The Ramsay sedation score was significantly higher , and the bispectral index score was lower in the DR group ( P < 0.001 ) compared with the MR group starting 10 min after drug administration .


The incidence of desaturation ( SpO2 < 90 % ) was significantly greater in the MR group compared with the DR group ( 15 vs. 1 , P < 0.001 ) .


The pain score was significantly lower ( 1.72 1.65 vs. 0.95 1.10 , P = 0.021 ) , and the satisfaction levels of interventionists were significantly higher ( 2.50 0.71 vs. 3.00 0.63 , P = 0.001 ) in the DR group compared with the MR group .


The combination of dexmedetomidine and remifentanil provided deeper sedation , less respiratory depression , better analgesia , and higher satisfaction for the interventionist during catheter ablation of A-fib compared with midazolam plus remifentanil , even at a lower dose of remifentanil .


High frequency oscillatory ventilation ( HFOV ) is theoretically ideal for lung protective strategy ventilation ( LPSV ) in acute respiratory distress syndrome ( ARDS ) .


However , recent studies revealed unsatisfactory outcomes .


The authors conducted a study to examine this phenomenon in patients with early phase of moderate to severe ARDS .


To evaluate the effectiveness of HFOV in patients with early phase of moderate to severe ARDS .


The primary outcome was 30 days all-cause mortality .


The study was a matched-case controlled clinical trial performed in the medical intensive care units , Faculty of Medicine , Siriraj Hospital .


The authors compared HFOV with LPSV in adult patients with the early phase of ARDS who received mechanical ventilation less than 72 hours and had moderate to severe hypoxemia ( PaO/FiO2 ratio less than or equal 150 ) .


Between June 2010 and February 2014 , 49 patients with moderate to severe ARDS were included .


Fourteen patients who received HFOV were matched with 16 patients who received LPSV .


The 30-day mortality in HFOV group was 61.5 % ; while in control group , 50 % ( p = 0.53 ) .


The authors found use of higher doses of sedative drugs and muscle relaxants in HFOV group .


In addition , this group had high-level of mean airway pressure ( mPaw ) .


The presence of hemodynamic instability was not different in both groups .


In adult patients in the early phase of moderate to severe ARDS who received mechanical ventilation for less than 72 hours , HFOV did not decrease the 30-day mortality .


Thus , this support should be only a rescue therapy for refractory hypoxemia cases and in highly selected patients .


Fluoroscopy-guided bronchoscopy is usually performed for the diagnosis of peripheral pulmonary lesions ( PPL ) , but the diagnostic yield varies widely among studies .


Endobronchial ultrasound ( EBUS ) can increase the diagnostic yield of bronchoscopic diagnosis of PPL .


To compare the diagnostic yield of fluoroscopy-guided bronchoscopy and EBUS with fluoroscopy-guided bronchoscopy in the study of PPL .


All patients who underwent bronchoscopy to study PPL from January 2009 to December 2012 were prospectively included .


145 consecutive patients were randomly distributed in two groups : EBUS and fluoroscopy ( 50 patients , 71.3 8.2 years ) or fluoroscopy alone ( 95 patients , 68 10.5 years ) .


The mean diameter of the lesions was 41.97 19.22 mm .


Cytological brushing and transbronchial biopsies were obtained .


All procedures were performed under fluoroscopic guidance with intravenous conscious sedation .


EBUS was performed using an endoscopic ultrasound system equipped with a 20-MHz radial miniprobe introduced via a guide-sheath .


Bronchoscopist , cytologist , study protocol , techniques and tools were the same throughout the whole study .


129 ( 89 % ) patients had malignant disease .


A diagnosis with bronchoscopy was established in 105 ( 72.4 % ) patients .


EBUS plus fluoroscopy obtained a diagnostic yield in 78 % of patients and fluoroscopy alone in 69.5 % ( non-significant ) .


In contrast , for lesions smaller than 30 mm , EBUS plus fluoroscopy guidance provided significantly greater diagnostic performance than fluoroscopy alone ( 90 vs. 52 % ; P = .05 ) .


Bronchoscopy under EBUS plus fluoroscopy guidance is a technique that has become useful for the diagnostic of LPPs , especially those smaller than 30 mm in diameter .


The clinical benefit of inhaled antibiotics in non-cystic fibrosis bronchiectasis has not been established in randomised controlled trials .


We aimed to assess safety and efficacy of aztreonam for inhalation solution ( AZLI ) in patients with non-cystic fibrosis bronchiectasis and Gram-negative bacterial colonisation .


AIR-BX1 and AIR-BX2 were two double-blind , multicentre , randomised , placebo-controlled phase 3 trials , which included patients aged 18 years or older who had bronchiectasis and history of positive sputum or bronchoscopic culture for target Gram-negative organisms .


Patients were randomly assigned to receive either AZLI or placebo ( 1:1 ) .


Randomisation was done without stratification and the code was generated by a Gilead designee .


In both studies , two 4-week courses of AZLI 75 mg or placebo ( three-times daily ; eFlow nebulizer ) were each followed by a 4-week off-treatment period .


Primary endpoint was change from baseline Quality of Life-Bronchiectasis Respiratory Symptoms scores ( QOL-B-RSS ) at 4 weeks .


These trials are registered with ClinicalTrials.gov , numbers are NCT01313624 for AIR-BX1 and NCT01314716 for AIR-BX2 .


We recruited participants from 47 ambulatory clinics for AIR-BX1 and 65 ambulatory clinics for AIR-BX2 ; studies were done between April 25 , 2011 , and July 1 , 2013 .


In AIR-BX1 , of the 348 patients screened , 134 were randomly assigned to receive AZLI and 132 to receive placebo .


In AIR-BX2 , of the 404 patients screened , 136 were randomly assigned to receive AZLI and 138 to receive placebo .


The difference between AZLI and placebo for adjusted mean change from baseline QOL-B-RSS was not significant at 4 weeks ( 0.8 [ 95 % CI -3.1 to 4.7 ] , p = 0.68 ) in AIR-BX1 , but was significant ( 4.6 [ 1.1 to 8.2 ] , p = 0.011 ) in AIR-BX2 .


The 4.6 point difference in QOL-B-RSS after 4 weeks in AIR-BX2 was not deemed clinically significant .


In both studies , treatment-related adverse events were more common in the AZLI group than in the placebo group , as were discontinuations from adverse events .


The most commonly reported treatment-emergent adverse events were dyspnea , cough , and increased sputum .


Each was more common for AZLI-treated than for placebo-treated patients , but the incidences were more balanced in AIR-BX2 .


AZLI treatment did not provide significant clinical benefit in non-cystic fibrosis bronchiectasis , as measured by QOL-B-RSS , suggesting a continued need for placebo-controlled studies to establish the clinical benefit of inhaled antibiotics in patients with this disorder .


Gilead Sciences .


To evaluate a novel aqueous oxygen peroxide ( AOP ) wound therapy ( BioxyQuell ) in a multi-centre , primary care-based , randomised , double-blind , placebo-controlled , parallel-group trial , monitoring long-term healing outcomes over 12 months .


Sixty-one patients with chronic , stable venous leg ulceration were treated with either AOP solution or sterile water placebo applied as a lavage over 2 weeks .


The patients ' wounds were dressed weekly and assessed fortnightly over the following 6 weeks .


Patients who completed the initial 8-week trial were invited into a 10-month follow-up trial .


The primary endpoints of the study were wound healing at 8 weeks , 12 weeks , 6 months and 12 months , and wound size reduction during the treatment phase .


Secondary endpoints were reductions in wound bioburden and pain .


Patients treated with AOP were more likely to heal at 6 months ( p = 0.014 ) and 12 months ( p = 0.006 ) , but not at 8 weeks ( p = 0.979 ) or 12 weeks ( p = 0.263 ) .


Patients treated with AOP had greater wound area reduction ( p = 0.015 ) , reductions in pain measured on a 100-point scale ( p = 0.001 ) and wound bioburden reduction ( p = 0.005 ) during the treatment phase .


The addition of AOP treatment provides substantial benefits to patients with chronic venous leg ulceration compared with current best practice .


This study investigated interleukin-10 and nitric oxide plasma levels following surgery to determine whether there is a correlation between these two variables and if different desflurane anesthesia flow rates influence nitric oxide and interleukin-10 concentrations in circulation .


Forty patients between 18 and 70 years and ASA I-II physical status who were scheduled to undergo thyroidectomy were enrolled in the study .


Patients were allocated into two groups to receive two different desflurane anesthesia flow rates : high flow ( Group HF ) and low flow ( Group LF ) .


Blood samples were drawn at the beginning ( t0 ) and end ( t1 ) of the operation and after 24h ( t2 ) .


Plasma interleukin-10 and nitric oxide levels were measured using an enzyme-linked-immunosorbent assay and a Griess reagents kit , respectively .


Hemodynamic and respiratory parameters were assessed .


There was no statistically significant difference between the two groups with regard to interleukin-10 levels at the times of measurement .


Interleukin-10 levels were increased equally in both groups at times t1 and t2 compared with preoperative concentrations .


For both groups , nitric oxide circulating concentrations were significantly reduced at times t1 and t2 compared with preoperative concentrations .


However , the nitric oxide value was lower for Group HF compared to Group LF at t2 .


No correlation was found between the IL-10 and nitric oxide levels .


Clinical usage of two different flow anesthesia forms with desflurane may increase interleukin-10 levels both in Group HF and Group LF ; nitric oxide levels circulating concentrations were significantly reduced at times t1 and t2 compared with preoperative concentrations ; however , at 24h postoperatively they were higher in Group LF compared to Group HF .


No correlation was detected between interleukin-10 and nitric oxide levels .


It is unclear whether achieving multiple risk factor ( RF ) goals through protocol-guided intensive medical therapy is feasible or improves outcomes in type 2 diabetes mellitus .


This study sought to quantify the relationship between achieved RF goals in the BARI 2D ( Bypass Angioplasty Investigation Revascularization 2 Diabetes ) trial and cardiovascular events/survival .


We performed a nonrandomized analysis of survival/cardiovascular events and control of 6 RFs ( no smoking , non-high-density lipoprotein cholesterol < 130 mg/dl , triglycerides < 150 mg/dl , blood pressure [ systolic < 130 mmHg ; diastolic < 80 mmHg ] , glycosylated hemoglobin < 7 % ) in BARI 2D .


Cox models with time-varying number of RFs in control were adjusted for baseline number of RFs in control , clinical characteristics , and trial randomization assignments .


In 2,265 patients ( mean age 62 years , 29 % women ) followed up for 5 years , the mean SD number of RFs in control improved from 3.5 1.4 at baseline to 4.2 1.3 at 5 years ( p < 0.0001 ) .


The number of RFs in control during the trial was strongly related to death ( global p = 0.0010 ) and the composite of death , myocardial infarction , and stroke ( global p = 0.0035 ) in fully adjusted models .


Participants with 0 to 2 RFs in control during follow-up had a 2-fold higher risk of death ( hazard ratio : 2.0 ; 95 % confidence interval : 1.3 to 3.3 ; p = 0.0031 ) and a 1.7-fold higher risk of the composite endpoint ( hazard ratio : 1.7 ; 95 % confidence interval : 1.2 to 2.5 ; p = 0.0043 ) , compared with those with 6 RFs in control .


Simultaneous control of multiple RFs through protocol-guided intensive medical therapy is feasible and relates to cardiovascular morbidity and mortality in patients with coronary disease and type 2 diabetes mellitus .


( Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [ BARI 2D ] ; NCT00006305 ) .


The objective of this prospective multicenter cohort study was to characterise the use of pharmacological and non-pharmacological treatment for cardiovascular disease ( CVD ) risk factors and intermittent claudication ( IC ) symptoms in clinical practice patients with peripheral artery disease ( PAD ) , and to determine the care gap with international guidelines and evidence-based therapy .


From 2011 through 2013 , participating centres enrolled consecutive patients with PAD of atherosclerotic , origin demonstrated by ultrasound , ankle brachial index ( ABI ) < 0.9 and symptoms of IC .


A seven item grid was built for the assessment of care gap ( percentage of patients eligible for a treatment who did not receive it ) .


cerebrovascular disease or at least two CVD risk factors .


Care gap was lower than 25 % for any method to stop smoking , lipid lowering agents , antiplatelet and/or anticoagulation therapy and any kind of exercise program ; between 25 % and 50 % for ACE inhibitors / angiotensin II antagonist therapy ; between 50 % and 75 % for beta-blocker therapy ; and higher than 75 % for supervised exercise program and use of cilostazol .


Patients with and without CADI cerebrovascular disease were differently treated with clopidogrel ( 27.3 % and 4.8 % , p < 0.001 ) , any antiplatelet/anticoagulant therapy ( 98.7 % and 83.3 % , p < 0.001 ) and beta-blockers ( 46.8 % and 16.0 % , p < 0.001 ) .


All patients ( 232 ) presented at least one CVC risk factor , 90.2 % at least two , and 91.5 % had either established CAD or


Many gaps with evidence-based recommendations are still present in the pattern of the use of pharmacological and non-pharmacological treatment for CVD risk factors and IC symptoms in clinical practice PAD patients .


This study applied a pharmacodynamic model-based approach to evaluate the long-term durability and glycemic control of pioglitazone in comparison with other oral glucose-lowering drugs in Japanese type 2 diabetes mellitus ( T2DM ) patients .


Japanese T2DM patients were enrolled in a prospective , randomized , open-label , blinded-end point study and received pioglitazone with or without other oral glucose-lowering drugs ( excluding another thiazolidinedione [ TZD ] ) ( n = 293 ) or oral glucose-lowering drugs excluding TZD ( n = 294 ) .


Treatment was adjusted to achieve glycosylated hemoglobin ( HbA1c ) < 6.9 % , and samples for fasting plasma glucose ( FPG ) and HbA1c were collected over 2.5-4 years .


A simultaneous cascading indirect response model structure was applied to describe the time course of FPG and HbA1c .


HbA1c levels were described using both an FPG-dependent and an FPG-independent function .


To account for titration , drug effects for both treatment groups were implemented using a time-dependent Emax model .


Pioglitazone was superior in both time to maximum effect and the magnitude of reduction achieved in FPG and HbA1c .


A greater reduction in median FPG ( -21 mg/dL vs. -9 mg/dL ) was observed with pioglitazone ( P < 0.05 ) .


Maximum drug effect for FPG was predicted to occur earlier ( 11 months ) for pioglitazone than for the control group ( 14 months ) .


The simulated additional reduction in FPG and HbA1c achieved with pioglitazone was predicted to be maintained beyond the currently observed study duration .


Pioglitazone was found to result in improved glycemic control and durability compared with control treatment .


This model-based approach enabled the quantification of differences in FPG and HbA1c for both treatment groups and simulation to evaluate longer-term durability on FPG and HbA1c .


The integrated treatment of first episode psychosis has been shown to improve functionality and negative symptoms in previous studies .


In this paper , we describe a study of integrated treatment ( individual psychoeducation complementary to pharmacotherapy ) versus treatment as usual , comparing results at baseline with those at 6-month re-assessment ( at the end of the study ) for these patients , and online training of professionals to provide this complementary treatment , with the following objectives : 1 ) to compare the efficacy of individual psychoeducation as add-on treatment versus treatment as usual in improving psychotic and mood symptoms ; 2 ) to compare adherence to medication , functioning , insight , social response , quality of life , and brain-derived neurotrophic factor , between both groups ; and 3 ) to analyse the efficacy of online training of psychotherapists .


This is a single-blind randomised clinical trial including patients with first episode psychosis from hospitals across Spain , randomly assigned to either a control group with pharmacotherapy and regular sessions with their psychiatrist ( treatment as usual ) or an intervention group with integrated care including treatment as usual plus a psychoeducational intervention ( 14 sessions ) .


Training for professionals involved at each participating centre was provided by the coordinating centre ( University Hospital of lava ) through video conferences .


Patients are evaluated with an extensive battery of tests assessing clinical and sociodemographic characteristics ( Positive and Negative Syndrome Scale , State-Trait Anxiety Inventory , Liebowitz Social Anxiety Scale , Hamilton Rating Scale for Depression , Scale to Assess Unawareness of Mental Disorders , Strauss and Carpenter Prognostic Scale , Global Assessment of Functioning Scale , Morisky Green Adherence Scale , Functioning Assessment Short Test , World Health Organization Quality of Life instrument WHOQOL-BREF ( an abbreviated version of the WHOQOL-100 ) , and EuroQoL questionnaire ) , and brain-derived neurotrophic factor levels are measured in peripheral blood at baseline and at 6 months .


The statistical analysis , including bivariate analysis , linear and logistic regression models , will be performed using SPSS .


This is an innovative study that includes the assessment of an integrated intervention for patients with first episode psychosis provided by professionals who are trained online , potentially making it possible to offer the intervention to more patients .


NCT01783457 clinical trials.gov .


Date of registration in primary registry 23 January 2013 .


Heavy episodic drinking ( HED ) is a serious problem among college women at high-risk for developing eating disorders ( EDs ) .


The main objectives of this study are to determine the relationship of the self-rating of the effects of alcohol ( SRE ) questionnaire and HED over time , and to determine the effects of relationship breakups on HED among college-aged women at high-risk for EDs .


Data collected from 163 participants in a randomized controlled trial evaluating the effectiveness of an ED prevention program were used in the analyses .


Measures included the SRE , obtained at baseline , and self-reports of the number of HED episodes and relationship breakups each month for the past 12 months .


Generalized linear mixed-effect regression models with Poisson distribution were conducted to test the effects of several variables on reported HED episodes over 12 months .


Analyses demonstrated that SRE scores and the presence of a breakup predicted increased HED over time .


The SRE may be useful in identifying individuals at risk of or with EDs who are at increased risk of HED .


Furthermore , relationship breakups predict HED .


Findings from the current study could be used to inform clinical interventions for this population .


The aim of this study was to compare the Ilizarov circular fixator ( IL ) and locked intramedullary nailing ( IM ) .


Patients with isolated tibia shaft fractures were randomly allocated to either the IL ( n = 31 ) or IM ( n = 27 ) method .


Conventional radiographs , postoperative pain assessment , self-appraisal scores and complications were evaluated .


At the clinical 1-year follow-up , the patients were also evaluated by an independent observer .


The minority of patients had open fractures , two and nine patients in the IM and IL groups , respectively .


Eight patients in the IM group and four in the IL group sustained major complications ( p = 0.107 ) .


In the IM group , two patients developed compartment syndrome , one deep infection , one hardware failure , one delayed union , one pseudarthrosis and two had a malunion .


In the IL group , two patients developed pseudarthrosis and two had a malunion .


Superficial pin-site infections were observed in 16 patients in the IL group .


The fractures had healed radiographically at 12 weeks in both groups .


At the 1-year follow-up , there were differences in pain ( VAS ) and satisfaction ( VAS ) scores in favor of IL treatment ( VAS , p = 0.03 and p = 0.02 , respectively ) .


There were no differences between the groups with regard to range of motion ( ROM ) in the knee and ankle joints .


The registration of local tenderness and pain revealed that there were 19 patients with anterior knee pain in the IM group and one in the IL group at the 1-year follow-up ( p < 0.001 ) .


The IL is a safe and reliable alternative to IM for the treatment of tibial shaft fractures , with a low complication rate and good clinical outcome .


Both treatments were well tolerated , but at the 1-year follow-up the patients in the IM group had more pain and were less satisfied .


Finally , there was a high frequency of anterior knee pain in the IM group .


The objective of this study was to evaluate whether increased serum 25-hydroxyvitamin D3 ( 25OHD3 ) concentrations , in response to calcium/vitamin D ( CaD ) supplementation , are associated with improved lipids in postmenopausal women .


The parent trial was a double-blind , randomized , placebo-controlled , parallel-group trial designed to test the effects of CaD supplementation ( 1,000 mg of elemental calcium + 400 IU of vitamin D3 daily ) versus placebo in postmenopausal women .


Women from the general community , including multiple sites in the United States , were enrolled between 1993 and 1998 .


This cohort included 300 white , 200 African-American , and 100 Hispanic participants who were randomly selected from the Women 's Health Initiative CaD trial .


Serum 25OHD3 and lipid ( fasting plasma triglycerides [ TG ] , high-density lipoprotein cholesterol [ HDL-C ] , and calculated low-density lipoprotein cholesterol [ LDL-C ] ) levels were assessed before and after CaD randomization .


There was a 38 % increase in mean serum 25OHD3 concentrations after 2 years ( 95 % CI , 1.29-1 .47 , P < 0.001 ) for women randomized to CaD ( 24.3 ng/mL postrandomization mean ) compared with placebo ( 18.2 ng/mL ) .


Women randomized to CaD had a 4.46-mg / dL mean decrease in LDL-C ( P = 0.03 ) .


Higher concentrations of 25OHD3 were associated with higher HDL-C levels ( P = 0.003 ) , along with lower LDL-C and TG levels ( P = 0.02 and P < 0.001 , respectively ) .


Supplemental CaD significantly increases 25OHD3 concentrations and decreases LDL-C .


Women with higher 25OHD3 concentrations have more favorable lipid profiles , including increased HDL-C , lower LDL-C , and lower TG .


These results support the hypothesis that higher concentrations of 25OHD3 , in response to CaD supplementation , are associated with improved LDL-C .


To compare the effectiveness of expectant management versus methotrexate in selected cases of tubal ectopic pregnancy .


A double-blind randomized trial included 23 selected patients with a confirmed diagnosis of tubal pregnancy who met the inclusion criteria ( hemodynamic stability , initial serum - hCG concentration < 2,000 mIU/mL , declining titers of - hCG 48 h prior to treatment , visible tubal pregnancy on transvaginal ultrasound , a tubal mass < 5.0 cm and fertility desire ) .


The patients were divided into two groups : 10 patients in the methotrexate group ( MTX 50 mg/m ( 2 ) administered as a single intramuscular dose ) and 13 patients in the placebo group ( saline solution administered in a single intramuscular dose ) .


Quantitative variables were expressed as means standard deviations and compared by Student 's t test or Mann-Whitney test .


Dichotomous variables ( success/treatment failure ) were presented as proportions and compared by the Fisher exact test .


Successful treatment with negative titers of - hCG occurred in 9 cases ( 90.0 % ) of the methotrexate group and in 12 ( 92.3 % ) of the placebo group ( p > 0.999 ) .


The - hCG values became undetectable at 22 15.4 days in the methotrexate group and 20.6 8.4 days in the placebo group ( p = 0.80 ) .


This study showed no statistically significant difference between the treatment with methotrexate and placebo , with similar success rates and similar time interval for - hCG to become undetectable .


To compare intermittent treatment ( IT ) versus continuous treatment ( CT ) using cyproterone acetate ( CPA ) in bone metastatic prostate cancer patients , we conducted an open-label , multicenter randomized trial .


Continuous androgen deprivation therapy is the standard treatment in metastatic prostate cancer .


Intermittent treatment might maintain efficacy while toxicity and costs are reduced .


Patients received CPA 100 mg tid in the prephase .


Patients with a PSA decline of 90 % or PSA < 4 ng/ml were randomized .


If patients were progressive , LHRH analogues were added .


Primary end point was time to PSA progression .


A total of 366 patients were recruited ; 258 reached a good response after 3 or 6 months and were randomized .


A total of 131 patients randomized to IT and 127 to CT. .


Patients on IT had an average of 1.7 episodes on CPA , before LHRH analogues were started .


The mean time without treatment in IT was 463 days versus 422 days on treatment .


There were statistical significant differences between IT and CT in 3 of the 5 functional scales of EORTC QLQ C 30 ; however , the clinical relevance of this finding appears modest .


Symptom and potency scales showed significant advantages for IT .


There were no differences in time to PSA progression on CPA , time to PSA and/or clinical progression on LHRH analogues and time to cancer-specific and overall survival .


IT by CPA is associated with less symptoms and modest advantages in QOL domains .


There were no differences in time to PSA progression , clinical progression or survival .


Nausea and vomiting are frequently seen in patients undergoing cesarean section ( CS ) under regional anesthesia .


We aimed to compare the antiemetic efficacy of ondansetron and dexamethasone combination with that of the use of each agent alone to decrease the incidence of post-delivery intraoperative nausea and vomiting ( IONV ) during CS under spinal anesthesia .


To compare the antiemetic efficacy of ondansetron and dexamethasone combination with that of the single use of each agent to decrease the incidence of postdelivery IONV during CS under spinal anesthesia .


A randomized , prospective , double blind study was performed on 90 patients undergoing planned CS under spinal anesthesia .


Patients received 4mg ondansetron in Group O , 8mg dexamethasone in GroupD , 4mg ondansetron +8 mg dexamethasone in Group OD intravenously within 1-2 minutes after the umbilical cord was clamped .


Frequency of postdelivery IONV episodes was recorded .


A total of 86 eligible patients were included in the study .


There were 29 patients in Group O , 29 patients in Group D and 28 patients in Group OD .


There were no statistically significant difference between the groups in terms of baseline characteristics and intraoperative managements .


Frequency of intraoperative nausea , retching and vomiting experiences were similar between the groups ( p > 0.05 ) .


Single dose 4mg ondansetron , 8mg dexamethasone , or combined use of 8mg dexamethasone +4 mg ondansetron , given intravenously is all effective agents for the control of postdelivery IONV .


Combined use of dexamethasone and ondansetron for the same indication does not seem to increase the antiemetic efficacy .


We hypothesized increasing obstructive sleep apnea ( OSA ) severity would be associated with nondipping blood pressure ( BP ) in increased cardiovascular disease ( CVD ) risk .


Baseline data from 298 cardiology patients recruited for a multicenter randomized controlled trial were examined .


Dipping was defined as a sleep-related BP or heart rate ( HR ) reduction of at least 10 % .


Logistic regression models were fit , adjusting for age , sex , race , BMI , CVD risk factors , CVD , and study site .


There was a statistically significant 4 % increase in the odds of nondipping SBP per 1-unit increase in both apnea hypopnea index ( AHI ) and oxygen desaturation index ( ODI ) .


There was no significant relationship between AHI and nondipping mean arterial pressure ( MAP ) ; however , a 3 % increase in the odds of nondipping MAP per 1-unit increase in ODI was observed [ odds ratio ( OR ) = 1.03 ; 95 % confidence interval ( CI ) 1.00-1 .05 ] .


At severe OSA levels , a 10 and 4 % increase in odds of nondipping DBP per 1-unit increase in AHI and ODI were observed , respectively .


A 6 % [ OR = 1.06 ; 95 % CI ( 1.01-1 .10 ) ] increase in nondipping HR odds was observed with each increase in ODI until the upper quartile of ODI .


In patients at cardiovascular risk and moderate-to-severe OSA , increasing AHI and/or ODI were associated with increased odds of nondipping SBP and nondipping MAP .


More severe levels of AHI and ODI also were associated with nondipping DBP .


These results support progressive BP burden associated with increased OSA severity even in patients managed by cardiology specialty care .


In patients with retinitis pigmentosa ( RP ) , the inner segment ellipsoid zone ( EZ ; also known as the inner segment/outer segment [ IS/OS ] border ) is a marker of the usable visual field at a given point in time and of the progression of the disease over time .


Here we compare the change in the width per year of the EZ band in patients with autosomal dominant ( ad ) and x-linked ( xl ) RP .


Using optical coherence tomography ( OCT ) , 9-mm horizontal and vertical line scans through the fovea were obtained for one eye of 26 xlRP patients and 33 adRP patients .


Scans were repeated on average 2.0 years later ( range , 0.6-4 .8 years ) .


Using a manual segmentation procedure , the EZ band was delineated and its horizontal width ( HW ) and vertical width ( VW ) were determined .


The adRP and xlRP patients had similar initial EZ HW ( xlRP : 11.8 5.4 , adRP : 12.4 6.3 , P = 0.69 ) and VW ( xlRP : 8.5 4.9 , adRP : 11.4 7.1 , P = 0.09 ) .


However , between visits the absolute loss and percent loss of the EZ width per year was significantly greater for xlRP than adRP for both HW ( xlRP : 1.0 0.6 / y , 9.6 5.6 % / y ; adRP : 0.4 0.5 / y , 3.4 5.4 % / y ; P < 0.001 ) and VW ( xlRP : 0.8 0.8 / y , 9.2 8.9 % / y ; adRP : 0.3 0.5 / y , 4.2 6.4 % / y ; P < 0.01 ) .


There was a weak correlation between the loss of EZ width per year and the initial width for xlRP ( r ( 2 ) = 0.17 , P = 0.036 ) , but no correlation for adRP ( r ( 2 ) = 0.004 , P = 0.73 ) .


The test-retest difference of EZ HW was 0.2 0.5 .


The OCT data here support a faster rate of loss per year in the case of xlRP .


( ClinicalTrials.gov number , NCT00100230 . )


The purpose of this study was to compare manipulative therapy ( MT ) plus rehabilitation to rehabilitation alone for recurrent ankle sprain with functional instability ( RASFI ) to determine short-term outcomes .


This was an assessor-blind , parallel-group randomized comparative trial .


Thirty-three eligible participants with RASFI were randomly allocated to receive rehabilitation alone or chiropractic MT plus rehabilitation .


All participants undertook a daily rehabilitation program over the course of the 4-week treatment period .


The participants receiving MT had 6 treatments over the same treatment period .


The primary outcome measures were the Foot and Ankle Disability Index and the visual analogue pain scale , with the secondary outcome measure being joint motion palpation .


Data were collected at baseline and during week 5 .


Missing scores were replaced using a multiple imputation method .


Statistical analysis of the data composed of repeated-measures analysis of variance .


Between-group analysis demonstrated a difference in scores at the final consultation for the visual analogue scale and frequency of joint motion restrictions ( P .006 ) but not for the Foot and Ankle Disability Index ( P = .26 ) .


This study showed that the patients with RASFI who received chiropractic MT plus rehabilitation showed significant short-term reduction in pain and the number of joint restrictions in the short-term but not disability when compared with rehabilitation alone .


No validated patient-reported outcome ( PRO ) measure exists for functional dyspepsia ( FD ) assessment .


Verbal descriptions of different upper abdominal symptoms may be poorly distinguishable to patients .


To investigate whether understanding of FD symptoms is enhanced by pictograms symbolising the nature of the symptoms , besides verbal descriptors .


Consecutive FD patients were randomised to fill out a questionnaire assessing nineupper gastrointestinal symptoms ( post-prandial fullness , early satiation , epigastric pain , epigastric burning , bloating centred in the upper abdomen , nausea , vomiting , heartburn , regurgitation ) with or without accompanying pictograms .


Symptoms were rated for frequency and severity ( 0-5 ) , and patients also identified the most bothersome symptom .


Subsequently , in-depth history was taken by an expert clinician , who filled out the same symptom ratings .


Concordance between patient and clinician ratings was quantified using chi-square and kappa statistics .


Content validity of pictograms was first confirmed by 15 FD patients .


Next , 76 patients ( 52 women , age 42.21.9 ) were randomised to questionnaires with or without pictograms .


The concordance with clinician 's assessment as gold standard rose from 36 without to 48 % for questions with pictograms ( P < 0.0001 ) .


Considering the Rome III subdivision , benefit in concordance with pictograms was present for post-prandial distress , epigastric pain syndrome and reflux symptoms .


Kappa statistics confirmed these gains ( weighted kappa values for concordance of symptom frequency ratings rose from 0.214 to 0.446 with pictograms ) , and also showed better concordance of the most bothersome symptom with pictograms .


Pictograms accompanying verbal descriptors significantly improve concordance of functional dyspepsia symptom ratings by patients with evaluation by their physicians .


Non-cellulose dried matrix spotting ( DMS ) cards are an alternative to filter paper ( FP ) for bloodspots .


We compared the interpatient distributions of bloodspot areas between DMS and FP for a fixed volume of application of whole blood , and examined correlations of areas with hematocrit .


EDTA-whole blood adult patient samples ( n = 49 ; 25 males , 24 females ) were utilized after routine measurement of hemoglobin and hematocrit .


Replicate ( 4 ) bloodspots were produced by bolus drop application of 50L whole blood via a fixed-volume pipettor to either FP or DMS .


Dried bloodspot areas were determined by image analysis .


Hematocrits ( HCT ) were normally distributed ( HCT = 30.95.3 % ) .


For both FP and DMS , bloodspot areas ( a , cm ( 2 ) ) across patients were normally distributed : for FP , a = 1.110.056 cm ( 2 ) ( 5.0 % ) ; for DMS , a = 0.3780.037 cm ( 2 ) ( 9.9 % ) .


Relative bloodspot area differences across the population range were > 20 % for both DMS and FP .


Correlation of bloodspot areas to hematocrit was negative for FP ( r = -0.80 ) but positive for DMS ( r = +0.78 ) .


Interpatient variation in blood volume per area is a preanalytical variable for both DMS and FP bloodspots .


Hematocrit is but one interpatient variable , as correlations of fixed-volume bloodspot areas with hematocrit across patients were substantially inexact ( r ( 2 ) < 0.65 ) .


We explored the theorized upregulation of platelet-activating factor ( PAF ) - mediated biologic responses following lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) inhibition using human platelet aggregation studies in an in vitro experiment and in 2 clinical trials .


Full platelet aggregation concentration response curves were generated in vitro to several platelet agonists in human plasma samples pretreated with rilapladib ( selective Lp-PLA2 inhibitor ) or vehicle .


This was followed by a randomized , double-blind crossover study in healthy adult men ( n = 26 ) employing a single-agonist dose assay of platelet aggregation , after treatment of subjects with 250 mg oral rilapladib or placebo once daily for 14 days .


This study was followed by a second randomized , double-blind parallel-group trial in healthy adult men ( n = 58 ) also treated with 250 mg oral rilapladib or placebo once daily for 14 days using a full range of 10 collagen concentrations ( 0-10 g/ml ) for characterizing EC50 values for platelet aggregation for each subject .


Both clinical studies were conducted at the GlaxoSmithKline Medicines Research Unit in the Prince of Wales Hospital , Sydney , Australia .


EC50 values derived from multiple agonist concentrations were compared and no pro-aggregant signals were observed during exposure to rilapladib in any of these platelet studies , despite Lp-PLA2 inhibition exceeding 90 % .


An increase in collagen-mediated aggregation was observed 3 weeks post drug termination in the crossover study ( 15.4 % vs baseline ; 95 % confidence interval [ CI ] , 3.9-27 .0 ) , which was not observed during the treatment phase and was not observed in the parallel-group study employing a more robust EC50 examination .


Lp-PLA2 inhibition does not enhance platelet aggregation .


1 ) Study 1 : ClinicalTrials.gov NCT01745458 2 ) Study 2 : ClinicalTrials.gov NCT00387257 .


To evaluate the benefits of home-based pulmonary rehabilitation ( PR ) in patients with severe and very severe chronic obstructive pulmonary disease ( COPD ) .


Randomized clinical trial involving 58 patients .


Pulmonary function , quality of life evaluated by the Saint George Respiratory Questionnaire , breathlessness evaluated by the London Chest Activity of Daily Living Scale , and exercise tolerance evaluated by 6-minute walk distance were assessed at baseline and at 12 weeks .


The program consisted of 2 weekly visits by a physiotherapist in the first 2 weeks , followed by visits twice a month , as well as weekly telephone calls .


Training included breathing and stretching exercises and strength exercises ( upper and lower limbs ) , along with endurance training , including walking , stair climbing , cycling , and treadmill walking , depending on available patient resources .


The treatment group ( TG ; n = 23 ) and control group ( CG ; n = 18 ) completed the study .


Following the intervention , no statistically significant differences were found in pulmonary function in the TG and CG .


The TG exhibited statistically significant differences in the activity domain ( P = .008 ) , impact domain ( P < .001 ) , and total scores of the Saint George Respiratory Questionnaire ( P < .001 ) .


In addition , the TG demonstrated statistically significant differences in all domains of the London Chest Activity of Daily Living Scale and no differences were observed in the CG after 12 weeks .


There was a statistically significant difference in the 6-Minute Walk Distance in the TG after rehabilitation ( P = .008 ) .


This study offers evidence that home-based PR promotes benefits in the quality of life , breathlessness in activities of daily living , and exercise capacity in patients with severe and very severe COPD .


Home-based PR must be considered as part of the treatment for patients who live far from hospitals even in severe COPD .


Two of the more common methods of pain management after TKA are peripheral nerve blocks and intraarticular/periarticular injections .


However , we are not aware of any study directly comparing the commonly used combination of a continuous femoral block given with a single-shot sciatic block with that of a periarticular injection after TKA .


This randomized clinical trial compared a combined femoral and sciatic nerve block with periarticular injection as part of a multimodal pain protocol after total knee arthroplasty with respect to ( 1 ) pain ; ( 2 ) narcotic use ; ( 3 ) quadriceps function and length of stay ; and ( 4 ) peripheral nerve complications .


One hundred sixty patients completed randomization into two treatment arms : ( 1 ) peripheral nerve blocks ( PNB ; n = 79 ) with an indwelling femoral nerve catheter and a single shot sciatic block ; or ( 2 ) periarticular injection ( PAI ; n = 81 ) using ropivacaine , epinephrine , ketorolac , and morphine .


All patients received standardized general anesthesia and oral medications .


The primary outcome was postoperative pain , on a 0 to 10 scale , measured on the afternoon of postoperative day 1 ( POD 1 ) .


Secondary outcomes were narcotic use , quadriceps function , length of stay , and peripheral nerve complications .


Mean pain scores on the afternoon of POD 1 were not different between groups ( PNB group : 2.9 [ SD 2.4 ] ; PAI group : 3.0 [ SD 2.2 ] ; 95 % confidence interval , -0.8 to 0.6 ; p = 0.76 ) .


Mean pain scores taken at three times points on POD 1 were also similar between groups .


Hospital length of stay was shorter for the PAI group ( 2.44 days [ SD 0.65 ] versus 2.84 days [ SD 1.34 ] for the PNB group ; p = 0.02 ) .


Narcotic consumption was higher the day of surgery for the PAI group ( PAI group : 11.7 mg morphine equivalents [ SD 13.1 ] ; PNB group : 4.6 mg [ SD 9.1 ] ; p < 0.001 ) , but thereafter , there was no difference .


More patients in the PNB group had sequelae of peripheral nerve injury ( mainly dysesthesia ) at 6-week followup ( nine [ 12 % ] versus one [ 1 % ] ; p = 0.009 ) .


Patients receiving periarticular injections had similar pain scores , shorter lengths of stay , less likelihood of peripheral nerve dysesthesia , but greater narcotic use on the day of surgery compared with patients receiving peripheral nerve blocks .


Periarticular injections provide adequate pain relief , are simple to use , and avoid the potential complications associated with nerve blocks .


Level I , therapeutic study .


See Guidelines for Authors for a complete description of levels of evidence .


Acute otorrhea is a common problem in children with tympanostomy tubes .


We recently demonstrated that treatment with antibiotic-glucocorticoid eardrops is clinically superior to oral antibiotics and initial observation .


The aim of this study was to assess the cost-effectiveness of these three common treatment strategies for this condition .


We performed an open-label pragmatic trial in which 230 children with acute uncomplicated tympanostomy-tube otorrhea were randomly allocated to receive 1 of 3 treatments : hydrocortisone-bacitracin-colistin eardrops , oral amoxicillin-clavulanate suspension , and initial observation ( no assigned medication prescription to fill ) .


Parents kept a daily diary capturing ear-related symptoms , health care resource use , and non-health care costs for 6 months .


At 2 weeks and 6 months , the study doctor visited the children at home performing otoscopy .


Using a societal perspective , treatment failure ( otoscopic presence of otorrhea at 2 weeks ) and number of days with otorrhea as reported in the daily diary were balanced against the costs .


Antibiotic-glucocorticoid eardrops were clinically superior to oral antibiotics and initial observation both at 2 weeks and 6 months .


At 2 weeks , mean total cost per patient was US$ 42.43 for antibiotic-glucocorticoid eardrops , US$ 70.60 for oral antibiotics , and US$ 82.03 for initial observation .


At 6 months , mean total cost per patient was US$ 368.20 , US$ 420.73 , and US$ 640.44 , respectively .


Because of the dominance of eardrops , calculating incremental cost-effectiveness ratios was redundant .


Antibiotic-glucocorticoid eardrops are clinically superior and cost less than oral antibiotics and initial observation in children with tympanostomy tubes who develop otorrhea .


The safety and efficacy of bivalirudin compared with heparin with or without glycoprotein IIb/IIIa inhibitors in patients with acute myocardial infarction ( AMI ) undergoing primary percutaneous coronary intervention ( PCI ) are uncertain .


To determine if bivalirudin is superior to heparin alone and to heparin plus tirofiban during primary PCI .


Multicenter , open-label trial involving 2194 patients with AMI undergoing primary PCI at 82 centers in China between August 2012 and June 2013 .


Patients were randomly assigned to receive bivalirudin with a post-PCI infusion ( n = 735 ) , heparin alone ( n = 729 ) , or heparin plus tirofiban with a post-PCI infusion ( n = 730 ) .


Among patients treated with bivalirudin , a postprocedure 1.75 mg/kg/h infusion was administered for a median of 180 minutes ( IQR , 148-240 minutes ) .


The primary end point was 30-day net adverse clinical events , a composite of major adverse cardiac or cerebral events ( all-cause death , reinfarction , ischemia-driven target vessel revascularization , or stroke ) or bleeding .


Additional prespecified safety end points included the rates of acquired thrombocytopenia at 30 days , and stent thrombosis at 30 days and 1 year .


Net adverse clinical events at 30 days occurred in 65 patients ( 8.8 % ) of 735 who were treated with bivalirudin compared with 96 patients ( 13.2 % ) of 729 treated with heparin ( relative risk [ RR ] , 0.67 ; 95 % CI , 0.50-0 .90 ; difference , -4.3 % , 95 % CI , -7.5 % to -1.1 % ; P = .008 ) ; and 124 patients ( 17.0 % ) of 730 treated with heparin plus tirofiban ( RR for bivalirudin vs heparin plus tirofiban , 0.52 ; 95 % CI , 0.39-0 .69 ; difference , -8.1 % , 95 % CI , -11.6 % to -4.7 % ; P < .001 ) .


The 30-day bleeding rate was 4.1 % for bivalirudin , 7.5 % for heparin , and 12.3 % for heparin plus tirofiban ( P < .001 ) .


There were no statistically significant differences between treatments in the 30-day rates of major adverse cardiac or cerebral events ( 5.0 % for bivalirudin , 5.8 % for heparin , and 4.9 % for heparin plus tirofiban , P = .74 ) , stent thrombosis ( 0.6 % vs 0.9 % vs 0.7 % , respectively , P = .77 ) , acquired thrombocytopenia ( 0.1 % vs 0.7 % vs 1.1 % ; P = .07 ) , or in acute ( < 24-hour ) stent thrombosis ( 0.3 % in each group ) .


At the 1-year follow-up , the results remained similar .


Among patients with AMI undergoing primary PCI , the use of bivalirudin with a median 3-hour postprocedure PCI-dose infusion resulted in a decrease in net adverse clinical events compared with both heparin alone and heparin plus tirofiban .


This finding was primarily due to a reduction in bleeding events with bivalirudin , without significant differences in major adverse cardiac or cerebral events or stent thrombosis .


clinicaltrials.gov Identifier : NCT01696110 .


This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement ( SAVR ) or transcatheter aortic valve replacement ( TAVR ) in high-risk patients with severe aortic stenosis .


The PARTNER ( Placement of Aortic Transcatheter Valve ) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients , but sex-specific outcomes are unknown .


In all , 699 patients ( 300 female ) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve .


Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females .


Baseline characteristics differed between the sexes .


Despite higher Society of Thoracic Surgeons mortality risk scores ( 11.9 vs. 11.6 ; p = 0.05 ) , female patients had lower prevalence of coronary artery disease ( 64.4 % vs. 83.7 % ) , prior coronary artery bypass graft surgery ( 19.8 % vs. 61.2 % ) , peripheral vascular disease ( 36.4 % vs. 46.9 % ) , diabetes mellitus ( 35.6 % vs. 45.6 % ) , and elevated creatinine ( 11.7 % vs. 23.9 % ) .


Among female patients , procedural mortality trended lower with TAVR versus SAVR ( 6.8 % vs. 13.1 % ; p = 0.07 ) and was maintained throughout follow-up ( hazard ratio [ HR ] : 0.67 ; 95 % confidence interval [ CI ] : 0.44 to 1.00 ; p = 0.049 ) , driven by the transfemoral arm ( HR : 0.55 ; 95 % CI : 0.32 to 0.93 ; p = 0.02 ) .


Among male patients , although procedural mortality was lower with TAVR ( 6 % vs. 12.1 % ; p = 0.03 ) , there was no overall survival benefit ( HR : 1.15 ; 95 % CI : 0.82 to 1.61 ; p = 0.42 ) .


In this retrospective subanalysis of high-risk , symptomatic aortic stenosis patients in the PARTNER trial , female subjects had lower late mortality with TAVR versus SAVR .


This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients .


A randomized , controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities .


( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .


Cardiovascular disease is a major cause of morbidity and mortality in patients with chronic obstructive pulmonary disease ( COPD ) .


Preliminary studies have shown that both airflow obstruction and systemic inflammation may contribute to endothelial dysfunction in COPD .


Lung volume reduction surgery ( LVRS ) is a treatment option in selected patients with COPD with emphysema that improves breathing mechanics and lung function .


To determine the effect of LVRS on endothelial function and systemic inflammation .


We conducted a randomized controlled trial in 30 patients scheduled for LVRS .


In the intervention group , immediate LVRS was performed after baseline evaluation followed by reassessment 3 months later .


In the control group , reassessment followed 3 months after baseline evaluation , and thereafter LVRS was performed .


The primary outcome measures were the treatment effect on endothelial function and systemic inflammation .


In the LVRS group 14 patients completed the trial and 13 in the control group .


LVRS led to a relative reduction in mean ( SD ) residual volume/total lung capacity of -12 % ( 12 % ) and an increase in FEV1 of 29 % ( 27 % ) .


Flow-mediated dilatation of the brachial artery increased in the intervention group as compared with the control group ( +2.9 % ; 95 % confidence interval , +2.1 to +3.6 % ; P < 0.001 ) , whereas there was no significant change in systemic inflammation .


A significant treatment effect on mean blood pressure was observed ( -9.0 mm Hg ; 95 % confidence interval , -17.5 to -0.5 ; P = 0.039 ) .


Endothelial function and blood pressure are improved 3 months after LVRS in patients with severe COPD and emphysema .


LVRS may therefore have beneficial effects on cardiovascular outcomes .


Clinical trial registered with www.clinicaltrials.gov ( NCT 01020344 ) .


The addition of fluvastatin significantly improves sustained virological response ( SVR ) in pegylated interferon and ribavirin ( peg-IFN/RBV ) combination therapy for patients infected with the hepatitis C virus .


However , the add-on effect on telaprevir-based triple combination therapy remains unknown .


The aim of this study was to investigate the effect of fluvastatin on telaprevir-based combination therapy by conducting a prospective , open-label , randomized , controlled trial .


Among 124 genotype 1b-infected chronic hepatitis C patients recruited , 116 eligible patients were allocated randomly to two study arms ; they received 12 weeks of telaprevir/peg-IFN/RBV , followed by 12 weeks of peg-IFN/RBV with or without 24 weeks of fluvastatin ( fluvastatin group and control group , respectively ) .


Treatment outcomes and adverse effects were compared between the two groups .


There were 56 men and 60 women , median age 60 years ( range , 28-71 years ) .


Rapid virological response and end of treatment response rates were 87.9 % ( 51/58 ) and 96.6 % ( 56/58 ) in the control group and 75.9 % ( 44/58 ) and 98.3 % ( 57/58 ) in the fluvastatin group , respectively .


SVR rates in the control group and the fluvastatin group were 84.5 % ( 49/58 ) and 81.0 % ( 47/58 ) , respectively ; there was no significant difference ( P = 0.806 ) .


Stratified analysis showed that no factors associated with the SVR rate were found between the two groups .


No adverse events were associated with fluvastatin .


In this trial , administration of fluvastatin with telaprevir/peg-IFN/RBV was a safe combination .


However , fluvastatin had no add-on effect on 24-week telaprevir-based combination therapy for chronic hepatitis C genotype 1b-infected patients .


Weight loss is a common problem in patients with Squamous Cell Carcinoma of the Head and Neck ( SCCHN ) treated with radiotherapy ( RT ) .


The aims of the present study were to determine if treated volume ( TV ) , as a measure of the radiation dose burden , can predict weight loss in patients with oropharyngeal cancer and to analyze weight loss and body mass index ( BMI ) in the same patient group in relation to 5-year overall survival .


The ARTSCAN trial is a prospective , randomized , multicenter trial in patients with SCCHN .


Nutritional data from the ARTSCAN trial were analyzed retrospectively using univariate and multivariate statistical methods based on information on percentage weight loss from the start of RT up to five months after the termination of RT ( study cohort 1 , n = 232 ) and information on patients ' BMI at the start of RT ( study cohort 2 , n = 203 ) .


TV was defined as the volume of the patient receiving at least 95 % of the prescribed dose .


TV64 .6 Gy encompasses macroscopic tumor and TV43 .7 Gy elective lymph nodes of the neck .


TV64 .6 Gy and TV43 .7 Gy were both significantly correlated with higher weight loss up to five months after the termination of RT in study cohort 1 ( p < 0.001 for both ) .


BMI at the start of RT was shown to be a prognostic factor for 5-year overall survival in study cohort 2 but weight loss was not .


The hazard ratios and 95 % confidence intervals were 3.78 ( 1.46-9 .75 ) and 2.57 ( 1.43-4 .62 ) in patients with underweight and normal weight , respectively .


TV can predict weight loss during RT in patients with oropharyngeal cancer regardless of clinical stage .


A high BMI ( > 25 kg/m2 ) at the start of RT is positively associated with survival in patients with oropharyngeal cancer .


This study was conducted to observe the effect of a structured educational program on drug adherence and self-care management in people with epilepsy in a developing country .


A total of 180 consecutive people with epilepsy were enrolled from the epilepsy clinic of a tertiary care hospital in North India .


Out of these , 90 were randomized to the epilepsy health education group and received the educational program and 90 were in the control group and received the standard of care but did not receive any structured educational program .


The modified Morisky Medication Adherence Scale ( MMAS ) and Epilepsy Self-Efficacy Scale ( ESES ) were administered to assess drug adherence and self-care , respectively , on the day of enrollment .


The patients enrolled in the epilepsy health education group received 4 sessions of the structured educational program .


The MMAS and ESES questionnaires were again administered to both groups after 6months .


Continuous and categorical variables were compared between control and epilepsy health education groups using a chi-square test , with p value less than 0.05 considered significant .


A comparison between pretest and posttest MMAS scores and ESES scores was done using a paired t-test .


In the epilepsy health education group , the pretest mean MMAS score was 6.58 whereas the posttest mean MMAS score was 7.53 ; the difference was significant ( p = 0.001 ) .


The mean MMAS scores for the control group 's pretest and posttest were 6.46 and 6.58 , respectively , which were not significantly different ( p = 0.224 ) .


On comparing the ESES scores at the beginning of the study and after 6months , there was no significant change in both groups .


The present study proves the efficacy of a structured educational program in improving drug adherence in a cohort of people with epilepsy with low educational background .


The objective of this study was to determine the effects of axillary lymph node dissection ( ALND ) versus sentinel lymph node biopsy alone ( SLNB ) on the survival of patients with 3 or more metastatic lymph nodes ( MLN ) in invasive breast cancer .


Data of 9521 patients with invasive T1-2M0 breast carcinoma and initial treatment with SLNB completed or not by ALND and 3 or more MLN were extracted from the SEER database .


Univariate and multivariate analyses were performed .


Overall , 9521 patients were included in the study .


SLNB-alone compared with ALND did not result in different overall survival ( OS ) or specific survival ( SS ) for patients with 3 or more MLN ( p = 0.46 and 0.58 , respectively ) .


In subgroup analyses , OS was comparable between SLNB-alone and ALND when patients had only 3 or more than 3 MLN .


When patients had 3 MLN , the 5-year SS was significantly better for patients with ALND compared with SLNB-alone : 91.5 % and 85.1 % , respectively ( p = 0.02 ) .


The Hazard Ratio ( HR ) for OS comparing SLNB-alone with ALND adjusting for age , adjuvant radiotherapy , tumor size , estrogen receptor status , grade and tumor type resulted in an HR of 1.05 ( 95 % CI , 0.72-1 .54 , p = 0.77 ) .


In conclusion , patients with a T1-T2 invasive breast cancer and at least 3 MLN do not benefit from ALND after SLNB for specific and overall survival , thus limiting ALND to a staging procedure .


A subgroup of patients with 3 MLN had a better SS with ALND , possibly due to an under-staging of the SLNB-alone group .


The aim of the current study was to determine the incorporation of cis ( c ) 9 , trans ( t ) 11-conjugated linoleic acid ( CLA ) and t10 , c12-CLA into porcine erythrocytes-both isomers were supplemented in equal proportions .


The study group consisted of 16 piglets randomly assigned into experimental and control group .


For the period of 5 weeks , the piglets from the experimental group were receiving a 1.2 % CLA supplement while the controls were supplemented with the same amount of sunflower oil .


For the remaining 7 weeks , the piglets were fed without a supplement .


Blood samples to evaluate incorporation of CLA into erythrocyte membranes were taken from all animals on weekly basis .


Compared to t10 , c12-CLA isomer , proportion of c9 , t11-CLA isomer in the membrane of erythrocytes was higher for the whole time of the study period .


After 4 weeks of feeding , it approaches the plateau .


The peak value for both isomers was measured at the end of week 5 , with a value of 3.24 g c9 , t11-CLA/100 g of fatty acids and a 1.09 g t10 , c12-CLA/100 g of fatty acids ( p < 0.0001 ) .


After cessation of supplementation , the proportion of both isomers gradually decreased to be almost completely washed out-in 7 weeks .


During supplementation with equivalent amounts of CLA isomers , their proportion in membranes of porcine erythrocytes increases with time , with higher proportion of c9 , t11-CLA .


CLA isomers probably differently incorporate into different cell membranes at different species which could explain its various biological functions .


Currently , endovascular treatment is indicated to treat femoropopliteal lesions 15 cm .


However , the Achilles ' heel of femoropopliteal endovascular repair remains restenosis .


Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty .


A recently released prospective registry using a newer generation of self-expandable nitinol stents ( Misago ; Terumo Corp. , Tokyo , Japan ) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions .


To date , no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions .


The BATTLE trial was designed to compare paclitaxel eluting stents ( Zilver PTX ) and a last generation bare self-expandable nitinol stents ( Misago RX , Terumo Corp. , Tokyo , Japan ) in the treatment of intermediate length femoropopliteal lesions ( 14 cm ) .


A prospective , randomized ( 1:1 ) , controlled , multicentric and international study has been designed .


One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions 14 cm in symptomatic patients ( Rutherford 2 to 5 ) : bare stent group and paclitaxel eluting stent group .


The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index > 2.4 ( restenosis of > 50 % ) at the target lesion and assessed by duplex scan .


Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver PTX stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease .


This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions .


It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length .


Clinicaltrials.gov identifier : NCT02004951 .3 December 2013 .


This clinical trial evaluated the pharmacokinetics and safety/tolerability of amikacin/fosfomycin solution using a vibrating plate nebulizer , in mechanically ventilated patients with ventilator-associated tracheobronchitis ( VAT ) or ventilator-associated pneumonia ( VAP ) .


Nine adult patients were consented to receive three escalating doses of a combination of 50mg/mL amikacin and 20mg/mL fosfomycin ; doses were separated by 242hr .


On day 3 , patients received two blinded , randomized treatments ( amikacin/fosfomycin and volume-matched placebo ) , separated by 2hr .


All treatments were administered with a single-patient , multitreatment nebulizer ( Investigational eFlow ( ) Inline Nebulizer System ; PARI Pharma GmbH , positioned in the inspiratory limb tubing between the ventilator and the patient .


The nebulizer remained in-line until all treatments had been delivered .


Concentrations of amikacin and fosfomycin were measured in tracheal aspirate and plasma samples obtained during the 24hr after each dose .


Fifteen minutes after dosing with the 300/120mg amikacin/fosfomycin combination , tracheal aspirate amikacin concentrationsSD were 12,3903,986 g/g , and fosfomycin concentrations were 6,1742,548 g/g ( n = 6 ) .


Airway clearance was rapid .


Plasma concentrations were subtherapeutic ; the highest observed amikacin plasma concentration was 1.4 g/mL , and the highest observed fosfomycin plasma concentration was 0.8 g/mL .


Administration time was approximately 2min/mL .


No adverse effects on respiratory rate , peak airway pressures , or oxygenation were observed during or following drug or placebo administration .


High tracheal aspirate concentrations of amikacin and fosfomycin were achieved in mechanically ventilated patients with VAT or VAP after aerosolized administration with an inline nebulizer system .


No adverse respiratory effects were noted during or following drug administration .


To investigate whether low-intensity ergometer aerobic training has beneficial effect on glucose tolerance in nondiabetic patients with severely impaired stroke .


Fifty-four severely impaired stroke survivors were recruited and randomly assigned to the experimental group and control group .


They have no diabetes history with fasting plasma glucose less than 7 mmol/L .


Both groups participated in a 6-week rehabilitation training program with low-intensity ergometer aerobic training added only in the experimental group 3 times per week .


Primary outcome variables were fasting glucose , fasting insulin , 2-hour glucose , and homeostasis model assessment-insulin resistance ( HOMA-IR ) in oral glucose tolerance test before and after intervention .


Before intervention , 36 of 54 ( 66.7 % ) were diagnosed with impaired glucose status or diabetic glucose tolerance totally .


The average 2-hour plasma glucose level was 9.14 1.39 mmol/L .


After intervention , aerobic training significantly improved fasting insulin ( from 8.51 2.01 U/mL to 7.11 2.02 U/mL ) , 2-hour glucose level ( from 9.13 1.14 mmol/L to 7.22 1.23 mmol/L ) , and HOMA-IR ( from 1.62 1.01 to 1.29 .79 ) in the intervention group compared with the control group ( P < .05 ) .


Aerobic training also significantly improved their glucose tolerance state ( P < .05 ) .


Preliminary findings suggest that abnormal glucose tolerance may be highly present among severely impaired nondiabetic stroke patients and low-intensity ergometer aerobic training may have beneficial role in improving glucose tolerance .


Randomized controlled trial with immediate follow-up .


To evaluate the immediate effects of a low-amplitude , high-velocity thrust thoracic spine manipulation ( TSM ) on pain and scapular kinematics during elevation and lowering of the arm in individuals with shoulder impingement syndrome ( SIS ) .


The secondary objective was to evaluate the immediate effects of TSM on scapular kinematics during elevation and lowering of the arm in individuals without symptoms .


Considering the regional interdependence among the shoulder and the thoracic and cervical spines , TSM may improve pain and function in individuals with SIS .


Comparing individuals with SIS to those without shoulder pathology may provide information on the effects of TSM specifically in those with SIS .


Fifty subjects ( mean SD age , 31.8 10.9 years ) with SIS and 47 subjects ( age , 25.8 5.0 years ) asymptomatic for shoulder dysfunction were randomly assigned to 1 of 2 interventions : TSM or a sham intervention .


Scapular kinematics were analyzed during elevation and lowering of the arm in the sagittal plane , and a numeric pain rating scale was used to assess shoulder pain during arm movement at preintervention and postintervention .


For those in the SIS group , shoulder pain was reduced immediately after TSM and the sham intervention ( mean SD preintervention , 2.9 2.5 ; postintervention , 2.3 2.5 ; P < .01 ; moderate effect size [ Cohen d = 0.2 ] ) .


Scapular internal rotation increased 0.5 0.02 ( P = .04 ; small effect size [ Cohen d < 0.1 ] ) during elevation of the arm after TSM and sham intervention in the SIS group only .


Subjects with and without SIS who received TSM and asymptomatic subjects who received the sham intervention had a significant increase ( 1.6 2.7 ) in scapular upward rotation postintervention ( P < .05 ; small effect size [ Cohen d < 0.2 ] ) , which was not considered clinically significant .


Scapular anterior tilt increased 1.0 4.8 during elevation and lowering of the arm postmanipulation ( P < .05 ; small effect size [ Cohen d < 0.2 ] ) in the asymptomatic subjects who received TSM .


Shoulder pain in individuals with SIS immediately decreased after a TSM .


The observed changes in scapular kinematics following TSM were not considered clinically important .


Therapy , level 4 .


J Orthop Sports Phys Ther 2014 ; 44 ( 7 ) :475 -487 .


Epub 22 May 2014 .


doi :10.2519 / jospt .2014.4760 .


The considerably high risk of skin cancer development among transplant recipients warrants effective and efficient patient education on sun-protective behaviors .


To evaluate the effectiveness and patient satisfaction of a brief educational video on skin cancer risks and sun-protective behaviors in the transplant population during a routine posttransplant follow-up visit , as compared with an educational handout .


One hundred posttransplant patients were randomized to receive either video or pamphlet education about skin cancer .


The primary outcome measure was knowledge acquisition , which was assessed using a 10-criterion grading instrument before and after the assigned educational intervention .


The secondary outcome measure was patient satisfaction with the particular educational intervention received .


Comparison between the 2 treatment groups demonstrated that the video group had significantly greater improvement in knowledge scores ( 3.96 1.69 ) as compared with the pamphlet group ( 1.76 1.42 , p < .01 ) .


Moreover , subjects in the video group rated the educational material as more useful and appealing than did subjects in the pamphlet group .


These findings suggest an inherent appeal for audio-visual presentation and point its potential to improve patients ' knowledge of their increased risk of skin cancer and preventive skin cancer measures .


Nitrite exhibits hypoxia-dependent vasodilator properties , selectively dilating capacitance vessels in healthy subjects .


Unlike organic nitrates , it seems not to be subject to the development of tolerance .


Currently , therapeutic options for decompensated heart failure ( HF ) are limited .


We hypothesized that by preferentially dilating systemic capacitance and pulmonary resistance vessels although only marginally dilating resistance vessels , sodium nitrite ( NaNO2 ) infusion would increase cardiac output but reduce systemic arterial blood pressure only modestly .


We therefore undertook a first-in-human HF proof of concept/safety study , evaluating the hemodynamic effects of short-term NaNO2 infusion .


Twenty-five patients with severe chronic HF were recruited .


Eight received short-term ( 5 minutes ) intravenous NaNO2 at 10 g/kg/min and 17 received 50 g/kg/min with measurement of cardiac hemodynamics .


During infusion of 50 g/kg/min , left ventricular stroke volume increased ( from 43.2221.5 to 51.8423.6 mL ; P = 0.003 ) , with marked falls in pulmonary vascular resistance ( by 29 % ; P = 0.03 ) and right atrial pressure ( by 40 % ; P = 0.007 ) , but with only modest falls in mean arterial blood pressure ( by 4 mm Hg ; P = 0.004 ) .


The increase in stroke volume correlated with the increase in estimated trans-septal gradient ( = pulmonary capillary wedge pressure-right atrial pressure ; r = 0.67 ; P = 0.003 ) , suggesting relief of diastolic ventricular interaction as a contributory mechanism .


Directionally similar effects were observed for the above hemodynamic parameters with 10 g/kg/min ; this was significant only for stroke volume , not for other parameters .


This first-in-human HF efficacy/safety study demonstrates an attractive profile during short-term systemic NaNO2 infusion that may be beneficial in decompensated HF and warrants further evaluation with longer infusion regimens .


Individual assessment of the amplitude of a physiologic reflex evoked by a standardized noxious test ( SNT ) before surgical stimulation has been suggested to predict movement upon the forthcoming surgical stimulation .


This study aimed to compare the ability of pupillary dilatation reflex amplitude ( PDRA ) evoked by an SNT and estimated remifentanil effect-site concentration ( Ce ) to predict movement upon surgical stimulation .


Eighty female patients were anesthetized for vacuum aspiration with propofol ( Ce 4 g/ml ) and remifentanil .


Remifentanil Ce was randomized to 0 , 1 , 3 , or 5ng/ml .


SNT was a 60-mA , 5-s , 100-Hz tetanus applied on median nerve before cervix dilatation .


PDRA was calculated as the difference in pupillary diameter after and before SNT .


Movement upon cervix dilatation was recorded by an independent observer .


Ability of PDRA and estimated remifentanil Ce to discriminate movers from non-movers during cervix dilatation was measured as the area under the receiver operating characteristics curve .


Twenty-one of the 76 patients analyzed moved during cervix dilatation .


Mean PDRA ( 1 SD ) evoked by SNT was 2.01.2 mm in movers and 0.60.7 in non-movers ( P < 0.0001 ) .


Remifentanil Ce was 0.20.4 ng/ml in movers and 3.01.7 in non-movers ( P < 0.0001 ) .


Area under the receiver operating characteristics curve for PDRA was 0.90 ( 95 % CI , 0.83 to 0.96 ) and for remifentanil Ce 0.94 ( 0.89 to 0.98 ) , without any significant difference between the two areas .


PDRA evoked by an SNT is as accurate as the estimated remifentanil Ce to predict movement upon cervix dilatation .


PDRA could be valuable when estimated opioid Ce is not available or reliable .


Tobacco smoking is the leading cause of preventable death in developed countries .


Our previous studies in animal models and humans suggest that repeated activation of cue-induced craving networks followed by electromagnetic stimulation of the dorsal prefrontal cortex ( PFC ) can cause lasting reductions in drug craving and consumption .


We hypothesized that disruption of these circuitries by deep transcranial magnetic stimulation ( TMS ) of the PFC and insula bilaterally can induce smoking cessation .


Adults ( N = 115 ) who smoke at least 20 cigarettes/day and failed previous treatments were recruited from the general population .


Participants were randomized to receive 13 daily sessions of high-frequency , low-frequency or sham stimulation following , or without , presentation of smoking cues .


Deep TMS was administered using an H-coil version targeting the lateral PFC and insula bilaterally .


Cigarette consumption was evaluated during the treatment by measuring cotinine levels in urine samples and recording participants ' self-reports as a primary outcome variable .


Dependence and craving were assessed using standardized questionnaires .


High ( but not low ) frequency deep TMS treatment significantly reduced cigarette consumption and nicotine dependence .


The combination of this treatment with exposure to smoking cues enhanced reduction in cigarette consumption leading to an abstinence rate of 44 % at the end of the treatment and an estimated 33 % 6 months following the treatment .


This study further implicates the lateral PFC and insula in nicotine addiction and suggests the use of deep high-frequency TMS of these regions following presentation of smoking cues as a promising treatment strategy .


The differential diagnosis between pre - and postcapillary pulmonary hypertension ( PH ) is of major therapeutic relevance and thus requires optimal clinical probability assessment with echocardiography .


We prospectively analyzed 152 consecutive patients referred to a PH center over a 1-year period undergoing quasi-simultaneous ( within 1 hour ) echocardiography and right heart catheterization .


Echocardiography was performed as usually recommended for the assessment of PH and left heart conditions .


PH was defined as a mean pulmonary artery pressure 25 mm Hg .


Postcapillary PH was diagnosed on the basis of a pulmonary capillary wedge pressure > 15 mm Hg .


Ten of 152 patients ( 7 % ) had no PH , 81 of 152 ( 53 % ) had precapillary PH , and 61 of 152 ( 40 % ) had postcapillary PH. The following five echocardiographic variables were found to predict precapillary PH : right heart chamber larger than the left ( P = .0018 ) , left ventricular eccentricity index > 1.2 ( P = .0039 ) , dilated inferior vena cava without inspiratory collapse ( P = .0076 ) , E/e ' ratio 10 ( P = .00001 ) , and the right ventricle forming the heart apex ( P = .0144 ) .


Beta coefficients from multiple logistic regression were significant for dilated inferior vena cava without inspiratory collapse ( P = .0464 ) and E/e ' ratio 10 ( P = .0002 ) .


The score based on coefficients , ranging from 3 to 34 points , resulted in optimal discrimination at > 5 , with a positive predictive value of 67.9 % and a negative predictive value of 77.5 % for precapillary PH.


Echocardiography enables a clinically satisfactory differential diagnosis between pre - and postcapillary PH.


Multiple prospective studies have confirmed safety and efficacy of laparoscopic inguinal herniorraphy with single-port compared to multiport surgery .


This prospective randomized controlled trial aimed to assess safety , efficacy and potential benefits of single-port total extraperitoneal inguinal herniorraphy beyond the learning curve .


All referred patients with inguinal/femoral hernias were enrolled from December 2011 to February 2013 .


Exclusion criteria included workers compensation cases .


Identical balloon dissector , light-weight mesh and non-absorbable tacks were used in all cases .


For single-port cases Triport was used while structural balloon trocar/inflation bulb for multiport cases .


Results were analyzed with IBM ( ) SPSS ( ) version 22 for Windows .


Participation rate was 100 % with 157 inguinal/femoral hernias in 100 patients : 51 randomized to single-port and 49 to multiport group .


There was no conversion to open surgery/need for additional ports .


There were no statistical differences between single-port and multiport groups with respect to age , sex , body mass index , American Society of Anesthesiologists scores , preoperative pain , hernia defect sizes and length of hospital stay .


Operation times were equivalent for single-port and multiport 60.0 vs 61.0 min , P = 0.23 , respectively .


Significantly , single-port patients ingested fewer pain killers : 6 tablets vs 14 Dextropropoxyphene tablets , P < 0.001 , experienced less pain ( visual analog scores ) on day 1 and 7 post-op op : 2.5 and 0 , P < 0.001 compared to 4.5 and 2.5 , P < 0.001 , respectively , returned to work/normal physical activities 7days quicker : 7.0 vs 14.0 , P < 0.001 and had higher cosmetic scar scores at 6-week follow-up : 24 vs 21 , P < 0.001 , compared to multiport patients .


There were no mortalities , morbidities or recurrences after follow-up of 6-21months .


Compared to multiport , single-port laparoscopic total extraperitoneal inguinal herniorraphy , when performed by a high-volume and highly dedicated hernia surgeon , resulted in significantly reduced postoperative pain , analgesic requirements , quicker return to work/normal activities , improved cosmesis , and equivalent safety and efficacy .


Some patients with severe asthma have frequent exacerbations associated with persistent eosinophilic inflammation despite continuous treatment with high-dose inhaled glucocorticoids with or without oral glucocorticoids .


In this randomized , double-blind , double-dummy study , we assigned 576 patients with recurrent asthma exacerbations and evidence of eosinophilic inflammation despite high doses of inhaled glucocorticoids to one of three study groups .


Patients were assigned to receive mepolizumab , a humanized monoclonal antibody against interleukin-5 , which was administered as either a 75-mg intravenous dose or a 100-mg subcutaneous dose , or placebo every 4 weeks for 32 weeks .


The primary outcome was the rate of exacerbations .


Other outcomes included the forced expiratory volume in 1 second ( FEV1 ) and scores on the St. George 's Respiratory Questionnaire ( SGRQ ) and the 5-item Asthma Control Questionnaire ( ACQ-5 ) .


Safety was also assessed .


The rate of exacerbations was reduced by 47 % ( 95 % confidence interval [ CI ] , 29 to 61 ) among patients receiving intravenous mepolizumab and by 53 % ( 95 % CI , 37 to 65 ) among those receiving subcutaneous mepolizumab , as compared with those receiving placebo ( P < 0.001 for both comparisons ) .


Exacerbations necessitating an emergency department visit or hospitalization were reduced by 32 % in the group receiving intravenous mepolizumab and by 61 % in the group receiving subcutaneous mepolizumab .


At week 32 , the mean increase from baseline in FEV1 was 100 ml greater in patients receiving intravenous mepolizumab than in those receiving placebo ( P = 0.02 ) and 98 ml greater in patients receiving subcutaneous mepolizumab than in those receiving placebo ( P = 0.03 ) .


The improvement from baseline in the SGRQ score was 6.4 points and 7.0 points greater in the intravenous and subcutaneous mepolizumab groups , respectively , than in the placebo group ( minimal clinically important change , 4 points ) , and the improvement in the ACQ-5 score was 0.42 points and 0.44 points greater in the two mepolizumab groups , respectively , than in the placebo group ( minimal clinically important change , 0.5 points ) ( P < 0.001 for all comparisons ) .


The safety profile of mepolizumab was similar to that of placebo .


Mepolizumab administered either intravenously or subcutaneously significantly reduced asthma exacerbations and was associated with improvements in markers of asthma control .


( Funded by GlaxoSmithKline ; MENSA ClinicalTrials.gov number , NCT01691521 . )


Although oral ketamine has been used in some cases to reduce pain in children , the use of this drug to reduce pain after tonsillectomy has not been studied yet .


This double-blind clinical trial was conducted in 2009 in 92 children who were aged three to nine years old , met ASA I or II criteria , and were candidate for tonsillectomy .


Patients were divided randomly into two groups .


Half an hour before general anesthesia , 5 mg/kg ketamine mixed in 2 cc/kg apple juice was given to the children in oral ketamine group and 2 cc/kg of apple juice alone was given to the children in the peritonsillar group .


After general anesthesia and three minutes before surgery 1 cc of 0.9 % normal saline in the oral group and 1cc of ketamine ( 0.5 mg/kg ) in the peritonsillar group was injected to the tonsil bed of patients .


There was no difference between the two groups in terms of sex , age , and weight .


Duration of surgery was significantly shorter in the peritonsillar group ( P < 0.001 ) and the severity of postoperative bleeding was significantly higher in peritonsillar group ( P = 0.022 ) .


However , postoperative bleeding recurred in 25 patients ( 27 % ) and there was no statistically significant difference between the two groups .


The level of pain in children six hours after surgery according to CHEOPS criteria was significantly lower in the peritonsillar group ( 0.9 0.8 ) than in the oral group ( 2.6 1 ) ( P < 0.001 ) .


The finding of this study showed that , compared with the peritonsillar infiltration of ketamine , the use of oral ketamine before general anesthesia was less effective in reducing postoperative pain of tonsillectomy in children .


Websites and phone apps are increasingly used to track weights during weight loss interventions , yet the longitudinal accuracy of these self-reported weights is uncertain .


Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic .


We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5 % weight loss when using self-reported compared to clinic weights .


This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction ( POWER ) trial , a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor .


One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions .


All intervention participants ( n = 277 ) received a digital scale and were asked to track their weight weekly on a study website .


Research staff used a standard protocol to measure weight in the clinic .


Differences ( self-reported weight - clinic weight ) indicate if self-report under ( - ) or over ( + ) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month ( n = 225 ) and 24-month ( n = 191 ) clinic visits .


The absolute value of the differences ( absolute difference ) describes the overall accuracy .


Underestimation of self-reported weights increased significantly from 6 months ( mean -0.5 kg , SD 1.0 kg ) to 24 months ( mean -1.1 kg , SD 2.0 kg ; P = .002 ) .


The average absolute difference also increased from 6 months ( mean 0.7 kg , SD 0.8 kg ) to 24 months ( mean 1.3 , SD 1.8 kg ; P < .001 ) .


Participants who achieved the study weight loss goal at 24 months ( based on clinic weights ) had lower absolute differences ( P = .01 ) compared to those who did not meet this goal .


At 24 months , there was 9 % misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome .


At 24 months , those with self-reported weights ( n = 191 ) had three times the weight loss compared to those ( n = 73 ) without self-reported weights ( P < .001 ) .


Underestimation of weight increased over time and was associated with less weight loss .


In addition to intervention adherence , weight loss programs should emphasize accuracy in self-reporting .


ClinicalTrials.gov : NCT00783315 ; http://clinicaltrials.gov/show/NCT00783315 ( Archived by WebCite at http://www.webcitation.org/6R4gDAK5K ) .


The quality of surgery with D3 resection in randomized controlled clinical trial [ Japan Clinical Oncology Group study ( JCOG0404 ) ] was assessed by evaluation of the photo documentation of both open and laparoscopic surgeries .


A multi-institutional randomized-controlled trial ( JCOG0404 ) was conducted to evaluate open and laparoscopic D3 resection ( complete mesocolic excision + ligation and dissection at the root of the main vessels ) for Stage II/III colon cancer ( UMIN-CTR number C000000105 ) .


A total of 1057 ( open , 528 ; laparoscopic , 529 ) eligible patients were enrolled .


For quality control , it was ensured that the surgeries were performed by accredited surgeons , and a central committee reviewed each surgery on the basis of the submitted photographs of the resected field , specimen and skin incision .


For right-sided tumors , the rate of D3 resection was 98.5 % ( 131/133 ) in the open arm and 100 % ( 136/136 ) in the laparoscopic arm , and for left-sided tumors , they were 97.9 % ( 322/329 ) and 98.2 % ( 320/326 ) , respectively .


Sufficient length of the resected longitudinal margin was ensured in all cases .


The skin incisions made in all the cases were < 8 cm as defined in the protocol in laparoscopic arm .


Completion of high quality surgery with D3 resection was confirmed in JCOG0404 by central peer review of photographs of the surgical procedures in addition to operator regulations .


This study suggests that the central review of the photo documentation is one of the important tools to assure a quality control of surgical technique in the Phase III randomized-controlled study .


Diffusion tensor imaging ( DTI ) is a magnetic resonance imaging ( MRI ) technique enabling visualization and measurement of white matter tracts .


Attention deficit hyperactivity disorder ( ADHD ) has been studied with DTI earlier with variable results , yet there is little research on remitted ADHD .


To compare the brain white matter between ADHD drug nave subjects whose ADHD symptoms have mostly subsided and healthy controls .


Tract-based spatial statistics ( TBSS ) was used to compare 30 subjects with adolescent ADHD with control subjects at the age of 22-23 years .


The study population was derived from a population-based Northern Finland Birth Cohort 1986 .


Fractional anisotropy ( FA ) , mean diffusivity ( MD ) , and measures of diffusion direction ( 1-3 ) were calculated .


Permutation testing was used to test for differences in mean values of FA , MD , and 1-3 between the groups .


The results were corrected for multiple comparisons across the whole white matter skeleton .


The ADHD group showed increased FA related to decreased radial diffusivity in the left forceps minor ( P < 0.05 ) .


In the vicinity along the same tract , axial diffusion was significantly decreased without any significant effect on FA .


No between-group difference in MD was observed .


Regressor analysis revealed no gender - , IQ - or GAF-related changes .


After removal of left handed subjects the statistical significance was only barely lost .


In a setting with remitted ADHD , the results may represent a compensatory mechanism in the left forceps minor .


MK-0888 is an investigational VEGFR-2 inhibitor with demonstrated potent in vitro enzyme activity .


Clinical investigation in healthy volunteers and cancer patients was undertaken to evaluate its pharmacokinetic properties and early safety profile .


Early data were used to guide whether further clinical development was warranted .


Five phase I studies were conducted .


Studies 1-4 were conducted in healthy male volunteers and examined safety and pharmacokinetics across a dose range of 0.5-100 mg .


Single-dose and limited multiple-dose escalations were performed .


Three formulations and food effect were assessed .


Study 5 was a dose escalation study in cancer patients , evaluating pharmacokinetics and safety at doses of 6-100 mg administered up to twice daily .


Safety : MK-0888 was generally well tolerated in healthy volunteers at single doses up to 100 mg and in cancer patients at doses up to 100 mg twice daily .


Pharmacokinetics : After single-dose administration , MK-0888 was readily absorbed with a T ( max ) of 4-5 h and a half-life of 11.3-22 .7 h. AUC , C ( max ) , and C ( 24h ) increased in a slightly less than dose proportional manner .


With longer duration multiple-dose administration ( 2 weeks ) , trough concentrations decreased from Day 2 at doses of 50 mg twice daily and higher , suggestive of autoinduction of metabolism .


The efficacious trough pharmacokinetic target was not attained at steady state .


The pharmacokinetic behavior of MK-0888 does not support continued development .


The early pharmacokinetic profile of the compound provides important information as to the probability of success of MK-0888 achieving efficacious exposures .


Osteoarthritis is the most frequent joint disease and is a leading cause of pain and locomotor disability in elderly people .


The treatment of osteoarthritis includes non-pharmacological , pharmacological , and surgical therapies .


Silver level evidence has been found concerning balneotherapy in osteoarthritis .


The aim of this study was to evaluate how Lake Hvz thermal mineral water therapy influences pain , knee function , and quality of life in patients with knee osteoarthritis , compared to the control group .


randomized , controlled , single-blind , follow-up study .


Spa Hvz and St. Andrew Hospital for Rheumatic Diseases


This study included 77 outpatients between 45 and 75 years of age with mild to moderate osteoarthritis of the knee meeting the American College of Rheumatology classification criteria .


Patients were randomized into two groups .


In group I ( n = 38 ) , subjects bathed in Lake Hvz and in group II ( N. = 39 ) , patients were treated in a pool full of tap water .


Water temperature was 34 C for both groups .


Participants underwent 30-minute therapy sessions , five times a week for three weeks .


Outcome measures were pain visual analogue scale scores , active flexion degree , knee circumference , stair-climb time , Western Ontario and McMaster Universities osteoarthritis index ( WOMAC ) , and EuroQoL Group 5-Dimension Self-Report Questionnaire score ( EQ-5D ) .


Study parameters were recorded at baseline , immediately after treatment , and after 15 weeks .


Comparison of the two groups revealed a statistically significant difference in pain visual analogue scale scores ( P < 0.01 ) , active flexion degree ( P < 0.01 ) , physical function components of WOMAC ( P < 0.05 ) , and EQ-5D scores ( P < 0.05 ) even after 15 weeks .


Balneotherapy improved pain , function as well as the quality of life in patients with knee osteoarthritis .


Balneotherapy is a potentially useful treatment modality for patients with knee osteoarthritis .


As new members of a drug class are developed , head-to-head trials are an important strategy to guide personalised treatment decisions .


We assessed two glucagon-like peptide-1 receptor agonists , once-weekly albiglutide and once-daily liraglutide , in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs .


We undertook this 32-week , open-label , phase 3 non-inferiority study at 162 sites in eight countries : USA ( 121 sites ) , Australia ( 9 sites ) , Peru ( 7 sites ) , Philippines ( 7 sites ) , South Korea ( 5 sites ) , UK ( 5 sites ) , Israel ( 4 sites ) , and Spain ( 4 sites ) .


841 adult participants ( aged 18 years ) with inadequately controlled type 2 diabetes and a BMI between 20 and 45 kg/m ( 2 ) were enrolled and randomised in a 1:1 ratio to receive albiglutide 30 mg once weekly titrated to 50 mg at week 6 , or liraglutide 06 mg once daily titrated to 12 mg at week 1 and 18 mg at week 2 .


The randomisation schedule was generated by an independent randomisation team by the permuted block method with a fixed block size of 16 .


Participants and investigators were unmasked to treatment .


The primary endpoint was change from baseline in HbA1c for albiglutide versus liraglutide , with a 95 % CI non-inferiority upper margin of 03 % .


The primary analysis was by modified intention to treat .


The study is registered with ClinicalTrials.gov , number NCT01128894 .


422 patients were randomly allocated to the albigultide group and 419 to the liraglutide group ; 404 patients in the abliglutide group and 408 in the liraglutide group received the study drugs .


The primary endpoint analysis was done on the modified intention-to-treat population , which included 402 participants in the albiglutide group and 403 in the liraglutide group .


Model-adjusted change in HbA1c from baseline to week 32 was -078 % ( 95 % CI -087 to -069 ) in the albigludite group and -099 % ( -108 to -090 ) in the liraglutide group ; treatment difference was 021 % ( 008-034 ; non-inferiority p value = 00846 ) .


Injection-site reactions occurred in more patients given albiglutide than in those given liraglutide ( 129 % vs 54 % ; treatment difference 75 % [ 95 % CI 36-114 ] ; p = 00002 ) , whereas the opposite was the case for gastrointestinal events , which occurred in 490 % of patients in the liraglutide group versus 359 % in the albiglutide group ( treatment difference -131 % [ 95 % CI -199 to -64 ] ; p = 000013 ) .


Patients who received once-daily liraglutide had greater reductions in HbA1c than did those who received once-weekly albiglutide .


Participants in the albiglutide group had more injection-site reactions and fewer gastrointestinal events than did those in the liraglutide group .


GlaxoSmithKline .


Up to 20 % of women experience postpartum depression ( PPD ) .


PPD is associated with anxiety and poor health-related quality of life ( HRQOL ) .


Efficacious treatments are critical ; many women with PPD prefer complementary therapies .


Thus , the current study examined yoga as a complementary therapy for PPD .


Fifty-seven postpartum women with scores 12 on the Hamilton Depression Rating Scale were randomly assigned to a yoga ( N = 28 ) or wait-list control ( N = 29 ) group .


The yoga intervention consisted of 16 classes over 8 weeks .


Outcomes were depression , anxiety , and HRQOL .


The yoga group experienced significantly greater rate of improvement in depression , anxiety , and HRQOL , relative to the control group with moderate to large effects .


Reliable Change Index analyses revealed that 78 % of women in the yoga group experienced clinically significant change .


These findings support yoga as a promising complementary therapy for PPD , and warrant large-scale replication studies .


http://clinicaltrials.gov/NCT02213601 .


The incidence of obesity hypoventilation syndrome ( OHS ) may be increasing in parallel with the present obesity epidemic .


Despite extensive noninvasive ventilation ( NIV ) and continuous positive airway pressure ( CPAP ) use in patients with OHS , information regarding efficacy is limited .


We performed a large , multicenter randomized controlled study to determine the comparative efficacy of NIV , CPAP , and lifestyle modification ( control group ) using daytime PaCO2 as the main outcome measure .


Sequentially screened patients with OHS with severe sleep apnea were randomized into the above-mentioned groups for a 2-month follow up .


Arterial blood gas parameters , clinical symptoms , health-related quality-of-life assessments , polysomnography , spirometry , 6-minute-walk distance , dropouts , compliance , and side effects were evaluated .


Statistical analysis was performed using intention-to-treat analysis , although adjustments for CPAP and NIV compliance were also analyzed .


In total , 351 patients were selected , and 221 were randomized .


NIV yielded the greatest improvement in PaCO2 and bicarbonate , with significant differences relative to the control group but not relative to the CPAP group .


In the CPAP group , PaCO2 improvement was significantly different than in the control group only after CPAP compliance adjustment .


Additionally , clinical symptoms and polysomnographic parameters improved similarly with NIV and CPAP relative to the control .


However , some health-related quality-of-life assessments , the spirometry , and 6-minute-walk distance results improved more with NIV than with CPAP .


Dropouts were similar between groups , and compliance and secondary effects were similar between NIV and CPAP .


NIV and CPAP were more effective than lifestyle modification in improving clinical symptoms and polysomnographic parameters , although NIV yielded better respiratory functional improvements than did CPAP .


Long-term studies must demonstrate whether this functional improvement has relevant implications .


Clinical trial registered with www.clinicaltrials.gov ( NCT01405976 ) .


Cure rates for localized high-risk prostate cancers ( PCa ) and some intermediate-risk PCa are frequently suboptimal with local therapy .


Outcomes are improved by concomitant androgen-deprivation therapy ( ADT ) with radiation therapy , but not by concomitant ADT with surgery .


Luteinizing hormone-releasing hormone agonist ( LHRHa ; leuprolide acetate ) does not reduce serum androgens as effectively as abiraterone acetate ( AA ) , a prodrug of abiraterone , a CYP17 inhibitor that lowers serum testosterone ( < 1 ng/dL ) and improves survival in metastatic PCa .