Outcomes were compared between assessment points and between tumor sites .


Nasality in nonlaryngeal sites was significantly reduced by treatment .


Most affected in articulation were the oral or oropharyngeal cancer sites , followed by the nasal or nasopharyngeal sites .


One year after treatment , vowel space had not recovered and consonant articulation had weakened .


Laryngeal sites were less affected in articulation by tumor or treatment .


Analyses of articulatory-acoustic features are a useful instrument for assessing articulation and speech quality objectively .


Assessment of a number of sounds representing various articulation manners , places , and tongue shapes revealed patterns of speech deterioration after chemoradiotherapy .


The results suggest that patients ' speech could benefit from articulation exercises to address changes in muscle coordination and/or sensitivity and to counteract side effects and `` underexercise '' atrophy .


The aim of this study was to assess the effects of pioglitazone on blood glucose control and inflammatory biomarkers in diabetic patients receiving insulin after kidney transplantation .


In a randomized placebo-controlled trial , 62 diabetic kidney transplant patients were followed for 4 months after randomly assigned to placebo and pioglitazone ( 30 mg/d ) groups .


All of the patients continued their insulin therapy irrespective of the group that they were assigned to , in order to evaluate the effects of addition of pioglitazone on blood glucose and inflammation biomarkers including serum C-reactive protein , high-sensitivity C-reactive protein , and interleukin-18 levels , as well as erythrocyte sedimentation rate .


At baseline , there were no significant differences in laboratory studies between the two groups .


After 4 months of intervention , along with significant improvement in hemoglobin A1c in the pioglitazone group , daily insulin requirements also decreased and lipid profile improved significantly .


In addition , erythrocyte sedimentation rate , C-reactive protein , and high-sensitivity C-reactive protein values were significantly lower in the pioglitazone group ( P = .03 , P < .001 , and P = .01 ) .


Interleukin-18 levels were not significantly different at the end of the study between the two groups , but it had a decreasing trend in the pioglitazone group ( P = .002 ) .


Pioglitazone complementing insulin in diabetic kidney transplant patients not only improved glycemic control , evidenced by hemoglobin A1c , and reduced daily insulin requirement , but also decreased inflammatory markers which may have an impact on overall cardiovascular events and mortalities beyond glycemic control .


Gut microbiota modifiers may have beneficial effects of non-alcoholic fatty liver disease ( NAFLD ) but randomised controlled trials ( RCT ) are lacking in children .


To perform a double-blind RCT of VSL # 3 vs. placebo in obese children with biopsy-proven NAFLD .


Of 48 randomised children , 44 ( 22 VSL # 3 and 22 placebo ) completed the study .


The main outcome was the change in fatty liver severity at 4 months as detected by ultrasonography .


Secondary outcomes were the changes in triglycerides , insulin resistance as detected by the homoeostasis model assessment ( HOMA ) , alanine transaminase ( ALT ) , body mass index ( BMI ) , glucagon-like peptide 1 ( GLP-1 ) and activated GLP-1 ( aGLP-1 ) .


Ordinal and linear models with cluster confidence intervals were used to evaluate the efficacy of VSL # 3 vs. placebo at 4 months .


At baseline , moderate and severe NAFLD were present in 64 % and 36 % of PLA children and in 55 % and 45 % of VSL # 3 children .


The probability that children supplemented with VSL # 3 had none , light , moderate or severe FL at the end of the study was 21 % , 70 % , 9 % and 0 % respectively with corresponding values of 0 % , 7 % , 76 % and 17 % for the placebo group ( P < 0.001 ) .


No between-group differences were detected in triglycerides , HOMA and ALT while BMI decreased and GLP-1 and aGLP1 increased in the VSL # 3 group ( P < 0.001 for all comparisons ) .


A 4-month supplement of VSL # 3 significantly improves NAFLD in children .


The VSL # 3-dependent GLP-1 increase could be responsible for these beneficial effects .


Trial identifier : NCT01650025 ( www.clinicaltrial.gov ) .


Exposure to electromagnetic fields has been reported to have analgesic and antinociceptive effects in several organisms .


To test the effect of very low-intensity transcranial magnetic stimulation on symptoms associated with fibromyalgia syndrome .


A double-blinded , placebo-controlled clinical trial was performed in the Sagrado Corazn Hospital , Seville , Spain .


Female fibromyalgia patients ( 22 to 50 years of age ) were randomly assigned to either a stimulation group or a sham group .


The stimulation group ( n = 28 ) was stimulated using 8 Hz pulsed magnetic fields of very low intensity , while the sham group ( n = 26 ) underwent the same protocol without stimulation .


Pressure pain thresholds before and after stimulation were determined using an algometer during the eight consecutive weekly sessions of the trial .


In addition , blood serotonin levels were measured and patients completed questionnaires to monitor symptom evolution .


A repeated-measures ANOVA indicated statistically significant improvement in the stimulation group compared with the control group with respect to somatosensory pain thresholds , ability to perform daily activities , perceived chronic pain and sleep quality .


While improvement in pain thresholds was apparent after the first stimulation session , improvement in the other three measures occurred after the sixth week .


No significant between-group differences were observed in scores of depression , fatigue , severity of headaches or serotonin levels .


No adverse side effects were reported in any of the patients .


Very low-intensity magnetic stimulation may represent a safe and effective treatment for chronic pain and other symptoms associated with fibromyalgia .


The increasing prevalence of cardiometabolic disease ( CMD ) in combination with an ageing population is a major public health problem .


Early detection and management of individuals at risk for CMD is required to prevent future health problems with associated costs .


General practice is the optimal health care setting to accomplish this goal .


Prevention programs for identification and treatment of patients with an increased risk for CMD in primary care have been proven feasible .


However , the effectiveness and cost-effectiveness have yet to be demonstrated .


The ` Personalized Prevention Approach for CardioMetabolic Risk ' ( PPA CMR ) is such a prevention program .


The objective of the INTEGRATE study is to investigate the effectiveness and cost-effectiveness of PPA CMR , as well as to establish determinants for participation and compliance .


The INTEGRATE study is designed as a stepped-wedge randomized controlled trial with a waiting list control group .


In approximately 40 general practices , all enlisted patients without CMD aged 45-70 years , are invited to participate in PPA CMR .


After an online risk estimation , patients with a score above risk threshold are invited to the GP for additional measurements , detailed risk profiling and tailored treatment of risk factors through medication and/or lifestyle counseling .


At baseline and after twelve months of follow-up lifestyle , health and work status of all participants are established with online questionnaires .


Additionally after twelve months , we will determine health care utilization , costs of PPA CMR and compliance .


Primary endpoints are the number of newly detected patients with CMD and changes in individual risk factors between the intervention and waiting list control group .


Medical data will be extracted from the GPs ' electronic medical records .


In order to assess factors related to participation , we will send questionnaires to non-participants and assess characteristics of participating practices .


For all participants , additional demographic characteristics will be available through Statistics Netherlands .


The INTEGRATE study will provide insight into the effectiveness and cost-effectiveness of PPA CMR as well as determinants for participation and compliance , which represents essential information to guide further large-scale implementation of primary prevention programs for CMD .


NTR4277 , The Netherlands National Trial Register , 26-11-2013 .


To investigate whether different study-to-participant communication methods increase response , increase response from hard-to-engage individuals , and influence participants ' consent decisions .


A randomized controlled trial within the Avon Longitudinal Study of Parents and Children .


Cohort members were invited to re-enroll at age 18 and consent to linkage to their health and administrative records .


Participants were randomized to receive one of eight combinations of three interventions : a prior-notification postcard or no contact , a standard or professionally designed consent pack , and a phone or postal reminder .


The primary outcome was return of the consent form ( `` response '' ) , with consent decision being the secondary outcome .


Of 1,950 participants , 806 ( 41 % ) responded .


Response rates were 2.7 % higher ( 95 % confidence interval : -0.06 , 5.5 % ; P = 0.06 ) among those receiving designed packs than among those receiving standard packs and 6.4 % higher ( 2.3 , 10.6 % ; P = 0.002 ) among those receiving phone reminders ( compared with postal reminders ) .


The prior-notification postcard did not influence response rates [ difference = 0 % ( -2.8 , 2.8 % ; P = 1.0 ) ] , and we found no evidence that the communication method influenced consent decision .


This trial provides evidence that communication material design can influence response rates and that phone reminders have superior cost/benefit returns over designed materials .


Experimental evaluation of communications strategies and dissemination of findings may benefit cohort studies .


To evaluate the necessity of endoscopic nasobiliary drainage ( ENBD ) catheter placement after clearance of common bile duct ( CBD ) stones .


Patients enrolled in this study were randomly divided into two groups , according to whether or not they received ENBD after the removal of CBD stones .


Group 1 ( ENBD group ) was then subdivided into three groups : G1a patients received an endoscopic papillary balloon dilatation ( EPBD ) , G1b patients received an endoscopic sphincterotomy ( EST ) , and G1c patients received neither .


Group 2 ( non-ENBD group ) patients were also subdivided into three groups ( G2a , G2b , and G2c ) , similar to Group 1 .


The maximum CBD diameter , the time for C-reactive protein ( CRP ) to normalize , levels of serum amylase , total serum bilirubin ( TB ) and alanine aminotransferase ( ALT ) , and postoperative hospitalization duration ( PHD ) were measured .


A total of 218 patients ( 139 males , 79 females ) , with an average age of 60.110.8 years , were enrolled in this study .


One hundred and thirteen patients who received ENBD were included in Group 1 , and 105 patients who did not receive ENBD were included in Group 2 .


The baseline clinical characteristics were similar in both groups .


There were no significant differences in post-endoscopic retrograde cholangiopancreatography ( ERCP ) - related complications when Groups 1 and 2 were compared .


Seventy-seven patients underwent EPBD , and 41 received an ENBD tube ( G1a ) and 36 did not ( G2a ) .


Seventy-three patients underwent EST , and 34 patients received an ENBD tube ( G1b ) and 39 did not ( G2b ) .


The remaining 68 patients underwent neither EPBD nor EST ; of these patients , 38 received an ENBD tube ( G1c ) and 30 did not ( G2c ) .


For each of the three pairs of subgroups ( G1a vs G2a , G1b vs G2b , G1c vs G2c ) , there were no significant differences detected in the PHD or the time to normalization of CRP , TB and ALT .


In the EPBD group , the incidence of post-ERCP pancreatitis , hyperamylasemia and overall patient complications was significantly higher for G2a ( post-ERCP pancreatitis : 6/36 vs 0/41 , P = 0.0217 ; hyperamylasemia : 11/36 vs 4/41 , P = 0.0215 ; overall patient complications : 18/36 vs 7/41 , P = 0.0029 ) .


After successful CBD stone clearance , ENBD is only beneficial when an EPBD procedure has been performed .


Asthma is the most prevalent chronic disease to complicate pregnancies worldwide , affecting around 12 % of pregnant women in Australia .


Oxidative stress and inflammation manifest during pregnancy ; however asthma in pregnancies further intensifies oxidative stress .


Consumption of antioxidant-rich foods has been shown to be beneficial for asthma control in non-pregnant asthmatic adults .


It has not been investigated whether antioxidant-rich foods can improve the elevated oxidative stress that occurs with asthma in pregnancy , thereby improving asthma control .


The primary aim of this study is to determine whether increased consumption of antioxidant-rich foods for 12 weeks will improve maternal asthma control , compared to standard dietary intake during pregnancy .


A 12 week , parallel randomized controlled trial will be conducted .


One hundred and sixty eight pregnant women with mild , moderate , or severe asthma , currently using inhaled corticosteroids , and with poor diet quality , will be recruited at approximately12 weeks gestation .


Following a 4 week run-in period , women will be randomized to either a 12 week antioxidant intervention ( increased consumption of antioxidant-rich foods ( 5 servings/day vegetables , 2 servings/day fruit , 8 servings/day grains ( mostly wholegrains ) , 3-4 serving/week lean meat ) or standard pregnancy care .


The primary outcome is asthma control score ( decrease of 0.5 , the minimally clinically significant change ) .


Secondary outcomes include plasma antioxidants , markers of oxidative stress , and time to , and number of , exacerbations .


With two-tailed t-tests at 80 % power , a sample size of 52 completions per group is required .


Allowing for a 78 % retention including a 20 % removal of women from the analysis due to non-compliance , we will recruit 168 women .


It is expected that this 12 week study will improve asthma control .


This is significant because asthma is the most prevalent condition to complicate pregnancies and contributes to poor maternal , neonatal and infant health outcomes .


Our research will provide the first evidence to show that , in pregnancy , consumption of antioxidant-rich foods is a key modifier of clinical asthma status .


This research is crucial for contributing to the evidence base to inform future guidelines given existing clinical and research gaps .


ACTRN12613000301763 .


This study aimed to compare the clinical and radiographic success of preveneered posterior NuSmile and Kinder Krowns over one year and to assess the level of parental satisfaction with their esthetics .


Three trained operators placed 120 crowns in a split-mouth design with a random allocation for 36 participants ( mean age : 5.8 years ) who received two , four , six , or eight crowns .


Blind assessment of the clinical and radiographic performance of the restorations was performed by four calibrated examiners after one year .


Results were analyzed by Fisher 's exact test and McNemar test .


Examiner reliability was determined by Cohen 's kappa score .


Visual analogue scale ( VAS ) was used to assess the level of parental satisfaction .


All crowns but one were retained , and the majority ( 83 percent ) had no facing fractures .


Parental satisfaction was high ( 9.4 / 10 on the VAS ) .


Primary maxillary first molar crowns had more occlusal facing fractures than their mandibular counterparts ( P = .02 ) .


Primary mandibular second molar crowns showed more facing fractures than their maxillary counterparts ( P = .008 ) .


Both types showed no statistical difference in most categories , but Kinder Krowns had more facing fractures ( P < .02 ) .


Posterior preveneered crowns have predictable durability at 12 months while offering natural appearance to restored teeth .


To determine whether physical activity may affect cognitive performance in patients with Parkinson 's disease by measuring reaction times in patients participating in the Berlin BIG study .


Randomized controlled trial , rater-blinded .


Ambulatory care .


Patients with mild to moderate Parkinson 's disease ( N = 60 ) were randomly allocated to 3 treatment arms .


Outcome was measured at the termination of training and at follow-up 16 weeks after baseline in 58 patients ( completers ) .


Patients received 16 hours of individual Lee Silverman Voice Treatment-BIG training ( BIG ; duration of treatment , 4wk ) , 16 hours of group training with Nordic Walking ( WALK ; duration of treatment , 8wk ) , or nonsupervised domestic exercise ( HOME ; duration of instruction , 1hr ) .


Cued reaction time ( cRT ) and noncued reaction time ( nRT ) .


Differences between treatment groups in improvement in reaction times from baseline to intermediate and baseline to follow-up assessments were observed for cRT but not for nRT .


Pairwise t test comparisons revealed differences in change in cRT at both measurements between BIG and HOME groups ( intermediate : -52 ms ; 95 % confidence interval [ CI ] , -84 / -20 ; P = .002 ; follow-up : 55ms ; CI , -105 / -6 ; P = .030 ) and between WALK and HOME groups ( intermediate : -61 ms ; CI , -120 / -2 ; P = .042 ; follow-up : -78 ms ; CI , -136 / -20 ; P = .010 ) .


There was no difference between BIG and WALK groups ( intermediate : 9ms ; CI , -49 / 67 ; P = .742 ; follow-up : 23ms ; CI , -27 / 72 ; P = .361 ) .


Supervised physical exercise with Lee Silverman Voice Treatment-BIG or Nordic Walking is associated with improvement in cognitive aspects of movement preparation .


Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality .


In general , the patients are already malnourished , and early postoperative enteral nutrition is recommended .


However , there is no consensus concerning the best enteral access route in these cases .


A prospective randomized trial was performed from 2008 to 2012 with 59 patients who underwent esophagectomy , total gastrectomy , or pancreaticoduodenectomy .


In all , 4 patients declined to participate , and 13 did not meet the inclusion criteria and were excluded .


Of the 42 included patients , 21 had nasoenteric tubes , and 21 had a jejunostomy .


The two groups were similar in demographic and clinical aspects .


The nasoenteric ( NE ) and jejunostomy groups underwent early enteral therapy in 71 and 62 % of cases ( p > 0.05 ) , respectively .


The median length of enteral therapy use was less in the NE group ( 5.0 vs. 8.5 days ) , but the difference was not statistically significant .


The NE group required introduction of parenteral therapy more frequently than the jejunostomy group ( p < 0.05 ) .


Complications related to the enteral route occurred in 38.0 and 28.5 % of patients ( p > 0.05 ) in the NE and jejunostomy groups , respectively .


In the NE group , there were four losses and four tube obstructions .


In the jejunostomy group , there were two losses , four obstructions , and two cases of leakage around the tube .


In the latter group , patients who underwent therapy for a longer time had tubal complications ( p < 0.05 ) and longer intensive care unit and hospital stays ( p < 0.05 ) .


The two enteral routes were associated with the same number of complications .


However , the presence of a jejunostomy allowed enteral therapy for longer periods , especially in patients with complications , thus avoiding the need for parenteral nutrition .


To assess the efficacy and safety of intravitreal bevacizumab ( IVB ) compared with ranibizumab ( IVR ) in the treatment of macular oedema due to branch retinal vein occlusion ( BRVO ) .


In this prospective , randomised , non-inferiority trial , 75 participants with macular oedema due to BRVO received intravitreal injections of ranibizumab or bevacizumab after 1:1 block randomisation .


The primary outcome measure was the difference in mean changes in best-corrected visual acuity ( BCVA ) at 6months .


Secondary outcome measures included mean change in central retinal thickness ( CRT ) , the proportion of patients improving by > 15 letters and the proportion of patients developing neovascularisation .


Participants received either IVR ( n = 37 ) or IVB ( n = 38 ) .


The mean BCVA at baseline was 52.814.4 letters ( 20/80 ) and 56.110.0 letters ( 20/80 ) ( p = 0.24 ) in the ranibizumab and bevacizumab groups , respectively .


At 6months , the mean gains in BCVA were +18.1 letters ( p < 0.0001 ; 95 % CI , +12.8 to +22.6 ) in the ranibizumab group and +15.6 letters ( p < 0.0001 ; 95 % CI +12.0 to +20.5 ) in the bevacizumab group .


The difference between the mean visual gains of the treated groups ( bevacizumab-ranibizumab ) was -2.5 letters ( 95 % CI -8.0 to +5.0 ; p = 0.74 ) .


Mean reductions in CRT at 6months were 177.1122.3 m in the ranibizumab group ( p < 0.0001 ) and 201.7166.2 m in the bevacizumab group ( p < 0.0001 ) , with no significant difference between the two groups ( p = 0.48 ) .


The mean numbers of ranibizumab and bevacizumab injections were 3.21.5 and 3.01.4 , respectively ( p = 0.55 ) .


Two serious adverse events occurred in the ranibizumab group and one in the bevacizumab group but both were unrelated to intravitreal injections .


This study demonstrated significant gain in visual acuity in eyes with BRVO treated with either bevacizumab or ranibizumab .


Pro-re-nata strategy was effective in maintaining the visual gain .


http://www.ctri.nic.in/ CTRI/2012/01 / 003120 .


To investigate the ability of the prostate genetic score ( PGS-33 ) , a germ-line biomarker of prostate cancer ( PCa ) risk , to categorize men participating in the Prostate , Lung , Colorectal and Ovarian ( PLCO ) Cancer Screening Trial .


We obtained the genetic data from the Cancer Genetic Markers of Susceptibility ( CGEMS ) , a nested case control study examining germ-line DNA in the screened arm of the PLCO trial .


A PGS-33 was calculated based on their genotype at 33 PCa associated single nucleotide polymorphisms ( SNPs ) .


The primary outcome was the diagnosis of PCa and primary predictor was PGS-33 .


We identified 2,244 subjects ( no cancer , N = 1017 ) and cases ( N = 1227 ) .


The PGS-33 ( P < 0.001 ) , prostate specific antigen ( PSA ; P < 0.001 ) , family history of PCa ( < 0.001 ) , abnormal digital rectal exam ( DRE , P < 0.001 ) , and history of ever smoking ( P = 0.037 ) were associated with a PCa diagnosis .


In multivariable analysis , the log ( PGS-33 ) was associated with PCa diagnosis with an odds ratio of 1.68 ( 95 % CI 1.36-2 .08 , P < 0.001 ) , log ( PSA ) ( OR 8.2 ; 95 % CI 6.75-10 .04 , P < 0.001 ) , and family history of PCa ( OR 2.01 ; 95 % CI 1.26-3 .20 , P = 0.003 ) .


PGS-33 quartiles noted an increasing rate of PCa detection in addition to PSA : 43.2 % ( Q1 ) , 47.8 % ( Q2 ) , 58.8 % ( Q3 ) , and 69.4 ( Q4 ) ( P < 0.001 ) and improvement in PSA performance ( P < 0.001 ) .


Germ-line DNA in the form of the PGS-33 is able to risk stratify men regarding their risk of PCa .


The PGS-33 may have implications regarding who may benefit most from PCa screening and possibly add to PSA performance .


Community-based health education programs may be helpful in improving health outcomes in patients with chronic illnesses .


This study aimed to evaluate community-based health education strategies in the management of hypertensive patients with low socioeconomic status in Dongguan City , China .


This was a randomized , non-blinded trial involving 360 hypertensive patients enrolled in the community health service centre of Liaobu Town , Dongguan City , China .


Participants were randomized to receive one of the three community-based health education programs over 2 years : self-learning reading ( Group 1 ) , monthly regular didactic lecture ( Group 2 ) , monthly interactive education workshop ( Group 3 ) .


Outcomes included the changes in the proportion of subjects with normalized blood pressure ( BP ) , hypertension-related knowledge score , adherence to antihypertensive treatment , lifestyle , body mass index and serum lipids .


After the 2-y intervention , the proportion of subjects with normalized BP increased significantly in Group 2 ( from 41.2 % to 63.2 % , p < 0.001 ) , and increased more substantially in Group 3 ( from 40.2 % to 86.3 % , p < 0.001 ) , but did not change significantly in Group 1 .


Improvements in hypertension-related knowledge score , adherence to regular use of medications , appropriate salt intake and regular physical activity were progressively greater from group 1 to group 2 to group 3 .


Group 3 had the largest reductions in body mass index and serum LDL cholesterol levels .


Interactive education workshops may be the most effective strategy in community-based health promotion education programs for hypertensive patients in improving patients ' knowledge on hypertension and alleviating clinical risk factors for preventing hypertension-related complications .


Cocaine dependence is a major public health problem with no available robustly effective pharmacotherapy .


This study 's aim was to determine if treatment with sertraline ( SERT ) or SERT plus gabapentin ( GBP ) improved treatment retention , depressive symptoms , and/or cocaine use .


Depressed cocaine-dependent patients ( N = 99 ) were enrolled in a 12-week , double-blind , randomized , placebo ( PLA ) - controlled , clinical trial and placed in research beds at a residential treatment facility ( Recovery Centers of Arkansas ) .


They were randomized by depressive symptom severity and inducted onto 1 of the following while residing at the Recovery Centers of Arkansas : SERT ( 200 mg/d ) , SERT ( 200 mg/d ) plus GBP ( 1200 mg/d ) , or PLA .


Participants transferred to outpatient treatment at the start of their third week , continued receiving study medications or PLA ( weeks 3-12 ) , and participated in weekly individual cognitive behavioral therapy .


Compliance was facilitated through the use of contingency management procedures .


Supervised urine samples were obtained thrice weekly and self-reported mood weekly .


At the end of 12 weeks , participants were tapered off the study medication over 5 days and referred to a local treatment program .


Sertraline , but not SERT plus GBP , showed a significantly lower overall percentage of cocaine-positive urine samples compared with that of PLA .


A significantly greater percentage of participants experienced relapse in the PLA group ( 88.9 % ) compared with that of the SERT group ( 65.2 % ) .


Hamilton depression ratings decreased significantly over time regardless of the treatment group .


Retention in treatment did not differ significantly between the treatment groups .


Sertraline plus GBP may not be superior to SERT alone in delaying relapse among abstinent cocaine-dependent individuals undergoing cognitive behavioral therapy .


To evaluate and compare the efficacy of platelet-rich fibrin ( PRF ) with enamel matrix derivative ( EMD ; Emdogain ) in the treatment of periodontal intrabony defects in patients with chronic periodontitis , six months after surgery .


Forty-four ( 44 ) intrabony defects in 30 patients ( 15 males ) were randomly allocated into two treatment groups : EMD ( n = 22 ) and PRF ( n = 22 ) .


Measurement of the defects was done using clinical and cone beam computed tomography at baseline and 6 months .


Clinical and radiographic parameters such as probing depth , clinical attachment level , intrabony defect depth and defect angle , were recorded at baseline and 6 months post-operatively .


Within group change was evaluated using the Wilcoxon signed rank test .


Intergroup comparisons were made using the Mann-Whitney U test .


Postsurgical measurements revealed that there was an equal reduction in probing depth and a greater but statistically non-significant attachment gain for the Emdogain group when compared to the platelet-rich fibrin group .


The Emdogain group presented with significantly greater percentage defect resolution ( 43.07 % 12.21 ) than did the platelet-rich fibrin group ( 32.41 % 14.61 ) .


Post-operatively the changes in defect width and defect angle were significant in both groups , but upon intergroup comparison they were found to be statistically non-significantly different .


Both Emdogain and platelet-rich fibrin were effective in the regeneration of intrabony defects .


Emdogain was significantly superior in terms of percentage defect resolution .


HM30181 is a third generation P-glycoprotein ( P-gp ) inhibitor currently under development .


The objectives of this study were to evaluate the effects of a single dose of HM30181 on the pharmacodynamics and pharmacokinetics of loperamide , a P-gp substrate , and to compare them with those of quinidine .


Eighteen healthy male subjects were administered loperamide alone ( period 1 ) or with loperamide plus quinidine or HM30181 in period 2 or 3 , respectively .


In period 3 , subjects randomly received one of three HM30181 doses : 15 , 60 or 180mg .


Changes in pupil size , alertness , oxygen saturation and the oral bioavailability of loperamide were assessed in each period .


In addition , the pharmacokinetics of HM30181 were determined .


Pupil size , alertness and oxygen saturation did not change over time when loperamide alone or loperamide plus HM30181 was administered while HM30181 significantly increased the systemic exposure to loperamide , i.e. the geometric mean ratio ( 90 % confidence interval ) of AUC ( 0 , tlast ) for loperamide with and without HM30181 was 1.48 ( 1.08 , 2.02 ) .


Co-administered quinidine significantly increased the systemic exposure to loperamide 2.2-fold ( 1.53 , 3.18 ) , which also markedly reduced pupil size , resulting in a decrease of 24.7 mmh in the area under the effect curve of pupil size change from baseline compared with loperamide alone .


HM30181 inhibits P-gp mainly in the intestinal endothelium , which can be beneficial because pan-inhibition of P-gp , particularly in the brain , could lead to detrimental adverse events .


Further studies are warranted to investigate adequately the dose-exposure relationship of HM30181 , along with its duration of effect .


Most stroke rehabilitation studies have been performed in high-income countries .


The aim of this study was to identify the main barriers for patient inclusion in a research protocol performed in Brazil .


We evaluated reasons for exclusion of patients in a pilot , randomized , double-blinded clinical trial of stroke rehabilitation .


Descriptive statistical analysis was performed .


Only 5.6 % of 571 screened patients were included .


Recurrent stroke was responsible for exclusion of 45.4 % of potentially eligible patients .


Recurrent stroke represented a big barrier to enroll patients in the protocol .


External validity of rehabilitation trials will benefit from definition of study criteria according to regional characteristics of patients , including rates of recurrent stroke .


http://www.clinicaltrials.gov .


Unique identifier : NCT01333579 .


Patients with colorectal cancer with liver metastases undergo hepatic resection with curative intent .


Positron emission tomography combined with computed tomography ( PET-CT ) could help avoid noncurative surgery by identifying patients with occult metastases .


To determine the effect of preoperative PET-CT vs no PET-CT ( control ) on the surgical management of patients with resectable metastases and to investigate the effect of PET-CT on survival and the association between the standardized uptake value ( ratio of tissue radioactivity to injected radioactivity adjusted by weight ) and survival .


A randomized trial of patients older than 18 years with colorectal cancer treated by surgery , with resectable metastases based on CT scans of the chest , abdomen , and pelvis within the previous 30 days , and with a clear colonoscopy within the previous 18 months was conducted between 2005 and 2013 , involving 21 surgeons at 9 hospitals in Ontario , Canada , with PET-CT scanners at 5 academic institutions .


Patients were randomized using a 2 to 1 ratio to PET-CT or control .


The primary outcome was a change in surgical management defined as canceled hepatic surgery , more extensive hepatic surgery , or additional organ surgery based on the PET-CT .


Survival was a secondary outcome .


Of the 263 patients who underwent PET-CT , 21 had a change in surgical management ( 8.0 % ; 95 % CI , 5.0 % -11.9 % ) .


Specifically , 7 patients ( 2.7 % ) did not undergo laparotomy , 4 ( 1.5 % ) had more extensive hepatic surgery , 9 ( 3.4 % ) had additional organ surgery ( 8 of whom had hepatic resection ) , and the abdominal cavity was opened in 1 patient but hepatic surgery was not performed and the cavity was closed .


Liver resection was performed in 91 % of patients in the PET-CT group and 92 % of the control group .


After a median follow-up of 36 months , the estimated mortality rate was 11.13 ( 95 % CI , 8.95-13 .68 ) events/1000 person-months for the PET-CT group and 12.71 ( 95 % CI , 9.40-16 .80 ) events/1000 person-months for the control group .


Survival did not differ between the 2 groups ( hazard ratio , 0.86 [ 95 % CI , 0.60-1 .21 ] ; P = .38 ) .


The standardized uptake value was associated with survival ( hazard ratio , 1.11 [ 90 % CI , 1.07-1 .15 ] per unit increase ; P < .001 ) .


The C statistic for the model including the standardized uptake value was 0.62 ( 95 % CI , 0.56-0 .68 ) and without it was 0.50 ( 95 % CI , 0.44-0 .56 ) .


The difference in C statistics is 0.12 ( 95 % CI , 0.04-0 .21 ) .


The low C statistic suggests that the standard uptake value is not a strong predictor of overall survival .


Among patients with potentially resectable hepatic metastases of colorectal adenocarcinoma , the use of PET-CT compared with CT alone did not result in frequent change in surgical management .


These findings raise questions about the value of PET-CT scans in this setting .


clinicaltrials.gov Identifier : NCT00265356 .


Intravenous recombinant tissue-type plasminogen activator ( r-tPA ) , despite a risk of early symptomatic intracranial hemorrhage ( sICH ) , is of net clinical benefit to acute stroke patients .


We tested if predictive models could identify patients least likely to be harmed by sICH or those who gained no net benefit .


We used the Third International Stroke Trial ( IST-3 ) trial data set , an international , multicenter , open treatment randomized trial of 0.9 mg/kg r-tPA versus control in 3035 patients with acute ischemic stroke .


We compared the discrimination and calibration of previously developed predictive models for ICH and poststroke poor outcome and developed a new model using variables selected by systematic review .


We calculated the absolute and relative risk reduction of death or dependency with r-tPA in patients at a low , medium , or high predicted risk of sICH or poor functional outcome .


Prediction models for sICH or poor outcome ( Hemorrhage After Thrombolysis [ HAT ] ; Sugar , Early Infarct Signs , Dense Artery , Age , National Institutes of Health ( NIH ) Stroke Score ( SEDAN ) ; Glucose Race Age Sex Pressure Stroke Severity [ GRASPS ] ; Stroke Thrombolytic Predictive Instrument ; Dense Artery , Rankin Score , Age , Glucose , Onset to Treatment Time , NIHSS [ DRAGON ] ; Totaled Health Risks in Vascular Events [ THRIVE ] ; our new model ; and a model with National Institutes of Health Stroke Scale and age ) had similar area under receiver operator characteristic curves ( AUROCC ) to predict sICH ( P for difference > 0.05 ) .


The simplest model ( with covariates National Institutes of Health Stroke Scale and age ) predicted both sICH ( AUROCC , 0.63 ; 95 % CI , 0.58-0 .68 ) and poststroke poor functional outcome ( AUROCC , 0.80 ; 95 % CI , 0.77-0 .82 ) similarly to complex models .


There was no evidence that the effect of r-tPA in patients at high predicted risk of sICH or poor functional outcome after stroke was less than in those at lower risk .


There is a clinically relevant net positive effect of r-tPA in patients with acute stroke at a high predicted risk of sICH or poor functional outcome .


http://www.controlled-trials.com .


Unique identifier : ISRCTN25765518 .


We sought to determine whether the design of 3 different double-lumen endobronchial tubes ( DLT ) ( Rusch , Mallinckrodt , Fuji ) has an effect on the ease of placement over an airway exchange catheter ( AEC ) using a video laryngoscope .


A convenience sample of 17 anesthesia residents and fellows with at least 3 years of anesthesia training was recruited from teaching hospitals in Toronto for a randomized crossover trial .


Each participant passed each DLT over an AEC in an airway simulator , visualized and video recorded via a video laryngoscope ( GlideScope ) .


The order of exchange was randomized by blindly pulling the name of the manufacturer of a DLT from a box .


The primary outcome was time to intubate , defined as time from the bronchial lumen entering the GlideScope view to the bronchial lumen passing the vocal cords .


Also recorded were participants ' subjective rating of the ease of use and failure rate , defined as an attempt > 150-second duration .


Time to intubate was faster with the Fuji-Phycon DLT ( median 2 seconds ) compared with both the Rusch ( median 27 seconds , P = 0.0144 ) and Mallinckrodt ( median 21 seconds , P = 0.0117 ) .


On a scale of 1 to 10 , with 10 being very easy to use and 1 being very difficult , the Fuji-Phycon was judged to be easier to use ( median 10 seconds ) compared with the Rusch ( median 3 , P = 0.0186 ) and the Mallinckrodt ( median 4 seconds , P = 0.0123 ) .


The Rusch was associated with significantly more failures than the other DLTs , P = 0.002 .


The Fuji-Phycon DLT was easier to pass over an AEC in this simulator trial and warrants consideration in patients with difficult airways who require 1-lung ventilation .


Acute kidney injury ( AKI ) after cardiac surgery procedures is associated with poor patient outcomes .


Cystatin C as a marker for renal failure has been shown to be of prognostic value ; however , a wide range of its predictive accuracy has been reported .


The aim of the study was to evaluate whether the measurement of pre - and postoperative serum cystatin C improves the prediction of AKI .


In a single-centre , prospective study of 70 patients ( 74 9 ys ; range 47-85 ys ; 77 % male ) , cystatin C was measured six times : ( T1 = preoperative , T2 = start cardiopulmonary bypass ( CPB ) , T3 = 20 min after CPB , T4 = end of operation ; T5 = 24 h postoperatively ; T6 = 7d postoperatively ) .


Predictive property , in terms of the need for renal replacement therapy ( RRT ) , was analysed by receiver operating characteristics ( ROC ) statistics and described by the area under the curve ( AUC ) .


With respect to RRT ( n = 8 ) , serum cystatin C was significantly higher at the end of the operation ( T4 ) , 24 h postoperatively at T5 and at T6 .


The AUCs for preoperative T1 and intraoperative T2/3 cystatin C were < 0.7 ( 95 % CI , 0.47-0 .85 ) .


The earliest significant predictive AUCs were found at the end of the operation ( T4 : p = 0.03 95 % CI 0.58-0 .88 AUC 0.73 ) and 24 h postoperatively ( T5 : p = 0.003 95 % CI 0.74-0 .96 AUC 0.85 ) .


Early postoperative serum cystatin C increase appears to be a moderate biomarker in the prediction of AKI , whereas a preoperative and intraoperative cystatin C increase has only a limited diagnostic and predictive value .


To examine whether 12 weeks of treatment with a dipeptidyl peptidase-4 ( DPP-4 ) inhibitor , sitagliptin , influences the insulin secretion induced by glucose , glucose-dependent insulinotropic polypeptide ( GIP ) and glucagon-like peptide-1 ( GLP-1 ) during a hyperglycaemic clamp in patients with type 2 diabetes ( T2DM ) .


A randomized , double-blind , placebo-controlled study was conducted over 12 weeks , during which 25 patients with T2DM completed treatment with either sitagliptin ( 100mg once daily ) or placebo as add-on therapy to metformin [ sitagliptin group ( n = 12 ) : meanstandard error of the mean ( s.e.m. ) age 542.5 years , means.e.m .


HbA1c 7.80.2 % ; placebo group ( n = 13 ) : means.e.m .


age : 573.0 years , means.e.m .


HbA1c 7.90.2 % ] .


In weeks 1 and 12 , the patients underwent three 2-h 15-mM hyperglycaemic clamp experiments with infusion of either saline , GLP-1 or GIP .


- cell function was evaluated according to first-phase , second-phase , incremental and total insulin and C-peptide responses .


In the sitagliptin group , the mean HbA1c concentration was significantly reduced by 0.9 % ( p = 0.01 ) .


The total - cell response during GIP infusion improved significantly from week 1 to week 12 , both within the sitagliptin group ( p = 0.004 ) and when compared with the placebo group ( p = 0.04 ) .


The total - cell response during GLP-1 infusion was significantly higher ( p = 0.001 ) when compared with saline and GIP infusion , but with no improvement from week 1 to week 12 .


No significant changes in - cell function occurred in the placebo group .


Treatment with the DPP-4 inhibitor sitagliptin over 12 weeks in patients with T2DM partially restored the lost insulinotropic effect of GIP , whereas the preserved insulinotropic effect of GLP-1 was not further improved .


A gradual enhancement of the insulinotropic effect of GIP , therefore , possibly contributes to the antidiabetic actions of DPP-4 inhibitors .


Fluticasone and formoterol are effective in the treatment of asthma .


When a corticosteroid alone fails to control asthma , combination therapy is the treatment of choice .


The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol ( BUD/FOR ) , fluticasone alone ( FLU ) , and the single-capsule combination of fluticasone/formoterol ( FLU/FOR ) on lung function in patients with mild-to-moderate persistent asthma .


This was a randomized , multicenter , open phase III trial conducted in Brazil .


The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 ( in L ) at the final visit .


The secondary analyses were PEF , level of asthma control , serum cortisol levels , frequency of adverse events , adherence to treatment , and appropriate inhaler use .


We randomized 243 patients to three groups : FLU/FOR ( n = 79 ) , BUD/FOR ( n = 83 ) , and FLU ( n = 81 ) .


In terms of the mean FEV1 after 12 weeks of treatment , the difference between the FLU/FOR and BUD/FOR groups was 0.22 L ( 95 % CI : -0.06 to 0.49 ) , whereas the difference between the FLU/FOR and FLU groups was 0.26 L ( 95 % CI : -0.002 to 0.52 ) .


Non-inferiority was demonstrated by the difference between the lower limits of the two 95 % CIs ( -0.06 vs. -0.002 ) .


The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group .


There were no significant differences among the groups regarding patient adherence , patient inhaler use , or safety profile of the formulations .


The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety , making it a new treatment option for persistent asthma .


Atrial fibrillation is associated with decline of cognitive function .


Observational evidence suggests that anticoagulation might protect against this decline .


We report the first randomized controlled trial evidence on the effect of anticoagulation on cognitive function in elderly patients with atrial fibrillation .


A total of 973 patients aged75 years with atrial fibrillation were recruited from primary care and randomly assigned to warfarin ( n = 488 ; target international normalized ratio , 2-3 ) or aspirin ( n = 485 ; 75 mg/d ) .


Neither participants nor investigators were masked to group assignment .


Follow-up was for a mean of 2.7 years ( SD , 1.2 ) .


Cognitive outcome was assessed using the Mini-Mental State Examination at 9 - , 21 - , and 33-month follow-up .


Participants who had a stroke were censored from the analysis , which was by intention to treat with imputation for missing data .


There was no difference between mean Mini-Mental State Examination scores in people assigned to warfarin or aspirin at 9 or 21 months .


At 33-month follow-up , there was a nonsignificant difference of 0.56 in favor of warfarin that decreased to 0.49 ( 95 % confidence interval , -0.01 to 0.98 ) after imputation .


We found no evidence that anticoagulation confers clinically important protection over aspirin against cognitive decline as measured by the Mini-Mental State Examination in atrial fibrillation in the first 33 months of treatment other than that provided by preventing clinical stroke .


http://www.controlled-trials.com .


Unique identifier : ISRCTN89345269 .


The aim of this study was to identify the effects of a communication skills training ( CST ) program for oncologists , developed based on patient preferences regarding oncologists ' communication .


Thirty oncologists were randomly assigned to either an intervention group ( IG ; 2-day CST workshop ) or control group ( CG ) .


Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up .


A total of 1,192 patients ( response rate , 84.6 % ) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale , satisfaction with the consultation , and trust in their oncologist after the consultation .


At the follow-up survey , the performance scores of the IG had improved significantly , in terms of their emotional support ( P = .011 ) , setting up a supportive environment ( P = .002 ) , and ability to deliver information ( P = .001 ) , compared with those of the CG .


Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves ( P = .001 ) .


Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG ( P = .027 ) .


However , the CST program did not affect patient satisfaction with oncologists ' style of communication .


A CST program based on patient preferences is effective for both oncologists and patients with cancer .


Oncologists should consider CST as an approach to enhancing their communication skills .


Attention bias modification treatment ( ABMT ) is a promising novel treatment for anxiety disorders , but clinical trials have focused largely on stand-alone formats among adults .


This randomized controlled trial examined the augmenting effects of threat-based ABMT on cognitive behavioral therapy ( CBT ) in clinically anxious youth .


Sixty-three treatment-seeking children with anxiety disorder were randomly assigned to 1 of the following 3 treatment groups : ABMT + CBT ; ABMT placebo + CBT ; and CBT-alone .


Participants in the 2 ABMT conditions received repeated training on dot-probe tasks either designed to shift attention away from threats ( active ) or designed to induce no changes in attention patterns ( placebo ) .


Primary outcome measures were frequency and severity of anxiety symptoms as determined by a clinician using a semi-structured interview .


Self - and parent-rated anxiety measures and threat-related attention bias scores were also measured before and after treatment .


Both the active and placebo ABMT groups showed greater reductions in clinician-rated anxiety symptoms than the CBT-alone group .


Furthermore , only the active ABMT group showed significant reduction in self - or parent-rated anxiety symptoms .


Finally , all groups showed a shift in attention patterns across the study , starting with a bias toward threat at baseline and shifting attention away from threat after treatment .


Active and placebo ABMT might augment the clinical response to CBT for anxiety .


This effect could arise from benefits associated with performing computer-based paradigms such as the dot-probe task .


Given the absence of group differences in attention-bias changes during treatment , possible mechanisms and methodological issues underlying the observed findings are discussed .


Clinical trial registration information-Augmenting Effects of ABMT on CBT in Anxious Children : A Randomized Clinical Trial ; http://clinicaltrials.gov/; NCT01730625 .


To analyze the effect of psychological intervention on reducing performance anxiety and the consequences of the intervention on first-year pharmacy students .


In this experimental study , 236 first-year undergraduate pharmacy students from a private university in Malaysia were approached between weeks 5 and 7 of their first semester to participate in the study .


The completed responses for the Westside Test Anxiety Scale ( WTAS ) , the Kessler Perceived Distress Scale ( PDS ) , and the Academic Motivation Scale ( AMS ) were received from 225 students .


Out of 225 students , 42 exhibited moderate to high test anxiety according to the WTAS ( score ranging from 30 to 39 ) and were randomly placed into either an experiment group ( n = 21 ) or a waiting list control group ( n = 21 ) .


The prevalence of test anxiety among pharmacy students in this study was lower compared to other university students in previous studies .


The present study 's anxiety management of psychoeducation and systematic education for test anxiety reduced lack of motivation and psychological distress and improved grade point average ( GPA ) .


Psychological intervention helped significantly reduce scores of test anxiety , psychological distress , and lack of motivation , and it helped improve students ' GPA .


Treatment for patients with chronic lymphocytic leukaemia who are elderly or who have comorbidities is challenging because fludarabine-based chemoimmunotherapies are mostly not suitable .


Chlorambucil remains the standard of care in many countries .


We aimed to investigate whether the addition of ofatumumab to chlorambucil could lead to better clinical outcomes than does treatment with chlorambucil alone , while also being tolerable for patients who have few treatment options .


We carried out a randomised , open-label , phase 3 trial for treatment-naive patients with chronic lymphocytic leukaemia in 109 centres in 16 countries .


We included patients who had active disease needing treatment , but in whom fludarabine-based treatment was not possible .


We randomly assigned patients ( 1:1 ) to receive oral chlorambucil ( 10 mg/m ( 2 ) ) on days 1-7 of a 28 day treatment course or to receive chlorambucil by this schedule plus intravenous ofatumumab ( cycle 1 : 300 mg on day 1 and 1000 mg on day 8 ; subsequent cycles : 1000 mg on day 1 ) for three to 12 cycles .


Assignment was done with a randomisation list that was computer generated at GlaxoSmithKline , and was stratified , in a block size of two , by age , disease stage , and performance status .


The primary endpoint was progression-free survival in the intention-to-treat population and assessment was done by an independent review committee that was masked to group assignment .


The study is registered with ClinicalTrials.gov , number NCT00748189 .


We enrolled 447 patients , median age 69 years ( range 35-92 ) .


Between Dec 22 , 2008 , and May 26 , 2011 , we randomly assigned 221 patients to chlorambucil plus ofatumumab and 226 patients to chlorambucil alone .


Median progression-free survival was 224 months ( 95 % CI 190-252 ) in the group assigned to chlorambucil plus ofatumumab compared with 131 months ( 106-138 ) in the group assigned to chlorambucil only ( hazard ratio 057 , 95 % CI 045-072 ; p < 00001 ) .


Grade 3 or greater adverse events were more common in the chlorambucil plus ofatumumab group ( 109 [ 50 % ] patients ; vs 98 [ 43 % ] given chlorambucil alone ) , with neutropenia being the most common event ( 56 [ 26 % ] vs 32 [ 14 % ] ) .


Grade 3 or greater infections had similar frequency in both groups .


Grade 3 or greater infusion-related adverse events were reported in 22 ( 10 % ) patients given chlorambucil plus ofatumumab .


Five ( 2 % ) patients died during treatment in each group .


Addition of ofatumumab to chlorambucil led to clinically important improvements with a manageable side-effect profile in treatment-naive patients with chronic lymphocytic leukaemia who were elderly or had comorbidities .


Chlorambucil plus ofatumumab is therefore an important treatment option for these patients who can not tolerate more intensive therapy .


GlaxoSmithKline , Genmab A/S .


To compare the efficacy and safety of weekly albiglutide with daily sitagliptin , daily glimepiride , and placebo .


Patients with type 2 diabetes receiving metformin were randomized to albiglutide ( 30 mg ) , sitagliptin ( 100 mg ) , glimepiride ( 2 mg ) , or placebo .


Blinded dose titration for albiglutide ( to 50 mg ) and glimepiride ( to 4 mg ) was based on predefined hyperglycemia criteria .


The primary end point was change in HbA1c from baseline at week 104 .


Secondary end points included fasting plasma glucose ( FPG ) , weight , and time to hyperglycemic rescue .


Baseline characteristics were similar among the albiglutide ( n = 302 ) , glimepiride ( n = 307 ) , sitagliptin ( n = 302 ) , and placebo ( n = 101 ) groups .


Baseline HbA1c was 8.1 % ( 65.0 mmol/mol ) ; mean age was 54.5 years .


The mean doses for albiglutide and glimepiride at week 104 were 40.5 and 3.1 mg , respectively .


At week 104 , albiglutide significantly reduced HbA1c compared with placebo ( -0.9 % [ -9.8 mmol/mol ] ; P < 0.0001 ) , sitagliptin ( -0.4 % [ -4.4 mmol/mol ] ; P = 0.0001 ) , and glimepiride ( -0.3 % [ -3.3 mmol/mol ] ; P = 0.0033 ) .


Outcomes for FPG and HbA1c were similar .


Weight change from baseline for each were as follows : albiglutide -1.21 kg ( 95 % CI -1.68 to -0.74 ) , placebo -1.00 kg ( 95 % CI -1.81 to -0.20 ) , sitagliptin -0.86 kg ( 95 % CI -1.32 to -0.39 ) , glimepiride 1.17 kg ( 95 % CI 0.70-1 .63 ) .


The difference between albiglutide and glimepiride was statistically significant ( P < 0.0001 ) .


Hyperglycemic rescue rate at week 104 was 25.8 % for albiglutide compared with 59.2 % ( P < 0.0001 ) , 36.4 % ( P = 0.0118 ) , and 32.7 % ( P = 0.1504 ) for placebo , sitagliptin , and glimepiride , respectively .


Rates of serious adverse events in the albiglutide group were similar to comparison groups .


Diarrhea ( albiglutide 12.9 % , other groups 8.6-10 .9 % ) and nausea ( albiglutide 10.3 % , other groups 6.2-10 .9 % ) were generally the most frequently reported gastrointestinal events .


Added to metformin , albiglutide was well tolerated ; produced superior reductions in HbA1c and FPG at week 104 compared with placebo , sitagliptin , and glimepiride ; and resulted in weight loss compared with glimepiride .


Despite a favorable clinical experience , little evidence exists for the efficacy of greater occipital nerve block ( GONB ) in migraine treatment .


Considering such a premise , we wished to evaluate the therapeutic efficacy of GONB in patients affected by migraine headaches .


A randomized double-blinded controlled trial was conducted on 48 patients suffering from migraine headaches .


A syringe containing 1.0 mL of lidocaine 2 % , 0.5 mL of either saline ( control group , N = 24 ) or triamcinolone 0.5 mL ( intervention group , N = 24 ) was prepared for each patient .


Patients were assessed prior to the injection , and also 2 weeks , 1 month , and 2 months thereafter for severity and frequency of pain , times to use analgesics and any appeared side effects .


No significant differences were revealed in pain severity , pain frequency , and analgesics use between the two groups at the four study time points including at baseline , and 2 , 4 , and 8 weeks after the intervention .


However , in both groups , the indices of pain severity , pain frequency , and analgesics use were significantly reduced at the three time points after the intervention compared with before the intervention .


GONB with triamcinolone in combination with lidocaine or normal saline with lidocaine results in reducing pain severity and frequency as well as use of analgesics up to two months after the intervention , however any difference attributed to the drug regimens by assessing of the trend of pain characteristics changes .


The aim of the article was to investigate the effect of ondansetron preloading with crystalloid infusion after spinal anesthesia during cesarean delivery .


A total of 66 parturient women scheduled for elective caesarean sections were randomly assigned to two groups .


Five minutes before spinal anesthesia , Group O patients were injected with 4 mg of ondansetron , while Group S patients were injected with 5 mL physiological saline .


Maternal blood pressure and heart rate were measured at 2 minute intervals for 30 minutes .


After delivery , umbilical cord blood samples were analyzed .


Maternal hypotension and nausea were significantly lower in ondansetron-treated patients versus placebo ( p = 0.011 vs. 0.004 ) .


Umbilical venous pH was significantly higher in ondansetron-treated patients ( p = 0.006 ) , while partial pressure of carbon dioxide ( Pco 2 ) was significantly lower ( p = 0.002 ) .


Decreases in maternal systolic and mean arterial blood pressures were significantly lower in ondansetron-treated patients ( p = 0.008 vs. 0.025 ) , with less requirement for phenylephrine administration compared with controls ( p = 0.029 ) .


Ondansetron preloading combined with crystalloid infusion significantly reduced hypotension and nausea , while improving acid-base status , as well as reducing vasoconstrictor use .


The common bean is a staple crop in many African and Latin American countries and is the focus of biofortification initiatives .


Bean iron concentration has been doubled by selective plant breeding , but the additional iron is reported to be of low bioavailability , most likely due to high phytic acid ( PA ) concentrations .


The present study evaluated the impact of PA on iron bioavailability from iron-biofortified beans .


Iron absorption , based on erythrocyte incorporation of stable iron isotopes , was measured in 22 Rwandese women who consumed multiple , composite bean meals with potatoes or rice in a crossover design .


Iron absorption from meals containing biofortified beans ( 8.8 mg Fe , 1320 mg PA/100 g ) and control beans ( 5.4 mg Fe , 980 mg PA/100 g ) was measured with beans containing either their native PA concentration or with beans that were 50 % dephytinized or > 95 % dephytinized .


The iron concentration of the cooked composite meals with biofortified beans was 54 % higher than in the same meals with control beans .


With native PA concentrations , fractional iron absorption from the control bean meals was 9.2 % , 30 % higher than that from the biofortified bean meals ( P < 0.001 ) .


The quantity of iron absorbed from the biofortified bean meals ( 406 g ) was 19 % higher ( P < 0.05 ) than that from the control bean meals .


With 50 % and > 95 % dephytinization , the quantity of iron absorbed from the biofortified bean meals increased to 599 and 746 g , respectively , which was 37 % ( P < 0.005 ) and 51 % ( P < 0.0001 ) higher than from the control bean meals .


PA strongly decreases iron bioavailability from iron-biofortified beans , and a high PA concentration is an important impediment to the optimal effectiveness of bean iron biofortification .


Plant breeders should focus on lowering the PA concentration of high-iron beans .


This trial was registered at clinicaltrials.gov as NCT01521273 .


The exact force systems as well as their progressions generated by removable thermoplastic appliances have not been investigated .


Thus , the purposes of this experimental study were to quantify the forces and moments delivered by a single aligner and a series of aligners ( Invisalign ; Align Technology , Santa Clara , Calif ) and to investigate the influence of attachments and power ridges on the force transfer .


We studied 970 aligners of the Invisalign system ( 60 series of aligners ) .


The aligners came from 30 consecutive patients , of which 3 tooth movements ( incisor torque , premolar derotation , molar distalization ) with 20 movements each were analyzed .


The 3 movement groups were subdivided so that 10 movements were supported with an attachment and 10 were not .


The patients ' ClinCheck ( Align Technology , Santa Clara , Calif ) was planned so that the movements to be investigated were performed in isolation in the respective quadrant .


Resin replicas of the patients ' intraoral situation before the start of the investigated movement were taken and mounted in a biomechanical measurement system .


An aligner was put on the model , the force systems were measured , and the calculated movements were experimentally performed until no further forces or moments were generated .


Subsequently , the next aligners were installed , and the measurements were repeated .


The initial mean moments were about 7.3 Nmm for maxillary incisor torque and about 1.0 N for distalization .


Significant differences in the generated moments were measured in the premolar derotation group , whether they were supported with an attachment ( 8.8 Nmm ) or not ( 1.2 Nmm ) .


All measurements showed an exponential force change .


Apart from a few maximal initial force systems , the forces and moments generated by aligners of the Invisalign system are within the range of orthodontic forces .


The force change is exponential while a patient is wearing removable thermoplastic appliances .


This study aims to evaluate the treatment effects of physical exercise on menopausal symptoms in middle-aged female medical staff experiencing perimenopausal syndrome .


A total of 157 female medical staff aged 40 to 55 years and with a Kupperman index score of 15 points or higher were randomized 1:1 into an intervention group ( n = 78 ) or a control group ( n = 79 ) .


Women in the intervention group were asked to perform aerobic physical exercise ( walking with strides ) three times a week or more , whereas those in the control group continued as normal .


Measurements were taken at baseline and on weeks 4 , 8 , and 12 , with total Kupperman index score , scores on individual elements of the scale , weight , and waist circumference recorded .


In addition , fasting blood glucose , triglycerides , total cholesterol , high-density lipoprotein cholesterol , and low-density lipoprotein cholesterol were recorded at baseline and on week 12 .


The effects of physical exercise therapy on perimenopausal syndrome were evaluated by comparing changes in these parameters between the control group and the intervention group .


Fifty-four and 57 women completed all three follow-ups in the intervention and control groups , respectively .


On week 12 , the mean ( SD ) change in total Kupperman index score ( -9.23 [ 6.23 ] ) from baseline to week 12 ; the mean ( SD ) changes in individual scores for paresthesia ( -1.08 [ 1.51 ] ) , insomnia ( -1.00 [ 1.46 ] ) , irritability ( -1.00 [ 1.34 ] ) , joint or muscle pain ( -0.75 [ 0.74 ] ) , fatigue ( -0.56 [ 0.75 ] ) , headache ( -0.54 [ 0.75 ] ) , formication ( -0.38 [ 0.66 ] ) , and sexual life ( -0.62 [ 1.71 ] ) ; and the mean ( SD ) changes in total cholesterol ( -0.76 [ 0.63 ] mmol/L ) and triglycerides ( -0.20 [ 0.50 ] mmol/L ) were significantly higher in the intervention group than in the control group ( P < 0.05 ) .


In the intervention group , total Kupperman index score , weight , body mass index , waist circumference , triglycerides , and total cholesterol were significantly lower on week 12 compared with baseline ( P < 0.05 ) .


Physical exercise can substantially reduce menopausal symptoms and improve blood lipid status and body weight .


In-hospital cardiac arrest ( IHCA ) outcomes vary widely between hospitals , even after adjusting for patient characteristics , suggesting variations in practice as a potential etiology .


However , little is known about the standards of IHCA resuscitation practice among US hospitals .


To describe current US hospital practices with regard to resuscitation care .


A nationally representative mail survey .


A random sample of 1000 hospitals from the American Hospital Association database , stratified into 9 categories by hospital volume tertile and teaching status ( major teaching , minor teaching , and nonteaching ) .


Surveys were addressed to each hospital 's cardiopulmonary resuscitation ( CPR ) committee chair or chief medical/quality officer .


A 27-item questionnaire .


Responses were received from 439 hospitals with a similar distribution of admission volume and teaching status as the sample population ( P = 0.50 ) .


Of the 270 ( 66 % ) hospitals with a CPR committee , 23 ( 10 % ) were chaired by a hospitalist .


High frequency practices included having a rapid response team ( 91 % ) and standardizing defibrillators ( 88 % ) .


Low frequency practices included therapeutic hypothermia and use of CPR assist technology .


Other practices such as debriefing ( 34 % ) and simulation training ( 62 % ) were more variable and correlated with the presence of a CPR committee and/or dedicated personnel for resuscitation quality improvement .


The majority of hospitals ( 79 % ) reported at least 1 barrier to quality improvement , of which the lack of a resuscitation champion and inadequate training were the most common .


There is wide variability among hospitals and within practices for resuscitation care in the United States with opportunities for improvement .


Medications for respiratory disorders including asthma and chronic obstructive pulmonary disease ( COPD ) are typically delivered to the lung by means of a handheld inhaler .


Patient preference for and ability to use the inhaler may influence their adherence to maintenance therapy , and adherence may affect treatment outcomes .


In this study , patient experience of using a dry powder inhaler ( DPI ) , the ELLIPTA DPI , in clinical trials of a new maintenance therapy for asthma and COPD was investigated .


The ELLIPTA DPI has been designed to contain two separate blister strips from which inhalation powder can be delivered , and to be simple to use with a large , easy-to-read dose counter .


Semi-structured , in-depth , qualitative interviews were carried out 2-4 weeks after patients had completed one of six phase IIIa clinical trials using the ELLIPTA DPI .


Interview participants were asked about their satisfaction with various attributes of the inhaler and their preference for the ELLIPTA DPI relative to currently-prescribed inhalers , and responses were explored using an inductive content analysis approach .


Participants also rated the performance of the inhaler on several criteria , using a subjective 1-10 scale .


Participants with asthma ( n = 33 ) and COPD ( n = 42 ) reported high levels of satisfaction with the ELLIPTA DPI .


It was frequently described as straightforward to operate and easy to use by interview participants .


Ergonomic design , mouthpiece fit , and dose counter visibility and ease of interpretation emerged as frequently cited drivers of preference for the ELLIPTA DPI compared with their current prescribed inhaler .


Of participants with asthma , 71 % preferred the ELLIPTA DPI to DISKUS and 60 % to metered dose inhalers .


Of participants with COPD , 86 % preferred the ELLIPTA DPI to DISKUS , 95 % to HandiHaler , and 85 % to metered dose inhalers .


Overall average performance scores were > 9 ( out of 10 ) in participants with asthma and COPD .


The ELLIPTA DPI was associated with high patient satisfaction and was preferred to other inhalers by interview participants with asthma and COPD .


The development of an inhaler that is regarded as easy and intuitive to use may have positive implications for adherence to therapy in asthma and COPD .


Despite the high incidence and the economic impact of the common cold , there are still no effective therapeutic options available .


Although traditional Chinese medicine ( TCM ) is widely used in China to treat the common cold , there is still a lack of high-quality clinical trials .


This article sets forth the protocol for a high-quality trial of a new TCM drug , Baoji Tablets , which is designed to treat the common cold with summer-heat and dampness syndrome ( CCSDS ) .


The trial is evaluating both the efficacy and safety of Baoji Tablets .


This study is designed as a multicenter , phase II , parallel-group , double-blind , double-dummy , randomized and placebo-controlled trial .


A total of 288 patients will be recruited from four centers .


The new tablets group are administered Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g.


The old pills group are administered dummy Baoji Tablets 0.9 g and Baoji Pills 3.7 g.


The placebo control group are administered dummy Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. All drugs are taken three times daily for 3 days .


The primary outcome is the duration of all symptoms .


Secondary outcomes include the duration of primary and secondary symptoms , changes in primary and secondary symptom scores and cumulative symptom score at day 4 , as well as an evaluation of treatment efficacy .


This is the first multicenter , double-blind , double-dummy , randomized and placebo-controlled trial designated to treat CCSDS in an adult population from China .


It will establish the basis for a scientific and objective assessment of the efficacy and safety of Baoji Tablets for treating CCSDS , and provide evidence for a phase III clinical trial .


This study is registered with the Chinese Clinical Trial Registry .


The registration number is ChiCTR-TRC-13003197 .


Diabetes is a chronic disease characterized by elevated blood glucose levels .


The appropriate goals in the management of diabetes include maintaining blood glucose levels as close to the normal range as possible , minimizing the adverse effects of free radicals by enhancing antioxidant defenses .


Supplementation with appropriate vitamins may therefore be of value in the prevention and treatment of diabetes .


A total of 92 patients with diabetic neuropathy were enrolled in this randomized controlled study from the general medicine department of a tertiary care hospital .


Patients were randomized into two groups viz. , usual care ( n = 46 ) and intervention group ( n = 46 ) .


Usual care group patients received pregabalin with oral hypoglycemic agents .


Patients in the intervention group received vitamin-E along with their regular medicines .


Pain intensity and quality of life ( QoL ) of patients were assessed using Neuropathy Pain Score and RAND 36 questionnaire .


Blood samples were analyzed for the levels of random blood sugar level and HbA ( 1c ) at the baseline and on the 12th week .


Significant ( p < 0.05 ) decrease in the random blood sugar level was observed in intervention group when compared with the usual care group and a significant ( p < 0.01 ) reduction in total pain score , and a significant ( p < 0.05 ) improvement in physical health after 12 week treatment of vitamin-E was observed .


The study concluded that vitamin-E is a natural antioxidant and it is found to be effective in reducing pain score in diabetic neuropathy patients .


The future studies may be directed towards extended duration of action .


Childbirth is an important experience in a woman 's life , and unfavorable birth experiences have been shown to negatively impact postpartum maternal health .


Aim of this study was to evaluate the effects of music therapy on postpartum pain , anxiety level , satisfaction and early pospartum depression rate .


Totally 161 primiparous women were recruited and randomized either music group ( n = 80 ) or a control group ( n = 81 ) .


Women in the music group listened to self-selected music during labor .


Postpartum pain intensity , anxiety level and satisfaction rate were measured using the visual analog scale ( VAS ) , postpartum depression rate was assessed with Edinburg Postpartum Depression Scale ( EPDS ) at postpartum day one and day eight .


Mothers in the music therapy group had a lower level of postpartum pain and anxiety than the control group and it was statistically significant at all time intervals ( 1 , 4 , 8 , 16 and 24h , p < 0.001 ) .


A significant difference was observed between the two groups in terms of satisfaction rate ( p < 0.001 ) and postpartum depression rate at postpartum day one and day eight ( p < 0.05 ) .


We only measured the effect of music therapy on early postpartum depression rate .


Effect of music on late postpartum depression rate should be investigated in future .


Using music therapy during labor decreased postpartum anxiety and pain , increased the satisfaction with childbirth and reduced early postpartum depression rate .


Music therapy can be clinically recommended as an alternative , safe , easy and enjoyable nonpharmacological method for postpartum well-being .


Learners can focus on mastery ( i.e. task orientation ) or on learning relative to others ( i.e. ego orientation ) .


Previous research suggests task orientations are optimal for learning , a benefit usually linked to the suggestion that qualitative comments are better for learning than quantitative comparisons ( i.e. grades ) .


Yet , it is not clear if the observed effects are attributable to the feedback orientation ( i.e. task versus ego ) , feedback format ( i.e. comments versus numerical scores ) , or an interaction between the two .


Here , we aimed to clarify the effects of feedback orientation and feedback format during simulation-based training in endotracheal intubation .


Forty-one medical students were randomly assigned to four feedback conditions : Task-oriented Numerical ; Ego-oriented Numerical ; Task-oriented Comment , and Ego-oriented Comment .


Participants performed a total of 20 trials of endotracheal intubation .


Pre-test , post-test and retention test assessments included the use of hand motion analysis and a global rating scale ( GRS ) .


Participants rated feedback credibility , self-assessment and self-confidence using Likert-type scales .


Analyses of variance were used to examine group differences .


Participants ' performance did not differ significantly on the easiest ( p > 0.2 ) or two complex variations of intubation ( p > 0.3 ) .


For the moderately difficult variation , analyses of hand motion and GRS data revealed significant group differences at post-test ( p < 0.05 ) , but no differences on the retention test .


Analysis of participants ' perceptions showed significant interactions whereby the Ego-oriented Numerical group rated feedback credibility ( p < 0.01 ) higher than the Task-oriented Numerical group ; the two Comment groups did not differ .


Some participants recounted negative experiences with the feedback they received .


Medical students responded to feedback in ways that challenge previous education research .


Specifically , students preferred and improved more in the short term ( but not at retention ) when receiving Ego-oriented feedback in Numerical form .


Although learning retention did not differ significantly across feedback conditions , students ' perceptions of themselves and of the teacher and training environment did differ and the implications for trainees ' future learning must be considered .


To evaluate the in situ caries performance and safety of two experimental fluoride dentifrice formulations ( 1450 ppm fluoride ) with and without 2 % isopentane as an excipient , in comparison to a positive control , currently marketed dentifrice ( 1450 ppm fluoride ) and a negative control dentifrice ( 0 ppm fluoride ) .


This was a single-center , examiner-blind , randomized , controlled , four-treatment cross-over study .


During each treatment period , the subject wore a modified mandibular partial denture fitted with two gauze-covered , partially demineralized human enamel specimens , and brushed at home for one timed minute , twice daily , for two weeks .


At the end of each treatment period , the enamel specimens were removed from the dentures for analysis .


During the week between treatment periods , subjects returned to their usual dental hygiene practices for four to five days , received a dental prophylaxis , and used a study-designated non-fluoride dentifrice for two to three days before starting the next treatment .


Treatment effect on enamel specimen remineralization was assessed by surface microhardness ( SMH ) .


Enamel fluoride uptake was assessed using microdrill enamel biopsy .


All fluoride-containing dentifrices demonstrated significant , superior SMH recovery and levels of fluoride uptake compared to the negative control dentifrice .


No significant differences were observed for either efficacy variable between the experimental dentifrice formulations and the positive control dentifrice .


No significant difference was observed between the 2 % isopentane dentifrice and the 0 % isopentane dentifrice for SMH recovery .


The addition of 2 % isopentane did not positively or negatively affect fluoride efficacy in this model .


PBT2 is a metal protein-attenuating compound that might reduce metal-induced aggregation of mutant huntingtin and has prolonged survival in a mouse model of Huntington 's disease .


We aimed to assess the safety , tolerability , and efficacy of PBT2 in patients with Huntington 's disease .


In this 26-week , randomised , double-blind , placebo-controlled trial , adults ( 25 years old ) with early-stage to mid-stage Huntington 's disease were randomly assigned ( 1:1:1 ) by a centralised interactive response system to once daily PBT2 250 mg , PBT2 100 mg , or placebo .


Randomisation was stratified by site with a block size of three .


Participants , carers , the steering committee , site investigators , study staff , and the study sponsor were masked to treatment assignment .


Primary endpoints were safety and tolerability .


The safety population consisted of all participants who were randomly assigned and had at least one dose of study drug .


The principal secondary endpoint was cognition , measured by the change from baseline to week 26 in the main composite Z score of five cognitive tests ( Category Fluency Test , Trail Making Test Part B , Map Search , Symbol Digit Modalities Test , and Stroop Word Reading Test ) and scores on eight individual cognitive tests ( the five aforementioned plus the Trail Making Test Part A , Montreal Cognitive Assessment , and the Speeded Tapping Test ) .


The intention-to-treat population comprised participants who were randomly assigned and had at least one efficacy assessment after administration of study drug .


This trial is registered with ClinicalTrials.gov , NCT01590888 .


Between April 18 , 2012 , and Dec 14 , 2012 , 109 participants were randomly assigned to PBT2 250 mg ( n = 36 ) , PBT2 100 mg ( n = 38 ) , or placebo ( n = 35 ) at 19 research centres in Australia and the USA .


32 ( 89 % ) individuals on PBT2 250 mg , 38 ( 100 % ) on PBT2 100 mg , and 34 ( 97 % ) on placebo completed the study .


Six serious adverse events ( acute coronary syndrome , major depression , pneumonia , suicide attempt , viral infection , and worsening of Huntington 's disease ) occurred in five participants in the PBT2 250 mg group , three ( fall with subdural haematoma , suicide attempt , and hospital admission for stabilisation of Huntington 's disease ) occurred in two participants in the PBT2 100 mg group , and one ( increasing aggression ) occurred in a participant in the placebo group .


The site investigators deemed all , except the worsening of Huntington 's disease , as unrelated to study drug .


32 ( 89 % ) participants on PBT2 250 mg , 30 ( 79 % ) on PBT2 100 mg , and 28 ( 80 % ) on placebo had at least one adverse event .


Compared with placebo , neither PBT2 100 mg ( least-squares mean 002 , 95 % CI -010 to 014 ; p = 0772 ) nor PBT2 250 mg ( 007 , -005 to 020 ; p = 0240 ) significantly improved the main composite cognition Z score between baseline and 26 weeks .


Compared with placebo , the Trail Making Test Part B score was improved between baseline and 26 weeks in the PBT2 250 mg group ( 1765 s , 065-3465 ; p = 0042 ) but not in the 100 mg group ( 079 s improvement , -1575 to 1732 ; p = 0925 ) ; neither dose significantly improved cognition on the other tests .


PBT2 was generally safe and well tolerated in patients with Huntington 's disease .


The potential benefit on executive function will need to be confirmed in a larger study .


Prana Biotechnology Limited .


A retrospective radiographical study .


To construct a predictive model for pelvic tilt ( PT ) based on the sacrofemoral-pubic ( SFP ) angle in patients with thoracolumbar kyphosis secondary to ankylosing spondylitis ( or AS ) .


PT is a key pelvic parameter in the regulation of spine sagittal alignment that can be used to plan the appropriate osteotomy angle in patients with AS with thoracolumbar kyphosis .


However , it could be difficult to measure PT in patients with femoral heads poorly visualized on lateral radiographs .


Previous studies showed that the SFP angle could be used to evaluate PT in adult patients with scoliosis .


However , this method has not been validated in patients with AS .


A total of 115 patients with AS with thoracolumbar kyphosis were included .


Full-length anteroposterior and lateral spine radiographs were all available , with spinal and pelvic anatomical landmarks clearly identified .


PT , SFP angle , and global kyphosis were measured .


The patients were randomly divided into group A ( n = 65 ) and group B ( n = 50 ) .


In group A , the predictive model for PT was constructed by the results of the linear regression analysis .


In group B , the predictive ability and accuracy of the predictive model were investigated .


In group A , the Pearson correlation analysis revealed a strong correlation between the SFP angle and PT ( r = 0.852 ; P < 0.001 ) .


The predictive model for PT was constructed as PT = 72.3-0 .82 ( SFP angle ) .


In group B , PT was predicted by the model with a mean error of 4.6 ( SD = 4.5 ) with a predictive value of 78 % .


PT can be accurately predicted by the SFP angle using the current model : PT = 72.3-0 .82 ( SFP angle ) , when the femur heads are poorly visualized on lateral radiographs in patients with AS with thoracolumbar kyphosis .


4 .


In type 2 diabetes , acute hyperglycemia worsens endothelial function and inflammation , while resistance to GLP-1 action occurs .


All these phenomena seem to be related to the generation of oxidative stress .


A Mediterranean diet , supplemented with olive oil , increases plasma antioxidant capacity , suggesting that its implementation can have a favorable effect on the aforementioned phenomena .


In the present study , we test the hypothesis that a Mediterranean diet using olive oil can counteract the effects of acute hyperglycemia and can improve the resistance of the endothelium to GLP-1 action .


Two groups of type 2 diabetic patients , each consisting of twelve subjects , participated in a randomized trial for three months , following a Mediterranean diet using olive oil or a control low-fat diet .


Plasma antioxidant capacity , endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels were evaluated at baseline and at the end of the study .


The effect of GLP-1 during a hyperglycemic clamp , was also studied at baseline and at the end of the study .


Compared to the control diet , the Mediterranean diet increased plasma antioxidant capacity and improved basal endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels .


The Mediterranean diet also reduced the negative effects of acute hyperglycemia , induced by a hyperglycemic clamp , on endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels .


Furthermore , the Mediterranean diet improved the protective action of GLP-1 on endothelial function , nitrotyrosine , 8-iso-PGF2a , IL-6 and ICAM-1 levels , also increasing GLP-1-induced insulin secretion .


These data suggest that the Mediterranean diet , using olive oil , prevents the acute hyperglycemia effect on endothelial function , inflammation and oxidative stress , and improves the action of GLP-1 , which may have a favorable effect on the management of type 2 diabetes , particularly for the prevention of cardiovascular disease .


To investigate the effect of a 9-month physical activity intervention on cardiorespiratory fitness and adiposity among prepubertal children .


Prepubertal children ( 8 - to 9-year-olds , N = 220 , 103 girls ) were randomly assigned to a 9-month physical activity intervention or a control group .


The intervention provided 70 minutes ( 5 days/week ) of moderate to vigorous physical activity .


Maximum oxygen consumption ( Vo2max percentile ) and dual-energy radiograph absorptiometry measured cardiorespiratory fitness and adiposity , respectively .


Intention-to-treat analysis was performed to assess baseline and follow-up cardiorespiratory fitness , percentage fat mass ( % FM ) , percentage central fat mass ( % CFM ) , and estimated visceral adipose tissue ( VAT ) area .


The intervention group increased in cardiorespiratory fitness ( 5.4 th percentile ; 95 % confidence interval [ CI ] , 1.8 to 8.9 ) and decreased in % FM ( -0.7 % ; 95 % CI , -1.1 to -0.4 ) and % CFM ( -1.3 % ; 95 % CI , -1.9 to -0.7 ) .


Reductions in % FM were evident for both nonoverweight ( -0.62 % ; 95 % CI , -1.07 to -0.17 ) and overweight or obese ( -0.86 % ; 95 % CI,-1 .46 to -0.25 ) intervention participants .


Conversely , the control group displayed no change in cardiorespiratory fitness while exhibiting increases in % FM ( 0.4 % ; 95 % CI , 0.1 to 0.7 ) , % CFM ( 0.6 ; 95 % CI , 0.1 to 1.1 ) , and VAT area ( 3.0 cm ( 2 ) ; 95 % CI , 1.6 to 4.4 ) .


Nonoverweight control participants increased in % FM ( 0.52 % ; 95 % CI , 0.13 to 0.91 ) , and their overweight and obese counterparts increased in VAT ( 4.76 cm ( 2 ) ; 95 % CI , 1.90 to 7.63 ) .


The physical activity intervention improved cardiorespiratory fitness , reduced % FM , and prevented accumulation of % CFM among prepubertal children with varying adiposity levels .


These findings provide support for daily physical activity recommendations to prevent excess fat mass accumulation in childhood .


Applying a direct renin inhibitor ( DRI ) to advanced stage chronic kidney disease ( CKD ) patients is a matter of controversy .


The purpose of this study was to evaluate the effect of the DRI , aliskiren , in patients with therapy-resistant hypertension undergoing hemodialysis ( HD ) .


The study was a prospective , randomized multicenter trial exploring the antihypertensive effect of aliskiren in comparison with amlodipine , a calcium channel blocker , in patients undergoing HD .


A total of 83 participants whose blood pressure ( BP ) had previously been treated with more than one antihypertensive agent and not having achieved the BP goal of < 140/90 mmHg were randomly assigned to either aliskiren 150 mg or amlodipine 5 mg as an add-on therapy .


A significant decrease in pre-dialysis clinic BP and home BP was found only in the amlodipine group and not in the aliskiren group .


In contrast , there was a significant decrease in atrial natriuretic peptide ( ANP ) in the aliskiren group but not in the amlodipine group .


N-terminal pro-B-type natriuretic hormone remained unchanged in both groups .


Aliskiren significantly reduced angiotensin I and II , plasma renin activity , and increased plasma renin content .


However , such changes were not observed in the amlodipine group .


Amlodipine , not aliskiren , effectively reduces BP in CKD patients with refractory hypertension undergoing HD .


Aliskiren suppresses the renin-angiotensin system and reduces ANP .


Whether the DRI is beneficial in improving cardiovascular events in patients undergoing HD remains to be elucidated in future studies .


We determined the feasibility of a definitive trial comparing the effectiveness of group vs individual urotherapy for children with bladder-bowel dysfunction .


Children 6 to 10 years old with bladder-bowel dysfunction were recruited during the course of 1 year .


Feasibility data on screening , eligibility , recruitment and protocol compliance rates were collected .


Patients with high grade hydronephrosis , vesicoureteral reflux or learning disabilities and those who had previously undergone urotherapy were excluded .


Patients were randomized to 1-hour group urotherapy or 15-minute individual urotherapy .


Symptoms and quality of life were measured using the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire and the Pediatric Incontinence Questionnaire at baseline and at 3 to 6 months of followup .


Within/between group comparisons were conducted using t-tests .


Of 455 screened children 79 were eligible and 60 were recruited to participate .


A total of 24 patients randomized to group urotherapy and 25 randomized to individual urotherapy completed the pilot trial ( 6 undergoing group and 5 undergoing individual urotherapy withdrew from the study ) .


Symptomology scores between group and individual urotherapy were not different at followup ( mean SD 14.7 7.9 vs 13.4 6.3 , p = 0.54 , 95 % CI -5.4 -2.8 ) .


Quality of life scores between patients undergoing group and individual urotherapy at baseline differed ( mean SD 21.1 10.8 vs 31.0 14.3 , p < 0.01 , 95 % CI 2.7-7 .3 ) but became similar at followup ( 21.0 14.2 vs 20.1 15.3 , p = 0.84 , 95 % CI -9.4 -7.6 ) .


Within group analyses demonstrated improvement in symptomology from baseline to followup in patients undergoing group ( mean SD 3.6 7.6 , p = 0.03 , 95 % CI 0.4-6 .8 ) and individual urotherapy ( 6.0 5.4 , p < 0.01 , 95 % CI 3.8-8 .3 ) .


Within group quality of life analyses revealed improvement in Pediatric Incontinence Questionnaire scores from baseline to followup in patients undergoing individual urotherapy ( p < 0.01 , 95 % CI 5.0-16 .9 ) only .


Urotherapy , regardless of modality , effectively improved bladder-bowel dysfunction symptoms .


A definitive randomized controlled trial is feasible , considering that a high recruitment rate ( 76 % ) for this population has been established .


To describe changes in and predictors of comfortable gait speed ( GS-C ) after using a foot-drop stimulator ( FDS ; Bioness L300 ; Bioness Inc , Valencia , CA ) for 42 weeks in persons who had sustained a stroke .


Secondary analysis of prospective assessments .


Multicenter clinical trial .


A total of 99 subjects who had sustained a stroke 3 months earlier and who had GS-C 0.8 m/s and drop foot with a mean age of 60.7 years and a poststroke time of 4.8 years .


GS-C was assessed at baseline and at 30 weeks with and without use of an FDS ( therapeutic effect ) and at 6 , 12 , 30 , 36 , and 42 weeks with use of an FDS ( total effect ) .


After subjects participated in 8 physical therapy sessions , an FDS was used for ambulation over the course of 42 weeks .


Changes in mean GS-C over time , FDS `` responder '' status defined as either 0.1 m/s gain in GS-C ( the minimal clinically important difference [ MCID ] ) or advancing by one Perry Ambulation Category ( PAC ) , and the incidence and nature of adverse events ( AEs ) .


A total of 74 ( 75 % ) and 69 ( 70 % ) of 99 subjects completed assessments at 30 weeks and 42 weeks , respectively .


Baseline GS-C was 0.42 m/s without use of an FDS and 0.49 m/s with use of an FDS .


GS-C improved to 0.54 m/s at 30 weeks without use of an FDS ( effect size = 0.75 ) and 0.54 , 0.55 , 0.58 , 0.60 , and 0.61 m/s at 6 , 12 , 30 , 36 , and 42 weeks with use of an FDS , respectively ( effect size 0.84 at 42 weeks ) .


Half of the subjects achieved a maximum GS-C by 12 weeks .


Approximately 18 % were PAC responders and 29 % were MCID responders for 30-week therapeutic effect , and 55 % were PAC responders and 67 % were MCID responders for 42-week total effect .


After logistic regression , the following factors emerged as the strongest predictors of FDS responders : younger age , faster baseline GS-C and Timed Up and Go , and balance .


At 42 weeks , 60 % reported a device-related AE ; 92 % were mild and 96 % were anticipated .


When an FDS was used , GS-C improved progressively over 42 weeks , with 50 % of patients achieving a clinically meaningful 42-week total effect and 50 % achieving a maximum GS-C by 12 weeks .


Younger patients with greater mobility levels may benefit most from use of an FDS .


AEs were frequent , mild , and reversible .


One of the advantages of Internet-based research is the ability to efficiently recruit large , diverse samples of international participants .


Currently , there is a dearth of information on the behind-the-scenes process to setting up successful online recruitment tools .


The objective of the study was to examine the comparative impact of Spanish - and English-language keywords for a Google AdWords campaign to recruit pregnant women to an Internet intervention and to describe the characteristics of those who enrolled in the trial .


Spanish - and English-language Google AdWords campaigns were created to advertise and recruit pregnant women to a Web-based randomized controlled trial for the prevention of postpartum depression , the Mothers and Babies/Mams y Bebs Internet Project .


Search engine users who clicked on the ads in response to keyword queries ( eg , pregnancy , depression and pregnancy ) were directed to the fully automated study website .


Data on the performance of keywords associated with each Google ad reflect Web user queries from February 2009 to June 2012 .


Demographic information , self-reported depression symptom scores , major depressive episode status , and Internet use data were collected from enrolled participants before randomization in the intervention study .


The Google ads received high exposure ( 12,983,196 impressions ) and interest ( 176,295 clicks ) from a global sample of Web users ; 6745 pregnant women consented to participate and 2575 completed enrollment in the intervention study .


Keywords that were descriptive of pregnancy and distress or pregnancy and health resulted in higher consent and enrollment rates ( i.e. , high-performing ads ) .


In both languages , broad keywords ( eg , pregnancy ) had the highest exposure , more consented participants , and greatest cost per consent ( up to US $ 25.77 per consent ) .


The online ads recruited a predominantly Spanish-speaking sample from Latin America of Mestizo racial identity .


The English-speaking sample was also diverse with most participants residing in regions of Asia and Africa .


Spanish-speaking participants were significantly more likely to be of Latino ethnic background , not married , completed fewer years of formal education , and were more likely to have accessed the Internet for depression information ( P < .001 ) .


The Internet is an effective method for reaching an international sample of pregnant women interested in online interventions to manage changes in their mood during the perinatal period .


To increase efficiency , Internet advertisements need to be monitored and tailored to reflect the target population 's conceptualization of health issues being studied .


ClinicalTrials.gov NCT00816725 ; http://clinicaltrials.gov/show/NCT00816725 ( Archived by WebCite at http://www.webcitation.org/6LumonjZP ) .


Excessive systemic inflammatory response remains as a major problem underlying severe burns .


This study aimed to assess the effect of low-dose glucocorticoid treatment in downregulating systemic inflammation in severely burned patients .


A prospective study from 2001 to 2014 at our hospital was conducted to compare the patients who received low-dose glucocorticoid during the acute phase with those who did not .


Patients with burns 70 % or greater of their total body surface area were included , and their plasma levels of inflammatory cytokines and clinical outcomes were compared .


A total of 69 patients were included in this study , with 31 patients receiving glucocorticoid treatment and the others not .


Patient demographics including age , burn size , and incidence of inhalation injury were similar in both groups .


The incidence of pulmonary infection and stress ulcer ( and/or hemorrhage ) was 24.2 % and 3.0 % in the treatment group , respectively , significantly lower than 47.8 % and 19.6 % of the control group ( P < .05 ) .


Length of hospital stay was almost 13 days shorter in the treatment group ( P < .05 ) , whereas there was no significant difference in the overall mortality , duration of mechanical ventilation , and incidence of sepsis between the 2 groups .


The enzyme-linked immunosorbent assay results confirmed that the plasma levels of C-reactive protein , tumor necrosis factor - , interleukin-6 , and interleukin-8 were significantly lower in the treatment group ( P < .05 ) .


Low dose of glucocorticoid treatment during the acute phase could reduce the levels of proinflammatory cytokines in severely burned patients and subsequently decrease the incidence of pulmonary infection and stress ulcer , as well as the length of hospital stay .


To compare the effectiveness and safety of add on therapy of bromocriptine with metformin in type 2 diabetes mellitus ( DM ) patients .


Adult type 2 DM patients fulfilling the inclusion criteria were randomized in three groups .


Group A received metformin ( 1000 mg / day ) , while group B patients were treated with metformin ( 1000 mg/day ) plus bromocriptine ( 0.8 mg/day ) and group C received metformin ( 1000 mg/day ) plus bromocriptine ( 1.6 mg/day ) for 12 weeks .


Fasting plasma glucose ( FPG ) , postprandial plasma glucose ( PPPG ) , and body weight were measured at week 4 , 8 , and 12 visits and glycosylated hemoglobin ( HbA ( 1C ) ) at week 12 visit .


Metformin alone and in combination with bromocriptine in escalating dose ( 0.8 mg/day and 1.6 mg/day ) significantly ( P < 0.05 ) decreased FPG and PPPG levels at weeks 4 , 8 , and 12 compared with pretreatment values .


HbA ( 1C ) level in all three treatment groups significantly ( P < 0.05 ) decreased at week 12 as compared with pretreatment baseline value .