Ten-year cumulative incidence of distant metastasis and DFS were @ % and @ % for patients with TRG @ ( complete regression ) , @ % and @ % for TRG @ and @ ( intermediate regression ) , and @ % and @ % for TRG @ and @ ( poor regression ) , respectively ( P = @ and P = @ , respectively ) .


On multivariable analysis , residual lymph node metastasis ( ypN + ) and TRG were the only independent prognostic factors for cumulative incidence of distant metastasis ( P < @ and P = @ , respectively ) and DFS ( P < @ and P = @ , respectively ) , whereas local recurrence was significantly affected by ypN status ( P < @ ) and lymphatic invasion ( P = @ ) .


Complete and intermediate tumor regressions were associated with improved long-term outcome in patients with rectal carcinoma after preoperative CRT independent of clinicopathologic parameters .


This classification system needs to be prospectively tested in multiple data sets to validate its reproducibility in a wider setting .


The current standard for pain control following liver surgery is intravenous , patient-controlled analgesia ( IV PCA ) or epidural analgesia .


We have developed a modification of a regional technique called medial open transversus abdominis plane ( MOTAP ) catheter analgesia .


The MOTAP technique involves surgically placed catheters through the open surgical site into a plane between the internal oblique muscle and the transverse abdominis muscle superiorly .


The objective of this trial is to assess the efficacy of this technique .


This protocol describes a multicentre , prospective , blinded , randomized controlled trial .


One hundred and twenty patients scheduled for open liver resection through a subcostal incision will be enrolled .


All patients will have two MOTAP catheters placed at the conclusion of surgery .


Patients will be randomized to one of two parallel groups : experimental ( local anaesthetic through MOTAP catheters ) or placebo ( normal saline through MOTAP catheters ) .


Both groups will also receive IV PCA .


The primary endpoint is mean cumulative postoperative opioid consumption over the first @ postoperative days ( @ hours ) .


Secondary outcomes include pain intensity , patient functional outcomes , and the incidence of complications .


This trial has been approved by the ethics boards at participating centres and is currently enrolling patients .


Data collection will be completed by the end of @ with analysis mid-@ and publication by the end of @ .


Telephone-administered therapies have emerged as an alternative method of delivery for the treatment of depression , yet concerns persist that the use of the telephone may have a deleterious effect on therapeutic alliance .


The purpose of this study was to compare therapeutic alliance in clients receiving cognitive behavioral therapy ( CBT ) for depression by telephone ( T-CBT ) or face-to-face ( FtF-CBT ) .


We randomized @ participants to receive @ sessions of T-CBT or FtF-CBT .


The Working Alliance Inventory ( WAI ) was administered at Weeks @ and @ .


Depression was measured during treatment and over @ year posttreatment follow-up using the Hamilton Rating Scale for Depression and Patient Health Questionnaire-@ .


There were no significant differences in client or therapist WAI between T-CBT or FtF-CBT ( Cohen 's f ranged from @ to @ , all ps > @ ) .


All WAI scores predicted depression end of treatment outcomes ( Cohen 's f ranged from @ to @ , all ps < @ ) .


The relationship between the WAI and depression outcomes did not vary by treatment group ( Cohen 's f ranged from @ to @ , ps > @ ) .


The WAI did not significantly predict depression during posttreatment follow-up ( all ps > @ ) .


Results from this analysis do not support the hypothesis that the use of the telephone to provide CBT reduces therapeutic alliance relative to FtF-CBT .


To design an educational activity and evaluate its effectiveness on increasing third-year pharmacy students ' knowledge and confidence to recommend self-care products to patients .


Faculty members created a self-care activity , the Amazing Self-Care Race , for educational use in a pharmaceutical care laboratory course .


Student teams worked competitively to complete @ stations focused on self-care .


A complex , real-world case was presented at each station .


Student recommendations were presented to a facilitator .


Prior to and following the activity , students were invited to complete an online anonymous survey instrument .


Eighty-six students completed presurvey and postsurvey instruments to assess their knowledge and perceived confidence to recommend a self-care product to a patient prior to and following participation in the Amazing Self-Care Race .


Students demonstrated a significant increase in their ability and confidence to recommend self-care products following the activity ( p < @ ) .


The Amazing Self-Care Race is an effective educational activity that increases student knowledge and confidence in self-care therapeutics .


The activity helped students to develop self-care skills , enabled them to learn through doing , encouraged them to synthesize information while making self-care recommendations , and helped them to develop confidence by thinking on their feet .


To determine the relationship between coronary plaque detected with coronary computed tomographic ( CT ) angiography and clinical parameters and cardiovascular risk factors in asymptomatic patients with diabetes .


All patients signed institutional review board-approved informed consent forms before enrollment .


Two hundred twenty-four asymptomatic diabetic patients ( @ men ; mean patient age , @ years ; mean duration of diabetes , @ years ) underwent coronary CT angiography .


Total coronary artery wall volume in all three vessels was measured by using semiautomated software .


The coronary plaque volume index ( PVI ) was determined by dividing the wall volume by the coronary length .


The relationship between the PVI and cardiovascular risk factors was determined with multivariable analysis .


The mean PVI ( standard deviation ) was @ mm ( @ ) @ .


The mean coronary artery calcium ( CAC ) score ( determined with the Agatston method ) was @ ; @ % of total plaque was noncalcified .


The PVI was related to age ( standardized = @ , P < @ ) , male sex ( standardized = @ , P < @ ) , body mass index ( BMI ) ( standardized = @ , P < @ ) , and duration of diabetes ( standardized = @ , P = @ ) .


A greater percentage of soft plaque was present in younger individuals with a shorter disease duration ( P = @ ) .


The soft plaque percentage was directly related to BMI ( P = @ ) .


Patients with discrepancies between CAC score and PVI rank quartiles had a higher percentage of soft and fibrous plaque ( @ % @ vs @ % @ -LSB- P = @ -RSB- and @ % @ vs @ % @ -LSB- P < @ -RSB- , respectively ) .


In asymptomatic diabetic patients , BMI was the primary modifiable risk factor that was associated with total and soft coronary plaque as assessed with coronary CT angiography .


Walnut consumption is associated with reduced risk of coronary heart disease ( CHD ) .


We assessed the effect of walnuts on lipid and glucose metabolism , adipokines , inflammation and endothelial function in healthy Caucasian men and postmenopausal women @years old .


Forty subjects ( meanSEM : age @years , BMI @ kg/m ( @ ) ; @ females ) were included in a controlled , cross-over study and randomized to receive first a walnut-enriched ( @g/d ) and then a Western-type ( control ) diet or vice-versa , with each lasting @weeks and separated by a @-week wash-out .


At the beginning and end of each diet phase , measurements of fasting values , a mixed meal test and an assessment of postprandial endothelial function ( determination of microcirculation by peripheral artery tonometry ) were conducted .


Area under the curve ( AUC ) , incremental AUC ( iAUC ) and treatmenttime interaction ( shape of the curve ) were evaluated for postprandial triglycerides , VLDL-triglycerides , chylomicron-triglycerides , glucose and insulin .


Compared with the control diet , the walnut diet significantly reduced non-HDL-cholesterol ( walnut vs. control : -@ vs. -@ mg/dL ; p = @ ) and apolipoprotein-B ( -@ vs. -@ mg/dL ; p = @ ) after adjusting for age , gender , BMI and diet sequence .


Total cholesterol showed a trend toward reduction ( p = @ ) .


Fasting VLDL-cholesterol , LDL-cholesterol , HDL-cholesterol , triglycerides and glucose , insulin , HOMA-IR , and HbA@c did not change significantly .


Similarly , fasting adipokines , C-reactive protein , biomarkers of endothelial dysfunction , postprandial lipid and glucose metabolism and endothelial function were unaffected .


Daily consumption of @g of walnuts for @weeks significantly reduced non-HDL-cholesterol and apolipoprotein-B , which may explain in part the epidemiological observation that regular walnut consumption decreases CHD risk .


A subgroup of oropharyngeal squamous cell carcinoma ( OPC ) is infected with high-risk human papillomavirus ( HPV ) .


The object of this study is to evaluate the efficacy of adjuvant chemotherapy with S-@ , an oral @-fluorouracil prodrug , on survival of patients with OPC according to HPV status .


Among OPC patients of stage III or IV who received definitive treatment from @ to @ , @ who were confirmed tumor-free after primary treatment were analyzed .


Before @ , none of the patients received S-@ adjuvant chemotherapy ( S-@ ( - ) - group ) ; however , all patients who were eligible were administered S-@ ( S-@ ( + ) - group ) after @ .


The expression of thymidylate synthase ( TYMS ) involved in @-FU metabolism was also examined in protein and mRNA levels .


Although there was a trend to disease-free and overall survival benefit in HPV-negative patients with S-@ , it did not achieve statistical significance ( P = @ and P = @ , respectively ) .


For the HPV-positive patients , the survivals were similar with or without S-@ administration .


TYMS-expression in HPV-positive OPC tissues was significantly higher than in HPV-negative ones in both protein and mRNA levels ( P = @ and P = @ , respectively ) .


The current study provides a rationale to plan a randomized trial to compare the efficacy of S-@ according to the HPV status in OPCs .


It is an inherent assumption in randomised controlled trials that the drug effect can be estimated by subtracting the response during placebo from the response during active drug treatment .


To test the assumption of additivity .


The primary hypothesis was that the total treatment effect is smaller than the sum of the drug effect and the placebo effect .


The secondary hypothesis was that non-additivity was most pronounced in participants with large placebo effects .


We used a within-subject randomised blinded balanced placebo design and included @ healthy volunteers ( @ % males ) , mean ( SD ) age @ ( @ ) years .


Experimental pain was induced by injections of hypertonic saline into the masseter muscle .


Participants received four injections with hypertonic saline along with lidocaine or matching placebo in randomised order : A : received hypertonic saline/told hypertonic saline ; B : received hypertonic saline + lidocaine/told hypertonic saline ; C : received hypertonic saline + placebo/told hypertonic saline + pain killer ; D : received hypertonic saline + lidocaine/told hypertonic saline + pain killer .


The primary outcome measure was the area under the curve ( AUC , mm ( @ ) ) of pain intensity during injections .


There was a significant difference between the sum of the drug effect and the placebo effect ( mean AUC @ mm ( @ ) ( @ % CI , @-@ ) ) and the total treatment effect ( mean AUC @ mm ( @ ) ( @ % CI , @-@ ) ) ( P = @ ) .


This difference was larger for participants with large versus small placebo effects ( P = @ ) , and the difference correlated significantly with the size of the placebo effect ( r = @ , P = @ ) .


Although this study examined placebo effects and not the whole placebo response as in randomised controlled trials , it does suggest that the additivity assumption may be incorrect , and that the estimated drug effects in randomised controlled trials may be underestimated , particularly in studies reporting large placebo responses .


The implications for randomised controlled trials and systematic reviews need to be discussed .


Cardiovascular diseases ( CVD ) are a leading cause of death worldwide including the Middle East .


This is caused in part by the dysregulation of adipose tissue leading to increased production of pro-inflammatory adipokines and reduction in cardio-protective adipokines such as adiponectin .


Ethnicity has been recognized as a major factor in the association between CVD risk factors and the different circulating adipokines .


In this study , for the first time , the relationship between traditional cardiovascular risk factors , Metabolic Syndrome ( MetS ) and circulating level of adipokines in Arab ethnicity was investigated .


We conducted a population-based cross-sectional survey on @ adult Arab participants living in Kuwait .


Traditional cardiovascular risk factors such as blood pressure ( BP ) , low density lipoprotein ( LDL ) and triglyceride ( TG ) were measured .


Plasma levels of circulating Leptin , Plasminogen Activator Inhibitor ( PAI-@ ) visfatin , adiponectin , resistin and adipsin were assessed using the multiplexing immunobead-based assay .


Circulating levels of High sensitivity C-Reactive Protein ( hsCRP ) , Leptin , PAI-@ and adiponectin were significantly higher in Arab women than men ( p < @ ) .


In multi-variate analysis , the homeostasis model assessment-insulin resistance ( HOMA-IR ) and body mass index ( BMI ) showed strong association with most of the biomarkers ( p < @ ) .


HsCRP showed significant association with all risk factors ( p < @ ) .


Leptin , PAI-@ and adipsin showed significant positive correlation with BMI , unlike adiponectin which showed inverse correlation ( p < @ ) .


Subjects in the highest tertile of leptin , PAI-@ and hsCRP had higher odds of having Metabolic Syndrome ( MetS ) ( odd ratio -LSB- OR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- = @-@ @ ) and ( OR = @ , @ % CI = @-@ @ ) , ( OR = @ , @ % CI = @-@ @ ) respectively .


On the other hand subjects with highest tertile of adiponectin had lower odds of having MetS ( OR = @ , @ % CI = @-@ @ ) .


Leptin , PAI-@ and hsCRP showed significant positive association with increased MetS components ( P-trend < @ ) , while adiponectin was negatively associated with increased MetS components ( P-trend < @ ) .


Our results show positive association between hsCRP , leptin , PAI-@ with increased MetS components and increase the odds of having MetS .


Adiponectin on the other hand showed inverse correlation with MetS components and associated with reduction in MetS .


Overall , our data highlights the significant clinical value these markers have in MetS especially hsCRP which can be used as good marker of low grade inflammation in Arabs .


Studies utilizing beta-hydroxy-beta-methylbutyrate ( HMB ) supplementation in trained populations are limited .


No long-term studies utilizing HMB free acid ( HMB-FA ) have been conducted .


Therefore , we investigated the effects of @ weeks of HMB-FA supplementation on skeletal muscle hypertrophy , body composition , strength , and power in trained individuals .


We also determined the effects of HMB-FA on muscle damage and performance during an overreaching cycle .


A three-phase double-blind , placebo - and diet-controlled randomized intervention study was conducted .


Phase @ was an @-week-periodized resistance-training program ; Phase @ was a @-week overreaching cycle ; and Phase @ was a @-week taper .


Muscle mass , strength , and power were examined at weeks @ , @ , @ , and @ to assess the chronic effects of HMB-FA ; and assessment of these , as well as cortisol , testosterone , and creatine kinase ( CK ) was performed at weeks @ and @ of the overreaching cycle .


HMB-FA resulted in increased total strength ( bench press , squat , and deadlift combined ) over the @-week training ( @ @ vs. @ @ kg , p < @ ) ; a greater increase in vertical jump power ( @ @ vs. @ @ W , p < @ ) ; and increased lean body mass gain ( @ @ vs. @ @ kg , p < @ ) in HMB-FA - and placebo-supplemented groups , respectively .


During the overreaching cycle , HMB-FA attenuated increases in CK ( -@ @ vs. @ @ IU/l , p < @ ) and cortisol ( -@ @ vs. @ @ g/dl , p < @ ) in the HMB-FA - and placebo-supplemented groups , respectively .


These results suggest that HMB-FA enhances hypertrophy , strength , and power following chronic resistance training , and prevents decrements in performance following the overreaching .


The current study tested whether perceived social support serves as a mediator of anxiety and depressive symptom change following evidence-based anxiety treatment in the primary care setting .


Gender , age , and race were tested as moderators .


Data were obtained from @ adult patients ( age M = @ , SD = @ ; @ % female ; @ % White , @ % Hispanic , @ % Black ) who participated in a randomized effectiveness trial ( coordinated anxiety learning and management -LSB- CALM -RSB- study ) comparing evidence-based intervention ( cognitive-behavioral therapy and/or psychopharmacology ) to usual care in the primary care setting .


Patients were assessed with a battery of questionnaires at baseline , as well as at @ , @ , and @ months following baseline .


Measures utilized in the mediation analyses included the Abbreviated Medical Outcomes ( MOS ) Social Support Survey , the Brief Symptom Index ( BSI ) - Somatic and Anxiety subscales , and the Patient Health Questionnaire ( PHQ-@ ) .


There was a mediating effect over time of perceived social support on symptom change following treatment , with stronger effects for @-month depression than anxiety .


None of the mediating pathways were moderated by gender , age , or race .


Perceived social support may be central to anxiety and depressive symptom changes over time with evidence-based intervention in the primary care setting .


These findings possibly have important implications for development of anxiety interventions .


The article presents the results of psychosocial burdens in special educators ( specialists in the field of oligophrenopedagogy ) with intellectually disabled students .


In theoretical part , specific context of occupational stress in special educators was introduced .


Additionally , the need of broader research context regarding occupational stress and the risk of burnout in special educators working with intellectually disabled individuals were included .


The results were obtained using Plichta and Pyzalski 's Questionnaire of Occupational Burdens in Teaching ( QOBT ) .


The presented results are based on a research sample ( N = @ ) of special educators ( female ) teaching intellectually disabled students attending special schools in the city of Ldz .


The obtained results were compared with the results coming from a large random sample of public school teachers working with non-intellectually disabled children from the Lodi voivodeship ( N = @ ) and referred to the norms of QOBT .


The results show significant percentage of respondents obtaining high level of occupational burdens ( conflict situations - @ % , organizational burdens - @ % , lack of work sense - @ % , global score - @ % ) .


Seniority is not related to the level of burdens .


Some significant differences concerning the level of occupational burdens between both groups of teachers were found .


The study showed e.g. the strong need for supporting special educators in the workplace context and the need of implementing preventive and remedial measures at both individual and organizational levels ( especially in terms of improving personal relationships in a workplace ) .


Generally , the results show similarity of the stressors ' ranking in special educators and school teachers working with non-intellectually disabled children .


Chronic kidney disease ( CKD ) is public health concern even in Asian countries .


TRK-@STP , a sustained release tablet of an orally-active prostacyclin analogue , beraprost sodium , is suggested to suppress worsening of some parameters of renal filtration function , containing in slope of @/serum creatinine ( @/SCr ) vs. time in a phase II clinical trial .


We describe the design of the phase IIb/III trial of TRK-@STP , CASSIOPEIR ( CRF Asian Study with Oral PGI@ derivative for Evaluating Improvement of Renal function ) conducted in approximately @ centers in China , Hong Kong , Japan , Malaysia , Republic of Korea , Taiwan , and Thailand .


A total of @ patients ( n = @ per group ) with primary glomerular disease or nephrosclerosis were planned to be enrolled .


Patients were randomized into one of three treatment groups in a double-bind , placebo-controlled manner : TRK-@STP @ g b.i.d. ; TRK-@STP @ g b.i.d. ; or placebo .


The treatment period is planned to last @ to @ years .


The primary efficacy endpoint is the renal composite endpoint including doubling of SCr and ESRD ( dialysis induction , renal transplantation , or increase in SCr to @ mg/dL ) .


This trial targeting CKD patients is designed to ( a ) demonstrate the superiority of TRK-@STP over placebo using renal composite endpoints , ( b ) determine the recommended clinical dose , and ( c ) assess the safety of TRK-@STP in this population and setting .


Indacaterol is a long-acting beta-@ agonist for once-daily treatment of COPD .


We evaluated the effects of indacaterol @g on lung hyperinflation compared with placebo and open-label tiotropium @g .


We measured physical activity during treatment with indacaterol @g and matched placebo .


We performed a randomized , three-period , cross-over study ( @days of treatment separated by two wash-out periods of @days ) with indacaterol @g or matching placebo and tiotropium @g .


Lung function was assessed by body plethysmography and spirometry .


Physical activity was measured for one week by a multisensory armband at the end of both treatment periods with indacaterol/matched placebo .


The primary endpoint was peak inspiratory capacity at the end of each treatment period .


@ patients ( mean age , @years ; mean post-bronchodilator FEV@ , @ % ) , were randomized and @ patients completed the study .


Peak inspiratory capacity was @ L greater with Indacaterol at day @ compared to placebo ( p < @ ) .


Similar results were observed for tiotropium .


Both bronchodilators also significantly improved other parameters of lung hyperinflation compared with placebo .


All parameters of physical activity were significantly increased during treatment with indacaterol versus placebo .


Indacaterol @g improved lung hyperinflation in patients with moderate COPD , which was associated with an increase of physical activity .


Available drug treatments for bipolar disorder fail to reverse patients ' cognitive deficits .


Erythropoietin has neurotrophic actions and aids neurocognitive function .


The aim of the study was to investigate the potential of erythropoietin to treat cognitive dysfunction in bipolar disorder .


Patients with an ICD-@ diagnosis of bipolar disorder in remission were randomized , with stratification by age and gender , to receive @ weekly erythropoietin ( @,@ IU ) or saline ( sodium chloride -LSB- NaCl -RSB- , @ % ) infusions in a double-blind , parallel-group design .


The first patient was randomized in September @ and last assessment was completed in October @ .


Patients were assessed at baseline and at weeks @ and @ .


The primary outcome was change in verbal memory indexed by the total words recalled across Rey Auditory Verbal Learning Test learning trials ( I-V ) from baseline to week @ ; secondary outcomes were sustained attention and facial expression recognition ; and tertiary outcomes were attention , executive function , subjective cognitive function , and mood .


Analysis was by intention to treat , using repeated-measures analysis of covariance adjusted for stratification variables and mood .


The statistical threshold for which results were considered significant was P @ ( @-tailed ) .


@ patients were randomized ; given @ dropout after baseline , results were analyzed for @ patients ( erythropoietin : n = @ ; saline : n = @ ) .


There was no significant improvement of verbal memory in erythropoietin versus saline groups ( P = @ ) .


However , erythropoietin enhanced sustained attention ( P = @ ) , recognition of happy faces ( P = @ ) , and speed of complex information processing across learning , attention , and executive function ( P = @ ) .


These effects occurred in absence of changes in simple reaction times or mood ( P values @ ) and were maintained after red blood cell normalization .


This is the first trial investigating erythropoietin to treat cognitive dysfunction in bipolar disorder .


The findings highlight erythropoietin as a candidate treatment for deficits in attention and executive function in bipolar disorder .


The objective was to compare retinal morphology and function following intravitreal injections of bevacizumab ( Avastin ) or triamcinolone ( Volon A ) in patients with early diabetic macular edema ( DME ) .


The study was planned as a randomized , prospective , interventional clinical trial .


A total of @ diabetic patients with treatment-nave , clinically significant macular edema were included in this study and randomized to two equal groups .


One group initially received three injections of @ mg bevacizumab in monthly intervals .


The second group received a single injection of @ mg triamcinolone , followed by two sham interventions .


Functional and anatomic results were evaluated monthly using ETDRS vision charts and spectral-domain optical coherence tomography .


According to the study protocol , retreatment after @ months was dependent on functional and anatomic outcome in a PRN regimen .


Baseline best corrected visual acuity ( BCVA ) was @ logMAR and central retinal subfield thickness ( CSRT ) was @m in the bevacizumab group and @ logMAR and @ m CSRT in the triamcinolone group .


After @ months , BCVA improved to @ logMAR ( bevacizumab ) and @ m CRST and @ logMAR ( triamcinolone ) and @m CSRT .


After @ months , BCVA further recovered in the bevacizumab group ( @ logMAR ) but slightly decreased in the triamcinolone group ( @ logMAR ) .


Intravitreal bevacizumab and triamcinolone are both equally effective in reducing CSRT in early DME .


After @ months , rehabilitation of vision was comparable in both treatment arms , whereas at the final follow-up at month @ , BCVA was superior in the bevacizumab than in the triamcinolone sample .


This may be related to cataract development following steroid treatment , as well as to substance-specific mechanisms within the angiogenic versus the inflammatory cascade .


To determine the prevalence and characteristics of fetal alcohol spectrum disorders ( FASD ) among first grade students ( @ - to @-year-olds ) in a representative Midwestern US community .


From a consented sample of @ % of all first graders enrolled in public and private schools , an oversample of small children ( @th percentile on height , weight , and head circumference ) and randomly selected control candidates were examined for physical growth , development , dysmorphology , cognition , and behavior .


The children 's mothers were interviewed for maternal risk .


Total dysmorphology scores differentiate significantly fetal alcohol syndrome ( FAS ) and partial FAS ( PFAS ) from one another and from unexposed controls .


Alcohol-related neurodevelopmental disorder ( ARND ) is not as clearly differentiated from controls .


Children who had FASD performed , on average , significantly worse on @ cognitive and behavioral tests and measures .


The most predictive maternal risk variables in this community are late recognition of pregnancy , quantity of alcoholic drinks consumed @ months before pregnancy , and quantity of drinking reported for the index child 's father .


From the final multidisciplinary case findings , @ techniques were used to estimate prevalence .


FAS in this community likely ranges from @ to @ per @ children ( midpoint , @ ) , PFAS from @ to @ per @ children ( midpoint , @ ) , and the total rate of FASD is estimated at @ to @ per @ children , or @ % to @ % ( midpoint , @ % ) .


Children who have FASD are more prevalent among first graders in this Midwestern city than predicted by previous , popular estimates .


Cancer-associated inflammation plays a driver role in pancreatic tumor development and progression .


Moreover , recent studies have implicated the inflammatory tumor microenvironment in modulating therapy response and inducing resistance .


The aim of this study is to investigate the prognostic and predictive value of the inflammatory biomarkers serum ferritin and C-reactive protein ( CRP ) in advanced pancreatic cancer patients .


We measured pretreatment serum ferritin and CRP levels in @ patients with inoperable pancreatic cancer participating in a phase III trial .


Serum ferritin and CRP levels were examined for correlations with overall survival using Kaplan-Meier analysis .


When analyzed on a categorical basis , patients with higher ferritin ( > median ) or CRP ( > @th percentile ) had shorter overall survival .


Moreover , the two biomarkers were not correlated suggesting independent mechanisms of production and release .


However , when patients were evaluated by their ferritin and CRP levels , only patients with elevation in both inflammatory biomarkers showed a significant decrease in overall survival .


Serum ferritin and CRP are independent prognostic factors for shorter survival in patients with inoperable pancreatic tumors .


Moreover , the evaluation of patients based on both biomarkers suggested that their prognostic value , although independent , reflected the broader state of cancer-associated inflammation .


Thus , serum ferritin and CRP should be further explored as clinical biomarkers .


To study efficacy and safety of baclofen for treatment of alcohol dependence .


@ patients with alcohol dependence had been randomized into one of two treatment groups ( @ patients in each ) : patients of the @st group were treated with baclofen ( @ mg/day ) for @ months while patients of the @nd one received identically looking placebo .


All the study subjects were scheduled to come to the clinic on the weekly basis to control alcohol use and compliance with the study medications ( by riboflavin marker in urine ) and also - for psychiatric evaluations ( severity of craving for alcohol , anxiety and depression ) .


Alcohol use evaluated with the Time Line Follow Back technique and gamma-glutamiltranspeptidase activity in blood .


To assess anxiety Spielberger state-trait inventory and Hamilton scale were used .


Depression was assessed with Montgomery-Ashberg scale .


To evaluate carving for alcohol used Obsessive-Compulsive Drinking scale , Penn Alcohol Craving scale , and Visual Analog Scale of Craving .


Overall treatment effect assessed with the Clinical Global Impression scale .


The study design was double blind .


Baclofen did no differ significantly from placebo on either of primary or secondary outcome variables .


However , primary outcome variables of retention in treatment and drinking were slightly better in the baclofen group compared to placebo , and those differences were close to the level of statistical significance .


There were no differences between the groups in either rate of adverse events or liver enzymes activity which is an evidence of safety and good tolerability of baclofen in alcohol dependent patients .


Further studies of baclofen for alcohol dependence in the larger sample size are needed .


Pregabalin ( Lyrica ( ) ) is approved as an immediate-release ( IR ) formulation for administration twice ( BID ) or three times ( TID ) a day depending on indication .


Once daily ( QD ) dosing may be appropriate for ease of clinical use and patient convenience .


The objectives of this analysis were : ( @ ) to evaluate the pharmacokinetics of pregabalin controlled-release ( CR ) administered with food relative to the pregabalin IR formulation administered fasted ; ( @ ) to evaluate the pharmacokinetics of a two-tablet dose of pregabalin CR compared with the equivalent one-tablet dose of pregabalin CR ; and ( @ ) to determine the safety and tolerability of multiple-dose administration of pregabalin CR and IR .


The pharmacokinetic properties of pregabalin CR were determined in four phase I , open-label , multiple-dose crossover studies ( @-@ participants/study ) .


Pregabalin CR ( @ , @ , @ or @mg/day ) administered QD was compared with pregabalin IR ( @ , @ , @ or @mg/day , respectively ) administered either BID or TID .


Blood samples were collected up to @h post-dose .


Pharmacokinetic parameters were estimated from plasma concentration-time data using standard noncompartmental methods .


Adverse events were monitored throughout all studies .


Eight-four healthy participants ( @-@years of age ) received pregabalin .


For all pregabalin CR doses , total exposure was equivalent to the corresponding pregabalin IR dose .


Relative bioavailability of pregabalin CR was @-@ % of pregabalin IR , and bioequivalence criteria with respect to the @-h steady-state exposure ( area under the plasma concentration-time curve from @ to @h -LSB- AUC@ -RSB- ) were met .


Administration of a two-tablet dose of pregabalin CR was bioequivalent to one-tablet pregabalin CR .


The relative bioavailability of two-tablet pregabalin CR was @-@ % of one-tablet pregabalin CR , and bioequivalence criteria with respect to AUC@ and peak plasma concentrations were met .


Pregabalin CR pharmacokinetic parameters were dose proportional following administration of @-@mg / day pregabalin CR .


Pregabalin was well tolerated across studies , with no serious or severe adverse events .


Total daily exposure with multiple-dose pregabalin CR is equivalent to the corresponding pregabalin IR dose .


The radial artery ( RA ) is a useful conduit for coronary artery bypass grafting ( CABG ) but is susceptible to vasospasm during harvesting .


We evaluated the usefulness of fasudil , a Rho kinase inhibitor , in dilating the RA graft and increasing graft free flow ( GFF ) compared with the conventional graft-dilating agents papaverine and verapamil-nitroglycerin ( VG ) .


Between June @ and January @ , @ patients with ischemic heart disease who underwent isolated CABG using the RA were enrolled and randomly assigned to fasudil ( n = @ ) , papaverine ( n = @ ) , or VG ( n = @ ) .


Fasudil ( @ mmol/L ) , papaverine ( @ mmol/L ) mixed with heparinized blood , or VG ( @ mol/L each of verapamil and nitroglycerin ) was injected intraluminally into the RA graft after harvesting .


Main outcome measures were RA GFF , hemodynamic changes , and histopathologic examination of the RA .


In the fasudil group , GFF increased significantly ( p < @ ) from @ @ at baseline to @ @ mL/min after injection .


GFF increased significantly ( p < @ ) from @ @ to @ @ mL/min in the papaverine group and increased significantly ( p < @ ) from @ @ to @ @ mL/min in the VG group .


The GFF was significantly higher ( p = @ ) in fasudil-treated RA than in papaverine - or VG-treated RA .


Histopathologically , RA graft diameter was markedly increased after fasudil injection , and the structure of the multiple elastic lamellae was intact .


Blood pressure did not change significantly after drug injection in all groups .


Fasudil exhibited a very potent vasodilatory effect on the RA compared with conventional papaverine or VG , resulting in increased GFF .


This agent is useful for dilating RA grafts in CABG .


The objective of this pilot trial was to evaluate the safety and efficacy of AKL@ , a patented botanical formulation containing extracts of Picrorhiza kurroa , Ginkgo biloba , and Zingiber officinale , as add-on therapy for patients with chronic obstructive pulmonary disease ( COPD ) and chronic cough .


This randomized , double-blind , placebo-controlled trial enrolled male and female patients > @ years old with COPD and Leicester Cough Questionnaire ( LCQ ) score of < @ .


The @-week study period comprised a @-week single-blind placebo run-in period followed by add-on treatment with AKL@ or placebo twice daily for @ weeks .


The primary study endpoint was the change from week @ to week @ in cough-related health status , as assessed by the LCQ .


Of @ patients enrolled , @ were randomized to AKL@ and @ to placebo .


Patients included @ ( @ % ) men and @ ( @ % ) women of mean ( standard deviation -LSB- SD -RSB- ) age of @ ( @ ) years ; @ ( @ % ) patients were smokers and @ ( @ % ) were ex-smokers .


The mean ( SD ) change from baseline in LCQ score at @ weeks was @ ( @ ) in the AKL@ group and @ ( @ ) in the placebo group , with mean difference in change of @ ( @ % confidence interval : -@ to @ ; P = @ ) .


The St George 's Respiratory Questionnaire score improved substantially in the AKL@ treatment group by a mean ( SD ) of -@ ( @ ) versus worsening in the placebo group ( +@ -LSB- @ -RSB- ) , with mean difference in change of -@ ( @ % confidence interval : -@ to @ ; P = @ ) .


There were no significant differences between treatment groups in change from baseline to week @ in other patient-reported measures , lung function , or the @-minute walk distance .


Further study is needed with a larger patient population and over a longer duration to better assess the effects of add-on therapy with AKL@ in COPD .


Smokers with depressive symptoms have more difficulty quitting smoking than the general population of smokers .


The present study examines a web-based treatment using acceptance and commitment therapy ( ACT ) for smokers with depressive symptoms .


The study aimed to determine participant receptivity to the intervention and its effects on smoking cessation , acceptance of internal cues , and depressive symptoms .


Smokers who had positive screening results for depressive symptoms at baseline ( n = @ ) were selected from a randomized controlled trial ( N = @ ) comparing web-based ACT for smoking cessation ( WebQuit.org ) with Smokefree.gov .


Forty-five participants ( @ % ) completed the three-month follow-up .


Compared to Smokefree.gov , WebQuit participants spent significantly more time on site ( p = @ ) and had higher acceptance of physical cravings ( p = @ ) .


While not significant , WebQuit participants were more engaged and satisfied with their program and were more accepting of internal cues overall .


There was preliminary evidence that WebQuit participants had higher quit rates ( @ % versus @ % ) and lower depressive symptoms at follow-up ( @ % versus @ % ) than those in Smokefree.gov .


This was the first study of web-based ACT for smoking cessation among smokers with depressive symptoms , with promising evidence of receptivity , efficacy , impact on a theory-based change process , and possible secondary effects on depression .


A fully powered trial of the ACT WebQuit.org intervention specifically for depressed smokers is needed .


This was part of a clinical trial registered as NCT # @ at www.clinicaltrials.gov .


Students in German medical schools frequently complain that the subject ` clinical examination ' is not taught in a satisfying manner due to time constraints and lack of personnel resources .


While the effectiveness and efficiency of practice-oriented teaching in small groups using near-peer teaching has been shown , it is rarely used in German medical schools .


We investigated whether adding a new near-peer teaching course developed with student input plus patient examination under supervision in small groups improves basic clinical examination skills in third year medical students compared to a traditional clinical examination course alone .


Third year medical students registered for the mandatory curricular clinical examination course at the medical faculty of the Technische Universitt Mnchen were invited to participate in a randomised trial with blinded outcome assessment .


Students were randomised to the control group participating in the established curricular physical examination course or to the intervention group , which received additional near-peer teaching for the same content .


The learning success was verified by a voluntary objective structured clinical examination ( OSCE ) .


A total of @ students were randomised and @ ( @ % ) participated in the final OSCE .


Students in the control group scored a median of @ % ( @th percentile @ % , @th percentile @ % ) of the maximum possible total points of the OSCE compared to @ % ( @ % , @ % ; p < @ ) for students in the intervention group .


Only two students in the intervention group received a lower score than the best student in the control group .


Adding a near-peer teaching course to the routine course significantly improved the clinical examination skills of medical students in an efficient manner in the context of a resource-constrained setting .


A prospective randomized study .


To compare occupational radiation exposure to the surgeon , as well as the patient , during posterior lumbar spine instrumentation in @ navigated cases ( navigated ) versus @ cases using the freehand technique ( non-navigated ) .


The use of navigation increases the accuracy of posterior lumbar instrumentation.A further speculated benefit of navigation is the reduction of radiation exposure of the surgeon .


However , this has so far not been evaluated in such comparative manner .


Radiation exposure to the surgeon was measured by digital dosimeters placed at the level of the eye , chest , and dominant forearm .


Radiation exposure was measured from the time of positioning of the patient to the end of the procedure both for navigated ( intraoperative @-dimensional -LSB- @D -RSB- fluoroscopy-based ) and non-navigated ( @-dimensional fluoroscopy-guided ) freehand posterior lumbar spine instrumentations .


A @D fluoroscopic scan was routinely performed at the end of the procedure for all patients .


Patients were distributed evenly in the @ groups in terms of sex , age , body mass index , and the number of operated levels .


The accumulated radiation dose for the surgeon was significantly higher in the non-navigated group ; up to @ times .


The radiation dose for the patient was higher with the freehand technique , @ cGycm ( non-navigated ) versus @ cGycm ( navigated ) , without reaching a statistically significant level .


Radiation exposure to the surgeon during pedicle screw placement with the freehand technique is up to @ times greater than with the use of navigation .


In the latter group , the only radiation exposure comes from the preoperative-level control and positioning of the @D C-arm before @D fluoroscopic acquisition .


Furthermore , neuronavigation also reduces the cumulative dose for the patient .


Our previous laboratory and clinical data suggested that one mechanism underlying the development of platinum resistance in ovarian cancer is the acquisition of DNA methylation .


We therefore tested the hypothesis that the DNA hypomethylating agent @-aza-@ ' - deoxycytodine ( decitabine ) can reverse resistance to carboplatin in women with relapsed ovarian cancer .


Patients progressing @-@ months after previous platinum therapy were randomised to decitabine on day @ and carboplatin ( AUC @ ) on day @ , every @ days or carboplatin alone .


The primary objective was response rate in patients with methylated hMLH@ tumour DNA in plasma .


After a pre-defined interim analysis , the study closed due to lack of efficacy and poor treatment deliverability in @ patients treated with the combination .


Responses by GCIG criteria were @ out of @ vs @ out of @ and by RECIST were @ out of @ vs @ out of @ for carboplatin and carboplatin/decitabine , respectively .


Grade @/@ neutropenia was more common with the combination ( @ % vs @ % ) as was G@/@ carboplatin hypersensitivity ( @ % vs @ % ) .


With this schedule , the addition of decitabine appears to reduce rather than increase the efficacy of carboplatin in partially platinum-sensitive ovarian cancer and is difficult to deliver .


Patient-selection strategies , different schedules and other demethylating agents should be considered in future combination studies .


To evaluate the impact of Playworks on students ' physical activity during recess .


Twenty-seven elementary schools from six U.S. cities were grouped into blocks and randomly assigned to implement Playworks ( treatment ) or not ( control ) during an entire school year ( either @-@ or @-@ ) .


Study data were collected at the end of the school year only .


Fourth - and @th-grade students ( n = @ ) reported on their physical activity during recess , and a subset ( n = @ ) wore accelerometers during recess .


Teachers ( n = @ ) also reported on their students ' physical activity during recess .


A significantly higher percentage of teachers in treatment schools reported that their students engaged in an intense physical activity during recess ( p = @ ) .


Marginally significant differences between treatment and control groups were found for the mean number of accelerometer intensity counts recorded per minute during recess ( p = @ ) and the mean percentage of time spent in vigorous physical activity during recess ( p = @ ) .


No significant differences were found for student reports about their physical activity during recess ( p = @ ) .


Teachers in Playworks schools reported that students were more active during recess , but accelerometer and student survey measures showed either no impacts or marginally significant impacts .


Adults with intellectual disability ( ID ) are physically very inactive .


This study will compare two approaches to increasing physical activity in adults with ID : a lifestyle physical activity ( light-moderate intensity ) approach and a structured exercise ( moderate-vigorous intensity ) approach .


The trial will compare the short-term ( @-month ) and long-term ( @-month ) outcomes and sustainability of each approach with a usual-care control group .


A three-arm randomised controlled trial ( RCT ) will be conducted .


Ninety adults with ID aged @-@ will be randomly assigned to one of three groups : @ ) a lifestyle physical activity group ( n = @ ) , @ ) a structured exercise group ( n = @ ) , or @ ) a usual care control group ( n = @ ) .


Participants in both groups will receive a @-week intervention delivered by exercise specialists in the community with disability service staff , after which intervention will continue for @months , delivered by disability service staff only .


Primary outcomes are aerobic fitness , @-hour energy expenditure , and proxy-reported everyday physical activity .


Secondary outcomes include objectively assessed physical activity and sedentary behaviour , intervention compliance , functional walking capacity , participation in domestic activities , muscle strength , body composition , psychosocial outcomes , quality of life and health care costs .


The trial results will determine the effectiveness and sustainability of two approaches to increasing physical activity and exercise among adults with ID .


Poor nutritional quality of complementary foods often limits growth .


Animal source foods , such as milk or meat , are often unaffordable .


Local affordable alternatives are needed .


We evaluate the efficacy of @ newly developed , rice-based complementary food products : WinFood ( WF ) with small fish and edible spiders and WinFood-Lite ( WF-L ) fortified with small fish , against @ existing fortified corn-soy blend products , CSB + ( purely plant based ) and CSB + + ( @ % dried skimmed milk ) .


In total , @ infants aged @ mo were enrolled in this randomized , single-blinded study for @ mo , designed primarily to assess increments in fat-free mass by a deuterium dilution technique and change in plasma ferritin and soluble transferrin receptor .


Secondary endpoints were changes in anthropometric variables , including knee-heel length .


Data were analyzed by the intention-to-treat approach .


There was no difference in fat-free mass increment in WF or WF-L compared with CSB + -LSB- WF : +@ kg ( @ % CI : -@ , @ kg ) ; WF-L : +@ kg ( @ % CI : -@ , @ kg ) -RSB- or CSB + + -LSB- WF : -@ kg ( @ % CI : -@ , @ kg ) ; WF-L : +@ kg ( @ % CI : -@ , @ kg ) -RSB- and no effect on iron status .


The @-mm ( @ % CI : -@ , @ mm ) greater increase in knee-heel length in WF-L than in CSB + was not significant .


No difference was found between the locally produced products ( WF and WF-L ) and the CSBs .


Micronutrient fortification may be necessary , and small fish may be an affordable alternative to milk to improve complementary foods .


The dietary role of edible spiders needs to be further explored .


This trial was registered at controlled-trials .


com as ISRCTN@ .


To compare the effectiveness and safety of two glycemic control regimens in stable critical care patients receiving parenteral nutrition ( PN ) .


Prospective , randomized open-label clinical trial .


Eligible postoperative critical care patients in the ICU began PN on the first to the seventh day of ICU admission .


The PN admixture included regular insulin , in doses sufficient to maintain @ or more goal blood glucose ( BG ) levels between @ and @mg/dl .


After @ to @days of PN containing regular insulin , patients were randomized to @ more days of regular insulin at the same dose or @ % of their total daily regular insulin dose provided in PN solution as glargine insulin .


Capillary BG monitoring was performed every @hours .


Twenty one patients were randomized to each treatment group .


Median APACHE II scores were not significantly different between the two groups within the first @-hour of ICU admission .


There were no significant differences between the two groups at day @ for mean daily dextrose ( @ vs. @ g ; p = @ ) or insulin ( @ vs. @ units ; p = @ ) doses .


The percentage of BG values in the goal ( @-@mg / dl ) , hyperglycemic ( > @mg/dl ) , and hypoglycemic ( < @mg/dl ) BG levels were similar between the two groups ( @ % vs. @ % , p = @ ; @ % vs. @ % , p = @ ; @ % vs. @ % , p = @ , respectively ) .


Mean daily BG levels were not significantly different between the two groups on each of the @ study days ( day @ : @ vs. @mg/dl , p = @ ; day @ : @ vs. @mg/dl , p = @ ; day @ : @ vs. @mg/dl ; p = @ ) .


These data suggest that , compared with regular insulin added to PN , glargine insulin results in similar glycemic control and rates of hyperglycemia and hypoglycemia in stable critical care patients .


Everolimus synergistically enhances taxane-induced cytotoxicity in breast cancer cells in vitro and in vivo in addition to demonstrating a direct antiproliferative activity .


We aim to determine pharmacodynamics changes and response of adding everolimus to standard neoadjuvant chemotherapy in triple-negative breast cancer ( TNBC ) .


Phase II study in patients with primary TNBC randomized to T-FEC ( paclitaxel @ mg/m ( @ ) i.v. weekly for @ weeks , followed by @-fluorouracil @ mg/m ( @ ) , epirubicin @ mg/m ( @ ) , and cyclophosphamide @ mg/m ( @ ) every @ weeks for four cycles ) versus TR-FEC ( paclitaxel @ mg/m ( @ ) i.v. and everolimus @ mg PO weekly for @ weeks , followed by FEC ) .


Tumor samples were collected to assess molecular changes in the PI@K/AKT/mTOR pathway , at baseline , @ h , @ weeks , and at surgery by reverse phase protein arrays ( RPPA ) .


Clinical end points included @-week clinical response rate ( @-week RR ) , pathological complete response ( pCR ) , and toxicity .


Sixty-two patients were registered , and @ were randomized , @ received T-FEC , and @ received TR-FEC .


Median age was @ ( range @-@ ) .


There was downregulation of the mTOR pathway at @ h in the TR-FEC arm .


Twelve-week RR by ultrasound were @ % versus @ % , ( P = @ ) , and pCR were @ % versus @ % ( P = @ ) for T-FEC and TR-FEC , respectively .


mTOR downregulation at @ h did not correlate with @-week RR in the TR-FEC group ( P = @ ) .


Main NCI grade @/@ toxicities included anemia , neutropenia , rash/desquamation , and vomiting in both arms .


There was one case of grade @ pneumonitis in the TR-FEC arm .


No grade @/@ stomatitis occurred .


The addition of everolimus to paclitaxel was well tolerated .


Everolimus downregulated mTOR signaling but downregulation of mTOR at @ h did not correlate with @-week RR in the TR-FEC group .


Pain after total knee arthroplasty ( TKA ) is usually severe .


Recently , the usefulness of local periarticular injection analgesia ( PAI ) and peripheral nerve block ( PNB ) has been reported .


We report a prospective blinded randomized trial of PAI versus PNB in patients undergoing primary TKA , in accordance with the CONSORT statement @ .


A total of @ patients undergoing TKA under spinal anesthesia were randomized to receive PNB group or PAI group .


In the PNB group , femoral nerve block and sciatic nerve block were performed .


In the PAI group , a special mixture containing ropivacaine , saline , epinephrine , morphine hydrochloride , and dexamethasone was injected into the periarticular soft tissue .


Pain intensity at rest was assessed using a numerical rating scale ( NRS : @-@ ) after surgery .


Use of a diclofenac sodium suppository ( @mg ) was allowed for all patients at any time after surgery , and the diclofenac sodium suppository usage was assessed .


The NRS for patient satisfaction at @ hours after surgery was examined .


The average NRS for pain at rest up to @ hours after surgery was low in both groups .


Within @ hours after surgery , the diclofenac sodium suppository usage was similar in both groups .


There were no significant differences in the NRS for patient satisfaction in both groups .


The analgesic effects of PAI and PNB are similar .


PAI may be considered superior to PNB because it is easier to perform .


Therapeutic Level @ .


Most patients with heart failure are diagnosed and managed in primary care , however , underdiagnosis and undertreatment are common .


We assessed whether implementation of a diagnostic-therapeutic strategy improves functionality , health-related quality of life , and uptake of heart failure medication in primary care .


A selective screening study followed by a single-blind cluster randomized trial in primary care .


The study population consists of patients aged @ years or over who presented themselves to the general practitioner in the previous @ months with shortness of breath on exertion .


Patients already known with established heart failure , confirmed by echocardiography , are excluded .


Diagnostic investigations include history taking , physical examination , electrocardiography , and serum N-terminal pro B-type natriuretic peptide levels .


Only participants with an abnormal electrocardiogram or an N-terminal pro B-type natriuretic peptide level exceeding the exclusionary cutpoint for non-acute onset heart failure ( > @ pmol/L ( @ pg/ml ) ) will undergo open-access echocardiography .


The diagnosis of heart failure ( with reduced or preserved ejection fraction ) is established by an expert panel consisting of two cardiologists and a general practitioner , according to the criteria of the European Society of Cardiology guidelines.Patients with newly established heart failure are allocated to either the ` care as usual ' group or the ` intervention ' group .


Randomization is at the level of the general practitioner .


In the intervention group general practitioners receive a single half-day training in heart failure management and the use of a structured up-titration scheme .


All participants fill out quality of life questionnaires at baseline and after six months of follow-up .


A six-minute walking test will be performed in patients with heart failure .


Information on medication and hospitalization rates is extracted from the electronic medical files of the general practitioners .


This study will provide information on the prevalence of unrecognized heart failure in elderly with shortness of breath on exertion , and the randomized comparison will reveal whether management based on a half-day training of general practitioners in the practical application of an up-titration scheme results in improvements in functionality , health-related quality of life , and uptake of heart failure medication in heart failure patients compared to care as usual .


To determine the effects of constant exposure to cattle persistently infected ( PI ) with bovine viral diarrhea virus ( BVDV ) on health and performance of feedlot cattle .


@ controlled trials .


Crossbred feedlot cattle ( trial @ , n = @ ; trial @ , @ ; trial @ , @ ) .


Weaned calves were or were not vaccinated against BVDV at feedlot arrival ( trial @ ) or @ ( trial @ ) or @ ( trial @ ) weeks before feedlot arrival .


During trial @ , half of the calves were commingled with PI cattle throughout the feeding period .


During trial @ , @ calves were exposed to PI cattle before weaning and all calves were exposed to PI cattle throughout the feeding period .


During trial @ , all study calves were exposed to PI cattle throughout the feeding period .


Morbidity and mortality rates and average daily gain ( ADG ) data were analyzed .


During trial @ , calves maintained with PI cattle had a higher morbidity rate regardless of BVDV vaccination than did calves not exposed to PI cattle ; however , for calves maintained with PI cattle , the morbidity rate for those vaccinated against BVDV was less than that for those not vaccinated against BVDV .


During trial @ , calves exposed to PI cattle before weaning or vaccinated against BVDV had lower morbidity and mortality rates and increased ADG , compared with those for calves not exposed to PI cattle before weaning or vaccinated against BVDV .


During trial @ , health and performance did not vary between calves that were and were not vaccinated against BVDV .


Exposure of cattle to BVDV naturally or through vaccination before or at feedlot arrival mitigated the negative effects of constant exposure to PI cattle .


The efficacy of a slow-release insecticidal and repellent collar containing @ % imidacloprid and @ % flumethrin ( Seresto , Bayer Animal Health ) in preventing Leishmania infantum infection was evaluated in a large population of dogs living in a hyper-endemic area of Sicily ( Italy ) .


A total of @ dogs , negative for L. infantum were enrolled in a multicentre , controlled study .


Dogs were divided into two homogeneous groups , defined as G@ ( n = @ ) and G@ ( n = @ ) .


Before the start of the sand fly season , dogs in G@ were treated with the collar while animals in G@ were left untreated , serving as negative controls .


Dogs were serially sampled on day D@ , D@ , D@ and D@ in order to assess Leishmania infection by IFAT , PCR on skin ( D@-D@ ) and bone marrow ( D@ ) and cytology on bone marrow aspirate ( D@ ) .


Three dogs ( @ % ) in G@ and @ ( @ % ) in G@ became positive for L. infantum in at least one of the diagnostic tests employed in the study .


The number of seropositive dogs in G@ increased in the course of the study from @ ( D@ ) to @ ( D@ ) , with some of them also positive in other diagnostic tests .


Eight ( @ % ) of the seropositive dogs in G@ showed an increase in antibody titers ranging from @:@ to @:@,@ .


At the last follow-up , some of dogs in G@ displayed overt clinical signs suggestive of leishmaniosis .


The mean incidence density rate at the final follow-up was @ % for G@ and @ % for G@ , leading to a mean efficacy of the collar in protecting dogs at both sites of @ % .


The slow-release collar tested in this study was shown to be safe and highly effective in preventing L. infantum infection in a large population of dogs .


Protection conferred by a single collar ( up to eight months ) spanned an entire sand fly season in a hyper-endemic area of southern Italy .


The regular use of collars , at least during the sand fly season , may represent a reliable and sustainable strategy for the prevention of leishmaniosis in dogs living in or travelling to an endemic area .


Meaningful delays occurred in the Interventional Management of Stroke ( IMS ) III trial .


Analysis of the work flow will identify factors contributing to the in-hospital delays .


In the endovascular arm of the IMS III trial , the following time intervals were calculated : stroke onset to emergency department arrival ; emergency department to computed tomography ( CT ) ; CT to intravenous tissue plasminogen activator start ; intravenous tissue plasminogen activator start to randomization ; randomization to groin puncture ; groin puncture to thrombus identification ; thrombus identification to start of endovascular therapy ; and start of endovascular therapy to reperfusion .


The effects of enrollment time , CT angiography use , interhospital transfers , and intubation on work flow were evaluated .


Delays occurred notably in the time intervals from intravenous tissue plasminogen activator initiation to groin puncture ( median @ minutes ) and start of endovascular therapy to reperfusion ( median @ minutes ) .


The CT to groin puncture time was significantly shorter during working hours than after .


Times from emergency department to reperfusion and groin puncture to reperfusion decreased over the trial period .


Patients with CT angiography had shorter emergency department to reperfusion and onset to reperfusion times .


Transfer of patients resulted in a longer onset to reperfusion time compared with those treated in the same center .


Age , sex , National Institutes of Health Stroke Scale score , and intubation did not affect delays .


Important delays were identified before reperfusion in the IMS III trial .


Delays decreased as the trial progressed .


Use of CT angiography and endovascular treatment in the same center were associated with time savings .


These data may help in optimizing work flow in current and future endovascular trials .


Dosages of vitamin D necessary to prevent or treat vitamin D deficiency in children remain to be clarified .


To determine the effects of vitamin D@ @ IU/d on serum @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- , PTH , and markers of bone turnover ( osteocalcin and collagen type @ cross-linked C-telopeptide ) in black children and white children , and to explore whether there is a threshold level of @ ( OH ) D associated with maximal suppression of serum PTH concentration .


Healthy @ - to @-year-old Pittsburgh-area black ( n = @ ) and white ( n = @ ) children not receiving vitamin supplements , enrolled from October through March from @ through @ , were randomized to vitamin D@ @ IU or placebo daily for @ months .


The mean baseline concentration of @ ( OH ) D was < @ ng/mL in both the vitamin D-supplemented group and the placebo group ( @ @ and @ @ ng/mL , respectively ) .


The mean concentration was higher in the supplemented group than in the placebo group at @ months ( @ @ vs @ @ ng/mL ; P < @ ) and also at @ months ( @ @ vs @ @ ; P = @ ) , after adjusting for baseline @ ( OH ) D , race , gender , pubertal status , dietary vitamin D intake , body mass index , and sunlight exposure .


Increases were only significant in black children , when examined by race .


The association between @ ( OH ) D and PTH concentrations was inverse and linear , without evidence of a plateau .


Overall , vitamin D supplementation had no effect on PTH and bone turnover .


Vitamin D@ supplementation with @ IU/d in children with mean baseline @ ( OH ) D concentration < @ ng/mL effectively raised their mean @ ( OH ) D concentration to @ ng/mL but failed to reach @ ng/mL .


Vitamin D supplementation had no effect on PTH concentrations .


Vitamin D may be a regulator of skeletal muscle function , although human trials investigating this hypothesis are limited to predominantly elderly populations .


We aimed to assess the effect of oral vitamin D@ in healthy young males upon skeletal muscle function .


Participants ( n = @ ) received an oral dose of @,@ IU day ( -@ ) vitamin D@ ( VITD ) or a visually identical placebo ( PLB ) for @ months .


Serum @ -LSB- OH -RSB- D and intact parathyroid hormone ( iPTH ) were measured at baseline and at week @ , @ and @ .


Muscle function was assessed in n = @ participants by isokinetic dynamometry and percutaneous isometric electromyostimulation at baseline and at week @ and @ .


Baseline mean total serum @ -LSB- OH -RSB- D was @ @ and @ @ nmol L ( -@ ) for PLB and VITD , respectively .


VITD showed a significant improvement in total @ -LSB- OH -RSB- D at week @ ( @ @ nmol L ( -@ ) ) that remained elevated throughout the trial ( P < @ ) .


Contrastingly , PLB showed a significant decrease in @ -LSB- OH -RSB- D at week @ ( @ @ nmol L ( -@ ) ) compared with baseline .


Despite marked increases in total serum @ -LSB- OH -RSB- D in VITD and a decrease in PLB , there were no significant changes in any of the muscle function outcome measures at week @ or @ for either group ( P > @ ) .


Elevating total serum @ -LSB- OH -RSB- D to concentrations > @ nmol L ( -@ ) has no effect on skeletal muscle function .


We postulate that skeletal muscle function is only perturbed in conditions of severe deficiency ( < @ nmol L ( -@ ) ) .


The addition of bevacizumab to paclitaxel or capecitabine has demonstrated improved progression-free survival ( PFS ) and objective response rate ( ORR ) as compared with chemotherapy alone in patients with HER@-negative locally recurrent or metastatic breast cancer ( LR/MBC ) .


We evaluated the efficacy and safety of first-line therapy of paclitaxel and bevacizumab with or without capecitabine in patients with HER@-negative LR/MBC .


In this multicentre , open-label , randomised phase II trial , women with HER@-negative LR/MBC were randomly assigned in a @:@ ratio to paclitaxel ( @ mg/m@ intravenously -LSB- IV -RSB- on days @ , @ , and @ ) and bevacizumab ( @ mg/kg IV on days @ and @ ) every @ weeks for six cycles , followed by bevacizumab ( @ mg/kg IV on day @ ) every @ weeks ( AT ) or to paclitaxel ( @ mg/m@ IV on days @ and @ ) , bevacizumab ( @ mg/kg IV on day @ ) and capecitabine ( @ mg/m@ orally twice daily on days @ ) every @ weeks for eight cycles , followed by bevacizumab and capecitabine at the same doses every @ weeks ( ATX ) .


The primary end-point was investigator-assessed PFS .


Secondary end-points included ORR , duration of response , overall survival ( OS ) and safety .


Exploratory analyses were conducted to evaluate the impact of capecitabine on OS and to validate a novel prognostic model .


This trial is registered with EudraCT , number @-@-@ .


Median PFS was significantly longer in ATX as compared with AT ( @ months versus @ months ; stratified hazard ratio ( HR ) , @ ; @ % confidence interval ( CI ) , @ ; p < @ ) .


The ORR in ATX patients with measurable disease ( n = @ ) was higher than that in AT ( @ % versus @ % ; p = @ ) .


The median duration of response was @ versus @ months for , respectively , ATX and AT ( p < @ ) .


Median OS was @ months for ATX and @ months for AT ( p = @ ) .


The increased rate of grade @ adverse events related to the addition of capecitabine , being hand-foot syndrome ( @ % versus @ % for AT ) and neutropenia ( @ % versus @ % for AT ) , generally did not preclude continuation of treatment .


Exploratory analyses indicated that ( @ ) patients receiving capecitabine at some line for treatment have significantly improved OS and ( @ ) a prognostic model can classify patients into three risk groups associated with OS .


In patients with HER@-negative LR/MBC , addition of capecitabine to paclitaxel and bevacizumab significantly improved PFS , ORR and response duration .


This combination was reasonably well tolerated and may be considered of use as first-line treatment in rapidly progressive disease .


We investigated the determinants and clinical correlations of MRI-detected brain volume loss ( BVL ) among patients with relapsing-remitting multiple sclerosis from the phase @ trials of fingolimod : FREEDOMS , FREEDOMS II , and TRANSFORMS .


Post hoc analyses were conducted in the intent-to-treat populations from each trial and in a combined dataset of @,@ patients from the trials and their extensions .


The relationship between brain volume changes and demographic , clinical , and MRI parameters was studied in pairwise correlations ( Pearson ) and in multiple regression models .


The relative frequency of confirmed disability progression was evaluated in the combined dataset by strata of concurrent BVL at up to @ years .


Increasing age , disease duration , T@ lesion volume , T@-hypointense lesion volume , and disability were associated with reduced brain volume ( p < @ , all ) .


The strongest individual baseline predictors of on-study BVL were T@ lesion volume , gadolinium-enhancing lesion count , and T@-hypointense lesion volume ( p < @ , all ) .


During each study , BVL correlated most strongly with cumulative gadolinium-enhancing lesion count , new/enlarged T@ lesion count ( p < @ , both ) , and number of confirmed on-study relapses ( p < @ ) .


Over @ years in the combined dataset ( mean exposure to study drug , @ years ) , confirmed disability progression was most frequent in patients with greatest BVL .


Rate of BVL in patients during the fingolimod trials correlated with disease severity at baseline and new disease activity on study , and was associated with worsening disability .


To study the changes in cortisol levels during and after cardiac surgery after an inductive dose of either etomidate or thiopentone and their consequences .


A prospective , randomized , double-blinded study was conducted in @ patients undergoing elective cardiac surgery .


They received either etomidate or thiopentone for induction .


Serum cortisol levels were measured preoperatively , and then at @ - , @ - , @ - , and @-hour All of the patients received standard anesthesia and surgery .


The data also included patients perioperative management and outcome .


There is no difference in patients ' characteristics .


The baseline plasma morning cortisols in the two groups were comparable ( @ @ mcg/dL in etomidate group vs. @ @ mcg/dL in thiopentone group ) .


In both groups , during surgery , the cortisol levels rose to higher levels and reached peak levels at four to eight hours and related to surgical stress .


At all times , the etomidate group had lower cortisol levels but only at @-hour the etomidate group had significantly lower cortisol level ( @ @ vs. @ @ mcg/dL ) .


At @ hours , in both groups , cortisol levels were lower than at @-hour but did not return to normal baseline levels .


There were no differences in the dose of inotropic use and ICU stay .


However surprisingly the etomidate group had shorter hospital stay .


A single dose of etomidate usedfor induction in elective cardiac patients can partially and reversibly inhibit of the cortisol synthesis for , at least , @ hours , but its association with any hemodynamic consequences can not be concluded .


To observe improved effects of Jingjin acupuncture on fine activity of hemiplegic hand in recovery period of stroke .


Fifty cases were randomly divided into an observation group and a control group , @ cases in each one .


Regular western medicine treatment , rehabilitation training and regular acupuncture ( in which Shuigou ( GV @ ) , Baihui ( GV @ ) , Neiguan ( PC @ ) , etc. were selected ) were applied in both groups .


Additionally , muscles in palm side of affected hand , dorsal metacarpophalangeal joints and proximal interphalangeal joints were treated with acupuncture in the observation group , once every other day and electroacupuncture was applied when arrival of qi was acquired .


Baxie ( EX-UE @ ) in the affected hand were needled in the control group , and electroacupuncture was added when arrival of qi was acquired .


Ten days of treatment was considered a treatment course , and after two courses Lindmark score , Brunnstrom movement function grade , joint range of hand and Barthel index ( BI ) were observed in two groups .


Compared before the treatment , the Lindmark score in two groups were both improved after the treatment ( both P < @ ) .


Compared with the control group , the motor coordination ability , sensory function and total score of Lindmark in observation group were obviously improved ( differences before and after treatment : @ + / - @ vs @ + / - @ , @ + / - @ vs @ + / - @ , @ + / - @ vs @ + / - @ , all P < @ ) .


The Brunnstrom movement function grade was significantly improved in both groups after treatment ( both P < @ ) , which was more obvious in the observation group ( P < @ ) .


The joint range of hemiplegic hand was improved in both groups after treatment ( both P < @ ) , which was more obvious in the observation group -LSB- differences before and after treatment : ( @ + / - @ ) degrees vs ( @ + / - @ ) degrees , p < @ -RSB- .


The score of BI was also significantly improved after treatment in two groups ( both P < @ ) .


The Jingjin acupuncture could effectively improve fine activity of hemiplegic hand in recovery period of stroke prove daily life ability .


This study aimed to explore the possible mechanism of spironolactone in reduction of atrial fibrosis in elderly patients with atrial fibrillation .


@ patients with atrial fibrillation and @ matching patients with sinus rhythm were included into this study , in which the former patients were randomly divided into the conventional treatment group ( @ cases ) and spironolactone ( @ mg/d ) treatment group ( @ cases ) .


They underwent follow-ups for @ months .


The levels of serum aldosterone , PICP ( propeptide of type I procollagen ) and CITP ( carboxy-terminal cross-linking telopeptide of type I collagen ) were determined before and after treatment .


The concentrations of serum PICP , CITP and aldosterone and left atrial size in the atrial fibrillation group were all higher than the control group ( t values were @ , @ , @ , @ , respectively , p < @ ) , with a significant statistical difference .


The concentrations of serum PICP and aldosterone were both positively corelated to the left atrial size in the atrial fibrillation group ( r values were @ and @ , respectively ) .


The levels of serum aldosterone and PICP after treatment were both decreased compared to those before treatment in the spironolactone treatment group and conventional treatment group , especially in the spironolactone treatment group .


There were statistical differences in the levels of serum aldosterone and PICP after treatment between the two groups ( t values were @ and @ , respectively , p < @ ) .


Spironolactone could reduce the levels of serum aldosterone and PICP in patients with atrial fibrillation , so as to reduce the atrial fibrosis and delay the occurrence and development of atrial fibrillation .


The presence of tumor cells at the margins of breast lumpectomy specimens is associated with an increased risk of ipsilateral tumor recurrence .


Twenty to @ % of patients undergoing breast-conserving surgery require second procedures to achieve negative margins .


This study evaluated the adjunctive use of the MarginProbe device ( Dune Medical Devices Ltd , Caesarea , Israel ) in providing real-time intraoperative assessment of lumpectomy margins .


This multicenter randomized trial enrolled patients with nonpalpable breast malignancies .


The study evaluated MarginProbe use in addition to standard intraoperative methods for margin assessment .


After specimen removal and inspection , patients were randomized to device or control arms .


In the device arm , MarginProbe was used to examine the main lumpectomy specimens and direct additional excision of positive margins .


Intraoperative imaging was used in both arms ; no intraoperative pathology assessment was permitted .


In total , @ patients were enrolled .


False-negative rates were @ and @ % and false-positive rates were @ and @ % in the device and control arms , respectively .


All positive margins on positive main specimens were resected in @ % ( @ of @ ) of cases in the device arm , versus @ % ( @ of @ ) in the control arm ( p < @ ) .


A total of @ % ( @ of @ ) of patients in the device arm underwent a reexcision procedure compared with @ % ( @ of @ ) in the control arm ( @ % absolute , @ % relative reduction ) .


The difference in tissue volume removed was not significant .


Adjunctive use of the MarginProbe device during breast-conserving surgery improved surgeons ' ability to identify and resect positive lumpectomy margins in the absence of intraoperative pathology assessment , reducing the number of patients requiring reexcision .


MarginProbe may aid performance of breast-conserving surgery by reducing the burden of reexcision procedures for patients and the health care system .


To determine the prevalence of impaired olfaction in individuals presenting for cardiac surgery and the independent association between impaired olfaction and postoperative delirium and cognitive decline .


Nested prospective cohort study .


Academic hospital .


Individuals undergoing coronary artery bypass , valve surgery , or both ( n = @ ) .


Olfaction was measured using the Brief Smell Identification Test , with impaired olfaction defined as an olfactory score below the fifth percentile of normative data .


Delirium was assessed using a validated chart review method .


Cognitive performance was assessed using a neuropsychological testing battery at baseline and @ to @ weeks after surgery .


Impaired olfaction was identified in @ of @ participants ( @ % ) before surgery .


Impaired olfaction was associated with greater adjusted risk of postoperative delirium ( relative risk = @ , @ % confidence interval = @-@ @ , P = @ ) .


There was no association between impaired olfaction and change in composite cognitive score in the overall study population .


Impaired olfaction is prevalent in individuals undergoing cardiac surgery and is associated with greater adjusted risk of postoperative delirium but not cognitive decline .


Impaired olfaction may identify unrecognized vulnerability to postoperative delirium in individuals undergoing cardiac surgery .


WHO recommends daily co-trimoxazole for children born to HIV-infected mothers from @ weeks of age until breastfeeding cessation and exclusion of HIV infection .


We have previously reported on the effectiveness of continuation of co-trimoxazole prophylaxis up to age @ years in these children .


We assessed the protective efficacy and safety of prolonging co-trimoxazole prophylaxis until age @ years in HIV-exposed children .


We undertook an open-label randomised controlled trial alongside two observational cohorts in eastern Uganda , an area with high HIV prevalence , malaria transmission intensity , and antifolate resistance .


We enrolled HIV-exposed infants between @ weeks and @ months of age and prescribed them daily co-trimoxazole until breastfeeding cessation and HIV-status confirmation .


At the end of breastfeeding , children who remained HIV-uninfected were randomly assigned ( @:@ ) to discontinue co-trimoxazole or to continue taking it up to age @ years .


At age @ years , children who continued co-trimoxazole prophylaxis were randomly assigned ( @:@ ) to discontinue or continue prophylaxis from age @ years to age @ years .


The primary outcome was incidence of malaria ( defined as the number of treatments for new episodes of malaria diagnosed with positive thick smear ) at age @ years .


For additional comparisons , we observed @ HIV-infected children who took continuous co-trimoxazole prophylaxis and @ HIV-unexposed uninfected children who never received prophylaxis .


We measured grade @ and @ serious adverse events and hospital admissions .


All children were followed up to age @ years and all analyses were by intention to treat .


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


@ HIV-exposed infants were enrolled between Aug @ , @ , and March @ , @ .


After breastfeeding ended , @ children were not infected with HIV and were randomly assigned to stop ( n = @ ) or continue ( n = @ ) co-trimoxazole up to age @ years .


At age @ years , @ HIV-exposed children who had remained on co-trimoxazole prophylaxis were randomly assigned to discontinue ( n = @ ) or continue ( n = @ ) co-trimoxazole from age @ years to age @ years .


We recorded @ malaria episodes ( @ per person-years ) in the @ HIV-exposed children assigned to continue co-trimoxazole until age @ years compared with @ episodes ( @ per person-years ) in the @ children assigned to stop co-trimoxazole at age @ years ( incidence rate ratio @ , @ % CI @-@ ; p < @ ) .


There was no evidence of malaria incidence rebound in the year after discontinuation of co-trimoxazole in the HIV-exposed children who stopped co-trimoxazole at age @ years , but incidence increased significantly in HIV-exposed children who stopped co-trimoxazole at age @ years ( odds ratio @ , @ % CI @-@ ; p = @ ) .


Incidence of grade @ or @ serious adverse events , hospital admissions , or deaths did not significantly differ between HIV-exposed , HIV-unexposed , and HIV-infected children .


We aimed to determine the relationship between blood lactate , carboxy-hemoglobin ( COHb ) levels and the severity of clinical findings in patients with CO poisoning .


Patients over @ years old and of both gender who were admitted to Emergency Department with the diagnosis of CO poisoning between @ and @ were enrolled in this study .


Detailed physical examination of each patient was performed , patients and their relatives were informed about the study and written consents were noted .


The levels of consciousness , physical examination findings , electrocardiographic findings , Glasgow Coma Scale ( GCS ) scores , laboratory results ( lactate , COHb , CK-MB , Troponin-I levels ) and applied treatments -LSB- normobaric oxygen therapy ( NBOT ) , hyperbaric oxygen therapy ( HBOT ) -RSB- were recorded to standart data entry form for each patient .


`` SPSS for Windows version @ '' package program was used for statistical analysis of the data .


Total @ patients were included in this study .


Thirty five patients ( @ % ) received HBOT and lactate ; COHb , CKMB , Troponin-I levels of this group were higher than the other patients .


Lactate and COHb levels were statistically significantly higher in patients with GCS < @ than the ones with GCS = @ ( p < @ ) .


The patients whose both Troponin-I and CK-MB levels increased have higher lactate levels ( p = @ ) , but COHb levels of these patients did not change ( p = @ ) .


According to our study , blood lactate and COHb levels were both correlated with the changes of consciousness in CO poisoning .


Blood lactate levels together with COHb in defining indications for HBO treatment might be suggested .


To evaluate ixekizumab , an anti-interleukin-@A ( anti-IL-@A ) monoclonal antibody , in @ populations of rheumatoid arthritis ( RA ) patients : biologics-naive patients and patients with an inadequate response to tumor necrosis factor ( TNF ) inhibitors .


In this phase II , randomized , double-blind study , placebo or ixekizumab was administered subcutaneously to @ biologics-naive patients and @ patients with an inadequate response to TNF inhibitors at weeks @ , @ , @ , @ , @ , @ , and @ with concomitant disease-modifying antirheumatic drugs .


The primary objective was to determine the dose-response relationship of ixekizumab as measured by the proportion of biologics-naive patients meeting the American College of Rheumatology @ % improvement criteria ( ACR@ ) at week @ .


Using a logistic regression model defined a priori , a statistically significant dose-response relationship as measured by ACR@ response rates at week @ was detected in biologics-naive patients ( P = @ ) .


For patients with an inadequate response to TNF inhibitors , ACR@ responses at week @ were significantly better with ixekizumab than placebo ( P < @ ) .


Decreases in the Disease Activity Score in @ joints using the C-reactive protein level ( DAS@-CRP ) , Clinical Disease Activity Index ( CDAI ) , and CRP level from baseline were observed at week @ in the ixekizumab groups in both populations ( P < @ versus placebo ) .


Onset of action was rapid in some dose groups in both populations , with improvements in the ACR@ , DAS@-CRP , CRP levels , and CDAI observed by day @ ( P < @ ) .


Adverse events occurred with similar frequencies overall in the ixekizumab and placebo groups .


Infections were more frequent with ixekizumab than placebo ( biologics-naive @ % versus @ % ; inadequate responders to TNF inhibitors @ % versus @ % ) .


No mycobacterial or invasive fungal infections were reported .


Ixekizumab improved RA signs and symptoms in RA patients who were either naive to biologics treatment or had an inadequate response to TNF inhibitors .


The safety profile was similar to that of other biologic agents , with no unexpected safety concerns .


Io compare the difference on the clinical efficacy in treatment of chronic nephritis albuminuria between acupuncture and moxibustion at `` Xiasanhuang '' , DONG 's extra points and benazepril hydrochloride so as to provide the effective therapeutic method for the treatment of chronic nephritis albuminuria .


Methods One hundred and six cases of nephritis albuminuria were randomized into an acupuncture and moxibustion group and a western medication group , @ cases in each one .


In the acupuncture and moxibustion group , acupuncture and moxibustion were applied to `` Xiasanhuang '' ( Tianhuang fuxue namely `` shenguan '' , `` Dihuang '' , `` Renhuang '' ) , once a day , the interval of @ days once every @ treatments .


In the western medication group , benazepril hydrochloride was prescribed for oral administration , @ to @ mg each time , once a day .


The treatment of @ months made , one session in the two groups .


After @ session treatment , the clinical efficacy , red blood cell count ( RBC ) of urinary sediment , @ h urine protein quantitation and creatinine clearance rate ( Ccr ) before and after treatment were observed in the two groups .


The total effective rate was @ % ( @/@ ) in the acupuncture and moxibustion group , superior to @ % ( @/@ ) in the western medication group ( P < @ ) .


After treatment , RBC of urinary sediment and @ h urine protein quantitation were reduced as compared with those before treatment ( P < @ , P < @ ) , and the results in the acupuncture and moxibustion group were lower than those in the western medication group ( P < @ , P < @ ) .


After treatment , Ccr in the acupuncture and moxibustion group was higher than that before treatment ( P < @ ) and higher than that in the western medication group ( P < @ ) .


Ccr was not different significantly before and after treatment in the western medication group ( P > @ ) .


Acupuncture and moxibustion at DONG 's extra points ( Xiasanhuang ) reduce proteinuria and improve kidney , function in patients of chronic nephritis and the efficacy is better than that with benazepril hydrochloride .


Depression is a common comorbidity of diabetes , undesirably affecting patients ' physical and mental functioning .


Psychological interventions are effective treatments for depression in the general population as well as in patients with a chronic disease .


The aim of this study was to assess the efficacy of individual mindfulness-based cognitive therapy ( MBCT ) and individual cognitive behavior therapy ( CBT ) in comparison with a waiting-list control condition for treating depressive symptoms in adults with type @ or type @ diabetes .


In this randomized controlled trial , @ outpatients with diabetes and comorbid depressive symptoms ( i.e. , Beck Depression Inventory-II -LSB- BDI-II -RSB- @ ) were randomized to MBCT ( n = @ ) , CBT ( n = @ ) , or waiting list ( n = @ ) .


All participants completed written questionnaires and interviews at pre - and postmeasurement ( @ months later ) .


Primary outcome measure was severity of depressive symptoms ( BDI-II and Toronto Hamilton Depression Rating Scale ) .


Anxiety ( Generalized Anxiety Disorder @ ) , well-being ( Well-Being Index ) , diabetes-related distress ( Problem Areas In Diabetes ) , and HbA@c levels were assessed as secondary outcomes .


Results showed that participants receiving MBCT and CBT reported significantly greater reductions in depressive symptoms compared with patients in the waiting-list control condition ( respectively , P = @ and P < @ ; d = @ and @ ; clinically relevant improvement @ % and @ % vs. @ % ) .


Both interventions also had significant positive effects on anxiety , well-being , and diabetes-related distress .


No significant effect was found on HbA@c values .


Both individual MBCT and CBT are effective in improving a range of psychological symptoms in individuals with type @ and type @ diabetes .


To explore the better therapy in the treatment of ganglion .


Ninety cases of ganglion were randomized into a two-way quintuple puncture group , a common quintuple puncture group and a fire needling group , @ cases in each one .


In the two-way quintuple puncture group , the `` @-in-@ '' multiple penetrating needling technique was used .


In the common quintuple puncture group , the traditional `` @-in-@ '' multiple penetrating needling technique was applied .


In the fire needling group , the traditional multiple fire needling technique was adopted .


The treatment was given once a day , @ treatments made one session and the efficacy was analyzed statistically after @ session treatment in the three groups .


All of the three therapeutic methods achieved the efficacy on ganglion .


The curative rate was @ % ( @/@ ) in the two-way quintuple puncture group , which was better obviously than @ % ( @/@ ) in the common quintuple puncture group and @ % ( @/@ ) in the fire needling group ( both P < @ ) .


The two-way quintuple puncture technique achieves the remarkably superior efficacy on ganglion as compared with the common quintuple puncture technique and fire needling technique .


Existing evidence suggests that administration of intravenous fluids has been shown to improve outcomes including pain in gynecological laparoscopic surgery but the optimum fluid dose has not been determined .


To determine the effect of administration of intravenous fluids on post-operative pain and pulmonary function after gynecological laparoscopy .


In a prospective randomized double-blinded study @ ASA @ and @ elective patients undergoing gynecological laparoscopy were randomized to receive intravenous compound sodium lactate @ ml kg ( -@ ) ( CSL@-restrictive ) or @ ml kg ( -@ ) ( CSL@-liberal ) administered intra-operatively .


The primary outcome measure was the post-operative pain score at @ , @ and @ h , assessed by @-@ verbal rating scale ( VRS ) .


Pulmonary function ( FEV@ , FVC , PEFR ) and oxygen saturation were also measured .


Patients who received CSL @ had lower post-operative pain scores than CSL @ ( ANCOVA-mean difference = @ , @ % CI @-@ @ , P = @ ) .


Post-operative pain VRS was lower in CSL@ than CSL@ at @ h ( mean difference @ , @ % CI @-@ @ , P = @ ) .


Patients in CSL@ reported shoulder tip pain less frequently than those in CSL@ ( @ vs. @ % of assessments , P = @ , OR @ ) but reported wound pain more frequently @ vs. @ % , P = @ , OR @ ) .


Indices of pulmonary function did not differ between groups at any time .


Liberal compared to restrictive administration of i.v. crystalloid is associated with a clinical modest reduction in pain .


Pulmonary dysfunction was not increased with liberal fluid administration .


Borderline personality disorder ( BPD ) is associated with a high socioeconomic burden .


Although a number of evidence-based treatments for BPD are currently available , they are not widely disseminated ; furthermore , there is a need for more research concerning their efficacy and cost-effectiveness .


Such knowledge promises to lead to more efficient use of resources , which will facilitate the effective dissemination of these costly treatments .


This study focuses on the efficacy and cost-effectiveness of Mentalization-Based Treatment ( MBT ) , a manualized treatment for patients with BPD .


Studies to date have either investigated MBT in a day hospitalization setting ( MBT-DH ) or MBT offered in an intensive outpatient setting ( MBT-IOP ) .


No trial has compared the efficacy and cost-effectiveness of these MBT programmes .


As both interventions differ considerably in terms of intensity of treatment , and thus potentially in terms of efficacy and cost-effectiveness , there is a need for comparative trials .


This study therefore sets out to investigate the efficacy and cost-effectiveness of MBT-DH versus MBT-IOP in patients with BPD .


A secondary aim is to investigate the association between baseline measures and outcome , which might improve treatment selection and thus optimize efficacy and cost-effectiveness .


A multicentre randomized controlled trial comparing MBT-DH versus MBT-IOP in severe BPD patients .


Patients are screened for BPD using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders , and are assessed before randomization , at the start of treatment and @ , @ , @ , @ , @ and @ months after the start of treatment .


Patients who refuse to participate will be offered care as usual in the same treatment centre .


The primary outcome measure is symptom severity as measured by the Brief Symptom Inventory .


Secondary outcome measures include parasuicidal behaviour , depression , substance use , social , interpersonal , and personality functioning , attachment , mentalizing capacities , and quality of life .


All analyses will be conducted based on the intention-to-treat principle .


Cost-effectiveness will be calculated based on costs per quality-adjusted life-year .


This multisite randomized trial will provide data to refine criteria for treatment selection for severe BPD patients and promises to optimize ( cost - ) effectiveness of the treatment of BPD patients .


Neuroplasticity drives recovery of walking after a lesion of the descending tract .


Intramuscular coherence analysis provides a way to quantify corticomotor drive during a functional task , like walking and changes in coherence serve as a marker for neuroplasticity .


Although intramuscular coherence analysis is already applied and rapidly growing in interest , the reproducibility of variables derived from coherence is largely unknown .


The purpose of this study was to determine the test-retest reliability and agreement of intramuscular coherence variables obtained during walking in healthy subjects .


Ten healthy participants walked on a treadmill at a slow and normal speed in three sessions .


Area of coherence and peak coherence were derived from the intramuscular coherence spectra calculated using rectified and non-rectified M. tibialis anterior Electromyography ( EMG ) .


Reliability , defined as the ability of a measurement to differentiate between subjects and established by the intra-class correlation coefficient , was on the limit of good for area of coherence and peak coherence when derived from rectified EMG during slow walking .


Yet , the agreement , defined as the degree to which repeated measures are identical , was low as the measurement error was relatively large .


The smallest change to exceed the measurement error between two repeated measures was @ % of the average value .


For normal walking and/or other EMG-processing settings , not rectifying the EMG and/or high-pass filtering with a high cutoff frequency ( @ Hz ) the reliability was only moderate to poor and the agreement was considerably lower .


Only for specific conditions and EMG-processing settings , the derived coherence variables can be considered to be reliable measures .


However , large changes ( > @ % ) are needed to indicate a real difference .


So , although intramuscular coherence is an easy to use and a sufficiently reliable tool to quantify intervention-induced neuroplasticity , the large effects needed to reveal a real change limit its practical use .


To analyze the efficacy and safety of mexidol and their effect on the dynamics of neurological signs of the disease , emotional status and quality of life in patients with chronic cerebral ischemia ( CCI ) .


We studied @ patients with CCI who received mexidol in dose @ mg a day during @ days by introvenal introduction with the following peroral administration in doses @ mg twice a day during @ days .


A comparison group included @ patients with CCI matched for age , risk factors and severity of neurological symptoms , who did not receive mexidol .


Patients of both groups received standard treatment that included medications needed for the complete correction of the risk factors .


Cognitive function ( MMSE ) , movement activity and quality of life ( SF-@ ) were assessed .


To the end of the study ( @th day ) , a decrease in the severity of movement disorders , normalization of SF-@ scores and improvement of mean values of screening-assessment of cognitive function were identified in patients of the main group compared to those of the comparison group .


The high efficacy and safety of treatment of CCI patients with mexidol using .


To compare the efficacy of non-nutritive sweetened beverages ( NNS ) or water for weight loss during a @-week behavioral weight loss treatment program .


An equivalence trial design with water or NNS beverages as the main factor in a prospective randomized trial among @ men and women was employed .


All participants participated in a behavioral weight loss treatment program .


The results of the weight loss phase ( @ weeks ) of an ongoing trial ( @ year ) that is also evaluating the effects of these two treatments on weight loss maintenance were reported .


The two treatments were not equivalent with the NNS beverage treatment group losing significantly more weight compared to the water group ( @ kg versus @ kg ; P < @ ) after @ weeks .


Participants in the NNS beverage group reported significantly greater reductions in subjective feelings of hunger than those in the water group during @ weeks .


These results show that water is not superior to NNS beverages for weight loss during a comprehensive behavioral weight loss program .


Adequate monitoring tools are required to optimise the immunosuppressive therapy of an individual patient .


Particularly , in calcineurin inhibitors , as critical dose drugs with a narrow therapeutic range , the optimal monitoring strategies are discussed in terms of safety and efficacy .


Nevertheless , no pharmacokinetic monitoring markers reflect the biological activity of the drug .