the public health services ( PHS ) , people are asked to visit a website to request a test kit .


They can then do a chlamydia test at home , send it anonymously to a laboratory , and , within two weeks , they can review their test results online and be treated by their general practitioner or the PHS .


Unfortunately , the participation rates are low and the process is believed to be not ( cost - ) effective .


The objective of this study was to assess whether the low participation rate of screening for chlamydia at home , via an invitation letter asking to visit a website and request a test kit , could be improved by optimizing the invitation letter through systematically applied behavior change theories and evidence .


The original letter and a revised letter were randomly sent out to 13,551 citizens , 16 to 29 years old , in a Dutch municipality .


Using behavior change theories , the revised letter sought to increase motivation to conduct chlamydia screening tests .


The revised letter was tailored to beliefs that were found in earlier studies : risk perception , advantages and disadvantages ( attitude ) , moral norm , social influence , and response - and self-efficacy .


Revisions to the new letter also sought to avoid possible unwanted resistance caused when people feel pressured , and included prompts to trigger the desired behavior .


No significant differences in test package requests were found between the two letters .


There were also no differences between the original and revised letters in the rates of returned tests ( 11.80 % , 581/4922 vs. 11.07 % , 549/4961 ) or positive test results ( 4.8 % , 23/484 vs. 4.1 % , 19/460 ) .


It is evident that the new letter did not improve participation compared to the original letter .


It is clear that the approach of inviting the target population through a letter does not lead to higher participation rates for chlamydia screening .


Other approaches have to be developed and pilot tested .


This study was designed to compare two approaches to negative-pressure wound therapy : 125-mmHg pressure with a polyurethane foam dressing and 75-mmHg pressure with a silicone-coated dressing .


Forty patients with diabetic foot wounds , after incision and drainage or amputation for infection , were assigned randomly to negative-pressure wound therapy with 75-mmHg continuous pressure with a silicone-covered dressing ( 75-mmHg group ) or 125-mmHg with a polyurethane foam dressing ( 125-mmHg group ) for up to 4 weeks or until surgical closure .


There was no difference in the proportion of wounds that were closed surgically ( 75-mmHg group , 50 percent ; 125-mmHg group , 60 percent ) , wounds that demonstrated 50 percent wound area reduction ( 75-mmHg group , 65 percent ; 125-mmHg group , 80 percent ) , or wounds that demonstrated 50 percent wound volume reduction after 4 weeks of therapy ( 75-mmHg group , 95 percent ; 125-mmHg group , 90 percent ) .


The authors ' results suggest that there was no difference in outcomes in wounds treated with low pressure ( 75 mmHg ) with a silicone-coated interface and high pressure ( 125 mmHg ) with a polyurethane foam interface .


Therapeutic , II .


In the AVAGAST study , fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival ( OS ) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer .


Geographic differences in efficacy were observed in AVAGAST , but the study only included 12 Chinese patients .


AVATAR , a study similar in design to AVAGAST , was a randomized , double-blind , phase III study conducted in Chinese patients with advanced gastric cancer .


Patients more than 18 years of age with gastric adenocarcinoma were randomized 1:1 to capecitabine-cisplatin plus either bevacizumab or placebo .


The primary endpoint was OS ; secondary endpoints included progression-free survival ( PFS ) and safety .


In total , 202 patients were included ( placebo n = 102 ; bevacizumab n = 100 ) .


Baseline characteristics were well balanced .


The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm [ hazard ratio , 1.11 ( 95 % CI , 0.79-1 .56 ) ; P = 0.5567 ] .


Median PFS was also similar in both arms .


Bevacizumab plus capecitabine-cisplatin was well tolerated .


Grade 3-5 adverse events ( AEs ) occurred in 60 % of bevacizumab-treated and 68 % of placebo-treated patients , respectively .


Grade 3-5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumab-treated patients and 15 % of placebo-treated patients , mainly grade 3-5 hemorrhage ( bevacizumab 4 % , placebo 12 % ) .


Addition of bevacizumab to capecitabine-cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR .


There was no difference in OS between the two arms and PFS was similar in both arms .


Safety findings were as previously experienced with bevacizumab , including AVAGAST ; no new safety signals were reported .


Excessive recreational screen time ( i.e. , screen use for entertainment ) is a global public health issue associated with adverse mental and physical health outcomes .


Considering the growing popularity of screen-based recreation in adolescents , there is a need to identify effective strategies for reducing screen time among adolescents .


The aim of this paper is to report the rationale and study protocol for the ` Switch-off 4 Healthy Minds ' ( S4HM ) study , an intervention designed to reduce recreational screen time among adolescents .


The S4HM intervention will be evaluated using a cluster randomized controlled trial in eight secondary schools ( N = 322 students ) in New South Wales , Australia .


The 6-month multi-component intervention will encourage adolescents to manage their recreational screen time using a range of evidence-based strategies .


The intervention is grounded in Self-Determination Theory ( SDT ) and includes the following components : an interactive seminar for students , eHealth messaging , behavioral contract and parental newsletters .


All outcomes will be assessed at baseline and at 6-months ( i.e. , immediate post-test ) .


The primary outcome is recreational screen time measured by the Adolescent Sedentary Activity Questionnaire ( ASAQ ) .


Secondary outcomes include : self-reported psychological well-being , psychological distress , global physical self-concept , resilience , pathological video gaming and aggression , and objectively measured physical activity ( accelerometry ) and body mass index ( BMI ) .


Hypothesized mediators of behavior change will also be explored .


The S4HM study will involve the evaluation of an innovative , theory-driven , multi-component intervention that targets students and their parents and is designed to reduce recreational screen time in adolescents .


The intervention has been designed for scalability and dissemination across Australian secondary schools .


Estimates show that as many as one in 10 patients are harmed while receiving hospital care .


Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour , with little involvement of patients .


The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care .


Over the past 3 years , our research team have developed , tested and refined the PRASE ( Patient Reporting and Action for a Safe Environment ) intervention , which gains patient feedback about quality and safety on hospital wards .


A multi-centre , cluster , wait list design , randomised controlled trial with an embedded qualitative process evaluation .


The aim is to assess the efficacy of the PRASE intervention , in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England .


The PRASE intervention comprises two tools : ( 1 ) a 44-item questionnaire which asks patients about safety concerns and issues ; and ( 2 ) a proforma for patients to report ( a ) any specific patient safety incidents they have been involved in or witnessed and ( b ) any positive experiences .


These two tools then provide data which are fed back to wards in a structured feedback report .


Using this report , ward staff are asked to hold action planning meetings ( APMs ) in order to action plan , then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results .


fieldworker diaries , ethnographic observation of APMs , structured interviews with APM lead and collection of key data about intervention wards .


Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework .


This study will be one of the largest patient safety trials ever conducted , involving 32 hospital wards .


The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level .


Incorporating the ` patient voice ' is critical if patient feedback is to be situated as an integral part of patient safety improvements .


ISRCTN07689702 , 16 Aug 2013 .


We aim to obtain the intra-subject coefficient of variability of a highly variable antidepressant agomelatine in humans , and propose an adjusted bioequivalence assessment strategy .


A single-dose , randomized crossover design was conducted in four periods ( reference administered thrice , placebo administered once ) separated by seven days .


A validated LC-MS/MS assay was used to measure drug concentrations in serial blood samples .


The intra-subject coefficient of variability was calculated using the residual variance of ANOVA analysis , and the results for Cmax and AUC0-t was 78.34 % and 43.52 % , respectively , in Chinese healthy subjects .


The sample size required for standard BE study were 124 ( 192 , 340 ) if the expected deviation between the reference and generic products was set to 0 ( 5 % , 10 % ) .


Agomelatine meets the criteria for highly variable drug in Chinese healthy male subjects , and the traditional BE criteria for agomelatine needs to be adjusted to alleviate the resource and ethical burden of using a large numbers of subjects in clinical trials .


Our clinical data on the intra-subject variability of agomelatine PK in Chinese healthy population enables to adjust bioequivalence ( BE ) assessment approach for agomelatine based on the RSABE approaches recommended by regulatory agencies .


ChiCTR.org ChiCTR-TTRCC-13003835 .


Impairment of HDL function has been associated with cardiovascular events in patients with kidney failure .


The protein composition of HDLs is altered in these patients , presumably compromising the cardioprotective effects of HDLs .


This post hoc study assessed the relation of distinct HDL-bound proteins with cardiovascular outcomes in a dialysis population .


The concentrations of HDL-associated serum amyloid A ( SAA ) and surfactant protein B ( SP-B ) were measured in 1152 patients with type 2 diabetes mellitus on hemodialysis participating in The German Diabetes Dialysis Study who were randomly assigned to double-blind treatment of 20 mg atorvastatin daily or matching placebo .


The association of SAA ( HDL ) and SP-B ( HDL ) with cardiovascular outcomes was assessed in multivariate regression models adjusted for known clinical risk factors .


High concentrations of SAA ( HDL ) were significantly and positively associated with the risk of cardiac events ( hazard ratio per 1 SD higher , 1.09 ; 95 % confidence interval , 1.01 to 1.19 ) .


High concentrations of SP-B ( HDL ) were significantly associated with all-cause mortality ( hazard ratio per 1 SD higher , 1.10 ; 95 % confidence interval , 1.02 to 1.19 ) .


Adjustment for HDL cholesterol did not affect these associations .


In patients with diabetes on hemodialysis , SAA ( HDL ) and SP-B ( HDL ) were related to cardiac events and all-cause mortality , respectively , and they were independent of HDL cholesterol .


These findings indicate that a remodeling of the HDL proteome was associated with a higher risk for cardiovascular events and mortality in patients with ESRD .


To assess the effects of different frequencies of thalamic Deep-Brain-Stimulation ( DBS ) on cognitive performance of patients suffering from Essential Tremor ( ET ) .


In 17 ET-patients with thalamic-DBS , Tremor-Rating-Scale ( TRS ) , standardized phonemic and semantic verbal fluency ( VF ) , Stroop-Color-Word-Test and Digit-span-test were investigated in three randomized stimulation-settings : i ) high-frequency stimulation ( HFS ) , ii ) low-frequency stimulation ( LFS ) and iii ) OFF-stimulation ( DBS-OFF ) .


Paired-samples t-test for TRS and one-way repeated measures analysis of variance for cognitive performance were calculated .


Tremor was reduced during HFS ( MeanTRS-HFS = 12.9 9.6 ) compared to DBS-OFF ( MeanTRS-OFF = 44.4 19.8 , P < .001 ) and to LFS ( MeanTRS-10 Hz = 50.0 24.2 ; P < .001 ) .


While performance of Stroop-task and digit-span remained unaffected by stimulation-settings ( P > .05 ) , phonemic and semantic VF differed significantly between the three conditions ( FPvf = 5.28 , FSvf = 3.41 , both P < .05 ) .


Post-hoc comparisons revealed significant differences for both phonemic and semantic VF between LFS ( MeanPvf-10 Hz = 54.6 9.2 , MeanSvf-10 Hz = 56.4 7.9 ) and HFS ( MeanPvf-ON = 48.3 11.4 , MeanSvf-ON = 51.1 11.0 , both P < .05 ) , while DBS-OFF ( MeanPvf-OFF = 51.2 9.3 , MeanSvf-OFF = 53.6 12.9 ) and HFS and DBS-OFF and LFS did not differ significantly ( P > .05 ) .


HFS compared to LFS or DBS-OFF significantly reduced tremor but simultaneously worsened VF while working memory and cognitive inhibition remained unaffected .


In contrast , LFS enhanced VF but did not ameliorate tremor .


The data emphasize the relevance of thalamocortical loops for verbal fluency but also suggest that more sophisticated DBS-regimes in ET may improve both motor and cognitive performance .


Previous findings suggest that language disorders may occur in severely brain-injured patients and could interfere with behavioral assessments of consciousness .


However , no study investigated to what extent language impairment could affect patients ' behavioral responses .


Objective .


To estimate the impact of receptive and/or productive language impairments on consciousness assessment .


Twenty-four acute and subacute stroke patients with different types of aphasia ( global , n = 11 ; Broca , n = 4 ; Wernicke , n = 3 ; anomic , n = 4 ; mixed , n = 2 ) were recruited in neurology and neurosurgery units as well as in rehabilitation centers .


The Coma Recovery Scale-Revised ( CRS-R ) was administered .


We observed that 25 % ( 6 out of 24 ) of stroke patients with a diagnosis of aphasia and 54 % ( 6 out of 11 ) of patients with a diagnosis of global aphasia did not reach the maximal CRS-R total score of 23 .


An underestimation of the consciousness level was observed in 3 patients with global aphasia who could have been misdiagnosed as being in a minimally conscious state , even in the absence of any documented period of coma .


More precisely , lower subscores were observed on the communication , motor , oromotor , and arousal subscales .


Consciousness assessment may be complicated by the co-occurrence of severe language deficits .


This stresses the importance of developing new tools or identifying items in existing scales , which may allow the detection of language impairment in severely brain-injured patients .


Prenatal consumption of omega-3 fatty acids can act as an adjuvant in the development of the immune system and affect the inflammatory response of neonates .


We conducted a double-blind , randomized , placebo-controlled trial in Cuernavaca , Mexico .


We randomly assigned 1,094 pregnant women ( 18-35 years of age ) to receive 400 mg/d of algal docosahexaenoic acid ( DHA ) or placebo from 18 to 22 weeks of gestation through delivery .


Birth outcomes and respiratory symptoms information until 18 months were available for 869 mother-child pairs .


Questionnaires were administered , and maternal blood samples were obtained at baseline .


Maternal atopy was based on specific IgE levels .


During follow-up , information on infants ' respiratory symptoms was collected through questionnaires administered at 1 , 3 , 6 , 9 , 12 , and 18 months of age .


Negative binomial regression models were used to evaluate the effect of supplementation on respiratory symptoms in infants .


Among infants of atopic mothers , a statistically significant protective effect of DHA treatment was observed on phlegm with nasal discharge or nasal congestion ( 0.78 ; 95 % CI , 0.60-1 .02 ) and fever with phlegm and nasal discharge or nasal congestion ( 0.53 ; 95 % CI , 0.29-0 .99 ) , adjusting for potential confounders .


Our results support the hypothesis that DHA supplementation during pregnancy may decrease the incidence of respiratory symptoms in children with a history of maternal atopy .


ClinicalTrials.gov ; No. : NCT00646360 ; URL : www.clinicaltrials.gov .


Physical activity ( PA ) predicts cardiovascular mortality in the population at large .


Less is known about its prognostic value in patients with chronic heart failure ( HF ) .


Data from 836 patients with implantable cardioverter defibrillator without or with cardiac resynchronization therapy enrolled in the Sensitivity of the InSync Sentry OptiVol feature for the prediction of Heart Failure ( SENSE-HF ) ( 1 ) study and the Diagnostic Outcome Trial in Heart Failure ( DOT-HF ) were pooled .


The devices continuously measured and stored total daily active time ( single-axis accelerometer ) .


Early PA ( average daily activity over the earliest 30-day study period ) was studied as a predictor of time to death or HF-related hospital admission ( primary end point ) .


Data from 781 patients were analyzed ( 6510 years ; 85 % men ; left ventricular ejection fraction , 267 % ) .


Older age , shorter height , ischemic cause , peripheral artery disease , atrial fibrillation , diabetes mellitus , rales , peripheral edema , higher New York Heart Association class , lower diastolic blood pressure , and no angiotensin II receptor blocker/angiotensin-converting enzyme inhibitor use were associated with reduced early PA. .


The primary end point occurred in 135 patients ( 157 months of follow-up ) .


In multivariable analysis including baseline variables , early PA predicted death or HF hospitalization , with a 4 % reduction in risk for each 10 minutes per day additional activity ( hazard ratio [ HR ] , 0.96 ; confidence interval [ CI ] , 0.94-0 .98 ; P = 0.0002 compared with a model with the same baseline variables but without PA ) .


PA also predicted death ( HR , 0.93 ; CI , 0.90-0 .96 ; P < 0.0001 ) and HF hospitalization ( HR , 0.97 ; CI , 0.95-0 .99 ; P = 0.011 ) .


Early PA , averaged over a 30-day window early after defibrillator implantation or cardiac resynchronization therapy in patients with chronic HF , predicted death or HF hospitalization , as well as mortality and HF hospitalization separately , accounting for baseline HF severity .


Clinical Trial Registration Information - URL : http://www.clinicaltrials.gov .


Unique identifiers : NCT00400985 , NCT00480077 .


To comprehensively evaluate the effect of a short-term diabetes self-management education ( DSME ) on metabolic markers and atherosclerotic parameters in patients with type 2 diabetes .


76 patients with type 2 diabetes were recruited in this study .


They were divided into the intervention group ( n = 36 ) and control group ( n = 40 ) .


The patients in the intervention group received a 3-month intervention , including an 8-week education on self-management of diabetes mellitus and subsequent 4 weeks of practice of the self-management guidelines .


The patients in the control group received standard advice on medical nutrition therapy .


Metabolic markers , carotid intima-media thickness ( CIMT ) , and carotid arterial stiffness ( CAS ) of the patients in both groups were assessed before and after the 3-month intervention .


There was a significant reduction in hemoglobin A1c ( HbA1c , -0.2 0.56 % versus 0.08 0.741 % ; P < 0.05 ) and body weight ( -1.19 1.39 kg versus -0.61 2.04 kg ; P < 0.05 ) in the intervention group as compared to the control group .


However , no significant improvements were found in other metabolic markers , CIMT and CAS ( P > 0.05 ) .


DSME can improve HbA1c and body weight in patients with type 2 diabetes .


To compare anterior chamber paracentesis ( ACP ) with standard medical management of acute primary angle closure ( APAC ) .


Prospective study .


Patients with APAC and intraocular pressure ( IOP ) 50 mm Hg were enrolled .


Patients were randomized to receive ACP and medical treatment ( group 1 ) or medical management alone ( group 2 ) .


There were 26 patients ( mean age 69.3 10.4 years , 31 eyes ) in group 1 and 28 patients ( mean age 67.0 9.7 years , 30 eyes ) in group 2 .


The IOP in group 1 was significantly lower at 15 minutes , 30 minutes , and 1 hour after treatment ( p < 0.05 ) .


At 1 , 2 , and 24 hours after treatment , visual acuity was significantly better in group 1 than in group 2 .


At each time point after treatment , the grade of corneal edema was not different between the groups .


Pain score at 1 and 2 hours after treatment was significantly lower in group 1 than in group 2 ; however , no difference was noted at 24 hours after treatment .


The mean follow-up period in group 1 was 16.1 1.3 months and in group 2 was 15.6 1.4 months ( p = 0.803 ) .


At last follow-up , IOP , pupil size , number of eyes with nonreactive pupils , and centre endothelial cell counts were not different ; however , visual acuity was significantly better in group 1 ( 0.43 0.06 logMAR vs 0.74 0.10 logMAR , p = 0.007 ) .


Immediate ACP is a safe and effective for rapidly lowering IOP , and is associated with better visual acuity than medical treatment alone .


Bone fracture is a common cause of acute pain in emergency and orthopedics departments .


Targeting the multifaceted mechanisms of pain with combinations of multiple analgesics ( multimodal analgesia ) can increase the pain control efforts efficacy and decrease the adverse effects of each medication .


One hundred and fifty-three patients with acute bone fracture were randomly allocated to two groups receiving intravenous morphine sulfate ( 74 patients ) or oral oxycodone plus intravenous acetaminophen ( 79 patients ) .


Pain scores and drugs ' adverse effects were assessed 10 , 30 and 60 min after treatment .


Pain scores were similar between groups before , 30 and 60 min after medication but patients in morphine sulfate group experienced less pain 10 min after medication .


Eight ( 10.8 % ) patients in morphine sulfate group and 26 ( 32.9 % ) patients in acetaminophen/oxycodone group experienced nausea that was statistically significant higher ( P value = 0.001 ) .


Itching was seen in 12 ( 15.1 % ) patients of acetaminophen/oxycodone group and three ( 4.0 % ) patients of patients in morphine sulfate group ( P value = 0.02 ) .


Intravenous acetaminophen plus oral oxycodone is as effective as intravenous morphine sulfate in acute pain control in emergency department but with a less desirable safety profile .


Salacia oblonga , Tinospora cordifolia , Emblica offinalis Gaertn , Curcuma longa and Gymnema sylvestre are Ayurvedic medicinal plants reported to lower plasma glucose levels in animal models .


To our knowledge , however , no clinical validations of those extracts for efficacy have been .


The aim of this study was to evaluate the effect of polyherbal combination in patients with type 2 diabetes mellitus .


We screened 250 patients enrolled in a diabetes mellitus screening camp held at District Ayurvedic Hospital , Kottayam , Kerala , India .


Of these , 89 patients diagnosed with type 2 diabetes mellitus and 50 healthy volunteers of similar age group were included in the study .


Patients were treated with a polyherbal combination drug namely G-400 ( 1000 mg/d ) for 8 wk with a follow-up of 2wk interval .


Fasting and postprandial blood glucose levels measured after 8 wk of G-400 treatment in patients were significantly lower .


Indeed diabetic rats showed similar protection with G-400 administration .


Furthermore , glycosylated hemoglobin , serum total cholesterol , both high - and low-density lipoprotein cholesterol , and triglycerides showed a significant improvement in G-400-administered patients .


Toxicologic profile of the drug was assessed by analyzing the enzyme activities of alkaline phosphatase and alanine aminotransferase along with the concentration of blood urea nitrogen and creatinine in blood and found insignificant change compared with control .


Short-term supplementation of G-400 not only attenuates the hyperglycemia , but also acts as hypolipidemic agent in patients with diabetes .


Further study should be done for the long-term effect of the drug in larger populations .


To study therapeutic effects of comprehensive traditional Chinese medicine therapy for preventing postsurgery stiffness after operation for terrible triad of the elbow .


From December 2008 to December 2013,32 patients with elbow triad were randomly divided into two groups : therapy group and control group .


There were 17 patients in control group including 12 males and 5 females with a mean age of ( 41.0 7.1 ) years old .


The patients in control group were received the past procedure therapy .


There were 15 patients in therapy group , including 10 males and 5 females with a mean age of ( 41.3 7.6 ) years old .


The patients in therapy group were received comprehensive traditional Chinese medicine therapy , including passive exercise training at early stage ( 0 to 2 weeks after operation ) , transition from passive to active exercise training at middle stage ( 3 to 4 weeks after operation ) , and active exercise training at late stage ( 5 to 12 weeks after operation ) .


Other treatment methods , such as orally taking or externally use of Chinese herbal medicine , manipulation and physiotherapy , were used at all stages .


The Mayo Elbow Performance Score , patient satisfaction and complications were evaluated and analyzed .


All the patients were followed up , and the mean duration was 7.5 months .


There were no complications such as internal fixation loosing , obvious displacement fracture and heterotopic ossification occurred .


The Mayo score and patient satisfaction in therapy group were higher than those in control group ( t = 12.78 , P = 0.00 ; 2 = 8.719 , P = 0.003 ) .


Seven patients needed reoperation in control group , compared with 1 patient in therapy group ( 2 = 4.626 , P = 0.032 ) .


The comprehensive traditional Chinese medicine therapy is effective to prevent postoperative stiffness after operation for terrible triad of the elbow by using different methods at different stages , which is worthy of spread and application .


The purpose of this study was to assess the repeatability of water-fat MRI and diffusion-tensor imaging ( DTI ) as quantitative biomarkers of pediatric lower extremity skeletal muscle .


MRI at 3 T of a randomly selected thigh and lower leg of seven healthy children was studied using water-fat separation and DTI techniques .


Muscle-fat fraction , apparent diffusion coefficient ( ADC ) , and fractional anisotropy ( FA ) values were calculated .


Test-retest and interrater repeatability were assessed by calculating the Pearson correlation coefficient , intraclass correlation coefficient , and Bland-Altman analysis .


Bland-Altman plots show that the mean difference between test-retest and interrater measurements of muscle-fat fraction , ADC , and FA was near 0 .


The correlation coefficients and intraclass correlation coefficients were all between 0.88 and 0.99 ( p < 0.05 ) , suggesting excellent reliability of the measurements .


Muscle-fat fraction measurements from water-fat MRI exhibited the highest intraclass correlation coefficient .


Interrater agreement was consistently better than test-retest comparisons .


Water-fat MRI and DTI measurements in lower extremity skeletal muscles are objective repeatable biomarkers in children .


This knowledge should aid in the understanding of the number of participants needed in clinical trials when using these determinations as an outcome measure to noninvasively monitor neuromuscular disease .


As new techniques emerge to quantify patients ' health status , new opportunities are created to validate patient-reported outcome questionnaires .


The Seattle Angina Questionnaire ( SAQ ) , a widely used coronary artery disease-specific health status tool , has not been validated against daily records of angina frequency and sublingual nitroglycerin ( SL NTG ) use .


Additional evidence supporting the validity of the SAQ could justify its broader use as an outcome for clinical studies designed to evaluate treatments that may improve patients ' symptoms , function , and quality of life .


We used data from 917 patients with type 2 diabetes mellitus , coronary artery disease , and stable angina from the multinational Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina ( TERISA ) trial .


The number of angina episodes and SL NTG used were recorded and transmitted daily using an electronic diary .


In cross-sectional analyses , there was a strong relationship between the 2 SAQ angina frequency questions ( ie , frequency of angina and SL NTG use ) and the corresponding diary responses , with correlation coefficients of -0.64 for angina frequency ( 95 % confidence interval,-0 .68 to -0.60 ) and -0.69 for SL NTG use ( 95 % confidence interval , -0.73 to -0.66 ) .


Longitudinally , changes in SAQ angina frequency scores from day 1 to week 8 also correlated with changes in angina frequency ( -0.42 ; 95 % confidence interval , -0.48 to -0.30 ) and SL NTG use by diary ( -0.38 ; 95 % confidence interval , -0.43 to -0.32 ) over the corresponding time period .


Correlations were similar when stratified by age , sex , or geography .


In a multinational cohort of patients with stable angina , the SAQ angina frequency domain was significantly correlated , both cross sectionally and longitudinally , with daily diary entries of angina frequency and SL NTG use .


These data further support the validity of the SAQ angina frequency domain across a broad spectrum of patients with stable angina .


http://www.clinicaltrials.gov .


Unique identifier : NCT01425359 .


To observe the change of intra-abdominal pressure ( IAP ) in severe acute pancreatitis ( SAP ) patients , and to study the effect of Qingyi Chengqi Decoction ( QCD ) on it .


Eighty-six SAP patients from Department of General Surgery and Department of Digestive Diseases , Qingyang People 's Hospital , Gansu Province , who were in line with diagnosis standard of SAP , were assigned to the treatment group ( 44 cases ) and the control group ( 42 cases ) from March 2012 to May 2013 .


All patients received routine Western medicine .


Those in the treatment group took QCD additionally .


Main clinical symptoms and APACHE II were observed .


The serum levels of amylase ( AMY ) , C-reactive protein ( CRP ) , and IAP were examined .


The incidence of secondary infection rate ( SIR ) , drainage rate ( percutaneous catheter drainage and operation ) , mortality , and mean days in ward were also recorded .


Main clinical symptoms were significantly improved in the treatment group .


APACHE II score , serum levels of AMY , CRP , and IAP obviously decreased in the treatment group .


The incidence of SIR , drainage rate , and the mortality were also significantly lower in the treatment group than in the control group .


The mean days in ward were also markedly shortened ( P < 0.01 ) .


QCD could relieve inflammatory response , lower IAP , SIR , and mortality , increase the curative rate and improve the prognosis of SAP .


The incidence of postoperative pharyngolaryngeal complications after laryngeal mask airway ( LMA ) insertion can be as high as 50 % .


Over-inflation of the LMA cuff may be a causal factor .


We conducted a single-centre parallel group randomised trial to determine whether maintaining LMA-ProSeal intra-cuff pressures below 60 cm H2O decreases postoperative pharyngolaryngeal complications .


We recruited 120 adult patients who were scheduled to undergo elective surgery under general anaesthesia .


Appropriate sized LMA-ProSeal was inserted and the cuff was inflated with air ( to no more than the maximum recommended volume ) until there was no audible leak .


Patients were randomised to either the control group ( n = 60 ) , where the intra-cuff pressure was noted and no further action was taken , or to the pressure-monitored group ( n = 60 ) , where intra-cuff pressure was maintained below 60 cm H2O .


Pharyngolaryngeal complications consisting of sore throat , dysphonia and dysphagia were assessed at 1 , 2 , and 24 h postoperatively .


Patients , anaesthesiologists and assessors were blinded to group allocation .


The primary outcome was a composite endpoint of any pharyngolaryngeal complication at any of the three time points .


Secondary outcomes were the incidence of individual outcomes at each time point .


The incidence of pharyngolaryngeal complications at any time point was 42 % in the routine care group and 32 % in the pressure-monitored group ( 95 % CI for difference +28 to -7 % , p = 0.26 ) .


There was no difference between groups for any of the secondary outcomes .


Our study failed to demonstrate a statistically significant reduction in postoperative pharyngolaryngeal complications by limiting intra-cuff pressures in the LMA-Proseal .


To evaluate canine erythrocyte concentrates ( ECs ) for the presence of procoagulant phospholipid ( PPL ) , determine whether PPL concentration changes during the course of storage of ECs , and ascertain whether prestorage leukoreduction ( removal of leukocytes via gravity filtration ) reduces the development of PPL .


10 whole blood units ( 420 g each ) collected from 10 random-source , clinically normal dogs ( 1 U/dog ) .


The dogs were randomized to 1 of 2 groups .


Of the 10 whole blood units collected , 5 were processed through a standard method , and 5 underwent leukoreduction .


Whole blood units were processed to generate ECs , from which aliquots were aseptically collected from each unit weekly for 5 weeks .


Supernatants from the concentrates were evaluated for procoagulant activity , which was converted to PPL concentration , by use of an automated assay and by measurement of real-time thrombin generation .


Supernatants from stored canine ECs contained procoagulant activity as measured by both assays .


In general , the PPL concentration gradually increased during the storage period , but leukoreduction reduced the development of increased procoagulant activity over time .


The presence of PPL in canine ECs may be associated with procoagulant and proinflammatory effects in vivo , which could have adverse consequences for dogs treated with ECs .


Treatment of tobacco use in mental health settings is rare despite high rates of comorbidity .


With a focus on early intervention , we evaluated a tobacco treatment intervention among adolescents and young adults recruited from outpatient , school-based , and residential mental health settings and tested for gender differences .


Intervention participants received computerized motivational feedback at baseline , 3 months , and 6 months and were offered 12 weeks of cessation counseling and nicotine patches .


Usual care participants received a self-help guide and brief cessation advice .


We examined 7-day point prevalence abstinence with biochemical confirmation at 3 , 6 , and 12 months ; smoking reduction ; and 24-hr quit attempts .


At baseline , the sample ( N = 60 , 52 % female , mean age = 19.52.9 years , 40 % non-Hispanic Caucasian ) averaged 76 cigarettes/day , 62 % smoked daily , 38 % smoked 30 min of waking , 12 % intended to quit in the next month , 47 % had a parent who smoked , and 3 of 5 of participants ' closest friends smoked on average .


During the 12-month study , 47 % of the sample reduced their smoking , 80 % quit for 24 hr , and 11 % , 13 % , and 17 % confirmed 7-day point prevalence abstinence at 3 - , 6 - , and 12-month follow-up , respectively , with no differences by treatment condition ( ps > .400 ) .


Over time , abstinence was greater among girls ( adjusted odds ratio [ AOR ] = 8.9 ) than among boys , and abstinence was greater for lighter smokers than heavier smokers ( AOR = 4.5 ) ( p < .05 ) .


No mental health or other measured variables predicted abstinence .


Adolescent and young adult smokers with mental health concerns are a challenging group to engage and to effectively treat for tobacco addiction , particularly heavier smokers and boys .


Innovative approaches are needed .


Limited pharmacological options are available for the management of Alzheimer 's disease ( AD ) in severe stages .


Cognitive-enhancing properties of saffron , the dried stigma of Crocus sativus L. , have been evidenced in different studies .


We aimed to compare the efficacy and safety of saffron extract versus memantine in reducing cognitive deterioration of patients with moderate to severe AD .


In this randomized double-blind parallel-group study , 68 patients with moderate to severe AD ( Mini-Mental State Examination score of 8-14 ) received memantine ( 20mg/day ) or saffron extract ( 30mg/day ) capsules for 12months .


Participants were evaluated every month by Severe Cognitive Impairment Rating Scale ( SCIRS ) and Functional Assessment Staging ( FAST ) in addition to recording the probable adverse events .


Both treatment groups showed similar outcomes as demonstrated by insignificant effect for timetreatment interaction on SCIRS scores [ F ( 2.95 , 194.78 ) = 2.25 , p = 0.08 ] .


There was no significant difference between the two groups in the scores changes from baseline to the endpoint on SCIRS ( p = 0.38 ) and FAST ( p = 0.87 ) .


The frequency of adverse events was not significantly different between the two groups as well .


In addition to its favorable safety profile , 1-year administration of saffron extract capsules showed to be comparable with memantine in reducing cognitive decline in patients with moderate to severe AD .


Confirmatory studies with larger sample sizes and longer follow-up periods are warranted .


NT-pro-BNP level is increased in both systolic and diastolic heart failure ( HF ) and furthermore increases more during exercise .


In diastolic HF , NT-pro-BNP might increase more during isometric exercise than during isotonic exercises because of increased afterload .


We studied NT-pro-BNP values during isometric ( hand-grip ) and isotonic ( cycloergometer ) exercise in HF patients with preserved left ventricular ejection fraction and different degrees of diastolic dysfunction .


We studied 87 patients , aged 58 7.9 years , 42.6 % females , with heart failure with LVEF > 40 % and diastolic dysfunction .


The patients were randomly distributed in two groups : 43 patients ( Group I ) and 44 patients ( Group II ) .


Group I underwent ramp exercise testing on a cycloergometer .


Group II performed an isometric handgrip test .


Plasma NT-pro-BNP levels were measured at rest and immediately after exercise .


An abnormal relaxation ( AR ) pattern was recorded in 30 patients of Group I and 31 patients of Group II .


Pseudonormalisation ( PSN ) and restrictive ( R ) pattern were noted in 13 patients of each group .


As concerns Group I , NT-pro-BNP levels were increased in all patients , particularly in those with PSN or R pattern ( p < 0.05 ) .


During exercise NT-pro-BNP decreases significantly in AR ( 1033 516.63 to 800.51 675.89 pg/mL ) but not in PSN or R patients ( 1656.75 977.48 to 1486.38 1182.51 pg/mL ) .


For Group II , NT-pro-BNP registered a similar increase as in Group I , with maximal values in PSN or R subgroup as compared to abnormal relaxation ( p < 0.05 ) .


At peak exercise , NT-pro-BNP was practically unchanged as compared to the rest values for the whole group ( -6 % ) and for the two subgroups ( AR -6.7 % and PSN or R -5.21 % ) .


We compared rest and exercise NT-pro-BNP with E/E ' ratio > 12 in order to identify increased diastolic filling pressure in the LV ; AUC was 0.70 and 0.66 for rest and exercise NT-pro-BNP in case of isotonic testing and 0.74 and 0.72 in case of isometric exercise .


Our data suggest that in HF patients with preserved left ventricular ejection fraction , moderate isotonic and isometric exercises do not determine a significant increase ( isometric exercise ) or even decrease ( isotonic exercise ) in the value of NT-pro-BNP .


Positively reinforcing properties of alcohol are in part mediated by activation of the ventral striatum ( VS ) .


Alcohol-induced release of endogenous opioids is thought to contribute to this response .


Preclinical studies show that the opioid antagonist naltrexone ( NTX ) can block this cascade , but its ability to do so in treatment-seeking alcoholics has not been examined .


Our objective was to study the effects of NTX on alcohol-induced VS activation and on amygdala response to affective stimuli in treatment-seeking alcohol-dependent inpatients .


Sixty-three treatment-seeking alcoholics were randomized to receive NTX ( 50mg ) or placebo ( PLC ) daily .


On Day 7 , participants underwent an alcohol cue reactivity session , and craving was measured using the Penn Alcohol Craving Scale .


On Day 9 , participants received a saline infusion followed by an alcohol infusion and also viewed affective stimuli in a magnetic resonance scanner .


Irrespective of medication treatment condition , the alcohol infusion did not activate the VS in the alcohol-dependent patients .


Unexpectedly , VS activation was greater in NTX treated patients than in the PLC group .


NTX treated patients also reported increased craving in response to alcohol cue exposure , and increased subjective response to alcohol ( `` high '' and `` intoxicated '' ) compared to PLC subjects .


No significant effects of alcohol infusion on brain response to affective stimuli were in the NTX or PLC groups .


Unlike previous findings in social drinkers , a moderate level of intoxication did not activate the VS in treatment-seeking alcoholics .


This is likely to reflect tolerance to the positively reinforcing properties of alcohol in this clinical population .


Our findings may help explain the efficacy of NTX to reduce heavy drinking , but not to maintain abstinence .


Catechol-O-methyltransferase ( COMT ) metabolizes catecholamines in the prefrontal cortex ( PFC ) .


A common polymorphism in the COMT gene ( COMT val158met ) has pleiotropic effects on cognitive and emotional processing .


The met allele has been associated with enhanced cognitive processing but impaired emotional processing relative to the val allele .


We genotyped healthy , white men in relation to the COMT val158met polymorphism .


They were given a single 4 mg dose of the selective noradrenaline reuptake inhibitor ( NRI ) reboxetine or placebo in a randomized , double-blind between-subjects model and then completed an emotional memory task 2 hours later .


We included 75 men in the study ; 41 received reboxetine and 34 received placebo .


In the placebo group , met/met carriers did not demonstrate the usual memory advantage for emotional stimuli that was observed in val carriers .


Reboxetine restored this emotional enhancement of memory in met/met carriers , but had no significant effect in val carriers .


We studied only men , thus limiting the generalizability of our findings .


We also relied on self-reported responses to screening questions to establish healthy volunteer status , and in spite of the double-blind design , participants were significantly better than chance at identifying their intervention allocation .


Emotional memory is impaired in healthy met homozygotes and selectively improved in this group by reboxetine .


This has potential translational implications for the use of reboxetine , which is currently licensed as an antidepressant in several countries , and edivoxetine , a new selective NRI currently in development .


Topical corticosteroids are used with systemic therapies for treatment of plaque psoriasis , but data from randomized clinical trials to document efficacy of combination therapy are lacking .


To evaluate efficacy and safety of adding topical corticosteroid therapy from the time that etanercept dosage is reduced from initial label dose [ 50 mg twice weekly ( BIW ) ] to maintenance dose [ 50 mg once weekly ( QW ) ] .


In this phase 3b , multicentre , randomized , open-label study , patients with moderate-to-severe plaque psoriasis received etanercept 50 mg BIW for 12 weeks , and then were randomized to etanercept 50 mg BIW or 50 mg QW plus topical agent as needed to achieve static physician global assessment ( sPGA ) status of clear for 12 weeks .


Endpoints included percentage change in Psoriasis Area and Severity Index ( PASI ) score from week 12 to week 24 ( primary endpoint ) ; proportion of patients achieving 50 % improvement in ( PASI 50 ) , PASI 75 and PASI 90 ; patients achieving sPGA of clear/almost clear ; and change in affected body surface area ( BSA ) .


Mean difference [ 95 % confidence interval ( CI ) ] between etanercept arm ( n = 140 ) and etanercept plus topical arm ( n = 142 ) in change in PASI score from week 12 to week 24 was 16.2 % ( -3.5 % , 35.8 % ) .


PASI response rates were similar between groups .


Percentage ( 95 % CI ) of patients achieving sPGA status of clear/almost clear was 40.6 % ( 32.5 % , 48.6 % ) and 45.8 % ( 37.6 % , 54.0 % ) at week 12 for patients in etanercept and etanercept plus topical arms , respectively , and 53.5 % ( 45.3 % , 61.7 % ) and 45.4 % ( 37.2 % , 53.6 % ) at week 24 .


Difference ( 95 % CI ) between groups in change in affected BSA from week 12 to week 24 was 4.9 % ( -23.4 % , 33.2 % ) .


Patients who received etanercept 50 mg QW at week 12 plus as-needed topical therapy and those who stayed on etanercept 50 mg BIW maintained clinical response through week 24 with no notable differences in PASI responses .


Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete , particularly for patients with more advanced-stage disease .


To determine whether laparoscopic resection is noninferior to open resection , as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen .


A multicenter , balanced , noninferiority , randomized trial enrolled patients between October 2008 and September 2013 .


The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada .


A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection .


Standard laparoscopic and open approaches were performed by the credentialed surgeons .


The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm , distal margin without tumor , and completeness of total mesorectal excision .


A 6 % noninferiority margin was chosen according to clinical relevance estimation .


Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled .


Successful resection occurred in 81.7 % of laparoscopic resection cases ( 95 % CI , 76.8 % -86.6 % ) and 86.9 % of open resection cases ( 95 % CI , 82.5 % -91.4 % ) and did not support noninferiority ( difference , -5.3 % ; 1-sided 95 % CI , -10.8 % to ; P for noninferiority = .41 ) .


Patients underwent low anterior resection ( 76.7 % ) or abdominoperineal resection ( 23.3 % ) .


Conversion to open resection occurred in 11.3 % of patients .


Operative time was significantly longer for laparoscopic resection ( mean , 266.2 vs 220.6 minutes ; mean difference , 45.5 minutes ; 95 % CI , 27.7-63 .4 ; P < .001 ) .


Length of stay ( 7.3 vs 7.0 days ; mean difference , 0.3 days ; 95 % CI , -0.6 to 1.1 ) , readmission within 30 days ( 3.3 % vs 4.1 % ; difference , -0.7 % ; 95 % CI , -4.2 % to 2.7 % ) , and severe complications ( 22.5 % vs 22.1 % ; difference , 0.4 % ; 95 % CI , -4.2 % to 2.7 % ) did not differ significantly .


Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete ( 77 % ) and nearly complete ( 16.5 % ) in 93.5 % of the cases .


Negative circumferential radial margin was observed in 90 % of the overall group ( 87.9 % laparoscopic resection and 92.3 % open resection ; P = .11 ) .


Distal margin result was negative in more than 98 % of patients irrespective of type of surgery ( P = .91 ) .


Among patients with stage II or III rectal cancer , the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes .


Pending clinical oncologic outcomes , the findings do not support the use of laparoscopic resection in these patients .


clinicaltrials.gov Identifier : NCT00726622 .


To investigate the effect of intracervical and intravaginal application of seminal plasma on the endometrium , as assessed by endometrial/subendometrial vascularization and endometrial volume between the day of oocyte retrieval and the day of embryo transfer in an in-vitro fertilization/intracytoplasmic sperm injection ( IVF/ICSI ) cycle .


This was a double-blind , placebo-controlled , randomized study including patients undergoing a first or second IVF/ICSI cycle .


Homologous seminal plasma or placebo ( sodium chloride ) was injected into the cervix and posterior vaginal fornix just after follicle aspiration .


Three-dimensional power Doppler examination was performed 30min before oocyte retrieval and 30min before embryo transfer .


Main outcome measures were changes in vascularization flow index ( VFI ) , flow index ( FI ) and vascularization index ( VI ) of the endometrium/subendometrium using VOCAL ( Virtual Organ Computer-aided AnaLysis ) and endometrial volume .


One hundred patients agreed to participate in the study .


Twenty-three patients were excluded , mainly as a result of canceled embryo transfer .


Data were analyzed from 40 patients receiving seminal plasma and 37 receiving placebo .


No significant differences between the two groups were seen in VFI , FI or VI of the endometrium or subendometrium or in endometrial volume on the day of oocyte pick-up and on the day of embryo transfer .


Neither endometrial/subendometrial vascularization parameters nor endometrial volume seem to be affected by the application of seminal plasma in patients undergoing their first or second IVF/ICSI cycle .


To assess the efficacy and safety of lifitegrast ophthalmic solution 5.0 % compared with placebo in subjects with dry eye disease .


Prospective , randomized , double-masked , placebo-controlled , parallel arm , multicenter clinical trial .


A total of 588 adult subjects with dry eye disease .


Eligible subjects were randomized 1:1 to receive topically administered lifitegrast ( 5.0 % ) or placebo ( vehicle ) twice daily for 84 days after a 14-day open-label placebo run-in period .


After enrollment ( day 0 ) , subjects were evaluated at days 14 , 42 , and 84 .


Key objective ( fluorescein and lissamine staining scores [ Ora scales ] ) and subjective ( Ocular Surface Disease Index [ OSDI ] , 7-item visual analog scale , and ocular discomfort score [ Ora scale ] ) measures were assessed at all visits .


The primary objective efficacy measure ( sign ) was mean change from baseline inferior corneal staining score ( ICSS ) at day 84 .


The co-primary subjective efficacy measure ( symptom ) was the mean change from baseline in the visual-related function subscale score of the Ocular Surface Disease Index ( VR-OSDI ) .


Supportive measures included corneal fluorescein scores ( superior , central , total region ) and conjunctival lissamine scores ( nasal , temporal , total region ) and symptom scores at day 84 .


The study met the primary objective efficacy ICSS end point in demonstrating superiority of lifitegrast compared with placebo ( P = 0.0007 ) .


Lifitegrast significantly reduced corneal fluorescein staining ( superior , P = 0.0392 ; total cornea , P = 0.0148 ) and conjunctival lissamine staining ( nasal , P = 0.0039 ; total conjunctiva , P = 0.0086 ) at day 84 versus placebo .


Significant ( P < 0.05 ) improvements in nasal and total lissamine scores were observed at day 14 and maintained through day 84 .


The study did not meet the co-primary subjective VR-OSDI measure ( P = 0.7894 ) .


However , significant improvements were observed at day 84 in ocular discomfort ( P = 0.0273 ) and eye dryness ( P = 0.0291 ) , the most common and severe symptoms reported at baseline in both groups .


There were no unanticipated or serious ocular adverse events ( AEs ) .


The most frequent reported ocular AEs were transient intermittent instillation site symptoms ( irritation , discomfort ) primarily on the initial lifitegrast dose at day 0 .


Lifitegrast ophthalmic solution 5.0 % significantly reduced corneal fluorescein and conjunctival lissamine staining and improved symptoms of ocular discomfort and eye dryness compared with placebo when administered twice daily over 84 days .


The objectives of this study were to assess whether 25 g/d lupin protein , integrated into a mixed diet , might affect cardiovascular risk factors and whether l-arginine was responsible for these effects .


Seventy-two hypercholesterolemic subjects participated in the randomized , controlled , double-blind three-phase crossover study .


They were assigned to three diets with 25 g/d lupin protein ( LP ) , milk protein ( MP ) or milk protein plus 1.6 g/d arginine ( MPA ) each for 28 d in a random order interrupted by 6-week washout periods .


Lupin protein and the comparator milk protein were incorporated into complex food products ( bread , roll , sausage , and vegetarian spread ) .


Arginine was administered via capsules .


Sixty-eight subjects were included in final analyses .


Compared with MP , LDL cholesterol was significantly lower after LP .


Compared with MP and MPA , homocysteine was significantly lower after LP .


Compared with baseline , concentrations of total , LDL , and HDL cholesterol significantly decreased after LP and MPA .


Triacylglycerols and uric acid significantly decreased after LP .