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


We explored the theorized upregulation of platelet-activating factor ( PAF ) - mediated biologic responses following lipoprotein-associated phospholipase A@ ( Lp-PLA@ ) inhibition using human platelet aggregation studies in an in vitro experiment and in @ 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-PLA@ inhibitor ) or vehicle .


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


This study was followed by a second randomized , double-blind parallel-group trial in healthy adult men ( n = @ ) also treated with @ mg oral rilapladib or placebo once daily for @ days using a full range of @ collagen concentrations ( @-@ g/ml ) for characterizing EC@ 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 .


EC@ 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-PLA@ inhibition exceeding @ % .


An increase in collagen-mediated aggregation was observed @ weeks post drug termination in the crossover study ( @ % vs baseline ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) , which was not observed during the treatment phase and was not observed in the parallel-group study employing a more robust EC@ examination .


Lp-PLA@ inhibition does not enhance platelet aggregation .


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 @ 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 @-minute walk distance were assessed at baseline and at @ weeks .


The program consisted of @ weekly visits by a physiotherapist in the first @ 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 = @ ) and control group ( CG ; n = @ ) 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 = @ ) , impact domain ( P < @ ) , and total scores of the Saint George Respiratory Questionnaire ( P < @ ) .


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 @ weeks .


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


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 ( @ ) pain ; ( @ ) narcotic use ; ( @ ) quadriceps function and length of stay ; and ( @ ) peripheral nerve complications .


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


All patients received standardized general anesthesia and oral medications .


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


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


Mean pain scores on the afternoon of POD @ were not different between groups ( PNB group : @ -LSB- SD @ -RSB- ; PAI group : @ -LSB- SD @ -RSB- ; @ % confidence interval , -@ to @ ; p = @ ) .


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


Hospital length of stay was shorter for the PAI group ( @ days -LSB- SD @ -RSB- versus @ days -LSB- SD @ -RSB- for the PNB group ; p = @ ) .


Narcotic consumption was higher the day of surgery for the PAI group ( PAI group : @ mg morphine equivalents -LSB- SD @ -RSB- ; PNB group : @ mg -LSB- SD @ -RSB- ; p < @ ) , but thereafter , there was no difference .


More patients in the PNB group had sequelae of peripheral nerve injury ( mainly dysesthesia ) at @-week followup ( nine -LSB- @ % -RSB- versus one -LSB- @ % -RSB- ; p = @ ) .


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 @ children with acute uncomplicated tympanostomy-tube otorrhea were randomly allocated to receive @ of @ 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 @ months .


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


Using a societal perspective , treatment failure ( otoscopic presence of otorrhea at @ 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 @ weeks and @ months .


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


At @ months , mean total cost per patient was US$ @ , US$ @ , and US$ @ , 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 @ patients with AMI undergoing primary PCI at @ centers in China between August @ and June @ .


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


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


The primary end point was @-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 @ days , and stent thrombosis at @ days and @ year .


Net adverse clinical events at @ days occurred in @ patients ( @ % ) of @ who were treated with bivalirudin compared with @ patients ( @ % ) of @ treated with heparin ( relative risk -LSB- RR -RSB- , @ ; @ % CI , @-@ @ ; difference , -@ % , @ % CI , -@ % to -@ % ; P = @ ) ; and @ patients ( @ % ) of @ treated with heparin plus tirofiban ( RR for bivalirudin vs heparin plus tirofiban , @ ; @ % CI , @-@ @ ; difference , -@ % , @ % CI , -@ % to -@ % ; P < @ ) .


The @-day bleeding rate was @ % for bivalirudin , @ % for heparin , and @ % for heparin plus tirofiban ( P < @ ) .


There were no statistically significant differences between treatments in the @-day rates of major adverse cardiac or cerebral events ( @ % for bivalirudin , @ % for heparin , and @ % for heparin plus tirofiban , P = @ ) , stent thrombosis ( @ % vs @ % vs @ % , respectively , P = @ ) , acquired thrombocytopenia ( @ % vs @ % vs @ % ; P = @ ) , or in acute ( < @-hour ) stent thrombosis ( @ % in each group ) .


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


Among patients with AMI undergoing primary PCI , the use of bivalirudin with a median @-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 .


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 @-year survival with SAVR or TAVR for high-risk patients , but sex-specific outcomes are unknown .


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


Baseline characteristics and @-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 ( @ vs. @ ; p = @ ) , female patients had lower prevalence of coronary artery disease ( @ % vs. @ % ) , prior coronary artery bypass graft surgery ( @ % vs. @ % ) , peripheral vascular disease ( @ % vs. @ % ) , diabetes mellitus ( @ % vs. @ % ) , and elevated creatinine ( @ % vs. @ % ) .


Among female patients , procedural mortality trended lower with TAVR versus SAVR ( @ % vs. @ % ; p = @ ) and was maintained throughout follow-up ( hazard ratio -LSB- HR -RSB- : @ ; @ % confidence interval -LSB- CI -RSB- : @ to @ ; p = @ ) , driven by the transfemoral arm ( HR : @ ; @ % CI : @ to @ ; p = @ ) .


Among male patients , although procedural mortality was lower with TAVR ( @ % vs. @ % ; p = @ ) , there was no overall survival benefit ( HR : @ ; @ % CI : @ to @ ; p = @ ) .


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 ; NCT@ ) .


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 @ patients scheduled for LVRS .


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


In the control group , reassessment followed @ 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 @ patients completed the trial and @ in the control group .


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


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


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


Endothelial function and blood pressure are improved @ 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 @ ) .


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


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


There were @ men and @ women , median age @ years ( range , @-@ years ) .


Rapid virological response and end of treatment response rates were @ % ( @/@ ) and @ % ( @/@ ) in the control group and @ % ( @/@ ) and @ % ( @/@ ) in the fluvastatin group , respectively .


SVR rates in the control group and the fluvastatin group were @ % ( @/@ ) and @ % ( @/@ ) , respectively ; there was no significant difference ( P = @ ) .


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 @-week telaprevir-based combination therapy for chronic hepatitis C genotype @b-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 @-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 @ , n = @ ) and information on patients ' BMI at the start of RT ( study cohort @ , n = @ ) .


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


TV@ @ Gy encompasses macroscopic tumor and TV@ @ Gy elective lymph nodes of the neck .


TV@ @ Gy and TV@ @ Gy were both significantly correlated with higher weight loss up to five months after the termination of RT in study cohort @ ( p < @ for both ) .


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


The hazard ratios and @ % confidence intervals were @ ( @-@ @ ) and @ ( @-@ @ ) 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 ( > @ kg/m@ ) 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 @ consecutive people with epilepsy were enrolled from the epilepsy clinic of a tertiary care hospital in North India .


Out of these , @ were randomized to the epilepsy health education group and received the educational program and @ 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 @ sessions of the structured educational program .


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


Continuous and categorical variables were compared between control and epilepsy health education groups using a chi-square test , with p value less than @ 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 @ whereas the posttest mean MMAS score was @ ; the difference was significant ( p = @ ) .


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


On comparing the ESES scores at the beginning of the study and after @months , 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 @ or more metastatic lymph nodes ( MLN ) in invasive breast cancer .


Data of @ patients with invasive T@-@M@ breast carcinoma and initial treatment with SLNB completed or not by ALND and @ or more MLN were extracted from the SEER database .


Univariate and multivariate analyses were performed .


Overall , @ 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 @ or more MLN ( p = @ and @ , respectively ) .


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


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


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 @ ( @ % CI , @-@ @ , p = @ ) .


In conclusion , patients with a T@-T@ invasive breast cancer and at least @ 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 @ 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 ) @ , trans ( t ) @-conjugated linoleic acid ( CLA ) and t@ , c@-CLA into porcine erythrocytes-both isomers were supplemented in equal proportions .


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


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


For the remaining @ 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 t@ , c@-CLA isomer , proportion of c@ , t@-CLA isomer in the membrane of erythrocytes was higher for the whole time of the study period .


After @ weeks of feeding , it approaches the plateau .


The peak value for both isomers was measured at the end of week @ , with a value of @ g c@ , t@-CLA/@ g of fatty acids and a @ g t@ , c@-CLA/@ g of fatty acids ( p < @ ) .


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


During supplementation with equivalent amounts of CLA isomers , their proportion in membranes of porcine erythrocytes increases with time , with higher proportion of c@ , t@-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 @ 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 ( @ cm ) .


A prospective , randomized ( @:@ ) , 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 @ cm in symptomatic patients ( Rutherford @ to @ ) : bare stent group and paclitaxel eluting stent group .


The primary endpoint is freedom from in-stent restenosis at @ year defined by a peak systolic velocity index > @ ( restenosis of > @ % ) 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 .


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 @mg/mL amikacin and @mg/mL fosfomycin ; doses were separated by @hr .


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


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 @hr after each dose .


Fifteen minutes after dosing with the @/@mg amikacin/fosfomycin combination , tracheal aspirate amikacin concentrationsSD were @,@,@ g/g , and fosfomycin concentrations were @,@,@ g/g ( n = @ ) .


Airway clearance was rapid .


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


Administration time was approximately @min/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 @ mmol/L .


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


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


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


The average @-hour plasma glucose level was @ @ mmol/L .


After intervention , aerobic training significantly improved fasting insulin ( from @ @ U/mL to @ @ U/mL ) , @-hour glucose level ( from @ @ mmol/L to @ @ mmol/L ) , and HOMA-IR ( from @ @ to @ @ ) in the intervention group compared with the control group ( P < @ ) .


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


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 , @ @ years ) with SIS and @ subjects ( age , @ @ years ) asymptomatic for shoulder dysfunction were randomly assigned to @ of @ 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 , @ @ ; postintervention , @ @ ; P < @ ; moderate effect size -LSB- Cohen d = @ -RSB- ) .


Scapular internal rotation increased @ @ ( P = @ ; small effect size -LSB- Cohen d < @ -RSB- ) 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 ( @ @ ) in scapular upward rotation postintervention ( P < @ ; small effect size -LSB- Cohen d < @ -RSB- ) , which was not considered clinically significant .


Scapular anterior tilt increased @ @ during elevation and lowering of the arm postmanipulation ( P < @ ; small effect size -LSB- Cohen d < @ -RSB- ) 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 @ .


J Orthop Sports Phys Ther @ ; @ ( @ ) :@ -@ .


Epub @ May @ .


doi :@ / jospt @ .


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 @-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 @ treatment groups demonstrated that the video group had significantly greater improvement in knowledge scores ( @ @ ) as compared with the pamphlet group ( @ @ , p < @ ) .


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 ( NaNO@ ) 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 NaNO@ infusion .


Twenty-five patients with severe chronic HF were recruited .


Eight received short-term ( @ minutes ) intravenous NaNO@ at @ g/kg/min and @ received @ g/kg/min with measurement of cardiac hemodynamics .


During infusion of @ g/kg/min , left ventricular stroke volume increased ( from @ to @ mL ; P = @ ) , with marked falls in pulmonary vascular resistance ( by @ % ; P = @ ) and right atrial pressure ( by @ % ; P = @ ) , but with only modest falls in mean arterial blood pressure ( by @ mm Hg ; P = @ ) .


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


Directionally similar effects were observed for the above hemodynamic parameters with @ 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 NaNO@ 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 @ g/ml ) and remifentanil .


Remifentanil Ce was randomized to @ , @ , @ , or @ng/ml .


SNT was a @-mA , @-s , @-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 @ patients analyzed moved during cervix dilatation .


Mean PDRA ( @ SD ) evoked by SNT was @ mm in movers and @ in non-movers ( P < @ ) .


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


Area under the receiver operating characteristics curve for PDRA was @ ( @ % CI , @ to @ ) and for remifentanil Ce @ ( @ to @ ) , 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 = @ ) who smoke at least @ cigarettes/day and failed previous treatments were recruited from the general population .


Participants were randomized to receive @ 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 @ % at the end of the treatment and an estimated @ % @ 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 @ consecutive patients referred to a PH center over a @-year period undergoing quasi-simultaneous ( within @ 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 @ mm Hg .


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


Ten of @ patients ( @ % ) had no PH , @ of @ ( @ % ) had precapillary PH , and @ of @ ( @ % ) had postcapillary PH. The following five echocardiographic variables were found to predict precapillary PH : right heart chamber larger than the left ( P = @ ) , left ventricular eccentricity index > @ ( P = @ ) , dilated inferior vena cava without inspiratory collapse ( P = @ ) , E/e ' ratio @ ( P = @ ) , and the right ventricle forming the heart apex ( P = @ ) .


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


The score based on coefficients , ranging from @ to @ points , resulted in optimal discrimination at > @ , with a positive predictive value of @ % and a negative predictive value of @ % 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 @ to February @ .


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 @ for Windows .


Participation rate was @ % with @ inguinal/femoral hernias in @ patients : @ randomized to single-port and @ 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 @ vs @ min , P = @ , respectively .


Significantly , single-port patients ingested fewer pain killers : @ tablets vs @ Dextropropoxyphene tablets , P < @ , experienced less pain ( visual analog scores ) on day @ and @ post-op op : @ and @ , P < @ compared to @ and @ , P < @ , respectively , returned to work/normal physical activities @days quicker : @ vs @ , P < @ and had higher cosmetic scar scores at @-week follow-up : @ vs @ , P < @ , compared to multiport patients .


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


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 @ 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-@ , which was administered as either a @-mg intravenous dose or a @-mg subcutaneous dose , or placebo every @ weeks for @ weeks .


The primary outcome was the rate of exacerbations .


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


Safety was also assessed .


The rate of exacerbations was reduced by @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) among patients receiving intravenous mepolizumab and by @ % ( @ % CI , @ to @ ) among those receiving subcutaneous mepolizumab , as compared with those receiving placebo ( P < @ for both comparisons ) .


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


At week @ , the mean increase from baseline in FEV@ was @ ml greater in patients receiving intravenous mepolizumab than in those receiving placebo ( P = @ ) and @ ml greater in patients receiving subcutaneous mepolizumab than in those receiving placebo ( P = @ ) .


The improvement from baseline in the SGRQ score was @ points and @ points greater in the intravenous and subcutaneous mepolizumab groups , respectively , than in the placebo group ( minimal clinically important change , @ points ) , and the improvement in the ACQ-@ score was @ points and @ points greater in the two mepolizumab groups , respectively , than in the placebo group ( minimal clinically important change , @ points ) ( P < @ 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 , NCT@ . )


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 @ in @ 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 , @ mg/kg ketamine mixed in @ cc/kg apple juice was given to the children in oral ketamine group and @ cc/kg of apple juice alone was given to the children in the peritonsillar group .


After general anesthesia and three minutes before surgery @ cc of @ % normal saline in the oral group and @cc of ketamine ( @ 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 < @ ) and the severity of postoperative bleeding was significantly higher in peritonsillar group ( P = @ ) .


However , postoperative bleeding recurred in @ patients ( @ % ) 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 ( @ @ ) than in the oral group ( @ @ ) ( P < @ ) .


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 @ % 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 = @ ) 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 @ days before the @-month ( n = @ ) and @-month ( n = @ ) clinic visits .


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


Underestimation of self-reported weights increased significantly from @ months ( mean -@ kg , SD @ kg ) to @ months ( mean -@ kg , SD @ kg ; P = @ ) .


The average absolute difference also increased from @ months ( mean @ kg , SD @ kg ) to @ months ( mean @ , SD @ kg ; P < @ ) .


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


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


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


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 .


The quality of surgery with D@ resection in randomized controlled clinical trial -LSB- Japan Clinical Oncology Group study ( JCOG@ ) -RSB- was assessed by evaluation of the photo documentation of both open and laparoscopic surgeries .


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


A total of @ ( open , @ ; laparoscopic , @ ) 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 D@ resection was @ % ( @/@ ) in the open arm and @ % ( @/@ ) in the laparoscopic arm , and for left-sided tumors , they were @ % ( @/@ ) and @ % ( @/@ ) , respectively .


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


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


Completion of high quality surgery with D@ resection was confirmed in JCOG@ 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 @ subjects with adolescent ADHD with control subjects at the age of @-@ years .


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


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


Permutation testing was used to test for differences in mean values of FA , MD , and @-@ 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 < @ ) .


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-@ is an investigational VEGFR-@ 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 @-@ were conducted in healthy male volunteers and examined safety and pharmacokinetics across a dose range of @-@ mg .


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


Three formulations and food effect were assessed .


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


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


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


With longer duration multiple-dose administration ( @ weeks ) , trough concentrations decreased from Day @ at doses of @ 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-@ does not support continued development .


The early pharmacokinetic profile of the compound provides important information as to the probability of success of MK-@ 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 @ outpatients between @ and @ 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 = @ ) , subjects bathed in Lake Hvz and in group II ( N. = @ ) , patients were treated in a pool full of tap water .


Water temperature was @ C for both groups .


Participants underwent @-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 @-Dimension Self-Report Questionnaire score ( EQ-@D ) .


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


Comparison of the two groups revealed a statistically significant difference in pain visual analogue scale scores ( P < @ ) , active flexion degree ( P < @ ) , physical function components of WOMAC ( P < @ ) , and EQ-@D scores ( P < @ ) even after @ 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-@ receptor agonists , once-weekly albiglutide and once-daily liraglutide , in patients with type @ diabetes inadequately controlled on oral antidiabetic drugs .


We undertook this @-week , open-label , phase @ non-inferiority study at @ sites in eight countries : USA ( @ sites ) , Australia ( @ sites ) , Peru ( @ sites ) , Philippines ( @ sites ) , South Korea ( @ sites ) , UK ( @ sites ) , Israel ( @ sites ) , and Spain ( @ sites ) .


@ adult participants ( aged @ years ) with inadequately controlled type @ diabetes and a BMI between @ and @ kg/m ( @ ) were enrolled and randomised in a @:@ ratio to receive albiglutide @ mg once weekly titrated to @ mg at week @ , or liraglutide @ mg once daily titrated to @ mg at week @ and @ mg at week @ .


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


Participants and investigators were unmasked to treatment .


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


The primary analysis was by modified intention to treat .


The study is registered with ClinicalTrials.gov , number NCT@ .


@ patients were randomly allocated to the albigultide group and @ to the liraglutide group ; @ patients in the abliglutide group and @ in the liraglutide group received the study drugs .


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


Model-adjusted change in HbA@c from baseline to week @ was -@ % ( @ % CI -@ to -@ ) in the albigludite group and -@ % ( -@ to -@ ) in the liraglutide group ; treatment difference was @ % ( @-@ ; non-inferiority p value = @ ) .


Injection-site reactions occurred in more patients given albiglutide than in those given liraglutide ( @ % vs @ % ; treatment difference @ % -LSB- @ % CI @-@ -RSB- ; p = @ ) , whereas the opposite was the case for gastrointestinal events , which occurred in @ % of patients in the liraglutide group versus @ % in the albiglutide group ( treatment difference -@ % -LSB- @ % CI -@ to -@ -RSB- ; p = @ ) .


Patients who received once-daily liraglutide had greater reductions in HbA@c 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 .


Up to @ % 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 @ on the Hamilton Depression Rating Scale were randomly assigned to a yoga ( N = @ ) or wait-list control ( N = @ ) group .


The yoga intervention consisted of @ classes over @ 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 @ % 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 .


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 PaCO@ as the main outcome measure .


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


Arterial blood gas parameters , clinical symptoms , health-related quality-of-life assessments , polysomnography , spirometry , @-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 , @ patients were selected , and @ were randomized .


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


In the CPAP group , PaCO@ 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 @-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 ( NCT@ ) .


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 CYP@ inhibitor that lowers serum testosterone ( < @ ng/dL ) and improves survival in metastatic PCa .


The possibility that greater androgen suppression in patients with localized high-risk PCa will result in improved clinical outcomes makes paramount the reassessment of neoadjuvant ADT with more robust androgen suppression .


A neoadjuvant randomized phase II trial of LHRHa with AA was conducted in patients with localized high-risk PCa ( N = @ ) .


For the first @ weeks , patients were randomly assigned to LHRHa versus LHRHa plus AA .


After a research prostate biopsy , all patients received @ additional weeks of LHRHa plus AA followed by prostatectomy .


The levels of intraprostatic androgens from @-week prostate biopsies , including the primary end point ( dihydrotestosterone/testosterone ) , were significantly lower ( dehydroepiandrosterone , ( @ ) - androstene-@ ,@ - dione , dihydrotestosterone , all P < @ ; testosterone , P < @ ) with LHRHa plus AA compared with LHRHa alone .


Prostatectomy pathologic staging demonstrated a low incidence of complete responses and minimal residual disease , with residual T@ - or lymph node-positive disease in the majority .


LHRHa plus AA treatment suppresses tissue androgens more effectively than LHRHa alone .


Intensive intratumoral androgen suppression with LHRHa plus AA before prostatectomy for localized high-risk PCa may reduce tumor burden .


We evaluated the analgesic effect of ropivacaine infiltration into the surgical wound after caesarean section .


In a double-blind trial , @ patients who were scheduled for caesarean section under spinal anaesthesia were randomly assigned to receive either @ % ropivacaine or placebo ( NaCl @ % ) through a multi-orifice catheter that was placed into the surgical wound , between the muscle fascia and the subcutaneous tissue .


The study drug was administered as a bolus of @ml at the end of the operation , followed by an infusion at @ml/h for @h .


All patients were also given paracetamol and ibuprofen .


The primary outcome was the total amount of rescue oxycodone needed during the first @h post-operatively .


Secondary outcomes included pain and patient satisfaction scores .


Analyses were according to intention to treat .


The mean ( standard deviation ) amount of oxycodone administered during the first @h was @ mg in the ropivacaine group and @ mg in the placebo group ( @ % confidence interval for the difference between means , -@ -@ mg ; P = @ ) .


There were no differences between the groups in pain scores or in patient satisfaction scores .


Continuous wound infiltration with ropivacaine did not decrease the need for opioids and had no impact on pain scores or patient satisfaction after caesarean section .


Botulinum toxin type A is a first-line treatment for post-stroke focal spasticity , and the accuracy in delivering the toxin to the target muscles may influence the treatment outcome .


Our aim was to compare the reduction of spasticity and the related finger position at rest improvement in post-stroke patients treated with botulinum toxin type A in upper limb muscles using ultrasound guidance and manual needle placement .


In a randomized clinical trial , two groups of @ stroke patients were treated with botulinum toxin type A injections in the wrist and finger flexor muscles of the affected upper limb using ultrasound guidance or manual needle placement .


The Modified Ashworth Scale and the finger position at rest were measured at baseline and one month after toxin injections .


After one month of follow-up from toxin injections , the Modified Ashworth Scale and finger position at rest significantly improved in both treatment groups , although these clinical outcomes were significantly better in patients treated under ultrasound guidance than in patients injected using manual needle placement .


Ultrasound guidance for botulinum toxin type A injections could improve clinical outcome measures better than manual needle placement in post-stroke patients with spasticity .


This study was designed to investigate the topical anesthetic efficacy of four different solutions including lidocaine spray , bupivacaine , ropivacaine , and prilocaine used in patients undergoing transnasal fiberoptic nasopharyngolaryngoscopic examination ( TFL ) .


The study included @ patients who underwent anterior rhinoscopy and TFL examination as a part of routine otolaryngological evaluation in our outpatient clinics .


Of these , @ were female and @ were male patients .


The mean age of the patients was @ @ years ( aged between @ and @ years ) .


The patients were randomly divided into five groups .


Five groups received one of the local anesthetics studied in our trial ( @ % lidocaine , @ % ropivacaine , @ % bupivacaine , @ % prilocaine , and saline solution ) in each right side of the nose for @ minutes before TFL .


Each separate examination was performed on the right side of the nasal cavity .


After the examination , the patients were asked to note the intensity of the pain that they have experienced during the TFL , by using a @-mm visual analog scale ( VAS ) .


The mean VAS scores were @ ( SD , @ ) in the lidocaine group , @ ( SD , @ ) in the prilocaine group , @ ( SD , @ ) in the ropivacaine group , @ ( SD , @ ) in the bupivacaine group , and @ ( SD , @ ) in the saline solution group .


The lidocaine and prilocaine groups had significantly better VAS scores versus ropivacaine , bupivacaine , and saline solution groups ( p < @ ) .


To provide ideal examination comfort and optimum patient tolerability during TFL evaluation of upper respiratory airway topical lidocaine and prilocaine applications were found to be more efficacious and effective medication for anesthesia of the intranasal mucosa compared with bupivacaine and ropivacaine solutions .


N ( @ ) - methylnicotinamide ( NMN ) was proposed as an in vivo probe for drug interactions involving renal cation transporters , which , for example , transport the oral antidiabetic drug metformin , based on a study with the inhibitor pyrimethamine .


The role of NMN for predicting other interactions with involvement of renal cation transporters ( organic cation transporter @ , OCT@ ; multidrug and toxin extrusion proteins @ and @-K , MATE@ and MATE@-K ) is unclear .


We determined inhibition of metformin or NMN transport by trimethoprim using cell lines expressing OCT@ , MATE@ , or MATE@-K .


Moreover , a randomized , open-label , two-phase crossover study was performed in @ healthy volunteers .


In each phase , @ mg metformin hydrochloride was administered p.o. in the evening of day @ and in the morning of day @ .


In phase B , @ mg trimethoprim was administered additionally p.o. twice daily for @ days .


Metformin pharmacokinetics and effects ( measured by OGTT ) and NMN pharmacokinetics were determined .


Trimethoprim inhibited metformin transport with K i values of @ , @ , and @ M and NMN transport with IC@ values of @ , @ , and @ M for OCT@ , MATE@ , and MATE@-K , respectively .


In the clinical study , trimethoprim increased metformin area under the plasma concentration-time curve ( AUC ) by @ % and decreased metformin and NMN renal clearances by @ and @ % , respectively ( p @ ) .


Moreover , decreases of NMN and metformin renal clearances due to trimethoprim correlated significantly ( r S = @ , p = @ ) .


These data on the metformin-trimethoprim interaction support the potential utility of N ( @ ) - methylnicotinamide as an endogenous probe for renal drug-drug interactions with involvement of renal cation transporters .


Variability in responsiveness to clopidogrel is a clinical problem in secondary prevention after cerebral ischaemia which has been suggested to be linked to competitive metabolization of clopidogrel and cytochrome P@ ( CYP ) @A@-oxidated statins such as simvastatin .


We assessed the hypothesis that simvastatin , in contrast to CYP @C@-metabolized fluvastatin , reduces clopidogrel-mediated platelet inhibition .


We performed a randomized , double-blind , double-dummy , two period crossover study in @ patients with cerebral ischaemia ( @F , @M ) , aged @ years ( meanSD ) .


After a @ day period in which all patients received @mg clopidogrelday ( -@ ) , patients additionally received either @mg simvastatinday ( -@ ) or @mg fluvastatinday ( -@ ) for @ days .


Regimens were crossed over after a @ day wash-out period and switched regimens were continued for another @ days .


Platelet aggregation , clopidogrel active metabolite ( CAM ) plasma concentrations and routine laboratory parameters including prothrombin time ( PT ) Quick percent value were assessed at baseline and following each treatment phase .


Clopidogrel reduced platelet aggregation in all patients as expected .


Platelet aggregation and CAM plasma concentrations were unaltered when simvastatin or fluvastatin was added to clopidogrel .


Simvastatin decreased PT Quick percent value ( decrease from @ % to @ % , P < @ ) when combined with clopidogrel but there was no such change following treatment with fluvastatin and clopidogrel .


Our data indicate that treatment with CYP @A@-metabolized simvastatin does not jeopardize clopidogrel-mediated inhibition of platelet aggregation .


After co-administration of simvastatin and clopidogrel we observed a decrease in the PT Quick percent value which could be due to simvastatin-induced reduction of activity of prothrombin fragment @ + @ .


The aim of this study was to test the efficacy of long-term , daily intake of erythritol and xylitol candy , compared with sorbitol candy , on the development of enamel and dentin caries lesions .


The study was a double-blind randomized controlled prospective clinical trial .


Altogether @ primary school children , first - and second-graders at baseline , from southeastern Estonia participated in this @-year intervention .


Each child consumed four erythritol , xylitol or sorbitol ( control ) candies three times per school day .


The daily intake of polyol was about @ g.


The International Caries Detection and Assessment System ( ICDAS ) was used in the clinical examinations by four calibrated examiners at baseline and at @ , @ and @ months .


The annual examination analyses and the follow-up analyses confirmed that the number of dentin caries teeth and surfaces at @ months follow-up and surfaces at @ months follow-up was significantly lower in the mixed dentition in the erythritol group than in the xylitol or control group .


Time of enamel/dentin caries lesions to develop and of dentin caries lesions to progress was significantly longer in the erythritol group compared to the sorbitol and xylitol groups .


Also the increase in caries score was lower in the erythritol group than in the other groups .


In the follow-up examinations , a lower number of dentin caries teeth and surfaces was found in the erythritol group than in the xylitol or control groups .


Time to the development of caries lesions was longest in the erythritol group .


Patients ' recall of provided information during bad news consultations is poor .


According to the attentional narrowing hypothesis , the emotional arousal caused by the bad news might be responsible for this hampered information processing .


Because affective communication has proven to be effective in tempering patients ' emotional reactions , the current study used an experimental design to explore whether physician 's affective communication in bad news consultations decreases patients ' anxiety and uncertainty and improves information recall .


Two scripted video-vignettes of a bad news consultation were used in which the physician 's verbal communication was manipulated ( standard vs. affective condition ) .


Fifty healthy women ( i.e. , analogue patients ) randomly watched @ of the @ videos .


The effect of communication on participants ' anxiety , uncertainty , and recall was assessed by self-report questionnaires .


Additionally , a moderator analysis was performed .


Affective communication reduced anxiety ( p = @ ) and uncertainty ( p = @ ) , and improved recall ( p = @ ) , especially for information about prognosis ( p = @ ) and , to some extent , for treatment options ( p = @ ) .


The moderating effect of ( reduced ) anxiety and uncertainty on recall could not be confirmed and showed a trend for uncertainty .


Physicians ' affective communication can temper patients ' anxiety and uncertainty during bad news consultations , and enhance their ability to recall medical information .


The reduction of anxiety and uncertainty could not explain patients ' enhanced recall , which leaves the underlying mechanism unspecified .


Our findings underline the importance of addressing patients ' emotions and provide empirical support to incorporate this in clinical guidelines and recommendations .


Trials aimed at preventing cognitive decline through cognitive stimulation among those with normal cognition or mild cognitive impairment are of significant importance in delaying the onset of dementia and reducing dementia prevalence .


One challenge in these prevention trials is sample recruitment bias .


Those willing to volunteer for these trials could be socially active , in relatively good health , and have high educational levels and cognitive function .


These participants ' characteristics could reduce the generalizability of study results and , more importantly , mask trial effects .


We developed a randomized controlled trial to examine whether conversation-based cognitive stimulation delivered through personal computers , a webcam and the internet would have a positive effect on cognitive function among older adults with normal cognition or mild cognitive impairment .


To examine the selectivity of samples , we conducted a mass mail-in survey distribution among community-dwelling older adults , assessing factors associated with a willingness to participate in the trial .


Two thousand mail-in surveys were distributed to retirement communities in order to collect data on demographics , the nature and frequency of social activities , personal computer use and additional health-related variables , and interest in the prevention study .


We also asked for their contact information if they were interested in being contacted as potential participants in the trial .


Of @,@ surveys returned ( @ % response rate ) , @ surveys had complete data for all the variables of interest .


Among them , @ showed interest in the study and provided their contact information ( operationally defined as the committed with interest group ) , @ provided contact information without interest in the study ( committed without interest group ) , @ showed interest , but provided no contact information ( interest only group ) , and @ showed no interest and provided no contact information ( no interest group ) .


Compared with the no interest group , the committed with interest group were more likely to be personal computer users ( odds ratio ( OR ) = @ ) , physically active ( OR = @ ) and had higher levels of loneliness ( OR = @ ) .


Increasing potential participants ' familiarity with a personal computer and the internet before trial recruitment could increase participation rates and improve the generalizability of future studies of this type .


The Institute of Medicine has included the comparison of minimally invasive surgical techniques in its research agenda .


This study seeks to evaluate a model for the comparison of minimally invasive procedures using patient-reported outcomes .


A double-blinded randomized controlled trial ( NCT@ ) was conducted .


Baseline data were obtained , standardized anesthesia was induced , and patients were randomized to single-port ( SP ) or @-port ( FP ) laparoscopic cholecystectomy .


Perioperative care was standardized .


The outcomes were pain ( Visual Analog Scale ) on postoperative day @ ( primary ) and quality of life ( Patient-Reported Outcomes Measures Information System and Linear Analog Self-Assessment ) , serum cytokines , and heart rate variability ( secondary ) .


Analysis was intention to treat .


Using identical occlusive dressings , patients and the outcomes assessor remained blinded until postoperative day @ .


Fifty-five patients were randomized to each arm .


There was no difference in demographics .


Visual Analog Scale pain score on postoperative day @ was significantly different from baseline in each group ( SP : @ @ to @ @ vs FP : @ @ to @ @ ) , but not different from each other ( p = @ ) .


Patients in the FP arm reported significantly less fatigue on postoperative day @ than patients in the SP group ( @ @ vs @ @ ; p = @ ) .


Fewer patients in the FP group required postoperative oral narcotics before discharge ( @ % vs @ % ; p = @ ) .


Cytokines levels and heart rate variability were similar between arms .


In patients followed for > @ year , no difference in umbilical hernia rates was noted .


Early postoperative quality of life data captured differences in fatigue , indicating improved recovery after FP within a controlled trial .


Physiologic measures were similar , suggesting that the differences between SP and FP are minimal .


The aim of this study was to evaluate the effects of pistachio nuts as an adjunct to diet and exercise on body composition , metabolic , inflammatory , and oxidative stress parameters in Asian Indians with metabolic syndrome .


In this @-wk randomized control trial , @ individuals with the metabolic syndrome were randomized to either pistachio ( intervention group ) or control group ( diet as per weight and physical activity profile , modulated according to dietary guidelines for Asian Indians ) after @ wk of a diet and exercise run in .


In the first group , unsalted pistachios ( @ % energy ) were given daily .


A standard diet and exercise protocol was followed for both groups .


Body weight , waist circumference ( WC ) , magnetic resonance imaging estimation of intraabdominal adipose tissue and subcutaneous abdominal adipose tissue , fasting blood glucose ( FBG ) , fasting serum insulin , glycosylated hemoglobin , lipid profile , high-sensitivity C-reactive protein ( hs-CRP ) , adiponectin , free fatty acids ( FFAs ) , tumor necrosis factor ( TNF ) - , leptin , and thiobarbituric acid reactive substances ( TBARS ) were assessed before and after the intervention .


Statistically significant improvement in mean values for various parameters in the intervention group compared with control group were as follows : WC ( P < @ ) , FBG ( P < @ ) , total cholesterol ( P < @ ) , low-density lipoprotein cholesterol ( P < @ ) , hs-CRP ( P < @ ) , TNF - ( P < @ ) , FFAs ( P < @ ) , TBARS ( P < @ ) , and adiponectin levels ( P < @ ) .


A single food intervention with pistachios leads to beneficial effects on the cardiometabolic profile of Asian Indians with metabolic syndrome .


Multidetector CT ( MDCT ) is the established imaging modality in diagnostics of urolithiasis .


The aim of iterative reconstruction ( IR ) is to allow for a radiation dose reduction while maintaining high image quality .


This study evaluates its performance in MDCT for assessment of urolithiasis .


Fifty-two patients underwent non-contrast abdominal MDCT .


Twenty-six patients were referred to MDCT under suspicion of urolithiasis , and examined using a dose-reduced scan protocol ( RDCT ) .


Twenty-six patients , who had undergone standard-dose MDCT , served as reference for radiation dose comparison .


RDCT images were reconstructed using an IR system ( iDose@ , Philips Healthcare , Cleveland , OH , USA ) .


Objective image noise ( OIN ) was recorded and five radiologists rated the subjective image quality independently .


Radiation parameters were derived from the scan protocols .


The CTDIvol could be reduced by @ % to @ mGy ( P < @ ) .


The same reduction was achieved for DLP and effective dose to @mGy * cm ( P < @ ) and @ mSv ( P < @ ) .


IR led to a reduction of the OIN of up to @ % compared with classic filtered back projection ( FBP ) ( P < @ ) .


The OIN declined with increasing IR levels .


RDCT with FBP showed the lowest scores of subjective image quality ( @ ) .


Mean scores improved with increasing IR levels .


iDose@ was rated with the best mean score ( @ ) .


The evaluated IR-tool and protocol may be applied to achieve a considerable radiation dose reduction in MDCT for diagnostics of urolithiasis while maintaining a confident image quality .


Best image quality , suitable for evaluation of the entire abdomen concerning differential diagnoses , was achieved with iDose@ .


To evaluate the role of calcium infusion as a preventive strategy of ovarian hyperstimulation syndrome ( OHSS ) in women at high risk in in vitro fertilization ( IVF ) / intracytoplasmic sperm injection ( ICSI ) treatment cycles .


Double-blinded randomized controlled trial .


University hospital department of obstetrics and gynecology and private IVF center .


Two hundred women at risk to develop OHSS undergoing IVF/ICSI treatment cycle .


The intervention group ( group @ ; n = @ ) received intravenous infusion of @ mL @ % calcium gluconate in @ mL @ % saline solution on the day of ovum pick-up ( OPU ) and days @ , @ , and @ after , and the placebo group ( group @ ; n = @ ) received @ mL @ % saline solution on the day of OPU and days @ , @ , and @ after .


Incidence of OHSS .


OHSS incidence was significantly higher in the placebo group ( group @ ) than in the calcium infusion group ( group @ ) : @ ( @ % ) vs. @ ( @ % ) ; moderate OHSS was significantly higher in group @ than in group @ : @ ( @ % ) vs. @ ( @ % ) ; and severe OHSS was significantly higher in group @ than in group @ : @ ( @ % ) vs. @ .


Intravenous calcium infusion effectively reduced the incidence of OHSS development without reduction in the pregnancy rate .


Constitutive activation of the epidermal growth factor receptor ( EGFR ) is prevalent in epithelial cancers , particularly in non-small cell lung carcinoma ( NSCLC ) .


Mutations identified in EGFR predict the sensitivity to EGFR-targeted therapy .


Detection of these mutations is mainly based on tissue biopsy , which is invasive , expensive , and time consuming .


Noninvasive , real-time , inexpensive detection and monitoring of EGFR mutations in patients with NSCLC is highly desirable .


We developed a novel core technology , electric field-induced release and measurement ( EFIRM ) , which relies on a multiplexible electrochemical sensor that can detect EGFR mutations directly in bodily fluids .


We established EFIRM for the detection of the EGFR mutations in vitro and correlated the results with tumor size from xenografted mice .


In clinical application , we demonstrated that EFIRM could detect EGFR mutations in the saliva and plasma of @ patients with NSCLC .


Finally , a blinded test was performed on saliva samples from @ patients with NSCLC .


The receiver operating characteristic analysis indicated that EFIRM detected the exon @ deletion with an area under the curve of @ and the L@R mutation with an area under the curve of @ .


Our data indicate that EFIRM is effective , accurate , rapid , user-friendly , and cost effective for the detection of EGFR mutations in the saliva of patients with NSCLC .


We termed this saliva-based EGFR mutation detection ( SABER ) .


Postcancer fatigue is a frequently occurring problem , impairing quality of life .


Little is known about ( neuro ) physiological factors determining postcancer fatigue .


It may be hypothesized that postcancer fatigue is characterized by low peripheral muscle fatigue and high central muscle fatigue .


The aims of this study were to examine whether central and peripheral muscle fatigue differ between fatigued and non-fatigued cancer survivors and to examine the effect of cognitive behavioral therapy ( CBT ) on peripheral and central muscle fatigue of fatigued cancer survivors in a randomized controlled trial .


Sixteen fatigued patients in the intervention group ( CBT ) and eight fatigued patients in the waiting list group were successfully assessed at baseline and six months later .


Baseline measurements of @ fatigued patients were compared with @ non-fatigued patients .


A twitch interpolation technique and surface electromyography were applied , respectively , during sustained contraction of the biceps brachii muscle .


Muscle fiber conduction velocity ( MFCV ) and central activation failure ( CAF ) were not significantly different between fatigued and non-fatigued patients .


Change scores of MFCV and CAF were not significantly different between patients in the CBT and waiting list groups .


Patients in the CBT group reported a significantly larger decrease in fatigue scores than patients in the waiting list group .


Postcancer fatigue is neither characterized by abnormally high central muscle fatigue nor by low peripheral muscle fatigue .


These findings suggest a difference in the underlying physiological mechanism of postcancer fatigue vs. other fatigue syndromes .


Reactivation of human herpesvirus ( HHV ) -@ and HHV-@ has been linked to various posttransplant adverse events through immunomodulatory effects .


The potential utility of monitoring for HHV-@ and HHV-@ viremia remains unclear .


In this clinical trial , @ liver transplant recipients were randomized to be monitored in real-time for HHV-@ and HHV-@ viremia by polymerase chain reaction at regular intervals from @ to @ weeks after transplantation ( `` monitoring '' group ) or to undergo usual care ( `` no-monitoring '' group ) .


Therapeutic intervention for a positive polymerase chain reaction result included reduction in immunosuppression and preemptive antiviral therapy , at the discretion of the attending team .


The primary outcome was a composite of adverse events indirectly attributable to viral reactivation ( including opportunistic infection , graft rejection and severe hepatitis C virus recurrence ) .


In the `` monitoring '' group , HHV-@ and HHV-@ viremia occurred in @ of @ patients ( @ % ) and @ of @ patients ( @ % ) patients , respectively .


We found no cases of symptomatic HHV-@ and HHV-@ disease .


Some therapeutic interventions were performed in @ % of viremic episodes .


There were no differences in cumulative incidence of the primary outcome between the `` monitoring '' and `` no-monitoring '' groups at @ year ( @ % vs. @ % ; odds ratio , @ ; @ % confidence interval , @-@ @ ) or at @ years after transplantation ( @ % vs. @ % ; odds ratio , @ ; @ % confidence interval , @-@ @ ) .


However , we found a trend toward a lower incidence of graft rejection at year @ in the `` monitoring '' group ( @ % vs. @ % ; P = @ ) .


In this first trial , no benefit could be demonstrated from routine monitoring of HHV-@ and HHV-@ viremia in graft or patient outcome after liver transplantation .


To compare therapeutic effects between suspine rotation and flexion manipulation for treating lumbar disc herniation .


From December @ to January @ , @ patients with lumbar disc herniation were treated , including @ males and @ females , ranging in age from @ to @ years ,@ patients with age over @ years old .


According to diagnosis the ladder of the @ cases bulging type , @ hernia type , @ cases free type .


The patients were randomly divided into treatment group ( @ cases ) and control group ( @ cases ) .


All the patients were treated with the three-dimensional computer-controlled traction therapeutic apparatus , with continued traction for @ minutes .


After traction , flexion manipulation and rotat-ing manipulation were respectively adopted in treatment group and control group ( on alternate days one time , @ times as a course of treatment ) .


The symptoms and signs ( including back pain and discomfort , lower limb pain and numbness , powerless urination and defecation , numbness in perineum , straight-leg raising degree , ability of lower extremity walking , work and live ) of patients were observed after treatment .


All patients were followed up for @ to @ months with an average of @ months .


After treatment , the symptoms and signs of patients have significantly improved ( P < @ ) , but the symptomes of powerless urination and defecation , numbness in perineum was not improved obviously ( P > @ ) .


Forty-two of @ patients in treatment group got excellent result , moderate in @ , poor in @ ; Twenty of @ patients in control group got excellent result , moderate in @ , poor in @ .


The whole effect of lumbar backwards rotation manipulation is more satisfactory than flexsion manipulation for treating lumbar intervertebral disc herniation .


But spinning force and times should be noticed .


Gastroscopy and gastroscopic mucosal biopsy techniques have become increasingly used as of late for evaluating symptoms presumed to be originated in the upper gastrointestinal tract .


Patients often complain however of abdominal pain post-gastroscopic mucosal biopsy , and this study aimed to explore the necessity of acid inhibitors when abdominal pain worsened .


In this randomized , double-blinded , placebo-controlled study , we screened @ participants , and ultimately enrolled @ into the study .


These @ participants were randomly assigned in a @:@ ratio to receive acid inhibitors ( esomeprazole , treatment group , n = @ ; dose ,@ mg/d ) or matched placebo ( control group , n = @ ) for @ days post-gastroscopic mucosal biopsy .


The presence of abdominal pain was observed pre-and post-gastroscopy , and the therapeutic effect of esomeprazole was assessed .


This study was registered at the Chinese clinical trial registry as ChiCTR-TRC-@ .


Ten subjects were lost to followup ( @ in treatment group ; @ in the control group ) .


There was no significant difference in the number of subjects with aggravating abdominal pain ( treatment @ % vs. control @ % ; p > @ ) between the two groups .


Esomeprazole did not significantly ( p > @ ) affect the rate of abdominal pain within @ h ( treatment @ % vs. control @ % ) , @ h ( treatment @ % vs. control @ % ) , and @ h ( treatment @ % vs. control @ % ) on abdominal pain in all in the evaluated subjects .


Between the two groups however , a statistically significant difference ( p < @ ) was found on overall effective treatment rates at @ h ( treatment @ % vs. control @ % ) and at @ h ( treatment @ % vs. control @ % ) in the subjects with worsened abdominal pain .


The study suggests that routine prophylaxis with acid inhibitors is not recommended for all patients post-gastroscopic mucosal biopsy , however acid inhibitors should be administered for patients with aggravating abdominal pain .


To characterize relationships between specific immune cell subsets in bone marrow ( BM ) or granulocyte colony-stimulating factor-mobilized peripheral blood ( PB ) stem cells collected from unrelated donors and clinical outcomes of patients undergoing transplantation in BMTCTN @ .


Fresh aliquots of @ BM and @ PB stem-cell allografts from North American donors randomly assigned to donate BM or PB stem cells and numbers of transplanted cells were correlated with overall survival ( OS ) , relapse , and graft-versus-host disease ( GvHD ) .


Patients with evaluable grafts were similar to all BMTCTN @ patients .


The numbers of plasmacytoid dendritic cells ( pDCs ) and nave T cells ( Tns ) in BM allografts were independently associated with OS in multivariable analyses including recipient and donor characteristics , such as human leukocyte antigen mismatch , age , and use of antithymocyte globulin .


BM recipients of > median number of pDCs , nave CD@ ( + ) T cells ( CD@Tns ) , or nave CD@ ( + ) T cells ( CD@Tns ) had better @-year OS ( pDCs , @ % v @ % ; P = @ ; CD@Tns , @ % v @ % ; P = @ ; CD@Tns , @ % v @ % ; P = @ ) .


Transplantation of more BM Tns was associated with less grade @ to @ acute GvHD but similar rates of relapse .


Transplantation of more BM pDCs was associated with fewer deaths resulting from GvHD or from graft rejection .


Analysis of PB grafts did not identify a donor cell subset significantly associated with OS , relapse , or GvHD .


Donor immune cells in BM but not PB stem-cell grafts were associated with survival after unrelated-donor allogeneic hematopoietic stem-cell transplantation .


The biologic activity of donor immune cells in allogeneic transplantation varied between graft sources .


Donor grafts with more BM-derived Tns and pDCs favorably regulated post-transplantation immunity in allogeneic hematopoietic stem-cell transplantation .


Tryptophan not only is an amino acid essential to protein synthesis but also serves as a precursor in @ important metabolic pathways : the serotonin and the kynurenine pathways .


Tryptophan is related to sleeping patterns .


The objective of the present study was to determine the tryptophan requirement of term infants using the indicator amino acid oxidation ( IAAO ) method with L - -LSB- @-C -RSB- phenylalanine as the indicator .


Enterally fed infants were randomly assigned to tryptophan intakes ranging from @ to @mgkgday as part of an elemental diet .


After @-day adaptation to the test diet , -LSB- C -RSB- bicarbonate and L - -LSB- @-C -RSB- phenylalanine tracers were given enterally .


Breath samples were collected at baseline and during isotopic plateaus .


The mean tryptophan requirement was determined by using the biphasic linear regression crossover analysis on the fraction of CO@ recovery from L - -LSB- @-C -RSB- phenylalanine oxidation ( FCO@ ) .


Data are presented as meanstandard deviation .


A total of @ term neonates ( gestational age @ weeks ) were studied at @ days .


FCO@ decreased until a tryptophan intake of @mgkgday ; additional increases in tryptophan intake did not affect FCO@ .


Mean requirement was determined to be @mgkgday .


The mean tryptophan requirement for elemental formula-fed term infants is @mgkgday .


This requirement is lower than the present recommended intake of @mgkgday , which is based on the average intake of a breastfed infant .


Although the surgical and oncological therapies of primary spinal tumors ( PSTs ) have changed significantly over the last few decades , the prognosis of this rare disease is still poor .


The decision-making process in the multidisciplinary management is handicapped by the lack of large-scale population-based prognostic studies .


The objective of the present study was to investigate preoperative factors associated with PST mortality and to develop a predictive scoring system of poor survival .


This is a large-scale ambispective cohort study .


The study included @ consecutive patients with PSTs , treated surgically over an @-year period at a tertiary care spine referral center for a population of @ million .


Survival was the outcome measure .


Patients were randomly divided into a training cohort ( n = @ ) and a validation cohort ( n = @ ) .


In the training cohort , @ preoperative factors were investigated using Cox proportional hazard models .


Based on the mortality-related variables , a simple scoring system of mortality was created , and three groups of patients were identified .


Kaplan-Meier and log-rank analyses were used to compare the survival in the three groups .


The model performance was assessed by measuring the discriminative ability ( c-index ) of the model and by applying a pseudo-R ( @ ) goodness-of-fit test ( Nagelkerke R ( @ ) , RN ( @ ) ) .


Internal validation was performed using bootstrapping in the training cohort and assessing the discrimination and explained variation of the model in the validation cohort .


Patient age , spinal region , tumor grade , spinal pain , motor deficit , and myelopathy/cauda equina syndrome were significantly associated with poor survival in the multivariate analysis ( p < @ , RN ( @ ) = @ ) .


Based on these variables , we developed the Primary Spinal Tumor Mortality Score ( PSTMS ) , where an eight-point scale was divided into three categories ( low , medium , and high mortality ) .


The three PSTMS categories were significantly associated with the overall survival ( p < @ , RN ( @ ) = @ , c = @ ) .


The model performance remained similarly high in the validation cohort ( RN ( @ ) = @ , c = @ ) .


The present study identifies six predictive variables for mortality in PSTs .


Using these six variables , an easy-to-use scoring system was developed that can be applied to the estimation of postoperative survival in all types of PST patients .


To prospectively assess the added value of gadolinium-enhanced and diffusion-weighted ( DWI ) MRI for the diagnosis of pelvic recurrence from colorectal cancer ( CRC ) .


Fifty-two patients with suspected pelvic recurrence from CRC underwent pelvic MRI with T@-weighted ( `` T@ '' ) , gadolinium-enhanced fat-suppressed T@-weighted ( `` gadolinium '' ) and DWI MR sequences .


Three readers ( senior radiologist : R@ , two residents : R@ , R@ ) scored the likelihood of recurrence on `` T@ , '' `` T@ + DWI , '' and `` T@ + Gadolinium . ''


Twenty-seven patients had @ sites of pelvic recurrence .


On `` T@ , '' R@ achieved AUC of @ , sensitivity @ % , specificity @ % .


For R@ , these figures were @ , @ % , @ % , for R@ @ , @ % , @ % .


Both Gadolinium injection and DWI significantly improved AUCs for residents but not for the senior radiologist : up to @ ( R@ , P = @ ) and to @ ( R@ , P = @ ) with DWI and to @ ( R@ , P = @ ) , @ ( R@ , P = @ ) after gadolinium .


All readers achieved slightly better AUCs with `` T@ + DWI '' than with `` T@ + Gadolinium '' but not significantly ( P = @ , P = @ , P = @ ; respectively ) .