Erythropoietin increased costs by @ per patient ( @ % CI , @ to @,@ ) , that is , @,@ per avoided transfusion ( @ % CI , @,@ to @,@ ) .


With autologous reinfusion , mean erythrocyte use was @ U/patient and transfusion rate was @ % with erythropoietin ( n = @ ) and @ U/patient and @ % without ( n = @ ) .


Compared with controls , autologous blood reinfusion did not result in erythrocyte reduction and increased costs by @ per patient ( @ % CI , @ to @,@ ) .


In hip - and knee-replacement patients ( hemoglobin level , @ to @ g/dl ) , even with a restrictive transfusion trigger , erythropoietin significantly avoids transfusion , however , at unacceptably high costs .


Autologous blood salvage devices were not effective .


The safety and efficacy of adalimumab for patients with moderately to severely active ulcerative colitis ( UC ) has been reported up to week @ from the placebo-controlled trials ULTRA ( Ulcerative Colitis Long-Term Remission and Maintenance with Adalimumab ) @ and @ .


Up to @ years of data for adalimumab-treated patients from ULTRA @ , @ , and the open-label extension ULTRA @ are presented .


Remission per partial Mayo score , remission per Inflammatory Bowel Disease Questionnaire ( IBDQ ) score , and mucosal healing rates were assessed in adalimumab-randomized patients from ULTRA @ and @ up to week @ .


Corticosteroid-free remission was assessed in adalimumab-randomized patients who used corticosteroids at lead-in study baseline .


Maintenance of remission per partial Mayo score and mucosal healing was assessed in patients who entered ULTRA @ in remission per full Mayo score and with mucosal healing , respectively .


As observed , last observation carried forward ( LOCF ) and nonresponder imputation ( NRI ) were used to report efficacy .


Adverse events were reported for any adalimumab-treated patient .


A total of @/@ ,@ patients enrolled in ULTRA @ or @ were randomized to receive adalimumab and included in the intent-to-treat analyses of the studies .


Of these , @ patients remained on adalimumab after @ years of follow-up .


Rates of remission per partial Mayo score , remission per IBDQ score , mucosal healing , and corticosteroid discontinuation at week @ were @ % , @ % , @ % ( NRI ) , and @ % ( observed ) , respectively .


Of the patients who were followed up in ULTRA @ ( @/@ ,@ ) , a total of @ patients remained on adalimumab @ years later .


Remission per partial Mayo score and mucosal healing after ULTRA @ or @ to year @ of ULTRA @ were maintained by @ % and @ % of patients , respectively ( NRI ) .


Adverse event rates were stable over time .


Remission , mucosal healing , and improved quality of life were maintained in patients with moderately to severely active UC with long-term adalimumab therapy , for up to @ years .


No new safety signals were reported .


Robotic thyroidectomy ( RoT ) is frequently performed due to its excellent cosmesis and recovery features .


However , postoperative pain in the operating field after RoT remains a concern due to extensive tissue dissection and tension during the operation .


The aim of this study was to evaluate the anterior chest pain and the effect of levobupivacaine spraying on postoperative pain control after bilateral axillo-breast approach ( BABA ) RoT .


We randomized @ adult patients scheduled for BABA RoT into the control group ( group C , n = @ ) or the levobupivacaine group ( group L , n = @ ) .


At the end of surgery , patients in groups C and L were sprayed with the same volume ( @ ml ) of normal saline and @ % levobupivacaine , respectively , on the flap dissection area .


Pain scores , the consumption of patient-controlled analgesia ( PCA ) , and other adverse effects were assessed at @ , @ , @ , and @ h postoperatively .


Patients in group L showed lower pain scores than those of group C at @ h ( @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- ; p = @ ) , @ h ( @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- ; p < @ ) , @ h ( @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- ; p = @ ) and @ h ( @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- ; p < @ ) postoperatively .


PCA consumption of group L was less than that of group C at @ , @ , and @ h after surgery .


There were no significant differences in postoperative nausea-vomiting , headache , or dizziness .


Local anesthetic-related adverse effects were not reported .


Levobupivacaine spray on the operative field at the end of BABA RoT reduced postoperative pain and PCA consumption without adverse events .


In dental applications , as in all other medical applications , pain needs to be prevented or at least controlled .


The use of the tooth as a model for studying pain mechanisms is well established .


In the current study , we aimed to evaluate and compare the analgesic effects of gabapentin and lornoxicam , respectively , vs a placebo for postendodontic treatment pain .


Clinical research was planned as prospective , randomized , and placebo controlled .


Each subject was given @mg gabapentin ( group G : N = @ ) , @mg lornoxicam ( group L : N = @ ) , or a placebo ( group C : N = @ ) @ min prior to endodontic treatment .


At @ ( T ( @ ) ) , @ ( T ( @ ) ) , @ ( T ( @ ) ) , and @ ( T ( @ ) ) h after preoperative ( T ( @ ) ) time points , the analgesic efficacies of the agents were evaluated by using the visual analog scale ( VAS ) .


In group G , VAS values were significantly greater at T ( @ ) time point than at T ( @ ) or T ( @ ) .


T ( @ ) time point VAS value in group L was lower than at T@ time point and greater than at T ( @ ) .


In group C , T ( @ ) time point VAS values were significantly lower at T ( @ ) and T ( @ ) time points and greater than at T ( @ ) time point .


VAS values in group G at T ( @ ) time point were significantly lower than in group C or group L ( P < @ ) .


Based on the obtained data , prophylactic lornoxicam controlled postendodontic treatment pain more effectively than did the placebo drugs , and gabapentin was more effective in controlling the pain than either lornoxicam or the placebo .


To compare the outcomes of the nasal obstruction , the main symptom of the patients who underwent radiofrequency and lateral displacement of the inferior turbinate and patients who were treated with radiofrequency alone .


The prospective randomised study was conducted at the Department of Otorhinolaryngology and Head-Neck Surgery , Balikesir University Medical School , Balikesir , Turkey , between July and December @ .


It included @ patients , diagnosed with allergic or non-allergic chronic rhinitis with inferior turbinate hypertrophy which was refractory to medical therapy .


Half of the patients were treated with radiofrequency , and the rest with radiofrequency and lateral displacement .


The main symptom of the patients was nasal obstruction .


The frequency and degree of nasal obstruction were evaluated by patients ' self-assessments using the standard @-cm visual analogue scale .


The evaluations were performed first pre-operatively and on the @st , @rd , @th and @th days postoperatively as well as at the end of the @th week .


SPSS @ was used for statistical analysis .


Nasal obstruction frequency and severity scores in patients treated with both radiofrequency and lateral displacement on post-operative days @ , @ and @ were found to be significantly lower ( p < @ ) compared to the patients treated with only radiofrequency .


The study demonstrated that radiofrequency and lateral displacement together is an effective method to prevent inferior turbinate oedema in the early post-operative period .


Sarpogrelate is a selective @-hydroxytryptamine receptor subtype @A antagonist that inhibits platelet aggregation and vasoconstriction .


The aim of this study was to compare the pharmacokinetics of a sarpogrelate controlled-release formulation ( CR ) with those of the immediate-release formulation ( IR ) .


The effect of food on the pharmacokinetics of CR sarpogrelate was also evaluated .


A randomized , open-label , @-period , @-treatment crossover study was conducted in @ healthy male subjects .


Subjects were allocated into one of six sequence groups .


In one period , a @-mg IR formulation was administered three times at @-h intervals , and in the other two periods , a @-mg CR formulation was administered once to fasting and once to fed subjects .


Each period was separated by a @-day washout period .


Serial blood samples were collected up to @h after the first drug administration in each period .


The plasma concentrations of sarpogrelate were analysed by liquid chromatography-tandem mass spectrometry .


Pharmacokinetic parameters were calculated by non-compartmental methods .


After the administration of the IR formulation , the plasma concentration reached a peak at @h and the drug was eliminated with a half-life ( t@/@ ) of @h .


After administration of the CR formulation , the plasma concentration reached a peak at @h and the drug was eliminated with a t@/@ of @h .


The geometric mean ratios ( CR/IR ) for sarpogrelate area under the plasma concentration-time curve ( AUC ) and the maximum plasma drug concentration ( Cmax ) were @ ( @ % confidence interval ( CI ) : @-@ ) and @ ( @ % CI : @-@ ) .


When CR was administered to fed subjects , the time to peak concentration was prolonged to @h and t@/@ was shortened to @h .


The geometric mean ratios ( fasting/fed ) for sarpogrelate AUC and Cmax were @ ( @ % CI : @-@ ) and @ ( @ % CI : @-@ ) .


After the administration of CR and IR formulations of the same daily dose of sarpogrelate hydrochloride , the overall systemic exposure was slightly higher for the CR than for the IR formulation , whereas peak concentration was comparable between the two formulations .


Food reduced the bioavailability of sarpogrelate CR .


With increasing numbers of type @ diabetes ( DM@ ) and hypertension patients , there is a pressing need for effective , time-efficient and sustainable strategies to help physicians support their patients to achieve higher physical activity levels .


SMARTER will determine whether physician-delivered step count prescriptions reduce arterial stiffness over a one-year period , compared with usual care , in sedentary overweight/obese adults with DM@/hypertension .


Randomized , allocation-concealed , assessor-blind , multisite clinical trial .


The primary outcome is change in arterial stiffness over one year .


The secondary outcomes include changes in physical activity , individual vascular risk factors , medication use , and anthropometric parameters .


Assessments are at baseline and one year .


Participants are sedentary/low active adults with @BMI < @ kg/m@ followed for DM@/hypertension by a collaborating physician .


The active arm uses pedometers to track daily step counts and review logs with their physicians at @ to @-month intervals .


A written step count prescription is provided at each visit , aiming to increase counts by @,@ steps/day over one year , with an individualized rate increase .


The control arm visits physicians at the same frequency and receives advice to engage in physical activity @-@ minutes/day .


SMARTER will enroll @ individuals to detect a @ % difference in arterial stiffness change between arms .


Arterial stiffness is assessed noninvasively with carotid femoral pulse wave velocity using applanation tonometry .


The importance of SMARTER lies not simply in the use of pedometer-based monitoring but also on its integration into a prescription-based intervention delivered by the treating physician .


Equally important is the measurement of impact of this approach on a summative indicator of arterial health , arterial stiffness .


If effectiveness is demonstrated , this strategy has strong potential for widespread uptake and implementation , given that it is well-aligned with the structure of current clinical practice .


To show non-inferiority of trimethoprim-sulfamethoxazole compared with vancomycin for the treatment of severe infections due to meticillin resistant Staphylococcus aureus ( MRSA ) .


Parallel , open label , randomised controlled trial .


Four acute care hospitals in Israel .


Adults with severe infections caused by MRSA susceptible to trimethoprim-sulfamethoxazole and vancomycin .


Patients with left sided endocarditis , meningitis , chronic haemodialysis , and prolonged neutropenia were excluded .


Trimethoprim-sulfamethoxazole @ mg/@ mg twice daily versus vancomycin @ g twice daily for a minimum of seven days and then by indication .


The primary efficacy outcome was treatment failure assessed at day @ , consisting of death , persistence of haemodynamic instability or fever , stable or worsening Sequential Organ Failure Assessment score , and persistence of bacteraemia .


The primary safety outcome was all cause mortality at day @ .


Non-inferiority was defined by a difference of less than @ % for treatment failure .


@ patients were included in the trial , of whom @ ( @ % ) had bacteraemia .


No significant difference in treatment failure was seen for trimethoprim-sulfamethoxazole ( @/@ , @ % ) versus vancomycin ( @/@ , @ % ) - risk ratio @ ( @ % confidence interval @ to @ ) .


However , trimethoprim-sulfamethoxazole did not meet the non-inferiority criterion-absolute difference @ % ( @ % confidence interval -@ % to @ % ) .


For patients with bacteraemia , the risk ratio was @ ( @ to @ ) .


In a multivariable logistic regression analysis , trimethoprim-sulfamethoxazole was significantly associated with treatment failure ( adjusted odds ratio @ , @ to @ ) .


The @ day mortality rate was @/@ ( @ % ) , with no significant difference between arms .


Among patients with bacteraemia , @/@ ( @ % ) treated with trimethoprim-sulfamethoxazole and @/@ ( @ % ) with vancomycin died ( risk ratio @ , @ to @ ) .


High dose trimethoprim-sulfamethoxazole did not achieve non-inferiority to vancomycin in the treatment of severe MRSA infections .


The difference was particularly marked for patients with bacteraemia .


Trial registration Clinical trials NCT@ .


The study aims to evaluate the efficacy and safety of two Chinese herbal formulae for the treatment of stable COPD .


A multicenter , double-blind , double-dummy , and randomized controlled trial ( RCT ) was conducted .


All groups were treated with additional conventional medicines .


There were a @-month treatment and a @-month follow-up for @ times .


Primary outcomes included lung function test , exacerbation frequency , score of SGRQ .


Second outcomes consisted of @MWD , BODE index , psychological field score , inflammatory factors and cortisol .


A total of @ patients were randomly divided into two active treatment groups ( Bushen Yiqi ( BY ) granule group , n = @ ; Bushen Fangchuan ( BF ) tablet group , n = @ ) and a placebo group ( n = @ ) .


Finally @ patients completed the study .


BY granule & BF tablet increased the values of VC , FEV@ ( % ) and FEV@/FVC ( % ) , compared with placebo .


BY granule improved PEF .


Both treatments reduced acute exacerbation frequency ( P = @ ) , BODE index and psychological field score , while improved @MWD .


In terms of descent rang of SGRQ score , both treatments increased ( P = @ ) .


Both treatments decreased inflammatory cytokines , such as IL-@ , and IL-@ ( P = @ ) .


BY granule obviously descended IL-@ ( P < @ ) , IL-@ ( P = @ ) , IL-@ , compared with placebo .


They improved the level of IL-@ and cortisol .


BY granule raised cortisol ( P = @ ) and decreased TNF - .


Both treatments slightly descended TGF-@ .


In terms of safety , subject compliance and drug combination , there were no differences ( P > @ ) among three groups .


BY granule and BF tablet were positively effective for the treatment of COPD , and the former performed better in general .


Adjuvant endocrine therapy compromises bone health in patients with breast cancer , causing osteopenia , osteoporosis , and fractures .


Antiresorptive treatments such as bisphosphonates prevent and counteract these side-effects .


In this trial , we aimed to investigate the effects of the anti-RANK ligand antibody denosumab in postmenopausal , aromatase inhibitor-treated patients with early-stage hormone receptor-positive breast cancer .


In this prospective , double-blind , placebo-controlled , phase @ trial , postmenopausal patients with early hormone receptor-positive breast cancer receiving treatment with aromatase inhibitors were randomly assigned in a @:@ ratio to receive either denosumab @ mg or placebo administered subcutaneously every @ months in @ trial centres in Austria and Sweden .


Patients were assigned by an interactive voice response system .


The randomisation schedule used a randomly permuted block design with block sizes @ and @ , stratified by type of hospital regarding Hologic device for DXA scans , previous aromatase inhibitor use , and baseline bone mineral density .


Patients , treating physicians , investigators , data managers , and all study personnel were masked to treatment allocation .


The primary endpoint was time from randomisation to first clinical fracture , analysed by intention to treat .


As an additional sensitivity analysis , we also analysed the primary endpoint on the per-protocol population .


Patients were treated until the prespecified number of @ first clinical fractures was reached .


This trial is ongoing ( patients are in follow-up ) and is registered with the European Clinical Trials Database , number @-@-@ , and with ClinicalTrials.gov , number NCT@ .


Between Dec @ , @ , and July @ , @ , @ eligible patients were enrolled into the trial , of whom @ were randomly assigned to receive denosumab @ mg ( n = @ ) or placebo ( n = @ ) subcutaneously every @ months .


Compared with the placebo group , patients in the denosumab group had a significantly delayed time to first clinical fracture ( hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- , p < @ ) .


The overall lower number of fractures in the denosumab group ( @ ) than in the placebo group ( @ ) was similar in all patient subgroups , including in patients with a bone mineral density T-score of -@ or higher at baseline ( n = @ , HR @ -LSB- @ % CI @-@ -RSB- , p < @ ) and in those with a bone mineral density T-score of less than -@ already at baseline ( n = @ , HR @ -LSB- @ % CI @-@ -RSB- , p = @ ) .


The patient incidence of adverse events in the safety analysis set ( all patients who received at least one dose of study drug ) did not differ between the denosumab group ( @ events , @ % ) and the placebo group ( @ events , @ % ) , nor did the numbers of serious adverse events ( @ vs @ -LSB- @ % in each group -RSB- ) .


The main adverse events were arthralgia and other aromatase-inhibitor related symptoms ; no additional toxicity from the study drug was reported .


Despite proactive adjudication of every potential osteonecrosis of the jaw by an international expert panel , no cases of osteonecrosis of the jaw were reported .


@ patients ( @ % of the full analysis set ) died during the study , of which one death ( in the denosumab group ) was thought to be related to the study drug .


Adjuvant denosumab @ mg twice per year reduces the risk of clinical fractures in postmenopausal women with breast cancer receiving aromatase inhibitors , and can be administered without added toxicity .


Since a main side-effect of adjuvant breast cancer treatment can be substantially reduced by the addition of denosumab , this treatment should be considered for clinical practice .


Fractalkine ( CX@CL@ ) is a chemokine associated with atherosclerosis and inflammation .


There is limited knowledge of fractalkine levels during acute myocardial infarction ( AMI ) and stem cell treatment .


We aimed to investigate the time profile of circulating fractalkine and gene expression of its receptor CX@CR@ during AMI , and the influence of intracoronary autologous bone marrow stem cell ( mBMC ) transplantation ( given @ days after AMI ) on fractalkine levels .


We examined fractalkine levels at different time points by enzyme-linked immunosorbent assay ( ELISA ) in @ patients with AMI , and @ patients with stable angina pectoris ( AP ) undergoing percutaneous coronary intervention ( PCI ) , and in @ patients included in the randomized Autologous Stem-Cell Transplantation in Acute Myocardial Infarction ( ASTAMI ) trial .


Patients with AMI had significantly elevated levels @ - and @ h after PCI compared to patients with stable AP .


After @ h levels were similar in the two groups .


An inverse pattern was observed in gene expression levels .


No correlation between fractalkine levels and myocardial injury or infarct size was seen .


We could not demonstrate any influence of autologous mBMC transplantation on fractalkine levels .


Fractalkine levels are elevated the first @ h after PCI in patients with AMI , however , not correlated to infarct size .


The inverse pattern in gene expression of fractalkine receptor ( CX@CR@ ) might be a compensatory mechanism .


No effect of autologous mBMC transplantation given @ days after AMI on fractalkine levels was observed .


This prospective comparative study was done to evaluate the effectiveness of implants of different design ( titanium elastic intramedullary nail versus anatomical precontoured dynamic compression plate ) in treatment of displaced midshaft clavicular fractures .


Sixty-six patients between @ and @years of age were included in this study .


They were randomized in two groups to be treated with either elastic intramedullary nail ( EIN ) or plate .


Clinical and radiological assessments were performed at regular intervals .


Outcomes and complications of both groups over @years of follow-up time were compared .


Length of incision , operation time , blood loss and duration of hospital stay were significantly less for the EIN group .


American Shoulder and Elbow Surgeons ( ASES ) and Constant Shoulder scores were significantly higher ( p < @ ) in the plating group than the EIN group for the first @months but there was no significant difference found between the two groups regarding functional and radiological outcome at the @-year follow-up .


Significantly higher rates of refracture after implant removal ( p = @ ) in the plating group was observed .


Infection and revision surgery rates were also higher in the plate group , but this difference was insignificant ( p > @ ) .


EIN is a safe , minimally invasive surgical technique with a lower complication rate , faster return to daily activities , excellent cosmetic and comparable functional results , and can be used as an equally effective alternative to plate fixation in displaced midshaft clavicle fractures .


Level @ .


Adjuvant therapy with an aromatase inhibitor improves outcomes , as compared with tamoxifen , in postmenopausal women with hormone-receptor-positive breast cancer .


In two phase @ trials , we randomly assigned premenopausal women with hormone-receptor-positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of @ years .


Suppression of ovarian estrogen production was achieved with the use of the gonadotropin-releasing-hormone agonist triptorelin , oophorectomy , or ovarian irradiation .


The primary analysis combined data from @ patients in the two trials .


After a median follow-up of @ months , disease-free survival at @ years was @ % in the exemestane-ovarian suppression group and @ % in the tamoxifen-ovarian suppression group ( hazard ratio for disease recurrence , second invasive cancer , or death , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) .


The rate of freedom from breast cancer at @ years was @ % in the exemestane-ovarian suppression group , as compared with @ % in the tamoxifen-ovarian suppression group ( hazard ratio for recurrence , @ ; @ % CI , @ to @ ; P < @ ) .


With @ deaths ( @ % of the patients ) , overall survival did not differ significantly between the two groups ( hazard ratio for death in the exemestane-ovarian suppression group , @ ; @ % CI , @ to @ ; P = @ ) .


Selected adverse events of grade @ or @ were reported for @ % of the patients in the exemestane-ovarian suppression group and @ % of those in the tamoxifen-ovarian suppression group , with profiles similar to those for postmenopausal women .


In premenopausal women with hormone-receptor-positive early breast cancer , adjuvant treatment with exemestane plus ovarian suppression , as compared with tamoxifen plus ovarian suppression , significantly reduced recurrence .


( Funded by Pfizer and others ; TEXT and SOFT ClinicalTrials.gov numbers , NCT@ and NCT@ , respectively . )


urgent development of effective interventions to prevent rapidly rising childhood obesity in China is needed .


Between May @ and December @ , a cluster randomized controlled trial was conducted among @th graders in eight urban primary schools randomly assigned to intervention or control groups in Nanjing , China .


A multi-component intervention program was implemented within the treatment group , while students in the control group followed their usual health education curriculum without additional intervention .


At baseline , @ and @ students were enrolled in the intervention and control group , respectively .


The prevalence of excess body weight was @ % , with @ % in the intervention group and @ % in the control group ( p = @ ) .


The mean ( SD ) BMI and WC was @ ( @ ) and @ ( @ ) for participants in intervention schools , and @ ( @ ) and @ ( @ ) for students in control group , separately ( p = @ and @ , respectively ) .


Compared to those who were not aware of what lifestyle/behavior factors were unhealthy , students who were aware of the unhealthy lifestyle / behavior factors consumed fewer fried snacks ( @ serves/week vs @ serves/week ; p < @ ) , soft drinks ( @ ml/week vs @ ml/week ; p < @ ) , but larger amount of meat ( @ g/week vs @ g/week ; p = @ ) , and reported less screen time ( @ minutes/week vs @ minutes/week ; p < @ ) .


Moreover , there was no difference within physical activity time between these two groups ( @ minutes/week vs @ minutes/week ; p = @ ) .


Main characteristics of participants were balanced at baseline within intervention and control schools , but a gap existed between healthy lifestyle knowledge and actual healthy behavior in students .


To explore experiences of mild-stroke survivors in the context of early supported discharge .


The meanings patients attributed to activities and participation in the home recovery process were our main interest .


Eight participants ( @-@ years ) from a randomised controlled study were selected for this sub-study .


This purposive sample had received rehabilitation in their homes in the post-stroke acute phase of recovery as part of the larger study .


Extensive interview data were analysed using an interpretive strategy and systematic text condensation .


Coping theory was included in later stages of analysis .


The mild-stroke survivors ' stories revealed that life had changed profoundly .


Differences and similarities in experienced changes were related to : self-perceived health , the body , practical activities , taking part in society , and self-perception .


The findings showed the ways in which life changed for mild-stroke survivors , experienced challenges , and survivors ' thoughts about the future .


Mild-stroke rehabilitation should focus more strongly on basic concerns related to self-perceived health , self-perception , and body , since these dimensions seem to complicate daily activities and close relationships .


Professionals should also be aware of patients who experience an uncertain situation and unresolved rehabilitation needs , which still can be present @-@ months after the stroke .


When living with mild stroke , entrance to practical and social activities seemed founded on the patients ' perception of the body and self as comprehensible or not .


Comprehending their own changed body and sense of self seem to be a long-term process when living with mild stroke .


It is suggested that long-term follow-up be incorporated in home rehabilitation service , also in the context of early supported discharge .


This may contribute to help patient cope more optimally with activities and participation of importance to them .


To show that albiglutide , a glucagon-like peptide-@ receptor agonist , is an effective and generally safe treatment to improve glycaemic control in patients with type @ diabetes mellitus whose hyperglycaemia is inadequately controlled with pioglitazone ( with or without metformin ) .


In this @-year , randomized , double-blind , placebo-controlled study , @ adult patients on a regimen of pioglitazone ( with or without metformin ) were randomly assigned to receive additional treatment with albiglutide -LSB- @ mg subcutaneous ( s.c. ) once weekly , n = @ -RSB- or matching placebo ( n = @ ) .


The primary efficacy endpoint was change from baseline to week @ ( intention-to-treat ) in glycated haemoglobin ( HbA@c ) .


The model-adjusted change from baseline in HbA@c at week @ was significantly better with albiglutide than with placebo ( -@ % , @ % confidence interval -@ , -@ ; p < @ ) .


Change from baseline fasting plasma glucose was -@ mmol/l in the albiglutide group and +@ mmol/l in the placebo group ( p < @ ) ; a significantly higher percentage of patients reached the HbA@c goals with albiglutide ( p < @ ) , and the rate of hyperglycaemia rescue up to week @ for albiglutide was @ versus @ % for placebo ( p < @ ) .


Albiglutide plus pioglitazone had no impact on weight , and severe hypoglycaemia was observed rarely ( n = @ ) .


With few exceptions , the results of safety assessments were similar between the groups , and most adverse events ( AEs ) were mild or moderate .


The @-week incidence rates for gastrointestinal AEs for albiglutide and placebo were : @ and @ % , respectively ( diarrhoea : @ and @ % ; nausea : @ and @ % ; vomiting : @ and @ % ) .


Albiglutide @ mg administered once weekly as an add-on to pioglitazone ( with or without metformin ) provided effective and durable glucose lowering and was generally well tolerated .


The recently published SARA study was a prospective , multi-centre randomized controlled trial that compared CA to antiarrhythmic drug therapy ( ADT ) in @ patients with persistent atrial fibrillation ( AF ) .


The study found that recurrence of AF or atrial flutter occurred significantly less often in the CA arm compared to the ADT arm ( @ % vs. @ % , p = @ ) .


Despite this clear superiority in terms of efficacy , the authors were not able to demonstrate a corresponding Quality of Life ( QoL ) improvement .


We sought to investigate this apparent disparity using alternative analytical methods .


We were able to show that a high coefficient of variation existed for all QoL measures at each time point which may explain the lack of statistical difference originally reported .


We reanalyzed the raw QoL data from the SARA study using paired sample t-tests for the change in QOL for individual patients between baseline and @ month ( final ) follow up .


For patients randomized to ADT the difference in QoL after @ months was not significant for any of the four QoL domains ( global , physical , psychological and sexual ) whereas for patients randomized to CA all comparisons were significant ( global , p < @ ; physical , p = @ ; psychological , p < @ ; sexual , p = @ ) .


In the SARA study , after @ months ' follow up , CA significantly improved QoL for patients with persistent AF whereas medical therapy had no appreciable effect .


The aim of this study was to investigate the influence on fertility and pregnancy outcome in cervical intraepithelial neoplasia ( CIN ) patients after a loop electrosurgical excision procedure ( LEEP ) or cold-knife conization ( CKC ) .


@ patients with CIN-II-III who wanted to conceive were prospectively enrolled in this randomized clinical trial to receive either the LEEP or CKC procedure .


Fertility , neonatal and maternal outcomes were observed and compared .


@ evaluable patients were divided into two groups .


There were @ in the LEEP group and @ in the CKC group .


The preterm premature rupture of membranes ( @ vs. @ % ; p = @ ) , preterm delivery rate ( @ vs. @ % ; p = @ ) and low birth weight infants rate ( < @,@ g ) ( @ vs. @ % ; p = @ ) were higher in the CKC group than in the LEEP group , but there was no difference in mean birth weight , cesarean delivery , labor induction , or neonatal intensive care unit admission .


There was no case of neonatal mortality .


In a prospective evaluation the findings of this study demonstrate that LEEP is safer for future pregnancies when compared to CKC .


LEEP should be an appropriate choice for patients with CIN who want to become pregnant later in life .


Current neonatal resuscitation guidelines recommend tracheal suctioning of nonvigorous neonates born through meconium-stained amniotic fluid .


We evaluated the effect of tracheal suctioning at birth in @ lambs with asphyxia induced by cord occlusion and meconium aspiration during gasping .


Tracheal suctioning at birth ( n = @ ) decreased amount of meconium in distal airways ( @ @ particles/mm ( @ ) lung area ) compared to no suction ( @ @ particles/mm ( @ ) ; n = @ ; P < @ ) .


Three lambs in the suction group had cardiac arrest during suctioning , requiring chest compressions and epinephrine .


Onset of ventilation was delayed in the suction group ( @ @ vs. @ @ s in no-suction group ; P = @ ) .


There was no difference in pulmonary blood flow , carotid blood flow , and pulmonary or systemic blood pressure between the two groups .


Left atrial pressure was significantly higher in the suction group .


Tracheal suctioning resulted in higher Pao@/FiO@ levels ( @ @ vs. @ @ mm Hg ) and ventilator efficiency index ( @ @ vs. @ @ ) .


Two lambs in the no-suction group required inhaled nitric oxide .


Lung @-nitrotyrosine levels were higher in the suction group ( @ @ ng/g protein ) compared with the no-suction group ( @ @ ) .


Tracheal suctioning improves oxygenation and ventilation .


Suctioning does not improve pulmonary/systemic hemodynamics or oxidative stress in an ovine model of acute meconium aspiration with asphyxia .


A randomized controlled trial was conducted to find out whether antiviral therapy in patients with hepatitis B-related hepatocellular carcinoma ( HCC ) improves long-term survival after hepatic resection .


Despite advances in surgery and in multidisciplinary treatment , there is still no effective adjuvant treatment to prevent HCC recurrence after R@ resection for HCC .


Whether antiviral therapy is useful in reducing postoperative HCC recurrence is unclear .


Between May @ and April @ , patients who received R@ hepatic resection for HBV-related HCC were randomly assigned to receive no treatment ( the control group , n = @ ) or antiviral therapy ( adefovir @ mg/d , the antiviral group , n = @ ) .


The baseline clinical , laboratory , and tumor characteristics of the @ groups were comparable .


The @ - , @ - , and @-year recurrence-free survival rates for the antiviral group and the control group were @ % , @ % , @ % and @ % , @ % , @ % , respectively .


The corresponding overall survival rates for the @ groups were @ % , @ % , @ % and @ % , @ % , @ % , respectively .


The recurrence-free survival and overall survival for the antiviral group were significantly better than the control group ( P = @ , P = @ ) .


After adjusting for the confounding prognostic factors in a Cox model , the relative risks of recurrence and death for antiviral treatment were @ -LSB- @ % confidence interval ( CI ) : @-@ @ ; P = @ -RSB- and @ ( @ % CI : @-@ @ ; P < @ ) .


Antiviral therapy was an independent protective factor of late tumor recurrence ( HR = @ , @ % CI : @-@ @ ; P = @ ) but not of early tumor recurrence -LSB- hazard ratio ( HR ) = @ , @ % CI : @-@ @ ; P = @ -RSB- .


In patients with hepatitis B-related HCC , adefovir antiviral therapy reduced late HCC recurrence and significantly improved overall survival after R@ hepatic resection .


The effectiveness of simulation is rarely evaluated .


The aim of this study was to assess the impact of a short training course on the ability of anesthesiology residents to comply with current difficult airway management guidelines .


Twenty-seven third-year anesthesiology residents were assessed on a simulator in a `` ca n't intubate , ca n't ventilate '' scenario before the training ( the pretest ) and then randomly @ , @ , or @ months after training ( the posttest ) .


The scenario was built so that the resident was prompted to perform a cricothyrotomy .


Compliance with airway management guidelines and the cricothyrotomy 's duration and technical quality were assessed as a checklist score -LSB- @ to @ -RSB- and a global rating scale -LSB- @ to @ -RSB- .


After training , all @ residents ( @ % ) complied with the airway management guidelines , compared with @ ( @ % ) in the pretest ( P < @ ) .


In the pretest and the @ - , @ - , and @-month posttests , the median -LSB- range -RSB- duration of cricothyrotomy was respectively @ s -LSB- @ to @ -RSB- , @ s -LSB- @ to @ -RSB- , @ s -LSB- @ to @ -RSB- , and @ s -LSB- @ to @ -RSB- ( P < @ vs. in the pretest ) , the median -LSB- range -RSB- checklist score was @ -LSB- @ to @ -RSB- , @ -LSB- @ to @ -RSB- , @ -LSB- @ to @ -RSB- , and @ -LSB- @ to @ -RSB- ( P < @ vs. in the pretest ) and the median -LSB- range -RSB- global rating scale was @ -LSB- @ to @ -RSB- , @ -LSB- @ to @ -RSB- , @ -LSB- @ to @ -RSB- , and @ -LSB- @ to @ -RSB- ( P < @ vs. in the pretest ) .


There were no significant differences between performance levels achieved in the @ - , @ - , and @-month posttests .


The training session significantly improved the residents ' compliance with guidelines and their performance of cricothyrotomy .


To study the impact of administration of dydrogesterone in early pregnancy on pregnancy outcome and its correlation with Th@ and Th@ cytokine levels .


Double-blind , randomized , placebo-controlled study .


A medical college and its associated hospital .


Women with either : -LSB- @ -RSB- a history of idiopathic recurrent pregnancy loss ( RPL ) , in either a dydrogesterone group or a placebo group , or -LSB- @ -RSB- no history of miscarriage .


Dydrogesterone @ mg/day from confirmation of pregnancy to @ weeks of gestation .


Occurrence of another pregnancy loss and concentrations of T-helper ( Th ) @ ( interferon - and tumor necrosis factor - ) and Th@ ( interleukin ( IL ) -@ and IL-@ ) cytokines in serum at recruitment ( @-@ weeks of gestation ) and at abortion or @ weeks of gestation , using commercially available ELISA kits .


Occurrence of another abortion after @ consecutive abortions was significantly higher ( @ of @ ; @ % ) in women with RPL compared with healthy pregnant controls ( @ of @ ; @ % ) .


Risk of occurrence of miscarriage after @ abortions was @ times higher in the placebo group vs. the treatment group ( risk ratio = @ , @ % CI = @-@ @ ) .


Mean gestational age at delivery ( excluding those aborted before @ weeks of gestation ) increased significantly in the dydrogesterone group ( @ weeks ) compared with the placebo group ( @ weeks ) .


Baby weight was significantly lower in the placebo group ( @ g ) compared with the healthy pregnant controls ( @ g ) .


At recruitment , serum IL-@ and tumor necrosis factor - levels were significantly lower in the RPL group compared with the healthy pregnant controls .


However , serum interferon - level was significantly higher in the RPL group ( @ pg/mL ) compared with the healthy pregnant controls ( @ pg/mL ) .


The present study supports the use of dydrogesterone in women with recurrent abortions to improve pregnancy outcome , such as a reduction in abortions and improved gestational age and baby weight at delivery .


However , these outcomes were not modulated by Th@ and Th@ cytokine production .


The aim of this study was to evaluate the feasibility of low-concentration iso-osmolar Iodixanol @ compared with Iohexol @ in patients with coronary artery bypass grafts ( CABGs ) undergoing coronary computed tomographic angiography ( CCTA ) .


A total of @ consecutive patients undergoing CABG follow-up with the use of CCTA were prospectively enrolled , with @ patients assigned to Iodixanol @ and @ patients assigned to Iohexol @ .


In both groups , the contrast medium was injected at an injection rate of @ mL/s in the patients with a body mass index of greater than @ kg/m@ and @ mL/s in the patients with a body mass index of @ kg/m@ or lower .


The contrast volume was determined by the flow rate and scan time .


Image quality score and visualization of bypass grafts were evaluated .


Subjective assessment of image quality for each coronary artery segment was determined using a @-point grading scale by @ reviewers , whereas objective evaluation of image quality was conducted by measuring the mean CT attenuation values ( hounsfield unit -LSB- HU -RSB- ) in terms of SD , contrast-noise ratio , and signal-noise ratio in the ascending aorta .


The mean ( SD ) contrast volume for the Iodixanol @ and Iohexol @ groups was @ ( @ ) and @ ( @ ) mL , respectively , with no significant difference ( P = @ ) .


The mean ( SD ) CT attenuation value in the Iodixanol @ group was @ ( @ ) , which was lower than in the Iohexol @ group , which was @ ( @ ) ( P = @ ) .


The subjective image quality for the Iodixanol @ group was superior to that for the Iohexol @ group in the arterial graft vessels ( P = @ ) , whereas there was no significant difference between the @ groups in the venous graft vessels ( P = @ ) .


There was no significant difference in terms of SD of the ascending aorta , signal-noise ratio , and contrast-noise ratio between the @ groups .


Low-concentration iso-osmolar Iodixanol @ provides image quality comparable with that of Iohexol @ , allowing diagnostic CCTA follow-up of patients with CABGs .


To evaluate the tolerability and immunogenicity of a booster dose of the quadrivalent meningococcal conjugate vaccine MenACWY-CRM ( Menveo , Novartis Vaccines and Diagnostics , Siena , Italy ) administered @years after primary vaccination of adolescents enrolled in a phase @ study with either MenACWY-CRM or MenACWY-D ( Menactra , Sanofi Pasteur , Swiftwater , Pennsylvania ) .


A total of @ healthy adolescents participated , including @ initial study participants who received primary vaccination with MenACWY-CRM ( n = @ ) or MenACWY-D ( n = @ ) @years previously and @ age-matched vaccine-nave controls .


A subset of MenACWY-CRM ( n = @ ) and MenACWY-D ( n = @ ) recipients were administered a MenACWY-CRM booster dose @years postprimary vaccination .


Immunogenicity prior to and after the booster dose of MenACWY-CRM was measured by serum bactericidal assay with human complement ( hSBA ) .


Local and systemic reactions and adverse events were monitored in subjects receiving the booster dose .


At @years postprimary vaccination , @ % , @ % , and @ % of subjects initially vaccinated with MenACWY-CRM ( n = @ ) showed hSBA titers @ against serogroups C , W-@ , and Y , respectively ; this was lower for serogroup A ( @ % ) .


Significantly more MenACWY-CRM recipients had hSBA titers @ for serogroups W-@ and Y than MenACWY-D recipients ( n = @ ) .


A MenACWY-CRM booster dose resulted in @ % -@ % of subjects demonstrating hSBA titers @ against all serogroups , irrespective of primary vaccination ( MenACWY-CRM , n = @ ; MenACWY-D , n = @ ) .


The booster dose was well tolerated without significant adverse events .


MenACWY-CRM can be used to boost adolescents who have received a primary vaccination with either MenACWY-CRM or MenACWY-D .


The effectiveness of clinic-based pulmonary rehabilitation in advanced COPD is well established , but few data exist for less severe patients treated in alternative settings .


The purpose of this study was to investigate whether a novel , community-based exercise program ( CBE ) was feasible and effective for patients with moderate COPD .


Nineteen patients with moderate COPD ( mean FEV@ @ % ) and self-reported exercise impairment were randomized to @-weeks of progressive endurance and strength training at a local health club under the guidance of a certified personal trainer , or to continuation of unsupervised habitual physical activity .


Outcomes assessed at baseline and @ weeks included session compliance , intensity adherence , treadmill endurance time , muscle strength , dyspnea , and health status .


Compliance was @ % and adherence was @ % .


Comparisons between CBE and control groups yielded the following mean ( SEM ) differences in favor of CBE : endurance time @ ( @ ) seconds versus -@ ( @ ) seconds ( P = @ ) and TDI @ ( @ ) versus -@ ( @ ) ( P < @ ) .


The CBE group increased muscle strength ( weight lifted ) by @ kilograms per subject per week of training ( P < @ ) .


SGRQ was not significantly changed .


We demonstrated the feasibility and effectiveness of a novel community-based exercise program involving health clubs and personal trainers for patients with moderate COPD .


Among patients with a proximal vessel occlusion in the anterior circulation , @ to @ % of patients die within @ days after stroke onset or do not regain functional independence despite alteplase treatment .


We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core , a proximal intracranial arterial occlusion , and moderate-to-good collateral circulation .


We randomly assigned participants to receive standard care ( control group ) or standard care plus endovascular treatment with the use of available thrombectomy devices ( intervention group ) .


Patients with a proximal intracranial occlusion in the anterior circulation were included up to @ hours after symptom onset .


Patients with a large infarct core or poor collateral circulation on computed tomography ( CT ) and CT angiography were excluded .


Workflow times were measured against predetermined targets .


The primary outcome was the score on the modified Rankin scale ( range , @ -LSB- no symptoms -RSB- to @ -LSB- death -RSB- ) at @ days .


A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care ( shift analysis ) .


The trial was stopped early because of efficacy .


At @ centers worldwide , @ participants were enrolled , of whom @ received intravenous alteplase ( @ in the intervention group and @ in the control group ) .


In the intervention group , the median time from study CT of the head to first reperfusion was @ minutes .


The rate of functional independence ( @-day modified Rankin score of @ to @ ) was increased with the intervention ( @ % , vs. @ % in the control group ; P < @ ) .


The primary outcome favored the intervention ( common odds ratio , @ ; @ % confidence interval , @ to @ ; P < @ ) , and the intervention was associated with reduced mortality ( @ % , vs. @ % in the control group ; P = @ ) .


Symptomatic intracerebral hemorrhage occurred in @ % of participants in intervention group and @ % of participants in control group ( P = @ ) .


Among patients with acute ischemic stroke with a proximal vessel occlusion , a small infarct core , and moderate-to-good collateral circulation , rapid endovascular treatment improved functional outcomes and reduced mortality .


( Funded by Covidien and others ; ESCAPE ClinicalTrials.gov number , NCT@ . )


Infants and children who undergo cardiopulmonary bypass and cardiac surgery are at risk of postoperative fluid overload .


Peritoneal dialysis catheter ( PDC ) and peritoneal dialysis are reported to be effective means of postoperative fluid management .


We sought to test the hypothesis that PDC insertion in the operating room at the time of Norwood palliation would decrease the time to achieve a negative fluid balance in a group of neonates with hypoplastic left heart syndrome .


A single center randomized controlled trial was performed .


We randomized neonates with hypoplastic left heart syndrome to prophylactic PDC , with or without dialysis , or standard care ( ie , no PDC ) .


Twenty-two neonates were included ; @ were randomized to PDC and @ were randomized to standard care .


The mean time to first postoperative negative fluid balance was @ @ days for the prophylactic PDC group and @ @ days for the standard care group ( P = @ ) .


There was no difference between the @ groups in time to lactate @ mmol/L , maximum vasoactive-inotrope score on postoperative days @ to @ , time to sternal closure , time to first extubation , modified clinical outcome score , or hospital length of stay .


Twenty-one patients ( @ % ) survived to hospital discharge .


Four patients randomized to prophylactic PDC had @ or more serious adverse events compared with no patients in the standard care group ( P = @ ) .


Prophylactic PDC , with or without dialysis , did not decrease the time to achieve a negative fluid balance after the Norwood procedure , did not alter physiological variables postoperatively , and was associated with more severe adverse events .


AWARD-@ was an adaptive , seamless , double-blind study comparing dulaglutide , a once-weekly glucagon-like peptide-@ ( GLP-@ ) receptor agonist , with placebo at @weeks and sitagliptin up to @weeks .


The study also included a dose-finding portion whose results are presented here .


Type @ diabetes ( T@D ) patients on metformin were randomized @:@:@ to seven dulaglutide doses , sitagliptin ( @mg ) , or placebo .


A Bayesian algorithm was used for randomization and dose selection .


Patients were adaptively randomized to dulaglutide doses using available data on the basis of a clinical utility index ( CUI ) of glycosylated haemoglobin A@c ( HbA@c ) versus sitagliptin at @weeks and weight , pulse rate ( PR ) and diastolic blood pressure ( DBP ) versus placebo at @weeks .


The algorithm randomly assigned patients until two doses were selected .


Dulaglutide @ mg was determined to be the optimal dose .


Dulaglutide @ mg met criteria for the second dose .


Dulaglutide @ mg showed the greatest Bayesian mean change from baseline ( @ % credible interval ) in HbA@c versus sitagliptin at @weeks -@ ( -@ to -@ ) % .


Dulaglutide @ mg showed the greatest placebo-adjusted mean change in weight -LSB- -@ ( -@ to -@ ) kg -RSB- and in PR -LSB- @ ( -@ to @ ) bpm -RSB- .


Dulaglutide @ mg showed the greatest placebo-adjusted mean change in DBP -LSB- -@ ( -@ to @ ) mmHg -RSB- .


The Bayesian algorithm allowed for an efficient exploration of a large number of doses and selected dulaglutide doses of @ and @ mg for further investigation in this trial .


To evaluate the anti-inflammatory and analgesic effect of Bromelain ( pineapple extract ) administered orally in the postoperative after extraction of impacted lower molars .


This is a prospective , placebo-controlled , unicentric , double-blind study ; the sample size was @ patients .


The pre and postoperative outcomes , evaluated on the third ( D@ ) and eighth day ( D@ ) , included inflamtion , pain and oral aperture , as well as the need for analgesics .


One group received Bromelain @mg per day for three days and @mg on days @ to @ .


The other group received placebo in the same dosage .


All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples .


Although there were no statistically significant differences between the treatment groups , a trend towards less inflammation and improved oral aperture was observed in the group that received Bromelain , compared to the group that received placebo .


This trend can be attributed completely to random reasons , since there is no statistical difference in the results .


Further studies are necessary to analyze different administration patterns and doses of Bromelain for the use in the postoperative of impacted third molars .


Cholera is endemic in Bangladesh with epidemics occurring each year .


The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting .


We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and hand washing to vaccination in this setting .


We did this cluster-randomised open-label trial in Dhaka , Bangladesh .


We randomly assigned @ clusters ( @:@:@ ) to vaccination only , vaccination and behavioural change , or no intervention .


The primary outcome was overall protective effectiveness , assessed as the risk of severely dehydrating cholera during @ years after vaccination for all individuals present at time of the second dose .


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


Of @,@ people present at baseline , we analysed @,@ : @,@ assigned to vaccination only , @,@ assigned to vaccination and behavioural change , and @,@ assigned to non-intervention .


Vaccine coverage was @ % in the vaccination only group and @ % in the vaccination and behavioural change group .


Overall protective effectiveness was @ % ( @ % CI lower bound @ % ; p = @ ) in the vaccination group and @ % ( @ % CI lower bound @ % ; p = @ ) in the vaccination and behavioural change group .


We recorded no vaccine-related serious adverse events .


Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban populations with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such populations .


The purpose of the study was to evaluate the efficacy of antimicrobial photodynamic therapy ( aPDT ) used as an adjunct to the endodontic re-treatment in the eradication of microorganisms from previously filled root canals .


The study sample consisted of @ randomly selected patients with root filled and infected root canal system with chronic apical periodontitis on incisors or canines , who have had previously endodontic treatment .


Microbiological samples from the root canals were collected after accessing the canal , following the endodontic re-treatment and after the aPDT procedure .


During instrumentation , the root canals were irrigated with @ % sodium hypochlorite ( NaOCl ) , and the final irrigation protocol included @ % ethylenediaminetetraacetic acid followed by NaOCl .


Root canals were filled with a phenothiazinium chloride and irradiated with a diode laser ( = @ nm , @ mW ) for @ min .


Microbiological samples from the root canals were cultivated on selective plates , and the identification was done by micromorphology , macromorphology and different API strips as well as bacterial counts ( colony forming units ) .


Fourteen bacteria species were isolated from the root canals initially , with a mean value of @ species per canal .


Although endodontic re-treatment alone produced a significant reduction in the number of bacteria species ( p < @ ) , the combination of endodontic treatment and aPDT was statistically more effective ( p < @ ) .


No bacteria were cultivated from the main root canals of @ teeth .


The results indicated that the aPDT used as an adjunct to the conventional endodontic therapy achieved a significant further reduction of intracanal microbial load .


Regional anesthesia is a commonly used technique in orthopedic procedures .


Sedation should reduce the patient 's anxiety and fear while increasing regional anesthesia quality .


This study evaluated the hemodynamic changes , level of sedation , both patients ' and surgeons ' levels of satisfaction and potential side effects in patient-controlled sedation using propofol .


This randomized clinical trial studied sixty ASA physical class I-III patients scheduled for total knee replacement surgery under combined spinal-epidural anesthesia .


Patients in Group P ( n = @ ) received propofol via a patient-controlled analgesia device with the following settings : intravenous propofol bolus dose @ g.kg ( -@ ) , @-minute lockout interval and no basal infusion .


In Group S , we infused saline @ using the same settings .


To determine the level of sedation , we used BIS and Observer 's Assessment of Alertness/Sedation Scale .


For all patients , we recorded the number of requests .


As the final evaluation , we scored surgeons ' and patients ' satisfaction on @-point scales .


Both BIS values and OAA/S scores were lower in Group P than in Group S. Patients ' satisfaction was higher in Group P , although there was no significant difference with respect to surgeons ' satisfaction between the groups .


The number of requests for sedation was significantly higher in Group S. However , most requests were considered unsuccessful .


This study suggests that patient-controlled sedation with propofol can be used efficiently in orthopedic procedures .


To evaluate outcomes relative to treatment using systemic methotrexate ( MTX ) alone or systemic MTX combined with ultrasound ( US ) - guided local injection of potassium chloride ( KCl ) or MTX in women with live tubal ectopic pregnancies .


Case-control study ( Canadian Task Force classification II-@ ) .


Departments of Obstetrics and Gynecology in @ hospitals in China .


Eighty-two women with live tubal ectopic pregnancies .


Participants in the study received treatment using either systemic MTX ( n = @ ; systemic treatment group ) or systemic MTX and US-guided local injection of either MTX or KCl ( n = @ ; combined treatment group ) .


Patient clinical features and outcomes were compared .


There were no significant differences between the patient groups insofar as baseline gestational age , - human chorionic gonadotropin concentration , or size of conceptus .


The success rate in patients who received combined therapy ( @ % ) was much higher than in those who received only systemic treatment ( @ % ) ( p < @ ) .


In the combined treatment group , the success rate was similar between women who received locally injected KCl ( @ % ) and those who received locally injected MTX ( @ % ) .


The significantly higher success rate in patients who received combined US-guided local injection and systemic MTX suggests that this is an efficient nonsurgical option in women with tubal pregnancy , high serum - human chorionic gonadotropin concentration , and fetal cardiac activity .


To determine whether an intervention that improves nursing home ( NH ) staff connections , communication , and problem solving ( CONNECT ) would improve implementation of a falls reduction education program ( FALLS ) .


Cluster randomized trial .


Community ( n = @ ) and Veterans Affairs ( VA ) NHs ( n = @ ) .


Staff in any role with resident contact ( n = @ ) .


NHs received FALLS alone ( control ) or CONNECT followed by FALLS ( intervention ) , each delivered over @ months .


CONNECT used storytelling , relationship mapping , mentoring , self-monitoring , and feedback to help staff identify communication gaps and practice interaction strategies .


FALLS included group training , modules , teleconferences , academic detailing , and audit and feedback .


NH staff completed surveys about interactions at baseline , @ months ( immediately after CONNECT or control period ) , and @ months ( immediately after FALLS ) .


A random sample of resident charts was abstracted for fall risk reduction documentation ( n = @ ) .


Change in facility fall rates was an exploratory outcome .


Focus groups were conducted to explore changes in organizational learning .


Significant improvements in staff perceptions of communication quality , participation in decision-making , safety climate , caregiving quality , and use of local interaction strategies were observed in intervention community NHs ( treatment-by-time effect P = @ ) but not in VA NHs , where a ceiling effect was observed .


Fall risk reduction documentation did not change significantly , and the direction of change in individual facilities did not relate to observed direction of change in fall rates .


Fall rates did not change in control facilities ( falls/bed per year : baseline , @ ; after intervention , @ ) but decreased by @ % in intervention facilities ( falls/bed per year : baseline , @ ; after intervention , @ ) ; the effect of treatment on rate of change was @ ( @ % confidence interval = @-@ @ ) .


CONNECT has the potential to improve care delivery in NHs , but the trend toward improving fall rates requires confirmation in a larger ongoing study .


To explore the clinical efficacy of gemcitabine concomitant with nedaplatin and drug resistance in the treatment of non-small cell lung cancer ( NSCLC ) and associated molecular predicators .


A total of @ patients diagnosed with NSCLC by histology served as the study objects and were randomly divided into an observation group treated with gemcitabine concomitant with nedaplatin and a control group with cisplatin concomitant with gemcitabine , @ cases for each group .


Short-term and long-term efficacies , adverse responses as well as the expression of nucleotide excision repair cross complementing @ ( ERCC@ ) , ribonucleotide reductase subunit M@ ( RRM@ ) and lung resistance-related protein ( LRP ) in NSCLC tissues in both groups were assessed .


The short-term objective response rate ( ORR ) and disease control rate ( DCR ) were @ % ( @/@ ) and @ % ( @/@ ) in the observation group and @ % ( @/@ ) and @ % ( @/@ ) in the control group , respectively , the differences not being statistically significant .


The time to progression ( TTP ) in both groups were @ ~ @ months , while the median TTP was @ d and @ d , respectively .


Though the survival was slightly higher in the control group , there were no significant differences in TTP and survival time .


The rates of decreased hemoglobin , vomiting and nausea as well as renal toxicity were evidently lower in the observation group , while other adverse responses demonstrated no significant difference .


The positive expression rates of ERCC@ , RRM@ and LRP were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in the observation group , respectively .


Compared with negative ERCC@ expression , ORR had decreasing trend and the overall survival time ( OS ) decreased significantly in patients with positive ERCC@ expression , which were markedly decreased by the positive expressions of RRM@ and LRP .


Gemcitabine concomitant with nedaplatin has significant effects in the treatment of NSCLC , with an adverse response rate obviously lower than for cisplatin concomitant with gemcitabine , suggesting that wider use in the clinic is warranted .


Additionally , the positive expressions of ERCC@ , RRM@ and LRP may increase patient drug resistance , so they can be applied as the chemotherapeutic predicators to guide individualized therapy of NSCLC patients .


Early antiretroviral therapy ( ART ) and virological suppression can affect evolving antibody responses to HIV infection .


We aimed to assess frequency and predictors of seronegativity in infants starting early ART .


We compared HIV antibody results between two of three treatment groups of the Children with HIV Early Antiretroviral Therapy ( CHER ) trial , done from July , @ , until July , @ , in which infants with HIV infection aged @-@ weeks with a percentage of CD@-positive T lymphocytes of at least @ % were randomly assigned to immediate ART for @ weeks ( ART-@W ) or deferred ART until clinical or immunological progression ( ART-Def ) .


We measured antibody from all available stored samples for ART-@W and ART-Def at trial week @ using three assays : fourth-generation enzyme immunoassay HIV antigen-antibody combination , HIV-@ and HIV-@ rapid antibody test , and quantitative anti-gp@ IgG ELISA .


We also assessed odds of seropositivity with respect to age of ART initiation and cumulative viral load .


The CHER trial was registered with ClinicalTrials.gov , number NCT@ .


The median age of the infants from when samples were taken ( @ samples from @ infants ) was @ weeks ( IQR @-@ ) .


More specimens from the ART-@W group were seronegative than from the ART-Def group by enzyme immunoassay ( ART-@W @ -LSB- @ % -RSB- of @ vs ART-Def eight -LSB- @ % -RSB- of @ ; p < @ ) and rapid antibody test ( @ -LSB- @ % -RSB- of @ vs eight -LSB- @ % -RSB- of @ ; p < @ ) .


Median anti-gp@ IgG concentration was lower in the ART-@W group ( @ g/L -LSB- IQR @-@ -RSB- ) than in the ART-Def group ( @ g/L -LSB- @-@ -RSB- ; p < @ ) .


If ART was started between @ and @ weeks of age , odds of seropositivity were increased @ times ( @ % CI @-@ ; p = @ ) compared with starting it between @ and @ weeks .


All children starting ART aged older than @ weeks were seropositive .


Cumulative viral load to week @ correlated with anti-gp@ IgG concentrations ( coefficient @ ; p < @ ) and increased odds of seropositivity ( odds ratio @ -LSB- @ % CI @-@ -RSB- ) adjusted for ART initiation age .


About half of children starting ART before @ weeks of age were HIV seronegative by almost @ years of age .


HIV antibody tests can not be used to reconfirm HIV diagnosis in children starting early ART .


Long-term effects of seronegativity need further study .


Clear guidelines are needed for retesting alongside improved diagnostic tests .


Topical applications of emollients such as sunflower seed oil and Aquaphor have been shown to reduce the incidence of bloodstream infections and mortality of preterm infants in resource-poor settings .


The causal mechanism for prevention of infection through cutaneous portals of entry is not well understood .


We examined the relationship between skin condition score as a measure of skin barrier integrity and risk for bloodstream infection , and the effect of emollients on that relationship .


Data for this study come from a randomized controlled trial of the impact of topical emollient therapy on nosocomial infections in @ preterm infants < @ weeks gestational age at Dhaka Shishu Hospital , Bangladesh .


Latent growth trajectory model with random-coefficient and multivariable logistic regression were utilized .


Rate of deterioration of skin condition was significantly lower ( P < @ ) in both emollient arms compared with the untreated control group .


Adjusted odds ratio of skin score for infection was @ ( @ % confidence interval : @-@ @ ) .


Emollients reduced the incidence of infection only when the skin had no signs of deterioration -LSB- Aquaphor incidence rate ratio : @ ( @ % confidence interval : @-@ @ ) and sunflower seed oil incidence rate ratio : @ ( @ % confidence interval : @-@ @ ) -RSB- .


Skin condition deteriorated progressively after birth and compromised skin condition increased the risk of infection .


Emollients preserved skin integrity and thus prevented infection in preterm neonates .


To optimize benefits of emollients for the prevention of bloodstream infection , use of emollients should begin immediately after birth when the skin is still intact .


To compare gadoxetic acid injection rates of @ mL/s and @ mL/s for hepatic arterial-phase magnetic resonance ( MR ) imaging .


In this prospective study , @ consecutive patients with suspected focal liver lesions were included and randomly divided into two groups .


Each group underwent dynamic liver MR imaging using a @-T scanner after an intravenous injection of gadoxetic acid at rates of either @ mL/s ( n = @ ) or @ mL/s ( n = @ ) .


Arterial phase images were analyzed after blinding the injection rates .


The signal-to-noise ratios ( SNRs ) of the liver , aorta , portal vein , hepatic vein , spleen , and pancreas were measured .


The contrast-to-noise ratios ( CNRs ) of the hepatocellular carcinomas ( HCC ) were calculated .


Finally , two experienced radiologists were independently asked to identify , if any , HCCs in the liver on the images and score the image quality in terms of the presence of artifacts and the proper enhancement of the liver , aorta , portal vein , hepatic vein , hepatic artery , spleen , pancreas , and kidney .


The SNRs were not significantly different between the groups ( p = @-@ @ ) .


The CNRs of the HCCs were not significantly different ( p = @ ) .


The sensitivity for HCC detection and the image quality scores were not significantly different between the two injection rates ( p = @-@ @ ) .


Image quality and sensitivity for hepatic HCCs of arterial-phase gadoxetic acid-enhanced MR were not significantly improved by reducing the contrast injection rate to @ mL/s compared with @ mL/s .


Gemcitabine plus a platinum-based agent ( eg , cisplatin or oxaliplatin ) is the standard of care for advanced biliary cancers .


We investigated the addition of cetuximab to chemotherapy in patients with advanced biliary cancers .


In this non-comparative , open-label , randomised phase @ trial , we recruited patients with locally advanced ( non-resectable ) or metastatic cholangiocarcinoma , gallbladder carcinoma , or ampullary carcinoma and a WHO performance status of @ or @ from @ hospitals across France and Germany .


Eligible patients were randomly assigned ( @:@ ) centrally with a minimisation procedure to first-line treatment with gemcitabine ( @ mg/m ( @ ) ) and oxaliplatin ( @ mg/m ( @ ) ) with or without cetuximab ( @ mg/m ( @ ) ) , repeated every @ weeks until disease progression or unacceptable toxicity .


Randomisation was stratified by centre , primary site of disease , disease stage , and previous treatment with curative intent or adjuvant therapy .


Investigators who assessed treatment response were not masked to group assignment .


The primary endpoint was the proportion of patients who were progression-free at @ months , analysed by intention to treat .


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


Between Oct @ , @ , and Dec @ , @ , @ patients were assigned to chemotherapy plus cetuximab and @ to chemotherapy alone .


@ ( @ % ; @ % CI @-@ ) patients assigned to chemotherapy plus cetuximab and @ ( @ % ; @-@ ) assigned to chemotherapy alone were progression-free at @ months .


Median progression-free survival was @ months ( @ % CI @-@ ) in the chemotherapy plus cetuximab group and @ months ( @-@ ) in the chemotherapy alone group .


Median overall survival was @ months ( @-@ ) in the chemotherapy plus cetuximab group and @ months ( @-@ ) in the chemotherapy alone group .


The most common grade @-@ adverse events were peripheral neuropathy ( in @ -LSB- @ % -RSB- of @ patients who received chemotherapy plus cetuximab vs ten -LSB- @ % -RSB- of @ who received chemotherapy alone ) , neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and increased aminotransferase concentrations ( @ -LSB- @ % -RSB- vs ten -LSB- @ % -RSB- ) .


@ serious adverse events were reported in @ ( @ % ) of @ patients who received chemotherapy plus cetuximab ( @ events in @ -LSB- @ % -RSB- patients were treatment-related ) , whereas @ serious adverse events were reported in @ ( @ % ) of @ patients who received chemotherapy alone ( @ events in @ -LSB- @ % -RSB- patients were treatment-related ) .


One patient died of atypical pneumonia related to treatment in the chemotherapy alone group .


The addition of cetuximab to gemcitabine and oxaliplatin did not seem to enhance the activity of chemotherapy in patients with advanced biliary cancer , although it was well tolerated .


Gemcitabine and platinum-based combination should remain the standard treatment option .


It is widely known that inflammation is related to type @ diabetes ( T@D ) , but few studies have shown a direct relationship between the immune system and T@D using a reliable biomarker .


Neutrophil : lymphocyte ratio ( NLR ) is an easy-to-analyze inflammation biomarker , but few studies have assessed the relationship between NLR and T@D .


In order to evaluate how NLR is related to T@D , we designed a large-scale cross-sectional and prospective cohort study in an adult population .


Participants were recruited from the Tianjin Medical University General Hospital-Health Management Centre .


Both a baseline cross-sectional ( n = @,@ ) and a prospective ( n = @,@ ) assessment were performed .


Participants without a history of T@D were followed up for @ years ( with a median follow-up of @ years ) .


Adjusted logistic and Cox proportional hazards regression models were used to assess relationships between the quintiles of NLR and T@D ( covariates : age , sex , BMI , smoking status , drinking status , hypertension , hyperlipidemia , and family history of cardiovascular disease , hypertension , hyperlipidemia , or diabetes ) .


The prevalence and incidence of T@D were @ % and @ / @ person-years respectively .


The adjusted odds ratio and hazard ratio ( @ % CI ) of the highest NLR quintile were @ ( @ , @ ) and @ ( @ , @ ) ( both P for trend < @ ) respectively as compared to the lowest quintile of NLR .


Leukocyte , neutrophil , and lymphocyte counts do not significantly predict the eventual development of T@D .


The present study demonstrates that NLR is related to the prevalence and incidence of T@D , and it suggests that NLR may be an efficient and accurate prognostic biomarker for T@D .


To compare the differences in the clinical efficacy on post-stroke upper limb spasmodio hemiplegia among the combined therapy of relaxing needling ( Huici ) technique combined with wheat-grain moxibustion , simple relaxing needling and conventional acupuncture .


Ninety patients were-randomized into a group with the combined therapy of relaxing needling technique combined with wheat-grain moxibustion ( a combined therapy group ) , a simple relaxing needling group and a conventional acupuncture group , @ cases in each group .


In the combined therapy group , the relaxing needling technique was used in combination with wheat-grain moxibustion .


The relaxing needling technique was applied to Jianyu ( LI @ ) , Quchi ( LI @ ) , Shousanli ( LI @ ) , etc. .


The wheat-grain moxibustion was applied to Qihai ( CV @ ) , Guanyuan ( CV @ ) , Mingmen ( GV @ ) , etc. .


In thel simple relaxing needling group , the relaxing needling technique was used simply .


In the conventional acupuncture group , the conventional lifting , thrusting and rotating technique with filiform needle was adopted at the same acupoints as the simple relaxing needling group .


The treatment was given once every day ; @ treatments made one session .


Totally @ sessions were required , with @ day at intervals .


The modified Ashworth scale ( MAS ) , Fugl-Meyer assessment ( FMA ) and Barthel index ( BD were adopted to assess the upper limb muscle tension , motor functioni and daily life activity .


After treatment , MAS score was all reduced as compared with that before treatment in each group , and FMA score and BI score were increased as compared with those before treatment ( all P < @ ) .


MAS score in the combined therapy group was lower than that in either the simple relaxing needling group or the conventional acupuncture group ( both P < @ ) , and the score in the simple relaxing needling group was lower than that in the conventional acupuncture group ( P < @ ) .


FMA score and BI score in the combined therapy group were higher than those in the simple relaxing needling group and the conventional acupuncture group ( both P < @ ) .


FMA score in the simple relaxing needleing group was higher than that the Enventional acupuncture group ( P < @ ) .


The total effective rate in the combined therapy group was @ % ( @/@ ) , higher ; than @ % ( @/@ ) in the simple relaxing needling group ( P < @ ) , and @ % ( @/@ ) in the conventionaP acupuncture group ( P < @ ) .


The combined therapy of relaxing needling technique and wheat-grain moxibustion achieves more satisfactory efficacy on post-stroke upper limb spasmodic hemiplegia compared with the simple relaxing needling and conventional acupuncture .


To determine if lactate concentrations in jugular venous and auricular arterial blood differ in anesthetized sheep .


Prospective , controlled experimental study .


Twelve healthy adult ewes , @-@years and weighing @-@kg .


Jugular venous blood was collected before anesthesia ( PreOv ) for measurement of lactate concentration , packed cell volume and total protein .


Ewes were administered a standard anesthesia protocol .


Jugular venous ( IntraOv ) and auricular arterial ( IntraOa ) blood samples were obtained @minutes after induction of anesthesia , and again in recovery ( PostOv and PostOa ) .


An additional blood sample was drawn @weeks post-operatively from non-fasted sheep ( NF_Lact ) .


Lactate concentrations were compared among PreOv , IntraOv and IntraOa , PostOv and PostOa , and between PreOv and NF_Lact with paired t-test and repeated measure analyses of variance ( anova ) with PreOv as a covariate ( p@ @ ) .


IntraOv lactate concentration had decreased from PreOv There were significant differences between arterial and venous IntraO and PostO lactate concentrations .


There was no significant difference between IntraO and PostO , or PreOv and NF_Lact .


Lactate concentrations were significantly lower in anesthetized sheep compared to non-anesthetized sheep .


Lactate concentrations in venous blood were higher than in arterial blood .


Therefore , anesthetic status and sampling site should be considered when interpreting lactate concentrations , and the sampling site should be consistent for repeated measurements .


This report details enrolment findings related to a Canadian randomized controlled trial comparing immediate to delayed intrauterine contraception ( IUC ) placement after a second trimester abortion .


We report acceptance of IUC , satisfaction with prior contraception , adherence to the CONSORT criteria , and challenges faced in the recruitment process .


Women seeking second trimester abortion and selecting either of two methods of IUC as their preferred contraception method were enrolled and randomized to insertion either immediately post-abortion or four weeks later .


Enrolled participants completed a Contraception Satisfaction Questionnaire detailing prior contraceptive satisfaction .


Among @ women assessed , @ ( @ % ) met eligibility criteria and IUC was chosen for post-abortion contraception by over one half of them ( @/@ , @ % ) .


When both types of device were available cost-free , women selected the levonorgestrel-releasing intrauterine system more than @ times more frequently than a copper IUD .


Participants had an average age of @ ( standard deviation -LSB- SD -RSB- @ ) years , and an average gestational age of @ ( SD @ ) weeks .


Almost one half ( @ % ) had had a prior abortion and @ % had a prior delivery .


Two thirds of participants were using a contraception method at the time of conception , but almost one third of these were using methods in the lowest tiers of effectiveness .


There was a weak correlation between prior contraceptive compliance and education level .


More than one half of eligible women seeking a second-trimester abortion chose IUC for post-abortion contraception .


In Canada , health care for unintended pregnancies is universally subsidized but contraception is not .


Offering comprehensive information on the range of contraceptive methods and providing cost-free IUC is an effective strategy to increase uptake of intrauterine contraception among Canadian women who wish to prevent further unintended pregnancy .


To assess efficacy and safety of lixisenatide once-daily versus placebo in type @ diabetes mellitus ( T@DM ) patients inadequately controlled on sulfonylurea ( SU ) metformin .


In this randomized , double-blind , two-arm , parallel-group , multicenter study , patients received lixisenatide @ g once-daily or placebo for @ weeks in a stepwise dose increase on top of SUs metformin .


Primary outcome was change in HbA@c from baseline to Week @ .


Lixisenatide provided a significant reduction in HbA@c at Week @ versus placebo ( LS mean : -@ % vs. -@ % ; p < @ ) and more patients achieved HbA@c < @ % ( @ % vs. @ % ; p < @ ) .


Lixisenatide significantly lowered FPG and body weight versus placebo .


In breakfast meal test patients , lixisenatide reduced @-hour PPG versus placebo ( LS mean : -@ vs. -@ mg/dL -LSB- -@ vs. -@ mmol/L -RSB- ; p < @ ) and glucose excursion ( -@ vs. +@ mg/dL -LSB- -@ vs. +@ mmol/L -RSB- ) , and reduced @-hour glucagon , insulin , proinsulin , and C-peptide .


The percentage of AEs was @ % for lixisenatide and @ % for placebo ; and for SAEs : @ % versus @ % , respectively .


Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo ( @ % vs. @ % , respectively ) ; one severe episode of hypoglycemia was reported with lixisenatide .


Once-daily lixisenatide significantly improved glycemic control , with a pronounced postprandial effect , without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over @ weeks .


To compare the efficacy of two surgical techniques for controllong nasal width after Le Fort I osteotomy .


Fifty-five patients who received the Le Fort I osteotomy have been included in this study .


They were randomly divided into @ groups .


The experimental group received extraoral ABS , and the control group received traditional intraoral ABS .


@D photos of the patient 's face were taken before operation and at postoperative @ months .


Alar width was measured on the @D photos .


Data was reported as means and standard deviations , and statistic analysis was done by using student t test .


Compared with presurgical data , G. lat-G .


lat increased by ( @ + / - @ ) mm , Al-Al increased by ( @ + / - @ ) mm and Sbal-Sbal increased by ( @ + / - @ ) mm in experimental group .


G. lat-G .


lat increased by ( @ + / - @ ) mm , Al-Al increased by ( @ + / - @ ) mm and Sbal-Sbal increased by ( @ + / - @ ) mm in the control group .


There was significant difference between two groups .


The surgical technique of ABS is the most important factor for determining the postoperative alar width .


Both techniques have better effect on the Sbal-Sbal width control than the G. lat-G .


lat and Al-Al width control .


Traditional intraoral ABS can more effectively control the alar width .


Both techniques can not completely control the alar base widening after Le Fort I osteotomy .


Artemisinin-based combination therapies ( ACTs ) are essential for the effective control of falciparum malaria in endemic countries .


However , in most countries , such choice has been carried out without knowing their effectiveness when deployed in real-life conditions , that is , when treatment is not directly observed .


We report here the results of a study assessing the effectiveness of the two ACTs currently recommended in Burkina Faso for the treatment of uncomplicated malaria , that is , artemether-lumefantrine ( AL ) and artesunate-amodiaquine ( ASAQ ) .


Between September @ and January @ , @ children were randomised to one of the two study arms and followed up for @ days .


Treatment was administered according to routine practices , that is , the first dose was given by study nurses who explained to the parent/guardian how to administer the other doses at home during the following @ days .


The results showed a significantly higher unadjusted adequate clinical and parasitological response in the ASAQ ( @ % ) than in the AL arm ( @ % ) at day @ but these trends were similar after correction with PCR data ( ASAQ ( @ % ) and AL ( @ % ) ) .


New infections started to appear after day @ , first in the AL and then in the ASAQ arm but at day @ day of follow-up we observed no difference in the occurrence of recrudescent infection .


Despite a lower cure rate than those reported in efficacy studies in which the treatment administration was directly observed , both AL and ASAQ can still be used for the treatment of uncomplicated malaria in Burkina Faso .


Social factors may be of importance causally and act as maintenance factors in patients with anorexia nervosa .


Oxytocin is a neuromodulatory hormone involved in social emotional processing associated with attentional processes .


This study aimed to examine the impact of oxytocin on attentional processes to social faces representing anger , disgust , and happiness in patients with anorexia nervosa .


A double-blind , placebo-controlled within-subject crossover design was used .


Intranasal oxytocin or placebo followed by a visual probe detection task with faces depicting anger , disgust , and happiness was administered to @ female subjects : @ patients with anorexia nervosa and @ control students .


Attentional bias to the disgust stimuli was observed in both groups under the placebo condition .


The attentional bias to disgust was reduced under the oxytocin condition ( a moderate effect in the patient group ) .


Avoidance of angry faces was observed in the patient group under the placebo condition and vigilance was observed in the healthy comparison group ; both of these information processing responses were moderated by oxytocin producing an increase in vigilance in the patients .


Happy/smiling faces did not elicit an attentional response in controls or the patients under either the placebo or oxytocin conditions .


Oxytocin attenuated attentional vigilance to disgust in patients with anorexia nervosa and healthy controls .


On the other hand , oxytocin changed the response to angry faces from avoidance to vigilance in patients but reduced vigilance to anger in healthy controls .


We conclude that patients with anorexia nervosa appear to use different strategies/circuits to emotionally process anger from their healthy counterparts .


The examination of cough reflex sensitivity through inhalational challenge can be utilized to demonstrate pharmacological end points .


Here we compare the effect of butamirate , dextromethorphan and placebo on capsaicin-induced cough in healthy volunteers .


In this randomized , placebo-controlled , six way crossover study the effect of dextromethrophan @mg , four doses of butamirate and placebo was evaluated on incremental capsaicin challenges performed at baseline and @ , @ , @ , @ , @ and @h following dosing .


The primary end point was the area under the curve ( AUC ( @,@ h ) ) of log@ C@ from pre-dose to @h after dosing .


Plasma butamirate metabolites were analyzed to evaluate pharmacokinetic and pharmacodynamic relationships .


Thirty-four subjects ( @ males , median age @ years ) completed the study .


Cough sensitivity decreased from baseline in all arms of the study .


Dextromethorphan was superior to placebo ( P = @ ) but butamirate failed to show significant activity with maximum attenuation at the @mg dose .


There was no apparent relationship between pharmacokinetic and pharmacodynamic parameters for butamirate .


We have demonstrated for the first time that dextromethorphan attenuates capsaicin challenge confirming its broad activity on the cough reflex .


The lack of efficacy of butamirate could be due to formulation issues at higher doses .


A variety of apheresis instruments are now available on the market for double dose plateletpheresis .


We compared three apheresis devices ( Fenwal Amicus , Fresenius COM.TEC and Trima Accel ) with regard to processing time , platelet ( PLT ) yield , collection efficiency ( CE ) and collection rate ( CR ) .


The single-needle or double-needle double plateletpheresis procedures of the three instruments were compared in a retrospective , randomized study in @ donors .


In the pre-apheresis setting , @ double plateletpheresis procedures performed with each instrument revealed no significant differences in donor 's age , sex , weight , hemoglobin , white blood cell and PLT count between three groups .


The blood volume processed to reach a target PLT yield of@ ( @ ) was higher in the COM.TEC compared with the Amicus and Trima ( @ vs. @ and @ml , respectively ; p < @ ) .


Also there was a significantly higher median volume of ACD used in collections on the COM.TEC compared with the Amicus and Trima ( @ vs. @ and @ml , respectively ; p < @ ) .


There was a significantly higher median time needed for the procedures on the COM.TEC compared with the Amicus and Trima ( @ vs. @ and @min , respectively ; p = @ ) .


The CE was significantly higher with the Trima compared with the Amicus and COM.TEC ( @ vs. @ and @ % , respectively ; p < @ ) .


Also , there was a significantly higher product volume on the Trima compared with the Amicus and COM.TEC ( @ vs. @ and @ ml , respectively ; p = @ ) .


Additionally , the CR was significantly lower with the COM.TEC compared with the Amicus and Trima ( @ vs. @ and @ plt@ ( @ ) / min , respectively ; p = @ ) .


There was no significant differences in PLT yield between the three groups ( p = @ ) .


Trima single-needle device collected double dose platelets more efficiently than Amicus and COM.TEC double-needle devices .


Blood volume processed , ACD-A volume , and median separation time was significantly higher with the COM.TEC .


Also , the CR was significantly lower with the COM.TEC .


To investigate clinical outcomes of coronary intervention using a biolimus-eluting stent ( BES ) compared with a sirolimus-eluting stent ( SES ) in patients with acute myocardial infarction ( AMI ) in the Limus Eluted from A Durable versus ERodable Stent ( LEADERS ) coating trial at the final @-year follow-up .


The LEADERS trial is a multicentre all-comer study , where patients ( n = @ ) were randomised to percutaneous intervention with either BES containing biodegradable polymer or SES containing durable polymer .


Out of @ patients enrolled in this trial , @ patients had percutaneous coronary intervention for AMI ( BES = @ , SES = @ ) and were included in the current analysis .


Patient-oriented composite endpoint ( POCE , including all death , all myocardial infarction ( MI ) and all revascularisations ) , major adverse cardiac events ( MACE , including cardiac death , MI and clinically indicated target vessel revascularisation ) and stent thrombosis were assessed at @-year follow-up .


The baseline clinical , angiographic and procedural characteristics were well matched between BES and SES groups .


In all patients with AMI , coronary intervention with a BES , compared with SES , significantly reduced POCE ( @ % vs @ % ; relative risk ( RR ) @ , @ % CI @ to @ , p = @ ) at @-year follow-up .


There was also a reduction in MACE rate in the BES group ( @ % vs @ % ; RR @ , @ % CI @ to @ , p = @ ) ; however , there was no difference in cardiac death and stent thrombosis .


In patients with ST-elevation MI ( STEMI ) , coronary intervention with BES significantly reduced POCE ( @ % vs @ % ; RR @ , @ % CI @ to @ , p = @ ) , MACE ( @ % vs @ % ; RR @ , @ % CI @ to @ , p = @ ) and cardiac death ( @ % vs @ % ; RR @ , @ % CI @ to @ , p = @ ) , along with a trend towards reduction in definite stent thrombosis ( @ % vs @ % ; RR @ , @ % CI @ to @ , p = @ ) , compared with SES .


BES , compared with SES , significantly improved safety and efficacy outcomes in patients with AMI , especially those with STEMI , at @-year follow-up .


The need for a fundoplication during repair of paraesophageal hiatal hernias ( PEH ) remains unclear .


Prevention of gastroesophageal reflux represents a trade-off against the risk of fundoplication-related side effects .


The aim of this trial was to compare laparoscopic mesh-augmented hiatoplasty with simple cardiophrenicopexy ( LMAH-C ) with laparoscopic mesh-augmented hiatoplasty with fundoplication ( LMAH-F ) in patients with PEH .


The study was designed as a patient - and assessor-blinded randomized controlled pilot trial , registration number : DRKS@ ( www.germanctr.de / ) .


Patients with symptomatic PEH were eligible and assigned by central randomization to LMAH-C or LMAH-F .


Endpoints were postoperative gastroesophageal reflux , complications , and quality of life @ months postoperatively .


Forty patients ( @ male , @ female ) were randomized .


Patients were well matched for baseline characteristics .


At @ months , the DeMeester score was higher after LMAH-C compared with LMAH-F ( @ @ vs. @ @ ; p = @ ) .


At @ months , the reflux syndrome score was higher after LMAH-C compared with LMAH-F ( @ @ vs. @ @ ; p = @ ) .


In @ % of LMAH-C patients and @ % of LMAH-F patients , postoperative esophagitis was present ( p = @ ) .


Values of dysphagia ( @ @ vs @ @ ; p = @ ) , gas bloating ( @ @ vs @ @ ; p = @ ) , and quality of life ( @ @ vs @ @ ; p = @ ) were similar .


Relevant postoperative complications occurred in @ ( @ % ) patients and did not differ between the groups .


Laparoscopic repair of PEH should be combined with a fundoplication to avoid postoperative gastroesophageal reflux and resulting esophagitis .


Fundoplication-related side effects do not appear to be clinically relevant .


Multicenter randomized trials are required to confirm these findings .


This study examined parental factors associated with outcomes of youth in the Treatment Options for type @ Diabetes in Adolescents and Youth ( TODAY ) clinical trial .


Of @ youth with type @ diabetes in the TODAY cohort , @ ( @ % ) had a parent participate and provide data at baseline , including weight , HbA@c , blood pressure , symptoms of depression , binge eating ( BE ) , and medical history .


Youth were followed @-@ @ years .


Data were analyzed using regression models and survival curve methods .


Parental diabetes ( @ % of parents ) was associated with higher baseline HbA@c ( P < @ ) and failure of youths to maintain glycemic control on study treatment ( @ % vs. @ % failure rate among those without a diabetic parent , P = @ ) .


Parental hypertension ( @ % of parents ) was associated with hypertension in youth during TODAY ( @ % vs. @ % of youth with and without parental hypertension had hypertension , P = @ ) and with higher youth baseline BMI z scores ( P = @ ) .


Parents had a mean baseline BMI of @ kg/m ( @ ) .


Parental obesity ( BMI > @ kg/m ( @ ) ) was associated with higher baseline BMI z scores in the youth ( P < @ ) .


Depressive symptoms in parents ( @ % of parents ) were related to youth depressive symptoms at baseline only ( P = @ ) ; subclinical BE in parents was related to the presence of subclinical BE ( P = @ ) and depressive symptoms ( P = @ ) in youth throughout the study period .


Parental diabetes and hypertension were associated with lack of glycemic control , hypertension , and higher BMI z scores in youth .


Further research is needed to better understand and address parental biological and behavioral factors to improve youth health outcomes .


To compare the @-year outcomes of the Ahmed FP@ Glaucoma Valve ( AGV ) ( New World Medical , Cucamonga , CA ) and the Baerveldt @-@ Glaucoma Implant ( BGI ) ( Abbott Medical Optics , Abbott Park , IL ) for the treatment of refractory glaucoma .


Multicenter , randomized , controlled clinical trial .


A total of @ patients , including @ in the AGV group and @ in the BGI group .


Patients aged @ to @ years with previous intraocular surgery or refractory glaucoma and intraocular pressure ( IOP ) of @ mmHg in whom glaucoma drainage implant ( GDI ) surgery was planned were randomized to implantation of an AGV or a BGI .


Surgical failure , IOP , visual acuity ( VA ) , use of glaucoma medications , and complications .


At @ years , IOP ( mean standard deviation -LSB- SD -RSB- ) was @ mmHg in the AGV group and @ mmHg in the BGI group ( P = @ ) .


The number of glaucoma medications in use at @ years ( mean SD ) was @ in the AGV group and @ in the BGI group ( P = @ ) .


The cumulative probability of failure during @ years of follow-up was @ % in the AGV group and @ % in the BGI group ( P = @ ) .


The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was @ in the AGV group ( @ % of AGV failures ) and @ in the BGI group ( @ % of BGI failures ; P = @ ) .


Eleven eyes in the AGV group ( @ % of AGV failures ) experienced persistent hypotony , explantation of implant , or loss of light perception compared with @ eyes ( @ % of failures ) in the BGI group .


Change in logarithm of the minimum angle of resolution VA ( mean SD ) at @ years was @ in the AGV group and @ in the BGI group ( P = @ ) .


Similar rates of surgical success were observed with both implants at @ years .


The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV , but the BGI was associated with twice as many failures because of safety issues .


Elective cholecystectomy for symptomatic gall stone disease carries low risk of postoperative infective complications .


Yet the routine use of prophylactic antibiotic is in vogue in many centres .


The aim of this study was to find out the efficacy of antibiotic prophylaxis in preventing postoperative infective complications in low risk elective laparoscopic cholecystectomy patients .


Randomised controlled trial was carried out in our hospital from @st Nov @ to @th Oct @ .


A total of @ patients were included in the study and were divided into Group A ( n = @ ) .


and Group B ( n = @ ) .


Group A was given single dose of injection Celfuroxime @ gm as prophylactic antibiotic at the time of induction of anaesthesia , and Group B was not given any antibiotic .


In both groups , age , sex , duration of surgery , American Society of Anesthesiologists classification , duration of surgery and length of hospital stay were recorded .


Patients were followed-up weekly for @ weeks and rates of superficial surgical site infections as well as intra-abdominal infections were recorded .


There were no significant differences in both groups in terms of age , sex , duration of surgery , length of hospital stay .


Eight ( @ % ) cases of superficial surgical site infection were noted in Group A and @ ( @ % ) in Group B which was insignificant statistically ( p > @ ) .


In low risk patients antibiotic prophylaxis does not seem to affect the incidence of postoperative infective complications in elective laparoscopic cholecystectomy .


The use of prophylactic antibiotics should be reserved for high risk patients undergoing laparoscopic cholecystectomy .


Myocardial perfusion SPECT ( MPS ) is one of the frequently used methods for quantification of perfusion defects in patients with known or suspected coronary artery disease .


This article describes open access software for automated quantification in MPS of stress-induced ischemia and infarction and provides phantom and in vivo validation .


A total of @ patients with known or suspected coronary artery disease underwent both stress and rest MPS .