This may suggest reductions in mortality associated with azithromycin MDA are due to a mechanism other than improved nutritional status .


This study was designed to determine whether a 4 day perioperative regimen of gabapentin added to celecoxib improves in-hospital rehabilitation and physical function on postoperative day 4 and 6 weeks and 3 months after total knee arthroplasty ( TKA ) .


After Research Ethics Board approval and informed consent , 212 patients were enrolled in a randomized , double-blinded , placebo-controlled study .


Two hours before surgery , patients received celecoxib 400 mg p.o. and were randomly assigned to receive either gabapentin 600 mg or placebo p.o. Two hours later , patients received femoral , sciatic nerve blocks , and spinal anaesthesia .


After operation , patients received gabapentin 200 mg or placebo three times per day ( TID ) for 4 days .


All patients also received celecoxib 200 mg q12 h for 72 h and i.v. patient-controlled analgesia for 24 h. Pain and function were assessed at baseline , during hospitalization , on postoperative day 4 ( POD4 ) , and 6 weeks and 3 months after surgery .


The gabapentin group used less morphine in the first 24 h after surgery [ G = 38.3 ( 29.5 mg ) , P = 48.2 ( 29.4 mg ) ] ( P < 0.0125 ) and had increased knee range of motion compared with the placebo group in-hospital ( P < 0.05 ) .


There were no differences between groups in favour of the gabapentin group for pain or physical function on POD 4 [ 95 % confidence interval ( CI ) : pain : -1.4 , 0.5 ; function : -6.3 , 2.0 ] , 6 weeks ( 95 % CI : pain : 0.1 , 1.9 ; function : -0.2 , 6.5 ) or 3 months ( 95 % CI : pain : -0.2 , 1.7 ; function : -2.2 , 4.3 ) after TKA .


In the context of celecoxib , spinal anaesthesia , femoral and sciatic nerve blocks , a dose of gabapentin 600 mg before operation followed by 4 days of gabapentin 200 mg TID decreased postoperative analgesic requirements and improved knee range of motion after TKA .


Gabapentin provided no improvement in pain or physical function on POD4 and 6 weeks or 3 months after surgery .


Under-reporting of substance use and other sensitive information is a substantial threat to internal study validity , particularly during the perinatal period .


Anonymous approaches are associated with greater disclosure but are incompatible with longitudinal follow-up .


Alternative approaches include use of a U.S. Federal Certificate of Confidentiality ( CoC ) and quasi-anonymous methods , in which there is no link between name and data .


However , the relative effect of these procedures on disclosure is unknown .


This randomized study was designed to evaluate the effects of consent condition ( anonymous , quasi-anonymous , CoC , and traditional confidentiality ) on disclosure of sensitive information among postpartum women .


Participants were 200 postpartum , primarily African-American women who were randomly assigned to one of the four consent conditions and completed a brief computer-delivered assessment of alcohol and drug use , sexual risk , intimate partner violence , and emotional distress .


Participants in the anonymous and quasi-anonymous conditions disclosed significantly more sensitive information than those in the traditional consent condition .


In contrast , no advantage in overall disclosure was observed for the CoC condition .


This result was largely consistent across specific content areas with the exception of emotional distress , disclosure of which was unrelated to consent condition .


Although use of a CoC has limited impact on disclosure , the quasi-anonymous method may increase disclosure to a similar extent as full anonymity .


Quasi-anonymous approaches should be considered when under-reporting is likely , a context in which the disadvantages of this approach must be balanced against its advantages .


Protein-energy wasting ( PEW ) is common in hemodialysis patients and is a powerful predictor of morbidity and mortality .


Although much progress has been made in recent years in identifying the causes and pathogenesis of PEW in hemodialysis patients , actual management by nutritional interventions is not always able to correct PEW .


Some investigators suggest that physical exercise may increase the anabolic effects of nutritional interventions , and therefore may have a potential to reverse PEW .


The aim of this study is to investigate the effect of intra-dialytic progressive exercise training and adequate nutritional supplementation on markers of PEW , functional capacities and quality of life of adult hemodialysis patients .


Fifty end-stage renal disease patients undergoing hemodialysis , who meet the diagnostic criteria for PEW , will be randomly allocated into an exercise or control group for 6 months .


The exercise consists of a progressive submaximal individualized cycling exertion using an adapted cycle ergometer , during the three weekly dialysis sessions .


Biological markers of nutrition ( albumin , prealbumin ) will be followed monthly and all patients will be assessed for body composition , walk function , muscle strength , postural stability and quality of life at baseline and during the eighth week ( t +2 ) , the sixteenth week ( t +4 ) and the twenty-fourth week ( t +6 ) of the 6-month adapted rehabilitation program .


The successful completion of this current trial may give precious clues in understanding PEW and encourage nephrologists to extend prescription of exercise programs as well as therapeutic and as preventive interventions in this high-risk population .


The protocol for this study was registered with the France Clinical Trials Registry NCT01813851 .


The knowledge of factors that may influence blood donation in Cameroon is limited .


The objectives of this study are to assess the characteristics of previous and potential blood donors by exploring the religious beliefs , and knowledge and understanding of blood donations among individuals present at a district hospital .


Forty-nine in-depth , semi-structured interviews were conducted among consenting , randomly selected 18 years or older community members present at a district hospital in the Adamaoua region during October and November 2011 .


Ninety-eight per cent ( 48/49 ) of the individuals present at this district hospital had heard of blood transfusions .


Forty-seven per cent ( 23/49 ) had not previously been asked to donate blood ; however , 94 % ( 44/47 ) said that they would donate if given the opportunity .


Thirty-three per cent ( 16/49 ) had previously donated blood to family members or for replacement , and 81 % of these said they would repeat donations .


The majority of both donors and non-donors were motivated to donate blood for altruistic reasons .


The findings suggest that community members present at this district hospital in Cameroon may be recruited for repeat blood donations .


Although the altruistic motivation to donate blood suggests that donors could be recruited from a district hospital population , targeted information about blood donations and accessible blood transfusion services need to be put in place .


The study may add to the understanding of the preconditions for blood donations and the possibility to establish sustainable blood transfusion services in the Adamaoua region in Cameroon .


Antibiotic-resistant strains of pathogenic bacteria are increasingly prevalent in hospitals and the community .


Acute exacerbations of COPD ( AE-COPD ) often result in administration of antibiotics although more than half of exacerbations are associated with detection of respiratory viruses and potentially pathogenic bacteria can only be detected in 20-30 % of cases .


There is a paucity of placebo-controlled clinical trials and up to today no single study has been powered sufficiently to prove the efficacy of antibiotic treatment in AE-COPD .


Most studies so far did not include current standards of care comprising administration of systemic corticosteroids .


A total of 980 patients with moderate acute exacerbations will be included in 22 German centers ( hospitals and private practices ) .


Patients will receive a standardized treatment for exacerbation including systemic corticosteroids , inhaled bronchodilators and supplementary oxygen if needed and will be randomized to additional treatment with placebo or antibiotic ( oral sultamicillin ) for five days.The primary endpoint is clinical failure defined by need for additional antibiotic treatment until day 30 .


Secondary endpoints will assure that management of AE-COPD without antibiotics does not result either in increased occurrence of relapse , new exacerbations , prolonged recovery , or unwanted long-term consequences .


ABACOPD will be the first sufficiently powered double-blind placebo-controlled study in the field to systematically assess the question whether antibiotics , known to increase antibiotic resistance , are really needed in a well-defined patient cohort receiving state-of-the art treatment in all other aspects .


ClinicalTrials.gov : NCT01892488 .


To determine the effects of resveratrol ( RES ) on growth and immune status in chickens receiving conventional vaccinations .


Two hundred forty 1-day-old layer chickens .


Chickens received conventional vaccinations throughout the study and were randomly assigned to 1 of 4 treatments in 6 replicate pens/treatment .


Treatments included 1 control group ( basal diet ) and 3 experimental groups fed the basal diet plus 200 , 400 , and 800 mg of RES/kg of diet .


At 40 days of age , 1 bird/pen was randomly selected to have blood and tissues collected to determine serum immunity indices ; mRNA relative expression of proinflammatory cytokines in splenocytes ; mRNA relative expression of nuclear transcription factor-B , growth hormone receptor , and insulin-like growth factor-1 in hepatocytes ; cell proliferation ; and apoptosis .


Average daily gain , antibody titers against Newcastle disease virus and avian influenza viruses H5 and H9 , and insulin-like growth factor-1 expression were quadratically increased with increasing RES concentration .


In hepatocytes , growth hormone receptor gene mRNA relative expression was quadratically increased and nuclear transcription factor-B gene mRNA relative expression was linearly decreased with increasing RES concentration .


In splenocytes , nterleukin-1 and tumor necrosis factor - mRNA relative expression was linearly decreased with increasing RES concentration .


Resveratrol supplementation delayed cell proliferation and reduced apoptosis in immunocytes .


With increasing RES concentration , proliferation index and relative weight of the thymus , ratio of CD4 + to CD8 + cells , and CD4 + cell count were quadratically increased , and IgM concentration was linearly increased .


Dietary resveratrol supplementation improved growth , protected immunocytes against antigen-induced apoptosis , and upregulated immune response in chickens that received conventional vaccinations .


Various external factors can influence patients ' experiences of noxious stimuli , but little is known of how patients ' natural behaviour may be relevant .


We ascertained how often patients spontaneously look or look away during venepuncture and associated reports of pain during a previously reported experimental randomized study .


The study was conducted in the outpatient department of a U.K. district general hospital .


Patients were randomized to hearing ` sharp scratch ' or the verbal cue ` ready ? '


immediately before venepuncture .


Whether patients looked or looked away during needle insertion was recorded .


Patients were asked to rate their pain using a verbal numerical rating score ( VNRS ) and verbal response scale ( VRS ) .


One hundred ninety-two patients were included ; mean age 51.7 years , 55 % male .


During needle insertion , 73 % spontaneously looked away , whereas 27 % looked .


There was no significant difference in the proportion of these patients assigned to the ` sharp scratch ' or ` ready ? '


groups , nor was there any difference in mean age or gender .


For the group that looked , mean VNRS was 0.48 and VRS was 1.27 , significantly less than the group that looked away ( mean VNRS 0.94 , p = 0.014 ; VRS 1.61 , p = 0.002 ) .


As previously reported , pain ratings between ` sharp scratch ' and ` ready ? '


groups were not significantly different .


Almost three quarters of patients spontaneously look away during venepuncture , but their pain ratings are almost twice that of the quarter of patients who look .


It is unclear why this may be , but previous experimental studies indicate that observing the body when a noxious stimulus is applied can have an analgesic effect .


The aim of this study was to investigate if there is any interaction between ondansetron and nefopam when they are continuously co-administrated during patient-controlled intravenous analgesia ( PCIA ) .


The study was a prospective , randomized , controlled , non-inferiority clinical trial comparing nefopam-plus-ondansetron to nefopam alone .


A total of 230 postoperative patients using nefopam for PCIA , were randomly assigned either to a group receiving continuous infusion of ondansetron ( Group O ) or to the other group receiving the same volume of normal saline continuously ( Group N ) .


Postoperative pain intensity scores , the sum of pain intensity difference over 24 hours postoperatively ( SPID24hr ) , the incidence of adverse events , and the total consumption of nefopam were evaluated respectively .


Postoperative pain was treated successfully in both groups .


The mean SPID24hr scores were 95.6 mm in Group N and 109.3 mm in Group O [ 95 % confidence interval ( CI ) -14.28 , 24.32 ] .


The lower margin of the 95 % CI was above the pre-determined non-inferiority margin ( -30 mm ) for SPID24hr , which indicated that nefopam-plus-ondansetron was not worse than the nefopam alone in term of analgesic efficacy .


In addition , there was no statistical difference between the two groups in term of cumulative consumption of nefopam .


Compared with Group N , postoperative vomiting was significantly reduced in Group O during the postoperative 24 hours ( P < 0.05 ) .


Less rescue antiemetics were given to patients in Group O than those receiving nefopam alone ( P < 0.05 ) .


There were no differences in postoperative nausea between the two groups .


Nefopam-plus-ondansetron is not inferior to nefopam alone in relieving the pain in PCIA after minimally invasive surgery .


In addition , adverse events are reduced without compromising analgesic efficacy .


To evaluate the efficacy of a delayed home exercise programme compared with normal care after primary total knee arthroplasty .


Single-blind , prospective , randomized , controlled trial .


A total of 108 participants ( 61 % females , mean age 69 years [ standard deviation 8.7 ] ) , were randomized to a home-based exercise group ( EG , n = 53 ) or to a control group ( CG , n = 55 ) .


Two months post-operatively , the EG received a home exercise programme , while the CG received no additional guidance .


The outcome measurements were : pain and disability , measured using the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) ; health-related quality of life ( HRQoL ) , measured using the Short Form-36 questionnaire ( SF-36 ) ; maximal walking speed ; isometric knee muscle strength ; and the Timed Up and Go ( TUG ) test .


Measurements were made at baseline and at 12 months thereafter .


At the 12-month follow-up , maximal walking speed ( p < 0.001 ) and knee flexion strength ( p = 0.009 ) were significantly greater in the EG .


Both groups showed similar improvements in all of the WOMAC subscale scores , the SF-36 summary scores and the TUG time .


Home-based training was not superior to normal care with regard to pain , disability or HRQoL , but resulted in greater improvement in objectively measured physical performance .


Corticosteroids have been evaluated for management of severe Mycoplasma pneumoniae pneumonia ( MP ) in children .


However , it is unclear whether the timing of treatment with corticosteroids affects the patients ' clinical outcome .


We did a prospective randomized clinical trial to evaluate the effect of early use of corticosteroids .


Fifty-three patients were randomly assigned to treatment with corticosteroids within 24 h after admission ( cases ) , and 53 patients were treated 72 h after admission ( control patients ) .


Cases had a shorter fever duration [ 6 days ( range 5-11 ) vs. 10 days ( range 8-23 ) , p < 0.001 ] and length of hospital stay [ 8 days ( range 5-15 ) vs. 10 days ( range 5-21 ) , p = 0.001 ] .


Four cases ( 1.9 % ) had a complete radiographic resolution time > 4 weeks compared with 10 control patients ( 17.5 % ; p = 0.038 ; Table 2 ) .


Early treatment with corticosteroids was associated with a better outcome in patients with severe MP .


Endotracheal intubation ( ETI ) is an essential resuscitation procedure in children .


Video laryngoscopes have been developed to avoid intubation failures in a variety of scenarios , including cardiopulmonary resuscitation .


We hypothesized that the video laryngoscope RIFL ( AI Medical Devices , Inc , Williamston , MI ) offers advantages in the ETI of a pediatric manikin while performing chest compressions ( CCs ) .


Randomized nonblinded crossover simulation trial conducted among 132 paramedics with no prior experience with RIFL .


Each participant performed intubations with Miller ( MIL ; Mercury Medical , Clearwater , FL ) laryngoscope and RIFL in a PediaSIM CPR training manikin ( FCAE HealthCare , Sarasota , FL ) in 3 airway scenarios : ( a ) normal airway at rest ( without concomitant CC ) , ( b ) normal airway with mechanically controlled CC , and ( c ) difficult airway with concomitant CC .


The primary outcome was the time to intubation , and secondary one was the success of the intubation attempt .


In the manikin at rest with normal airway , nearly all participants performed successful ETI both with MIL and RIFL , with similar intubation times .


However , in the other scenarios ( normal and difficult airway with uninterrupted CC ) , the results with RIFL were significantly better than with MIL ( P < .05 ) for all the analyzed variables ( success of first attempt , overall success rate , time to intubation , Cormac-Lehane grade , dental compression , and easy of intubation scores ) .


In simulated child arrest scenarios with normal/difficult airway conditions and with concomitant mechanical CC , paramedics performed better with the RIFL video laryngoscope than with the standard MIL .


To determine if a stabilised , stannous-containing sodium fluoride dentifrice provides greater enamel protection in situ against intraoral dietary erosive challenges compared with a sodium fluoride/potassium nitrate dentifrice .


A single-centre , investigator blind , randomised , supervised , two-treatment , non-brushing , four-period crossover in situ study was undertaken , with each test period being 15 days .


Thirty-five healthy adult subjects were recruited to participate in the study , which included four erosive acid challenges per day .


Subjects were randomised to product treatment , which included either : ( 1 ) a stannous-containing sodium fluoride dentifrice ( Oral-B ( ) Pro-Expert Sensitive ) or ( 2 ) a sodium fluoride/potassium nitrate dentifrice ( Sensodyne ( ) Pronamel ( ) ) .


Each study subject wore an intraoral appliance retaining two sterilised , polished human enamel samples for 6 hours/day .


Subjects swished with an allocated dentifrice slurry twice a day and with 250 ml of orange juice for 10 minutes ( 25 ml/minute over a 10-minute period ) four times per day .


The primary and secondary outcomes for this study were enamel loss measured using contact profilometry at days 15 and 5 , respectively , using parametric analysis methods .


At day 15 , a 38 % lower enamel loss ( P < 0.0001 ) was observed , with estimated medians of 2.03 m ( SE 0.247 ) and 3.30 m ( SE 0.379 ) , in favour of the stannous-containing dentifrice .


At day 5 , specimens treated with the stannous-containing sodium fluoride dentifrice demonstrated 25 % less enamel loss than those treated with the sodium fluoride/potassium nitrate dentifrice .


Treatment differences at day 5 were also statistically significant ( P < 0.05 ) , with estimated medians of 1.37 m ( SE 0.177 ) and 1.83 m ( SE 0.223 ) , respectively .


Results of this in situ study suggest the stabilised , stannous-containing sodium fluoride dentifrice could be used to provide significantly greater protection to enamel from erosive acid challenge compared with that provided by conventional fluoride-containing products .


To compare the effectiveness of the alveolar recruitment maneuver and the breath stacking technique with respect to lung mechanics and gas exchange in patients with acute lung injury .


Thirty patients were distributed into two groups : Group 1 - breath stacking ; and Group 2 - alveolar recruitment maneuver .


After undergoing conventional physical therapy , all patients received both treatments with an interval of 1 day between them .


In the first group , the breath stacking technique was used initially , and subsequently , the alveolar recruitment maneuver was applied .


Group 2 patients were initially subjected to alveolar recruitment , followed by the breath stacking technique .


Measurements of lung compliance and airway resistance were evaluated before and after the use of both techniques .


Gas analyses were collected before and after the techniques were used to evaluate oxygenation and gas exchange .


Both groups had a significant increase in static compliance after breath stacking ( p = 0.021 ) and alveolar recruitment ( p = 0.03 ) , but with no significant differences between the groups ( p = 0.95 ) .


The dynamic compliance did not increase for the breath stacking ( p = 0.22 ) and alveolar recruitment ( p = 0.074 ) groups , with no significant difference between the groups ( p = 0.11 ) .


The airway resistance did not decrease for either groups , i.e. , breath stacking ( p = 0.91 ) and alveolar recruitment ( p = 0.82 ) , with no significant difference between the groups ( p = 0.39 ) .


The partial pressure of oxygen increased significantly after breath stacking ( p = 0.013 ) and alveolar recruitment ( p = 0.04 ) , but there was no significant difference between the groups ( p = 0.073 ) .


The alveolar-arterial O2 difference decreased for both groups after the breath stacking ( p = 0.025 ) and alveolar recruitment ( p = 0.03 ) interventions , and there was no significant difference between the groups ( p = 0.81 ) .


Our data suggest that the breath stacking and alveolar recruitment techniques are effective in improving the lung mechanics and gas exchange in patients with acute lung injury .


This randomised , open-label , multicenter phase II study compared progression-free survival ( PFS ) of S-1 plus oxaliplatin ( SOX ) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer .


Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised to receive either S-1 ( 80/100/120mgday ( -1 ) based on body surface area ( BSA ) , orally , days 1-28 , every 6 weeks ) or SOX ( S-1 80/100/120mgday ( -1 ) based on BSA , orally , days 1-14 , plus oxaliplatin 100mgm ( -2 ) , intravenously , day 1 , every 3 weeks ) .


The primary end point was PFS .


Between January 2009 and July 2010 , 271 patients were randomly allocated to either S-1 ( n = 135 ) or SOX ( n = 136 ) .


Median PFS for S-1 and SOX were 2.8 and 3.0 months , respectively ( hazard ratio ( HR ) = 0.84 ; 95 % confidence interval ( CI ) , 0.65-1 .08 ; stratified log-rank test P = 0.18 ) .


Median overall survival ( OS ) was 6.9 vs 7.4 months ( HR = 1.03 ; 95 % CI , 0.79-1 .34 ; stratified log-rank test P = 0.82 ) .


The response rate ( RR ) was 11.5 % vs 20.9 % ( P = 0.04 ) .


The major grade 3/4 toxicities ( S-1 and SOX ) were neutropenia ( 11.4 % and 8.1 % ) , thrombocytopenia ( 4.5 % and 10.3 % ) and anorexia ( 12.9 % and 14.7 % ) .


Although SOX showed an advantage in RR , it provided no significant improvement in PFS or OS compared with S-1 alone .


Changes in cancer therapy , in addition to changes in obesity prevalence , suggest the need for a current assessment of weight gain patterns following breast cancer diagnosis .


The aim of this study was to evaluate factors associated with weight gain among breast cancer survivors prior to enrolling into a behavioral weight loss intervention .


Anthropometric measures and data on weight-related factors were collected at baseline on 665 breast cancer survivors .


Postdiagnosis weight gain was determined between entry into the trial and previous diagnosis up to 5 years .


Multivariate logistic regression analyses were used to evaluate the association between weight gain and influencing factors .


The mean weight gain was 4.5 % body weight ( standard deviation = 10.6 ) ; 44 % of women experienced 5 % body weight gain .


The risk of weight gain was inversely associated with age ( adjusted odds ratio ( ORadj ) = 0.97 , 95 % confidence interval ( 95 % CI ) 0.95-0 .99 ) , Hispanic ethnicity ( ORadj = 0.30 , 95 % CI 0.13-0 .68 ) , and overweight ( ORadj = 0.11 , 95 % CI 0.05-0 .23 ) or obese ( ORadj = 0.03 , 95 % CI 0.02-0 .07 ) status at diagnosis and positively associated with time elapsed since diagnosis ( ORadj = 1.19 / year , 95 % CI 1.04-1 .36 ) .


Women prescribed aromatase inhibitors were 46 % less likely to gain weight compared to women prescribed selective estrogen-receptor modulators ( ORadj = 0.54 , 95 % CI 0.31-0 .93 ) .


The risk of weight gain was positively associated with smoking at diagnosis ( ORadj = 2.69 , 95 % CI 1.12-6 .49 ) although this was attributable to women who subsequently quit smoking .


Postdiagnosis weight gain is common and complex and influenced by age , ethnicity , weight , smoking status , time elapsed since diagnosis , and endocrine-modulating therapy .


Weight gain continues to be a concern following a diagnosis of breast cancer .


Factors influencing this weight gain include age , ethnicity , weight , smoking status , time elapsed since diagnosis , and endocrine-modulating therapy .


Effective weight management strategies are needed for this population of women .


To observe the efficacy on post-stroke mild cognitive impairment ( MCI ) treated with acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy .


Seventy-three of stroke patients were randomized into an acupuncture group ( 37 cases ) and a conventional treatment group ( 36 cases ) .


Twenty healthy aged people in physical examination were collected as a control group .


In the acupuncture group , on the basis of the conventional treatment of internal medication , the acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy were applied .


In the conventional treatment group , no any therapy was used except the conventional treatment of internal medication .


In the control group , no any intervention was adopted .


Neuroscan Nuamps electroencephalogram recording analysis system was used to determine the event-related potentials P300 , and the amplitude and mini mental state examination ( MMSE ) score was observed before and after treatment in both groups .


After treatment , in the acupuncture group , P300 latent stage was shortened , and the amplitude and the score of MMSE were increased ( P < 0.05 , P < 0.01 ) .


In the conventional treatment group , above indices were not changed obviously as compared with that before treatment ( all P > 0.05 ) .


Compared with the conventional treatment group , the differences in P300 latent stage , amplitude and MMSE score were remarkable in the acupuncture group ( P < 0.05 , P < 0.01 ) .


The acupuncture at Jing-well points on the differentiated meridians and temple-three-needle therapy improves the cognitive function of the patients with MCI .


Postural tachycardia syndrome ( POTS ) is characterized clinically not only by an exaggerated increase in heart rate ( HR ) , but an associated cognitive impairment that disables many patients .


Modafinil might be effective in improving the cognitive symptoms , but modafinil may stimulate the sympathetic nervous system and worsen tachycardia in POTS .


We tested the hypothesis that modafinil would worsen tachycardia and orthostatic symptoms in POTS .


Patients with POTS ( n = 54 ) underwent a randomized crossover trial with modafinil 100 mg versus placebo .


Heart rate and systolic blood pressure ( SBP ) were measured seated and standing before modafinil or placebo administration and then hourly for 4 hours .


Over 4 hours , standing HR was not significantly different between the modafinil and placebo groups ( analysis of variance [ ANOVA ] Pdrug = 0.328 ) , but seated SBP was significantly higher in the modafinil group ( mean [ SD ] , 109 [ 12 ] mm Hg vs 104 [ 10 ] mm Hg ; P = 0.004 ) .


Modafinil also significantly increased both the seated SBP ( ANOVA Pdrug = 0.004 ) and the standing SBP ( ANOVA Pdrug = 0.041 ) over time .


There was no significant difference between modafinil and placebo over the 4-hour period with regard to POTS symptom burden scores ( 14 [ 12 ] vs 14 [ 12 ] ; P = 0.962 ) .


Modafinil did not significantly worsen standing HR or acute orthostatic symptoms in patients with POTS compared with the placebo group and improved upright blood pressure .


Therefore , modafinil could be tested as a potential treatment for the cognitive impairment in POTS .


To evaluate changes in anterior corneal topography and higher-order aberrations ( HOA ) after 14-days of rigid gas-permeable ( RGP ) contact lens ( CL ) wear in keratoconus subjects comparing two different fitting approaches .


Thirty-one keratoconus subjects ( 50 eyes ) without previous history of CL wear were recruited for the study .


Subjects were randomly fitted to either an apical-touch or three-point-touch fitting approach .


The lens ' back optic zone radius ( BOZR ) was 0.4 mm and 0.1 mm flatter than the first definite apical clearance lens , respectively .


Differences between the baseline and post-CL wear for steepest , flattest and average corneal power ( ACP ) readings , central corneal astigmatism ( CCA ) , maximum tangential curvature ( KTag ) , anterior corneal surface asphericity , anterior corneal surface HOA and thinnest corneal thickness measured with Pentacam were compared .


A statistically significant flattening was found over time on the flattest and steepest simulated keratometry and ACP in apical-touch group ( all p < 0.01 ) .


A statistically significant reduction in KTag was found in both groups after contact lens wear ( all p < 0.05 ) .


Significant reduction was found over time in CCA ( p = 0.001 ) and anterior corneal asphericity in both groups ( p < 0.001 ) .


Thickness at the thinnest corneal point increased significantly after CL wear ( p < 0.0001 ) .


Coma-like and total HOA root mean square ( RMS ) error were significantly reduced following CL wearing in both fitting approaches ( all p < 0.05 ) .


Short-term rigid gas-permeable CL wear flattens the anterior cornea , increases the thinnest corneal thickness and reduces anterior surface HOA in keratoconus subjects .


Apical-touch was associated with greater corneal flattening in comparison to three-point-touch lens wear .


The current debate on overdiagnosis and overtreatment of screen-detected ductal carcinoma in situ ( DCIS ) urges the need for prospective studies to address this issue .


A substantial number of DCIS lesions will never form a health hazard , particularly if it concerns non - to slow-growing low-grade DCIS .


The LORD study aims to evaluate the safety of active surveillance in women with low-risk DCIS .


This is a randomised , international multicentre , open-label , phase III non-inferiority trial , led by the Dutch Breast Cancer Research Group ( BOOG 2014-04 ) and the European Organization for Research and Treatment of Cancer ( EORTC-BCG 1401 ) .


Standard treatment will be compared to active surveillance in 1240 women aged 45 years with asymptomatic , screen-detected , pure low-grade DCIS based on vacuum-assisted biopsies of microcalcifications only .


Both study arms will be monitored with annual digital mammography for a period of 10 years .


The primary end-point is 10-year ipsilateral invasive breast cancer free percentage .


Secondary end-points include patient reported outcomes , diagnostic biopsy rate during follow-up , ipsilateral mastectomy rate and translational research .


To explore interest in and feasibility of the LORD study we conducted a survey among EORTC and BOOG centres .


A vast majority of EORTC and BOOG responding centres expressed interest in participation in the LORD study .


The proposed study design is endorsed by nearly all centres .


Although falls in people with Parkinson 's disease ( PD ) associate with dual tasking and freezing of gait ( FoG ) , it is not known whether falls during dual tasking are due to FoG .


This study investigated the effects of a cognitive task on the occurrence of falls and FoG when subjects with PD step in response to a postural perturbation .


Ten subjects with PD and a history of FoG as well as 10 age-matched subjects without PD stepped in response to large , backward displacements of the support surface , with and without performing a fluency task of listing items in a category .


Subjects with PD performed the task in the `` off '' and `` on '' dopaminergic medication states .


We recorded the percentage of trials with FoG ( a lack of step in response to the perturbation ) , foot-lift latencies , and trials with falls into a safety harness .


Dual tasking significantly increased the incidence of falls in people with PD , but subjects without PD did not fall in any condition .


Dual tasking did not significantly increase trials without steps or foot-lift latencies .


Falls were often coincident with a lack of step ( FoG ) in the single-task condition , but the increased falls with dual tasking occurred on trials with steps .


Levodopa tended to decrease FoG and falls with or without dual tasking .


However , medication did not significantly alter the effects of dual tasking on FoG or falls .


For people with PD and FoG , forward falls may not always be caused by FoG , particularly under attention-distracting conditions .


Observational studies suggest that breastfeeding benefits later maternal child-feeding practices , which in turn may contribute to positive eating attitudes .


We investigated the effect of a randomized intervention to increase duration and exclusivity of breastfeeding on pre-adolescent eating attitudes .


Long-term follow-up of the Promotion of Breastfeeding Intervention Trial ( PROBIT ) , a cluster-randomized trial in 31 maternity hospitals and affiliated polyclinics in Belarus .


Sites were randomly assigned an experimental intervention to promote longer duration and exclusivity of breastfeeding in mothers who initiated breastfeeding ( n = 16 sites ) , or a control intervention of continuing usual care ( n = 15 sites ) ; 17 046 healthy infants were enrolled in 1996-7 , of whom 13 751 ( 80.7 % ) completed the Children 's Eating Attitude Test ( ChEAT ) at 11.5 years of age .


A ChEAT score 22.5 ( 85th percentile ) was used as an indicator of problematic eating attitudes .


Analysis was based on intention-to-treat , accounting for clustering within hospitals/clinics .


Compared with the control arm , the experimental intervention substantially increased breastfeeding exclusivity ( 43.3 % vs 6.4 % exclusively breastfed at 3 months of age ) and duration of any breastfeeding throughout infancy .


The proportion of children with ChEAT scores 22.5 was lower in the experimental than control arm ( boys 11.4 % vs 17.2 % ; girls 18.5 % vs 23.4 % ) [ cluster-adjusted odds ratio ( OR ) , boys : 0.44 ; 95 % confidence interval ( CI ) : 0.21,0.93 ; girls : 0.51 ; 95 % CI : 0.27,0.99 ) .


Results were robust to adjustment for potential confounders and using a ChEAT score 25.5 ( 91st percentile ) as the outcome ( OR : 0.53 ; 95 % CI : 0.28,1.03 ) .


An intervention to improve the duration and exclusivity of breastfeeding among term infants in Belarus was associated with a reduction in problematic eating attitudes at 11.5 years of age .


This qualitative study examines performance bias , i.e. unintended differences between groups , in the context of a weight loss trial in which a novel patient counseling program was compared to usual care in general practice .


14/381 consecutive interviewees ( 6 intervention group , 8 control group ) within the CAMWEL ( Camden Weight Loss ) effectiveness trial process study were asked about their engagement with various features of the research study and a thematic content analysis undertaken .


Decisions to participate were interwoven with decisions to change behavior , to the extent that for many participants the two were synonymous .


The intervention group were satisfied with their allocation .


The control group spoke of their disappointment at having been offered usual care when they had taken part in the trial to access new forms of help .


Reactions to disappointment involved both movements toward and away from behavior change .


There is a prima facie case that reactions to disappointment may introduce bias , as they lead the randomized groups to differ in ways other than the intended experimental contrast .


In-depth qualitative studies nested within trials are needed to understand better the processes through which bias may be introduced .


To evaluate serum pharmacokinetics of tapentadol administered to healthy subjects as extended-release ( ER ) tablets .


Seven single-dose studies ( five randomized , crossover , bioequivalence studies ; a study in Japanese men ; and a randomized , crossover , effects-of-food study ) and one repeated-dose study .


Clinical research settings in the United States and The Netherlands .


Healthy males and females were enrolled into seven studies ; one study enrolled only Japanese males .


In the bioequivalence studies , subjects first received one polyethylene oxide - or hypromellose-based tapentadol ER tablet ( 50 , 100 , 150 , 200 , or 250 mg ; one dose per study ) , then ( after washout ) the other formulation ( matching dose ) .


In all other studies , subjects received polyethylene oxide-based tapentadol ER tablets .


In the repeated-dose study , subjects received one 250 mg tablet , then ( after washout ) one 250 mg tablet every 12 hours ( five doses ) .


In the food-effect study , subjects received one 250 mg tablet within 30 minutes after a high-fat meal or after 10 hours of fasting .


In the study in Japanese men , subjects received one 100 mg tablet .


Maximum tapentadol concentrations ( Cmax ) were typically observed 5 hours after dosing .


Mean terminal half-life values ranged from 4.4 to 5.9 hours .


Tapentadol Cmax and AUC values increased proportionally following single ER ( polyethylene oxide-based tablets ) doses of 50 to 250 mg .


Trough tapentadol concentrations increased during repeat dosing until reaching steady-state by the third dose .


Serum Cmax and area under the concentration-time curve ( AUC ) values at steady state were 1.6 and 1.9 times higher relative to single-dose administration .


Coadministration of the 250 mg dose with a high-fat meal increased Cmax and AUC values by an average of < 17 percent .


The pharmacokinetics of tapentadol ER are consistent after repeated and single-dose administration .


Tapentadol ER may be administered without regard to food intake .


No clinically significant differences were observed in the pharmacokinetics of tapentadol between Japanese and Caucasian subjects .


Children often require relief of pain and anxiety when undergoing painful procedures .


To determine the differences by comparing fentanyl and ketamine used in cancer-diagnosed children undergoing painful procedures .


A randomized , double-blinded , crossover trial was conducted with 55 children undergoing painful procedures ( intrathecal chemotherapy and/or bone marrow aspiration/biopsy ) .


Patients were randomly assigned in a double-blinded fashion to receive either intravenous fentanyl or ketamine at 1 mcg/kg/dose and 1 mg/kg/dose , respectively .


The result in effectiveness of the drug was measured using three parameters , 1 ) satisfaction score ranging from 0 to 10 , 2 ) perception of procedural pain using FLACC scale , Wong-Baker FACES Pain Rating Scale and Visual Analog Scale , and 3 ) the frequency of vomiting nausea score .


The satisfaction amongpatients receiving fentanyl was significantly greater than ketamine ( p = 0.007 ) .


In addition , both painful and nausea/vomiting were significantly decreased in the patients receiving fentanyl ( p = 0.002 and p < 0.001 , respectively ) .


No serious complications were observed


This study demonstrated that intravenous fentanyl generated a superior clinical effect in satisfaction , decreased pain and nausea/vomiting , and showed no significant side-effects over ketamine .


Fentanyl may also be recommended as a reasonable option before undergoing oncology procedures in children with cancer .


Coronary heart disease ( CHD ) places a major burden on the Australian health care system .


Determining the likelihood of CHD in a patient presenting with chest pain can be particularly difficult in a remote setting where access to transportation and specialised investigations including myocardial stress studies and coronary angiography can be difficult and delayed .


The objective is to develop a predictive model for determining the risk of CHD , including the value of high sensitivity C-reactive protein ( hsCRP ) , in patients presenting with chest pain with a particular emphasis on resources and information likely to be available in a remote primary health care setting .


A prospective , cross-sectional observational study of patients with no prior diagnosis of CHD presenting to a specialist chest pain assessment clinic at Cairns Hospital from November 2012 to May 2013 .


Out of the 163 participants included in the study analyses , a total of 38 were classified as CHD likely ( 23.3 % ( 95 % CI 17.1-30 .6 ) ) .


Logistic regression modelling identified two factors that were independently associated with likely CHD , namely the presence of typical chest pain ( OR 83.7 ( 95 % CI 21.7-322 .1 ) ) and an abnormal baseline ECG ( OR 12.8 ( 95 % CI 1.9-86 .0 ) ) .


In this study , it was demonstrated that the presence of typical chest pain and an abnormal resting ECG , remain the cornerstone of predicting a subsequent diagnosis of CHD .


This information is easily accessible in remote primary health care and should be utilised to expedite assessment in patients presenting with symptoms suggestive of CHD .


To determine whether ciclosporin is superior to prednisolone for the treatment of pyoderma gangrenosum , a painful , ulcerating skin disease with a poor evidence base for management .


Multicentre , parallel group , observer blind , randomised controlled trial .


39 UK hospitals , recruiting from June 2009 to November 2012 .


121 patients ( 73 women , mean age 54 years ) with clinician diagnosed pyoderma gangrenosum .


Clinical diagnosis was revised in nine participants after randomisation , leaving 112 participants in the analysis set ( 59 ciclosporin ; 53 prednisolone ) .


Oral prednisolone 0.75 mg/kg/day compared with ciclosporin 4 mg/kg/day , to a maximum dose of 75 and 400 mg/day , respectively .


The primary outcome was speed of healing over six weeks , captured using digital images and assessed by blinded investigators .


Secondary outcomes were time to healing , global treatment response , resolution of inflammation , self reported pain , quality of life , number of treatment failures , adverse reactions , and time to recurrence .


Outcomes were assessed at baseline and six weeks and when the ulcer had healed ( to a maximum of six months ) .


Of the 112 participants , 108 had complete primary outcome data at baseline and six weeks ( 57 ciclosporin ; 51 prednisolone ) .


Groups were balanced at baseline .


The mean ( SD ) speed of healing at six weeks was -0.21 ( 1.00 ) cm ( 2 ) / day in the ciclosporin group compared with -0.14 ( 0.42 ) cm ( 2 ) / day in the prednisolone group .


The adjusted mean difference showed no between group difference ( 0.003 cm ( 2 ) / day , 95 % confidence interval -0.20 to 0.21 ; P = 0.97 ) .


By six months , ulcers had healed in 28/59 ( 47 % ) participants in the ciclosporin group compared with 25/53 ( 47 % ) in the prednisolone group .


In those with healed ulcers , eight ( 30 % ) receiving ciclosporin and seven ( 28 % ) receiving prednisolone had a recurrence .


Adverse reactions were similar for the two groups ( 68 % ciclosporin and 66 % prednisolone ) , but serious adverse reactions , especially infections , were more common in the prednisolone group .


Prednisolone and ciclosporin did not differ across a range of objective and patient reported outcomes .


Treatment decisions for individual patients may be guided by the different side effect profiles of the two drugs and patient preference .


Trial registration Current Controlled Trials ISRCTN35898459 .


To assess otolaryngology physician knowledge of and attitudes toward the Patient Protection and Affordable Care Act ( PPACA ) and compare the association of bias toward the PPACA with knowledge of the provisions of the PPACA .


Cross-sectional survey .


Nationwide assessment .


Members of the American Academy of Otolaryngology-Head and Neck Surgery .


Otolaryngology physicians answered 10 true/false questions about major provisions of the PPACA .


They also indicated their level of agreement with 9 statements about health care and the PPACA .


Basic demographic information was collected .


Email solicitation was sent to 9972 otolaryngologists and 647 responses were obtained ( 6.5 % response rate ) .


Overall correct response rate was 74 % .


Fewer than 60 % of physicians correctly answered questions on whether small businesses receive tax credits for providing health insurance , the effect of the PPACA on Medicare benefits , and whether a government-run health insurance plan was created .


Academic center practice setting , bias toward the PPACA , and Democratic Party affiliation were associated with significantly more correct responses .


Overall physician knowledge of the PPACA is assessed as fair , although better than the general public in 2010 .


There are several areas where knowledge of physicians regarding the PPACA is poor , and this knowledge deficit is more pronounced within certain subgroups .


These knowledge issues should be addressed by individual physicians and medical societies .


Despite treatment with glucocorticoids , mortality remains high in patients with severe alcoholic hepatitis .


Oxidative stress and depletion of mitochondrial glutathione are implicated factors in liver injury .


The aim of this study was to evaluate the impact of the addition of metadoxine , a drug which possesses a multifactorial mechanism of action , including antioxidant properties , to standard treatment with glucocorticoids in patients with severe alcoholic hepatitis .


This randomized open label clinical trial was performed in Mexico 's General Hospital ( Registry Key DIC/10/107 / 03/043 ) .


We randomized 70 patients with severe alcoholic hepatitis .


The first group received prednisone ( 40 mg/day ) , and the second group received prednisone ( 40 mg/day ) plus metadoxine tablets ( 500 mg three times daily ) .


The duration of treatment in both groups was 30 days .


Survival at 30 and 90 days , development of complications , adverse events and response to treatment ( Lille model ) were assessed .


In the group receiving metadoxine , significant improvements were observed , as follows : survival at 30 days ( 74.3 vs. 45.7 % , P = 0.02 ) ; survival at 90 days ( 68.6 vs. 20.0 % , P = 0.0001 ) .


There was less development or progression of encephalopathy ( 28.6 vs. 60.0 % , P = 0.008 ) and hepatorenal syndrome ( 31.4 vs. 54.3 % , P = 0.05 ) , and the response to treatment ( Lille model ) was higher in the metadoxine group ( 0.38 vs. 0.63 , P = 0.001 ; 95 % CI 0.11 to 0.40 ) .


There were no differences between groups regarding the development or progression of variceal hemorrhage or infection .


The incidence of adverse events , mainly gastrointestinal , was similar in both groups .


Addition of metadoxine to glucocorticoid treatment improves the short-term survival of patients with severe alcoholic hepatitis and diminishes the development or progression of encephalopathy and hepatorenal syndrome .


Kidney transplantation is associated with rapid loss of bone mineral density ( BMD ) in the first months after transplantation .


The effect of pamidronate on bone loss after transplantation was evaluated in a randomized controlled trial .


Forty patients were enrolled in this study ( 16 in the pamidronate group and 24 in the control group ) .


Pamidrinate was administered as 30-mg intravenous infusion within 2 days after transplantation and 3 months later .


All of the patients received calcium and vitamin D supplementation .


Laboratory parameters and BMD ( lumbar spine and femoral neck ) were measured at baseline and 6 months after kidney transplantation .


Bone mineral density at the initiation of study had no significant differences between the two groups .


In each group , BMD of femoral neck and lumbar spine had no significant differences 6 months after transplantation in comparison to pretransplantation values .


There was no significant difference in BMD changes after intervention between two groups .


Parathyroid hormone level normalized in both of the pamidronate and control groups 6 months after kidney transplantation .


Glomerular filtration rate at the end of study was not significantly different between the two groups .


Our study suggests that administration of calcium and vitamin D following transplantation may be beneficial to counterbalance the substantial bone loss occurring within 6 months after transplantation , and addition of pamidronate has no beneficial effect in BMD in this short interval after kidney transplantation .


To compare the efficacy of metformin plus megestrol acetate ( MA ) with that of MA alone for treating endometrial atypical hyperplasia ( EAH ) .


This pilot study included 16 EAH patients who met at least one metabolic syndrome ( MS ) criterion and received either adjunctive metformin plus MA ( MET group ) or MA monotherapy ( MA group ) .


Each patient in the MA group received 160 mg of MA daily , whereas patients in the MET group received the same dose of MA plus 0.5 g of metformin thrice daily .


Treatment response was assessed by histological examination of dilation and curettage specimens obtained after 12 weeks of therapy .


Each group had eight patients , and half of the patients in each group were diagnosed with MS. The complete response ( CR ) rate was 75 % ( 6/8 ) in the MET group and 25 % ( 2/8 ) in the MA group ( p = 0.105 ) .


Complications of MS did not affect the response rates in either group .


In the MET group , 75 % ( 3/4 ) of the patients had CR in the presence or absence of MS. In the MA group , 50 % ( 2/4 ) of the patients with MS had CR , whereas no patient without MS had CR .


No irreversible toxicities were observed .


Metformin plus MA may be a potential alternative therapy for treating EAH , and the MS status of patients may have no effect on the efficacy of metformin plus MA therapy .


Real-time virtual sonography is an innovative imaging technology that detects the spatial position of an ultrasound probe and immediately reconstructs a section of computed tomography ( CT ) and/or magnetic resonance in accordance with the ultrasound image , thereby allowing a real-time comparison of those modalities .


A novel intraoperative navigation system for liver resection using real-time virtual sonography has been devised for the detection of tumors and navigation of the resection plane .


Sixteen patients with hepatic malignancies ( 26 tumors in total ) were involved in this study , and the system was used intraoperatively .


The tumor size ranged 2 to 140 mm ( 23 mm in median ) .


By the navigation system , operators could refer intraoperative ultrasound image displayed on the television monitor side-by-side with corresponding images of CT and/or magnetic resonance .


In addition , the system overlaid preoperative simulation on the CT image and highlighted the extent of resection so as to navigate the resection plane .


Because the system used electromagnetic power in the operation room , the feasibility and safety of the system was investigated as well as its validity .


The system could be used uneventfully in each operation .


All of the 26 tumors scheduled to be resected were detected by the navigation system .


The weight of the resected specimen correlated with the preoperatively simulated volume ( R = 0.995 , P < .0001 ) .


The feasibility and safety of the navigation system were confirmed .


The system should be helpful for intraoperative tumor detection and navigation of liver resection .


Anemia is a significant public health concern , especially among women and young children .


An improved understanding of the complex etiology of anemia is crucial for developing appropriate prevention strategies .


This paper examines the determinants of anemia in a large sample of Vietnamese women of reproductive age ( WRA ) .


We included baseline data from 4986 WRA participating in a randomized controlled trial ( PRECONCEPT ) .


Hemoglobin ( Hb ) concentrations were measured with Hemocue .


Plasma ferritin ( Fe ) , retinol binding protein ( RBP ) and markers of inflammation were assessed using the ELISA technique .


We used multivariate logistic regression to describe associations with anemia and structural equation modeling ( SEM ) to characterize direct and indirect pathways influencing Hb concentrations .


Prevalence of anemia , iron deficiency ( Fe < 12 g/l ) , insufficient iron stores ( Fe < 30 g/l ) and iron deficiency anemia was 19.7 , 3.5 , 14.4 and 1.9 % , respectively .


Ferritin concentration ( 0.29 per log-mg/dl ) , being an ethnic minority ( -0.24 compared with Kinh ) , number of children ( -0.17 ) and socioeconomic status ( 0.09 ) were directly associated with Hb concentration ( P < 0.05 ) .


Similarly , RBP was directly ( 0.27 per mg/dl ) associated with Hb and also indirectly ( 0.09 mg/dl ) with ferritin .


Hookworm infection was indirectly associated with Hb ( -0.11 ) through RBP and ferritin .


These findings illustrate the complex etiology of anemia and provide a useful framework for designing , targeting and evaluating appropriate strategies for the prevention and control of anemia .


Contrary to expectations , iron deficiency accounted for a very small proportion of anemia in Northern Vietnam .


The recent enormous increase in colonoscopy demand prompted this multicentre observational study assessing overall acceptability and efficacy of commonly used bowel preparations in Italian clinical practice .


Consecutive outpatients undergoing colonoscopy were recruited from 9 major gastroenterological centres in Italy .


Each patient evaluated overall acceptability of the bowel cleansing preparation through a 0-100mm Visual Analogue Scale .


The Visual Analogue Scale score was dichotomized by a median split : 80-100 ( high acceptability ) vs. 0-79 ( low acceptability ) .


Bowel cleansing was assessed through a validated scale .


The influence of potential individual determinants on patients ' acceptability and cleansing efficacy of the bowel preparations was determined by multivariate analyses .


599 evaluable patients were enrolled ; 57.3 % received 4L-PEG preparations , 29.5 % 2L-PEG preparations and 13.2 % 2-glasses-solutions ( Na-phosphate/Mg-citrate/Na-picosulphate-containing preparations ) .


Overall acceptability was significantly higher for 2L-PEG and 2-glasses solutions than 4L-PEG ( adjusted odds ratio , 4.72 ; and adjusted odds ratio 2.07 , respectively ) .


Successful bowel cleansing achieved with 4L-PEG ( 85.9 % ) was similar to 2L-PEG ( 85.3 % ; adjusted odds ratio 0.82 ) and significantly higher than 2-glasses solutions ( 69.6 % ; adjusted odds ratio 0.34 vs. 4L-PEG ) .


Split regimen , lower total preparation volume and colonoscopy reason ( periodical control vs. 1st procedure ) were significantly associated with high acceptability .


Age 60 years , dissatisfaction with the preparation taken , and 4/week bowel movements were major determinants of a poor bowel cleansing .


2L-PEG and 4L-PEG preparations provide the most effective bowel cleansing for colonoscopy in clinical practice , with a significantly higher acceptability for 2L-PEG preparations .


The prognostic importance of anemia for cardiovascular ( CV ) events and mortality has been extensively investigated .


However , little is known about the impact of transferrin saturation ( TSAT ) , a marker reflecting the availability of iron for erythropoiesis , on clinical outcome in dialysis patients .


A total of 879 anemic incident dialysis patients were recruited from the Clinical Research Center for End-Stage Renal Disease in Korea and were divided into 3 groups according to baseline TSAT of 20 % , 20-40 % , and > 40 % .


There were no differences in hemoglobin levels and the proportion of patients on erythropoiesis-stimulating agents or iron supplements among the 3 groups .


During a mean follow-up duration of 19.3 months , 51 ( 5.8 % ) patients died .


CV composite ( 11.71 vs. 5.55 events/100 patient-years , P = 0.001 ) and all-cause mortality rates ( 5.38 vs. 2.31 events/100 patient-years , P = 0.016 ) were significantly higher in patients with TSAT 20 % compared to those with TSAT 20-40 % ( reference group ) .


Cox regression analysis revealed that patients with TSAT 20 % had 1.62 - and 2.19-fold higher risks for CV composite outcome ( P = 0.046 ) and all-cause mortality ( P = 0.030 ) .


Moreover , TSAT 20 % was significantly associated with left ventricular hypertrophy [ odds ratio ( OR ) = 1.46 ] , high-sensitivity C-reactive protein 3 mg/dL ( OR = 2.09 ) , N-terminal pro B-type natriuretic peptide 10000 pg/mL ( OR = 2.04 ) , and troponin-T0 .1 ng/mL ( OR = 2.02 ) , on logistic regression analysis .


Low TSAT was a significant independent risk factor for adverse clinical outcome in incident dialysis patients with anemia , which may be partly attributed to cardiac dysfunction and inflammation .


Auvi-Q is a novel epinephrine autoinjector ( EAI ) that provides audio and visual cues for patients at risk for life-threatening allergic reactions .


We tested the preference for Auvi-Q or EpiPen with regard to method of instruction , preference to carry , device size , and device shape .


This large , multicenter , simulated-use study evaluated whether adults ( aged 18-65 years ) , caregivers ( parents/guardians aged 18-65 years of children aged 5-17 years ) , and children ( aged 11-17 years ) , with and without experience in using an EAI , had a preference for the current design of Auvi-Q or the current design of EpiPen .


Participants were given a scenario that involved anaphylaxis and were instructed to simulate use of an EAI .


They received and tested each device individually according to the randomization assignment .


After testing both devices , they completed a survey to indicate their preference for Auvi-Q versus EpiPen .


Among all 693 participants combined , Auvi-Q was preferred over EpiPen on all study end points ( P < .001 ) .


For experienced and inexperienced participants in all 3 groups ( adults , caregivers , and children ) , Auvi-Q was preferred over EpiPen for method of instruction , preference to carry , and device size ( all P < .001 ) .


The preference for Auvi-Q device shape was not significant among experienced children ( P = .10 ) ; however , it was significant for inexperienced children ( P = .04 ) and highly significant for experienced and inexperienced adults and caregivers ( P < .001 ) .


In this large multicenter , simulated-use study , Auvi-Q was preferred over EpiPen by experienced and inexperienced adults , caregivers , and children .


To observe the difference in the clinical efficacy on peripheral facial palsy between electro-acupuncture ( EA ) assisted with surface electromyography ( sEMG ) and conventional EA .


Sixty cases of peripheral facial palsy were randomized into an observation group and a control group , 30 cases in each one .


EA was applied during the first 15 days of sickness in the two groups , at Xiaguan ( ST 7 ) , Jiache ( ST 6 ) , Dicang ( ST 4 ) , Yangbai ( GB 14 ) , Taiyang ( EX-HN 5 ) , Quanliao ( SI 18 ) and Hegu ( LI 4 ) , once a day .


In the observation , group , 15 days after sickness , according to the situation in sEMG , on the basis of the acupoints in the previous treatment , the corresponding acupoints were reselected for EA .


In the control group , the conventional EA was kept on .


The treatment was given once every two days till the 35th day of sickness .


Separately , on the 5th , 15th and 35th days of sickness , according to the detection of sEMG in the patients of two groups , the means ratios of : root mean square ( RMS ) of musculi buccinators , orbicularis oris , frontalis and nasalis on the healthy and affected sides were recorded and analyzed .


The differences of ratio in RMS of musculi buccinators , orbicularis oris , frontalis and nasalis on the healthy and affected sides were significant statistically in comparison between the , 15th day and the 5th day , and between the 35th day and the 15th day of sickness within each group ( all P < 0.01 ) .


The differences of ratio in RMS of the muscles on the healthy and affected sides were significant statistically on the 15th and 35th days between the two groups ( all P < 0.05 ) .


EA assisted with sEMG achieves the significant efficacy on peripheral facial palsy , better than the conventional EA .


Interleukin-13 ( IL-13 ) has been implicated as a key driver of UC .


This trial evaluates the efficacy and safety of tralokinumab , an IL-13-neutralising antibody , as add-on therapy in adults with moderate-to-severe UC despite standard treatments .


Non-hospitalised adults with UC ( total Mayo score 6 ) were randomised to receive tralokinumab 300mg or placebo subcutaneously every 2weeks for 12weeks .


The primary end point was the rate of clinical response at week 8 .


Secondary efficacy end points included clinical remission and mucosal healing rates at week 8 and changes in total Mayo score , total modified Riley score , partial Mayo score and disease activity markers .


Clinical response rate was 38 % ( 21/56 ) for tralokinumab vs. 33 % ( 18/55 ) for placebo ( p = 0.406 ) .


Clinical remission rate was 18 % ( 10/56 ) vs. 6 % ( 3/55 ) ( p = 0.033 ) and mucosal healing rate was 32 % ( 18/56 ) vs. 20 % ( 11/55 ) ( p = 0.104 ) for tralokinumab vs placebo .


Changes to week 8 in total Mayo score and total modified Riley score were similar for tralokinumab and placebo ( least-squares mean difference between groups : -0.49 ( p = 0.394 ) and 0.25 ( p = 0.449 ) , respectively ) .


Partial Mayo score at week 4 was lower with tralokinumab than placebo ( least-squares mean difference between groups : -0.90 ( p = 0.041 ) ) .


No consistent patterns were observed for disease activity markers .


Tralokinumab had an acceptable safety profile .


Add-on therapy with tralokinumab did not significantly improve clinical response .


However , the higher clinical remission rate with tralokinumab than placebo suggests that tralokinumab may benefit some patients with UC .


Tralokinumab was well tolerated .


ClinicalTrials.gov number : NCT01482884 .


Colorectal cancer is the second-leading cause of cancer deaths in the United States .


The Strategies and Opportunities to Stop Colorectal Cancer ( STOP CRC ) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics .


The study will assess the effectiveness of a system-based intervention designed to improve the rates of colorectal-cancer screening using fecal immunochemical testing ( FIT ) in federally qualified health centers in Oregon and Northern California .


STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics .


Clinics will be randomized to one of two arms .


Clinics in the intervention arm ( 1 ) will use an automated , data-driven , electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits ( with pictographic instructions ) to them ; ( 2 ) will conduct an improvement process ( e.g. Plan-Do-Study-Act ) to enhance the adoption , reach , and effectiveness of the program .


Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits .


The primary outcomes are : proportion of age - and screening-eligible patients completing a FIT within 12months ; and cost , cost-effectiveness , and return on investment of the intervention .


This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients , including many with historically low colorectal-cancer screening rates .


If successful , the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates .


To compare the effect of monovision correction and multifocal intraocular lens ( IOL ) implantation on patient satisfaction , spectacle dependence , visual acuity , and dysphotopsia in cataract patients .


University Hospital of Alexandroupolis , Democritus University of Thrace , Alexandroupolis , Greece .


Prospective randomized trial .


Patients with a diagnosis of senile cataract with stage 2 nuclear opalescence were randomly assigned to 2 groups : monovision and multifocal IOL implantation .


Uncorrected ( UDVA ) and corrected ( CDVA ) distance visual acuity , Visual Function Index-14 ( VF-14 ) scores , and spectacle dependence were assessed prior to surgery and 6 months postoperatively .


The monovision group comprised 38 patients and the multifocal IOL implantation group , 37 patients .


Both techniques provided excellent refractive outcomes in UDVA and VF-14 scores ( all P < .01 ) .


No significant intergroup differences were detected in VF-14 scores at the final postoperative examination .


The monovision group patients presented significantly more spectacle dependence for near vision but less glare .


Monovision and multifocal IOL implantation provided excellent refractive outcomes for distance vision .


Multifocal IOL insertion was associated with less dependence on glasses overall but significantly more dysphotopsia .


No author has a financial or proprietary interest in any material or method mentioned .


This pilot study was set up to examine the effects of a continuous postoperative wound infusion system with a local anaesthetic on perioperative pain and the consumption of analgesics .


We included 42 patients in this prospective observational pilot study .


Patients were divided into two groups .


One group was treated in accordance with the WHO standard pain management protocol and in addition to that received a continuous local wound infusion treatment ( Group 1 ) .


Group 2 was treated with analgesics in accordance with the WHO standard pain management protocol , exclusively .


The study demonstrated a significantly reduced postoperative VAS score for stump pain in Group 1 for the first 5 days .


Furthermore , the intake of opiates was significantly reduced in Group 1 ( day 1 , Group 1 : 42.1 vs. Group 2 : 73.5 , p = 0.010 ; day 2 , Group 1 : 27.7 vs. Group 2 : 52.5 , p = 0.012 ; day 3 , Group 1 : 23.9 vs. Group 2 : 53.5 , p = 0.002 ; day 4 , Group 1 : 15.7 vs. Group 2 : 48.3 , p = 0.003 ; day 5 , Group 1 13.3 vs. Group 2 : 49.9 , p = 0.001 ) .


There were no significant differences between the two groups , neither in phantom pain intensity at discharge nor postoperative complications and death .


Continuous postoperative wound infusion with a local anaesthetic in combination with a standard pain management protocol can reduce both stump pain and opiate intake in patients who have undergone transfemoral amputation .


Phantom pain was not significantly affected .


Responses to a number of different plasticity-inducing brain stimulation protocols are highly variable .


However there is little data available on the variability of response to transcranial direct current stimulation ( TDCS ) .


We tested the effects of TDCS over the motor cortex on corticospinal excitability .


We also examined whether an individual 's response could be predicted from measurements of onset latency of motor evoked potential ( MEP ) following stimulation with different orientations of monophasic transcranial magnetic stimulation ( TMS ) .


Fifty-three healthy subjects participated in a crossover-design .


Baseline latency measurements with different coil orientations and MEPs were recorded from the first dorsal interosseous muscle prior to the application of 10 min of 2 mA TDCS ( 0.057 mA/cm2 ) .


Thirty MEPs were measured every 5 min for up to half an hour after the intervention to assess after-effects on corticospinal excitability .


Anodal TDCS at 2 mA facilitated MEPs whereas there was no significant effect of 2 mA cathodal TDCS .


A two-step cluster analysis suggested that approximately 50 % individuals had only a minor , or no response to TDCS whereas the remainder had a facilitatory effect to both forms of stimulation .


There was a significant correlation between the latency difference of MEPs ( anterior-posterior stimulation minus latero-medial stimulation ) and the response to anodal , but not cathodal TDCS .


The large variability in response to these TDCS protocols is in line with similar studies using other forms of non-invasive brain stimulation .


The effects highlight the need to develop more robust protocols , and understand the individual factors that determine responsiveness .


To evaluate the efficacy and safety of solifenacin in the management of irritative symptoms after transurethral resection of bladder tumors ( TURBTs ) with subsequent intravesical chemotherapy .


A total of 116 patients undergoing TURBT were randomly allocated into 2 groups , 58 patients in each group .


Group 1 patients received solifenacin 5 mg , 6 hours before surgery and 5 mg per day , after surgery for 2 weeks , whereas group 2 patients received a placebo .


Patients with low-risk non-muscle-invasive bladder cancer received immediate postoperative instillation of epirubicin .


Patients with medium - or high-risk non-muscle-invasive bladder cancer received postoperative instillation twice within 2 weeks , once immediately following the operation and once on the eighth postoperative day .


All patients completed bladder diaries before surgery , on the 1st , 7th , and 14th days after removal of the catheter with overactive bladder symptom scores completed preoperatively , and on the 7th and 14th days .


Additionally , the incidence and severity of catheter-related bladder discomfort were recorded at 6 , 12 , 24 , 48 , and 72 hours after the surgery .


The incidence and the severity of catheter-related bladder discomfort in group 1 , compared with group 2 , were significantly reduced ( P < .05 ) .


There was a significant difference in overactive bladder symptom scores between the 2 groups ( 5.67 vs 7.86 ; P < .001 ) .


Episodes of daytime , frequency , nocturia , urgency , and urge urinary incontinence in group 1 were also significantly lower than in group 2 ( P < .05 ) .


This study demonstrates that solifenacin can be beneficial for the management of irritative symptoms after TURBT with subsequent intravesical chemotherapy .


Oxaliplatin-based adjuvant therapy is the standard of care for stage III colon cancer .


Adjuvant capecitabine with or without oxaliplatin versus leucovorin and fluorouracil with or without oxaliplatin has not been directly compared ; therefore , we aimed to analyse the efficacy and safety of these treatments using individual patient data pooled from four randomised controlled trials .


We also assessed post-relapse survival , which has been postulated to be worse in patients receiving adjuvant oxaliplatin .


Patients with resected stage III colon cancer who were 18 years of age or older , with an Eastern Cooperative Oncology Group performance status of 0 or 1 , from four randomised controlled trials ( NSABP C-08 , XELOXA , X-ACT , and AVANT ; 8734 patients in total ) were pooled and analysed .


The treatment regimens included in our analyses were : XELOX ( oxaliplatin and capecitabine ) ; leucovorin and fluorouracil ; capecitabine ; FOLFOX-4 ( leucovorin , fluorouracil , and oxaliplatin ) ; and modified FOLFOX-6 ( mFOLFOX-6 ) .


Disease-free survival was the primary endpoint for all trials that supplied patients for this analysis .


Here , we compared disease-free , relapse-free , and overall survival between the patient groups who received capecitabine with or without oxaliplatin and those who received leucovorin and fluorouracil with or without oxaliplatin .


Post-relapse survival was compared between the combined XELOX and FOLFOX groups , and the leucovorin and fluorouracil groups .


Post-relapse survival was also compared between the capecitabine with or without oxaliplatin and leucovorin and fluorouracil with or without oxaliplatin groups .


Disease-free survival did not differ significantly between patients who received leucovorin and fluorouracil versus those who received capecitabine in adjusted analyses ( hazard ratio [ HR ] 102 [ 093-111 ; p = 072 ] ) or in unadjusted analyses ( HR 101 [ 95 % CI 092-110 ; p = 086 ] ) .


Relapse-free survival was similar ( adjusted HR 102 [ 093-112 ; p = 072 ] and unadjusted HR 101 [ 95 % CI 092-111 ; p = 086 ] ) , as was overall survival ( adjusted HR 104 [ 95 % CI 093-115 ; p = 050 ] and unadjusted HR 102 [ 092-114 ] ; p = 065 ) .


For overall survival , a significant interaction between oxaliplatin and fluoropyrimidine was recorded in the multiple Cox regression analysis ( p = 0014 ) .


Post-relapse survival was similar in adjusted ( p = 023 ) and unadjusted analyses ( p = 033 ) for the comparison of XELOX or FOLFOX versus leucovorin and fluorouracil , and was also similar for capecitabine-based regimens versus leucovorin and fluorouracil-based regimens ( unadjusted p = 026 ) .


Combination therapy with oxaliplatin provided consistently improved outcomes without adversely affecting post-relapse survival in the adjuvant treatment of stage III colon cancer , irrespective of whether the fluoropyrimidine backbone was capecitabine or leucovorin and fluorouracil .


These data add to the existing evidence that oxaliplatin plus capecitabine or leucovorin and fluorouracil is the standard of care for the adjuvant treatment of stage III colon cancer , and offers physicians flexibility to treat patients according to the patients ' overall physical performance and preference .


Genentech Inc. .


To determine the effect of vitamin D3 supplementation on 25-hydroxyvitamin D [ 25 ( OH ) D ] , lipid profile and markers of insulin resistance in obese adolescents .


In this double-blind , randomized , placebo-controlled trial , 58 obese adolescents ( n = 58 ; 12-18 years of age ) received either vitamin D3 ( 2,000 IU/day ) or placebo for 12 weeks .


Total 25 ( OH ) D , fasting plasma glucose , insulin and lipid profile were measured at baseline and following supplementation .


The trial was completed by 44/58 enrolled participants .


At the end of the 12 weeks , total serum 25 ( OH ) D concentrations increased to a modest degree ( median 6 ng/ml ) in the vitamin D-supplemented group ( p < 0.001 ) .


Supplementation showed no detectable changes in fasting plasma glucose , insulin , homeostatic model of assessment index ( HOMA-IR ) , lipids and highly sensitive C-reactive protein .


12 weeks of vitamin D3 supplementation in obese adolescents with 2,000 IU once daily resulted in a modest increase in 25 ( OH ) D concentration in obese adolescents , but did not affect the lipid profile and markers of insulin resistance and inflammation .


Further studies with higher doses of vitamin D3 and/or longer duration of supplementation are needed to understand if vitamin D3 supplementation can impact lipid profiles and markers of insulin resistance and inflammation in obese children .


Device-based pacing-induced diaphragmatic stimulation ( PIDS ) may have therapeutic potential for chronic heart failure ( HF ) patients .


We studied the effects of PIDS on cardiac function and functional outcomes .


In 24 chronic HF patients with CRT , an additional electrode was attached to the left diaphragm .


Randomized into two groups , patients received the following PIDS modes for 3weeks in a different sequence : ( i ) PIDS off ( control group ) ; ( ii ) PIDS 0ms mode ( PIDS simultaneously with ventricular CRT pulse ) ; or ( iii ) PIDS optimized mode ( PIDS with optimized delay to ventricular CRT pulse ) .


For PIDS optimization , acoustic cardiography was used .


Effects of each PIDS mode on dyspnoea , power during exercise testing , and LVEF were assessed .


Dyspnoea improved with the PIDS 0ms mode ( P = 0.057 ) and the PIDS optimized mode ( P = 0.034 ) as compared with the control group .


Maximal power increased from median 100.5 W in the control group to 104.0 W in the PIDS 0ms mode ( P = 0.092 ) and 109.5 W in the PIDS optimized mode ( P = 0.022 ) .


Median LVEF was 33.5 % in the control group , 33.0 % in the PIDS 0ms mode , and 37.0 % in the PIDS optimized mode ( P = 0.763 and P = 0.009 as compared with the control group , respectively ) .


PIDS was asymptomatic in all patients .


PIDS improves dyspnoea , working capacity , and LVEF in chronic HF patients over a 3 week period in addition to CRT .


This pilot study demonstrates proof of principle of an innovative technology which should be confirmed in a larger sample .


NCT00769678 .


Outcomes associated with episodes of hypotension while hospitalized with acute decompensated heart failure are not well understood .


Using data from Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ( ASCEND-HF ) , we assessed factors associated with in-hospital hypotension and subsequent 30-day outcomes .


Patients were classified as having symptomatic or asymptomatic hypotension .


Multivariable logistic regression was used to determine factors associated with in-hospital hypotension , and Cox proportional hazards models were used to assess the association between hypotension and 30-day outcomes .


We also tested for treatment interaction with nesiritide on 30-day outcomes and the association between in-hospital hypotension and renal function at hospital discharge .


Overall , 1555 of 7141 ( 21.8 % ) patients had an episode of hypotension , of which 73.1 % were asymptomatic and 26.9 % were symptomatic .


Factors strongly associated with in-hospital hypotension included randomization to nesiritide ( odds ratio , 1.98 ; 95 % confidence interval [ CI ] , 1.76-2 .23 ; P < 0.001 ) , chronic metolazone therapy ( odds ratio , 1.74 ; 95 % CI , 1.17-2 .60 ; P < 0.001 ) , and baseline orthopnea ( odds ratio , 1.31 ; 95 % CI , 1.13-1 .52 ; P = 0.001 ) or S3 gallop ( odds ratio , 1.21 ; 95 % CI , 1.06-1 .40 ; P = 0.006 ) .


In-hospital hypotension was associated with increased hazard of 30-day mortality ( hazard ratio , 2.03 ; 95 % CI , 1.57-2 .61 ; P < 0.001 ) , 30-day heart failure hospitalization or mortality ( hazard ratio , 1.58 ; 95 % CI , 1.34-1 .86 ; P < 0.001 ) , and 30-day all-cause hospitalization or mortality ( hazard ratio , 1.40 ; 95 % CI , 1.22-1 .61 ; P < 0.001 ) .


Nesiritide had no interaction on the relationship between hypotension and 30-day outcomes ( interaction P = 0.874 for death , P = 0.908 for death/heart failure hospitalization , P = 0.238 death/all-cause hospitalization ) .


Hypotension while hospitalized for acute decompensated heart failure is an independent risk factor for adverse 30-day outcomes , and its occurrence highlights the need for modified treatment strategies .


http://www.clinicaltrials.gov .


Unique identifier : NCT00475852 .


There is a lack of treatments providing survival benefit for patients with metastatic triple-negative breast cancer ( mTNBC ) , with no standard of care .


A randomized phase II trial showed significant benefit for gemcitabine , carboplatin , and iniparib ( GCI ) over gemcitabine and carboplatin ( GC ) in clinical benefit rate , response rate , progression-free survival ( PFS ) , and overall survival ( OS ) .


Here , we formally compare the efficacy of these regimens in a phase III trial .


Patients with stage IV/locally recurrent TNBC who had received no more than two previous chemotherapy regimens for mTNBC were randomly allocated to gemcitabine 1,000 mg/m ( 2 ) and carboplatin area under the curve 2 ( days 1 and 8 ) alone or GC plus iniparib 5.6 mg/kg ( days 1 , 4 , 8 , and 11 ) every 3 weeks .


Random assignment was stratified by the number of prior chemotherapies .


The coprimary end points were OS and PFS .


Patients receiving GC could cross over to iniparib on progression .


Five hundred nineteen patients were randomly assigned ( 261 GCI ; 258 GC ) .


In the primary analysis , no statistically significant difference was observed for OS ( hazard ratio [ HR ] = 0.88 ; 95 % CI , 0.69 to 1.12 ; P = .28 ) nor PFS ( HR = 0.79 ; 95 % CI , 0.65 to 0.98 ; P = .027 ) .


An exploratory analysis showed that patients in the second - / third-line had improved OS ( HR = 0.65 ; 95 % CI , 0.46 to 0.91 ) and PFS ( HR = 0.68 ; 95 % CI , 0.50 to 0.92 ) with GCI .


The safety profile for GCI was similar to GC .


The trial did not meet the prespecified criteria for the coprimary end points of PFS and OS in the ITT population .


The potential benefit with iniparib observed in second - / third-line subgroup warrants further evaluation .


Supposing divergent aetiology , we found it interesting to investigate outcomes between primary ( PH ) versus incisional ( IH ) hernias .


In addition , we wanted to analyse the effect of defect closure and mesh fixation techniques .


37 patients with PH and 70 with IH were enrolled in a prospective cohort-study , treated with laparoscopic ventral hernia repair ( LVHR ) and randomised to transfascial sutures .


In addition , we analysed results from a retrospective study with 36 PH and 51 IH patients .


Mean follow-up time was 38 months in the prospective study and 27 months in the retrospective study .


35 % of PH 's and 10 % of IH 's were recurrences after previous suture repair .


No late infections or mesh removals occurred .


Recurrence rates in the prospective study were 0 vs. 4.3 % ( p = 0.55 ) and the complication rates were 16 vs. 27 % ( p = 0.24 ) in favour of the PH cohort .


The IH group had a mesh protrusion rate of 13 vs. 5 % in the PH group ( p = 0.32 ) , and significantly ( p < 0.01 ) larger hernias and adhesion score , longer operating time ( 100 vs. 79 min ) and admission time ( 2.8 vs. 1.6 days ) .


Closure of the hernia defect did not influence rate of seroma , pain at 2 months , protrusion or recurrence .


An overall increased complication rate was seen after defect closure ( OR 3.42 ; CI 1.25-9 .33 ) .


With PH , in comparison to IH treated with LVHR , no differences were observed regarding recurrence , protrusion or complication rates .


Defect closure ( raphe ) , when using absorbable suture , did not benefit long-term outcomes and caused a higher overall complication rate .


( ClinicalTrials.gov number : NCT00455299 ) .


S-1-based regimens are commonly used for advanced gastric cancer ( AGC ) in Japan .


We performed this trial to evaluate the efficacy and safety of S-1 plus irinotecan ( SIri ) and S-1 plus paclitaxel ( SPac ) as first-line treatments for AGC in order to select the optimal regimen for a subsequent phase III trial .


Patients with previously untreated , locally advanced or metastatic measurable gastric adenocarcinoma were randomly assigned to receive SIri ( irinotecan 80 mg/m ( 2 ) was administered intravenously ( i.v. ) on day 1 and 15 , while 40 mg/m ( 2 ) S-1 was orally administered twice daily for three weeks from days 1-21 followed by a two-week pause ) or SPac ( paclitaxel 50 mg/m ( 2 ) was administered i.v. on day 1 and 8 , while 40 mg/m ( 2 ) S-1 was orally administered twice daily for two weeks from day 1-14 followed by a one-week pause ) regimen .


The primary end-point was the overall response rate ( ORR ) , and the secondary end-points were progression-free survival ( PFS ) , overall survival ( OS ) , and toxicity .


A total of 102 patients were enrolled .


The ORR was 33.3 % for SIri and 31.4 % for SPac , which did not achieved the predicted ORR in either group .


PFS and OS were 5.7 and 12.4 months for SIri , 4.6 and 11.9 months for SPac respectively .


No treatment-related deaths occurred during the study .


Although grade 3/4 neutropenia and anemia were more frequent in the Siri group , both regimens were well-tolerated .


Both regimens were well-tolerated in patients with AGC , but we conclude that neither regimen was optimal for a phase III trial .


Population-based studies on aspirin-intolerant asthma ( AIA ) are very few , and no previous population study has investigated risk factors for the condition .


To investigate the prevalence and risk factors of AIA in the general population .


A questionnaire on respiratory health was mailed to 30,000 randomly selected subjects aged 16-75 years in West Sweden , 29,218 could be traced and 18,087 ( 62 % ) responded .


The questionnaire included questions on asthma , respiratory symptoms , aspirin-induced dyspnoea and possible determinants .


The prevalence of AIA was 0.5 % , 0.3 % in men and 0.6 % in women ( P = 0.014 ) .


Sick leave , emergency visits due to asthma and all investigated lower respiratory symptoms were more common in AIA than in aspirin-tolerant asthma ( ATA ) .


Obesity was a strong risk factor for AIA ( BMI > 35 : odds ratio ( OR ) 12.1 ; 95 % CI 2.49-58 .5 ) , and there was a dose-response relationship between increasing body mass index ( BMI ) and risk of AIA .


Obesity , airborne occupational exposure and visible mould at home were considerably stronger risk factors for AIA than for ATA .


Current smoking was a risk factor for AIA ( OR 2.55 ; 95 % CI 1.47-4 .42 ) , but not ATA .


Aspirin-intolerant asthma identified in the general population was associated with a high burden of symptoms , uncontrolled disease and a high morbidity .


Increasing BMI increased the risk of AIA in a dose-response manner .


A number of risk factors , including obesity and current smoking , were considerably stronger for AIA than for ATA .


Statistical methods are very important to precisely measure breast cancer patient survival times for healthcare management .


Previous studies considered basic statistics to measure survival times without incorporating statistical modeling strategies .


The objective of this study was to develop a data-based statistical probability model from the female breast cancer patients ' survival times by using the Bayesian approach to predict future inferences of survival times .


A random sample of 500 female patients was selected from the Surveillance Epidemiology and End Results cancer registry database .


For goodness of fit , the standard model building criteria were used .


The Bayesian approach is used to obtain the predictive survival times from the data-based Exponentiated Exponential Model .


Markov Chain Monte Carlo method was used to obtain the summary results for predictive inference .


The highest number of female breast cancer patients was found in California and the lowest in New Mexico .


The majority of them were married .


The mean ( SD ) age at diagnosis ( in years ) was 60.92 ( 14.92 ) .


The mean ( SD ) survival time ( in months ) for female patients was 90.33 ( 83.10 ) .


The Exponentiated Exponential Model found better fits for the female survival times compared to the Exponentiated Weibull Model .


The Bayesian method is used to obtain predictive inference for future survival times .


The findings with the proposed modeling strategy will assist healthcare researchers and providers to precisely predict future survival estimates as the recent growing challenges of analyzing healthcare data have created new demand for model-based survival estimates .


The application of Bayesian will produce precise estimates of future survival times .


Improvement has been anecdotally observed in patients with persistent postconcussion symptoms ( PCS ) after mild traumatic brain injury following treatment with hyperbaric oxygen ( HBO ) .


The effectiveness of HBO as an adjunctive treatment for PCS is unknown to date .


To compare the safety of and to estimate the efficacy for symptomatic outcomes from standard PCS care alone , care supplemented with HBO , or a sham procedure .


Multicenter , double-blind , sham-controlled clinical trial of 72 military service members with ongoing symptoms at least 4 months after mild traumatic brain injury enrolled at military hospitals in Colorado , North Carolina , California , and Georgia between April 26 , 2011 , and August 24 , 2012 .


Assessments occurred before randomization , at the midpoint , and within 1 month after completing the interventions .


Routine PCS care was provided in specialized clinics .


In addition , participants were randomized 1:1:1 to 40 HBO sessions administered at 1.5 atmospheres absolute ( ATA ) , 40 sham sessions consisting of room air at 1.2 ATA , or no supplemental chamber procedures .


The Rivermead Post-Concussion Symptoms Questionnaire ( RPQ ) served as the primary outcome measure .


A change score of at least 2 points on the RPQ-3 subscale ( range , 0-12 ) was defined as clinically significant .


Change scores from baseline were calculated for the RPQ-3 and for the total RPQ .


Secondary measures included additional patient-reported outcomes and automated neuropsychometric testing .


On average , participants had sustained 3 lifetime mild traumatic brain injuries ; the most recent occurred 23 months before enrollment .


No differences were observed between groups for improvement of at least 2 points on the RPQ-3 subscale ( 25 % in the no intervention group , 52 % in the HBO group , and 33 % in the sham group ; P = .24 ) .


Compared with the no intervention group ( mean change score , 0.5 ; 95 % CI , -4.8 to 5.8 ; P = .91 ) , both groups undergoing supplemental chamber procedures showed improvement in symptoms on the RPQ ( mean change score , 5.4 ; 95 % CI , -0.5 to 11.3 ; P = .008 in the HBO group and 7.0 ; 95 % CI , 1.0-12 .9 ; P = .02 in the sham group ) .


No difference between the HBO group and the sham group was observed ( P = .70 ) .


Chamber sessions were well tolerated .


Among service members with persistent PCS , HBO showed no benefits over sham compressions .


Both intervention groups demonstrated improved outcomes compared with PCS care alone .


This finding suggests that the observed improvements were not oxygen mediated but may reflect nonspecific improvements related to placebo effects .


clinicaltrials.gov Identifier : NCT01306968 .


We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy , versus usual care , on one-year mortality .


We conducted a multicentre , open-label interventional , stratified ( centre ) , parallel randomised controlled trial , with a 11 ratio , with two-year follow-up .


Patients were aged 70 years or older treated with chemotherapy for solid tumour and at risk of malnutrition ( MNA , Mini Nutritional Assessment 17-23 .5 ) .


Intervention consisted of diet counselling with the aim of achieving an energy intake of 30 kCal/kg body weight/d and 1.2 g protein/kg/d , by face-to-face discussion targeting the main nutritional symptoms , compared to usual care .


Interviews were performed 6 times during the chemotherapy sessions for 3 to 6 months .


The primary endpoint was 1-year mortality and secondary endpoints were 2-year mortality , toxicities and chemotherapy outcomes .


Between April 2007 and March 2010 we randomised 341 patients and 336 were analysed : mean ( standard deviation ) age of 78.0 y ( 49 ) , 51.2 % male , mean MNA 20.2 ( 2.1 ) .


Distribution of cancer types was similar in the two groups ; the most frequent were colon ( 22.4 % ) , lymphoma ( 14.9 % ) , lung ( 10.4 % ) , and pancreas ( 17.0 % ) .


Both groups increased their dietary intake , but to a larger extent with intervention ( p < 0.01 ) .


At the second visit , the energy target was achieved in 57 ( 40.4 % ) patients and the protein target in 66 ( 46.8 % ) with the intervention compared respectively to 13 ( 13.5 % ) and 20 ( 20.8 % ) in the controls .


Death occurred during the first year in 143 patients ( 42.56 % ) , without difference according to the intervention ( p = 0.79 ) .


No difference in nutritional status changes was found .


Response to chemotherapy was also similar between the groups .


Early dietary counselling was efficient in increasing intake but had no beneficial effect on mortality or secondary outcomes .


Cancer cachexia antianabolism may explain this lack of effect .


ClinicalTrials.gov NCT00459589 .


The World Health Organization recommends 36 months of isoniazid preventive therapy ( 36IPT ) for adults infected with HIV living in TB-endemic countries .


We determined the rates and risk factors for isoniazid-associated hepatitis with the use of 36IPT .


One thousand six adults infected with HIV received 36IPT during a pragmatic randomized trial set in Botswana public health clinics providing HIV care .


Enrollment exclusion criteria included jaundice or elevations of serum transaminases ( ESTs ) > 2.5-fold the upper limit of normal ( ULN ) .


Participants with any CD4 + lymphocyte count were eligible and received antiretroviral therapy ( ART ) when CD4 + < 200 cells/L .


36IPT was stopped for severe hepatitis ( more than fivefold ULN EST ) but not for moderate hepatitis ( 2.5-fold to fivefold ULN EST ) .


Pharmacy refill records showed 2,237 person-years of isoniazid receipt ; 48 % of participants initiated ART by 36 months .


A total of 1.9 % ( 19 of 1,006 ) of participants were diagnosed with severe hepatitis ; three had jaundice and two of these developed hepatic encephalopathy .


Another 3.1 % ( 31 of 1,006 ) of participants experienced moderate hepatitis .


Thirty-eight percent ( 19 of 50 ) of participants with moderate to severe hepatitis concomitantly received ART .


Forty percent ( 20 of 50 ) of moderate to severe cases occurred within the first 2 months of IPT and during this period were not associated with receipt of ART at baseline ( hazard ratio , 1.49 ; 95 % CI , 0.20-11 .1 ; P = .70 ) .


Adults infected with HIV receiving 36IPT did not have an increased incidence of moderate to severe hepatitis or hepatic encephalopathy compared with published reports among people infected with HIV , people not infected with HIV in trials or public health programs .


Compared with participants not receiving ART , the risk of moderate to severe hepatitis was not increased by ART .


ClinicalTrials.gov ; No. : NCT00164281 ; URL : www.clinicaltrials.gov .


A disproportionate number of impoverished and minority children have asthma and receive suboptimal preventive care .


To evaluate whether the Prompting Asthma Intervention in Rochester-Uniting Parents and Providers ( PAIR-UP ) intervention , administered in primary care offices , improves the delivery of preventive care and reduces morbidity for urban children with asthma .


Cluster randomized trial in which 12 urban primary care practices were matched based on size and type and randomly allocated to the PAIR-UP intervention or usual care ( UC ) .


We enrolled 638 children aged 2 to 12 years with persistent or poorly controlled asthma in the waiting room prior to a visit with a clinician for any reason from October 2009 to January 2013 .


Blinded interviewers called caregivers within 2 weeks to inquire about preventive measures taken at the visit and called them 2 and 6 months later to assess symptoms .


Children enrolled at PAIR-UP practices received prompts for the caregiver and clinician at the time of the visit that outlined the child 's asthma severity or control as well as specific guideline-based recommendations to enhance preventive care .


These practices also received educational resources and periodic feedback on their asthma care performance .


The UC practices received copies of the asthma guidelines .


The primary outcome was symptom-free days ( SFDs ) per 2 weeks at the 2-month follow-up .


We enrolled 638 children ( participation rate of 80 % ; 36 % were black , 36 % were Hispanic , and 68 % had Medicaid insurance ) .


Groups were similar in demographic characteristics and asthma severity at baseline .


At the index visit , more children in the PAIR-UP group received a preventive medication action ( new medication , increased dose , recommendation to restart preventive medication ) than in the UC group ( 58 % vs 33 % ; odds ratio [ OR ] = 2.8 ; 95 % CI , 1.9 to 3.9 ) .


More children in the PAIR-UP group than in the UC group received an asthma action plan ( 61 % vs 23 % ; OR = 8.3 ; 95 % CI , 3.7 to 18.7 ) , discussions regarding asthma ( 93 % vs 78 % ; OR = 4.5 ; 95 % CI , 2.8 to 7.2 ) , and secondhand smoke counseling ( 80 % vs 63 % ; OR = 2.6 ; 95 % CI , 1.2 to 5.5 ) .


At the 2-month follow-up , children in the PAIR-UP group had more SFDs per 2 weeks than those in the UC group ( mean difference , 0.78 days ; 95 % CI , 0.29 to 1.27 ) .


At 6 months , the improvement in SFDs was no longer statistically significant ( mean difference , 0.56 ; 95 % CI , -0.14 to 1.25 ) .


The PAIR-UP intervention improved the delivery of preventive asthma care and reduced asthma morbidity for high-risk urban children with persistent asthma at 2 months , but the improvement in SFDs was no longer significant at 6 months .


clinicaltrials.gov Identifier : NCT01105754 .


The best treatment option for end-stage renal disease is usually a transplant , preferably a live donor kidney transplant ( LDKT ) .


The most effective ways to educate kidney transplant candidates about the risks , benefits , and process of LDKT remain unknown .