Our previous randomized , clinical trial showed that postoperative tight glycemic control ( TGC ) for children undergoing cardiac surgery did not reduce the rate of health care-associated infections compared with standard care ( STD ) .


Heterogeneity of treatment effect may exist within this population .


We performed a post hoc exploratory analysis of 980 children from birth to 36 months of age at the time of cardiac surgery who were randomized to postoperative TGC or STD in the intensive care unit .


Significant interactions were observed between treatment group and both neonate ( age 30 days ; P = 0.03 ) and intraoperative glucocorticoid exposure ( P = 0.03 ) on the risk of infection .


The rate and incidence of infections in subjects 60 days old were significantly increased in the TGC compared with the STD group ( rate : 13.5 versus 3.7 infections per 1000 cardiac intensive care unit days , P = 0.01 ; incidence : 13 % versus 4 % , P = 0.02 ) , whereas infections among those > 60 days of age were significantly reduced in the TGC compared with the STD group ( rate : 5.0 versus 14.1 infections per 1000 cardiac intensive care unit days , P = 0.02 ; incidence : 2 % versus 5 % , P = 0.03 ) ; the interaction of treatment group by age subgroup was highly significant ( P = 0.001 ) .


Multivariable logistic regression controlling for the main effects revealed that previous cardiac surgery , chromosomal anomaly , and delayed sternal closure were independently associated with increased risk of infection .


This exploratory analysis demonstrated that TGC may lower the risk of infection in children > 60 days of age at the time of cardiac surgery compared with children receiving STD .


Meta-analyses of past and ongoing clinical trials are necessary to confirm these findings before clinical practice is altered .


http://www.clinicaltrials.gov .


Unique identifier : NCT00443599 .


Recent studies have shown a decline in glomerular filtration rate and increased renal vasoconstriction after administration of normal saline when compared with IV solutions with less chloride .


In this study , we investigated the impact of normal saline versus a chloride-reduced , acetate-buffered crystalloid on the incidence of hyperkalemia during cadaveric renal transplantation .


The incidence of metabolic acidosis and kidney function were secondary aims .


In this prospective randomized controlled trial , 150 patients received normal saline or an acetate-buffered balanced crystalloid during and after cadaveric renal transplantation .


Venous blood gases were obtained at the start of anesthesia and every 30 minutes until discharge from the postoperative surveillance unit .


Serum creatinine and 24-hour urine output were obtained on postoperative days 1 , 3 , and 7 .


Patients received a similar amount of fluid ( median : 2625mL [ interquartile range : 2000 to 3100 ] vs 2500 mL [ 2000 to 3050 ] , P = 0.83 ) .


Hyperkalemia , defined as serum potassium > 5.9 mmol/L , occurred in 13 patients ( 17 % ) in the saline and 15 ( 21 % ) in the balanced group ( P = 0.56 ; difference between proportions -0.037 [ -16.5 % to 8.9 % ] ) .


Minimum base excess was lower in the saline group compared with the balanced regimen ( -4.5 mmol/L [ -6 to -2.4 ] vs -2.6 mmol/L [ -4 to -1 ] , P < 0.001 ) and maximum chloride was significantly higher in the saline group ( 109 mmol/L [ 107 to 111 ] vs 107 mmol/L [ 105 to 109 ] , P < 0.001 ) .


No difference in creatinine or urine output was seen postoperatively .


Significantly more patients needed catecholamines in the saline group ( 30 % vs 15 % , P = 0.03 ) .


The incidence of hyperkalemia differed by less than 17 % between groups .


Use of balanced crystalloid resulted in less hyperchloremia and metabolic acidosis .


Significantly more patients in the saline group required administration of catecholamines for circulatory support .


To examine changes in intake across food groups during a weight loss trial that produced significant and sustainable weight loss in lactating women receiving dietary treatment .


At 10-14 wk postpartum , 61 overweight and obese lactating Swedish women were randomized to a 12-wk dietary ( D ) , exercise ( E ) , combined ( DE ) , or control ( C ) treatment .


Food intake was assessed by 4-d weighed diet records which were used to examine changes in intake across seven food groups from baseline to 12 wk and 1 y after randomization .


Differences in changes in food choice between women receiving dietary treatment ( D+DE ) and no dietary treatment ( E+C ) were examined using multivariate linear regression .


At baseline , sweets and salty snacks contributed to 2110 percent of total energy intake ( E % ) .


During the intervention period , women receiving dietary treatment reduced their E % from sweets and salty snacks and caloric drinks and increased their E % from vegetables more than did women not receiving dietary treatment ( all P < 0.010 ) .


At 1 y , the increased E % from vegetables was maintained significantly higher among women receiving dietary treatment ( P = 0.002 ) .


Lactating women receiving dietary treatment achieved sustainable weight loss through changes in food choice in line with current dietary guidelines .


Suspected coronary artery disease ( CAD ) is one of the most common , potentially life-threatening diagnostic problems clinicians encounter .


However , no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients .


The PROMISE study is a prospective , randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD .


Patients are randomized to either ( 1 ) functional testing ( exercise electrocardiogram , stress nuclear imaging , or stress echocardiogram ) or ( 2 ) anatomical testing with 64-slice multidetector coronary computed tomographic angiography .


Tests are interpreted locally in real time by subspecialty certified physicians , and all subsequent care decisions are made by the clinical care team .


Sites are provided results of central core laboratory quality and completeness assessment .


All subjects are followed up for 1 year .


The primary end point is the time to occurrence of the composite of death , myocardial infarction , major procedural complications ( stroke , major bleeding , anaphylaxis , and renal failure ) , or hospitalization for unstable angina .


More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology , radiology , primary care , urgent care , and anesthesiology sites .


Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient .


The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD .


Quality of life , resource use , cost-effectiveness , and radiation exposure will be assessed .


Tolvaptan is a selective vasopressin receptor antagonist ( V2R ) that increases free water excretion .


We wanted to test the hypotheses that tolvaptan changes both renal handling of water and sodium and systemic hemodynamics during basal conditions and during nitric oxide ( NO ) - inhibition with L-NG-monomethyl-arginine ( L-NMMA ) .


Nineteen healthy subjects were enrolled in a randomized , placebo-controlled , double-blind , crossover study of two examination days .


Tolvaptan 15 mg or placebo was given in the morning .


L-NMMA was given as a bolus followed by continuous infusion during 60 minutes .


We measured urine output ( UO ) , free water clearance ( CH2O ) , fractional excretion of sodium ( FENa ) , urinary aquaporin-2 channels ( u-AQP2 ) and epithelial sodium channels ( u-ENaC ) , plasma vasopressin ( p-AVP ) , central and brachial blood pressure ( cBP , bBP ) .


During baseline conditions , tolvaptan caused a significant increase in UO , CH2O and p-AVP , and FENa was unchanged .


During L-NMMA infusion , UO and CH2O decreased more pronounced after tolvaptan than after placebo ( -54 vs.-42 % and -34 vs.-9 % respectively ) .


U-AQP2 decreased during both treatments , whereas u-ENaC decreased after placebo and increased after tolvaptan .


CBP and bBP were unchanged .


During baseline conditions , tolvaptan increased renal water excretion .


During NO-inhibition , the more pronounced reduction in renal water excretion after tolvaptan indicates that NO promotes water excretion in the principal cells , at least partly , via an AVP-dependent mechanism .


The lack of decrease in u-AQP2 by tolvaptan could be explained by a counteracting effect of increased plasma vasopressin .


The antagonizing effect of NO-inhibition on u-ENaC suggests that NO interferes with the transport via ENaC by an AVP-dependent mechanism .


To assess whether shared medical appointments ( SMAs ) for neuromuscular patients represent a way of using clinicians ' time efficiently without compromising quality of care for patients .


Patients with a chronic neuromuscular disease ( NMD ) ( n = 272 ) were randomly allocated to either an SMA or a regular individual annual appointment and followed up for a period of 6 months .


Data on resource utilization and quality of life ( EQ-5D ) were collected prospectively , using a health care perspective .


Incremental costs and changes in quality-adjusted life-years ( QALYs ) were computed using a probabilistic decision model .


Factors critical to the incremental cost-effectiveness of SMAs were explored in sensitivity analyses .


No substantial differences between SMAs and individual visits in terms of costs per QALY were found ( incremental cost-effectiveness ratio -960.00 ; 95 % confidence interval -34,600.00 , +36,800.00 ) .


Sensitivity analyses showed that the cost-effectiveness ratio was particularly sensitive to SMA group size and proportion of patients seeing their treating neurologist .


Cost-effectiveness of SMAs did not show a significant difference vs that of individual appointments based on data from our randomized controlled trial .


On the other hand , we were able to show that a minimum of 6 patients per SMA and 75 % of patients attending their treating neurologist are specific conditions under which SMAs qualify as a cost-effective alternative .


This implies that SMAs may be a means to increase productivity of the physician without compromising quality of care .


This study provides Class III evidence that SMAs are not significantly more cost-effective than individual appointments for patients with NMDs .


The study lacks the precision to exclude important differences in cost-effectiveness between SMAs and individual appointments .


Non-adjuvanted seasonal influenza vaccines show only modest efficacy in young children .


This study compared the immunogenicity , reactogenicity and safety of the MF59-adjuvanted trivalent subunit vaccine ( aTIV ) with two non-adjuvanted trivalent vaccines , TIV-1 , the non-adjuvanted version of aTIV , and TIV-2 , a split virion vaccine .


6078 children received two doses of aTIV ( n = 3125 ) , TIV-1 ( n = 1479 ) , or TIV-2 ( n = 1474 ) four weeks apart ( Days 1 and 29 ) .


Children aged 6 to < 36 months and 36 to < 72 months received 0.25 mL and 0.50 mL doses , respectively .


Immunogenicity was assessed by hemagglutination inhibition ( HI ) assay ( n = 2435 ) on Days 1 , 29 , 50 and 209 .


Safety was assessed up to Day 394 .


After the second vaccination ( Day 50 ) , the aTIV group showed significantly higher geometric mean HI titers and seroconversion rates than the TIV-1 or TIV-2 groups against all homologous and heterologous strains .


The difference was enhanced at HI titers 110 .


aTIV elicited a faster , more persistent antibody response , with significantly higher titers in the aTIV group after one vaccination ( Day 29 ) and after six months ( Day 209 ) than in either TIV group .


aTIV was more reactogenic than were TIV-1 and TIV-2 but rates of severe adverse events were very low for all three vaccines .


In infants and young children , the MF59-adjuvanted vaccine induced substantially faster ( after one dose ) , higher , persistent HI titers than the non-adjuvanted vaccines , with consistently higher seroprotection rates at increased threshold HI titers .


This trial is registered at clinicaltrials.gov : NCT01346592 .


When patients with type 2 diabetes start their first injectable therapy , clinicians can choose between glucagon-like peptide-1 ( GLP-1 ) receptor agonists and basal insulins .


In DURATION-3 , exenatide once weekly was compared with insulin glargine ( henceforth , glargine ) as first injectable therapy .


Here , we report the results of the final 3-year follow-up .


DURATION-3 was an open-label randomised trial done between May 13 , 2008 , and Jan 30 , 2012 .


Patients with type 2 diabetes aged 18 years or older were enrolled at 72 sites worldwide .


They were eligible when they had suboptimum glycaemic control ( HbA1c 7.1-11 .0 % [ 54-97 mmol/mol ] ) despite maximum tolerated doses of metformin alone or with a sulfonylurea for at least 3 months , a stable bodyweight for at least 3 months , and a BMI of 25-45 kg/m ( 2 ) ( 23-45 kg/m ( 2 ) in South Korea and Taiwan ) .


Patients were randomly assigned ( 1:1 ) by computer-generated random sequence with an interactive voice-response system ( block size four , stratified by country and concomitant therapy ) to once-weekly exenatide ( 2 mg subcutaneous injection ) or once-daily glargine ( titrated to target ) to be given in addition to their existing oral glucose-lowering regimens .


The primary efficacy measure at 3 years was change in HbA1c from baseline in patients given at least one dose of the assigned drug ( ie , analyses by modified intention to treat ) .


Patients , investigators , and data analysts were not masked to treatment assignment .


This trial is registered with ClinicalTrials.gov , number NCT00641056 .


456 patients underwent randomisation and received at least one dose of the assigned drug ( 233 given exenatide , 223 glargine ) .


At 3 years , least-squares mean HbA1c change was -1.01 % ( SE 0.07 ) in the exenatide group versus -0.81 % ( 0.07 ) in the glargine group ( least-squares mean difference -0.20 % , SE 0.10 , 95 % CI -0.39 to -0.02 ; p = 0.03 ) .


Transient gastrointestinal adverse events characteristic of GLP-1 receptor agonists were more frequent with exenatide than glargine ( nausea : 36 [ 15 % ] of 233 patients vs five [ 2 % ] of 223 ; vomiting : 15 [ 6 % ] vs six [ 3 % ] ; diarrhoea : 32 [ 14 % ] vs 15 [ 7 % ] ) , although frequency of these events did decrease after week 26 in the exenatide group .


The proportion of patients who reported serious adverse events in the exenatide group ( 36 patients [ 15 % ] ) was the same as that in the glargine group ( 33 [ 15 % ] ) .


The exposure-adjusted rate of overall hypoglycaemia was three times higher in patients given glargine ( 0.9 events per patient per year ) than in those given exenatide ( 0.3 events per patient per year ) .


Efficacy of once-weekly exenatide is sustained for 3 years .


GLP-1 receptor agonists could be a viable long-term injectable treatment option in patients with type 2 diabetes who have not yet started taking insulin .


Amylin Pharmaceuticals and Eli Lilly .


In the major trials of cardiac resynchronization therapy ( CRT ) , the survival benefit of the therapy , relative to control subjects , increases with QRS duration .


In the non-CRT heart failure population , however , a wide QRS duration is associated with a shorter survival .


Relative survival benefit from a therapy , however , is not synonymous with a longer absolute survival .


We sought to determine whether baseline QRS duration relates to the absolute survival after CRT .


In this prospective , longitudinal , observational study , 3,319 consecutive patients undergoing CRT ( QRS 120-149 ms 26 % , QRS 150-199 ms 58 % , and QRS 200 ms 16 % ) were assessed in relation to mortality over 10 years .


Overall mortality rates ( per 100 patient-years ) were 9.2 % , 9.3 % , and 13.3 % in the 3 groups , respectively ( all P < .001 ) .


Cardiac mortality rates were 6.2 , 6.0 , and 9.9 per 100 patient-years , respectively ( all P < .001 ) .


Compared with the QRS 120-149 ms group , cardiac mortality was highest in the QRS 200 ms group ( hazard ratio [ HR ] 1.72 [ 95 % CI 1.35-2 .19 ] , P < .001 ) , independent of age , gender , New York Heart Association class , presence of atrial fibrillation , heart failure etiology , and left ventricular ejection fraction .


Median survival after CRT was longest in patients with a width of QRS 120-149 ms and shortest in patients with a QRS 200 ms ( P < .001 ) .


In multivariable analyses , a QRS 200 ms emerged as a powerful independent predictor of both overall ( HR 1.44 [ 95 % CI 1.07-1 .94 ] , P = .017 ) and cardiac mortality ( HR 1.59 [ 95 % CI 1.14-2 .24 ] , P = .007 ) .


At long-term follow-up , absolute overall and cardiac survival after CRT is similar in patients with a preimplant QRS duration of 120 to 149 ms and 150 to 199 ms but markedly shorter in patients with a QRS 200 ms.


To compare the clinical efficacy in the treatment of allergic rhinitis ( AR ) of lung qi deficiency and cold syndrome between Jin 's three-needle therapy and western medication .


Sixty-six patients were randomized into an acupuncture group and a western medication group , 33 cases in each one .


In the acupuncture group , acupuncture was applied at three-nose points [ Yingxiang ( LI 20 ) , Shangyingxiang ( EX-HN 8 ) and Yintang ( GV 29 ) ; Cuanzhu ( BL 2 ) was added for frontal headache ] and three-back points [ Dazhu ( BL 11 ) , Fengmen ( BL 12 ) and Feishu ( BL 13 ) ] , once every day .


Ten treatments made one session .


Two sessions of treatment were required .


In the western medication group , desloratadine oral suspension was prescribed , 5 mg each time , once a day , for 20 days .


The scores of the symptoms and physical signs in AR patients as well as the clinical efficacy were observed between the two groups .


The total effective rate was 93.9 % ( 31/33 ) in the acupuncture group , which was better than 72.7 % ( 24/33 ) in the western medication group ( P < 0.05 ) .


After treatment , the scores of AR symptoms and physical signs as well as the total score were all reduced compared with those before treatment in the two groups ( all P < 0.01 ) .


The score of every item in the acupuncture group was lower than that in the western medication group after treatment ( score of symptoms : 4.70 + / - 2.07 vs 6.55 + / - 2.69 , score of physical signs : 0.85 + / - 0.67 vs 1.45 + / - +0.62 , total score : 5.36 + / - 2.70 vs 8.00 + / - 2.91 , all P < 0.01 ) .


Jin 's three-needle therapy achieves superior efficacy on AR of lung-qi deficiency and cold syndrome , which is better than desloratadine oral suspension .


To assess the efficacy of a psychoeducational intervention , Wide Awake Parenting ( WAP ) , to decrease symptoms of postnatal fatigue .


A randomized controlled trial .


Local government areas within the Australian state of Victoria .


Two hundred and two mothers were randomly allocated to either the professionally-led telephone support intervention ( n = 63 ) , self-directed written intervention ( n = 67 ) , or waitlist control ( n = 72 ) .


The professionally-led group received a workbook , home visit , and three telephone support calls .


The self-directed written group received the workbook only , and the control group received usual health care services .


Primary outcomes were symptoms of fatigue , depression , anxiety and stress , and health care beliefs and behaviors .


Mothers were followed up at 2 - and 6-weeks postintervention .


Mothers in the professionally-led group reported fewer symptoms of fatigue than mothers in the control condition at 6 weeks postintervention .


Mothers in either intervention had more positive attitudes toward their health - and self-care behaviors at postintervention and follow-up .


Mothers in the professionally-led intervention reported fewer symptoms of depression , anxiety , and stress than mothers in the other conditions at postintervention .


Wide Awake Parenting is effective in promoting mothers ' self-efficacy to prioritize , plan for , and engage in health and self-care behaviors to promote mental health and manage fatigue .


Implications and future opportunities for WAP are discussed .


Filgrastim or methionyl-granulocyte colony-stimulating factor ( Met-G-CSF ) , is a recombinant therapeutic protein widely used to treat severe neutropenia caused by myelosuppressive drugs in patients with nonmyeloid malignancies .


In addition to its role in the regulation of granulopoiesis , treatment with G-CSF is considered the standard approach to mobilize CD34 positive ( CD34 + ) mononuclear cells for reconstituting hemopoietic ability for bone marrow transplantation .


An intended biosimilar filgrastim ( coded BK0023 ) was produced in GMP conditions by E.coli fermentation according to an original recombinant process and showed physico-chemical properties and purity profile similar to Neupogen , a commercial preparation of filgrastim .


The aim of the present study was to demonstrate the comparability of BK0023 to Neupogen in terms of both in vitro biological activities and in vivo toxicology , pharmacokinetics and pharmacodynamics .


Cell proliferation and radioligand binding assays were conducted in NFS-60 cells to compare the biological activity and functional interaction with the G-CSF receptor in vitro , while preclinical in vivo studies , including pharmacokinetics and pharmacodynamics after repeated dose were performed in normal and neutropenic rats .


A phase I study was carried out in healthy male volunteers treated by multiple-dose subcutaneous administration of BK0023 and Neupogen to evaluate their pharmacodynamic effects as well as their pharmacokinetic and safety profile and to demonstrate their pharmacodynamic equivalence and pharmacokinetic bioequivalence .


The results reported in this work demonstrate that BK0023 is comparable in terms of biological activity , efficacy and safety to Neupogen .


BK0023 has the same pharmacokinetic profile , efficacy and safety as the reference commercial filgrastim Neupogen and therefore could be further developed to become a convenient option to treat neutropenia in oncological patients .


Healthcare technologies and patient care have evolved rapidly .


Healthcare communication techniques and technologies have lagged .


This pilot study was conducted at Duke University Hospital to investigate the benefits of using smartphones among healthcare team members to promote efficient and effective patient care .


This study used a pre-post implementation survey with an educational intervention .


Teams ( physicians , patient resource managers , physician assistants , and nurses ) from medicine and surgery were randomly assigned a smartphone .


A validated 28-question survey was used to assess user experience ( 7-point Likert scale , with 7 indicating more reliable , strongly agree , and faster ) .


Participants were encouraged to attend focus groups to provide feedback on survey content and overall experience .


Facilitators used guiding questions and transcripts were used for qualitative analysis .


Eighty-nine matched pre - and postsurveys were analyzed .


Postimplementation data results declined for a majority of items , although remained favorable .


This suggests the reality of smartphone use did not live up to expectations but was still considered an improvement over the current paging system .


Differences by device and user were found , such as the iPhone being easier to use and the BlackBerry more professional ; nonphysicians were more concerned about training and the sterility of the device .


Themes elicited from focus groups included challenges of the current paging system , text message content , device ease of use and utility , service coverage , and professionalism .


Participants in this study recognized the benefit of using smartphones to reach team members in a timely and convenient manner while having access to beneficial applications .


Lessons were learned for future implementations with more favorable experiences for participants .


Perhaps most striking was the shared acknowledgment that the current system does n't work well and an understanding of why .


Cold hypersensitivity in the hands and feet ( CHHF ) is one of the most common complaints among Asians , especially in women .


Korean red ginseng ( KRG ) , which is a steamed form of Panax ginseng , has vasodilating action in the peripheral vessels and increases blood flow under cold stress .


However , few studies have evaluated the effect of KRG on cold hypersensitivity .


This trial is a randomized , double-blind , placebo-controlled trial in 80 CHHF patients .


The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul , Korea .


The participants will take KRG or a placebo for eight weeks , after which they will be followed-up for four weeks .


During the administration period , six capsules of 500 mg KRG or placebo will be provided twice a day .


The primary outcome is change of skin temperature in the hands between baseline and after treatment .


The secondary outcomes include the visual analogue scale scores of cold hypersensitivity in the hands , change of skin temperature and the VAS scores of cold hypersensitivity in the feet , the recovery rate of the skin temperature by the cold stress test of the hands , the distal-dorsal difference of the hands , power variables of heart rate variability , and the 36-item short form health survey .


This study is the first trial to evaluate the efficacy of KRG on CHHF by using infrared thermography .


Our study will provide basic evidence regarding CHHF .


CliniacalTrials.gov NCT01664156 .


Studies relating to the cardiovascular effects of glucagon-like peptide-1 ( GLP-1 ) and its agonists , which slow gastric emptying , have not discriminated between fasting and postprandial , blood pressure ( BP ) and heart rate ( HR ) .


To determine whether exogenous GLP-1 modulates the effects of an intraduodenal ( ID ) glucose infusion on BP , HR , and splanchnic blood flow in healthy older subjects .


A double-blind randomized trial was conducted .


Community-dwelling residents attended a clinical research laboratory .


Ten healthy `` older '' subjects ( 9 male , 1 female ; age 73.2 1.5 y ) were studied .


Intravenous infusion of GLP-1 ( 0.9 pmol/kg/min ) , or saline ( 0.9 % ) for 90 min ( t = -30 -60 min ) .


Between t = 0-60 min , ID glucose was infused at 3 kcal/min .


BP , HR , superior mesenteric artery ( SMA ) flow , blood glucose , and serum insulin were measured .


During the fasting period ( t = -30 -0 min ) , GLP-1 had no effect on BP or HR .


In response to ID glucose ( t = 0-60 min ) , systolic BP decreased ( P < .001 ) , and both HR ( P < .001 ) and SMA flow ( P < .05 ) increased , on both days .


GLP-1 attenuated the maximum decrease in systolic BP ( P < .05 ) , tended to increase HR ( P = .09 ) , and increased SMA flow ( P < .01 ) .


GLP-1 diminished the glycemic response ( P < .05 ) .


In healthy older subjects , acute administration of GLP-1 attenuates the hypotensive response to ID glucose , and potentiates the increase in SMA flow .


The objective of the paper is to understand leadership in an online community , specifically , Wikipedia .


Wikipedia successfully aggregates millions of volunteers ' efforts to create the largest encyclopedia in human history .


Without formal employment contracts and monetary incentives , one significant question for Wikipedia is how it organizes individual members with differing goals , experience , and commitment to achieve a collective outcome .


Rather than focusing on the role of the small set of people occupying a core leadership position , we propose a shared leadership model to explain the leadership in Wikipedia .


Members mutually influence one another by exercising leadership behaviors , including rewarding , regulating , directing , and socializing one another .


We conducted a two-phase study to investigate how distinct types of leadership behaviors ( transactional , aversive , directive , and person-focused ) , the legitimacy of the people who deliver the leadership , and the experience of the people who receive the leadership influence the effectiveness of shared leadership in Wikipedia .


Our results highlight the importance of shared leadership in Wikipedia and identify trade-offs in the effectiveness of different types of leadership behaviors .


Aversive and directive leadership increased contribution to the focal task , whereas transactional and person-focused leadership increased general motivation .


We also found important differences in how newcomers and experienced members responded to leadership behaviors from peers .


These findings extend shared leadership theories , contribute new insight into the important underlying mechanisms in Wikipedia , and have implications for practitioners who wish to design more effective and successful online communities .


The study objective was to assess the effectiveness of a turmeric - and sandal wood oil-containing cream [ Vicco ( ) turmeric cream ( VTC ) ; Vicco Laboratories , Parel , India ] on radiodermatitis in patients with head and neck cancer undergoing radiotherapy .


A total of 50 patients with head and neck cancer requiring > 60 Gy of curative radiotherapy/chemoradiotherapy were enrolled in the study .


The volunteers were randomly divided into two groups of 25 patients .


Group 1 was assigned to a topical application of Johnson 's ( ) baby oil ( Johnson & Johnson Ltd , Baddi , India ) and Group 2 for VTC .


Prophylactic application of the cream was initiated on Day 1 and continued every day until 2 weeks after the end of treatment .


Both agents were symmetrically applied within the irradiated field five times a day , and the acute skin reactions were assessed twice weekly in accordance with the Radiation Therapy Oncology Group scores by an investigator who was unaware of the details .


The incidence of radiodermatitis increased with the exposure to radiation and was the highest in both groups at Week 7 .


However , a significant reduction in grades of dermatitis were seen in cohorts applying VTC at all time points , including 2 weeks post radiotherapy ( p < 0.015 to p < 0.001 ) .


The occurrence of Grade 3 dermatitis was lower in the cohorts using VTC and was statistically significant ( p < 0.01 ) .


Additionally , follow-up observations 2 weeks after the completion of radiotherapy also showed a reduced degree of radiodermatitis in cohorts applying VTC , which was significant ( p = 0.015 ) .


VTC is shown to be effective in preventing radiodermatitis and needs to be validated in larger double-blind trials .


For the first time , this study shows that the turmeric - and sandal oil-based cream was effective in preventing radiation-induced dermatitis .


Pemetrexed and erlotinib have been approved as second-line monotherapy for locally advanced or metastatic non-small cell lung cancer ( NSCLC ) .


This multicentre , randomised , open-label , parallel phase II study assessed efficacy and safety of pemetrexed versus pemetrexed + erlotinib in patients with advanced non-squamous NSCLC .


NSCLC stage III-IV patients who failed one prior platinum-based chemotherapy regimen , 1 measurable lesion by Response Evaluation Criteria in Solid Tumors , and Eastern Cooperative Oncology Group performance status 2 were eligible .


Patients received pemetrexed 500 mg/m ( 2 ) with vitamin B12 and folic acid q3w alone or combined with erlotinib 150 mg daily .


The primary end-point was progression-free survival ( PFS ) .


Secondary end-points were overall survival ( OS ) , time-to-treatment failure ( TTTF ) , response and toxicity .


Of 165 randomised non-squamous patients , 159 were treated ( pemetrexed : 83 ; pemetrexed + erlotinib : 76 ) .


The median PFS ( months ; 95 % CI ) was 2.89 ( 1.94 , 3.38 ) for pemetrexed versus 3.19 ( 2.86 , 4.70 ) for pemetrexed + erlotinib ( hazard ratio [ HR ] 0.63 ; 95 % CI : ( 0.44 , 0.90 ) ; P = 0.0047 ) .


The median OS ( months ; 95 % CI ) was 7.75 ( 5.29 , 10.41 ) for pemetrexed versus 11.83 ( 8.18 , 16.66 ) for pemetrexed + erlotinib ( HR : 0.68 ; 95 % CI : 0.46 , 0.98 ; P = 0.019 ) .


The median TTTF ( months : 95 % CI ) was 2.4 ( 1.74 , 2.99 ) for pemetrexed versus 3.0 ( 2.23 , 4.07 ) for pemetrexed + erlotinib ( HR 0.64 ; 95 % CI : 0.46 , 0.89 ; P = 0.0034 ) .


One patient died in pemetrexed + erlotinib arm due to febrile neutropenia .


Grades 3/4 drug-related toxicities ( in 5 % of patients ) in pemetrexed/pemetrexed + erlotinib were febrile neutropenia ( 2.4 % / 10.5 % ) , diarrhoea ( 1.2 % / 5.3 % ) , rash ( 1.2 % / 9.2 % ) ; anaemia ( 6 % / 11.8 % ) , leukopenia ( 9.6 % / 23.7 % ) , neutropenia ( 9.6 % / 25.0 % ) , and thrombocytopenia ( 4.8 % / 14.5 % ) .


Pemetrexed + erlotinib treatment significantly improved PFS , OS and TTTF in 2nd line non-squamous NSCLC and was associated with an increase in grade 3/4 toxicities compared with pemetrexed alone .


To determine the efficacy of oral zinc for treatment of idiopathic neonatal hyperbilirubinemia in near-term and term ( 35-41 weeks ) neonates .


Randomized placebo-controlled trial .


Tertiary-care teaching hospital .


Eighty newborns with idiopathic neonatal hyperbilirubinemia .


Neonates were randomized to receive either oral zinc sulfate ( 10 mg/d ) or placebo for 7 days .


Primary : total serum bilirubin levels at 48 ( 12 ) h , 96 ( 12 ) h and 144 ( 12 ) h after intervention .


Secondary : duration of phototherapy , and serum zinc and copper levels .


Baseline mean ( SD ) total serum bilirubin levels were 14.8 ( 3.8 ) and 14.4 ( 3.5 ) mg/dL in zinc and placebo groups , respectively .


No significant differences were observed in total bilirubin levels between the two groups after the intervention .


Mean ( SD ) total serum bilirubin levels in zinc and placebo groups were 13.9 ( 2.5 ) vs. 13.4 ( 1.9 ) mg/dL ( mean difference 0.566 ; 95 % CI -0.535 , 1.668 , P = 0.038 ) at 48 h , 13.1 ( 2.7 ) vs. 12.8 ( 2.3 ) mg/dL ( mean difference 0.234 ; 95 % CI -1.011 , 1.479 , P = 0.708 ) at 96 h and 8.0 ( 2.0 ) vs. 8.6 ( 1.2 ) mg/dL ( mean difference -0.569 , 95 % CI -1.382 , 0.242 , P = 0.166 ) at 144 h. Although the mean duration of phototherapy in the zinc group was less by 21.3 h ( 95 % CI 11.6 , 30.9 , P = 0.052 ) , the difference was not significant .


Post-intervention , serum zinc levels were significantly higher in the zinc-supplemented group while serum copper levels were comparable between the two groups .


Oral zinc sulfate , in a dose of 10 mg/day , is not effective in the management of idiopathic neonatal hyperbilirubinemia .


Enteral nutrition is one of the major risk factors for ventilator-associated pneumonia .


Abdominal massage is assumed to prevent the development of ventilator-associated pneumonia by reducing residual gastric volume .


To identify the effect of abdominal massage administered to critically ill patients with mechanical ventilation and continuous enteral feeding on the development of ventilator-associated pneumonia .


A randomized controlled design was used in this study .


This study was performed in a critical care unit of a university hospital in Turkey .


The sample of the study consisted of a total of 32 patients , selected randomly to receive abdominal massage ( n = 16 ) and a control group ( n = 16 ) .


The stratified randomization was used in this study .


Patients were stratified according to age and gender .


A fifteen-minute abdominal massage was administered to the patients in the intervention group twice daily .


No intervention was administered to the patients in the control group .


At the end of monitoring days a reduction , compared to the control patients , was identified .


The amount of gastric residual volume and abdominal circumference measurement of the patients in the intervention group had decreased .


This reduction was found to be significant in the statistical analysis ( p < 0.05 ) .


Also , although not reaching the statistical significance level , ventilator-associated pneumonia decreased in the intervention group with a ratio of 6.3 % compared to the control group ( 31.3 % ) ( p > 0.05 ) .


This study revealed that abdominal massage administered to intubated and enterally fed patients reduced gastric residual volume and abdominal distension .


In addition , a decrease in the ratio of ventilator-associated pneumonia was determined .


To study the effect of case management on quality of life , caregiver strain , and perceived quality of care ( QOC ) in patients with amyotrophic lateral sclerosis ( ALS ) and their caregivers .


We conducted a multicenter cluster randomized controlled trial with the multidisciplinary ALS care team as the unit of randomization .


During 12 months , patients with ALS and their caregivers received case management plus usual care or usual care alone .


Outcome measures were the 40-item ALS Assessment Questionnaire ( ALSAQ-40 ) , Emotional Functioning domain ( EF ) ; the Caregiver Strain Index ( CSI ) ; and the QOC score .


These measures were assessed at baseline and at 4 , 8 , and 12 months .


Case management resulted in no changes in ALSAQ-40 EF , CSI , or QOC from baseline to 12 months .


ALSAQ-40 EF scores in both groups were similar at baseline and did not change over time ( p = 0.331 ) .


CSI scores in both groups increased significantly ( p < 0.0001 ) .


Patients with ALS from both groups rated their perceived QOC at baseline with a median score of 8 , which did not change significantly during follow-up .


Within the context of multidisciplinary ALS care teams , case management appears to confer no benefit for patients with ALS or their caregivers .


This study provides Class III evidence that case management in addition to multidisciplinary ALS care does not significantly improve health-related quality of life of patients with ALS .


Supraglottic airway devices such as the LMA-Supreme ( LMA-S ) and I-gel , which have an additional lumen for the insertion of a gastric tube , can be useful in the management of the difficult airway .


To test the performance of these two devices in the difficult paediatric airway .


Randomised double-blind study .


Anaesthesia department , university hospital .


Sixty American Society of Anesthesiologists ( ASA ) I-II children undergoing elective surgery .


After obtaining ethical approval and written informed consent from the parents , we compared the size 2 LMA-S with the I-gel in a simulated airway scenario made more difficult by using a cervical collar to limit mouth opening and neck movement .


The primary aim was to compare the oropharyngeal leak pressure of the LMA-S and the I-gel .


The secondary aims were to compare success rate , insertion time , time to pass a gastric tube and fibreoptic view of the larynx .


Oropharyngeal leak pressure ( meanSD ) for the LMA-S was significantly higher than with the I-gel ( 20.93.2 versus 18.93.2 cmH2O , P = 0.019 ) .


First attempt success rate for the LMA-S was 100 and 90 % for the I-gel ( P > 0.05 ) .


Insertion time of the LMA-S was shorter than I-gel ( 11.21.8 versus 13.52.4 s , P = 0.001 ) .


Gastric tube placement was possible in all patients .


The mean insertion time of the gastric tube was shorter with the LMA-S than with the I-gel ( 10.33.6 versus 12.73.2 s , P = 0.009 ) .


Fibreoptic laryngeal views were similar in both groups .


In the simulated difficult airway in children , both airway devices provided effective ventilation .


Paediatric size 2 LMA-S sustained a higher airway pressure before leaking and was quicker to insert than the I-gel equivalent .


These differences may not be clinically significant .


Little evidence exists for the effectiveness of therapy for children with receptive language difficulties , particularly those whose difficulties are severe and persistent .


To establish the effectiveness of explicit speech and language therapy with visual support for secondary school-aged children with language impairments focusing on comprehension of coordinating conjunctions in a randomized control trial with an assessor blind to group status .


Fourteen participants ( aged 11 ; 3-16 ; 1 ) with severe RELI ( mean standard scores : CELF4 ELS = 48 , CELF4 RLS = 53 and TROG-2 = 57 ) , but higher non-verbal ( Matrices = 83 ) and visual perceptual skills ( Test of Visual Perceptual Skills ( TVPS ) = 86 ) were randomly assigned to two groups : therapy versus waiting controls .


In Phase 1 , the therapy group received eight 30-min individual sessions of explicit teaching with visual support ( Shape Coding ) with their usual SLT .


In Phase 2 , the waiting controls received the same therapy .


The participants ' comprehension was tested pre - , post-Phase 1 and post-Phase 2 therapy on ( 1 ) a specific test of the targeted conjunctions , ( 2 ) the TROG-2 and ( 3 ) a test of passives .


After Phase 1 , the therapy group showed significantly more progress than the waiting controls on the targeted conjunctions ( d = 1.6 ) and overall TROG-2 standard score ( d = 1.4 ) .


The two groups did not differ on the passives test .


After Phase 2 , the waiting controls made similar progress to those in the original therapy group , who maintained their previous progress .


Neither group showed progress on passives .


When the two groups were combined , significant progress was found on the specific conjunctions ( d = 1.3 ) and TROG-2 raw ( d = 1.1 ) and standard scores ( d = 0.9 ) .


Correlations showed no measures taken ( including Matrices and TVPS ) correlated significantly with progress on the targeted conjunctions or the TROG-2 .


Four hours of Shape Coding therapy led to significant gains on comprehension of coordinating conjunctions which were maintained after 4 months .


Given the significant progress at a group level and the lack of reliable predictors of progress , this approach could be offered to other children with similar difficulties to the participants .


However , the intervention was delivered one-to-one by speech and language therapists , thus the effectiveness of this therapy method with other methods of delivery remains to be evaluated .


Few studies have used biomarkers of whole-grain intake to study its relation to glucose metabolism .


We aimed to investigate the association between plasma alkylresorcinols ( AR ) , a biomarker of whole-grain rye and wheat intake , and glucose metabolism in individuals with metabolic syndrome ( MetS ) .


Participants were 30-65 years of age , with body mass index 27-40 kg/m ( 2 ) and had MetS without diabetes .


Individuals were recruited through six centers in the Nordic countries and randomized to a healthy Nordic diet ( ND , n = 96 ) , rich in whole-grain rye and wheat , or a control diet ( n = 70 ) , for 18-24 weeks .


In addition , associations between total plasma AR concentration and C17 :0 / C21 :0 homolog ratio as an indication of the relative whole-grain rye intake , and glucose metabolism measures from oral glucose tolerance tests were investigated in pooled ( ND + control ) regression analyses at 18/24 weeks .


ND did not improve glucose metabolism compared with control diet , but the AR C17 :0 / C21 :0 ratio was inversely associated with fasting insulin concentrations ( P = 0.002 ) and positively associated with the insulin sensitivity indices Matsuda ISI ( P = 0.026 ) and disposition index ( P = 0.022 ) in pooled analyses at 18/24 weeks , even after adjustment for confounders .


The AR C17 :0 / C21 :0 ratio was not significantly associated with insulin secretion indices .


Total plasma AR concentration was not related to fasting plasma glucose or fasting insulin at 18/24 weeks .


The AR C17 :0 / C21 :0 ratio , an indicator of relative whole-grain rye intake , is associated with increased insulin sensitivity in a population with MetS .


To discuss the drug intervention in diversity changes of TCRVbeta gene in AIDS patients with incomplete immune reconstitution .


PBMCs were isolated from 37 cases of AIDS patients failure to immune reconstitution before and after treatment with Immune 2 and 15 cases of HIV negative healthy donors .


The human gene TCRVbeta CDR3 diversity quantitative detection reagent box were used , and mapped the distribution of gene scanning and calculated different CDR3 fragme of each Vbeta family size .


( 1 ) Gaussian distribution of TCRVbeta families in patients with incomplete immune reconstitution after one year of HAART , had been broken with the occurrence of the offset TCR lineage .


After six months of treatment of traditional Chinese medicine combined HAART , the TCR lineage has been partially restored .


( 2 ) Evaluated by the D ( distance ) value calculated by a quantitative analysis software which the kit provides , there were no significant difference in D value change between the two groups , but with traditional Chinese medicine can reduce the data variability .


( 3 ) CD4 + T cell counts had a significant correlation ( r = -0.772 , P = 0.000 ) with TCRVbeta genetic diversity .


Study of the mechanism showed oligoclonal of TCRVbeta family can get recovery in some degrees after treated by Immune 2 plus HAART , suggesting that the medicine may promote T-cell receptor gene rearrangement , helping immune cells to effectively identify the virus to reduce T-cell apoptosis .


Studies examining the efficacy of a single preoperative dose of gabapentin for analgesia after cesarean delivery ( CD ) have been inconclusive .


The authors hypothesized that a perioperative course of gabapentin would improve analgesia after CD .


This single-center , randomized , double-blind , placebo-controlled , parallel-group , superiority trial was designed to determine the analgesic efficacy of a perioperative course of gabapentin when added to a multimodal analgesic regimen .


Women scheduled for elective CD during spinal anesthesia were randomized to receive a perioperative oral course of either gabapentin ( 600mg preoperatively followed by 200mg every 8h for 2 days ) or placebo .


Postoperative pain was measured at 24 and 48h , at rest and on movement , on a visual analogue scale ( VAS , 0 to 100mm ) .


The primary outcome was pain on movement at 24h .


Neonatal outcomes , opiate consumption , VAS satisfaction ( 0 to 100mm ) , adverse effects , and persistent pain were also assessed .


Baseline characteristics were similar between groups .


There was a statistically significant but small reduction in VAS pain score ( mean [ 95 % CI ] ) on `` movement '' ( 40mm [ 36 to 45 ] vs. 47mm [ 42 to 51 ] ; difference , -7 mm [ -13 to 0 ] ; P = 0.047 ) at 24h in the gabapentin ( n = 100 ) compared with control group ( n = 97 ) .


There was more sedation in the gabapentin group at 24h ( 55 vs. 39 % , P = 0.026 ) but greater patient VAS satisfaction ( 87 vs. 77mm , P = 0.003 ) .


A perioperative course of gabapentin produces a clinically insignificant improvement in analgesia after CD and is associated with a higher incidence of sedation .


To evaluate the performance of the first years since the beginning of a mammographic population-based screening program .


Women aged 49-69 were invited biennially for two-view film-screen mammography and double reading without arbitration was performed .


Interval cancers ( ICs ) from 2001 to 2006 were identified using screening archives , local pathology archives , and hospital discharge records .


The proportional incidence of IC was determined considering breast cancers expected without screening .


Three offsite radiologists experienced in breast cancer screening blindly evaluated mammograms prior to diagnosis , randomly mixed with negative mammograms ( 1:2 ratio ) .


Cases unrecalled at review were considered as true ICs , those recalled by only one reviewer as minimal signs , and those recalled by two or three reviewers as missed cancers .


T and N stage of the reviewed ICs were evaluated and compared .


A total of 86,276 first level mammograms were performed .


Mean recall rate was 6.8 % at first and 4.6 % at repeat screening .


We had 476 screen-detected cancers and 145 ICs ( 10 of them ductal carcinomas in situ ) .


Absolute incidence was 17 per 10,000 screening examinations .


Invasive proportional incidence was 19 % ( 44/234 ) in the first year , 39 % ( 91/234 ) in the second year , and 29 % ( 135/468 ) in the two-year interval .


Of 145 ICs , 130 ( 90 % ) were reviewed mixed with 287 negative controls : 55 % ( 71/130 ) resulted to be true ICs , 24 % ( 31/130 ) minimal signs , and 22 % ( 28/130 ) missed cancers .


The rate of ICs diagnosed in the first year interval was 21 % ( 15/71 ) for true ICs , 46 % ( 13/28 ) for missed cancers , and 39 % ( 12/31 ) for minimal signs , with a significant difference of true ICs rate compared to missed cancers rate ( p = 0.012 ) .


A higher rate of T3 and T4 stages was found for missed cancers ( 18 % , 5/28 ) compared to minimal signs ( 6 % , 2/31 ) or true ICs ( 8 % , 6/71 ) , while the rate of N2 and N3 stage for both minimal signs ( 19 % , 6/31 ) or missed cancers ( 25 % , 7/28 ) was higher than that for true ICs ( 10 % , 7/71 ) , although all these differences were not significant ( p 0.480 ) .


These results showed the possibility to comply with European Community standards in the first years of a screening program implementation .


Proponents of single-incision laparoscopic surgery ( SILS ) claim patients have less pain , faster recovery , and better long-term cosmetic results than patients who undergo multiport laparoscopy .


However , randomized comparisons are lacking .


This study presents the results of a prospective randomized trial of SILS or 3-port laparoscopic appendectomy .


Adults with uncomplicated acute appendicitis were randomized 1:1 to either SILS or 3-port laparoscopic appendectomy .


The primary end point was early postoperative pain ( measured by opiate usage and pain score in the first 12 hours ) .


Secondary end points were operative time , complication rate ( including conversions ) , and recovery time ( days of oral opiate usage and return to work ) .


After 6 months , body image and cosmetic appearance were assessed using a validated survey .


The trial was planned for 150 patients , but was halted after 75 patients when planned interim analysis showed that SILS patients had more postoperative pain ( pain score : 4.4 1.6 vs 3.5 1.5 ; p = 0.01 ) and higher inpatient opiate usage ( hydromorphone use : 3.9 1.9 mg vs 2.8 1.7 mg ; p = 0.01 ) than 3-port laparoscopy .


Operative time for SILS averaged 40 % longer ( 54 17 minutes vs 38 11 minutes ; p < 0.01 ) .


Only 1 SILS case was converted to 3-port .


There were no significant differences in length of stay , complications , oral pain medication usage after discharge , or return to work .


After 6 months , body image and cosmetic appearance were excellent for both groups and indistinguishable by most measures .


However , 3-port patients reported better physical attractiveness ( 4.0 0.4 vs 3.8 0.4 ; p = 0.04 ) and SILS patients reported better scars ( score 18.4 2.7 vs 16.4 3.0 ; p < 0.01 ) .


Results are reported as mean SD .


Single-incision laparoscopic surgery appendectomy resulted in more pain and longer operative times without improving short-term recovery or complications .


Long-term body image and cosmetic appearance were excellent in both groups .


Primary hyperuricemia , an excess of uric acid in the blood , is a major public health problem .


In addition to the morbidity that is attributable to gout , hyperuricemia is also associated with metabolic syndrome , hypertension , and cardiovascular disease .


This study aims to assess the genetic associations between Apolipoprotein E ( APOE ) polymorphisms and hyperuricemia in a Chinese population .


A total of 770 subjects ( 356 hyperuricemic cases and 414 normouricemic controls ) were recruited from the Ningxia Hui Autonomous Region , China .


A physical examination was performed and fasting blood was collected for biochemical tests , including determination of the levels of serum lipid , creatinine , and uric acid .


Multi-ARMS PCR was applied to determine the APOE genotypes , followed by an investigation of the distribution of APOE genotypes and alleles frequencies in the controls and cases .


The frequencies of the APOE-23 genotype ( 17.70 % vs. 10.39 % , P = 0.003 ) and the APOE-2 allele ( 10.53 % vs. 5.80 % , P = 0.001 ) were significantly higher in the hyperuricemic group than in the normouricemic group .


Furthermore , male cases were more likely to have the APOE-23 genotype and APOE-2 allele , compared with male controls .


In both Han and Hui subjects , cases were more likely to have the APOE-23 genotype and the APOE-2 allele compared with controls .


Furthermore , multivariate logistic regression showed that carriers of the APOE-23 genotype ( P = 0.001 , OR = 2.194 ) and the 2 allele ( P = 0.001 , OR = 2.099 ) were significantly more likely to experience hyperuricemia than carriers of the 3/3 genotype and the 3 allele after adjustment for sex , body mass index ( BMI ) , diastolic blood pressure ( DBP ) , triglyceride ( TG ) , low density lipoprotein cholesterol ( LDL-C ) , creatinine ( Cr ) and fasting blood glucose ( FBG ) .


The APOE-23 genotype and the APOE-2 allele are associated with serum uric acid levels in Chinese subjects , indicating that individuals carrying the APOE-2 allele have a higher risk of hyperuricemia than non-carriers .


To investigate the clinical application of the fast track surgery ( FTS ) model based on preoperative nutritional risk screening ( NRS ) in patients with esophageal cancer .


180 patients with esophageal cancer who underwent surgery between January 2008 and April 2014 were randomly divided into study and control groups based on matched-pairs .


The study group underwent assessment using the NRS 2002 and received treatment before surgery and the control group was treated by the conventional method .


Postoperative indicators including time to first exsufflation , time to defecation , time to chest tube removal , hospitalization duration , and postoperative complications were examined after surgery .


Compared with the control group , the postoperative indicators including time to first exsufflation ( 88.42.76 vs 57.832.68 hours ) , time to first defecation ( 4.681.71 vs 3.281.34 days ) , time to chest tube removal ( 4.300.25 vs 2.700.33 days ) , postoperative hospitalization durations ( 11.711.39 vs 9.000.78 days ) , and total complication rate ( 18.9 % [ 17/90 ] vs 6.67 % [ 6/90 ] ) were all significantly reduced in the study group ( p < 0.05 ) .


The FTS model based on NRS can effectively promote postoperative rehabilitation of patients , reduce the incidence of postoperative complications , and shorten hospital stay .


A randomized , controlled clinical trial was conducted to compare the safety and whitening efficacy of high-adhesion tooth-whitening strips with a marketed in-office professional tooth-whitening system .


This open-label study was conducted in a private dental practice , and adult volunteers were assigned ( 2:1 ) to either 9.5 percent hydrogen-peroxide whitening strips ( Strip group ) or an in-office light plus 25 percent hydrogen-peroxide whitening gel treatment ( In-office group ) .


The Strip group was instructed to treat the maxillary arch once daily for 30 minutes over a 20-day period , while the In-office group underwent professional application of light plus whitening gel in a single office visit .


Whitening response was measured as change in yellowness ( b * ) and lightness ( L * ) at Day 21 using standardized digital images of the maxillary anterior teeth , while safety was assessed as tooth sensitivity and oral irritation occurrence .


A total of 45 subjects enrolled , were randomized , and received treatment ; 44 completed the study .


At Day 21 , significant improvement in b * and L * was noted in both groups ( P0 .001 ) .


The adjusted mean ( SE ) L * in the Strip group ( 1.72 ( 0.104 ) ) was significantly greater than that in the In-office group ( 1.17 ( 0.153 ) ) ( P = 0.005 ) .


Both test products were well tolerated .


Overall , both the strip and in-office treatments resulted in significant tooth whitening .


To evaluate the High Five for Kids intervention effect on television within subgroups , examine participant characteristics associated with process measures and assess perceived helpfulness of television intervention components .


High Five ( randomized controlled trial of 445 overweight/obese 2-7 year-olds in Massachusetts [ 2006-2008 ] ) reduced television by 0.36 h/day .


1-year effects on television viewing , stratified by subgroup , were assessed using linear regression .


Among intervention participants ( n = 253 ) , associations of intervention component helpfulness with television reduction were examined using linear regression and associations of participant characteristics with processes linked to television reduction ( choosing television and completing intervention visits ) were examined using logistic regression .


High Five reduced television across subgroups .


Parents of Latino ( versus white ) children had lower odds of completing 2 study visits ( Odds Ratio : 0.39 [ 95 % Confidence Interval : 0.18 , 0.84 ] ) .


Parents of black ( versus white ) children had higher odds of choosing television ( Odds Ratio : 2.23 [ 95 % Confidence Interval : 1.08 , 4.59 ] ) , as did parents of obese ( versus overweight ) children and children watching 2 h/day ( versus < 2 ) at baseline .


Greater perceived helpfulness was associated with greater television reduction .


Clinic-based motivational interviewing reduces television viewing in children .


Low cost education approaches ( e.g. , printed materials ) may be well-received .


Parents of children at higher obesity risk could be more motivated to reduce television .


To evaluate efficacy and safety of intravitreal aflibercept ( IVT-AFL ) in Japanese patients with wet age-related macular degeneration ( wAMD ) from the VIEW 2 trial .


In this double-masked study , patients were randomised to : 0.5 mg IVT-AFL every 4weeks ( 0.5 q4 ) ; 2mg IVT-AFL every 4weeks ( 2q4 ) ; 2mg IVT-AFL every 8weeks ( 2q8 ) after 3 monthly injections ; or 0.5 mg ranibizumab every 4weeks ( Rq4 ) .


Main efficacy outcomes included vision maintenance and best-corrected visual acuity ( BCVA ) at week 52 .


At week 52 , all Japanese patients in the IVT-AFL groups ( n = 70 ) maintained vision , compared with 96 % of Japanese patients ( n = 23/24 ) treated with ranibizumab .


Japanese patients in all treatment groups showed improvement in BCVA after treatment .


The Rq4 , 2q4 and 2q8 groups experienced similar gains in BCVA from baseline .


The 0.5 q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline .


Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude .


Ocular treatment-emergent adverse events were balanced across treatment groups .


IVT-AFL was effective and well tolerated in Japanese patients .


Outcomes in this population were consistent with those in the overall VIEW 2 population .


NCT00637377 .


Observational studies suggest a role for dietary nutrients such as vitamin E and selenium in cataract prevention .


However , the results of randomized clinical trials of vitamin E supplements and cataract have been disappointing and are not yet available for selenium .


To test whether long-term supplementation with selenium and vitamin E affects the incidence of cataract in a large cohort of men .


The Selenium and Vitamin E Cancer Prevention Trial ( SELECT ) Eye Endpoints Study was an ancillary study of the Southwest Oncology Group-coordinated SELECT , a randomized placebo-controlled 4-arm trial of selenium and vitamin E conducted among 35,533 men , 50 years and older for African American participants and 55 years and older for all other men , at 427 participating sites in the United States , Canada , and Puerto Rico .


A total of 11,267 SELECT participants from 128 SELECT sites participated in the SELECT Eye Endpoints ancillary study .


Individual supplements of selenium ( 200 g per day from L-selenomethionine ) and vitamin E ( 400 IU per day of all rac -- tocopheryl acetate ) .


Incident cataract was defined as a lens opacity , age related in origin , and responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review .


Cataract extraction was defined as the surgical removal of an incident cataract .


During a mean ( SD ) of 5.6 ( 1.2 ) years of treatment and follow-up , 389 cases of cataract were documented .


There were 185 cataracts in the selenium group and 204 in the no selenium group ( hazard ratio , 0.91 ; 95 % CI , 0.75-1 .11 ; P = .37 ) .


For vitamin E , there were 197 cases in the treated group and 192 in the placebo group ( hazard ratio , 1.02 ; 95 % CI , 0.84-1 .25 ; P = .81 ) .


Similar results were observed for cataract extraction .


These data from a large cohort of apparently healthy men indicate that long-term daily supplementation with selenium and/or vitamin E is unlikely to have a large beneficial effect on age-related cataract .


ClinicalTrials.gov Identifier : NCT00784225 .


The course of bipolar disorder progressively worsens in some patients .


Although responses to pharmacotherapy appear to diminish with greater chronicity , less is known about whether patients ' prior courses of illness are related to responses to psychotherapy .


Embedded in the Systematic Treatment Enhancement Program for Bipolar Disorder ( STEP-BD ) was a randomized controlled trial of psychotherapy for bipolar depression comparing the efficacy of intensive psychotherapy with collaborative care ( a three-session psycho-educational intervention ) .


We assessed whether the number of previous mood episodes , age of illness onset , and illness duration predicted or moderated the likelihood of recovery and time until recovery from a depressive episode in patients in the two treatments .


Independently of treatment condition , participants with one to nine prior depressive episodes were more likely to recover and had faster time to recovery than those with 20 or more prior depressive episodes .


Participants with fewer than 20 prior manic episodes had faster time to recovery than those with 20 or more episodes .


Longer illness duration predicted a longer time to recovery .


Participants were more likely to recover in intensive psychotherapy than collaborative care if they had 10-20 prior episodes of depression [ number needed to treat ( NNT ) = 2.0 ] , but equally likely to respond to psychotherapy and collaborative care if they had one to nine ( NNT = 32.0 ) or > 20 ( NNT = 9.0 ) depressive episodes .


Number of previous mood episodes and illness duration are associated with the likelihood and speed of recovery among bipolar patients receiving psychosocial treatments for depression .


This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer .


Patients in the COLOR II randomized trial , comparing laparoscopic and open surgery for rectal cancer , completed the European Organization for Research and Treatment of Cancer ( EORTC ) QLQ-CR38 questionnaire before surgery , and after 4weeks , 6 , 12 and 24months .


Adjusted mean differences on a 100-point scale were calculated using changes from baseline value at the various time points in the domains of sexual functioning , sexual enjoyment , male and female sexual problems , and micturition symptoms .


Of 617 randomized patients , 385 completed this phase of the trial .


Their mean age was 671years .


Surgery caused an anticipated reduction in genitourinary function after 4weeks , with no significant differences between laparoscopic and open approaches .


An improvement in sexual dysfunction was seen in the first year , but some male sexual problems persisted .


Before operation 645 per cent of men in the laparoscopic group and 556 per cent in the open group reported some degree of erectile dysfunction .


This increased to 811 and 805 per cent respectively 4weeks after surgery , and 763 versus 755 per cent at 12months , with no significant differences between groups .


Micturition symptoms were less affected than sexual function and gradually improved to preoperative levels by 6months .


Adjusting for confounders , including radiotherapy , did not change these results .


Sexual dysfunction is common in patients with rectal cancer , and treatment ( including surgery ) increases the proportion of patients affected .


A laparoscopic approach does not change this .


NCT0029779 ( http://www.clinicaltrials.gov ) .


Rates of obesity are greatest in middle age .


Obesity is associated with altered activity of brain networks sensing food-related stimuli and internal signals of energy balance , which modulate eating behaviour .


The impact of healthy mid-life ageing on these processes has not been characterised .


We therefore aimed to investigate changes in brain responses to food cues , and the modulatory effect of meal ingestion on such evoked neural activity , from young adulthood to middle age .


Twenty-four healthy , right-handed subjects , aged 19.5-52 .6 years , were studied on separate days after an overnight fast , randomly receiving 50ml water or 554kcal mixed meal before functional brain magnetic resonance imaging while viewing visual food cues .


Across the group , meal ingestion reduced food cue-evoked activity of amygdala , putamen , insula and thalamus , and increased activity in precuneus and bilateral parietal cortex .


Corrected for body mass index , ageing was associated with decreasing food cue-evoked activation of right dorsolateral prefrontal cortex ( DLPFC ) and precuneus , and increasing activation of left ventrolateral prefrontal cortex ( VLPFC ) , bilateral temporal lobe and posterior cingulate in the fasted state .


Ageing was also positively associated with the difference in food cue-evoked activation between fed and fasted states in the right DLPFC , bilateral amygdala and striatum , and negatively associated with that of the left orbitofrontal cortex and VLPFC , superior frontal gyrus , left middle and temporal gyri , posterior cingulate and precuneus .


There was an overall tendency towards decreasing modulatory effects of prior meal ingestion on food cue-evoked regional brain activity with increasing age .


Healthy ageing to middle age is associated with diminishing sensitivity to meal ingestion of visual food cue-evoked activity in brain regions that represent the salience of food and direct food-associated behaviour .


Reduced satiety sensing may have a role in the greater risk of obesity in middle age .


To determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis .


This study was a post-hoc subgroup analysis of our randomised multicentre trial ( www.clinicaltrial.gov : NCT00348777 ) .


Participants who met the inclusion criteria of generalized osteoarthritis ( Kellgren , American College of Rheumatology , or Dougados criteria ) were extracted from the original randomised controlled trial .


They had been randomised using Zelen randomisation .


The treatment group received 18days of spa treatment in addition to a home exercise programme .


Main outcome was number of patients achieving minimal clinically important improvement at six months ( MCII ) ( -19.9 mm on the VAS pain scale and/or -9.1 points in a WOMAC function subscale ) , and no knee surgery .


Secondary outcomes included the `` patient acceptable symptom state '' ( PASS ) defined as VAS pain 32.3 mm and/or WOMAC function subscale 31 points .


From the original 462 participants , 214 patients could be categorized as having generalised osteoarthritis .


At sixth month , 182 ( 88 in control and 94 in SA group ) patients , were analysed for the main criteria .


MCII was observed more often in the spa group ( n = 52/94 vs. 38/88 , P = 0.010 ) .


There was no difference for the PASS ( n = 19/88 vs. 26/94 , P = 0.343 ) .


This study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA .


This study compared the efficacy of intravenous magnesium sulphate , terbutaline and aminophylline for children with acute , severe asthma poorly responsive to standard initial treatment .


We enrolled 100 children , aged one to 12 years , who had failed to respond to initial standard treatment for acute , severe asthma , in this randomised controlled trial .


They received either intravenous magnesium sulphate , terbutaline or aminophylline .


Responses were monitored using a modified Clinical Asthma Severity ( CAS ) score .


The primary outcome was treatment success , defined as a reduction in the CAS of four points or more 1 h after starting the intervention .


The magnesium sulphate group had higher treatment success ( 33/34 , 97 % ) than the terbutaline and aminophylline groups ( both 23/33 , 70 % ) ( p = 0.006 ) and faster resolution of retractions , wheeze and dyspnoea ( p < 0.001 ) .


No adverse events occurred among patients receiving magnesium sulphate , but two patients receiving terbutaline had hypokalemia and nine patients receiving aminophylline had nausea and , or , vomiting .


Adding a single dose of Intravenous magnesium sulphate to inhaled beta2-agonists and corticosteroids was more effective , and safer , than using terbutaline or aminophylline when treating a child with acute severe asthma poorly responsive to initial treatment .


To evaluate the efficacy and adverse effects of an i.v. infusion of paracetamol during the active phase of labor as compared with sterile water ( placebo ) as a method for intrapartum analgesia .


In a triple-blind , randomized , placebo-controlled trial , 120 low-risk primiparous women presenting in active labor at Ain Shams University Maternity Hospital , Cairo , Egypt , between August 2011 and October 2012 , were allocated to receive either 1000 mg i.v. of paracetamol ( n = 60 ) or sterile water ( n = 60 ) .


The primary outcomes were the efficacy of the drug to supply adequate analgesia as measured by a change in the visual analog scale ( VAS ) pain intensity score at various time points after drug administration and the need for additional rescue analgesia .


The secondary outcomes included the presence of adverse maternal or fetal events .


Compared to controls , i.v. infusion of paracetamol was associated with significantly lower VAS score 15 and 30 min after the start of medication ; also , there was a significantly lower incidence of need for rescue medication ( 8/57 [ 14 % ] vs 49/59 [ 83.1 % ] , P < 0.001 ) at 60 min after the start of medication .


There were no recorded maternal adverse effects in either group .


There were no differences in occurrence of intrapartum fetal distress or neonatal Apgar scores between both groups .


Paracetamol appears to be a safe and effective medicine that can be used during the intrapartum period .


Alternate day fasting ( ADF ; 24-h feeding/24-h 25 % energy intake at lunchtime ) , is effective for weight loss , but diet tolerability is questionable .


Moving the fast day meal to dinnertime , or dividing it into smaller meals , may improve tolerability .


Accordingly , this study compared the effects of ADF with three meal times on body weight and heart disease risk .


Obese subjects ( n = 74 ) were randomized to 1 of 3 groups for 8 weeks : 1 ) ADF-L : lunch , 2 ) ADF-D : dinner , or 3 ) ADF-SM : small meals .


Body weight decreased similarly ( P < 0.001 ) in all groups ( ADF-L : 3.50.4 kg , ADF-D 4.10.5 kg , ADF-SM 4.00.5 kg ) .


Reductions ( P < 0.001 ) in fat mass and visceral fat were also comparable .


Plasma lipids remained unchanged , and low density lipoprotein ( LDL ) particle size increased ( P < 0.05 ) in all groups ( 1.30.5 ) .


Systolic blood pressure decreased ( P < 0.05 ) by ADF-SM only .


Fasting glucose , insulin , and HOMA-IR remained unchanged .


Thus , allowing individuals to consume the fast day meal at dinner or small meals produces similar weight loss and cardio-protection as consuming the meal at lunch .


This flexibility in meal timing may increase tolerability and long-term adherence to ADF protocols .


To determine whether aminophylline reduced the duration of respiratory support in children admitted to intensive care with bronchiolitis .


A multicentre , randomised , double-blind , placebo controlled trial .


Paediatric intensive care units in teaching hospitals .


Forty-five children with severe bronchiolitis .


Patients were randomly assigned to receive an infusion of aminophylline ( 23 ) or placebo ( 22 ) .


The primary outcome measure was the number of hours of respiratory support required in the 120 hours after randomisation ; respiratory support was defined as either nasal continuous positive airways pressure or mechanical ventilation .


The trial was stopped early due to poor recruitment .


Respiratory support was required for a median of only 1.5 days ( interquartile range [ IQR ] , 0.4-3 .5 days ) in the aminophylline group compared with 1.9 days ( IQR , 0.3-3 .5 ) days in the placebo group .


However , more patients in the placebo group were receiving respiratory support at the time of randomisation and , after adjustment for this , there was no suggestion of a beneficial effect of aminophylline among the small number of patients studied ( P = 0.54 , exact log-rank test stratified by respiratory support at the time of randomisation and censored at the time of death in one child in the aminophylline group ) .


Not enough children were recruited for the study to test the hypothesis that aminophylline reduces the need for respiratory support in severe bronchiolitis .


Consequently , the role of aminophylline in the management of severe bronchiolitis remains unknown .


We aimed to compare the effectiveness of immobilization in abduction and external rotation vs immobilization in adduction and internal rotation after primary anterior dislocation of the shoulder .


The study randomized 102 patients ( age range , 15-55 years ) with the diagnosis of primary anterior dislocation of the shoulder to receive immobilization in adduction and internal rotation ( AdIR , n = 51 ) using sling and swathe bandage or immobilization in abduction and external rotation ( AbER , n = 51 ) with a stabilizer brace .


Patients received a rehabilitation program 3 weeks after the intervention .


After a 24-month follow-up , 33.3 % in the AdIR group and 3.9 % in the AbER group had recurrence ( P < .001 ) .


The difference in the recurrence rate was greater in the subgroup aged between 31 and 40 years ( 44.8 % in the AdIR group and 3.8 % in the AbER group , P < .001 ) .


Ten patients in the AbER group ( 19.6 % ) and 3 in the AdIR group ( 5.8 % ) discontinued shoulder immobilization before 3 weeks ( P = .03 ) .


In patients without recurrence , the anterior apprehension test was positive in 6 of 34 in the AdIR group ( 17.6 % ) and in 4 of 49 in the AbER group ( 8.1 % , P = .19 ) .


Immobilization with the shoulder joint in abduction and external rotation is an effective method to reduce the risk of recurrence after primary anterior shoulder dislocations and should be preferred to the traditional method of immobilization in adduction and internal rotation in clinical practice .


Deep brain stimulation ( DBS ) has been proposed as a treatment option for severe Tourette 's syndrome on the basis of findings from open-label series and small double-blind trials .


We aimed to further assess the safety and efficacy of bilateral globus pallidus internus ( GPi ) DBS in patient 's with severe Tourette 's syndrome .


In a randomised , double-blind , crossover trial , we recruited eligible patients ( severe medically refractory Tourette 's syndrome , age 20 years ) from two clinics for tertiary movement disorders in the UK .


Enrolled patients received surgery for GPi DBS and then were randomly assigned in a 1:1 ratio ( computer-generated pairwise randomisation according to order of enrolment ) to receive either stimulation on-first or stimulation off-first for 3 months , followed by a switch to the opposite condition for a further 3 month period .


Patients and rating clinicians were masked to treatment allocation ; an unmasked clinician was responsible for programming the stimulation .


The primary endpoint was difference in Yale Global Tic Severity Scale ( YGTSS ) total score between the two blinded conditions , assessed with repeated measures ANOVA , in all patients who completed assessments during both blinded periods .


After the end of the blinded crossover phase , all patients were offered continued DBS and continued to have open-label stimulation adjustments and objective assessments of tic severity until database lock 1 month after the final patient 's final trial-related visit .


This trial is registered with ClinicalTrials.gov , number NCT01647269 .


Between Nov 5 , 2009 , and Oct 16 , 2013 , we enrolled 15 patients ( 11 men , four women ; mean age 347 years [ SD 100 ] ) .


14 patients were randomly assigned and 13 completed assessments in both blinded periods ( seven in the on-first group , six in the off-first group ) .


Mean YGTSS total score in these 13 patients was 879 ( SD 92 ) at baseline , 807 ( SD 120 ) for the off-stimulation period , and 683 ( SD 186 ) for the on-stimulation period .


Pairwise comparisons in YGTSS total scores after Bonferroni correction were significantly lower at the end of the on-stimulation period compared with the off-stimulation period , with a mean improvement of 124 points ( 95 % CI 01-247 , p = 0048 ) , equivalent to a difference of 153 % ( 95 % CI 53-253 ) .


All 15 patients received stimulation in the open-label phase .


Overall , three serious adverse events occurred ( two infections in DBS hardware at 2 and 7 weeks postoperatively , and one episode of deep-brain-stimulation-induced hypomania during the blinded on-stimulation period ) ; all three resolved with treatment .


GPi stimulation led to a significant improvement in tic severity , with an overall acceptable safety profile .


Future research should concentrate on identifying the most effective target for DBS to control both tics and associated comorbidities , and further clarify factors that predict individual patient response .


UK National Health Service .


The Sodium Lowering in Dialysate ( SoLID ) trial is an ongoing a multi-center , prospective , randomised , single-blind ( assessor ) , controlled , parallel assignment clinical trial , enrolling 96 home and self-care hemodialysis ( HD ) patients from 7 centers in New Zealand .


The trial will evaluate the hypothesis that lower dialysate [ Na + ] during HD results in lower left ventricular ( LV ) mass .


Since it 's inception , observational evidence has suggested increased mortality risk with lower dialysate [ Na + ] , possibly due to exacerbation of intra-dialytic hypotension and subsequent myocardial micro-injury .


The Myocardial Micro-injury and Cardiac Remodeling Extension Study in the Sodium Lowering In Dialysate Trial ( Mac-SoLID study ) aims to determine whether lower dialysate [ Na + ] results in ( i ) increased levels of high-sensitivity Troponin T ( hsTnT ) , a well-established marker of intra-dialytic myocardial micro-injury in HD populations , and ( ii ) increased fixed LV segmental wall motion abnormalities , a marker of recurrent myocardial stunning and micro-injury , and ( iii ) detrimental changes in LV geometry due to maladaptive homeostatic mechanisms .


The SoLID trial and the Mac-SoLID study are funded by the Health Research Council of New Zealand .


Key exclusion criteria : patients who dialyse > 3.5 times per week , pre-dialysis serum sodium < 135 mM , and maintenance haemodiafiltration .


In addition , some medical conditions , treatments or participation in other dialysis trials that contraindicate the study intervention or confound its effects , will be exclusion criteria .


The intervention and control groups will receive dialysate sodium 135 mM and 140 mM respectively , for 12 months .


The primary outcome measure for the Mac-SOLID study is repeated measures of [ hsTnT ] at 0 , 3 , 6 , 9 , and 12 months .


The secondary outcomes will be assessed using cardiac magnetic resonance imaging ( MRI ) , and comprise LV segmental wall motion abnormality scores , LV mass to volume ratio and patterns of LV remodeling at 0 and 12 months .


The Mac-SoLID study enhances and complements the SoLID trial .


It tests whether potential gains in cardiovascular health ( reduced LV mass ) which low dialysate [ Na + ] is expected to deliver , are counteracted by deterioration in cardiovascular health through alternative mechanisms , namely repeated LV stunning and micro-injury .


Australian and New Zealand Clinical Trials Registry number : ACTRN12611000975998 .


The role of saturated fatty acids ( SFAs ) in chronic disease remains controversial ; inflammation is one pathway by which SFAs influence the risk for chronic disease .


The aim of this study was to investigate the associations between red blood cell ( RBC ) phospholipid SFAs and systemic inflammation .


As part of a randomized controlled trial , we measured RBC phospholipid FA composition in 55 generally healthy adults twice at 3-mo intervals .


We estimated associations of RBC total SFAs and two major SFA subtypes , palmitic and stearic acids , with C-reactive protein ( CRP ) , interleukin ( IL ) -6 , white blood count ( WBC ) , and a composite inflammation measure using generalized estimating equations in multivariable FA substitution models .


Mean ( SD ) SFA level across both visits was 45 % 3 % of the total RBC FAs , mainly palmitic ( 21 % 1 % ) and stearic ( 17 % 3 % ) acids .


In models adjusted for age , sex , race , smoking , body mass index , statin use , aspirin use , transunsaturated FAs , and -3 FAs , SFAs were significantly associated with IL-6 ( 20 % increase per 1 SD increment ; 95 % confidence interval [ CI ] , 0.03 % -43 % ; P = 0.05 ) and the composite inflammation measure ( P = 0.05 ) and marginally associated with CRP ( 34 % increase ; 95 % CI , -1 % to 81 % ; P = 0.06 ) , but not associated with WBC .


Stearic acid was positively associated with CRP ( 35 % increase ; 95 % CI , 2 % -79 % ; P = 0.04 ) .


Palmitic acid was marginally associated with the composite inflammation measure ( P = 0.06 ) and , upon additional -6 FA adjustment , significantly associated with IL-6 ( 15 % increase ; 95 % CI , 0.4 % -27 % ; P = 0.006 ) .


RBC SFAs , which represent longer-term dietary intake , are positively associated with inflammation .


In particular , palmitic acid was associated with IL-6 , and stearic acid was associated with CRP after multivariable adjustment .


To compare the efficacy and safety of two insulin intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin glargine with metformin and/or pioglitazone .


A multinational , randomized , open-label trial that compared insulin lispro low mixture ( LM25 ; n = 236 ) twice daily with a basal-prandial regimen of insulin glargine once daily and insulin lispro once daily ( IGL ; n = 240 ) over 24 weeks in patients with HbA1c 7.5-10 .5 % and fasting plasma glucose 6.7 mmol/l .


The primary objective was to assess non-inferiority [ per-protocol ( PP ) population ] , and then superiority [ intention-to-treat ( ITT ) population ] , of LM25 versus IGL according to change in HbA1c after 24 weeks ( non-inferiority margin 0.4 % , two-sided significance level 0.05 ) .


Estimated change [ least squares ( LS ) mean ( 95 % CI ) ] in HbA1c after 24 weeks : -1.30 ( -1.44 , -1.16 ) % with LM25 and -1.08 ( -1.22 , -0.94 ) % with IGL .


Non-inferiority was shown [ LS mean ( 95 % CI ) HbA1c treatment difference -0.21 ( -0.38 , -0.04 ) ( PP population ) ] ; gated superiority assessment showed a statistically significant advantage for LM25 ( p = 0.010 ; ITT population ) .


Mean blood glucose , glycaemic variability , overall tolerability and hypoglycaemic episodes per patient-year did not show significant differences between treatments during the study .


In patients with type 2 diabetes inadequately controlled on once-daily basal insulin glargine and metformin and/or pioglitazone , intensification with LM25 was superior to a basal-prandial approach in terms of reduction in HbA1c after 24 weeks and did not increase hypoglycaemia episodes .


Prototyping technologies for reconstructions consist of obtaining a 3-dimensional model of the object of interest .


Solid models are constructed by the deposition of materials in successive layers .


The purpose of this study was to perform a double-blind , randomized , prospective study to evaluate the efficacy of prototype use in head and neck surgeries .


Thirty-seven cases were randomized into prototype and nonprototype groups .


The following factors were recorded : the time of plate and locking screw apposition , flap size , time for reconstruction , and an aesthetic evaluation .


The prototype group exhibited a reduced surgical time ( 43.7 minutes vs 127.7 minutes , respectively ; p = .001 ) , a tendency to reduce the size of the bone flap taken for reconstruction , and better aesthetic results than the group that was not prototyped .


The use of prototyping demonstrated a trend toward a reduced surgical time , smaller bone flaps , and better aesthetic results .


This study 's objective was to determine the efficacy of benefits counseling in a clinical trial .


There has been concern that disability payments for psychiatric disorders reduce incentives for employment and rehabilitation .


Benefits counseling , with education about opportunities to work and the financial implications of work on receipt of disability benefits , may counter these disincentives .


This single-blind , six-month randomized clinical trial enrolled 84 veterans who had applied for service-connected compensation for a psychiatric condition .


Veterans were randomly assigned to either four sessions of benefits counseling or of a control condition involving orientation to the U.S Department of Veterans Affairs health care system and services .


Days of paid work and work-related activities were assessed at follow-up visits by using a timeline follow-back calendar .


Veterans assigned to benefits counseling worked for pay for significantly more days than did veterans in the control group ( effect size = .69 , p < .05 ) , reflecting an average of three more days of paid employment during the 28 days preceding the six-month follow-up .


Benefits counseling was associated with increased use of mental health services , but this correlation did not mediate the effect of benefits counseling on working .


Barriers to employment associated with disability payments are remediable with basic counseling .


More research is needed to understand the active ingredient of this counseling and to strengthen the intervention .


Many believe that the regular treatment for multibacillary ( MB ) leprosy cases could be shortened .


A shorter treatment allowing uniformity in treatment for all cases renders case classification superfluous and therefore simplifies leprosy control .


To evaluate the association between treatment duration and the trend in bacteriological index ( BI ) decrease over time among patients given Uniform MDT ( UMDT ) compared to those given regular MDT ( RMDT ) .


An open-label randomised clinical trial to compare the present routine treatment with one lasting six month .


Patient intake was from March 2007 to February 2012 .


To evaluate the trend of BI as a function of time , a multilevel linear with mixed effects model was fixed to the two study groups and also four groups after stratification by BI , less than 3 and 3 or more .


The BI fall was higher among those taking RMDT , this difference however was not statistically significant .


The results presented here support the possibility of use of UMDT in the field , but further follow up is still needed for a final conclusion .


To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus ( RAMP-DM ) led to improvements in biomedical outcomes , observed cardiovascular events and predicted cardiovascular risks after 12-month intervention in the primary care setting .


A random sample of 1,248 people with diabetes enrolled to RAMP-DM for at least 12months was selected and 1,248 people with diabetes under the usual primary care were matched by age , sex , and HbA1c level at baseline as the usual care group .


Biomedical and cardiovascular outcomes were measured at baseline and at 12-month after the enrollment .


Difference-in-differences approach was employed to measure the effect of RAMP-DM on the changes in biomedical outcomes , proportion of subjects reaching treatment targets , observed and predicted cardiovascular risks .


Compared to the usual care group , RAMP-DM group had lower cardiovascular events incidence ( 1.21 % vs 2.89 % , P = 0.003 ) , and net decrease in HbA1c ( -0.20 % , P < 0.01 ) , SBP ( -3.62 mmHg , P < 0.01 ) and 10-year cardiovascular disease ( CVD ) risks ( total CVD risk , -2.06 % , P < 0.01 ; coronary heart disease ( CHD ) risk , -1.43 % , P < 0.01 ; stroke risk , -0.71 % , P < 0.01 ) .


The RAMP-DM subjects witnessed significant rises in the proportion of reaching treatment targets of HbA1c , and SBP/DBP .


After adjusting for confounding variables , the significance remained for HbA1c , predicted CHD and stroke risks .


The RAMP-DM resulted in greater improvements in HbA1c and reduction in observed and predicted cardiovascular risks at 12months follow-up , which indicated a risk-stratification multidisciplinary intervention was an effective strategy for managing Chinese people with diabetes in the primary care setting .


ClinicalTrials.gov , NCT02034695 .


The incidence of sick sinus syndrome will increase due to population ageing .


Consequently , this will result in an increase in the number of pacemaker implantations .


The atrial lead is usually implanted in the right atrial appendage , but this position may be ineffective for prevention of atrial fibrillation .


It has been suggested that pacing distally in the coronary sinus might be more successful in preventing atrial fibrillation episodes .


The aim of this trial is to study the efficacy of distal coronary sinus versus right atrial appendage pacing in preventing atrial fibrillation episodes in patients with sick sinus syndrome .


This study is designed as a multicenter , randomized controlled trial .


Patients with sick sinus syndrome and at least one atrial fibrillation episode of 30 seconds or more in the six months before recruitment will be eligible for participation in this study.All participants will be randomized between pacing distally in the coronary sinus and right atrial appendage .


Randomization is stratified for all participating centers .


Conventional dual-chamber pacemakers with advanced home monitoring functionality will be implanted .


The ventricular lead will be implanted in the right ventricular apex .


The first three months of the 36-month follow-up period are considered as run-in time .


During the pre-randomization visit and follow-up , an interview , electrocardiogram and pacemaker assessment will be performed , prescribed antiarrhythmic medication will be reviewed and patients will be asked to complete an SF-36 questionnaire .


An echocardiographic examination will be conducted in the pre-randomization phase and at the end of each follow-up year .


Home monitoring will be used to send daily reports in case of atrial fibrillation episodes .


This randomized controlled trial is the first in which home monitoring will be used to compare atrial fibrillation recurrences between pacing in the distal coronary sinus or right atrial appendage .


Home monitoring gives the opportunity to accurately detect atrial fibrillation episodes and to study characteristics of atrial fibrillation episodes .


Should distal coronary sinus pacing significantly diminish atrial fibrillation recurrences , this study will redefine the preferential location of an atrial lead for preventive pacing .


Current Controlled Trials ISRCTN65911661 , registered on 8 July 2013 .


Negative lifestyle factors are known to be associated with increased cardiovascular risk ( CVR ) in children , but research on their combined impact on a general population of children is sparse .


Therefore , we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years .


Of the 540 randomly selected 6 - to 13-year-old children , 502 children participated in a baseline health assessment , and 64 % were assessed again after 4 years .


Measures included anthropometry , fasting blood samples , and a health assessment questionnaire .


Participants scored one point for each negative lifestyle factor at baseline : overweight ; physical inactivity ; high media consumption ; little outdoor time ; skipping breakfast ; and having a parent who has ever smoked , is inactive , or overweight .


A CVR score at follow-up was constructed by averaging sex - and age-related z-scores of waist circumference , blood pressure , glucose , inverted high-density lipoprotein , and triglycerides .


The age - , sex - , pubertal stage - , and social class-adjusted probabilities ( 95 % confidence interval ) for being in the highest CVR score tertile at follow-up for children who had at most one ( n = 48 ) , two ( n = 64 ) , three ( n = 56 ) , four ( n = 41 ) , or five or more ( n = 14 ) risky lifestyle factors were 15.4 % ( 8.9-25 .3 ) , 24.3 % ( 17.4-32 .8 ) , 36.0 % ( 28.6-44 .2 ) , 49.8 % ( 38.6-61 .0 ) , and 63.5 % ( 47.2-77 .2 ) , respectively .


Even in childhood , an accumulation of negative lifestyle factors is associated with higher CVR scores after 4 years .


These negative lifestyle factors are easy to assess in clinical practice and allow early detection and prevention of CVR in childhood .


Transcranial direct current stimulation ( tDCS ) and auditory residual inhibition ( RI ) are short lasting non-invasive techniques that can suppress tinnitus in some people .


A pilot study was undertaken to evaluate methods to measure a potential additive effect of these treatments .


Ten participants ( mean age 59 years ) with chronic tinnitus underwent four sessions of anodal tDCS of the left temporoparietal area ( LTA ) combined with 1min of auditory stimulation ( broadband noise presented at tinnitus minimum masking level [ MML ] +10 dB ) , either before , during or immediately after tDCS and in a sham controlled session .


Participants continuously monitored and recorded their MML on custom software prior to stimulation , during 20 min of tDCS , and 30 min following tDCS .


A tinnitus loudness rating was undertaken before and after completion of testing .


Nine out of ten participants completed the study , one participant dropped out after two sessions due to self-reported worsening in tinnitus symptoms .


Seven out of nine participants reported transient tinnitus suppression when sound stimulation was presented along with tDCS .


No reliable change in MML was observed .


This is the first study to examine the feasibility of continuously measuring MML while providing a combination of auditory and noninvasive brain stimulation simultaneously .


We propose modifications in the protocol used , to find ways to increase the duration of auditory RI and investigate its underlying mechanisms .


Recommendations for further research are discussed .


Apathy in the context of treated major depressive disorder ( MDD ) is a frequently observed phenomenon in clinical practice .


This study aimed to assess the validity of the Rothschild Scale for Antidepressant Tachyphylaxis ( RSAT ) and the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire ( CPFQ ) for measuring apathy , and to assess the relationship between apathy and possible contributing factors , in patients with MDD and residual apathy in the absence of depressed mood .


The underlying structure and validity of the RSAT and CPFQ were assessed via factor analysis and correlation with the Apathy Evaluation Scale-Clinician rated version ( AES-C ) in 483 patients who had previously responded to treatment with a selective serotonin reuptake inhibitor .


The relationship between apathy and contributing variables was investigated via structural equation modeling .


Correlation and regression analyses were conducted to examine the relationship between the Sheehan Disability Scale ( SDS ) and the RSAT , CPFQ , and AES-C .


The RSAT and CPFQ were validated with the AES-C with respect to energy and motivation .


The latent variable `` Energy and Interest '' , based on the energy , motivation , and interest items ( RSAT and CPFQ ) , was a major contributing factor to apathy .


Improvements in function ( SDS ) were significantly correlated with , and predicted by , improvements in apathy and cognitive and physical functioning ( assessed by the RSAT , CPFQ , and AES-C ) .


These analyses provide further information on apathy and its assessment in the context of treated MDD .


A better understanding of apathy will aid further investigation of this phenomenon and , ultimately , determination of the most appropriate approach for its clinical management .


Caring for people with dementia in dementia special care units is a demanding job .


Challenging behaviour is one of the factors influencing the job satisfaction and burnout of care staff .


A care programme for the challenging behaviour of nursing home residents with dementia might , next to diminishing the challenging behaviour of residents , improve job satisfaction and reduce the care staff 's feelings of burnout .


To determine the effects of a care programme for the challenging behaviour of nursing home residents with dementia on the burnout , job satisfaction and job demands of care staff .


The care programme was implemented according to a stepped wedge design in which care units were randomly divided over five groups with different time points of starting with implementation .


17 Dutch dementia special care units .


Care staff members of the 17 units .