Malondialdehyde-modified LDL ( MDA-LDL ) is an oxidized LDL and is increased in patients with diabetes or hypertriglyceridemia .


Elevated MDA-LDL has been reported to be a risk factor of atherosclerosis or cardiovascular disease .


Sitagliptin is a dipeptidyl peptidase-4 inhibitor and a new class of hypoglycemic agents .


In this study , the effects of increasing the dose of metformin and add-on sitagliptin on MDA-LDL were examined in type 2 diabetes patients .


Seventy patients with type 2 diabetes , inadequately controlled despite on-going treatment with metformin 500 mg/day , were enrolled in this randomized controlled trial .


The patients received additional metformin ( 500 mg/day ) or sitagliptin ( 50 mg/day ) for 6 months , and changes in metabolic parameters including MDA-LDL were evaluated .


After 6 months of treatment , add-on sitagliptin ( n = 35 ) improved fasting blood glucose ( FBG ) and hemoglobin A1c ( HbA1c ) to significantly greater extent than increasing the dose of metformin ( n = 35 ) .


There were no differences in total cholesterol and low-density lipoprotein cholesterol levels between two groups .


MDA-LDL levels ( mean S.E. ) decreased significantly with increasing the dose of metformin ( from 94.40 6.35 to 77.83 4.74 U/L , P < 0.005 ) , but remained unchanged with add-on sitagliptin treatment ( from 89.94 5.59 to 98.46 6.78 U/L , p > 0.05 ) .


Multiple linear regression analysis identified increasing the dose of metformin treatment as the only independent factor associated with decreased MDA-LDL ( coefficient 0.367 , P < 0.0119 ) , and no significant correlation between change in MDA-LDL and fasting blood glucose or HbA1c .


These results suggest that increasing the dose of metformin improves serum MDA-LDL levels in type 2 diabetes mellitus .


This study was designed to test the effect of the featured/featureless nature of deviant stimuli on mismatch negativity ( MMN ) , P300 ( P3a and P3b ) and on behavioral discrimination performances .


Ten healthy adults were submitted to stimuli contrasted by the presence or absence of a frequency sweep .


Discrimination performances were collected during the neurophysiological sessions .


MMN , P3a and P3b were much larger for featured deviants than for featureless ones .


Behavioral data ( d' , at ceiling level , and reaction times ) were not affected by the featured/featureless nature of the deviant stimulus .


Behavioral results and MMN amplitudes are in accordance with our previous study , using the same design albeit in an ignore condition and with collection of the behavioral data deferred until after the neurophysiological sessions .


The present study strengthens previous evidence suggesting that two mechanisms contribute to the MMN evoked by featured deviants : the memory comparison process and the adaptation/fresh-afferent phenomenons .


We here demonstrate that the neurophysiological processes underlying P300 generation are also impacted by the featured/featureless nature of the deviant stimulus and that the dissociation from behavioral data , which are not impacted , is also observed when both types of data are recorded simultaneously .


To evaluate the effect of an innovative model integrating telemonitoring of vital parameters and telephone support on 6-month survival and hospital admissions of elderly adults with heart failure ( HF ) .


Parallel-arm , randomized trial .


Geriatric acute care ward and outpatient clinic at Policlinico Campus Biomedico ( Rome , Italy ) .


Individuals with HF aged 65 and older ( mean age 80 ) randomly assigned to intervention ( n = 50 ) or control ( n = 46 ) .


Participants had an average ejection fraction of 46 % .


Telemonitoring system ( receives and communicates oxygen saturation , heart rate , and blood pressure readings ) and office-hours telephonic support provided by a geriatrician .


Combination of all-cause death and hospital admissions .


The two groups were similar with the exception of the prevalence of women and of disability ( both more common in the control group ) .


Three patients for each group were lost to follow-up ( final analyzed sample size : 90 ) .


Incidence of the main outcome was 42 % in the control group and 21 % in the intervention group ( relative risk = 0.51 , 95 % confidence interval ( CI ) = 0.26-0 .98 ) .


The results were unchanged after taking into account the setting of enrollment , sex , and disability ( hazard ratio = 0.42 , 95 % CI = 0.19-0 .94 ) .


Telemonitoring of elderly people with HF is feasible and reduces the risk of death and hospitalization .


Further studies are needed to confirm these findings and evaluate the cost-efficacy of the service .


Postoperative delirium in the intensive care unit ( ICU ) is a frequent complication after cardiac or thoracic surgery and is associated with increased morbidity and mortality .


In this single-center substudy of the BAG-RECALL trial ( NCT00682825 ) , we screened patients after cardiac or thoracic surgery in the ICU twice daily for delirium using the Confusion Assessment Method for the ICU .


The primary outcome was the incidence of delirium in patients who had been randomized to intraoperative Bispectral Index ( BIS ) - guided and end-tidal anesthetic concentration-guided depth of anesthesia protocols .


As a secondary analysis , a Bayesian stochastic search variable selection strategy was used to rank a field of candidate risk factors for delirium , followed by binary logistic regression .


Of 310 patients assessed , 28 of 149 ( 18.8 % ) in the BIS group and 45 of 161 ( 28.0 % ) in the end-tidal anesthetic concentration group developed postoperative delirium in the ICU ( odds ratio 0.60 , 95 % confidence interval , 0.35-1 .02 , P = 0.058 ) .


Low average volatile anesthetic dose , intraoperative transfusion , ASA physical status , and European System for Cardiac Operative Risk Evaluation were identified as independent predictors of delirium .


A larger randomized study should determine whether brain monitoring with BIS or an alternative method decreases delirium after cardiac or thoracic surgery .


The association between low anesthetic concentration and delirium is a surprising finding and could reflect that patients with poor health are both more sensitive to the effects of volatile anesthetic drugs and are also more likely to develop postoperative delirium .


Investigation of candidate methods to prevent delirium should be prioritized in view of the established association between postoperative delirium and adverse patient outcomes .


Angiogenesis contributes to the progression of urothelial carcinoma ( UC ) .


In the current study , the authors investigated the role of maintenance sunitinib in patients with advanced UC .


Patients with locally recurrent/metastatic UC and adequate organ function who achieved stable disease or a partial or complete response after 4 to 6 chemotherapy cycles were randomized to sunitinib at a dose of 50 mg/day ( 28 days on and 14 days off ) or placebo .


The primary endpoint was the 6-month progression rate .


Secondary endpoints were safety , survival , change in serum vascular endothelial growth factor ( VEGF ) / soluble VEGF receptor-2 ( sVEGFR2 ) , and the activity of sunitinib in patients who developed disease progression while receiving placebo .


A total of 38 eligible patients per treatment arm were required to select better therapy with 90 % probability ( = .05 ) .


A total of 54 eligible patients were randomized to either the sunitinib arm ( 26 patients ) or the placebo arm ( 28 patients ) .


The median number of cycles received was 2 cycles per treatment arm .


The most common grade 3 to 4 adverse events ( graded according to version 3.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events ) among patients receiving sunitinib were thrombocytopenia , diarrhea , mucositis , fatigue , and hypertension .


There were no grade 3 or 4 adverse events noted among > 5 % of patients receiving placebo .


The 6-month progression rate was 72 % versus 64 % .


The median progression-free survival ( PFS ) was 2.9 months ( range , 0.5 months-32 .5 months ) versus 2.7 months ( range , 0.8 months -65 months ) for the sunitinib versus placebo arms , respectively .


Patients receiving placebo were found to have no changes in their serum VEGF/sVEGFR2 levels over time .


Patients treated with sunitinib had no significant change in their VEGF level , but the sVEGFR2 level significantly decreased after cycles 1 and 2 ( P < .0001 ) and at the time of disease progression ( P = .0002 ) .


A baseline VEGF level that was at or greater than the median was found to be correlated with a longer PFS .


Sixteen patients who were receiving placebo received sunitinib at the time of disease progression , with the best responses being 1 partial response ( 6.3 % ) , 6 cases of stable disease ( 37.5 % ) , and 5 cases of progressive disease ( 31.3 % ) ; 4 patients were not evaluable for response .


The median PFS was 3.7 months ( range , 0.1 months-22 months ) .


The current multicenter study was limited by premature closure and a small sample size .


Maintenance sunitinib did not appear to improve the 6-month progression rate .


Open-label sunitinib was found to have only modest activity .


The sVEGFR2 level decreased among patients receiving sunitinib .


Families with low incomes experience an array of health and social challenges that compromise their resilience and lead to negative family outcomes .


Along with financial constraints , there are barriers associated with mental and physical health , poorer education and language .


In addition , vulnerable populations experience many services as markedly unhelpful .


This combination of family and service barriers results in reduced opportunities for effective , primary-level services and an increased use of more expensive secondary-level services ( e.g. , emergency room visits , child apprehensions , police involvement ) .


A systematic review of effective interventions demonstrated that promotion of physical and mental health using existing service was critically important .


The Families First Edmonton Trial ( FFE ) tests four service integration approaches to increase use of available health and social services for families with low-income .


It is a randomized , two-factor , single-blind , longitudinal effectiveness trial where low-income families ( 1168 ) were randomly assigned to receive either ( 1 ) Family Healthy Lifestyle plus Family Recreation service integration ( Comprehensive ) , ( 2 ) Family Healthy Lifestyle service integration , ( 3 ) Family Recreation service integration , or ( 4 ) existing services .


To be eligible families needed to be receiving one of five government income assistance programs .


The trial was conducted in the City of Edmonton between January 2006 and August 2011 .


The families were followed for a total of three years of which interventional services were received for between 18 and 24 months .


The primary outcome is the number of family linkages to health and social services as measured by a customized survey tool `` Family Services Inventory '' .


Secondary outcomes include type and satisfaction with services , cost of services , family member health , and family functioning .


Where possible , the measures for secondary outcomes were selected because of their standardization , the presence of published norming data , and their utility as comparators to other studies of low-income families .


As an effectiveness trial , community and government partners participated in all committees through a mutually agreed upon governance model and helped manage and problem solve with researchers .


Modifications were made to the FFE trial based on the pragmatics of community-based trials .


ClinicalTrials.gov NCT00705328 .


To determine the treatment outcome of combined androgen blockade ( CAB ) therapy using the non-steroidal antiandrogen bicalutamide or the steroidal antiandrogen chlormadinone in patients with prostate cancer .


In total , 124 patients with prostate cancer enrolled in the present study were randomized to receive CAB therapy using a gonadotropin-releasing hormone ( GnRH ) agonist , combined with bicalutamide or chlormadinone .


The survival of patients was analyzed .


The 5-year cancer-specific survival for the bicalutamide - and chlormadinone-treated groups were 91.7 % and 86.6 % , respectively , with no significant difference ( p = 0.39 ) .


Five-year overall survival was significantly ( p = 0.029 ) better in the bicalutamide-treated group .


Moreover , M1 patients in the chlormadinone group had significantly lower cancer-specific and overall survival compared to those in the bicalutamide-treated group .


However , in the case of M0 patients , no significant difference in cancer-specific nor in overall survival was observed .


CAB therapy using chlormadinone led to a significantly poorer survival outcome versus the use of bicalutamide .


However , because this survival trend was not observed in M0 cases , chlormadinone may still be an option for CAB therapy , depending on clinical stage and the severity of adverse effects , such as hot flashes .


Iodine deficiency is one of the most important causes of congenital hypothyroidism .


In addition to thyroid hormone replacement , iodine supplementation is also given to newborns with congenital hypothyroidism due to iodine deficiency .


We aimed to determine whether it is beneficial to administer iodine supplementation in addition to the L-thyroxine ( L-T4 ) treatment of newborns with congenital hypothyroidism due to iodine deficiency .


Of 51 newborns , 26 who were diagnosed with congenital hypothyroidism due to iodine deficiency were treated with L-T4 .


The remaining 25 cases were given L-T4 plus 100 g/day of oral iodine .


Free triiodothyronine ( fT3 ) , free thyroxine ( fT4 ) , thyroid-stimulating hormone ( TSH ) , thyroglobulin ( TG ) , thyroid volume , urine iodine and breast milk iodine levels were measured in the first and third months of treatment , and the data were compared between the two groups .


First - and third-month values of fT3 , fT4 , TSH , TG and thyroid volume for both groups were statistically similar .


There was no significant difference between the two groups in respect to falling levels of fT3 and TSH , the rate of increase of fT4 levels or the shrinkage rate of thyroid volume .


In this study , the addition of oral iodine to L-T4 treatment provided no benefit compared to treatment with L-T4 alone .


Cannabis users often claim that cannabis has the potential to enhance their creativity .


Research suggests that aspects of creative performance might be improved when intoxicated with cannabis ; however , the evidence is not conclusive .


The aim of this study was to investigate the acute effects of cannabis on creativity .


We examined the effects of administering a low ( 5.5 mg delta-9-tetrahydrocannabinol [ THC ] ) or high ( 22 mg THC ) dose of vaporized cannabis vs. placebo on creativity tasks tapping into divergent ( Alternate Uses Task ) and convergent ( Remote Associates Task ) thinking , in a population of regular cannabis users .


The study used a randomized , double-blind , between-groups design .


Participants in the high-dose group ( n = 18 ) displayed significantly worse performance on the divergent thinking task , compared to individuals in both the low-dose ( n = 18 ) and placebo ( n = 18 ) groups .


The findings suggest that cannabis with low potency does not have any impact on creativity , while highly potent cannabis actually impairs divergent thinking .


Currently , there is a debate whether the laparoscopic gastric imbrication ( LGI ) offers similar weight loss when compared to the laparoscopic sleeve gastrectomy ( LSG ) .


On the surface , they seem to offer similar-sized stomachs after the procedures are performed .


We chose to perform a randomized double-blinded trial to see if similar-sized pouches result in similar types of weight loss .


Our belief was that sleeve gastrectomy would offer at least a 10 % better weight loss over a 3-year period .


Thirty patients were randomized to one of two arms .


The patients and the third party administrator following the patients were blinded as to which procedure was chosen .


The surgeon had full knowledge of the patients ' surgery throughout the treatment .


The decision of which arm to place them was made by a single employee of the third party administrator and not shared with the employees following the patients .


Patients were then followed for 3 years .


There were no differences in weight , age , or BMI preoperatively .


There were no differences between the two groups at any follow-up time point from 6 months to 3 years .


Follow-up was 100 % .


Due to the large standard deviations present in both groups , there was no statistical difference between either of the groups in terms of weight loss .


The objective of the study was to examine post hoc associations between plasma sphingolipids and lipoprotein kinetics in men with the metabolic syndrome after rosuvastatin treatment .


Plasma sphingolipid profiling , determined by tandem mass spectrometry , was performed in a randomized , double-blind , triple-crossover trial ( n = 12 ) of 5-week treatment periods with placebo or rosuvastatin ( 10 or 40 mg/d ) with 2-week washouts between treatments .


Baseline plasma ceramides were associated with very low-density lipoprotein ( VLDL ) apolipoprotein ( apo ) - B-100 concentration ( r = 0.58 , P < .05 ) and inversely with VLDL apoB-100 fractional catabolic rate ( FCR ; r = -0.67 , P = .02 ) .


Posttreatment changes with rosuvastatin ( 40 mg/d ) in plasma ceramides were inversely associated with VLDL apoB-100 FCR ( r = -0.62 , P = .03 ) independent of changes in plasma triglycerides , cholesterol , and low-density lipoprotein-cholesterol .


By contrast , baseline and postrosuvastatin treatment plasma sphingomyelin levels were not associated with apoB-100 kinetics .


Plasma ceramides and sphingomyelin were not associated with the kinetics or concentrations of high-density lipoprotein apoA-I , and low-density lipoprotein apoB .


In the metabolic syndrome , the ability of rosuvastatin to increase VLDL apoB-100 FCR may reflect ceramide-specific mechanistic actions and/or sphingolipid exchange .


Laser hair removal has become an increasingly popular method to remove unwanted or excessive hair .


We have assessed the relative efficacy and discomfort associated with competing hair removal techniques , namely a high average power 810nm diode laser using an in-motion technique with a market-leading 810nm device with a single-pass vacuum-assisted technique .


This study has determined the long-term ( 6-12 months ) hair reduction efficacy and the relative pain induction intensities of these devices .


Prospective , randomized , side-by-side comparison of either the legs or axillae was performed comparing the Soprano XL 810nm diode in super hair removal ( SHR ) mode ( Alma Lasers , Buffalo Grove , IL ) hereafter known as the in-motion device vs. the LightSheer Duet 810nm diode laser ( Lumenis ) hereafter known as the single pass device .


Five laser treatments were performed 6 to 8 weeks apart with 1 , 6 , and 12 months follow-ups for hair counts .


Pain was assessed in a subjective manner by the patients on a 10-point grading scale .


Hair count analysis was performed in a blinded fashion .


There was a 33.5 % ( SD 46.8 % ) and 40.7 % ( SD 41.8 % ) reduction in hair counts at 6 months for the single pass and in-motion devices respectively ( P = 0.2879 ) .


The average pain rating for the single pass treatment ( mean 3.6 , 95 % CI : 2.8 to 4.5 ) was significantly ( P = 0.0007 ) greater than the in-motion treatment ( mean 2.7 , 95 % CI 1.8 to 3.5 ) .


This data supports the hypothesis that using diode lasers at low fluences and high average power with a multiple pass in-motion technique is an effective method for hair removal , with less pain and discomfort , while maintaining good efficacy .


The 6 month results were maintained at 12 month for both devices .


Mindfulness-based cancer recovery ( MBCR ) and supportive-expressive therapy ( SET ) are well-validated psycho-oncological interventions , and we have previously reported health benefits of both programs .


However , little is known about patients ' characteristics or program preferences that may influence outcomes .


Therefore , this study examined moderators of the effects of MBCR and SET on psychological well-being among breast cancer survivors .


A multi-site randomized controlled trial was conducted between 2007 and 2012 in two Canadian cities ( Calgary and Vancouver ) .


A total of 271 distressed stage I-III breast cancer survivors were randomized into MBCR , SET or a 1-day stress management seminar ( SMS ) .


Baseline measures of moderator variables included program preference , personality traits , emotional suppression , and repressive coping .


Outcome measures of mood , stress symptoms , quality of life , spiritual well-being , post-traumatic growth , social support , and salivary cortisol were measured pre - and post intervention .


Hierarchical regression analyses were used to assess moderator effects on outcomes .


The most preferred program was MBCR ( 55 % ) .


Those who were randomized to their preference improved more over time on quality of life and spiritual well-being post-intervention regardless of the actual intervention type received .


Women with greater psychological morbidity at baseline showed greater improvement in stress symptoms and quality of life if they received their preferred versus nonpreferred program .


Patients ' program preference and baseline psychological functioning , rather than personality , were predictive of program benefits .


These results suggest incorporating program preference can maximize the efficacy of integrative oncology interventions , and emphasize the methodological importance of assessing and accommodating for preferences when conducting mind-body clinical trials .


To examine the effect of an oral prenatal probiotic on group B Streptococcus ( GBS ) colonization and to demonstrate the feasibility of a larger randomized controlled trial .


This pilot study was an open-label , two-group quasi-experiment .


An urban central city nurse-midwifery and wellness center serving a diverse population .


Ten pregnant participants received the oral probiotic ( Florajen3 ) taken once daily , and 10 participants served as controls .


A questionnaire on dietary practices , vaginal cleansing , sexual history , and symptoms and GBS colony count samples were taken at 28 - , 32 - , and 36-weeks gestation .


Participants in the probiotic group reported no adverse events or minor side effects ; one half reported improved gastrointestinal symptoms .


Although two women in each group had positive qualitative prenatal GBS cultures at 36 weeks , the probiotic group participants had lower quantitative GBS colony counts .


The eight GBS negative averaged 90 % probiotic adherence compared with two GBS positive women who averaged 68 % .


Yogurt ingestion was inversely related ( p = .02 ) to GBS colonization .


Prenatal probiotic therapy has the potential to reduce GBS colonization .


The potential of the probiotic intervention appears to be linked to daily adherence .


A controlled clinical trial with a larger , adequately powered sample is feasible and justified .


Moderate alcohol consumption has been associated with both negative and favorable effects on health .


The mechanisms responsible for reported favorable effects remain unclear .


Higher ( not necessarily elevated ) concentrations of serum bilirubin , an antioxidant , have also been associated with reduced risk of cardiovascular disease and all-cause mortality .


This study tests the hypothesis that single dose alcohol consumption elevates bilirubin providing a potential link between these observations .


18 healthy individuals ( eight cigarette smokers ) were administered alcohol , calibrated to achieve blood concentrations of 20 , 80 and 120 mg/dL , in random order in three laboratory sessions separated by a week .


Each session was preceded by and followed by 5-7 days of alcohol abstinence .


Serum bilirubin was measured at 7:45 a.m. prior to drinking , at 2p .


m. , and at 7:45 the next morning .


Mixed effects regression models compared baseline and 24h post-drinking bilirubin concentrations .


Total serum bilirubin ( sum of indirect and direct ) concentration increased significantly after drinking from baseline to 24h in non-smokers ( from M = 0.38 , SD = 0.24 to M = 0.51 , SD = 0.30 , F ( 1,32.2 ) = 24.24 , p < .0001 ) but not in smokers ( from M = 0.25 , SD = 0.12 to M = 0.26 , SD = 0.15 , F ( 1,31.1 ) = 0.04 , p = 0.84 ) .


In nonsmokers the indirect bilirubin concentration and the ratio of indirect ( unconjugated ) to direct ( conjugated ) bilirubin also increased significantly .


Alcohol consumption leads to increases in serum bilirubin in nonsmokers .


Considering the antioxidant properties of bilirubin , our findings suggest one possible mechanism for the reported association between alcohol consumption and reduced risk of some disorders that could be tested in future longitudinal studies .


Earlier initiation of antiretroviral therapy ( ART ) in HIV-tuberculosis ( TB ) is associated with increased immune reconstitution inflammatory syndrome ( IRIS ) .


The severity , frequency , and complications of TB IRIS were evaluated in A5221 , a randomized trial of earlier ART ( within 2 weeks after TB treatment initiation ) vs. later ART ( 8-12 weeks after TB treatment ) in HIV-infected patients starting TB treatment .


In 806 participants , TB IRIS was defined using published clinical criteria .


Cases were classified as severe ( hospitalization/death ) , moderate ( corticosteroid use/invasive procedure ) , or mild ( no hospitalization/procedures/steroids ) .


Fisher exact , Wilcoxon , and log-rank tests were used for comparisons .


TB IRIS occurred in 61 ( 7.6 % ) patients : 10.4 % in earlier vs. 4.7 % in later ART , 11.5 % with CD4 < 50 vs. 5.4 % with CD4 50 cells per cubic millimeter .


The CD4/ART arm interaction was significant , P = 0.014 , with 44.3 % of TB IRIS occurring with CD4 < 50 and earlier ART .


TB IRIS occurred sooner with earlier vs. later ART initiation , at a median of 29 vs. 82 days after TB treatment initiation ( P < 0.001 ) .


IRIS manifestations included lymphadenopathy ( 59.0 % ) , constitutional symptoms ( 54.1 % ) , and radiographic changes ( 41.0 % ) ; central nervous system TB IRIS was uncommon ( 6.6 % ) .


TB IRIS was mild in 27.9 % , moderate in 41.0 % , and severe in 31.1 % .


No TB IRIS-associated deaths occurred .


IRIS management required 1 invasive procedures in 34.4 % , hospitalization in 31.1 % , and corticosteroids in 54.1 % .


TB IRIS was more frequent with earlier ART initiation and CD4 < 50 cells per cubic millimeter .


As ART is implemented earlier in HIV-TB coinfection , programs will require the diagnostic capabilities , clinical resources , and training necessary to manage TB IRIS .


Trelagliptin is a novel once-weekly oral DPP-4 inhibitor .


We assessed the efficacy and safety of trelagliptin versus the daily oral DPP-4 inhibitor alogliptin in Japanese patients with type 2 diabetes .


We did a randomised , double-blind , active-controlled , parallel-group , phase 3 , non-inferiority study at 26 sites in Japan .


We included individuals with type 2 diabetes inadequately controlled by diet and exercise .


We randomly assigned patients ( 2:2:1 ) to receive trelagliptin ( 100 mg ) once per week , alogliptin ( 25 mg ) once per day , or placebo for 24 weeks .


Randomisation was done electronically and independently from the study with permuted blocks of ten patients .


Patients and clinicians were masked to group assignment .


Patients in the trelagliptin group were given trelagliptin once a week and oral alogliptin placebo every day , whereas patients in the alogliptin group were given oral trelagliptin placebo once a week and oral alogliptin every day ( double-dummy design ) .


Patients in the placebo group were given an oral alogliptin placebo once a day and an oral trelagliptin placebo once a week .


Our primary outcome was between-groups difference in change in HbA1c concentration from baseline to the end of treatment .


The non-inferiority margin was 04 % .


Our analysis included all patients who were randomised and received at least one dose of study drug .


The study is registered with ClinicalTrials.gov , number NCT01632007 .


Between May 26 , 2012 , and Nov 20 , 2012 , we enrolled 357 patients .


243 patients were included in the analysis ( 101 for trelagliptin , 92 for alogliptin , and 50 for placebo ) .


In the primary analysis , the least squares mean change in HbA1c concentration was -033 % in the trelagliptin group ( SE 0059 ) and -045 % in the alogliptin group ( 0061 ) based on the ANCOVA model .


The least squares mean difference ( trelagliptin minus alogliptin ) of change from baseline in HbA1c concentration was 011 % ( 95 % CI -0054 to 0281 ) .


Trelagliptin was non-inferior to alogliptin .


Both active groups had significantly reduced mean HbA1c concentrations at end of treatment compared with placebo ( p < 00001 ) .


The frequency of adverse events was similar between groups .


No hypoglycaemia was reported with trelagliptin and the drug was well tolerated .


The once-weekly DPP-4 inhibitor trelagliptin showed similar efficacy and safety to alogliptin once daily in Japanese patients with type 2 diabetes .


Trelagliptin could be a useful new antidiabetes drug that needs to be given once a week .


Takeda Pharmaceutical Company .


According to the literature , voice rest following phonosurgery , as recommended in clinical practice , varies between 3 and 7 days .


However , up until now , no randomized trials have been published comparing voice rest of short versus long duration .


This is an ongoing prospective randomized study , comparing strict voice rest of 5 versus 10 days on the voice following phonosurgery .


Thirty-one elective patients operated on for benign laryngeal lesions were randomized .


They completed pre - and postoperative assessments , including perceptual voice quality ( Grade , Roughness , Breathiness , Asthenia , Strain , Instability scale ) , Voice Handicap Index total score , and voice analysis with both acoustic and aerodynamic measurements .


Additional factors such as smoking , vocal abuse , reflux , and preoperative speech therapy were also taken into account .


Sixteen patients were randomized to follow 5 days ' voice rest and 15 patients were randomized to 10 days ' voice rest .


Statistical analysis showed no significant differences in pre - or postoperative measurements between the 2 groups .


However , multilinear regression analysis for the effect of voice rest duration on postoperative values showed a significant improvement in maximum phonation time ( MPT ) with 10 days ' voice rest .


Preliminary results show a benefit of prolonged voice rest ( 10 days ' duration ) on MPT .


To explore the efficacy and safety of fondaparinux combined with tirofiban in patients with high risk unstable angina ( UA ) undergoing complex percutaneous coronary intervention ( PCI ) .


A total of 389 patients were enrolled and randomized into two groups receiving either fondaparinux with tirofiban or enoxaparin with tirofiban .


Bleeding , thrombosis and main adverse cardiovascular events ( MACE ) were compared between the two groups during hospitalization , at week 2 and week 4 after discharge .


No severe bleeding was observed during hospitalization in the both groups , while lower rate of mild and minor bleeding was shown in the fondaparinux group ( 0 vs 1.5 % and 18.2 % vs 34.5 % , P = 0.04 and P < 0.001 respectively ) .


No difference was found between the two groups in the rate of MACE during hospitalization , at week 2 and week 4 weeks after discharge .


The rates of death , recurrent myocardial infarction , refractory myocardial ischemia and target vessel revascularization were 0.5 % vs 1.0 % , 0.5 % vs 1.0 % , 1.6 % vs 1.0 % and 2.1 % vs 1.5 % during hospitalization ; 0 vs 0 , 1.0 % vs 0.5 % , 1.0 % vs 1.5 % , 0.5 % vs 1.0 % at week 2 after discharge ; 0.5 % vs 0.5 % , 0.5 % vs 0.5 % , 2.6 % vs 2.0 % , 0 vs 0.5 % at week 4 after discharge ( all P values > 0.05 ) .


The combination therapy of fondaparinux and tirofiban is of good safety and efficacy in high risk UA patients undergoing complex PCI .


Insulin adjustments to maintain glycemic control in individuals with type 1 diabetes often lead to wide glucose fluctuations , hypoglycemia , and increased body weight .


Dapagliflozin , an insulin-independent sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor , increases glucosuria and reduces hyperglycemia in individuals with type 2 diabetes .


The primary objective of this study was to assess short-term safety of dapagliflozin in combination with insulin ; secondary objectives included pharmacokinetic , pharmacodynamic , and efficacy parameters .


A 2-week , dose-ranging , randomized , double-blind , placebo-controlled proof-of-concept study randomly assigned 70 adults with type 1 diabetes ( HbA1c 7-10 % ) , who were receiving treatment with stable doses of insulin , to one of four dapagliflozin doses ( 1 , 2.5 , 5 , or 10 mg ) or placebo .


The insulin dose was not proactively reduced at randomization but could be adjusted for safety reasons .


Sixty-two patients ( 88.6 % ) completed the study .


Any hypoglycemia was common across all treatments ( 60.0-92 .3 % ) ; one major event of hypoglycemia occurred with dapagliflozin 10 mg .


No diabetic ketoacidosis occurred .


Pharmacokinetic parameters were similar to those observed in patients with type 2 diabetes .


Glucosuria increased by 88 g/24 h ( 95 % CI 55 to 121 ) with dapagliflozin 10 mg and decreased by -21.5 g/24 h ( 95 % CI -53.9 to 11.0 ) with placebo .


Changes from baseline with dapagliflozin 10 mg by day 7 were as follows : -2.29 mmol/L ( 95 % CI -3.71 to -0.87 [ -41.3 mg/dL ; 95 % CI -66.9 to -15.7 ] ) for 24-h daily average blood glucose ; -3.77 mmol/L ( 95 % CI -6.09 to -1.45 [ -63.1 mg/dL ; 95 % CI -111.5 to -14.8 ] ) for mean amplitude of glycemic excursion ; and -16.2 % ( 95 % CI -29.4 to -0.5 ) for mean percent change in total daily insulin dose .


Corresponding changes with placebo were as follows : -1.13 mmol/L ( 95 % CI -3.63 to 1.37 ) , -0.45 mmol/L ( 95 % CI -4.98 to 4.08 ) , and 1.7 % ( 95 % CI -22.8 to 33.9 ) , respectively .


However , for every efficacy parameter , the 95 % CIs for all dapagliflozin doses overlapped those for placebo .


This exploratory study of dapagliflozin in adults with type 1 diabetes demonstrated acceptable short-term tolerability and expected pharmacokinetic profiles and increases in urinary glucose excretion .


Within the dapagliflozin groups , dose-related reductions in 24-h glucose , glycemic variability , and insulin dose were suggested , which provide hope that SGLT2 inhibition may prove in larger randomized controlled trials to be efficacious in reducing hyperglycemia in type 1 diabetes .


To examine gender disparities in cognitive functioning in India and the extent to which education explains this disparity in later life .


This study uses baseline interviews of a prospective cohort study of 1,451 community-residing adults 45 years of age or older in four geographically diverse states of India ( Karnataka , Kerala , Punjab , Rajasthan ) .


Data collected during home visits includes cognitive performance tests , and rich sociodemographic , health , and psychosocial variables .


The cognitive performance tests include episodic memory , numeracy , and a modified version of the Mini-Mental State Examination .


We find gender disparity in cognitive function in India , and this disparity is greater in the north than the south .


We also find that gender disparities in educational attainment , health , and social and economic activity explain the female cognitive disadvantage in later life .


We report significant gender disparities in cognitive functioning among older Indian adults , which differ from gender disparities in cognition encountered in developed countries .


Our models controlling for education , health status , and social and economic activity explain the disparity in southern India but not the region-specific disparity in the northern India .


North Indian women may face additional sources of stress associated with discrimination against women that contribute to persistent disadvantages in cognitive functioning at older ages .


To evaluate an incentive-based intervention to increase time spent outdoors among children in a 9-month cluster randomised controlled trial .


Two hundred and eighty-five children aged 6-12years of age were randomised to the intervention ( n = 147 ) or control arm ( n = 138 ) in the Family incentive trial ( FIT ) .


The FIT intervention comprised of targeted education on myopia and good eye care habits , structured weekend outdoor activities and incentives for children to increase their daily steps via pedometers .


The main outcome measure was outdoor time , measured by the WHO questionnaire and a 1-week diary .


Interim analysis at 6months showed a significant increase in mean outdoor time per week in the intervention arm ( 14.75 hweek ( -1 ) ) compared to the control arm ( 12.40 hweek ( -1 ) ) as measured by the questionnaire ( p = 0.04 ) .


However , greater outdoor time was not statistically significant at the end of the trial ( 15.95 hweek ( -1 ) vs 14.34 h in the control group ( p = 0.29 ) .


There was an increase in outdoor time for children in the incentive-based physical activity outdoor program after 6months but not at the end of the trial .


Further larger school trials with better compliance with the intervention and longer duration could be conducted to evaluate clinical outcomes such as myopic shifts .


Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin , a dipeptidyl peptidase 4 inhibitor , to usual care in patients with type 2 diabetes and cardiovascular disease .


In this randomized , double-blind study , we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy .


Open-label use of antihyperglycemic therapy was encouraged as required , aimed at reaching individually appropriate glycemic targets in all patients .


To determine whether sitagliptin was noninferior to placebo , we used a relative risk of 1.3 as the marginal upper boundary .


The primary cardiovascular outcome was a composite of cardiovascular death , nonfatal myocardial infarction , nonfatal stroke , or hospitalization for unstable angina .


During a median follow-up of 3.0 years , there was a small difference in glycated hemoglobin levels ( least-squares mean difference for sitagliptin vs. placebo , -0.29 percentage points ; 95 % confidence interval [ CI ] , -0.32 to -0.27 ) .


Overall , the primary outcome occurred in 839 patients in the sitagliptin group ( 11.4 % ; 4.06 per 100 person-years ) and 851 patients in the placebo group ( 11.6 % ; 4.17 per 100 person-years ) .


Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome ( hazard ratio , 0.98 ; 95 % CI , 0.88 to 1.09 ; P < 0.001 ) .


Rates of hospitalization for heart failure did not differ between the two groups ( hazard ratio , 1.00 ; 95 % CI , 0.83 to 1.20 ; P = 0.98 ) .


There were no significant between-group differences in rates of acute pancreatitis ( P = 0.07 ) or pancreatic cancer ( P = 0.32 ) .


Among patients with type 2 diabetes and established cardiovascular disease , adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events , hospitalization for heart failure , or other adverse events .


( Funded by Merck Sharp & Dohme ; TECOS ClinicalTrials.gov number , NCT00790205 . )


The primary aim of this study was to determine whether mesh pore size influences the rate of chronic pain at 6-mo follow-up .


Another aim was to evaluate the rate of foreign body feeling and quality of life after inguinal hernia repair .


The patients were randomized into two study groups : the UM group received Ultrapro mesh ( pore size 3-4 mm ) and the OM group received Optilene LP mesh ( pore size 1 mm ) .


Pain scores were measured on a visual analog scale .


The feeling of a foreign body was a yes-or-no question .


Quality of life was evaluated using the Medical Outcome Study Short-Form-36 questionnaire .


A total of 67 patients in the UM group and 67 patients in the OM group were investigated 6 mo after operation .


There were no significant differences in the results of the pain questionnaire between the study groups .


Of the patients , 46.3 % in the UM group reported pain during different activities at 6-mo follow-up versus 34.3 % in the OM group ( P = 0.165 ) .


The feeling of a foreign body in the inguinal region was experienced by 47.8 % of the patients in the UM group and by 31.3 % of the patients in the OM group at 6-mo follow-up ( P = 0.052 ; risk ratio 1.52 , 95 % confidence interval : 1.00-2 .37 ) .


There were no significant differences in the quality of life according to the Short-Form 36 questionnaire between the two study groups at 6-mo follow-up .


In both study groups , the quality of life scores improved after operation by most dimensions .


Differences in mesh pore size did not influence the rate of chronic pain .


Although there was a trend for higher rate of foreign body feeling in the study group where a mesh with larger pores was used , we failed to find an explanation for this .


The pore size of meshes investigated in this study did not affect the quality of life after inguinal hernia repair .


Considering the fact that the quality of life improved significantly after operation , elective repair of symptomatic inguinal hernias should be undertaken as promptly as possible .


Surgical site infections are the third most frequent type of nosocomial infections .


Evidence-based recommendations have been given regarding preoperative hospitalization , hygiene and air-conditioning , patient conditions , and wound dressing .


However , no general recommendations concerning wound closure exist .


Systematic reviews and meta-analyses suppose a benefit of intracutaneous suture compared to skin staples in orthopedic and obstetric surgery .


Literature data for skin closure in elective abdominal surgery are still deficient .


Patients scheduled for any elective abdominal surgery requiring midline or horizontal laparotomy are potentially eligible for the trial .


Trial-specific exclusion criteria are date of admission exceeding four days prior to surgery , antibiotic treatment within the past 14 days , any previous midline or horizontal laparotomy in case the procedure requires the same skin incision as before , neurophysiological deficits or severe psychiatric or neurologic diseases that do not allow an informed consent or compliance , and participation in any other interventional trial with interference of intervention and outcome .


The trial is created for process innovation within standardized surgical procedures .


It is designed as a prospective randomized controlled single center trial in a parallel design including an active comparator and an intervention group .


The intervention addresses the closure of skin after the main surgical procedure : intracutaneous suture in the intervention group and transcutaneous skin stapling in the control group .


The rate of superficial surgical site infections is defined as the primary endpoint .


Secondary endpoints are time for skin closure , satisfaction with the cosmetic outcome 30 days after surgery , prolongation of hospital stay , and duration of sick-leave due to surgical site infections .


The primary efficacy analysis follows the intention-to-treat principle .


A 2 test will be applied .


The trial is expected to balance the shortcomings of the current evidence .


It will help to define the gold standard for wound closure in elective abdominal surgery .


Patients ' safety and quality of life are assumed to be enhanced .


Therapy costs are likely to be reduced and health care optimized .


German Clinical Trials Register ( DRKS ) DRKS00004542 .


Adjunctive behavioral smoking cessation treatments have the potential to improve outcomes beyond standard care .


The present study had two aims : ( 1 ) compare standard care ( SC ) for smoking ( four weeks of brief counseling and monitoring ) to SC plus prize-based contingency management ( CM ) , involving the chance to earn prizes on days with demonstrated smoking abstinence ( carbon monoxide ( CO ) 6 ppm ) ; and ( 2 ) compare the relative efficacy of two prize reinforcement schedules-one a traditional CM schedule , and the second an early enhanced CM schedule providing greater reinforcement magnitude in the initial week of treatment but equal overall reinforcement .


Participants ( N = 81 nicotine-dependent cigarette smokers ) were randomly assigned to one of the three conditions .


Prize CM resulted in significant reductions in cigarette smoking relative to SC .


These reductions were not apparent at follow-up .


We found no meaningful differences between the traditional and enhanced CM conditions .


Our findings reveal that prize CM leads to significant reductions in smoking during treatment relative to a control intervention , but the benefits did not extend long-term .


To study the therapeutic effect Bufei granule , which is a traditional Chinese drug that can enhance the immune function of the lung , on patients with stable chronic obstructive pulmonary disease ( COPD ) .


This is a randomized , double blinded , placebo-controlled , and multicenter clinical study .


Three medical centers in Tianjin , China , participated in the trial .


A total of 140 patients with stable COPD were enrolled and randomized into two groups , with 70 patients in each .


The treatment group was treated with Bufei granule , while the control group received Bufei placebo .


The pharmacological treatment lasted for 12 weeks from the date of enrollment .


Then , the indexes of patients were observed .


Data were analyzed to study the effect of Bufei granule , with the frequency of acute exacerbation as the primary outcome .


Traditional Chinese Medicine syndromes , Modified British Medical Research Council dyspnea scale score , St. George 's respiratory questionnaire scores , pulmonary function , and serum inflammatory marker levels [ including interleukin-6 ( IL-6 ) , interleukin-8 , tumor necrosis factor-alpha , and transformation growth factor-beta1 ] were the secondary outcomes .


During the 12-week treatment , treatment and control groups had no adverse reactions .


The analysis of the indexes obtained from all patients showed that the therapeutic effect in the treatment group was significantly better than that in the control group because most of the similar probabilities of primary and secondary outcomes were less than 0.05 , except for the level of IL-6 .


Bufei granule can treat patients with stable COPD by lowering the frequency of acute exacerbation , improving the quality of life , and alleviating the severity of inflammation .


Early risk-stratified chemotherapy is a standard treatment for breast , colorectal , and lung cancers , but not for high-risk localised prostate cancer .


Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer .


We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer .


We did this randomised phase 3 trial at 26 hospitals in France .


We enrolled patients with treatment-naive prostate cancer and at least one risk factor ( ie , stage T3-T4 disease , Gleason score of 8 , prostate-specific antigen concentration > 20 ng/mL , or pathological node-positive ) .


All patients underwent a staging pelvic lymph node dissection .


Patients were randomly assigned ( 1:1 ) to either androgen deprivation therapy ( ADT ; goserelin 108 mg every 3 months for 3 years ) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m ( 2 ) and estramustine 10 mg/kg per day on days 1-5 , every 3 weeks , or ADT only .


The randomisation was done centrally by computer , stratified by risk factor .


Local treatment was administered at 3 months .


Neither patients nor investigators were masked to treatment allocation .


The primary endpoint was relapse-free survival in the intention-to-treat population .


Follow-up for other endpoints is ongoing .


This study is registered with ClinicalTrials.gov , number NCT00055731 .


We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group .


Median follow-up was 88 years ( IQR 81-97 ) .


88 ( 43 % ) of 207 patients in the ADT plus docetaxel and estramustine group had an event ( relapse or death ) versus 111 ( 54 % ) of 206 in the ADT only group .


8-year relapse-free survival was 62 % ( 95 % CI 55-69 ) in the ADT plus docetaxel and estramustine group versus 50 % ( 44-57 ) in the ADT only group ( adjusted hazard ratio [ HR ] 071 , 95 % CI 054-094 , p = 0017 ) .


Of patients who were treated with radiotherapy and had data available , 31 ( 21 % ) of 151 in the ADT plus docetaxel and estramustine group versus 26 ( 18 % ) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect ( p = 061 ) .


We recorded no excess second cancers ( 26 [ 13 % ] of 207 vs 22 [ 11 % ] of 206 ; p = 057 ) , and there were no treatment-related deaths .


Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer .


Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival .


Ligue Contre le Cancer , Sanofi-Aventis , AstraZeneca , Institut National du Cancer .


Septic shock is common and has unacceptably high morbidity , mortality , and associated cost with numerous failed attempts at developing effective therapies .


Endotoxin , one of the most potent mediators of sepsis , is found in high levels in approximately 50 % of patients with septic shock .


Polymyxin B ( PMX ) hemoperfusion has been shown in numerous studies to successfully remove endotoxin and potentially improve outcomes .


EUPHRATES ( Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock ) is a theragnostic trial ( matching blood measurement to treatment capability ) of PMX hemoperfusion in patients with septic shock and confirmed endotoxemia as measured by the endotoxin activity assay ( EAA ) .


EUPHRATES is a pivotal regulatory trial that is multi-centered , placebo-controlled and blinded .


The trial is being conducted in fifty ICUs in the United States and Canada and is powered to enroll 360 patients .


Patients with persistent septic shock despite adequate fluid resuscitation on vasopressors for more than 2 and less than 30 hours are eligible for measurement of the EAA .


Those with EAA 0.60 are eligible to be randomized to treatment with two sessions of PMX hemoperfusion 24 hours apart .


The primary endpoint for the trial is 28-day all-cause mortality .


Unique features of the trial include absence of systemic inflammatory response ( SIRS ) criteria as a requirement for inclusion , use of the EAA to confirm endotoxemia as a requisite for treatment , and use of a detailed `` faade '' hemoperfusion event as a blinding mechanism .


The outcomes of the second interim analysis included a resizing of the trial to 650 patients and the addition of an exclusion criterion of subjects with multiple organ dysfunction score ( MODS ) 9 .


Results are anticipated in 2016 .


Clinicaltrials.gov identifier : NCT01046669 .


Registered : January 8 , 2010 .


To investigate baseline and concurrent predictors of non-use of illicit heroin among participants randomized to injectable opioids in the North American Opiate Medication Initiative ( NAOMI ) clinical trial .


NAOMI was an open-label randomized controlled trial comparing the effectiveness of injectable diacetylmorphine and hydromorphone for long-term opioid-dependency .


Outcomes were assessed at baseline and during treatment ( 3 , 6 , 9 , 12months ) .


Days of non-use of illicit heroin in the prior month at each follow-up visit were divided into three categories : Non-use ; Low use ( 1 to 7days ) and High use ( 8days or more ) .


Tested covariates were : Sociodemographics , Health , Treatment , Drug use and illegal activities .


Mixed-effect proportional odds models with random intercept for longitudinal ordinal outcomes were used to assess the predictors of the non-use of illicit heroin .


139 participants were included in the present analysis .


At each follow-up visit , those with non-use of illicit heroin represented 47.5 % to 54.0 % of the sample .


Fewer days of cocaine use ( p = 0.074 ) , fewer days engaged in illegal activities at baseline ( p < 0.01 ) and at each visit ( p < 0.01 ) , less money spent on drugs ( p < 0.001 ) , days with injection opioid or oral methadone treatment ( p < 0.001 ) and total mg of injectable opioids taken ( p < 0.001 ) , independently predicted lower use of illicit heroin .


The independent effect of several concurrent factors besides the injection of opioid dose suggests benefits from the clinic that go beyond the provision of the medication alone .


Thus , this supervised model of care presents an opportunity to maximize the beneficial impact of medical and psychosocial components of the treatment on improving outcomes associated with non-use of illicit heroin .


The use of videolaryngoscopes is recommended for morbidly obese patients .


The aim of the study was to evaluate the Levitan FPS optical stylet ( Levitan ) vs Lafy-Flex videolaryngoscope ( Lary-Flex ) in a group of MO patients .


Seventy-nine MO ( BMI > 40 kg m ( -2 ) ) patients scheduled for bariatric surgery were included in the study and randomly allocated to the Levitan FPS or Lary-Flex group .


The primary endpoint was time to intubation and evaluation laryngoscopic of glottic view .


Anesthesiologists were asked to evaluate the glottic view first under direct laryngoscopy using the videolaryngoscope as a standard laryngoscope ( monitor display was excluded from use ) and then using devices .


The secondary endpoint was the cardiovascular response to intubation and the participant 's evaluation of such devices .


The time to intubation was 8.572.66 sec .


versus 5.790.2 sec .


for Levitan and Lary-Flex , respectively ( P < 0.05 ) .


In all cases of CL grade > 1 under direct laryngoscopy , the study devices improved CL grade to 1 .


The Levitan FPS produced a greater cardiovascular response than the Lary-Flex videolaryngoscope .


The Lary-Flex videolaryngoscope and the Levitan FPS optical stylet improve the laryngeal visualization in morbidly obese patients , allowing for fast endotracheal intubation , but Lary-Flex produces less cardiovascular response to intubation attempt .


The aim of the present randomized , double-blind , placebo-controlled clinical trial was to assess the efficacy and tolerability of 0.5 % indomethacin ( INDOM ) eye drops in adult patients suffering from macular edema ( ME ) related to different etiology uveitis .


Forty-six eyes of 31 adult patients ( 20 females and 11 males ) mean age 39 years , affected by inflammatory ME , were randomized to receive a dose of commercial 0.5 % INDOM eye-drops four times per day ( 16 subjects = 23 eyes ) or placebo ( the vehicle of INDOM , 15 subjects = 23 eyes ) during a 6-month active therapy follow-up .


Study assessment at each visit included visual acuity testing ( VA ) , slit-lamp examination , IOP evaluation , and Heidelberg Spectralis optical coherence tomography ( OCT ) central foveal thickness ( CFT ) measurement .


Any variation in subjective symptoms and tolerability was also detected .


Statistical analysis showed , from baseline to the 6-month visit , a significant reduction in CFT ( P < 0.0001 ) and a significant improvement in VA only in the 0.5 % INDOM-treated group ; a global reduction of discomfort symptoms was present in both groups ( P < 0.001 ) .


The four times per day administration of 0.5 % INDOM eye drops in eyes affected with uveitic ME from different etiologies , compared with placebo , is associated with a significant reduction in ME at the 6-month follow-up visit , as measured by spectral-domain optical coherence tomography ( SD-OCT ) .


However , not all eyes showed a complete resolution of ME because of vitreoretinal traction .


( https://eudract.ema.europa.eu/index.html number , EUDRACT 2011-001522-20 . )


To assess the effect and safety of moderate-to-vigorous resistance exercise during pregnancy .


Randomized controlled study .


Two antenatal clinics in Gothenburg , Sweden .


Ninety-two healthy pregnant women .


The intervention was administered during gestational weeks 14-25 .


The intervention group received supervised resistance exercise twice a week , performed at an activity level equivalent to within moderate-to-vigorous ( n = 51 ) .


The control group received generalized exercise recommendation , a home-based training program and a telephone follow up ( n = 41 ) .


Health-related quality of life , physical strength , pain , weight , blood pressure , functional status , activity level , and perinatal data .


Functional status deteriorated during the intervention in both groups and pain increased .


Significant differences between the groups were obtained only for birthweight .


Newborns delivered by women who underwent resistance exercise during pregnancy were significantly heavier than those born to control women ; 3561 ( 452 ) g vs. 3251 ( 437 ) g ( p = 0.02 ) , a difference that disappeared when adjustment was made for gestational age ( p = 0.059 ) .


Both groups showed normal health-related quality of life , blood pressure , and perinatal data .


These findings indicate that supervised , moderate-to-vigorous resistance exercise does not jeopardize the health status of healthy pregnant women or the fetus during pregnancy , but instead appears to be an appropriate form of exercise in healthy pregnancy .


The interleukin ( IL ) -32 / tumor necrosis factor ( TNF ) a pathway is supposed to play a key role in the amplification of the immune response in chronic obstructive pulmonary disease ( COPD ) inflammation .


Inhaled corticosteroids ( ICS ) in combination with long-acting 2-agonists ( LABA ) have shown airway anti-inflammatory effects in recent studies , but the mechanism is still uncertain .


Patients were treated in a randomized , open-labeled , parallel group clinical trial with either a combination of salmeterol xinafoate/fluticasone propionate ( SF ; Seretide , GlaxoSmithKline ) Diskus ( 50/500 g twice daily ) or ipratropium bromide/salbutamol ( IS ; Combivent , Boehringer Ingelheim ) MDI ( 42 g/240 g quartic daily ) for 12 weeks .


At the start and the end of treatment , induced sputum was collected and the concentration of IL-32 and TNF - , the number of neutrophils and eosinophils were measured .


Following 12 weeks of treatment , a statistically significant fall from baseline in the concentration of TNF - in sputum ( P = 0.004 ) was seen after treatment with SF but not with IS .


However , neither treatment had significant effects on the concentration of IL-32 in sputum .


There was a decrease from baseline in the number of sputum neutrophils with SF that approached statistical significance ( P = 0.028 ) but not with IS , while the number of sputum eosinophils did not change significantly from baseline in either treatment group .


There was a statistically significant decline from baseline in the quality of life as assessed by the St George 's respiratory questionnaire in both the SF ( P = 0.004 ) and IS ( P = 0.030 ) treatment groups , but no evidence of improvement in lung function was observed in either group .


The sputum TNF - and neutrophils , but not IL-32 and macrophages , could be reduced by ICS/LABA treatment , suggesting that IL-32 could be involved in the corticosteroid resistance of COPD inflammation .


Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist ( TOPCAT ) patients with heart failure and preserved left ventricular ejection fraction assigned to spironolactone did not achieve a significant reduction in the primary composite outcome ( time to cardiovascular death , aborted cardiac arrest , or hospitalization for management of heart failure ) compared with patients receiving placebo .


In a post hoc analysis , an 4-fold difference was identified in this composite event rate between the 1678 patients randomized from Russia and Georgia compared with the 1767 enrolled from the United States , Canada , Brazil , and Argentina ( the Americas ) .


To better understand this regional difference in clinical outcomes , demographic characteristics of these populations and their responses to spironolactone were explored .


Patients from Russia/Georgia were younger , had less atrial fibrillation and diabetes mellitus , but were more likely to have had prior myocardial infarction or a hospitalization for heart failure .


Russia/Georgia patients also had lower left ventricular ejection fraction and creatinine but higher diastolic blood pressure ( all P < 0.001 ) .


Hyperkalemia and doubling of creatinine were more likely and hypokalemia was less likely in patients receiving spironolactone in the Americas with no significant treatment effects in Russia/Georgia .


All clinical event rates were markedly lower in Russia/Georgia , and there was no detectable impact of spironolactone on any outcomes .


In contrast , in the Americas , the rates of the primary outcome , cardiovascular death , and hospitalization for heart failure were significantly reduced by spironolactone .


This post hoc analysis demonstrated greater potassium and creatinine changes and possible clinical benefits with spironolactone in patients with heart failure and preserved ejection fraction from the Americas .


http://www.clinicaltrials.gov .


Unique identifier : NCT00094302 .


The relationship between low back pain ( LBP ) and the lifting/carrying of loads is still a matter of great discussion .


In teenagers , the weight of the school bag has been considered to play a pathogenic role in LBP but the relationship between the actual weight of the school bag and LBP symptoms does not seem to be a straightforward one .


Numerous factors have been identified that influence the perception of weight .


This study aimed to evaluate the influence of low back pain and the type of container on the perception of load heaviness by healthy teenagers .


A convenience sample of 80 healthy teenage males ( mean SD age 13.9 2.1 years ) was recruited from the members of two local sports clubs .


The volunteers were evaluated during one of their training sessions .


Information about a history of consequential LBP was gathered by questionnaire .


Subjects were invited to estimate the weight of three bags ( a typical school bag , a sports bag with the logo of a well-known brand , and a neutral bag ) containing two different loads ( total weights approximately 3 and 5 kg ) .


Consequential LBP ( i.e. , LBP requiring medical attention and/or interfering with usual sports activities ) was reported by 26.2 % of them .


The majority of the LBP episodes occurred 3 months before the tests .


Overall , teenagers significantly ( p 0.05 ) underestimated the weight of the sports bag compared with the school bag and the neutral bag .


Compared with those with no LBP , subjects with a history of LBP overestimated the weight of the heavier load .


Our results suggest that several subjective variables significantly influence the perception of load heaviness .


Until we have a better understanding of the mechanical role of the backpack weight versus the perception of its weight in the aetiology of LBP , any recommendations about the schoolbag weight limit should be viewed with caution .


Abdominal Cesarean sections ( C-sections ) are frequently associated with an increased risk of excessive or unpleasant scarring .


A topical scar gel containing extract of Allium cepae , allantoin and heparin ( Contractubex ; Merz Pharmaceuticals GmbH , Germany ) , has shown efficacy in improving the appearance of various scar types .


To investigate the efficacy of the topical scar gel , Contractubex , in the early treatment of C-section scars .


A total of 61 females , aged 18 years , who had given birth by elective C-section for the first time within the last 5-10 days , were included in this prospective , randomized , single-center study .


Patients were advised to apply the topical scar gel twice daily ( treatment group ) , or received no treatment ( control group ) .


Efficacy was evaluated at 6 and 12 weeks after a baseline visit using the Patient and Observer Scar Assessment Scale ( POSAS ) , a validated scar assessment tool comprised of a Patient Scale and an Observer Scale .


Analysis revealed a significant change in the POSAS Patient Scale total score , with a 14.2 % improvement in the treatment group compared with a decline of similar magnitude ( -14.8 % ) in the control group at week 6 .


Significant improvements were also seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color ( 13.6 % vs -18.5 % , respectively , P = 0.0284 ) , stiffness ( 12.5 % vs -34.6 % , respectively , P = 0.0029 ) , and irregularity ( 29.4 % vs -46.2 % , respectively , P = 0.0140 ) after 6 weeks of treatment .


No significant changes were observed for the POSAS Observer Scale total score or its subitems after treatment with the topical scar gel , although there was a strong overall trend in favor of the treatment group .


No significant adverse events were observed during the study .


Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves the color , stiffness and irregularity of C-section scars .


Existing treatments for postherpetic neuralgia , and for neuropathic pain in general , are limited by modest efficacy and unfavourable side-effects .


The angiotensin II type 2 receptor ( AT2R ) is a new target for neuropathic pain .


EMA401 , a highly selective AT2R antagonist , is under development as a novel neuropathic pain therapeutic agent .


We assessed the therapeutic potential of EMA401 in patients with postherpetic neuralgia .


In this multicentre , placebo-controlled , double-blind , randomised , phase 2 clinical trial , we enrolled patients ( aged 22-89 years ) with postherpetic neuralgia of at least 6 months ' duration from 29 centres across six countries .


We randomly allocated 183 participants to receive either oral EMA401 ( 100 mg twice daily ) or placebo for 28 days .


Randomisation was done according to a centralised randomisation schedule , blocked by study site , which was generated by an independent , unmasked statistician .


Patients and staff at each site were masked to treatment assignment .


We assessed the efficacy , safety , and pharmacokinetics of EMA401 .


The primary efficacy endpoint was change in mean pain intensity between baseline and the last week of dosing ( days 22-28 ) , measured on an 11-point numerical rating scale .


The primary efficacy analysis was intention to treat .


This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12611000822987 .


92 patients were assigned to EMA401 and 91 were assigned to placebo .


The patients given EMA401 reported significantly less pain compared with baseline values in the final week of treatment than did those given placebo ( mean reductions in pain scores -2.29 [ SD 1.75 ] vs -1.60 [ 1.66 ] ; difference of adjusted least square means -0.69 [ SE 0.25 ] ; 95 % CI -1.19 to -0.20 ; p = 0.0066 ) .


No serious adverse events related to EMA401 occurred .


Overall , 32 patients reported 56 treatment-emergent adverse events in the EMA401 group compared with 45 such events reported by 29 patients given placebo .


EMA401 ( 100 mg twice daily ) provides superior relief of postherpetic neuralgia compared with placebo at the end of 28 days of treatment .


EMA401 was well tolerated by patients .


Spinifex Pharmaceuticals .


It is not clear whether newly introduced cordless displacement systems are better able to manage gingiva than conventional systems .


The purpose of this invivo study was to evaluate the gingival management ability of 4 different displacement methods with a standardized subgingival preparation finish line .


The effects of 4 displacement techniques on gingival management and impression quality were evaluated by means of 6 evaluation criteria .


A subgingival preparation finish line of between 1 and 2 mm was ensured , andthe buccal aspects of 252 ( n = 63 ) teeth were clinically assessed for ease of application , time spent , bleeding , remnants , and dilatation .


The complete reproduction of the preparation finish line and the bubble and void formations on polyether impressions were also evaluated .


The data were statistically analyzed with the ( 2 ) test ( = .05 ) .


The Bonferroni correction was used to control Type I error for the pairwise comparison groups ( = .008 ) .


Statistically significant differences were found for all criteria among the groups ( P < .05 ) .


The nonimpregnated displacement cord group was the least effective group in terms of bleeding and impression quality ( P < .008 ) .


The aluminum chloride impregnated cord group and the displacement paste with cap group were found to be comparable in terms of remnants , dilatation , and impression quality ( P > .008 ) .


The retraction cap with paste group showed better results for ease of application , time spent , and bleeding than the aluminum chloride impregnated cord group ( P < .008 ) .


Although the group with aluminum chloride impregnated cord , displacement paste , and cap showed better results for dilatation , it was time consuming and difficult ( P < .008 ) .


Except for the nonimpregnated cord group , all of the groups were comparable and clinically useful , with perfect or acceptable impression qualities .


Osteoarthritis is the most prevalent joint disease and a common cause of joint pain , functional loss , and disability .


Conventional treatments demonstrate only modest clinical benefits without lesion reversal .


Autologous mesenchymal stromal cell ( MSC ) treatments have shown feasibility , safety , and strong indications for clinical efficacy .


We performed a randomized , active control trial to assess the feasibility and safety of treating osteoarthritis with allogeneic MSCs , and we obtain information regarding the efficacy of this treatment .


We randomized 30 patients with chronic knee pain unresponsive to conservative treatments and showing radiological evidence of osteoarthritis into 2 groups of 15 patients .


The test group was treated with allogeneic bone marrow MSCs by intra-articular injection of 40 10 ( 6 ) cells .


The control group received intra-articular hyaluronic acid ( 60 mg , single dose ) .


Clinical outcomes were followed for 1 year and included evaluations of pain , disability , and quality of life .


Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping .


Feasibility and safety were confirmed and indications of clinical efficacy were identified .


The MSC-treated patients displayed significant improvement in algofunctional indices versus the active controls treated with hyaluronic acid .


Quantification of cartilage quality by T2 relaxation measurements showed a significant decrease in poor cartilage areas , with cartilage quality improvements in MSC-treated patients .


Allogeneic MSC therapy may be a valid alternative for the treatment of chronic knee osteoarthritis that is more logistically convenient than autologous MSC treatment .


The intervention is simple , does not require surgery , provides pain relief , and significantly improves cartilage quality .


We aimed to evaluate treatment responses to atazanavir plus ritonavir ( ATV/r ) or efavirenz ( EFV ) in initial antiretroviral regimens among women and men , and determine if treatment outcomes differ by sex .


We performed a randomized trial of open-label ATV/r or EFV combined with abacavir/lamivudine ( ABC/3TC ) or tenofovir/emtricitabine ( TDF/FTC ) in 1857 human immunodeficiency virus type 1-infected , treatment-naive persons enrolled between September 2005 and November 2007 at 59 sites in the United States and Puerto Rico .


Associations of sex with 3 primary study endpoints of time to virologic failure , safety , and tolerability events were analyzed using Cox proportional hazards models .


Model-based population pharmacokinetic analysis was performed using nonlinear mixed effects modeling ( NONMEM version VII ) .


Of 1857 participants , 322 were women .


Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV , or men assigned to ATV/r .


The effects of ATV/r and EFV upon safety and tolerability risk did not differ significantly by sex .


With ABC/3TC , women had a significantly higher ( 32 % ) safety risk compared to men ; with TDF/FTC , the safety risk was 20 % larger for women compared to men , but not statistically significant .


Women had slower ATV clearance and higher predose levels of ATV compared to men .


Self-reported adherence did not differ significantly by sex .


This is the first randomized clinical trial to identify a significantly earlier time to virologic failure in women randomized to ATV/r compared to women randomized to EFV .


This finding has important clinical implications given that boosted protease inhibitors are often favored over EFV in women of childbearing potential .


NCT00118898 .


This study investigated strategies that may increase the yield of drug resistance testing prior to starting antiretroviral therapy ( ART ) , and whether transmitted and polymorphic resistance-associated mutations ( RAMs ) correlated with virological outcomes .


We carried out retrospective testing of baseline samples from patients entering the SENSE trial of first-line ART in Europe , Russia and Israel .


Prior to randomization to etravirine or efavirenz plus two nucleos ( t ) ide reverse transcriptase inhibitors ( NRTIs ) , plasma samples underwent routine Sanger sequencing of HIV-1 RT and protease ( ( plasma ) SS ) in order to exclude patients with transmitted RAMs .


Retrospectively , Sanger sequencing was repeated with HIV-1 DNA from baseline peripheral blood mononuclear cells ( PBMCSS ) ; baseline plasma samples were retested by allele-specific PCR targeting seven RT RAMs ( AS-PCR ) and ultra-deep RT sequencing ( UDS ) .


By ( plasma ) SS , 16/193 ( 8.3 % ) patients showed 1 transmitted RAM affecting the NRTIs ( 10/193 , 5.2 % ) , non-nucleoside reverse transcriptase inhibitors ( 4/193 , 2.1 % ) or protease inhibitors ( 2/193 , 1.0 % ) .


No additional RAMs were detected by AS-PCR ( n = 152 ) and UDS ( n = 24 ) ; PBMCSS ( n = 91 ) yielded two additional samples with one RAM each .


Over 48 weeks , 4/79 ( 5.1 % ) patients on etravirine and 7/78 ( 9.0 % ) on efavirenz experienced virological failure ; none had baseline RAMs .


Conversely , 11/79 ( 13.9 % ) patients randomized to etravirine had one polymorphic RAM from the etravirine score in baseline plasma ( V90I , V106I or E138A ) , without any impact on virological outcomes .


The detection of resistance increased marginally with PBMC testing but did not increase with sensitive plasma testing .


A careful consideration is required of the cost-effectiveness of different strategies for baseline HIV drug resistance testing .


This study aims to confirm the factor structure of the Menopause-Specific Quality of Life ( MENQOL ) questionnaire by using confirmatory factor analysis ( CFA ) and to determine whether improvements in menopause-specific health-related quality of life ( HRQOL ) observed with bazedoxifene ( BZA ) / conjugated estrogens ( CE ) relative to placebo are clinically meaningful .


Postmenopausal women with seven or more moderate to severe hot flushes per day ( or 50 per wk ) received BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , or placebo for 12 weeks .


HRQOL and treatment satisfaction were evaluated using the MENQOL questionnaire and the Menopause Symptoms Treatment Satisfaction Questionnaire , respectively .


The structure of the MENQOL questionnaire was evaluated using CFA .


To estimate clinically important differences ( CIDs ) in HRQOL , we used a repeated-measures model to estimate changes in MENQOL domain and total scores using Menopause Symptoms Treatment Satisfaction Questionnaire items as anchors .


The CFA model fits the MENQOL data ( Bentler 's comparative fit index > 0.9 ) .


CID estimates ranged from 0.5 to 1.2 for the MENQOL domains and total score .


Change from baseline in MENQOL vasomotor domain score for BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg compared with placebo was greater than the estimated CID , as were changes in MENQOL physical domain and total scores for BZA 20 mg/CE 0.625 mg compared with placebo .


CFA confirms the factor structure of the MENQOL questionnaire .


Treatment with BZA/CE provides clinically meaningful improvements in HRQOL in a population of postmenopausal women with bothersome vasomotor symptoms .


In schizophrenia , the ability to adaptively infer the thoughts and feelings of others ( i.e. , social cognition ) is strongly associated with community functioning .


Researchers have designed psychosocial interventions to improve social cognition with the aim of improving downstream social functioning .


Social Cognition and Interaction Training ( SCIT ) is one such intervention .


Previous research on SCIT has been promising , but has consisted largely of smaller trials with insufficient experimental control .


Randomized , controlled trial .


The current article reports on a controlled trial of 66 adults with schizophrenia randomized to receive either SCIT ( n = 33 ) , delivered in weekly group sessions , or treatment as usual ( n = 33 ) for 6 months .


Participants completed assessments of social cognition , social functioning , neurocognition and symptoms at baseline , post-treatment , and 3-month follow-up .


Primary analyses suggest that SCIT may improve social functioning , negative symptoms , and possibly hostile attributional bias .


Post-hoc analyses suggest a dose-response effect .


Findings are discussed in the context of continuing to refine and improve social cognitive interventions for schizophrenia .


Social cognitive intervention is a feasible and promising approach to improving social functioning among individuals with schizophrenia-spectrum disorders .


Dose-response findings suggest that delivering social cognitive interventions with greater frequency may maximize their benefit to patients .


Research on social cognitive interventions is still young and effects from well-controlled trials have been inconsistent .


It is not yet clear which components of social cognitive training may be the key active ingredients .


In the treatment of atopic dermatitis , pimecrolimus has high antipruritic effects .


To investigate the efficacy of 1 % pimecrolimus cream in comparison to 1 % hydrocortisone cream in non-atopic prurigo nodularis ( PN ) .


A randomized , controlled , double-blind study with intraindividual randomization was done in 30 patients ( 17 females , 13 males ; mean age 58.5 years ) with PN .


Pruritus intensity decreased significantly ( p < 0.001 ) on both treated sides as early as after 10 days of treatment ; scratch lesions improved ( p < 0.001 ) .


Quality of life as assessed by the Dermatology Life Quality Index improved significantly .


However , a significant advantage of pimecrolimus over hydrocortisone was not found .


The results suggest that the non-steroid pimecrolimus is an effective alternative for PN treatment .


The objective was to assess the feasibility and acceptability of nine positive psychology exercises delivered to patients hospitalized for suicidal thoughts or behaviors , and to secondarily explore the relative impact of the exercises .


Participants admitted to a psychiatric unit for suicidal ideation or behavior completed daily positive psychology exercises while hospitalized .


Likert-scale ratings of efficacy ( optimism , hopelessness , perceived utility ) and ease of completion were consolidated and compared across exercises using mixed models accounting for age , missing data and exercise order .


Overall effects of exercise on efficacy and ease were also examined using mixed models .


Fifty-two ( 85.3 % ) of 61 participants completed at least one exercise , and 189/213 ( 88.7 % ) assigned exercises were completed .


There were overall effects of exercise on efficacy ( ( 2 ) = 19.39 ; P = .013 ) but not ease of completion ( ( 2 ) = 11.64 ; P = .17 ) , accounting for age , order and skipped exercises .


Effect ( Cohen 's d ) of exercise on both optimism and hopelessness was moderate for the majority of exercises .


Exercises related to gratitude and personal strengths ranked highest .


Both gratitude exercises had efficacy scores that were significantly ( P = .001 ) greater than the lowest-ranked exercise ( forgiveness ) .


In this exploratory project , positive psychology exercises delivered to suicidal inpatients were feasible and associated with short-term gains in clinically relevant outcomes .


To evaluate the efficacy and safety of the selective sodium glucose co-transporter 2 inhibitor dapagliflozin in Japanese patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled by diet and exercise .


Patients received placebo or dapagliflozin ( 5 or 10 mg ) once daily for 24 weeks .


The primary outcome measure was change from baseline in glycated haemoglobin ( HbA1c ) .


Patients ( N = 261 ) had modestly elevated baseline HbA1c ( mean 7.5 % ) and most had mild or moderate renal impairment ( estimated glomerular filtration rate range 43-103 ml/min/1 .73 m ( 2 ) ) .


Greater reductions in mean HbA1c level were observed with dapagliflozin ( 5 mg , -0.41 % ; 10 mg , -0.45 % ) than with placebo ( -0.06 % ) at week 24 and these were greater in patients with higher baseline HbA1c levels .


Fasting plasma glucose ( FPG ) was also significantly reduced with dapagliflozin ( 5 mg , -8.6 mg/dl ; 10 mg , -13.7 mg/dl ) compared with placebo ( +5.8 mg/dl ) .


Dapagliflozin significantly reduced body weight ( 5 mg , -2.13 kg ; 10 mg , -2.22 kg ) compared with placebo ( -0.84 kg ) .


Overall , 47.7 and 64.8 % of patients with dapagliflozin 5 and 10 mg , respectively , and 51.7 % with placebo experienced 1 adverse event , mostly mild or moderate , and unrelated to study treatment .


Two patients on dapagliflozin 10 mg reported hypoglycaemia .


Four patients across all groups reported events suggestive of genital infection and four of urinary tract infection .


No events of pyelonephritis were reported .


Dapagliflozin ( 5 and 10 mg ) was well tolerated and effective in reducing HbA1c , FPG and body weight over 24 weeks in Japanese patients with T2DM inadequately controlled by diet and exercise .


The Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events ( CHANCE ) trial showed that the combined treatment of clopidogrel and aspirin decreases the 90-day risk of stroke without increasing hemorrhage in comparison with aspirin alone , but provided insufficient data to establish whether the benefit persisted over a longer period of time beyond the trial termination .


We report the 1-year follow-up outcomes of this trial .


The trial was a randomized , double-blind , placebo-controlled trial conducted at 114 centers in China .


We randomly assigned 5170 patients within 24 hours after onset of minor stroke or high-risk transient ischemic attack to clopidogrel-aspirin therapy ( loading dose of 300 mg of clopidogrel on day 1 , followed by 75 mg of clopidogrel per day for 90 days , plus 75 mg of aspirin per day for the first 21 days ) or to the aspirin-alone group ( 75 mg/d for 90 days ) .


The primary outcome was stroke event ( ischemic or hemorrhagic ) during 1-year follow-up .


Differences in outcomes between groups were assessed by using the Cox proportional hazards model .


Stroke occurred in 275 ( 10.6 % ) patients in the clopidogrel-aspirin group , in comparison with 362 ( 14.0 % ) patients in the aspirin group ( hazard ratio , 0.78 ; 95 % confidence interval , 0.65-0 .93 ; P = 0.006 ) .


Moderate or severe hemorrhage occurred in 7 ( 0.3 % ) patients in the clopidogrel-aspirin group and in 9 ( 0.4 % ) patients in the aspirin group ( P = 0.44 ) .


The early benefit of clopidogrel-aspirin treatment in reducing the risk of subsequent stroke persisted for the duration of 1-year of follow-up .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00979589 .


Schizophrenia ( SZ ) is a chronic illness that is treated symptomatically .


Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy .


Yoga can improve cognitive function among healthy individuals .


A recent open trial indicated significant benefits of yoga training ( YT ) in conjunction with conventional pharmacotherapy among patients with SZ .


To describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated .


Secondarily , the effects of YT on daily functioning living skills are evaluated .


Consenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT , adjunctive physical exercise ( PE ) or treatment as usual ( proposed N = 234 total , N = 78 in each group ) .


The trial involves YT or PE 5 days a week and lasts 3 weeks .


Participants are evaluated thrice over 6 months .


Cognitive functions measured by Trail Making Test , University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures .


A total of 309 participants have been randomised as of 31 August 2013 , which exceeded beyond 294 proposed after attrition .


Once participants begin YT or PE they generally complete the protocol .


No injuries have been reported .


Short term YT is feasible and acceptable to Indian SZ patients .


If beneficial effects of YT are detected , it will provide a novel adjunctive cognitive remediation strategy for SZ patients .


To evaluate the efficacy and safety of intravitreal injections of pegaptanib sodium in subjects with diabetic macular edema ( DME ) .


There were 243 subjects with DME who were randomized to receive , every 6 weeks , either an intravitreal injection of pegaptanib sodium or a sham injection .


The study was double-masked for the first 24 weeks , and then an open label phase continued to week 54 .


The primary efficacy endpoint was evaluated at week 24 , and safety was assessed throughout the 54 weeks .


The proportion of subjects who experienced more than 10 letters improvement of visual acuity in ETDRS chart from baseline to week 24 was statistically significantly greater ( p-value = 0.0003 ) in the pegaptanib sodium group , 20.3 % , than in the sham group , 5.0 % .


The incidence of treatment-related adverse events was similar between the treatment groups ( pegaptanib sodium group : 10.6 % , sham group : 10.0 % ) .


The reported adverse events were mainly mild or moderate ophthalmic events and related to the injection procedure .


During open-label phase up to 54 weeks , no new safety concerns were identified compared with the double-masked phase .


However , in light of the issue concerning proper maintenance of masking of the study treatments , the study was not considered as a well-controlled , double-masked study .


More than 670,000 total knee replacements are performed annually in the United States ; however , high-quality evidence to support the effectiveness of the procedure , as compared with nonsurgical interventions , is lacking .


In this randomized , controlled trial , we enrolled 100 patients with moderate-to-severe knee osteoarthritis who were eligible for unilateral total knee replacement .


Patients were randomly assigned to undergo total knee replacement followed by 12 weeks of nonsurgical treatment ( total-knee-replacement group ) or to receive only the 12 weeks of nonsurgical treatment ( nonsurgical-treatment group ) , which was delivered by physiotherapists and dietitians and consisted of exercise , education , dietary advice , use of insoles , and pain medication .


The primary outcome was the change from baseline to 12 months in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales , covering pain , symptoms , activities of daily living , and quality of life ( KOOS4 ) ; scores range from 0 ( worst ) to 100 ( best ) .


A total of 95 patients completed the 12-month follow-up assessment .


In the nonsurgical-treatment group , 13 patients ( 26 % ) underwent total knee replacement before the 12-month follow-up ; in the total-knee-replacement group , 1 patient ( 2 % ) received only nonsurgical treatment .


In the intention-to-treat analysis , the total-knee-replacement group had greater improvement in the KOOS4 score than did the nonsurgical-treatment group ( 32.5 vs. 16.0 ; adjusted mean difference , 15.8 [ 95 % confidence interval , 10.0 to 21.5 ] ) .


The total-knee-replacement group had a higher number of serious adverse events than did the nonsurgical-treatment group ( 24 vs. 6 , P = 0.005 ) .


In patients with knee osteoarthritis who were eligible for unilateral total knee replacement , treatment with total knee replacement followed by nonsurgical treatment resulted in greater pain relief and functional improvement after 12 months than did nonsurgical treatment alone .


However , total knee replacement was associated with a higher number of serious adverse events than was nonsurgical treatment , and most patients who were assigned to receive nonsurgical treatment alone did not undergo total knee replacement before the 12-month follow-up .


( Funded by the Obel Family Foundation and others ; MEDIC ClinicalTrials.gov number , NCT01410409 . )


It is not known whether high-risk plaque , as detected by coronary computed tomography angiography ( CTA ) , permits improved early diagnosis of acute coronary syndromes ( ACS ) independently to the presence of significant coronary artery disease ( CAD ) in patients with acute chest pain .


The primary aim of this study was to determine whether high-risk plaque features , as detected by CTA in the emergency department ( ED ) , may improve diagnostic certainty of ACS independently and incrementally to the presence of significant CAD and clinical risk assessment in patients with acute chest pain but without objective evidence of myocardial ischemia or myocardial infarction ( MI ) .


We included patients randomized to the coronary CTA arm of the ROMICAT-II ( Rule Out Myocardial Infarction/Ischemia Using Computer-Assisted Tomography II ) trial .


Readers assessed coronary CTA qualitatively for the presence of nonobstructive CAD ( 1 % to 49 % stenosis ) , significant CAD ( 50 % or 70 % stenosis ) , and the presence of at least 1 of the high-risk plaque features ( positive remodeling , low < 30 Hounsfield units plaque , napkin-ring sign , spotty calcium ) .


In logistic regression analysis , we determined the association of high-risk plaque with ACS ( MI or unstable angina pectoris ) during the index hospitalization and whether this was independent of significant CAD and clinical risk assessment .


Overall , 37 of 472 patients who underwent coronary CTA with diagnostic image quality ( mean age 53.9 8.0 years ; 52.8 % men ) had ACS ( 7.8 % ; MI n = 5 ; unstable angina pectoris n = 32 ) .


CAD was present in 262 patients ( 55.5 % ; nonobstructive CAD in 217 patients [ 46.0 % ] and significant CAD with 50 % stenosis in 45 patients [ 9.5 % ] ) .


High-risk plaques were more frequent in patients with ACS and remained a significant predictor of ACS ( odds ratio [ OR ] : 8.9 ; 95 % CI : 1.8 to 43.3 ; p = 0.006 ) after adjustment for 50 % stenosis ( OR : 38.6 ; 95 % CI : 14.2 to 104.7 ; p < 0.001 ) and clinical risk assessment ( age , sex , number of cardiovascular risk factors ) .


Similar results were observed after adjustment for 70 % stenosis .


In patients presenting to the ED with acute chest pain but negative initial electrocardiogram and troponin , presence of high-risk plaques on coronary CTA increased the likelihood of ACS independent of significant CAD and clinical risk assessment ( age , sex , and number of cardiovascular risk factors ) .


( Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography [ ROMICAT-II ] ; NCT01084239 ) .


Impaired arousal from sleep has been implicated in sudden infant death syndrome ( SIDS ) .


Sleeping in the prone position is a major risk factor for SIDS .


Epidemiological studies have shown that pacifier use decreases the risk of SIDS , even when infants sleep prone .


We examined spontaneous arousability in infants slept prone and supine over the first 6 months of life and hypothesised that spontaneous arousals would be increased in pacifier users , particularly in the prone position .


Healthy term infants ( n = 30 ) were studied on three occasions over the first 6 months after birth .


Spontaneous cortical arousals and subcortical activations were scored and converted into frequency per hour of sleep .


There was no effect of pacifier use on total time spent sleeping or awake or the number of spontaneous awakenings at any age .


There was also no effect of pacifier use on the frequency or duration of the total number of spontaneous arousals or on cortical arousals and subcortical activations .


Pacifier use did not alter infant spontaneous arousability at any of the three ages studied , in either the prone or supine sleeping position .


Any preventative effect of pacifiers for SIDS may be through physiological mechanisms other than increased arousability .


Restorative home care services are short-term and aimed at maximizing a person 's ability to live independently .


They are multidimensional and often include an exercise program to improve strength , mobility , and balance .


The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults .


A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service .


Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE ( as this was a new program , the intervention ) or the structured exercise program currently being used in the service ( control ) .


Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance , strength , mobility , falls efficacy , vitality , function , and disability .


There was no difference between the groups in the amounts of exercise undertaken during the 8-week intervention period .


Outcome measurement indicated that the LiFE program was as effective , and on 40 % of the measures , more effective , than the structured exercise program .


Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes .


Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy , the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown .


A randomised controlled trial ( RCT ) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa , Kenya .


The intervention was a minimum of seven sessions of multidimensional , person-centred care , given by HIV nurses trained in the palliative care approach over a period of 5months .


Rates of recruitment and refusal , the effectiveness of the randomisation procedure , trial follow-up and attrition and extent of missing data are reported .120 patients ( 60 randomised to control arm , 60 randomised to intervention arm ) were recruited over 5.5 months , with a refusal rate of 55.7 % .


During the study period , three participants died from cancer , three withdrew ( two moved away and one withdrew due to time constraints ) .


All of these patients were in the intervention arm : details are reported .


There were five additional missing monthly interviews in both the control and intervention study arm , bringing the total of missing data to 26 data points ( 4.3 % ) .


The quality and implications of these data are discussed extensively and openly , including the effect of full and ethical consent procedures , respondent burden , HIV stigma , accurate randomisation , patient safety and the impact of the intervention .


Data on recruitment randomisation , attrition and missing data in clinical trials should be routinely reported , in conjunction with the now established practice of publishing study protocols to enhance research integrity , transparency and quality .


Transparency is especially important in cross cultural settings , in which the sources of funding and trial design are often not based in the country of data collection .


Findings reported can be used to inform future RCTs in this area .


Clinicaltrials.gov NCT01608802 .


To evaluate the efficacy of inducing labour using a double-balloon catheter and oral misoprostol sequentially , in comparison with oral misoprostol alone .


A multicentre randomised controlled trial .


Five hospitals in Germany .


A total of 326 pregnant women with an unfavourable cervix undergoing labour induction at term .


Women were randomly assigned according to a computer-generated allocation sequence to sequential use of double-balloon catheter and oral misoprostol ( study group ) or oral misoprostol alone ( control group ) .


In the study group , the double-balloon catheter was used the first day before starting oral misoprostol the second day .