Determine whether an UBV is effective in teaching laypersons CO-CPR in a public setting and if viewing leads to superior responsiveness and CPR skills .


Adult lay bystanders were enrolled in a public shopping mall and randomized to : ( 1 ) Control ( CTR ) : sat idle for 60 s ; ( 2 ) UBV : watched a 60 s UBV on CO-CPR .


Subjects were read a scenario detailing a sudden collapse in the mall and asked to do what they `` thought was best '' on a mannequin .


Performance measures were recorded for 2 min : responsiveness ( time to call 911 and first CCs ) and CPR quality [ CC depth , rate , hands-off interval ( time without CC after first CC ) ] .


One hundred subjects were enrolled .


Demographics were similar between groups .


UBV subjects called 911 more frequently ( percent difference : 31 % ) and initiated CCs sooner in the arrest scenario ( median difference ( MD ) : 5 s ) .


UBV cohort had increased CC rate ( MD : 19 cpm ) and decreased hands-off interval ( MD : 27 s ) .


There was no difference in CC depth .


Bystanders with UBV training in a shopping mall had significantly improved responsiveness , CC rate , and decreased hands-off interval .


Given the short length of training , UBV may have potential as a ubiquitous intervention for public venues to help improve bystander reaction to arrest and CO-CPR performance .


To explore the eradication efficacies of triple versus quadruple furazolidone-based regimens for Helicobacter pylori ( H. pylori ) infection .


A total of 357 outpatients with H. pylori infection were enrolled from June to December 2010 .


There were 200 males and 157 females with an average age of ( 42 12 ) years .


A diagnosis of duodenal ulcer was made according to their endoscopic examination results .


They were randomly assigned into 4 treatment groups : 7-day triple ( n = 89 ) and 10-day triple ( n = 91 ) , rabeprazole 10 mg , amoxicillin 1 000 mg and furazolidone 100 mg twice daily for 7 and 10 days respectively .


7-day quadruple ( n = 88 ) and 10-day quadruple ( n = 89 ) , rabeprazole 10 mg , bismuth 220 mg , amoxicillin 1 000 mg and furazolidone 100 mg twice daily for 7 and 10 days respectively.H .


pylori status was re-assessed with ( 14 ) C-urea breath test after 4-week therapy .


Among them , 323 cases completed the study .


According to the analysis of intention-to-treat ( ITT ) , the H. pylori eradication rates were 71.91 % ( 64/89 ) in 7-day triple , 81.32 % ( 74/91 ) in 10-day triple , 78.41 % ( 69/88 ) in 7-day quadruple and 83.15 % ( 74/89 ) in 10-day quadruple groups .


No significant deviation existed among all groups ( P > 0.05 ) .


According the per-protocol ( PP ) analysis , H. pylori eradication rates were 78.05 % ( 64/82 ) in 7-day triple , 88.10 % ( 74/84 ) in 10-day triple , 87.34 % ( 69/79 ) in 7-day quadruple and 94.87 % ( 74/78 ) in 10-day quadruple groups .


Significant deviation existed among all groups ( P = 0.017 ) .


The H. pylori eradication rate in 10-day quadruple group was significantly higher than that in 7-day triple group ( P = 0.002 ) .


The total adverse reaction rate was 7.00 % ( 25/357 ) .


No significant difference existed among all groups ( P > 0.05 ) .


Quadruple treatments provide higher H. pylori eradication rates than triple therapies .


A 10-day treatment may improve H. pylori eradication rate .


And 10-day quadruple regimen with furazolidone and bismuth may be effective for H. pylori infection .


Prior studies show that adaptive servoventilation ( ASV ) is initially more effective than continuous positive airway pressure ( CPAP ) for patients with complex sleep apnea syndrome ( CompSAS ) , but choosing therapies has been controversial because residual central breathing events may resolve over time in many patients receiving chronic CPAP therapy .


We conducted a multicenter , randomized , prospective trial comparing clinical and polysomnographic outcomes over prolonged treatment of patients with CompSAS , with CPAP versus ASV .


Qualifying participants meeting criteria for CompSAS were randomized to optimized CPAP or ASV treatment .


Clinical and polysomnographic data were obtained at baseline and after 90 days of therapy .


We randomized 66 participants ( 33 to each treatment ) .


At baseline , the diagnostic apnea-hypopnea index ( AHI ) was 37.7 27.8 ( central apnea index [ CAI ] = 3.2 5.8 ) and best CPAP AHI was 37.0 24.9 ( CAI 29.7 25.0 ) .


After second-night treatment titration , the AHI was 4.7 8.1 ( CAI = 1.1 3.7 ) on ASV and 14.1 20.7 ( CAI = 8.8 16.3 ) on CPAP ( P 0.0003 ) .


At 90 days , the ASV versus CPAP AHI was 4.4 9.6 versus 9.9 11.1 ( P = 0.0024 ) and CAI was 0.7 3.4 versus 4.8 6.4 ( P < 0.0001 ) , respectively .


In the intention-to-treat analysis , success ( AHI < 10 ) at 90 days of therapy was achieved in 89.7 % versus 64.5 % of participants treated with ASV and CPAP , respectively ( P = 0.0214 ) .


Compliance and changes in Epworth Sleepiness Scale and Sleep Apnea Quality of Life Index were not significantly different between treatment groups .


Adaptive servoventilation ( ASV ) was more reliably effective than CPAP in relieving complex sleep apnea syndrome .


While two thirds of participants experienced success with CPAP , approximately 90 % experienced success with ASV .


Because both methods produced similar symptomatic changes , it is unclear if this polysomnographic effectiveness may translate into other desired outcomes .


Clinicaltrials.Gov NCT00915499 .


Carpal tunnel syndrome ( CTS ) is one of the commonest peripheral neuropathies which effects mainly middle aged women .


Different techniques are being tried to decrease the postoperative pain in patients operated for CTS .


The objective of this study was to compare effectiveness of local injection of steroid and mini incision technique in the treatment of carpal tunnel syndrome .


This randomized control trial was conducted at department of Orthopedics and department of Neurosurgery , Ayub Teaching Hospital , Abbottabad from Aug 2011 to Feb 2013 .


A total of 116 patients of CTS were randomly allocated to either of the two groups .58 Patient in Group A were subjected to local steroid injection and the same number of patient in Group B underwent mini incision technique .


All patients of were advised to report to the OPD after one month to determine intervention effectiveness in terms of improvement in at least one grade of pain .


In this study mean age of the patients was 32.8 + / - 5.1 years .


Female gender was in dominance with 99 ( 86.3 % ) cases .


In this study we compared the effectiveness of local steroid injection and mini incision technique in the treatment of carpel tunnel syndrome .


We found out that the steroid injection was effective in 69.0 % cases while mini incision technique was effective in 56.9 % cases .


The difference being statistically insignificant with a p-value of 0.17 .


The difference in pain after 1 month of the intervention was not statistically significant .


The assessment of myocardial fatty acid metabolism impairment by single-photon emission computed tomography ( SPECT ) using ( 123 ) I -- methyliodophenyl-pentadecanoic acid ( BMIPP ) might predict the risk of cardiac death in hemodialysis patients .


We investigated the potential of oral nicorandil to improve myocardial fatty acid metabolism after percutaneous coronary intervention ( PCI ) in this population .


We evaluated 128 hemodialysis patients who had obtained coronary revascularization by PCI ( 90 men and 38 women , 66 9 years ) .


Participants for the analysis were randomly assigned to either the nicorandil ( n = 63 ) or control group ( n = 65 ) .


BMIPP SPECT was performed every year after coronary revascularization by PCI .


Uptake on SPECT was graded in 17 segments on a 5-point scale ( 0 , normal ; 4 , absent ) and assessed as BMIPP summed scores ( SS ) .


The incidence of cardiac death was lower ( p = 0.004 ) in the nicorandil group ( 7/63 , 11.1 % ) than in the control group ( 21/65 , 32.3 % ) during a mean follow-up of 2.7 1.4 years .


BMIPP SS reduction rates improved in the nicorandil group compared with the control group from 3 years of administration .


In Kaplan-Meier analyses , free survival rate of cardiac death was higher in patients with a 20 % BMIPP SS reduction rate as compared with those with a < 20 % BMIPP SS reduction rate ( p = 0.0001 ) .


In multiple logistic analysis , oral administration of nicorandil was associated with 20 % reduction rates of BMIPP SS ( odds ratio 2.823 , p = 0.011 ) .


Long-term oral administration of nicorandil may improve impaired myocardial fatty acid metabolism after coronary revascularization by PCI in hemodialysis patients .


The immunogenicity and safety of the investigational diphtheria , tetanus , acellular pertussis , hepatitis B , poliomyelitis , Haemophilus influenzae type b ( Hib ) and meningococcal serogroup C ( MenC ) heptavalent combination vaccine were compared with those of licensed control vaccines .


In this open , phase II , randomized study ( NCT01090453 ) , 480 infants from Germany , France and Canada received the heptavalent vaccine ( Hepta group ) or hexavalent and monovalent MenC control vaccines ( HexaMenC group ) co-administered with a 13-valent pneumococcal conjugate vaccine at 2 , 4 and 12 months of age .


Immunogenicity was measured 1 month after the second primary dose , and before and 1 month after the booster dose .


Safety and reactogenicity were also evaluated .


Non-inferiority of immune responses to MenC and Hib induced by 2-dose primary vaccination with the heptavalent vaccine versus control vaccines was demonstrated .


In exploratory analyses , postprimary and postbooster functional antibody geometric mean titers against MenC tended to be lower ( 1119.5 vs. 3200.5 ; 2653.8 vs. 6028.4 ) and antibody geometric mean concentrations against Hib higher ( 1.594 vs. 0.671 g/mL ; 17.678 vs. 13.737 g/mL ) in the Hepta versus the HexaMenC group .


The heptavalent and control vaccines were immunogenic to all other antigens , although immune responses to poliovirus were lower than expected in both groups .


No differences in safety and reactogenicity profiles were detected between groups .


The heptavalent vaccine induced non-inferior MenC and Hib responses compared with control vaccines .


Both vaccination regimens , when administered at 2 , 4 and 12 months of age , had comparable safety profiles and were immunogenic to all antigens , with lower-than-expected responses to poliomyelitis .


The phase III EINSTEIN DVT and EINSTEIN PE trials demonstrated the potential of oral rivaroxaban for the treatment of deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ) .


The length of initial hospitalization in patients presenting with either symptomatic DVT or PE was assessed using hospitalization records from these trials .


Analyses were carried out in the intention-to-treat population , using non-parametric and parametric statistical methods .


Overall , 52 % ( 1781/3434 ) of EINSTEIN DVT patients and 90 % ( 4328/4821 ) of EINSTEIN PE patients were admitted to hospital .


The proportion of hospitalized patients with a length of stay of five or fewer days receiving rivaroxaban was 54 % compared with 31 % for enoxaparin/vitamin K antagonist ( VKA ) in patients with DVT .


For patients with PE , the corresponding values were 45 % and 33 % .


Stays of 6-10 days were observed in 29 % of rivaroxaban-treated patients compared with 45 % of enoxaparin/VKA-treated patients for DVT .


For patients with PE , these values were 39 % and 46 % in the rivaroxaban and enoxaparin/VKA groups , respectively .


Overall , length of stay was significantly shorter in the rivaroxaban group , compared with the enoxaparin/VKA group across all analyses performed ( p < 0.0001 ) .


Across regions , the observed admission rates and length of stay duration varied greatly : Asia had the longest overall hospitalization rates , whereas the lowest rates were reported in North America , Australia and New Zealand .


Nevertheless , a consistent trend was observed : length of hospital stay in patients with DVT or PE receiving rivaroxaban was shorter than , or at least similar to , patients receiving enoxaparin/VKA .


A single-drug regimen with rivaroxaban may reduce the burden on healthcare systems and patients , and provides effective and well tolerated treatment .


The studies shared an open-label design that allowed comparison of initial hospitalization , but limitations include the well monitored clinical trial setting in which decisions on admission and discharge could vary from real-world management .


Identification of cancer or inflammatory bowel disease in the intestinal tract by PET/computed tomography ( CT ) imaging can be hampered by physiological uptake of F-fluorodeoxyglucose ( F-FDG ) in the normal colon .


Previous work has localized this F-FDG uptake to the intestinal lumen , predominantly occupied by bacteria .


We sought to determine whether pretreatment with an antibiotic could reduce F-FDG uptake in the healthy colon .


Thirty patients undergoing restaging PET/CT for nongastrointestinal lymphoma were randomly selected to receive rifaximin 550 mg twice daily for 2 days before their scan ( post-rifaximin ) .


Their PET/CT images were compared with those from their prior study ( pre-rifaximin ) .


Cecal maximum standard uptake value ( SUVmax ) and overall colonic F-FDG uptake were compared between scans .


All PET/CT images were blindly scored by a radiologist .


The same comparison of sequential scans was also undertaken in 30 patients who did not receive antibiotics .


Thirty post-rifaximin scans were compared with 30 pre-rifaximin scans in the same patients .


SUVmax in the cecum was significantly lower in the patient 's post-rifaximin scans than in their pre-rifaximin scans ( P = 0.002 ) .


The percentage of scans with greater than grade 1 colonic F-FDG uptake was significantly lower in the post-rifaximin scans than in the pre-rifaximin scans ( P < 0.05 ) .


In contrast , there was no significant difference in the paired sequential scans from control patients , nor a reduction in the percentage of scans with greater than grade 1 colonic F-FDG uptake .


This pilot study shows that treatment with rifaximin for 2 days before PET/CT scanning can significantly reduce physiological F-FDG uptake in the normal colonic lumen .


Bioequivalence and comparability studies are necessary for changing formulations of large-molecule drugs , such as antibody drugs and protein products , and in the development of their biosimilars .


This study is the first application of modeling and simulation ( M&S ) in the design of bioequivalence and comparability studies of erythropoietin as an example of a large-molecule drug .


A novel population pharmacokinetic and pharmacodynamic ( PPK/PD ) model was developed for erythropoietin .


Based on this PPK/PD model , the probabilities of success of bioequivalence and comparability studies were simulated with various numbers of subjects and samples .


The simulation indicated that the minimum numbers of subjects and samples required to satisfy the criteria for bioequivalence and comparability studies were as follows : fewest for the area under the serum concentration-time curve , more for the area under the efficacy-time curve , and most for the maximum serum concentration of erythropoietin .


These results suggested that M&S could be successfully applied in the design of bioequivalence and comparability studies of large-molecule drugs .


A previous multicenter clinical trial of a needle-based fractional radiofrequency ( FRF ) treatment for facial and neck rhytides and laxity counterintuitively demonstrated a mean target temperature and treatment duration of 69.5 C and 4.9 seconds for subjects with lesser improvement and 67 C and 4.2 seconds for greater improvement .


To determine optimal temperature and duration settings for maximal clinical results in rhytides and laxity from a single FRF treatment of the face and neck .


A randomized , blinded , 3-arm clinical evaluation of FRF at a series of temperatures from 52-57 C to 67 C. Three blinded plastic surgeons and dermatologists scored rhytides using the Fitzpatrick Wrinkle Assessment Scale and laxity using the Alexiades Laxity Assessment Scale at 1 , 3 , and 6 months .


Blinded grading showed optimal improvement at 67 C and 3 seconds and decreased efficacy below 67 C , with mean rhytide reductions of 40 , 29 , and 25 % and mean laxity reductions of 34 , 36 , and 25 % in Arms 3 ( 67 C ) , 2 ( 62 C ) , and 1 ( 52 C-57 C ) , respectively .


A 100 % response rate was observed for all subjects treated at 62 C to 67 C target temperature .


The optimal target dermal temperature for facial and neck rhytide and laxity treatment is 67 C and duration of 3 to 4 seconds with a 100 % response rate after a single FRF treatment .


To reduce the spread of antibiotic resistance , there is a pressing need for worldwide implementation of effective interventions to promote more prudent prescribing of antibiotics for acute LRTI .


This study is a process analysis of the GRACE/INTRO trial of a multifactorial intervention that reduced antibiotic prescribing for acute LRTI in six European countries .


The aim was to understand how the interventions were implemented and to examine effects of the interventions on general practitioners ' ( GPs ' ) and patients ' attitudes .


GPs were cluster randomised to one of three intervention groups or a control group .


The intervention groups received web-based training in either use of the C-reactive protein ( CRP ) test , communication skills and use of a patient booklet , or training in both .


GP attitudes were measured before and after the intervention using constructs from the Theory of Planned Behaviour and a Website Satisfaction Questionnaire .


Effects of the interventions on patients were assessed by a post-intervention questionnaire assessing patient enablement , satisfaction with the consultation , and beliefs about the risks and need for antibiotics .


GPs in all countries and intervention groups had very positive perceptions of the intervention and the web-based training , and felt that taking part had helped them to reduce prescribing .


All GPs perceived reducing prescribing as more important and less risky following the intervention , and GPs in the communication groups reported increased confidence to reduce prescribing .


Patients in the communication groups who received the booklet reported the highest levels of enablement and satisfaction and had greater awareness that antibiotics could be unnecessary and harmful .


Our findings suggest that the interventions should be broadly acceptable to both GPs and patients , as well as feasible to roll out more widely across Europe .


There are also some indications that they could help to engender changes in GP and patient attitudes that will be helpful in the longer-term , such as increased awareness of the potential disadvantages of antibiotics and increased confidence to manage LRTI without them .


Given the positive effects of the booklet on patient beliefs and attitudes , it seems logical to extend the use of the patient booklet to all patients .


Durable post-treatment response is uncommon in chronic hepatitis B ( CHB ) patients on nucleos ( t ) ide analogue therapy .


Response , response predictors and safety were assessed in patients who switched from long-term entecavir ( ETV ) to peginterferon alfa-2a .


Hepatitis B e antigen ( HBeAg ) - positive CHB patients who had received ETV for 9-36 months , with HBeAg < 100 PEIU/ml and HBV DNA 1000 copies/ml , were randomised 1:1 to receive peginterferon alfa-2a 180 g/week or ETV 0.5 mg/day for 48 weeks .


The primary endpoint was HBeAg seroconversion at week 48 ( ClinicalTrials.gov : NCT00940485 ) .


200 patients were randomised ; 197 received 1 study drug dose .


Five patients who were anti-HBe-positive at baseline were excluded from the modified intention-to-treat population ( peginterferon alfa-2a , n = 94 ; ETV , n = 98 ) .


Patients who switched to peginterferon alfa-2a achieved higher week 48 HBeAg seroconversion rates vs. those who continued ETV ( 14.9 % vs. 6.1 % ; p = 0.0467 ) .


Only patients receiving peginterferon alfa-2a achieved HBsAg loss ( 8.5 % ) .


Among peginterferon alfa-2a-treated patients with HBeAg loss and HBsAg < 1500 IU/ml at randomisation , 33.3 % and 22.2 % achieved HBeAg seroconversion and HBsAg loss , respectively .


Early on-treatment HBsAg decline predicted response at week 48 ; highest rates were observed in patients with week 12 HBsAg < 200 IU/ml ( HBeAg seroconversion , 66.7 % ; HBsAg loss , 77.8 % ) .


Alanine aminotransferase elevations were not associated with viral rebound ( n = 38 ) .


Peginterferon alfa-2a was well-tolerated .


For patients who achieve virological suppression with ETV , switching to a finite course of peginterferon alfa-2a significantly increases rates of HBeAg seroconversion and HBsAg loss .


A response-guided approach may identify patients with the greatest chance of success .


To estimate effect sizes for a trial to compare preventable pulmonary complications ( PPCs ) , turning-related adverse events , mechanical ventilation duration , intensive care unit ( ICU ) length of stay , and ICU mortality between patients randomized to 2-hourly manual or continuous automated lateral rotation .


Randomized controlled trial pilot study with 15 patients selected randomly from eligible medical-surgical ICU patients from 2 tertiary hospitals and assigned randomly to the manual-turn or automated-turn protocol for up to 7 consecutive days .


A radiologist blinded to group and site assessed serial chest radiographs for PPCs .


Repeated-measures analysis with linear mixed models was used to estimate change in PPC score , and Wilcoxon rank sum or Fisher exact test was used to compare group differences in the secondary outcomes .


Of 16 patients enrolled , 12 ( 75 % ) completed the study .


Data from 15 patients , 7 manual turn and 8 automated turn , were analyzed .


Between-group differences in PPC incidence ( 67 % overall ) , change in PPC score ( = 0.15 , manual turn and = -0.44 , automated turn ) , and secondary outcomes were not significant ( P > .05 ) .


Standardized effect sizes were small to moderate for the outcome variables .


A sample size of 54 patients would be needed to detect statistically significant between-group differences in PPC over time .


The incidence of PPCs in adult patients receiving mechanical ventilation in a medical-surgical ICU was high .


Automated turning decreased PPCs with time but had little effect on secondary outcomes .


Safety outcomes were not substantially different between groups .


A modest efficacy effect supported reduced PPCs with automated turning to the lateral position .


There are so many studies associating blood pressure in children and adolescents with body fatness i.e. stating that high body fat is associated with high blood pressure in children and adolescents .


The purpose of this study was to determine that which portion of the body mass index , fat or fat free mass index is more influencing the blood pressure in Gujarati Indian adolescents .


733 schoolchildren of 10-18 years of both genders were chosen for this study .


The body fat percentage and blood pressure were measured and on the basis of body mass and fat mass , fat free mass index and various other indices were calculated .


The association of fat mass index and fat free mass index with blood pressure was computed using correlations .


The relationship of BMI with mean blood pressure of boys ( R = .326 ) was more strong than that in girls ( R = .149 ) .


The blood pressure was having more strong positive correlation with lean body mass index than that with fat mass index in all subjects ( R = 0.230 versus R = 0.184 ) , boys ( R = 0.285 versus R = 0.242 ) , & girls ( R = 0.179 versus R = -0.081 ) .


Fat free mass index has more strong association with blood pressure than fat mass index in the adolescent population irrespective of gender .


However as far as prevention of hypertension is concerned , reducing body fat ( rather than only body weight ) may remain an important measure to prevent hypertension as body fat mass is reducible while lean body mass may not be reducible and , in long term , obesity itself can lead to hypertension by various mechanisms .


Forming ` habit ' - defined as a learned process that generates automatic responses to contextual cues - has been suggested as a mechanism for behaviour maintenance , but few studies have applied habit theory to behaviour change .


This study used process evaluation data , taken from a randomised controlled trial of a healthy child-feeding intervention for parents previously shown to be effective , to explore the applicability to dietary behaviour change of predictions and recommendations drawn from habit theory .


The intervention supported parents in pursuing child-feeding habit goals in three domains ( giving fruit and vegetables , water , healthy snacks ) , over four fortnightly home visits .


We explored whether ( a ) the habit-formation model was acceptable to participants , ( b ) better-specified habit-formation goals yielded greater habit gains , and ( c ) habit gains were sustained ( d ) even when subsequent , new habit goals were pursued .


Qualitative and quantitative data were taken from 57 parents randomised to the intervention arm , and so analyses presented here used a pre-post intervention design .


Thematic analysis of post-intervention qualitative interviews evaluated acceptability , and self-reported habit goals were content-analysed .


ANOVAs explored changes in habit strength , recorded at home visits and one - and two-month follow-ups , across time and goals .


Participants understood and engaged positively with the habit-formation approach .


Although many seemingly poorly-specified habit goals were set , goal characteristics had minimal impact on habit strength , which were achieved within two weeks for all behaviours ( p 's < .001 ) , and were maintained or had increased further by the final follow-up .


The habit-formation model appears to be an acceptable and fruitful basis for dietary behaviour change .


N-acetyltransferase 2 ( NAT2 ) is involved in the metabolism of various environmental substances , both with and without carcinogenic potential .


Alcoholic and nonalcoholic caffeine-rich beverages may be associated with markers of inflammation .


Systemic lupus erythematosus ( SLE ) is a chronic , multifaceted inflammatory disease .


We investigated the effects of alcoholic and nonalcoholic caffeine-rich beverages on risk of SLE and determined whether the effects were modified by NAT2 status .


The NAT2 polymorphism was genotyped in 152 SLE cases and 427 healthy controls , all women and Japanese .


We assessed effect modification by testing an interaction term for the NAT2 polymorphism and consumption of beverages .


Consumption of black tea ( odds ratio [ OR ] 1.88 , 95 % confidence interval [ 95 % CI ] 1.03-3 .41 ) and coffee ( OR 1.57 , 95 % CI 0.95-2 .61 ) , but not green tea , was associated with an increased risk of SLE , while alcohol use ( OR 0.33 , 95 % CI 0.20-0 .55 ) was associated with a decreased risk of SLE .


There were significant interactions between the NAT2 polymorphism and either alcohol use ( Pinteraction = 0.026 ) or consumption of black tea ( Pinteraction = 0.048 ) .


The NAT2 polymorphism significantly modified the effects of alcohol use and black tea consumption on SLE , emphasizing the importance of incorporating genetic and metabolic information in studies on management of SLE .


Additional studies are warranted to confirm the findings suggested in this study .


To examine the effects of 12 weeks of periodized resistance training ( RT ) with and without combined creatine and whey protein supplementation on changes in body composition , muscular strength , and functional performance .


Twenty-two male volunteers ( 68.1 6.1 years ) were randomly assigned to one of three groups : RT plus supplementation ( RTS , n = 7 ) ; RT only ( RT , n = 7 ) ; or control ( C , n = 8 ) .


RTS consumed 0.3 g/kg/day of creatine for 5 days followed by 0.07 g/kg/day .


RTS also consumed one 35 g liquid protein ready-to-drink daily .


RT and RTS trained 3 days/week .


Following 12 weeks of training , there were no significant differences in the main measured outcome variables between RT and RTS .


RTS increased relative ( % change ) lean body mass ( LBM , 3.3 3.1 % ) compared with C ( p = 0.01 ) .


Compared to baseline , RT increased LBM at week 6 ( 60.2 8.3 to 61.6 9.4 kg ; p < 0.05 ) , and decreased fat mass ( 20.8 4.2 to 19.0 3.9 kg ; p = 0.05 ) and percentage body fat at week 12 ( 25.7 3.8 to 23.8 4.0 % ; p = 0.05 ) ; RTS increased LBM at week 6 ( p < 0.01 ) and week 12 ( 56.4 4.3 to 58.2 3.4 kg ; p < 0.01 ) , and decreased percentage body fat at week 12 ( 23.9 4.4 to 22.0 4.4 % ; p < 0.01 ) .


In addition , compared to C , relative bench press 1-RM increased for RTS ( 72.4 62.2 % ; p < 0.01 ) and RT ( 50.1 21.5 % ; p = 0.05 ) ; relative leg press 1-RM increased for RTS ( 129.6 39.4 % ; p < 0.0001 ) and RT ( 112.9 22.7 % ; p < 0.0001 ) ; RTS increased relative Margaria stair-climbing power ( 38.3 30.4 % ; p < 0.05 ) ; and , relative 400-m walk time decreased for RT ( -11 9.2 % ; p < 0.05 ) and RTS ( -9.6 9.4 % ; p = 0.05 ) .


RT increased estimated VO2Max at week 6 ( p < 0.01 ) and 12 ( 34.6 1.9 to 36.4 2.7 ml/kg/min ; p = 0.01 ) compared to baseline .


Lastly , RTS increased estimated VO2Max at week 12 ( 36.3 2.7 to 37.5 3.3 ml/kg/min ; p = 0.05 ) compared to baseline .


Creatine and whey protein supplementation may not provide additional benefits in older adults performing periodized RT to augment muscular and functional performance .


Our previous study found that cortical gray matter ( cGM ) volume predicted vascular cognitive impairment independent of age-related white matter changes ( WMC ) .


We aimed to investigate predictors for cGM volume in ischemic stroke patients with confluent WMC .


One-hundred post-stroke patients with confluent WMC were recruited into the study .


All volumetric measures were standardized by intracranial volume as volume ratio .


Univariate analyses and multivariate linear regression models were used to test relationship of cGM volume with basic demography , vascular risk factors , APOE status , WMC volume ( periventricular and deep WMC ) , infarct measures ( volume , number and location ) and microbleed ( number , presence and location ) .


After controlling for significant variables in the univariate analyses , multivariate linear regression models found that old age ( = -0.288 , p = 0.001 ) , low triglyceride ( = 0.194 , p = 0.027 ) , periventricular WMC ( PVWMC ) ( = -0.392 , p < 0.001 ) and presence of thalamic microbleed ( = -0.197 , p = 0.041 ) were independently predictive of less cGM volume ratio .


Age , PVWMC and left thalamic microbleed predict less cGM volume .


Alcohol consumption of college students has a fluctuating nature , which might impact the measurement of intervention effects .


By using 25 follow-up time-points , this study tested whether intervention effects are robust or might vary over time .


Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment ( EMA ) with 30 data time-points in total .


Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental ( n = 456 : web-based brief alcohol intervention ) and control condition ( n = 451 : no intervention ) .


Outcome measures were weekly alcohol consumption , frequency of binge drinking , and heavy drinking status .


According to the intention-to-treat principle , regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points .


Intervention effects were found for a ) weekly alcohol consumption at 1 , 2 , 3 , 4 , and 7 weeks follow-up , b ) frequency of binge drinking at 1 , 2 , 7 , and 12 weeks follow-up , and c ) heavy drinking status at 1 , 2 , 7 , and 16 weeks follow-up .


This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions .


Therefore , future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness .


Netherlands Trial Register NTR2665 .


Using phase 3 trial data for sunitinib versus interferon ( IFN ) - in treatment-naive patients with metastatic renal cell carcinoma , retrospective analyses characterized sunitinib-associated fatigue and its impact on patient-reported health-related quality of life ( HRQoL ) .


Patients received sunitinib at a dose of 50 mg/day on a schedule of 4 weeks on/2 weeks off ( 375 patients ) or IFN - at a dose of 9 MU subcutaneously 3 times per week ( 360 patients ) .


HRQoL was self-assessed using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-15-item ( FKSI-15 ) questionnaire , with fatigue assessed using its Disease-Related Symptoms subscale .


Fatigue was also assessed by providers using Common Terminology Criteria for Adverse Events ( CTCAE ) .


A repeated-measures model ( M1 ) and random intercept-slope model ( M2 ) characterized sunitinib-associated fatigue over time .


Another repeated-measures model examined the relationship between HRQoL scores and CTCAE fatigue grade .


M1 demonstrated that the initial increase in patient-reported fatigue with sunitinib was worst during cycle 1 , with mean values numerically better at subsequent cycles ; most pairwise comparisons of consecutive CTCAE fatigue cycle means were not found to be statistically significant .


M2 demonstrated that the overall trend ( slope ) for patient-reported and CTCAE fatigue with sunitinib was not statistically different from 0 .


The relationship between most HRQoL scores and CTCAE fatigue was close to linear regardless of treatment , with lower scores ( worse HRQoL ) corresponding to higher fatigue grade .


The majority of HRQoL scores were better with sunitinib versus IFN - for the same CTCAE fatigue grade .


Patients reported worse fatigue during the first sunitinib cycle .


However , in subsequent consecutive cycles , less fatigue was reported with no statistically significant worsening .


CTCAE fatigue assessment may not fully capture patient treatment experience .


Endogenous anterior uveitis ( AU ) , when untreated , may lead to vision loss .


This study compared the safety and efficacy of difluprednate versus prednisolone acetate for the treatment of this condition .


This phase III , double-masked , noninferiority study randomized patients with mild to moderate endogenous AU to receive difluprednate 0.05 % ( n = 56 ) four times daily , alternating with vehicle four times daily , or prednisolone acetate 1 % ( n = 54 ) eight times daily .


The 14-day treatment period was followed by a 14-day dose-tapering period and a 14-day observation period .


The primary efficacy end point was change in anterior chamber cell grade ( range , 0 for 1 cell to 4 for > 50 cells ) from baseline to day 14 .


At day 14 , the mean change in anterior chamber cell grade with difluprednate was noninferior to that with prednisolone acetate ( -2.2 vs. -2.0 , P = 0.16 ) .


The proportions of difluprednate-treated patients versus prednisolone acetate-treated patients demonstrating complete clearing of anterior chamber cells at day 3 were 13.0 % vs. 2.1 % ( P = 0.046 ) and at day 21 were 73.9 % vs. 63.8 % ( P = 0.013 ) .


A significant between-group difference in the mean IOP increase was seen at day 3 ( 2.5 mm Hg for difluprednate-treated patients and 0.1 mm Hg for prednisolone acetate-treated patients , P = 0.0013 ) but not at other time points .


The mean IOP values in both groups remained less than 21 mm Hg throughout the study .


Difluprednate 0.05 % four times daily is well tolerated and is noninferior to prednisolone acetate 1 % eight times daily for the treatment of endogenous AU .


( ClinicalTrials.gov number , NCT01201798 . )


To compare the differences in the efficacy on speech and swallowing dysfunction of medulla oblongata palsy ( MOP ) after brainstem infarction between electroacupuncture at eight-neck-occiput points and routine acupoints .


Seventy-two patients were randomized into a neck-occiput points group and a meridian points group , 36 cases in each one .


In the neck-occiput points group , the eight-neck-occiput points ( Neck 1-4 points , Occiput 1-4 points ) were selected .


In the meridian points group , Lianquan ( CV 23 ) , Futu ( LI 18 ) , Tongli ( HT 5 ) , Hegu ( LI 4 ) and the others were selected .


Electroacupuncture was used in the two groups , dense-dispersion wave , retaining for 30 min .


The treatment was given once a day , 5 treatments a week .


Totally , 4 weeks were required .


The symptom scores of speech and swallowing dysfunction were observed before and after treatment in the two groups .


The efficacy was compared between the two groups .


The scores of speech and swallowing dysfunction were improved significantly after treatment in the two groups ( P < 0.05 , P < 0.01 ) .


The results in the neck-occiput points group were better than those in the meridian points group ( both P < 0.01 ) .


The curative rate of speech dysfunction was 30.6 % ( 11/36 ) and that of swallowing dysfunction was 22.2 % ( 8 / 36 ) in the neck-occiput points group , which were better than 11.1 % ( 4/36 ) and 5.6 % ( 2/36 ) in the meridian points group , respectively .


The differences were significant in comparison of the two groups ( P < 0.01 , P < 0.05 ) .


Electroacupuncture at eight-neck-occiput points achieves a better efficacy on speech and swallowing dysfunction of MOP after brainstem infarction as compared with the routine acupoints .


This therapy is characterized as more accurate point localization and safer operation .


Wet-wrap treatment ( WWT ) has been advocated as a relatively effective treatment in children with severe atopic dermatitis ( AD ) .


WWT often serves as crisis intervention for AD .


We sought to evaluate the use of WWT with diluted corticosteroids in comparison with emollient in children with severe AD during 4 weeks in a proactive schedule during which the frequency of corticosteroid applications was tapered .


A randomized , double-blind , placebo-controlled study was performed in children aged 6 months to 10 years with severe AD ( objective SCORAD at least 40 5 ) , comparing WWT with diluted corticosteroids ( 1:3 mometasone furoate 0.1 % ointment and for the face 1:19 mometasone furoate 0.1 % ointment under a mask ) with emollient ( petrolatum 20 % in cetomacrogol cream ) .


The primary outcome was improvement of the objective SCORAD ; secondary outcomes included Patient-Oriented Eczema Measure and quality-of-life index .


WWT with diluted corticosteroids acted faster and was more efficacious than WWT with emollients .


Best results were obtained in age groups 6 to 9 years and 0 to 3 years .


The difference in efficacy evaluated by objective SCORAD was significant at all measuring points .


This also applied to the quality-of-life index .


The study group was relatively small .


WWT for severe AD is an effective therapy option for at least a period of 4 weeks .


The common variants in the fat mass and obesity-associated ( FTO ) gene have been associated with obesity and insulin resistance .


Recently , studies also linked FTO variants with macronutrient intakes .


We aimed to investigate whether diet interventions varying in macronutrients modified the effects of FTO genotypes on changes in insulin resistance .


We genotyped FTO variants rs1558902 and rs9939609 and measured insulin resistance in fasting plasma samples at baseline and at 6-mo and 2-y visits in 743 overweight or obese adults ( aged 30-70 y , 60 % women ) from a randomized weight-loss dietary interventional trial , the Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) trial .


We assessed interactions between FTO variants and intakes of dietary fat and protein in relation to change in body weight and insulin resistance using generalized estimating equation models .


We found significant interactions between rs1558902 and dietary fat on changes in homeostasis model assessment of insulin resistance ( HOMA-IR ) and insulin ( P = 0.003 and 0.004 , respectively ) .


Each risk allele ( A ) of rs1558902 showed a trend to be related to a 0.05-unit less reduction in both log ( insulin ) and log ( HOMA-IR ) among the participants assigned to low-fat diets ( both P = 0.06 ) , but this was not significantly related to reduction in those assigned to high-fat diets ( both P > 0.1 ) during the 2-y period of intervention .


Our data showed that the association between rs9939609 and changes in insulin resistance was not modified by diet macronutrient intakes .


Our results show that carriers of the risk alleles of rs1558902 benefit differently in improving insulin sensitivity by consuming high-fat weight-loss diets rather than low-fat diets .


Still , given our data , we acknowledge it is difficult to determine whether fat or carbohydrate contributed to the observed associations .


The ideal bioptic strategy for CaP detection is still to be completely defined .


The aim of our study is to compare transperineal ( TP ) and transrectal ( TR ) approaches , in a 14-core initial prostate biopsy for CaP detection .


A prospective controlled study was conducted enrolling 108 consecutive patients with a PSA level greater than 4 ng/mL and/or an abnormal DRE .


TR versus TP 14-core initial prostatic biopsies were performed on 54 and 54 patients , respectively , with a randomisation ratio of 1:1 .


The cancer detection rates were 46.29 ( 25 out of 54 patients ) , and 44.44 % ( 24 out of 54 patients ) , respectively , using the TR or the TP approach ( p = 0.846 ) .


The overall cancer core rate was significantly higher when the TP approach was used : 21.43 % ( 162 out of 756 cores ) and 16.79 % ( 127 out of 756 cores ) , with the TP and the TR approach , respectively ( p = 0.022 ) .


The cores were significantly longer performing TP approach : at the site `` 1 '' ( 14.92 versus 12.97 mm , p = 0.02 ) ; at `` 5 '' ( 15.53 versus 13.69 mm , p = 0.037 ) ; at `` 7 '' ( 15.06 versus 12.86 mm , p = 0.001 ) ; at `` 9 '' ( 14.92 versus 13.38 mm , p = 0.038 ) ; at `` 11 '' ( 16.32 versus 12.31 mm , p = 0.0001 ) ; at `` 12 '' ( 15.14 versus 12.19 mm , p = 0.0001 ) ; at `` 13 '' ( 17.49 versus 13.98 mm , p = 0.0001 ) ; at `` 14 '' ( 16.77 versus 13.36 mm , p = 0.0001 ) .


As to the biopsy related pain , the mean pain level perceived by patients during the TR approach was 1.56 1.73 versus 1.42 1.37 registered during TP approach ( p = 0.591 ) .


No significant differences were found in cancer detection rate , cancer core rate between TP and TR approaches for prostatic biopsy .


Even in terms of complication rate or pain level , it can not be concluded that one procedure is superior to the other one .


Apparently , strictly following our protocol , TP approach seems to offer a better sampling at the level of the apex and the TZ , however without adding any significant advantage in terms of overall cancer detection rate .


The role of patient age in the efficacy of mesenchymal stem cell ( MSC ) therapy in ischemic cardiomyopathy ( ICM ) is controversial .


This study sought to determine whether the therapeutic effect of culture-expanded MSCs persists , even in older subjects .


Patients with ICM who received MSCs via transendocardial stem cell injection ( TESI ) as part of the TAC-HFT ( Transendocardial Autologous Cells in Ischemic Heart Failure ) ( n = 19 ) and POSEIDON ( Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis ) ( n = 30 ) clinical trials were divided into 2 age groups : younger than 60 and 60 years of age and older .


Functional capacity was measured by 6-min walk distance ( 6MWD ) and quality of life using the Minnesota Living With Heart Failure Questionnaire ( MLHFQ ) score , measured at baseline , 6 months , and 1 year post-TESI .


Various cardiac imaging parameters , including absolute scar size , were compared at baseline and 1 year post-TESI .


The mean 6MWD was similar at baseline and increased at 1 year post-TESI in both groups : 48.5 14.6 m ( p = 0.001 ) for the younger and 35.9 18.3 m ( p = 0.038 ) for the older participants ( p = NS between groups ) .


The older group exhibited a significant reduction in MLHFQ score ( -7.04 3.54 ; p = 0.022 ) , whereas the younger than 60 age group had a borderline significant reduction ( -11.22 5.24 ; p = 0.058 ) from baseline ( p = NS between groups ) .


Although there were significant reductions in absolute scar size from baseline to 1 year post-TESI , the effect did not differ by age .


MSC therapy with TESI in ICM patients improves 6MWD and MLHFQ score and reduces myocardial infarction size .


Importantly , older individuals did not have an impaired response to MSC therapy .


To compare the intraoperative pain , anxiety , undesired movement , and cooperation between patients receiving oral diazepam or intravenous ( IV ) midazolam for conscious sedation during cataract surgery under topical anesthesia .


Ambulatory surgical center , Honolulu , Hawaii , USA .


Prospective randomized controlled trial .


Patients having first-time cataract extraction with topical anesthesia were randomized to receive sedation with oral diazepam 30 minutes before surgery or IV midazolam immediately preceding surgery .


The outcomes of intraoperative pain , anxiety , undesired movement , and poor cooperation were observed by the surgeon and recorded during surgery .


One hundred fifty-six cataract surgeries were included , 83 in the IV midazolam group and 73 in the oral diazepam group .


Twenty-four patients ( 29 % ) in the IV group and 7 patients ( 10 % ) in the oral group showed undesired movement ( P < .02 ) .


Seven patients ( 8 % ) in the IV group and 2 patients ( 3 % ) in the oral group showed poor cooperation ( P > .05 ) .


Fifteen patients ( 18 % ) in the IV group and 9 patients ( 12 % ) in the oral group had anxiety ( P > .05 ) .


Three patients ( 4 % ) in the IV group and 3 patients ( 4 % ) in the oral group experienced pain ( P > .05 ) .


Fewer patients receiving oral diazepam 30 minutes before cataract surgery than patients receiving IV midazolam immediately preceding surgery showed undesired movement during surgery .


There was no statistically significant difference in the number of patients showing poor cooperation or experiencing pain or anxiety between the 2 groups .


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


To compare the efficacy of 1-stage versus 2-stage lateral maxillary sinus lift procedures .


Sixty partially edentulous patients requiring 1 to 3 implants and having 1 to 3 mm of residual bone height and at least 5 mm bone width below the maxillary sinus , as measured on CT scans were selected .


They were randomised according to a parallel group study design into two equal arms to receive either a 1-stage lateral window sinus lift with simultaneous implant placement or a 2-stage procedure with implant placement delayed by 4 months , using a bone substitute in three different centres .


Implants were submerged for 4 months , loaded with reinforced provisional prostheses , which were replaced , after 4 months , by definitive prostheses .


Outcome measures , assessed by masked assessors , were : augmentation procedure failures ; prosthesis failures and implant failures ; complications ; and marginal peri-implant bone level changes .


Patients were followed up to 1 year after loading .


Only data of implants placed in 1 to 3 mm of bone height were reported .


Two patients dropped out from the 1-stage group and none from the 2-stage group .


No sinus lift procedure failed in the 1-stage group but one failed in the 2-stage group , the difference being not statistically significant ( P = 1.00 ) .


Two prostheses failed or could not be placed in the planned time in the 1-stage group and one in the 2-stage group , the difference being not statistically significant ( P = 0.51 ) .


Three implants failed in three patients of the 1-stage group , versus one implant in the 2-stage group , the difference being not statistically significant ( P = 0.28 ) .


Two complications occurred in the 1-stage group and one in the 2-stage group , the difference being not statistically significant ( P = 0.61 ) .


One year after loading , 1-stage treated patients lost an average of -1.01 mm ( SD : 0.56 ) of peri-implant bone and 2-stage sites about -0.93 mm ( SD : 0.40 ) .


There were no statistically significant differences in bone level change between groups 1 year after loading ( -0.08 mm 95 % CI : -0.33 to 0.18 P = 0.56 ) .


No statistically significant differences were observed between implants placed according to 1 - or 2-stage sinus lift procedures .


However this study may suggest that in patients having residual bone height between 1 to 3 mm below the maxillary sinus , there might be a slightly higher risk for implant failures when performing a 1-stage lateral sinus lift procedure .


The main aim was to investigate the effectiveness of a novel internal teat sealant ( ITS ) formulation containing bismuth subnitrate and the antiseptic chlorhexidine , in adult cows ( Trial A ) and nulliparous heifers ( Trial B ) , to reduce the incidence of new intramammary infection ( IMI ) between treatment and calving and reduce the prevalence of IMI within 6 days following calving .


In Trial A dairy cows ( n = 326 ) without history of clinical mastitis and with a maximum composite milk somatic cell count < 200,000 cells/mL during the current lactation were enrolled from three spring-calving mainly pasture-based herds immediately following the final milking .


In Trial B all heifers ( n = 166 ) were enrolled from two herds approximately 3 weeks before the start of calving .


Glands were randomly assigned to controls or treatment with ITS , and mammary secretion samples were taken from all glands prior to treatment , and on two occasions 0-4 and 3-6 days post-calving to determine the incidence of new IMI and the prevalence of IMI immediately post-calving .


Additionally , cows in Trial A were monitored for cases of clinical mastitis ( CM ) in the non-lactating period and animals in both trials were monitored for cases of CM within 30 days of calving .


The ITS reduced the estimated incidence of new IMI with both major and any pathogens compared to control glands in cows ( 6.2 vs. 14.2 % and 14.7 vs. 32.8 % , respectively ) and in heifers ( 3.0 vs. 13.1 % and 13.4 vs. 25.3 % , respectively ) ( p < 0.001 ) .


The ITS reduced the estimated prevalence of a major or any pathogen compared to untreated controls at both 0-4 and 3-6 days post-calving , in both cows and heifers .


Additionally , the ITS reduced the incidence of CM in the non-lactating period in cows ( -1.0 % , p = 0.01 ) and in the 30 days following calving in heifers ( -2.0 % , p = 0.06 ) , and tended to reduce the estimated incidence of CM in cows post-calving ( -1.7 % , p = 0.10 ) .


The novel ITS reduced the incidence of new IMI , and the prevalence of IMI at calving in both adult cows and heifers , and reduced the incidence of CM in the non-lactating period of cows and in the first 30 days after calving in heifers .


The results of these trials demonstrate the efficacy of a novel ITS for the control of mastitis in likely uninfected dairy cows over the non-lactating period and in heifers in late pregnancy .


We report the results of a phase II trial of adding the anti-ascular endothelial growth factor ( VEGF ) bevacizumab to gemcitabine neoadjuvant chemotherapy for patients with borderline and unresectable non-metastatic pancreatic cancer .


Patients were assigned to one of the two treatment arms .


Both groups received 1,000 mg/m ( 2 ) gemcitabine on days 1 , 8 , and 15 of a 4-week cycle for a total of four cycles .


Group 1 received 5 mg/kg bevacizumab for six weeks ( three doses ) , every second week , starting at week 6 of gemcitabine therapy .


Group 2 received 5 mg/kg bevacizumab for 12 weeks ( six doses ) , every second week , starting at week 1 of gemcitabine therapy .


The objective of the present study was to assess the rate of complete radical resection and overall survival .


A total of 30 patients were enrolled : 19 patients had unresectable and 11 patients had borderline-resectable pancreatic cancer .


Eleven patients ( 37 % ) underwent resection .


The median overall survival of patients who underwent tumor resection was 13 months ( 95 % confidence interval = 11-15 months ) .


In general , adding bevacizumab to neoadjuvant gemcitabine does not improve outcomes for patients with locally advanced pancreatic cancer .


However , in individual cases , surgery is consequently possible and prolonged survival may be observed .


Heavy drinking poses significant risks to the health and survival of individuals infected with HIV , particularly those coinfected with hepatitis C virus ( HCV ) .


However , little is known about patients ' perceptions of these risks , and whether these perceptions relate to their alcohol consumption .


A sample of 254 heavily drinking HIV primary care patients ( 78 % male ; 94.5 % minority ; 31.8 % with HCV ) reported on their perceptions of the medical risks of drinking and on their alcohol consumption prior to participation in a drinking-reduction intervention trial .


In the HIV-infected sample as a whole , 62.9 % reported that they had a medical problem made worse by drinking , and 64.3 % reported restricting drinking to avoid future medical problems .


Although patients coinfected with HIV/HCV reported greater efforts to restrict drinking to avoid future medical problems ( adjusted odds ratio = 1.94 ) , their reported drinking quantity and frequency did not differ from that of HIV mono-infected patients .


Awareness of medical risk was not associated with drinking level .


Effort to restrict drinking to avoid medical risk was associated with lower drinking quantity , frequency , and binge frequency ( ps < 0.05 ) , but the association with binge frequency was specific to patients without HCV .


Over one-third of HIV patients are unaware of the medical risks of drinking , and do not restrict use , suggesting the need for intervention in this group .


Patients coinfected with HIV/HCV may report more effort to restrict drinking , but their reported drinking quantity and frequency suggest that they are actually drinking just as heavily as HIV mono-infected patients .


Awareness of medical risk was unrelated to drinking , which suggests the need for interventions consisting of more than simple education .


However , reported effort to restrict drinking did predict less drinking , suggesting the importance of patient commitment and initiative in change .


In a nonclinical trial setting , we sought to determine the proportion of individuals with coronary artery disease ( CAD ) with optimal risk factor levels based on the COURAGE ( Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation ) trial .


In the COURAGE trial , the addition of percutaneous coronary intervention ( PCI ) to optimal medical therapy did not reduce the risk of death or myocardial infarction in stable CAD patients but resulted in more revascularization procedures .


The REGARDS ( REasons for Geographic And Racial Differences in Stroke ) study is a national prospective cohort study of 30,239 African-American and white community-dwelling individuals older than 45 years of age who enrolled in 2003 through 2007 .


We calculated the proportion of 3,167 participants with self-reported CAD meeting 7 risk factor goals based on the COURAGE trial : 1 ) aspirin use ; 2 ) systolic blood pressure < 130 mm Hg and diastolic blood pressure < 85 mm Hg ( < 80 mm Hg if diabetic ) ; 3 ) low-density lipoprotein cholesterol < 85 mg/dl , high-density lipoprotein cholesterol > 40 mg/dl , and triglycerides < 150 mg/dl ; 4 ) fasting glucose < 126 mg/dl ; 5 ) nonsmoking status ; 6 ) body mass index < 25 kg/m ( 2 ) ; and 7 ) exercise4 days per week .


The mean age of participants was 69 9 years ; 33 % were African American and 35 % were female .


Overall , the median number of goals met was 4 .


Less than one-fourth met5 of the 7 goals , and 16 % metall 3 goals for aspirin , blood pressure , and low-density lipoprotein cholesterol .


Older age , white race , higher income , more education , and higher physical functioning were independently associated with meeting more goals .


There is substantial room for improvement in risk factor reduction among U.S. individuals with CAD .


This trial examined diaries of hot flash events reported upon occurrence to assess the test/retest reliability of the diaries and their ability to measure treatment effects on hot flash frequency and severity .


Forty-two postmenopausal women ( aged 40 y ; 5-50 hot flashes/wk ) were randomized ( 3:3:1 ) to placebo , raloxifene 60 mg , or paroxetine 20 mg daily for 12 weeks .


Diaries of hot flash frequency and severity were evaluated at 1-week intervals ( twice before study treatment and thrice during study treatment ) .


Forty-one women were evaluated .


Baseline characteristics were similar between groups ( eg , mean , 29.8 hot flashes/wk ) .


Concordance correlation coefficients between screening ( week -2 ) and baseline ( week -1 ) measures of hot flash frequency and severity were 0.73 and 0.71 , respectively .


After 12 weeks , the mean ( 95 % CI ) percent changes from baseline in weekly hot flash frequency were as follows : placebo , -37.4 % ( -60.9 to -14.0 ) ; raloxifene , -14.2 % ( -37.7 to 9.3 ) ; paroxetine , -49.8 % ( -88.6 to -11.0 ) ; the mean ( 95 % CI ) percent changes in hot flash severity were as follows : placebo , -39.9 % ( -69.1 to -10.8 ) ; raloxifene , -9.6 % ( -38.8 to 19.6 ) ; paroxetine , -36.6 % ( -84.7 to 11.5 ) .


There were no significant differences in hot flash diary results between treatment groups .


Measures of hot flash frequency and severity show acceptable test/retest reliability between screening and baseline .


Reductions in vasomotor symptoms by raloxifene are numerically less than those seen with placebo , but no statistically significant treatment differences have been documented in this small study .


The large effect of placebo and the significant reduction in vasomotor symptoms by paroxetine are consistent with other studies .


The diary seems to be suitable for use in hot flash clinical trials .


We present a long-term safety , immunogenicity , and effectiveness study of a quadrivalent human papillomavirus ( HPV4 ) vaccine .


Sexually naive boys and girls aged 9 to 15 years ( N = 1781 ) were assigned ( 2:1 ) to receive HPV4 vaccine or saline placebo at day 1 and months 2 and 6 .


At month 30 , the placebo group ( n = 482 ) received HPV4 vaccine following the same regimen and both cohorts were followed through month 96 .


Subjects 16 years were eligible for effectiveness evaluations .


The primary objective was to evaluate the long-term anti-HPV6 / 11/16/18 serological levels .


The secondary objective was to estimate vaccine effectiveness against HPV6/11/16 / 18-related persistent infection or disease .


For each of the HPV4 vaccine types , vaccination-induced anti-HPV response persisted through month 96 .


Among 429 subjects who received HPV4 vaccine at a mean age of 12 , none developed HPV6/11/16 / 18-related disease or persistent infection of 12 months ' duration .


Acquisition of new sexual partners ( among those 16 years ) was 1 per year .


Subjects receiving HPV4 vaccine at month 30 ( mean age 15 years ) had a similar baseline rate of seropositivity to 1 of the 4 HPV types to those vaccinated at day 1 ( mean age 12 years ; 1.9 % [ 9 of 474 ] vs 1.7 % [ 20 of 1157 ] ) ; however , 4 of the 9 subjects vaccinated at the later age were seropositive to 3 vaccine types , indicating previous HPV exposure .


No new significant serious adverse events were observed for 8 years postvaccination in both genders .


When administered to adolescents , the HPV4 vaccine demonstrated durability in clinically effective protection and sustained antibody titers over 8 years .


A strong association exists between the use of tamsulosin and the occurance of intraoperative floppy iris syndrome .


Several methods were advocated to overcome the progressive intraopertive miosis.Our purpose was to investigate the effect of a mydriatic-cocktail soaked cellulose sponge on perioperative pupil diameter in tamsulosin-treated patients undergoing elective cataract surgery .


Patients using tamsulosin were dilated either with mydriatic-cocktail soaked sponge ( group 1 ) or with conventional eyedrop regimen ( group 2 ) .


Control patients not taking any 1 adrenergic receptor inhibtors were also dilated with mydriatic sponge ( group 3 ) .


In all groups oxybuprocain 0.4 % , cocain 4 % , tropicamide 1 % , phenylephrine 10 % , diclophenac 0.1 % along with chloramphenicol 0.5 % were used preoperatively.Pupil diameter ( mm ) was measured preoperatively , after nucleus delivery , and before IOL implantation .


Adverse effects associated with the use of sponge , minor and major intraoperative complications , the use of iris retractors and operation time were recorded.Differences in general between groups were analyzed with a one way analysis of variance ( ANOVA ) ; differences between groups in proportions were assessed by Fisher 's exact test .


Mean pupil diameter ( mm ) was preopertively : 7.52 1.21 , 7.30 1.55 and 7.99 0.96 ( ANOVA : p = 0.079 ) ; after nucleus delivery : 6 1.20 , 6.29 1.12 and 6.52 0.81 ( ANOVA : p = 0.123 ) ; before IOL implantation : 5.46 1.06 , 5.83 1.09 and 6.17 0.89 ( ANOVA : p = 0.0291 ) .


No adverse effect related to sponge use was detected .


Frequency of minor complications , and iris hook use was similar in the two tamsulosin treated group .


Operation time did not differ significantly in the three groups .


We have found that using a mydriatic cocktail-soaked wick - an alternative way to achieve intraoperative mydriasis for cataract surgery - was as effective and safe as the conventional repeated eyedrops regiment for tamsulosin treated patients .


Current Controlled Trials ISRCTN37834752 .


Gastroparesis remains a challenging syndrome to manage , with few effective treatments and a lack of rigorously controlled trials .


Tricyclic antidepressants are often used to treat refractory symptoms of nausea , vomiting , and abdominal pain .


Evidence from well-designed studies for this use is lacking .


To determine whether treatment with nortriptyline results in symptomatic improvement in patients with idiopathic gastroparesis .


The NORIG ( Nortriptyline for Idiopathic Gastroparesis ) trial , a 15-week multicenter , parallel-group , placebo-controlled , double-masked , randomized clinical trial from the National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium ( GpCRC ) , comparing nortriptyline with placebo for symptomatic relief in idiopathic gastroparesis .


One hundred thirty patients with idiopathic gastroparesis were enrolled between March 2009 and June 2012 at 7 US academic medical centers .


Patient follow-up was completed in October 2012 .


Inclusion criteria included delayed gastric emptying and moderate to severe symptom scores using the Gastroparesis Cardinal Symptom Index ( GCSI ) .


INTERVENTIONS Nortriptyline vs placebo .


Study drug dose was increased at 3-week intervals ( 10 , 25 , 50 , 75 mg ) up to 75 mg at 12 weeks .


The primary outcome measure of symptomatic improvement was a decrease from the patient 's baseline GCSI score of at least 50 % on 2 consecutive 3-week GCSI assessments during 15 weeks of treatment .


The primary symptomatic improvement outcome did not differ between 65 patients randomized to nortriptyline vs 65 patients randomized to placebo : 15 ( 23 % [ 95 % CI , 14 % -35 % ] ) in the nortriptyline group vs 14 ( 21 % [ 95 % CI , 12 % -34 % ] ) in the placebo group ( P = .86 ) .


Treatment was stopped more often in the nortriptyline group ( 19 [ 29 % { 95 % CI , 19 % -42 % } ] ) than in the placebo group ( 6 [ 9 % ] { 95 % CI , 3 % -19 % } ] ) ( P = .007 ) , but numbers of adverse events were not different ( 27 [ 95 % CI , 18-39 ] vs 28 [ 95 % CI , 19-40 ] ) ( P = .89 ) .


Among patients with idiopathic gastroparesis , the use of nortriptyline compared with placebo for 15 weeks did not result in improvement in overall symptoms .


These findings do not support the use of nortriptyline for idiopathic gastroparesis .


clinicaltrials.gov Identifier : NCT00765895 .


Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size .


We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling .


In a multicenter , double-blind , randomized trial , we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction ( STEMI ) who were undergoing percutaneous coronary intervention ( PCI ) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine ( administered intravenously at a dose of 2.5 mg per kilogram of body weight ) or matching placebo before coronary recanalization .


The primary outcome was a composite of death from any cause , worsening of heart failure during the initial hospitalization , rehospitalization for heart failure , or adverse left ventricular remodeling at 1 year .


Adverse left ventricular remodeling was defined as an increase of 15 % or more in the left ventricular end-diastolic volume .


A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year .


The rate of the primary outcome was 59.0 % in the cyclosporine group and 58.1 % in the control group ( odds ratio , 1.04 ; 95 % confidence interval [ CI ] , 0.78 to 1.39 ; P = 0.77 ) .


Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events , including recurrent infarction , unstable angina , and stroke .


No significant difference in the safety profile was observed between the two treatment groups .


In patients with anterior STEMI who had been referred for primary PCI , intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year .


( Funded by the French Ministry of Health and NeuroVive Pharmaceutical ; CIRCUS ClinicalTrials.gov number , NCT01502774 ; EudraCT number , 2009-013713-99 . )


To evaluate the effects of acute and daily consumption of high-oleic peanuts ( HOP ) on inflammation and glucose homeostasis in overweight/obese men .


In a 4-week randomized clinical trial , males with body mass index of 29.8 2.3 kg/m ( 2 ) and aged 18-50 years were assigned to the groups : control ( CT , n = 22 ) ; conventional peanuts ( CVP , n = 22 ) ; or HOP ( n = 21 ) .


They followed a hypocaloric-diet with or without 56 g/day of CVP or HOP .


Main outcomes were changes in fasting blood biomarkers and postprandial insulin , glucose , tumor necrosis factor-alfa ( TNF - ) , and interleukin-10 ( IL-10 ) responses after acute peanut intake .


At baseline , HOP showed significantly lower postprandial responses of glucose , insulin , and TNF - than CVP and CT. .


Changes in fasting blood biomarkers did not differ between groups after the 4-week intervention .


However , within groups , total cholesterol decreased in CT , and all groups reduced High-density lipoprotein ( HDL-c ) .


Triglycerides were reduced in HOP and CVP .


IL-10 increased significantly in all groups while only the CT and CVP showed increased TNF - after intervention .


Acute high-oleic peanut consumption leads to stronger moderation of postprandial glucose , insulin , and TNF - concentrations than CVP and control meal intake .


Whether daily intake of high-oleic peanuts has additional benefits to CVP remains uncertain .


To evaluate the safety and efficacy of urinary kallidinogenase for recombinant tissue-type plasminogen activator ( rt-PA ) intravenous thrombolytic treatment in patients with acute cerebral infarction .


All 200 patients with acute cerebral infarction were randomized 1:1 into an experimental group ( 100 cases ) and a control group ( 100 cases ) .


Patients in the control group were administrated rt-PA ( 0/9 mg/kg ) while patients in the experimental group were given urinary kallidinogenase by intravenous drip ( 0.15 PNAU/d , for 7 days ) after rt-PA intravenous thrombolytic treatment ( 0.9 mg/kg ) .


The main evaluation index was NIHSS and BI .


Compared to the control group , the NIHSS scores were significantly lower 7 and 90 days after thrombolytic therapy ( t = 2.391 , 2.714 ; p < 0.05 ) .


BI scores were obviously higher at 90 days after thrombolytic therapy in the experimental group ( t = 2.675 , p < 0.05 ) .


Urinary kallidinogenase may improve the treatment effect for rt-PA intravenous thrombolytic treatment in patients with acute cerebral infraction .


To assess the impact of dutasteride compared with placebo on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia , using pooled data from dutasteride phase III studies .


Nocturia was assessed using Question 7 of the International Prostate Symptom Score questionnaire .


Efficacy measures included : mean change in nocturia at 24 months ; proportion of patients with improvement/worsening in nocturia ; nocturnal voiding frequency at baseline and study end , overall and by baseline subgroups ; and nocturnal voiding frequency < 2 at study end in patients with baseline score 2 .


In total , 4,321 patients with a mean age of 66 years were evaluated .


From month 12 onwards , mean nocturia improvements were significantly superior with dutasteride than with placebo ( p 0.05 ) .


Reduction in nocturia was significantly better with dutasteride than with placebo across all baseline subgroups tested ( p 0.05 ) .


Also at month 24 , dutasteride therapy resulted in a greater proportion of subjects with nocturia improvement compared with placebo ( p 0.05 ) , with the largest treatment group differences in subjects with a baseline nocturia score of 2 or 3 .


Among patients with significant nocturia at baseline ( score 2 ) , significantly more subjects with dutasteride versus placebo had a score < 2 at month 24 ( 26 vs. 19 % , p < 0.001 ) .


After 24 months of treatment , dutasteride treatment provided significantly greater improvements in nocturia , and less worsening , compared with placebo , primarily in subjects with two or three nocturia episodes per night .


Studies specifically designed to assess nocturia are required to prospectively confirm these findings .


There is increasing interest in the extraskeletal effects of vitamin D , particularly in the obese state with regard to the development of insulin resistance and diabetes .


The objective of the study was to determine the effect of 2 doses of cholecalciferol ( vitamin D3 ) supplementation on insulin action ( Si ) and pancreatic - cell function in obese adolescents .


We performed a 12-wk double-blind , randomized comparison of the effect of vitamin D3 supplementation on Si and - cell function in obese Caucasian adolescents ( body mass index > 95 ( th ) percentile ) .


The subjects were randomly assigned to receive either 400 IU/d ( n = 25 ) or 2000 IU/d ( n = 26 ) of vitamin D3 .


Each subject underwent a 7-sample 75 g oral glucose tolerance test , with glucose , insulin , and C-peptide measurements , to calculate Si and - cell function as assessed by the disposition index ( DI ) , with use of the oral minimal model before and after supplementation .


A total of 51 subjects aged 15.0 1.9 y were enrolled .


Included for analysis at follow-up were a total of 46 subjects ( 20 male and 26 female adolescents ) , 23 in each group .


Initial serum 25-hydroxyvitamin D [ 25 ( OH ) D ] was 24.0 8.1 g/L .


There was no correlation between 25 ( OH ) D concentrations and Si or DI .


There was a modest but significant increase in 25 ( OH ) D concentration in the 2000 IU/d group ( 3.1 6.5 g/L , P = 0.04 ) but not in the 400 IU/d group ( P = 0.39 ) .


There was no change in Si or DI following vitamin D3 supplementation in either of the treatment groups ( all P > 0.10 ) .


The current study shows no effect from vitamin D3 supplementation , irrespective of its dose , on - cell function or insulin action in obese nondiabetic adolescents with relatively good vitamin D status .


Whether obese adolescents with vitamin D deficiency and impaired glucose metabolism would respond differently to vitamin D3 supplementation remains unclear and warrants further studies .


This trial was registered at clinicaltrials.gov as NCT00858247 .


Gestational diabetes mellitus ( GDM ) is associated with both maternal and offspring adverse effects .


The World Health Organization ( WHO ) has recently adopted novel GDM criteria .


The aim of this study was to evaluate the former WHO and a simplified version of the new International Association for Diabetes in Pregnancy Study Group ( IADPSG ) criteria as to prevalence of and risk factors for GDM in a Nordic Caucasian population .


A 75 g oral glucose tolerance test was performed in 687 women at 18-22 and 32-36 pregnancy weeks .


GDM was defined according to the WHO criteria as fasting plasma glucose 7.0 mmol/L and/or 2-hour plasma glucose 7.8 mmol/L and by a simplified version of the IADPSG criteria as either fasting glucose 5.1 mmol/L and/or 2-h plasma glucose 8.5 mmol/L .


One-hour glucose values were not available and were thus not included in the diagnosis of GDM by IADPSG .


Prevalence of GDM during pregnancy and risk factors for GDM at 18-22 weeks were studied in retrospect according to each of the two criteria .


The total prevalence of GDM during pregnancy was 6.1 % ( 42/687 ) for the WHO criteria and 7.4 % ( 51/687 ) for the simplified IADPSG criteria .


High maternal age and short stature were independently associated with WHO GDM .


Maternal age , fasting insulin and no regular exercise at 18-22 pregnancy weeks associated with simplified IADPSG GDM .


Simplified IADPSG criteria moderately increase GDM prevalence compared with the WHO criteria .


Risk factors for GDM differ with the diagnostic criteria used .


At the doses typically used to treat hypertriacylglycerolemia , fish oil may increase low-density lipoprotein ( LDL ) cholesterol and blood glucose levels .


The aim of the present study was to verify whether soy could attenuate the effects of fish oil on blood lipids and carbohydrate metabolism in patients with metabolic syndrome .


Sixty-five women ( 47.9 9.98 y ) were studied with the use of a parallel , randomized design .


The control group maintained the usual diet ; the second group received 29.14 g/d of soy ( kinako ) ; the third group received 3 g/d of fish oil n-3 fatty acids ; and the fourth group received fish oil ( 3 g/d ) and kinako ( 29.14 g/d ) .


Assessments were performed at baseline and after 45 and 90 d.


In relation to baseline values , fish oil increased ( P < 0.05 ) total and LDL cholesterol , glucose , insulin , and homeostasis model assessment of insulin resistance levels after 90 d. Comparisons among groups demonstrated a decrease ( P < 0.05 ) in total cholesterol in the fish oil and kinako group after 90 d as compared with the fish oil group .


LDL cholesterol decreased ( P < 0.01 ) in the kinako group as compared with the fish oil group .


Blood glucose and homeostasis model assessment of insulin resistance levels decreased after 90 d ( P < 0.01 and P < 0.05 , respectively ) and insulin levels decreased ( P < 0.05 ) after 45 d when the kinako group was compared with the fish oil group .


The present study showed that kinako moderates the adverse effects of high doses of fish oil on LDL cholesterol , total cholesterol , and glucose metabolism levels .


To compare the relative plaque control efficacy of a marketed 0.454 % stabilized stannous fluoride ( SnF2 ) dentifrice relative to a triclosan/copolymer dentifrice using digital plaque imaging analysis ( DPIA ) .


This was a randomized , two-treatment , double-blind , parallel group design study that compared SnF2 and triclosan/copolymer dentifrices over a period of 3 weeks .


DPIA was used to capture a digital image of the maxillary and mandibular anterior facial surfaces of 12 teeth and to calculate plaque area coverage .


Overnight DPIA images were taken at a baseline visit after which subjects were randomly assigned to one of the two treatment groups and were required to brush with their assigned dentifrice according to each manufacturer 's instructions .


Subjects had DPIA assessments on two separate days at the end of Week 3 .


96 subjects were randomized to treatment .


Plaque area data for 47 subjects per treatment group were compared at Week 3 using ANCOVA .


The SnF2 group demonstrated a statistically significant reduction in overnight plaque at Week 3 compared to baseline ( P = 0.002 ) .


The reduction for the triclosan group at Week 3 compared to baseline was not statistically significant ( P = 0.24 ) .


At Week 3 , the SnF2 group demonstrated a 17 % lower adjusted mean for overnight plaque relative to the triclosan group with a mean difference that was statistically significant ( P < 0.05 ) .


The Week 3 adjusted mean change from baseline in overnight plaque for the SnF2 group was 3 times greater versus that of the triclosan group ( P < 0.05 ) .


The study purpose was to analyze 5-year outcomes in a prospective , randomized trial of alemtuzumab ( ALEM ) versus rabbit antithymocyte globulin ( rATG ) induction in simultaneous kidney-pancreas transplantation ( SKPT ) .


From February 2005 through October 2008 , a total of 46 SKPTs ( 45 portal-enteric drainage ) were prospectively randomized to receive either single-dose ALEM ( 30 mg intraoperatively ) or multiple-dose rATG antibody induction ( starting intraoperatively , minimum of 3 doses administered ) with tacrolimus/mycophenolate and/or steroids .


Of 222 kidney transplant patients enrolled in the study , 46 received SKPTs ; 28 ( 61 % ) received ALEM and 18 ( 39 % ) received rATG induction .


Follow-up ranged from 54 to 98 months ( mean , 69 months ) .


There were no significant differences between the 2 groups in 5-year patient ( 82 % ALEM vs 89 % rATG ) , kidney graft ( 79 % ALEM vs 72 % rATG ) , or pancreas graft ( 64 % ALEM vs 56 % rATG ) survival rates .


Death-censored kidney ( 90 % ALEM vs 75 % rATG ) and pancreas ( 71 % ALEM vs 56 % rATG ) graft survival rates were likewise comparable ( both , P = NS ) .


Acute rejection ( 21 % ALEM vs 44 % rATG ; P = .11 ) and major infection ( 39 % ALEM vs 67 % rATG ; P = .13 ) rates were slightly lower in the ALEM group ; cytomegalovirus infections were significantly lower ( 0 % ALEM vs 17 % rATG ; P = .05 ) .


The incidence of late acute rejection was low in both groups .


There were no differences in early pancreas thromboses ( 3.6 % ALEM vs 11 % rATG ) , postoperative bleeding ( 11 % ALEM vs 0 % rATG ) , other surgical complications , or readmissions between groups .


In patients with functioning grafts , 5-year mean serum creatinine ( 1.4 ALEM vs 1.6 mg/dL rATG ) , calculated abbreviated Modification of Diet in Renal Disease glomerular filtration rate ( 55 ALEM vs 52 mL/min/1 .73 m ( 2 ) rATG ) , glycosylated hemoglobin ( both 5.4 % ) , and C-peptide ( 2.2 ALEM vs 2.3 ng/mL rATG ) levels were similar .


Single-dose ALEM and multiple dose rATG induction provided similar medium-term patient , kidney , and pancreas graft function and survival rates .


ALEM induction may be associated with less acute rejection and major infection over the long term .


To determine the mechanisms by which extended-release nicotinic acid reduces circulating lipoprotein ( a ) concentrations in hypertriglyceridemic patients .


Eight nondiabetic , obese male subjects ( aged 4812 years ; body mass index , 31.21.8 kg/m ( 2 ) ) with hypertriglyceridemia ( triglycerides , 22678 mg/dL ) were enrolled in an 8 week , double blind , placebo-controlled cross-over study .


At the end of each treatment phase , fasted subjects received a 10 mol/L per kg bolus injection of [ 5,5,5 - ( 2 ) H3 ] - l-Leucine immediately followed by constant infusion of [ 5,5,5 - ( 2 ) H3 ] - l-Leucine ( 10 mol L ( -1 ) kg ( -1 ) h ( -1 ) ) for 14 hours , and blood samples were collected .


A liquid chromatography-tandem mass spectrometry method was used to study apolipoprotein ( a ) ( Apo ( a ) ) kinetics .


The fractional catabolic rate of Apo ( a ) was calculated with a single compartmental model using the apolipoprotein B100 ( ApoB100 ) containing very low density lipoprotein tracer enrichment as a precursor pool .


Extended-release nicotinic acid decreased plasma triglycerides ( -46 % ; P = 0.023 ) , raised high-density lipoprotein cholesterol ( +20 % ; P = 0.008 ) , and decreased Apo ( a ) plasma concentrations ( -20 % ; P = 0.008 ) .


Extended-release nicotinic acid also decreased ApoB100 ( 22 % ; P = 0.008 ) and proprotein convertase subtilisin/kexin type 9 ( PCSK9 , -29 % ; P = 0.008 ) plasma concentrations .


Apo ( a ) fractional catabolic rate and production rates were decreased by 37 % ( 0.580.28 versus 0.360.19 pool/d ; P = 0.008 ) and 50 % ( 1.40.8 versus 0.70.4 nmol/kg per day ; P = 0.008 ) , respectively .


Extended-release nicotinic acid treatment decreased Apo ( a ) plasma concentrations by 20 % , production rates by 50 % , and catabolism by 37 % .


ApoB100 and PCSK9 concentrations were also decreased by treatment , but no correlation was found with Apo ( a ) kinetic parameters .


We sought to compare the effects of physical practice ( PP ) and mental practice ( MP ) on the immediate and long-term learning of the finger-to-thumb opposition sequence task ( FOS ) in children ; in addition , we investigated the transfer of this learning to an untrained sequence of movements and to the contralateral untrained hand .


This study included thirty-six 9 - and 10-year-old children who were randomly allocated into 3 groups : MP , PP , and no practice ( NP ) .


The MP and PP groups were subjected to a single session of training with the dominant trained hand .


MP participants were trained by mentally rehearsing the movements , PP participants were trained by executing the movements , and the NP group had no training .


The performance of the trained sequence ( TS ) and untrained reverse sequence ( URS ) by each of the 3 groups was evaluated under identical conditions before training , after 5 min , and at 4 days , 7 days , and 28 days after training .


Whereas both trained groups ( MP and PP ) showed statistically significant improvement in TS using the trained hand at all assessment points after the training , only MP participants were able to transfer the performance gains from the TS to the URS and from the trained hand to the untrained opposite hand .


Children were able to learn the FOS through MP or PP with a similar level of performance .


Unlike PP , MP allowed for the transfer of performance gain to the URS and to the opposite hand , suggesting that the internal representations developed by MP were effector-independent .


Renal dysfunction ( RD ) is associated with poor outcome in systolic heart failure ( HF ) .


Left ventricular ejection fraction ( LVEF ) is not depressed to a greater extent in patients with RD compared to patients with normal renal function , but it is relatively unknown whether other measures of myocardial function are impaired by RD. .


The objective of the present study is to evaluate whether RD in systolic HF is associated with excessive impairment of myocardial function , evaluated by strain analysis and cardiac biomarkers .


Patients with LVEF < 0.45 % were enrolled from an outpatient HF clinic .


The patients underwent advanced echocardiography .


Glomerular filtration rate was estimated by the CKD-EPI equation ( eGFR ) and patients grouped by eGFR : eGFR group-I , 90 ml/min/1 .73 m ( 2 ) ; eGFR group-II , 60-89 ml/min/1 .73 m ( 2 ) ; and eGFR group-III , 59 ml/min/1 .73 m ( 2 ) .


Multivariate regression models were developed to evaluate the associations between eGFR groups , echocardiographic measures and cardiac biomarkers .


A total of 149 patients participated in the study .


Median age was 69 years , 26 % were female ; LVEF was 33 % .


Patients with a low eGFR were older ( P < 0.001 ) , but there were no differences in frequency of atrial fibrillation , hypertension , diabetes and ischemic heart disease between eGFR groups ( P > 0.05 for all ) .


RD was associated with impaired global longitudinal strain ( P = 0.018 ) , increased E/e ' ( P = 0.032 ) , larger left atria ( P = 0.038 ) and increased levels of proANP ( P < 0.001 ) , NT-proBNP ( P < 0.001 ) and troponin I ( P = 0.019 ) after adjustment for traditional confounders .


Echocardiographic measures and biomarkers reflecting different aspects of myocardial function are impaired in systolic HF patients with RD and the increased mortality risk in these patients may partly be explained by a depressed cardiac function .


Previously , in a 40-week , randomised , double-blind , placebo-controlled core study comprising three phases ( 9-week dose confirmation , 5-week open-label dose optimisation and 6-month maintenance of effect ) in adults with attention-deficit/hyperactivity disorder ( ADHD ) , methylphenidate modified-release long-acting formulation ( MPH-LA ) at 40-80 mg/day controlled ADHD symptoms as well as decreased functional impairment with a good tolerability profile ( NCT01259492 ) .


Here , we report the long-term efficacy and safety from a 26-week , open-label extension phase of the same study ( NCT01338818 ) .


Patients in the extension study ( n = 298 ) initiated treatment with MPH-LA ( 20 mg/day ) , up-titrated in increments of 20 mg/week to reach individual patient 's daily optimal dose of 40-80 mg .


Adverse events ( AEs ) and serious adverse events ( SAEs ) were reported at the end of extension study for events monitored from ( 1 ) maintenance of effect phase baseline ( core study ; 12 months ) and ( 2 ) extension study baseline ( 6 months ) .


Mean changes in DSM-IV ADHD Rating Scale ( DSM-IV ADHD RS ) and Sheehan Disability Scale ( SDS ) total scores are reported for both the timelines .


Efficacy was also evaluated using clinician-rated instruments , namely Clinical Global Impression-Improvement Scale ( CGI-I ) and Clinical Global Impression-Severity Scale ( CGI-S ) .


No unexpected AEs were reported in the extension study .


Incidence of SAEs reported during 6 months and 12 months were similar ( 0.7 % ) , and no deaths were reported .


No SAEs were considered attributable to the drug at the end of 12 months .


There were no reports of patients with QT , QTcB or QTcF > 500 ms. The mean improvement in DSM-IV ADHD RS and SDS total scores at the end of 12 months were 0.9 and 1.4 points , respectively ; and at the end of 6 months were 7.2 and 4.8 , respectively .


The proportion of patients with improvement in CGI-S scale was 31.4 % and 52.1 % at the end of 12 and 6 months , respectively .


Overall , 69.4 % of patients showed clinical improvement in CGI-I scale at the end of 6 months .


In adult patients with ADHD , use of MPH-LA up to 1 year continued to be well tolerated while maintaining the clinical efficacy .


To investigate the efficiency of total knee arthroplasty ( TKA ) for varus osteoarthritic knees with tibial bone resection determined by lateral tibiofemoral joint 90 flexional gap measurement .


Between March and June 2013 , 60 patients ( 60 knees ) with varus osteoarthritic knees underwent TKA .


All patients were randomly divided into traditional osteotomy group ( control group , 30 cases ) and lateral tibiofemoral joint 90 flexional gap measurement resection group ( trial group , 30 cases ) .


There was no significant difference in gender , age , affected side , body mass index and preoperative knee society score ( KSS ) , range of motion ( ROM ) of the knee , anatomic tibiofemoral angle ( ATFA ) , patellar tilt angle , posterior condylar offset ( PCO ) , and joint line height between 2 groups ( P > 0.05 ) .


The bone resection thickness of the distal femoral lateral condyle , femoral posterior lateral condyle , and lateral tibial plateau were measured ; and the X-ray films were taken to measure and compare ATFA , patellar tilt angle , PCO , and joint line height after TKA .


The knee function recovery was evaluated with KSS score and ROM of the knee .


The bone resection thickness of the lateral tibial plateau and distal femoral lateral condyle in trial group was significantly smaller than that in control group ( P < 0.05 ) ; while the bone resection thickness of the femoral posterior lateral condyle was significantly bigger than that in control group ( P < 0.05 ) .


The 10 mm polyethylene insert was used in 19 cases of the trial group and in 8 cases of the control group , showing significant difference ( Z = -4.040 , P = 0.003 ) .


All the patients were followed up 13-16 months ( mean , 14.5 months ) .


Radiography at 6 weeks after TKA indicated that the ATFA , patellar tilt angle , and joint line height had no significant difference between 2 groups ( P > 0.05 ) ; the PCO of trial group was significantly lower than that of control group ( P < 0.05 ) .


The KSS score and ROM of the knee at 12 months after operation were significantly improved when compared with preoperative ones in 2 groups ( P < 0.05 ) , and trial group was significantly better than control group ( P < 0.05 ) .


It was an effective method to determine bone resection thickness using lateral tibiofemoral joint 90 flexional gap measurement in TKA for varus osteoarthritic knees , which can reduce the bone resection thickness of the tibial plateau and distal femoral lateral condyle and restore the joint line and PCO with better early recovery of the knee function .


The aim of the present study was to evaluate the reduction in bacterial loading uing MTAD as an irrigating solution in pulpectomized primary teeth .


A randomized , controlled clinical trial was performed that included primary teeth with pulp necrosis .


Sixty necrotic canals were included , 30 irrigated with MTAD ( experimental group ) and 30 with 1 % Na0Cl solution ( control group ) ; in all cases , 2 microbiological samples from within the canals were taken with sterile paper points , the first after the canal opening and before the first irrigation , and the second after instrumentation and final irrigation , before obturation .


All samples were evaluated by Agar plate method .


The results were statistically analyzed by student ` t ' test .


After analyzing samples before and after irrigation in the control group ( NaOCl ) , we found a significant decrease of bacterial load ( p = < 0.001 ) .


The same occurred in the MTAD group samples ( p = < 0.001 ) .


When both groups were compared post irrigation , a statistically significant difference was observed in favor of MTAD .


MTAD can be suggested as an alternative irrigant for pulpectomy of necrotic teeth .


To describe the imaging standards , grading protocol and baseline characteristics of polypoidal choroidal vasculopathy ( PCV ) from the EVEREST study .


In a prospective , multicentre study , confocal scanning laser ophthalmoscope indocyanine green angiography ( ICGA ) was performed using a standardised imaging protocol .


All images were graded using standardised , calibrated equipment by fellowship-trained ophthalmologists at the Central Reading Center .


Sixty-one patients with PCV were included in the study .


ICGA characteristics included : nodular appearance stereoscopically ( 56 eyes , 91.8 % ) , hypofluorescent halo ( 42 , 68.9 % ) , abnormal vascular network ( 54 , 88.5 % ) and pulsation of the polyps ( 4 , 6.6 % ) .


Colour fundus photography revealed orange subretinal nodules ( 34 , 55.7 % ) and massive submacular haemorrhage ( 8 , 13.1 % ) .


The mean area of the PCV lesion was 3.11 mm ( 2 ) ( range , 0.2-10 .7 mm ( 2 ) ) .


The vascular channels filled within 7.3-32 .0 s ( mean : 17.9 s ) while the mean filling time for polyps was 21.9 s ( range , 7.3-40 .4 s ) .


Patients with massive submacular haemorrhage were less likely to have abnormal vascular channels seen on ICGA ( 28.6 % vs 83.3 % for those without massive haemorrhage , p = 0.001 ) .


The imaging and grading protocols and baseline characteristics of a multicentre , randomised controlled trial of PCV are described in detail , and may serve as reference for future randomised , controlled trials on PCV .


This work was supported by Novartis Pharma AG , Basel , Switzerland grant number NCT00674323 ( clinicaltrials.gov ) .


To evaluate attainment of diabetes-related quality measures with canagliflozin 100 mg , canagliflozin 300 mg , and sitagliptin 100 mg in patients with type 2 diabetes mellitus .


This post hoc analysis used pooled data from two 52-week , randomized , double-blind , phase 3 clinical trials that evaluated the comparative efficacy of canagliflozin and sitagliptin .


One trial evaluated patients on metformin at baseline with add-on canagliflozin 100 mg , canagliflozin 300 mg , or sitagliptin 100 mg ; the other trial evaluated patients on metformin and a sulfonylurea at baseline with add-on canagliflozin 300 mg or sitagliptin 100 mg .


Individual diabetes-related quality measures , including glycated hemoglobin ( A1C ) , blood pressure ( BP ) , low-density lipoprotein cholesterol ( LDL-C ) , body mass index ( BMI ) , and change in body weight , were assessed .


At baseline , the proportions of patients meeting criteria for all quality measures were similar between groups .


At 52 weeks , compared with sitagliptin 100-mg treatment , canagliflozin 100 mg demonstrated either comparable or superior glycemic control .


Additionally , canagliflozin 100 mg versus sitagliptin 100 mg demonstrated superior attainment of BP , BMI , and weight-related quality measures ; no difference was seen with respect to LDL-C .


At 52 weeks , compared with sitagliptin 100-mg treatment , canagliflozin 300 mg demonstrated superior glycemic control at all thresholds of A1C , and superior BP , BMI , and weight-related quality measures ; there was no difference in LDL-C quality measure attainment .


We evaluated the comparative efficacy of canagliflozin 100 mg , canagliflozin 300 mg , and sitagliptin 100 mg on quality measure attainment after 52 weeks of treatment .


Compared with sitagliptin 100 mg , canagliflozin 100 mg demonstrated comparable or superior attainment of diabetes-related quality measures .


Compared with sitagliptin 100 mg , canagliflozin 300 mg demonstrated superior diabetes-related quality measure attainment , including glycemic , BP , and weight-related quality measures ; there was no difference in LDL-C quality measure attainment between either dosage of canagliflozin and the 100-mg dosage of sitagliptin .


This study aimed to determine the effect of topical lidocaine on Penetration-Aspiration Scale ( PAS ) scores and patient comfort and tolerance of flexible endoscopic evaluation of swallowing ( FEES ) examinations in dysphagic patients .


Adults with dysphagia referred for swallowing evaluation were recruited to participate in consecutive nonanesthetized and then anesthetized FEES examinations .


Under endoscopic visualization , participants consumed 6 swallows consisting of graduated volumes of milk , pudding , and cracker in each condition and recorded their discomfort and tolerance in the 2 conditions .


Penetration-Aspiration Scale scores were assigned in blinded fashion for each swallow .


Twenty-five adults participated in the study .


Although there was no statistically significant effect of anesthesia on PAS scores ( P = .065 ) , the odds of a higher PAS score were 33 % higher during anesthetized swallows .


The anesthetized condition yielded significantly less discomfort and pain during the examination , significantly less pain and discomfort during insertion and removal of the endoscope , and significantly greater overall tolerance than the nonanesthetized condition .


The use of topical lidocaine during FEES may impair swallowing ability in patients with dysphagia , but this result does not achieve statistical significance .


Topical nasal anesthesia significantly reduces subjective pain and discomfort and improves tolerance during FEES .


A prospective , randomized comparison of shock wave lithotripsy , retrograde intrarenal surgery and miniperc for the treatment of 1 to 2 cm radiolucent lower calyceal renal calculi was done to evaluate the safety and efficacy of these procedures .


Patients with a single 1 to 2 cm radiolucent lower calyceal renal stone who underwent treatment between January 2012 and May 2013 were included in study .


They were randomized to shock wave lithotripsy , retrograde intrarenal surgery and miniperc groups .


Patient demographic profiles , success and re-treatment rates , auxiliary procedures and complications were analyzed .


A total of 45 patients were enrolled in each of the shock wave lithotripsy , retrograde intrarenal surgery and miniperc groups .


Three , 2 and 4 patients , respectively , were excluded from final analysis due to a matrix stone diagnosis .


Mean procedure and fluoroscopy times were significantly greater in the miniperc group than in the other groups .


Hospital stay ( 3.1 days vs 3.1 hours and 1.3 days , p = 0.01 ) and the blood transfusion rate ( 13.3 % vs 0 % and 0 % , p = 0.03 ) were significantly higher for miniperc vs shock wave lithotripsy and retrograde intrarenal surgery , respectively .


The re-treatment rate ( 63.4 % vs 2.1 % and 2.2 % , p < 0.001 ) and the auxiliary procedure rate ( 20.2 % vs 8.8 % and 6.6 % , p = 0.02 ) were significantly greater for shock wave lithotripsy than for retrograde intrarenal surgery and miniperc , respectively .


The 3-month stone-free rate of shock wave lithotripsy , retrograde intrarenal surgery and miniperc was 73.8 % ( 31 of 42 patients ) , 86.1 % ( 37 of 43 ) and 95.1 % ( 39 of 41 ) , respectively ( p = 0.01 ) .


Miniperc and retrograde intrarenal surgery were more effective than shock wave lithotripsy to treat 1 to 2 cm radiolucent lower calyceal renal calculi in terms of a better stone-free rate , and lesser auxiliary and re-treatment rates .