We have previously shown that the PAM@-based risk of recurrence ( ROR ) score is significantly correlated with distant recurrence in both the translational research cohort within the Arimidex , Tamoxifen Alone or in Combination ( ATAC ) trial ( TransATAC ) and Austrian Breast and Colorectal Cancer Study Group @ ( ABCSG @ ) randomized trials .


Here , we focus on the ROR score for predicting distant recurrence after @ years of follow-up in a combined analysis of these two randomized trials .


Long-term follow-up data and tissue samples were obtained from @,@ postmenopausal women with hormone receptor-positive early-stage breast cancer from the ABCSG @ and TransATAC trials .


We used Cox proportional hazard regression models to determine the prognostic value of ROR for distant recurrence beyond @ years in the combined data set .


A total of @,@ women who did not have a recurrence @ years after diagnosis were included in the combined analyses .


The Clinical Treatment Score ( CTS ) was the strongest prognostic factor @ years after diagnosis ( univariable : likelihood ratio -LSB- LR -RSB- ( @ ) = @ , bivariable : LR ( @ ) = @ ) .


The ROR score was significantly prognostic by itself in years @ to @ .


In the node-negative/human epidermal growth factor receptor @-negative subgroup , more prognostic value for late distant recurrence was added by the ROR score compared with the CTS .


The ROR score added clinically meaningful prognostic information to the CTS in all patients and all subgroups in the late follow-up period .


These results suggest that the ROR score may be helpful for separating patients into risk groups who could be spared or potentially benefit from extended hormonal therapy beyond @ years of treatment .


This study measured the effects of dietary supplementation with lipid-based nutrient supplements ( LNSs ) on @-month-old children 's physical activity .


In a randomised , controlled , outcome-assessor blinded trial @ six-month-old children from Malawi received one of five interventions daily from @-@ months of age : @-g milk-LNS , @-g milk-LNS , @-g non-milk-LNS , @-g milk-LNS or @-g non-milk-LNS , or received no intervention in the same period ( control ) .


The control group received delayed intervention with corn-soy blend from @-@ months .


Physical activity was measured over @ week by ActiGraph GT@X + accelerometer at @ months .


Main outcome was mean vector magnitude accelerometer counts/@s .


Analyses were restricted to children with valid accelerometer data on at least @ days with minimum @h of wearing time per day .


Of the @ children recruited to this substudy , @ provided sufficient data for analysis .


The mean ( s.d. ) vector magnitude accelerometer counts in the total sample were @ ( @ ) .


The difference ( @ % CI ) in mean accelerometer counts , compared with the control group , was @ ( -@ to @ , P = @ ) in @-g milk-LNS , @ ( -@ to @ , P = @ ) in @-g milk-LNS , @ ( -@ to @ , P = @ ) in @-g non-milk-LNS , @ ( -@ to @ , P = @ ) in @-g milk-LNS and @ ( -@ to @ , P = @ ) in @-g non-milk-LNS groups .


Provision of @-@g doses of LNS daily for @ months did not increase physical activity of Malawian toddlers .


To present the impact of treatments on health-related quality of life ( HRQoL ) from the double-blind , randomised phase III COMBI-d study that investigated the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V@E/K-mutant metastatic melanoma .


COMBI-d showed significantly prolonged progression-free survival for the combination .


HRQoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C@ , a generic cancer questionnaire ( completed at baseline , during study treatment , at progression and post progression ) assessing various dimensions ( global health/QoL , functional status , and symptom impact ) .


A mixed-model , repeated-measures analyses of covariance evaluated differences between arms .


Questionnaire completion rates were > @ % at baseline , > @ % to week @ and > @ % at disease progression .


Baseline scores across both arms were comparable for all dimensions .


Global health dimension scores were significantly better at weeks @ , @ and @ for patients receiving the combination during treatment and at progression .


The majority of functional dimension scores ( physical , social , role , emotional and cognitive functioning ) trended in favour of the combination .


Pain scores were significantly improved and clinically meaningful ( @-@ point difference ) for patients receiving the combination for all follow-up assessments versus those receiving dabrafenib monotherapy .


For other symptom dimensions ( nausea and vomiting , diarrhoea , dyspnoea , and constipation ) , scores trended in favour of dabrafenib monotherapy .


This analysis demonstrates that the combination of dabrafenib and trametinib provides better preservation of HRQoL and pain improvements versus dabrafenib monotherapy while also delaying progression .


( Clinicaltrials.gov registration number : NCT@ ) .


The treatment of large ( @-@mm ) or giant ( @mm ) cerebral aneurysms remains technically challenging , with a much higher complication and recanalization rate than that is observed for smaller aneurysms .


The use of a flow diverter seems to facilitate the treatment of this special entity .


In a previous single-center prospective study approved by the Ethics Committee and China Food and Drug Administration ( CFDA ) , we obtained promising results , showing remarkable safety and effectiveness for the Tubridge flow diverter .


Nevertheless , the previous study may have been limited by biases due to its single-center design and limited number of subjects .


Furthermore , although various articles have reported durable results from treating aneurysms using flow diverters , increasing questions have arisen about this form of treatment .


Thus , prospective , multiple-center , randomized trials containing more subjects are needed .


This study is a multicenter , randomized , controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation .


A total of @ patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of @:@ .


The treatment group will receive Tubridge implantation alone or combined with bared coils , and the control group will be treated with stent-assisted coiling ( bare coils ) .


The primary endpoint will be the complete occlusion rate at @-month follow-up .


Secondary endpoints include the immediate technique success rate , overall mortality , adverse events ( ischemic stroke or intracranial bleeding ) within @days , @days and @year post-operation , and the rate of intra-stent stenosis and thrombosis @months post-operation .


This prospective trial may provide more information on the safety and efficacy of the Tubridge flow diverter and may potentially change the strategy for treatment of large or giant aneurysms .


The prevalence of obesity in men in the UK is amongst the highest in Europe but men are less likely than women to use existing weight loss programmes .


Developing weight management programmes which are appealing and acceptable to men is a public health priority .


Football Fans in Training ( FFIT ) , a men-only weight management programme delivered to groups of men at top professional football clubs , encourages men to lose weight by working with , not against , cultural ideals of masculinity .


To inform further development of interventions in football club settings , the current study explored who is attracted to FFIT and why overweight/obese men choose to take part .


A mixed-methods study analysing baseline data on @ men aged @-@years with BMI@kg/m@ who were participants in a randomised controlled trial of FFIT , and data from @ focus group discussions with @ men who had attended the programme .


Objectively-measured mean body mass index was @ kg/m@ ( sd @ ) .


Overall over @ % of participants were at very high or extremely high risk of future ill-health .


Around three-quarters of participants in all age groups were at ` very high ' risk of type @ diabetes , hypertension and cardiovascular disease ( @ % , @ % and @ % of men aged @-@ , @-@ and @-@years respectively ) .


A further @ % , @ % and @ % were at ` extremely high ' risk .


Qualitative data revealed that the powerful ` draw ' of the football club attracted men otherwise reluctant to attend existing weight management programmes .


The location and style of delivery of early FFIT sessions fostered team spirit ; men appreciated being with others ` like them ' and the opportunity to undertake weight management in circumstances that enhanced physical and symbolic proximity to something they valued highly , the football club .


The delivery of a weight management intervention via professional football clubs attracted men at high risk of ill-health .


The setting enabled men to join a weight management programme in circumstances that felt ` right ' rather than threatening to themselves as men .


FFIT is an example of how to facilitate health promotion activities in a way that is consistent with , rather than challenging to , common ideals of masculinity .


To evaluate the efficacy of sequential enteral nutrition support in patients with severe cerebral stroke .


Forty-nine patients with severe cerebral stroke met the inclusion criteria were randomly divided into sequential enteral nutrition group ( Group A , n = @ ) and conventional enteral nutrition group ( Group B , n = @ ) .


Patients in Group A received short-peptide-based enteral nutrition support first , then gradually transferred to intact protein enteral nutrition .


Meanwhile , patients in Group B constantly received intact protein enteral nutrition support .


The nutritional indexes and the rate of complications were compared between two groups .


The nutritional indexes were decreased in both groups within @ weeks after admission , but the decreasing levels of hemoglobin and albumin in Group A were significantly lower than those in Group B ( P < @ ) , and the incidence of infections and gastrointestinal hemorrhage in Group A was also lower than that in Group B ( P < @ ) .


However , there were no significant differences in body weight , BMI , triceps skinfold thickness , biceps circumference , arm muscle circumference between two groups ( P > @ ) .


Sequential enteral nutritional support can improve the nutritional status and decrease the incidence of complications in critical patients with cerebral stroke .


There are no effective and safe treatments for chronic hepatitis C virus ( HCV ) infection of patients who have advanced liver disease .


In this phase @ , open-label study , we assessed treatment with the NS@A inhibitor ledipasvir , the nucleotide polymerase inhibitor sofosbuvir , and ribavirin in patients infected with HCV genotypes @ or @ .


Cohort A enrolled patients with cirrhosis and moderate or severe hepatic impairment who had not undergone liver transplantation .


Cohort B enrolled patients who had undergone liver transplantation : those without cirrhosis ; those with cirrhosis and mild , moderate , or severe hepatic impairment ; and those with fibrosing cholestatic hepatitis .


Patients were assigned randomly ( @:@ ) to receive @ or @ weeks of a fixed-dose combination tablet containing ledipasvir and sofosbuvir , once daily , plus ribavirin .


The primary end point was sustained virologic response at @ weeks after the end of treatment ( SVR@ ) .


We enrolled @ patients , @ ( @ % ) with HCV genotype @ infection and @ ( @ % ) with HCV genotype @ infection .


In cohort A ( nontransplant ) , SVR@ was achieved by @ % -@ % of patients .


In cohort B ( transplant recipients ) , SVR@ was achieved by @ % -@ % of patients without cirrhosis or with compensated cirrhosis , by @ % -@ % of patients with moderate hepatic impairment , by @ % -@ % of patients with severe hepatic impairment , and by all @ patients with fibrosing cholestatic hepatitis .


Response rates in the @-and @-week groups were similar .


Thirteen patients ( @ % ) discontinued the ledipasvir and sofosbuvir combination prematurely because of adverse events ; @ patients died , mainly from complications related to hepatic decompensation .


The combination of ledipasvir , sofosbuvir , andribavirin for @ weeks produced high rates of SVR@ in patients with advanced liver disease , including those with decompensated cirrhosis before and after liver transplantation .


ClinTrials.gov : NCT@ .


Secondary peritonitis is an advanced form of complicated intra-abdominal infection ( cIAI ) requiring hospitalization , surgical source control , and empiric antibiotic therapy against causative aerobic and anaerobic bacteria .


This pooled analysis of four prospective , active-controlled randomized clinical trials compared the efficacy and safety of moxifloxacin with that of comparator antibiotics in patients with confirmed secondary peritonitis .


The primary efficacy endpoint was clinical success rate at test-of-cure ( TOC ) between day @ and @ post-therapy in the per-protocol ( PP ) population .


Safety and clinical efficacy were assessed also in the intent-to-treat population ( ITT ) .


Bacteriological success was assessed at TOC in the microbiologically-valid population as a secondary efficacy endpoint .


Overall clinical success rates at TOC were @ % ( @ of @ patients ) in the moxifloxacin and @ % ( @ of @ patients ) in the comparator treatment groups ( PP population , point estimate for the difference in success rates : -@ % ; @ % CI -@ % , @ % ) , respectively .


Similar clinical success rates between moxifloxacin and comparators were observed by anatomical site of infection , and ranged from @ % to @ % for moxifloxacin and from @ % to @ % for comparators , respectively .


Bacteriologic success rates were similar with moxifloxacin ( @ % ) and comparators ( @ % ) , respectively .


The proportion of patients experiencing any treatment-emergent adverse events was slightly higher with moxifloxacin ( @ % ) versus comparators ( @ % ) .


Rates of drug-related adverse events ( @ % versus @ % ) and deaths ( @ % versus @ % ) were similar in moxifloxacin and comparator groups ; none of the deaths were drug-related .


The data suggests that once-daily IV ( or IV/PO ) moxifloxacin has a comparable efficacy and safety profile to antibiotic regimens approved previously in the subgroup of patients with secondary peritonitis of mild-to-moderate severity .


International geographic differences in outcomes may exist for clinical trials of heart failure and reduced ejection fraction ( HF-REF ) , but there are few data for those with preserved ejection fraction ( HF-PEF ) .


We analyzed outcomes by international geographic region in the Irbesartan in Heart Failure with Preserved systolic function trial ( I-Preserve ) , the Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity ( CHARM ) - Preserved trial , the CHARM-Alternative and CHARM-Added HF-REF trials , and the Controlled Rosuvastatin Multinational Trial in HF-REF ( CORONA ) .


Crude rates of heart failure hospitalization varied by geographic region , and more so for HF-PEF than for HF-REF .


Rates in patients with HF-PEF were highest in the United States/Canada ( HF hospitalization rate @ per @ patient-years in I-Preserve ; @ in CHARM-Preserved ) , intermediate in Western Europe ( @ / @ and @ / @ ) , and lowest in Eastern Europe/Russia ( @ / @ and @ / @ ) .


The difference between the United States/Canada versus Eastern Europe/Russia persisted after adjustment for key prognostic variables : adjusted hazard ratios @ ( @ % confidence interval , @-@ @ ; P = @ ) in I-Preserve and @ ( @ % confidence interval , @-@ @ ; P = @ ) in CHARM-Preserved .


In HF-REF , rates of HF hospitalization were slightly lower in Western Europe compared with other regions .


For both HF-REF and HF-PEF , there were few regional differences in rates of all-cause or cardiovascular mortality .


The differences in event rates observed suggest there is international geographic variation in @ or more of the definition and diagnosis of HF-PEF , the risk profile of patients enrolled , and the threshold for hospitalization , which has implications for the conduct of future global trials .


To compare immediately loaded post-extractive single implants using a definitive abutment versus provisional abutment later replaced by custom-made abutment .


In two private clinics , @ patients in need of one single post-extractive implant in the maxilla or mandible from the left second premolar to the right second premolar area were randomised shortly before tooth extraction to provisional abutment ( PA ) and definitive abutment ( DA ) groups .


Three patients had to be excluded for buccal wall fracture after tooth extraction .


In the PA group , implants were immediately restored using a platform-switched provisional titanium abutment and definitive platform-switched titanium abutments were used in the DA group .


In both groups , a non-occluding provisional single crown was provided .


Implants were definitively restored after @ months .


In the PA group , the abutment was removed and the impression was made directly on the implant platform .


In the DA group an impression of the abutment was made using a retraction cord .


Outcome measures were : implant failures ; complications ; and marginal peri-implant bone level changes .


Patients were followed up to @ year after loading .


Twelve patients were randomised to the DA group and @ patients to the PA group .


At the @-month follow-up , no implant failed .


One biological complication occurred in the DA group and one mechanical complication occurred in the PA group .


All complications were successfully treated .


One year after loading , implants in the DA group lost an average of @ mm ( SD : @ ) of periimplant bone and implants in PA group about @ mm ( SD : @ ) .


At the @-month follow-up , there was a statistically significant difference in bone level change between groups ( mean difference : @ mm , CI @ % @ ; @ , P < @ ) .


Within the limits of this study , the non-removal of abutments placed at the time of surgery resulted in the maintenance of @ mm more bone levels around immediately restored postextractive single implants than repeated abutment removal , although this amount of bone maintenance may not have a clinical impact .


Conflicts of interest notification : Dr Tommaso Grandi and Dr Paolo Guazzi serve as consultants for JDentalCare .


This study was completely self-financed and no funding was sought or obtained , not even in the form of free materials .


To compare clinical profiles of Shang Ring versus conventional circumcisions .


Parallel group open-label randomized controlled trial with one-to-one allocations in @ sites .


We enrolled HIV-negative men aged @-@ years in Homa Bay , Kenya , and Lusaka , Zambia and followed them at @ , @ , @ , @ , @ , @ , and @ days after Shang Ring versus conventional circumcision .


We compared the duration of surgery , postoperative pain using a visual analog scale , adverse events rates , time to complete wound healing by clinical assessment , participant acceptability , and provider preferences between circumcision groups .


We randomized @ men to each group ; @ and @ contributed to the Shang Ring and conventional surgery analyses , respectively .


Adverse event rates were similar between groups .


Pain scores at most time points were similar , however , the Shang Ring group reported higher scores for worst pain during erections ( @ @ vs. @ @ ; P < @ ) .


Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision ( MC ) , @ % versus @ % ( P = @ ) in Kenya , and @ % versus @ % ( P < @ ) in Zambia .


Although median time to complete wound healing was @ days in both groups , conventional circumcisions healed on average @ days sooner ( P < @ ) .


Shang Ring procedures took one-third the time of conventional MC , @ versus @ minutes .


All circumcision providers preferred the Shang Ring .


Safety profiles of the @ techniques were similar , all MC providers preferred the Shang Ring technique , and study participants preferred the Shang Ring 's cosmetic results .


The Shang Ring should be considered for adult MC as programs scale-up .


In spite of widespread use of nasal CPAP there are comparatively few studies to guide the choice of nasal prongs .


To determine whether the Fisher & Paykel Healthcare ( FPH ) neonatal continuous positive airway pressure ( CPAP ) interface was effective in providing bubble CPAP when compared to the Hudson prong interface .


The study was a randomized cross-over study of twenty newborn infants @ g or more requiring CPAP for respiratory support at birth .


Infants were randomized to either the Fisher & Paykel Healthcare or Hudson CPAP interface for twenty four hours .


Crossover between interfaces occurred after subsequent twenty four hour periods .


The primary outcome was the provision of desired CPAP pressures , defined as provision of CPAP within one cm H@O of set pressure .


The percentage time CPAP was within one cm H@O of set pressure was @ % for the Hudson and @ % for the FPH interface ( p = @ ) .


Oxygen saturations for the Hudson interface were in target range for a median of @ % of the time , and , with the FPH interface , for a median of @ % of the time ( p = @ ) .


Clinically significant differences in primary or secondary outcomes between the two groups were not detected .


The nasal CPAP interfaces studied were equally effective in achieving desired bubble CPAP pressures and target saturations .


To determine the impact of music intervention on endothelial function , hemodynamics , and patient anxiety before , during , and after cardiac catheterization .


The effect of music therapy during cardiac catheterization on endothelial function and patient satisfaction has received limited study .


Seventy patients undergoing elective cardiac catheterization were randomized to music therapy ( n = @ ) or no music therapy ( n = @ ) .


Peripheral arterial tonometry was performed before and after catheterization .


A @ item ( @-point scale ) questionnaire evaluating patient anxiety and discomfort levels was also administered after the procedure .


Both study groups had similar baseline characteristics , fluoroscopy time , and contrast administration .


Reactive hyperemia index ( RHI ) change was @ @ in the music group and @ @ in the control group ( P = @ ) .


Systolic and diastolic blood pressure ( BP ) changes did not significantly differ between the two groups ( systolic BP change -@ @ mm Hg vs -@ @ mm Hg ; P = @ and diastolic BP change -@ @ mm Hg vs. @ @ mm Hg ; P = @ ) .


Heart rate changes were also comparable between the two groups ( -@ @ beats / min vs -@ @ beats/min ; P = @ ) .


Patient satisfaction questionnaire measurements were found to be similar in patients with and without music therapy ( @ -LSB- @-@ -RSB- vs @ -LSB- @-@ -RSB- ; P = @ ) .


In this study , music intervention did not elicit a vasodilator response , did not lower blood pressure or heart rate , and did not relieve anxiety or stress discomfort in patients who underwent coronary angiography .


The perineal wound is a major source of morbidity after abdominoperineal resection ( APR ) for rectal cancer , particularly after preoperative irradiation .


Myocutaneous flap reconstruction is a viable alternative to primary perineal wound repair providing well-vascularized non-irradiated tissue to fill the dead space , and improve wound healing .


Sixty patients with low rectal cancer receiving neoadjuvant radiotherapy were prospectively randomized to either primary perineal wound closure ( Group B ) or VRAM perineal reconstruction ( Group A ) .


The study was carried out in the surgical department , National Cancer Institute ( NCI ) , Cairo University over a period of @ years from August @ to July @ .


All patients were evaluated as regards incidence of perineal wound complications , abdominal wall complications , and added co-morbidity .


Perineal wound complications were observed in @ patients in group A ( @ % ) and in @ patients in group B ( @ % ) ( P = @ ) .


There was no significant difference in the incidence of abdominal wound morbidity between both groups .


Operative blood loss and time were lower in group B.


The vertical rectus myocutaneous flap ( VRAM ) is a relatively simple and reliable technique for perineal wound reconstruction after abdominoperineal resection .


Quantifying pediatric immunologic recovery by highly active antiretroviral therapy ( HAART ) initiation at different CD@ percentage ( CD@ % ) and age thresholds may inform decisions about timing of treatment initiation .


HIV-@-infected , HAART-naive children in Europe and the Americas were followed from @ through @ in PENPACT-@ .


Data from @ vertically infected children , with at least World Health Organization `` mild '' immunosuppression and CD@ % < @th percentile , were analyzed for improvement to a normal CD@ % ( @th percentile ) within @ years after HAART initiation .


Data from @ vertically infected children , regardless of immune status , were analyzed for CD@ % outcomes at @ years and viral failure within @ years .


Seventy-two percent of baseline immunosuppressed children recovered to normal within @ years .


Compared with `` severe '' immunosuppression , more children with `` mild '' immunosuppression ( difference @ % , @ % confidence interval -LSB- CI -RSB- : @ % to @ % ) or `` advanced '' immunosuppression ( difference @ % , @ % CI : @ % to @ % ) recovered a normal CD@ % .


For each @-year increase in baseline age , the proportion of children achieving a normal CD@ % declined by @ % ( @ % CI : @ % to @ % ) .


Combining baseline CD@ % and age effects resulted in > @ % recovery when initiating HAART with `` mild '' immunosuppression at any age or `` advanced '' immunosuppression at age < @ years .


Baseline CD@ % effects became greater with increasing age ( P = @ ) .


At @ years , most immunologic benefits were still significant but diminished .


Viral failure was highest in infancy ( @ % ) and adolescence ( @ % ) .


Initiating HAART at higher CD@ % and younger ages maximizes potential for immunologic recovery .


Guidelines should weigh immunologic benefits against long-term risks .


To evaluate and compare the visual , refractive , contrast sensitivity , and aberrometric outcomes with a diffractive bifocal and trifocal intraocular lens ( IOL ) of the same material and haptic design .


Sixty eyes of @ patients undergoing bilateral cataract surgery were enrolled and randomly assigned to one of two groups : the bifocal group , including @ eyes implanted with the bifocal diffractive IOL AT LISA @ ( Carl Zeiss Meditec , Jena , Germany ) , and the trifocal group , including eyes implanted with the trifocal diffractive IOL AT LISA tri @ MP ( Carl Zeiss Meditec ) .


Analysis of visual and refractive outcomes , contrast sensitivity , ocular aberrations ( OPD-Scan III ; Nidek , Inc. , Gagamori , Japan ) , and defocus curve were performed during a @-month follow-up period .


No statistically significant differences between groups were found in @-month postoperative uncorrected and corrected distance visual acuity ( P @ ) .


However , uncorrected , corrected , and distance-corrected near and intermediate visual acuities were significantly better in the trifocal group ( P < @ ) .


No significant differences between groups were found in postoperative spherical equivalent ( P = @ ) .


In the binocular defocus curve , the visual acuity was significantly better for defocus of -@ to -@ diopters in the trifocal group ( P @ ) and -@ to -@ diopters in the bifocal group ( P @ ) .


No statistically significant differences were found between groups in most of the postoperative corneal , internal , and ocular aberrations ( P @ ) , and in contrast sensitivity for most frequencies analyzed ( P @ ) .


Trifocal diffractive IOLs provide significantly better intermediate vision over bifocal IOLs , with equivalent postoperative levels of visual and ocular optical quality .


Higher heart rate is associated with poorer outcomes in patients with heart failure and reduced ejection fraction ( HF-REF ) .


Less is known about the association between heart rate and outcomes in patients with heart failure and preserved ejection fraction ( HF-PEF ) .


Therefore , we examined the relationship between heart rate and outcomes in the irbesartan in patients with heart failure and preserved systolic function trial ( I-Preserve ) in patients with an ejection fraction > @ % aged > @ years .


Heart rate was analysed as both a categorical ( tertiles ) and continuous variable .


Patients in sinus rhythm ( n = @ ) and atrial fibrillation ( n = @ ) were analysed separately .


The outcomes examined were the primary endpoint of the trial ( all-cause death or cardiovascular hospitalization ) , the composite of cardiovascular death or heart failure hospitalization ( and its components ) and all-cause death alone .


Higher heart rate was associated with a significantly higher risk of all outcomes studied for patients in sinus rhythm , even after adjustment for other prognostic variables , including N-terminal pro-B-type natriuretic peptide .


Each standard deviation ( @ bpm ) increase in heart rate was associated with an increase in risk of @ % for cardiovascular death or heart failure hospitalization ( P = @ ) .


No relationship between heart rate and outcomes was observed for patients in atrial fibrillation .


Beta-blocker treatment did not reduce the heart rate-risk relationship .


In patients with heart failure and preserved ejection fraction , heart rate is in sinus rhythm an independent predictor of adverse clinical outcomes and might be a therapeutic target in this syndrome .


Clinical Trial Registration - URL http://www.clinicaltrials.gov .


Unique identifier : NCT @ .


To observe the effect of warm-reinforcing needling combined with modern rehabilitation training on motor function of cerebral palsy ( CP ) children .


Sixty cases of CP children were randomly divided into acupuncture combined with rehabilitation ( Acu + Rehab , n = @ ) group and Rehab ( n = @ ) group .


Patients of the Acu + Rehab group were treated by warm-reinforcing needling stimulation of Jiaji ( EX-B @ ) , Jianyu ( LI @ ) , Quchi ( LI @ ) , Hegu ( LI @ ) , Zusanli ( ST @ ) , Yinlingquan ( GB @ ) , Sanyinjiao ( SP @ ) , Juegu ( GB @ ) , Yanglingquan ( GB @ ) , etc. , combined with Bobath rehabilitation therapy , and those of the Rehab group treated by Bobath rehabilitation ( stimulating key control points in the body , triggering reflexes that provide head and body control ) .


The treatment was conducted every day , with three months being a therapeutic course , two courses in all .


The Peabody Developmental Motor Scales @ ( PDMS-@ ) was used to evaluate the CP children 's motor function -LSB- @ ) gross motor : posture ( straightness ratio ) , locomotion and object manipulation ; @ ) fine motor : grasping and visual-Motor integration -RSB- .


After the treatment , of the @ and @ cases in the Acu + Rehab and Rehab groups , @ ( @ % ) and @ ( @ % ) were cured , @ ( @ % ) and @ ( @ % ) experienced marked improvement , @ ( @ % ) and @ ( @ % ) were invalid , with the effective rates being @ % and @ % respectively .


The therapeutic effect of the Acu + Rehab group was markedly superior to that of the Rehab group ( P < @ ) .


After @ months ' treatment , the scores of posture , locomotor , object manipulation and grasping , and visual-movement integration were significantly increased in comparison with pre-treatment in the same one group ( P < @ ) , and the effects of the Acu + Rehab group were obviously superior to those of Rehab group in increasing the scores of posture , locomotor , object manipulation and grasping after @ months ' treatment ( P < @ ) .


Warm-reinforcing needling combined with Bobath rehabilitation has a better therapeutic effect in improving gross motor and fine motor functions of CP children .


Data were obtained through a multisite clinical trial in which different types of genetic risk-related information were disclosed to individuals ( n = @ ) seeking a risk assessment for Alzheimer 's disease .


Six weeks after disclosure , @ % of participants correctly recalled the number of risk-increasing APOE alleles they possessed , and @ % correctly recalled their APOE genotype .


While @ % of participants recalled their lifetime risk estimate to within @ percentage points , only @ % correctly recalled their lifetime risk estimate exactly .


Correct recall of the number of APOE risk-increasing alleles was independently associated with higher education ( p < @ ) , greater numeracy ( p < @ ) and stronger family history of Alzheimer 's disease ( p < @ ) .


Before adjustments for confounding , correct recall of APOE genotype was also associated with higher education , greater numeracy and stronger family history of Alzheimer 's disease , as well as with higher comfort with numbers and European American ethnicity ( all p < @ ) .


Correct recall of the lifetime risk estimate was independently associated only with younger age ( p < @ ) .


Recall of genotype-specific information is high , but recall of exact risk estimates is lower .


Incorrect recall of numeric risk may lead to distortions in understanding risk .


Further research is needed to determine how best to communicate different types of genetic risk information to patients , particularly to those with lower educational levels and lower numeracy .


Health-care professionals should be aware that each type of genetic risk information may be differentially interpreted and retained by patients and that some patient subgroups may have more problems with recall than others .


Selexipag is a novel , oral , selective prostacyclin ( PGI@ ) receptor agonist in clinical development for the treatment of pulmonary arterial hypertension .


Film-coated tablets with strength between @ and @,@ g were used .


Bioequivalence between @ x @ g and a new @,@ g tablet was evaluated at steady state in healthy male subjects .


This was an open-label , @-treatment , @-period , crossover , up-titration , phase @ study .


The treatments were selexipag at @,@ g b.i.d. for @ days either as @ x @ g tablets ( reference : A ) or @ x @,@ g tablet ( test : B ) , both preceded by an up-titration phase starting from @ g b.i.d. doses , in @-g steps every @th day .


Subjects were randomized @ : @ to the A-B or B-A sequence .


The pharmacokinetics and tolerability of selexipag and its active metabolite , ACT-@ , were investigated .


@ subjects were enrolled in the study : @ subjects completed the study according to protocol , and @ subjects withdrew from the study .


The most frequent adverse events ( AEs ) were headache ( @ % ) , myalgia ( @ % ) , and jaw pain ( @ % ) .


There was no difference in nature and overall frequency of AEs between the two treatments .


Steady state was attained within @ days of the selexipag @,@ g b.i.d.


The @ % confidence intervals ( CIs ) of the geometric mean ratio ( B/A ) at steady state for AUC and Cmax , ss were within ( @ , @ ) bioequivalence interval : ( @ , @ ) and ( @ , @ ) , respectively , for selexipag and ( @ , @ ) and ( @ , @ ) , respectively , for the active metabolite , ACT-@ .


Bioequivalence was demonstrated between @ x @ g and @ x @,@ g selexipag at steady state .


The PASI score , the most common outcome measure in clinical trials of psoriasis treatment , is a non-linear scale that does not allow reliable assessment of subtle variations of its components ( erythema , induration , and desquamation ) .


Highlight treatment response patterns potentially hidden by PASI score 's compounded weighted-average calculation .


Patients with moderate-to-severe psoriasis enrolled in the phase-@ , @-week , randomized CHAMPION study , and received adalimumab , methotrexate , or placebo .


PASI scores were assessed post hoc for improvement , by body region and component .


At Week @ , a significantly greater percentage of adalimumab-treated patients vs methotrexate - and placebo-treated patients , achieved PASI @ , PASI @ and PASI @ response in each body region and component .


@ % of adalimumab-treated patients reached PASI @ response in the head and neck region vs @ % overall .


Two key components of PASI , induration and desquamation , were affected by treatment more than erythema , the third component .


Adalimumab was particularly effective in complete resolution of induration ( @ % of patients ) vs methotrexate ( @ % ) .


For all PASI body regions and components , mean percent improvement in score at Weeks @ , @ , @ , @ , and @ was significantly greater ( P < @ ) for adalimumab treatment vs methotrexate or placebo .


Adalimumab therapy resulted in complete resolution of individual body regions in at least @ % up to @ % of patients in CHAMPION .


This was more than twice that of methotrexate and placebo .


PASI improvement by body region is a novel and an important patient-relevant outcome worthy of reporting in future studies .


Progression of Parkinson 's disease ( PD ) is frequently characterized by the occurrence of freezing of gait ( FOG ) representing a disabling motor complication .


We aim to investigate safety and efficacy of transcranial direct current stimulation of the primary motor cortex of PD patients with FOG .


In this cross-over , double-blind , sham-controlled study , @ PD patients with FOG persisting in `` on '' state underwent anodal and sham direct current stimulation for @ consecutive days .


Clinical assessment over a @-month period was performed .


A significant improvement of gait , as assessed by the Stand Walk Sit test , with reduction in number and duration of FOG episodes , along with a significant reduction in the Unified Parkinson 's Disease Rating Scale score , were observed after anodal stimulation .


Beneficial effects were more evident after the entire @-day stimulation session , and persisted until the end of the observation period .


Anodal transcranial direct current stimulation of the motor cortex is safe and has therapeutic potential in PD patients with FOG .


Many patients who are candidates for implantable cardioverter defibrillators ( ICDs ) are not referred for potential implantation .


We sought to determine if a simple provider reminder would increase referrals .


We identified consecutive patients from January @ through July @ in the VA Palo Alto Health Care System with a left ventricular ejection fraction < @ % on echocardiography .


Patients were excluded using available administrative data only ( no chart review ) if they were known to have an ICD , if they were @ years old , or if they did not have a current primary care or cardiology provider within the system .


We randomized patients to no intervention or a clinical note to the provider in the medical record .


The outcomes were referral for consideration of defibrillator implantation ( primary ) and documented discussion ( secondary ) .


Of @ patients with left ventricular ejection fraction@ % , @ were known to have an ICD , @ were no longer followed in the healthcare system , and @ were @ years old , leaving @ patients to be randomized .


Forty-six patients were randomized to intervention and @ to control .


Eleven of @ ( @ % ) intervention patients were referred for consideration of ICD implantation during the following @ months versus @ of @ ( @ % ) control patients ( P = @ ) .


Overall , @ of @ ( @ % ) intervention patients versus @ of @ ( @ % ) control patients had documentation discussing potential candidacy for defibrillators ( P = @ ) .


In patients with low left ventricular ejection fraction , a simple electronic medical record-based intervention directed to their providers improved the rates of referral for ICD implantation .


The existing research findings regarding the effects of lemongrass ( Cymbopogon citratus ) tea on renal function indices are conflicting and inconclusive .


In the present study , we investigated the effects of infusions prepared from C citratus leaves on creatinine clearance rate ( CCr ) and estimated glomerular filtration rate ( eGFR ) in humans .


One hundred five subjects ( @ men and @ women ) aged @ to @years were randomly assigned to groups set to orally receive infusions prepared from @ , @ , or @g of C citratus leaf powder once daily , for @days .


Serum and urinary levels of urea , creatinine , pH , specific gravity , uric acid , electrolytes , diuretic indices , and eGFR were assessed at days @ , @ , and @ after the initiation of treatment .


Results obtained on days@ and @ were compared with baseline values .


CCr and eGFR decreased significantly at day @ in both male and female subjects in all the groups and in females treated with infusion prepared from @g of C citratus leaf powder for @days .


At day @ , CCr and eGFR were unchanged in those treated with infusions prepared from @ or @g of the leaf powder , whereas diuretic indices ( urine volume , urination frequency , diuretic action , and saliuretic indices ) increased above the baseline levels .


Serum and urinary creatinine levels significantly increased ( P < @ ) in both male and female subjects in all the groups .


Serum urea significantly increased in the groups treated with infusions prepared from @ or @g of the leaf powder ( P < @ ) for @days .


Serum electrolytes remained unchanged , but their urinary levels increased .


We observed dose - and time-dependent adverse effects of C citratus on CCr and eGFR .


At a high dose or with prolonged treatment with a low dose , eGFR decrease may be followed by a decline in the other renal function indices .


Treatment of complex fractures of the distal femur utilizing monoaxial locking plates ( e.g. Less Invasive Stabilisation System , LISS , Synthes ) is considered to be superior to conventional plating systems .


Due to the limitation that the thread forces the screw into pre-determined positions , modifications have been made to allow screw positioning within a range of @ ( Non Contact Bridging , NCB-DF , Zimmer ) .


For the first time , this multicenter prospective randomized clinical trial ( RCT ) investigates the outcome of LISS vs. NCB-DF treatment following complex fractures of the distal femur .


Since June @ , @ patients with a fracture of the distal femur ( AO ASIF @-A-C and periprosthetic fractures ) were enrolled in this study by four university trauma centres in southern Germany .


Clinical ( e.g. range of motion , Oxford knee score , Tegner score ) and radiological ( e.g. axis deviation , secondary loss of realignment ) follow-ups were conducted one and six weeks , as well as three , six , and @ months after the operation .


This study comprises data of @ patients ( @ male , @ female ; @ NCB-DF , @ LISS ) .


Polyaxial osteosynthesis using the NCB system tended to result in better functional knee scores and a higher range of motion .


Interestingly , fracture union tended to be more rapid using the polyaxial plating system .


We present the analysis of a multicenter prospective RCT to compare the monoaxial LISS vs. the polyaxial NCB-DF treatment following complex fractures of the distal femur .


NCB-DF treatment tended to result in better functional and radiological outcomes than LISS treatment .


Hemodynamic stability is one of the most critical concerns during induction of anesthesia .


Whether the pharmacokinetic model by Marsh or the one by Schnider will produce better hemodynamic stability remains unclear .


This study compared hemodynamic changes during induction between the two models .


@ patients who underwent elective surgery were randomly assigned to plasma target-controlled infusion by Marsh 's ( n = @ ) or Schnider 's ( n = @ ) model with an initial target concentration of @ gmL-@ .


The target was then reset and gradually titrated to a sedation level with a narcotrend index ( NI ) below @ .


Stroke volume , cardiac output , systemic vascular resistance , arterial pressure , target , and effect site concentration , and dose of propofol infused were recorded every minute during the first @ minutes of infusion .


Throughout the first @ minutes , stroke volume index and cardiac index were decreased significantly in both Marsh and Schnider groups , but no statistical difference was detected between the groups ( p > @ ) .


Central venous pressure ( CVP ) , systemic vascular resistance index ( SVRI ) , and heart rate ( HR ) did not significantly change during induction ( p > @ ) .


Time to loss of responsiveness ( LOR ) , and time for NI to decrease to @ was faster in Marsh than in Schnider ( @ @ minutes vs. @ @ min , p < @ ; @ @ minutes vs. @ @ minutes , p < @ , respectively ) .


When target concentrations are titrated according to NI during induction of anesthesia , Marsh 's model could induce sedation faster than Schnider 's .


Meanwhile , hemodynamic changes were not observed to be statistically different between the two models .


Hypotension induced by plasma target-controlled infusion of propofol could mainly be attributed to decreased stroke volume instead of vascular dilation .


The effects of box shape -- specifically width and height -- on the perception of heaviness were evaluated during individual and team lifting .


Large objects are perceived to be as much as @ % lighter than smaller objects with the same mass .


This size-weight illusion presents an obvious risk when lifting large and heavy boxes .


Recent research has shown that shape influences this illusion .


Specifically , increases in length and width do not produce identical decreases in perceived heaviness .


However , this effect has been documented only in individual lifting , mostly with small objects .


Individuals and teams lifted large boxes and reported their perceptions of heaviness .


The mass , height , and width of the boxes were varied independently to determine their unique effects on perceived heaviness .


For both types of lift , increasing width produced a greater mean illusory drop ( expressed as a percentage decrease with @ % confidence intervals ) in perceived heaviness ( @ + / - @ % during individual lifting and @ + / - @ % during team lifting ) than increasing height ( @ + / - @ % during individual lifting and @ + / - @ % during team lifting ) .


Size and shape are important factors in perceiving the heaviness of boxes during both individual and team lifting .


To avoid misperceiving weight and risking injury , lifters should be careful when approaching larger ( especially wider ) boxes .


Primary hyperparathyroidism ( PHPT ) is diagnosed by the presence of hypercalcemia and elevated or nonsuppressed parathyroid hormone ( PTH ) levels .


Although surgery is usually curative , some individuals fail or are unable or unwilling to undergo parathyroidectomy .


In such individuals , targeted medical therapy may be of value .


Cinacalcet normalized calcium level and lowered PTH in patients with PHPT in several phase @ and open-label studies .


We compared cinacalcet and placebo in subjects with PHPT unable to undergo parathyroidectomy .


Phase @ , double-blind , multi centere , randomized , placebo-controlled study .


Sixty-seven subjects ( @ % women ) with moderate PHPT were randomized ( @:@ ) to cinacalcet or placebo for @ weeks .


Achievement of a normal mean corrected total serum calcium concentration of @ mg/dl ( @ mmol/l ) .


Baseline median ( quartile @ ( Q@ ) , Q@ ) serum PTH was @ ( @ , @ ) pg/ml and mean ( s.d. ) serum Ca was @ ( @ ) mg/dl .


Serum Ca normalized ( @ mg/dl ) in @ % of cinacalcet - vs @ % of placebo-treated subjects ( P < @ ) .


Corrected serum Ca decreased by @ mg/dl from baseline in @ % of cinacalcet - vs @ % of placebo-treated subjects ( P < @ ) .


Least squares mean ( s.e.m. ) plasma PTH change from baseline was -@ % ( @ % ) ( cinacalcet ) vs -@ % ( @ % ) ( placebo ) ( P < @ ) .


Similar numbers of subjects in the cinacalcet and placebo groups reported adverse events ( AEs ) ( @ vs @ ) and serious AEs ( three vs four ) .


Most commonly reported AEs were nausea and muscle spasms .


These results demonstrate that cinacalcet normalizes serum calcium in this PHPT population and appears to be well tolerated .


This randomized phase III trial compared pathologic complete response ( pCR ) rates of early breast cancer ( EBC ) following neoadjuvant epirubicin-docetaxel ( ED ) capecitabine ( C ) , and evaluated the addition of trastuzumab in HER@-positive tumors .


Patients with invasive breast cancer ( except T@d ) were randomly assigned to receive six @-weekly cycles of ED ( both @ mg/m@ ) C ( @ mg/m@ , twice daily , days @-@ ) .


Patients with HER@-positive disease were further randomized to receive trastuzumab ( @ mg/kg , then @ mg/kg every @ weeks ) or not .


Primary end point : pCR rate at the time of surgery .


Five hundred thirty-six patients were randomized to ED ( n = @ ) or EDC ( n = @ ) ; @ patients were further randomized to trastuzumab ( n = @ ) or not ( n = @ ) .


pCR rate was significantly increased with EDC ( @ % versus @ % ED , P = @ ) , and nonsignificantly further increased with trastuzumab ( @ % EDC versus @ % ED , P = @ ) .


Rates of axillary node involvement at surgery and breast conservation were improved with EDC versus ED , but not significantly ; the addition of trastuzumab had no further impact .


Hormone receptor status , tumor size , grade , and C ( all P@ @ ) were independent prognostic factors for pCR .


Trastuzumab added to EDC significantly increased the number of serious adverse events ( @ versus @ ; P = @ ) , mainly due to infusion-related reactions .


These findings show that the integration of C into a neoadjuvant taxane - / anthracycline-based regimen is a feasible , safe , and effective treatment option , with incorporation of trastuzumab in HER@-positive disease .


This study explored the safety and efficacy of recombinant type I pancreatic elastase ( PRT-@ ) topically applied once to the external surface of an arteriovenous fistula .


This was a randomized , double-blind , placebo-controlled trial .


Adults with kidney disease undergoing creation of a radiocephalic fistula ( RCF ) or brachiocephalic fistula were randomized to treatment with placebo ( n = @ ) , PRT-@ at @ g ( n = @ ) , or PRT-@ at @ g ( n = @ ) .


The primary efficacy measure was unassisted primary patency ( PP ) over @ year .


Secondary efficacy measures were secondary patency ( SP ) , unassisted maturation by ultrasound interrogation , use for hemodialysis , and hemodynamically significant lumen stenosis .


Median PP was @ days for placebo and > @ days for the PRT-@ groups .


At @ year , @ % , @ % , and @ % of placebo , @-g , and @-g patients retained PP .


The risk of PP loss was nonsignificantly reduced for @ g ( hazard ratio -LSB- HR -RSB- , @ ; P = @ ) and @ g ( HR , @ ; P = @ ) vs placebo .


In the subset ( @ % of patients ) with a RCF , the median PP was @ days for placebo and > @ days for the PRT-@ groups .


At @ year , @ % , @ % , and @ % of placebo , @-g , and @-g RCFs retained PP .


The risk of RCF PP loss was nonsignificantly reduced by @ g ( HR , @ ; P = @ ) and significantly reduced by @ g ( HR , @ ; P = @ ) vs placebo .


At @ year , @ % , @ % , and @ % of placebo , @-g , and @-g patients retained SP .


The risk of SP loss was nonsignificantly reduced for @ g ( HR , @ ; P = @ ) and @ g ( HR , @ ; P = @ ) vs placebo .


In the subset with RCFs , @ % , @ % , and @ % of placebo , @-g , and @-g patients retained SP at @ year .


The risk of RCF SP loss was nonsignificantly reduced for @ g ( HR , @ ; P = @ ) and @ g ( HR , @ ; P = @ ) vs placebo .


At month @ , @ % , @ % ( P = @ ) , and @ % ( P < @ ) of the placebo , @-g , and @-g group fistulas had unassisted maturation by ultrasound interrogation .


At month @ in the subset with an RCF , @ % , @ % ( P = @ ) , and @ % ( P < @ ) of placebo , @-g , and @-g group fistulas had unassisted maturation by ultrasound interrogation .


Adverse event reports were not meaningfully different between groups .


PRT-@ appeared safe .


The primary efficacy end point was not met .


However , both PRT-@ doses were associated with improved unassisted maturation .


The @-g dose was associated with increased PP in the subset with RCF .


Ingestion of polyunsaturated fatty acids ( PUFAs ) has been proposed to influence several chronic diseases including coronary heart disease ( CHD ) and type-@ diabetes ( T@D ) .


There is strong evidence that omega-@ ( n-@ ) PUFAs provide protection against CHD and biomarkers of atherosclerosis .


In contrast , there is more limited and inconsistent data for T@D .


Few studies have examined the impact of n-@ PUFA-containing botanical oils on T@D .


Fifty-nine subjects with early-stageT@D or metabolic syndrome participated in an @-week , randomized , single-blind , parallel intervention study and were provided PUFA-containing oils .


Individuals received either corn oil ( CO ) , a botanical oil ( BO ) combination ( borage -LSB- Borago officinalis L. -RSB- / echium oil -LSB- Echium plantagineum L. -RSB- ) or fish oil ( FO ) .


The BO combination was enriched in alpha-linolenic , gamma-linolenic , and stearidonic acids and the FO in eicosapentaenoic and docosahexaenoic acids .


Serum fatty acids and other serum lipids ( triglycerides and total , HDL and LDL cholesterol ) , as well as markers of inflammation ( leptin , and C-reactive protein ) and glucose regulation ( glucose and hemoglobin A@c ) were assessed from fasting participants at baseline and after the intervention .


Compliance was verified by expected increases in specific PUFAs in each of the three oil arms .


Participants in the CO group showed no differences in serum lipids , markers of inflammation or glucose regulation between pre - and post-treatment measures .


Supplementation with BO significantly lowered total and LDL cholesterol levels and FO reduced serum triglycerides , hemoglobin A@c and increased HDL-cholesterol .


Short-term dietary supplementation with BO and FO improved biomarkers associated with T@D/metabolic syndrome .


The role of secondary cytoreductive surgery ( SCR ) in platinum-sensitive recurrent ovarian cancer ( ROC ) remains controversial .


The overall survival ( OS ) benefits for surgery reported in observational studies may be due to the selection of patients with better prognosis .


Using data from the CALYPSO trial , OS of patients who had SCR was compared to those treated with chemotherapy alone .


Multivariate analyses were performed to adjust for prognostic factors .


We also tested for an interaction between baseline prognostic groupings and the benefit of surgery .


Of the @ patients randomised in CALYPSO , @ % had SCR and @ % had chemotherapy alone .


OS was longer for the SCR group than for chemotherapy alone ( median , @ vs. @ months ; adjusted hazard ratio ( HR ) , @ ; P = @ ) .


For patients with SCR , the @-year OS was @ % for those with no measurable disease , and @ % if residual tumour was larger than @ cm .


Patients with good prognostic features benefited the most from SCR ( HR @ ; P < @ ) .


The benefit of SCR was less in patients with poorer prognostic features ( test of trend P < @ ) .


SCR was associated with improved OS in platinum-sensitive ROC , particularly in patients with favourable prognostic characteristics .


However , these findings may be due to selection bias , and hence randomised trials are still essential .


To evaluate the verbal and written preoperative information in patients undergoing surgery for malignant gynaecologic disease , in terms of satisfaction about preoperative received informations , hospitalization days , postoperative pain experienced using visual analogue scale ( VAS ) and number of pain drugs used daily .


From January @ to December @ , consecutive patients with diagnosis of endometrial cancer , referred to the Division of Gynecology of University Campus Bio-Medico of Rome , were enrolled .


Eligible subjects were randomized into two groups : Group V ( Verbal information ward ) consisted of patients who had verbal preoperative information about surgical procedure and postoperative management and Group W ( Written Information ward ) consisted of patients who had written preoperative information .


All preoperative and postoperative data were recorded .


Concerning satisfaction about preoperative received informations , patients were asked to complete the QLQ-C@ and the EORTC INFO@ .


@ patients were considered in this study .


Group W ( n = @ ) has a better info satisfaction ( p = @ , statistically significant ) , a mean VAS value lower ( p = @ , statistically significant ) and also a lower number of hospitalization days ( p = @ , statistically significant ) and pain medications used daily , ( p = @ , statistically significant ) , comparing with group V ( n = @ ) .


We support the use of preoperative information leaflet to better prepare patients for a surgical procedure , showing a faster recovery , low medications use and a better quality of life outcome .


In most Asian countries , @ - @ % of pharmaceutical sales are made in private drug outlets , by personnel with some training in drugs but not for the treatment of common health problems .


The objective of the study was to determine effects of focused training for private drug sellers to improve practices in treating acute respiratory infections and diarrhoea in children , and anaemia in pregnancy in Nepal .


Randomized controlled , four way nested design study incorporating four interventions for drug retailers in both hill and terai districts .


One group received mailed printed educational materials followed by mailed feedback ; a second received small group training followed by feedback ; a third received small group training only ; and a fourth , the control group , received no intervention .


Surrogate customer method was used to assess practices .


Outcomes were measured using multivariate linear regression .


A significant increase in the asking of key history questions , recommendation ( prescribing by drug retailers ) of cotrimoxazole , and advice-giving for pneumonia ; a significant increase in ORS recommendation , and advice giving for diarrhoea including the avoidance of antidiarrhoeals ; and a significant increase in asking key history questions and recommending appropriate products in pregnancy cases .


Training intervention as well as training followed by practice feedback was effective in improving the management of common illnesses and pregnancy by private drug sellers .


A post hoc analysis to determine the diagnostic yield of random biopsy in detecting high-grade cervical disease in women with negative colposcopy .


The ATHENA ( Addressing the Need for Advanced HPV Diagnostics ) trial screened more than @,@ women with cytology and high-risk human papillomavirus ( HPV ) DNA genotyping .


Colposcopy was performed in all women with abnormal cytology or positive HPV results .


A single random biopsy was taken at the squamocolumnar junction if colposcopy was adequate and no lesions were identified .


The random biopsy diagnosed @ % ( @/@ , @ % confidence interval -LSB- CI -RSB- @-@ @ % ) and @ % ( @/@ , @ % CI @-@ @ % ) of the total cervical intraepithelial neoplasia ( CIN ) grade @ or worse and grade @ or worse , respectively .


This additional disease was detected in both HPV @ or @ + and for @ other high-risk HPV + women .


For HPV @ or @ , the absolute risk for detection of CIN @ or worse on random biopsy in the overall population was @ % ( @/@ , @ % CI @-@ @ % ) and @ % ( @/@ , @ % CI @-@ @ % ) for CIN @ or worse .


By contrast , the absolute risk for @ other high-risk HPV + women was @ % ( @/@ , @ % CI @-@ % ) and @ % ( @/@ , @ % CI @-@ @ % ) for CIN @ or worse and CIN @ or worse , respectively .


A single random biopsy increased the detection of high-grade disease when no lesions were visualized at colposcopy .


The absolute risks of disease associated with the random biopsy were highest for women positive for genotype @ or @ .


Our study supports performing a random biopsy in women undergoing colposcopy without visible lesions , particularly in those positive for HPV @ or @ .


: II .


Pain and potential adverse events ( AE ) remain challenges for patients being treated with calcium hydroxylapatite ( CaHA ; Radiesse ) , especially CaHA not mixed with an anesthetic .


The blunt cannula may provide more comfortable and lower risk delivery of CaHA for nasolabial folds ( NLF ) correction .


This @-day pilot study was designed to compare the effectiveness and safety of standard needles with that of blunt cannulas for CaHA application .


Twenty patients with moderate to severe NLF received split-face injections of CaHA mixed with @ % lidocaine using a cannula for one NLF and needle for the other NLF .


At day @ , patients evaluated pain ; the treating investigator evaluated changes in NLF depth .


At @ , @ , @ , @ , and @days , the investigator evaluated AEs and NLF correction .


Patients recorded AEs in daily dairies .


After initial treatment , patients experienced greater pain and displayed increased erythema and swelling in the needle-treated side .


At days @ and @ , patients displayed greater instances of bruising , redness , and swelling in the needle-treated sides .


At day @ , @ patients showed slightly better correction in the cannula-treated sides .


The blunt cannula provided advantages in mitigation of pain and AEs , with a degree of correction similar to needle .


The addition of blunt cannulas to the clinical setting may be appropriate .


The aim of the study was to investigate the effects of the early initiation of passive and active range of motion exercises following arthroscopic rotator cuff repair .


The study included @ patients who underwent arthroscopic rotator cuff repair .


Patients were quasi-randomly assigned into accelerated ( ACCEL ) protocol ( n = @ ) and slow ( SLOW ) protocol ( n = @ ) groups .


Patients in both groups were treated with the same protocol .


Active range of motion was begun at the @rd week in the ACCEL group and the @th week in the SLOW group .


Range of motion was recorded at postoperative weeks @ , @ , @ , @ , and @ .


While active range of motion for all measurements improved across weeks , there were no differences between groups , with the exception of active total elevation which was greater at all time point measurements in the ACCEL group ( p < @ ) .


The early initiation of passive and gentle controlled active motion exercise following rotator cuff repairs does not appear to affect range of motion in the first @ postoperative months .


The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy .


The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists ( i.e. chiropractors , naprapaths , osteopaths , physicians and physiotherapists ) for patients seeking care for back and/or neck pain .


In addition women and men were compared regarding the occurrence of adverse events .


Participants were recruited among patients , ages @-@ , seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm .


The patients ( n = @ ) were randomized to one of three treatment arms @ ) manual therapy ( i.e. spinal manipulation , spinal mobilization , stretching and massage ) ( n = @ ) , @ ) manual therapy excluding spinal manipulation ( n = @ ) and @ ) manual therapy excluding stretching ( n = @ ) .


Treatments were provided by students in the seventh semester of total eight .


Adverse events were measured with a questionnaire after each return visit and categorized in to five levels ; @ ) short minor , @ ) long minor , @ ) short moderate , @ ) long moderate and @ ) serious adverse events , based on the duration and/or severity of the event .


Generalized estimating equations were used to examine the association between adverse event and treatments arms .


The most common adverse events were soreness in muscles , increased pain and stiffness .


No differences were found between the treatment arms concerning the occurrence of adverse event .


Fifty-one percent of patients , who received at least three treatments , experienced at least one adverse event after one or more visits .


Women more often had short moderate adverse events ( OR = @ ( @ % CI : @-@ @ ) ) , and long moderate adverse events ( OR = @ ( @ % CI : @-@ @ ) ) compared to men .


Adverse events after manual therapy are common and transient .


Excluding spinal manipulation or stretching do not affect the occurrence of adverse events .


The most common adverse event is soreness in the muscles .


Women reports more adverse events than men .


Surgical resection is the only curative treatment for gastric cancer .


However , the overall prognosis of gastric adenocarcinoma is poor and advanced disease may even make surgical treatment impossible .


It has been theoretically proposed that administration of chemotherapy before surgical resection may down-stage the disease state and facilitate resectability especially in locally-advanced tumors .


We wanted to assess the effect of administration of neoadjuvant chemotherapy on tumor resectability in patients with locally-advances gastric adenocarcinoma .


During a randomized-controlled trial , we divided @ patients with locally-advanced gastric adenocarcinoma into two groups of neoadjuvant chemotherapy and surgery ( case ) versus surgery alone ( control ) .


Because of patient dropouts , we analyzed the results for @ and @ patients in case and control groups respectively .


The study period was March @ , @ to March @ , @ .


A non-randomized set of @ patients were also added to the control group ( Multi-center analysis ) .


The analysis was repeated for non-randomized patients ( @ case patients versus @ control patients ) .


The mean age of patients in case and control groups was @ and @ years of age respectively ( p > @ ) .


Male to female ratio was @/@ and @/@ in case and control groups respectively ( p > @ ) .


In Randomized patients , @ patients ( @ % ) were resectable in case group ; while @ patients ( @ % ) were resectable in control group ( p < @ ) .


Multicenter analysis also revealed resectability in @ patients ( @ % ) and @ patients ( @ % ) of case and control groups respectively ( p < @ ) .


We conclude that neoadjuvant chemotherapy could increase tumor resectability rate in patients with locally-advanced gastric adenocarcinoma .


However , further studies are necessary to confirm the effect of this modality on patients ' overall survival .


This study was designed to evaluate and compare the efficacy and safety of nebulized dexmedetomidine , nebulized ketamine , and the combination of these drugs for premedication in pediatric outpatient dental surgeries .


A prospective , randomized , double-blinded study was conducted in the Alexandria Main University Hospital after approval of the Medical Ethics Committee .


Informed written consent was obtained from the patient 's parents .


Sixty children classified as ASA physical status I and II and aged @ to @ years were enrolled in the study .


Patients were randomly categorized into @ equal groups .


Group K was premedicated with nebulized ketamine ( @ mg/kg ) , group D was premedicated with nebulized dexmedetomidine ( @ g/kg ) , and group DK was premedicated with combined nebulized dexmedetomidine and ketamine ( @ g/kg + @ mg/kg ) .


The primary end point was the level of sedation when the child was first seen in the operating room @ minutes after sedation .


The secondary end points were tolerance of mask induction , hemodynamic changes , analgesia , sedation at emergence , and wake-up behavior .


Studied groups were comparable as regards demographic data ( age , weight , sex , and ASA physical status , all P > @ ) and patients ' acceptance of drugs ( P = @ ) .


Level of sedation at @ minutes was significantly greater in group DK than in either group K ( P = @ ) or group D ( P = @ ) .


Group DK had the briefest recovery times , followed in order by group K and group D with progressively longer recovery times .


Recovery times were significantly briefer in group DK than in either group K ( P = @ ) or group D ( P < @ ) .


Group DK had significantly briefer discharge times than group D ( P < @ ) .


Postoperative analgesia was significantly better in group DK compared with group K ( P = @ ) .


A nebulized combination of low-dose ketamine and dexmedetomidine produced more satisfactory sedation and provided a smoother induction of general anesthesia than nebulized ketamine or dexmedetomidine alone , with more rapid recovery and no significant side effects .


Maternal nutritional status is an important predictor of infant birthweight .


Most previous attempts to improve birthweight through multiple micronutrient supplementation have been initiated after women are pregnant .


Interventions to improve maternal nutritional status prior to conception may be more effective in preventing low birthweight and improving other infant health outcomes .


To compare the effects of maternal supplementation with animal-source food from preconception to term or from mid-gestation to term with routine prenatal care on birthweight , the prevalence of preterm births , intrauterine growth restriction , and infant growth during the first @ months of life and on maternal nutrient status and the incidence of maternal and infant infections .


Young women from @ rural communes in northwestern Vietnam were recruited when they registered to marry and were randomized to one of three interventions : animal-source food supplement @ days per week from marriage to term ( approximately @ months ) , animal-source food supplement @ days per week from @ weeks of gestation to term ( approximately @ months ) , or routine prenatal care without supplementalfeeding .


Data on infant birthweight and gestational age , maternal and infant anthropometry , micronutrient status , and infections in the infant and mother were collected at various time points .


In a preliminary study of women of reproductive age in this area of Vietnam , @ % of the women were underweight ( body mass index < @ ) and anemic .


About @ % had infections .


Rice was the dietary staple , and nutrient-rich , animal-source foods were rarely consumed by women .


Iron , zinc , vitamin A , folate , and vitamin B@ intakes were inadequate in about @ % of the women .


The study is still ongoing , and further data are not yet available .


The results of this study will provide important data regarding whether improved intake of micronutrient-rich animal-source foods that are locally available and affordable before and during pregnancy improves maternal and infant health and development .


This food-based approach may have global implications regarding how and when to initiate sustainable nutritional interventions to improve maternal and infant health .


Suvorexant , an orexin receptor antagonist , improves sleep in healthy subjects ( HS ) and patients with insomnia .


We compared the electroencephalographic ( EEG ) power spectral density ( PSD ) profile of suvorexant with placebo using data from a phase @ trial in patients with insomnia .


We also compared suvorexant 's PSD profile with the profiles of other insomnia treatments using data from @ HS studies .


Phase @ trial -- randomized , double-blind , two-period ( @ w per period ) crossover .


HS studies -- randomized , double-blind , crossover .


Sleep laboratories .


Insomnia patients ( n = @ ) or HS ( n = @ ) .


Phase @ trial -- suvorexant @ mg , @ mg , @ mg , @ mg , placebo ; HS study @ -- suvorexant @ mg , @ mg , placebo ; HS study @ -- gaboxadol @ mg , zolpidem @ mg , placebo ; HS study @ -- trazodone @ mg , placebo .


The PSD of the EEG signal at @-@ Hz of each PSG recording during nonrapid eye movement ( NREM ) and rapid eye movement ( REM ) sleep were calculated .


The day @ and day @ PSD profiles of suvorexant at all four doses during NREM and REM sleep in patients with insomnia were generally flat and close to @ ( placebo ) at all frequencies .


The day @ PSD profile of suvorexant in HS was similar to that in insomnia patients .


In contrast , the other three drugs had distinct PSD profiles in HS that differed from each other .


Suvorexant at clinically effective doses had limited effects on power spectral density compared with placebo in healthy subjects and in patients with insomnia , in contrast to the three comparison insomnia treatments .


These findings suggest the possibility that antagonism of the orexin pathway might lead to improvements in sleep without major changes in the patient 's neurophysiology as assessed by electroencephalographic .


Novel interventions tailored to blue collar workers are needed to reduce the disparities in smoking rates among occupational groups .


The main objective of this study was to evaluate the efficacy and usage of the Web-enhanced `` Tobacco Tactics '' intervention targeting operating engineers ( heavy equipment operators ) compared to the `` @-@-QUIT-NOW '' telephone line .


Operating engineers ( N = @ ) attending one of @ safety training sessions from @ through @ were randomized to either the Tobacco Tactics website with nurse counseling by phone and access to nicotine replacement therapy ( NRT ) or to the @-@-QUIT-NOW telephone line , which provided an equal number of phone calls and NRT .


The primary outcome was self-reported @-day abstinence at @-day and @-month follow-up .


The outcomes were compared using chi-square tests , t tests , generalized mixed models , and logistic regression models .


The average age was @ years and most were male ( @/@ , @ % ) and white ( @/@ , @ % ) .


Using an intent-to-treat analysis , the Tobacco Tactics website group showed significantly higher quit rates ( @/@ , @ % ) than the @-@-QUIT NOW group ( @/@ , @ % ) at @-day follow-up ( P = @ ) , but this difference was no longer significant at @-month follow-up .


There were significantly more positive changes in harm reduction measures ( quit attempts , number of cigarettes smoked per day , and nicotine dependence ) at both @-day and @-month follow-up in the Tobacco Tactics group compared to the @-@-QUIT-NOW group .


Compared to participants in the @-@-QUIT NOW group , significantly more of those in the Tobacco Tactics website group participated in the interventions , received phone calls and NRT , and found the intervention helpful .


The Web-enhanced Tobacco Tactics website with telephone support showed higher efficacy and reach than the @-@-QUIT-NOW intervention .


Longer counseling sessions may be needed to improve @-month cessation rates .


The National Lung Screening Trial ( NLST ) showed that screening with low-dose computed tomography ( CT ) as compared with chest radiography reduced lung-cancer mortality .


We examined the cost-effectiveness of screening with low-dose CT in the NLST .


We estimated mean life-years , quality-adjusted life-years ( QALYs ) , costs per person , and incremental cost-effectiveness ratios ( ICERs ) for three alternative strategies : screening with low-dose CT , screening with radiography , and no screening .


Estimations of life-years were based on the number of observed deaths that occurred during the trial and the projected survival of persons who were alive at the end of the trial .


Quality adjustments were derived from a subgroup of participants who were selected to complete quality-of-life surveys .


Costs were based on utilization rates and Medicare reimbursements .


We also performed analyses of subgroups defined according to age , sex , smoking history , and risk of lung cancer and performed sensitivity analyses based on several assumptions .


As compared with no screening , screening with low-dose CT cost an additional $ @,@ per person ( @ % confidence interval -LSB- CI -RSB- , @,@ to @,@ ) and provided an additional @ life-years per person ( @ % CI , @ to @ ) and @ QALYs per person ( @ % CI , @ to @ ) .


The corresponding ICERs were $ @,@ per life-year gained ( @ % CI , @,@ to @,@ ) and $ @,@ per QALY gained ( @ % CI , @,@ to @,@ ) .


However , the ICERs varied widely in subgroup and sensitivity analyses .


We estimated that screening for lung cancer with low-dose CT would cost $ @,@ per QALY gained , but we also determined that modest changes in our assumptions would greatly alter this figure .


The determination of whether screening outside the trial will be cost-effective will depend on how screening is implemented .


( Funded by the National Cancer Institute ; NLST ClinicalTrials.gov number , NCT@ . )


We evaluated the use of tamsulosine versus placebo for management of ureteral stent discomfort .


This prospective and randomized study was realized in the Department of Urology of three university hospital .


The participation was proposed at all patient having indication to receive an ureteral stent except for cancer .


The evaluation of the tolerance used two validate questionnaires : Ureteral Stent Symptom Questionnaire ( USSQ ) and IPSS completed by each patient the day of the insertion , next day , one week later and the day before and after the removal .


The main assessment criterion was the question `` global quality of life '' one week after the stent insertion .


Seventy-nine patients were randomized between June , @ and October , @ .


Despite phone reminders only @ ( @ % ) were complete questionnaires .


Out of @ , @ patients in the tamsulosine group and out of @ , @ in the phloroglucinol group .


The majority of the patients ( @ % ) were included for stone disease .


There is not significant difference between the @ groups using the USSQ and IPSS at day +@ , day +@ , pre-ablation and day +@ ablation .


A significant improvement of the scores was noted to day +@ by the ablation of the JJ in @ groups .


Our study did not show superiority of tamsulosine versus placebo in the improvement of the tolerance of ureteral stent .


Permissive hypercapnia is a ventilatory strategy used to prevent lung injury in ventilated extremely low birth weight ( ELBW , birth weight @,@ g ) infants .


However , there is retrospective evidence showing that high CO@ is associated with brain injury .


The objective of this study was to compare brain white matter development at term-equivalent age in ELBW infants randomized to hypercapnic vs. normocapnic ventilation during the first week of life and in healthy non-ventilated term newborns .


Twenty-two ELBW infants from a randomized controlled trial were included in this study ; @ received hypercapnic ( transcutaneous PCO@ -LSB- tcPCO@ -RSB- @-@ mmHg ) ventilation and @ normocapnic ( tcPCO@ @-@ mmHg ) ventilation during the first week of life while still intubated .


In addition , ten term healthy newborns served as controls .


Magnetic resonance imaging ( MRI ) with diffusion tensor imaging ( DTI ) was performed at term-equivalent age for the ELBW infants and at approximately @ weeks of age for the control infants .


White matter injury on conventional MRI was graded in the ELBW and control infants using a scoring system adopted from literature .


Tract-based spatial statistics ( TBSS ) was used to evaluate for differences in DTI measured fractional anisotropy ( FA , spatially normalized to a customized template ) among the ELBW and term control infants .


Conventional MRI white matter scores were not different ( @ vs. @ , P = @ ) between the hypercapnic and normocapnic ELBW infants .


TBSS analysis did not show significant differences ( P < @ , corrected ) between the two ELBW infant groups , although before multiple comparisons correction , hypercapnic infants had many regions with lower FA and no regions with higher FA ( P < @ , uncorrected ) compared to normocapnic infants .


When compared to the control infants , normocapnic ELBW infants had a few small regions with significantly lower FA , while hypercapnic ELBW infants had more widespread regions with significantly lower FA ( P < @ , fully corrected for multiple comparisons ) .


Normocapnic ventilation vs. permissive hypercapnia may be associated with improved white matter development at term-equivalent age in ELBW infants .


This effect , however , was small and was not apparent on conventional MRI .


Further research is needed using larger sample sizes to assess if permissive hypercapnic ventilation in ELBW infants is associated with worse white matter development .


Antidepressants are effective in adults with pain-related functional gastrointestinal disorders .


We investigated the effectiveness of citalopram in the treatment of childhood functional abdominal pain ( FAP ) .


Children with FAP , based on the Rome III criteria ( n = @ , aged @-@ years ) , were randomized to receive either citalopram @ mg/day or placebo for @ weeks .


Treatment response was defined as @ point reduction in the @-point Faces pain rating scale or ` no pain ' .


Depression , anxiety , somatization , and physician-rated global severity and improvement were also evaluated .


Patients were followed up for @ weeks after medication period .


Eighty-six patients completed the medication ( @ in each group ) .


Response rate in the citalopram and placebo groups based on per-protocol ( intention-to-treat ) analysis was @ % ( @ % ) and @ % ( @ % ) at week @ ( p = @ -LSB- @ -RSB- ) and @ % ( @ % ) and @ % ( @ % ) at week @ ( p = @ -LSB- @ -RSB- ) , respectively .


In per-protocol analysis , more reduction was observed in pain ( F = @ , p = @ ) and global severity scores ( F = @ , p = @ ) in the citalopram group compared with the placebo group over the study period .


Such differences were not present in the intention-to-treat analysis .


No difference was found between the two groups regarding change in depression , anxiety , or somatization score over the study .


Overall , we found a trend toward the effectiveness of citalopram in the treatment of children with FAP .


Trials with longer treatment duration in larger samples of patients are required in this regard .


Noninvasive continuous positive airway pressure ( CPAP ) is usually applied with a nasal or facial mask to treat mild acute respiratory failure ( ARF ) in infants .


A pediatric helmet has now been introduced in clinical practice to deliver CPAP .


This study compared treatment failure rates during CPAP delivered by helmet or facial mask in infants with respiratory syncytial virus-induced ARF .


In this multicenter randomized controlled trial , @ infants with respiratory syncytial virus-induced ARF were randomized to receive CPAP by helmet ( n = @ ) or facial mask ( n = @ ) .


The primary endpoint was treatment failure rate ( defined as due to intolerance or need for intubation ) .


Secondary outcomes were CPAP application time , number of patients requiring sedation , and complications with each interface .


Compared with the facial mask , CPAP by helmet had a lower treatment failure rate due to intolerance ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- , P = @ ) , and fewer infants required sedation ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- , P = @ ) ; the intubation rates were similar .


In successfully treated patients , CPAP resulted in better gas exchange and breathing pattern with both interfaces .


No major complications due to the interfaces occurred , but CPAP by mask had higher rates of cutaneous sores and leaks .


These findings confirm that CPAP delivered by helmet is better tolerated than CPAP delivered by facial mask and requires less sedation .


In addition , it is safe to use and free from adverse events , even in a prolonged clinical setting .


TG@ is a modified vaccinia Ankara ( MVA ) virus that expresses the hepatitis C virus ( HCV ) proteins NS@ , NS@ , and NS@B .


We performed a phase II open-label study to determine the efficacy , safety , and immunotherapeutic properties of TG@ in combination with pegylated interferon -@ a and ribavirin ( PEG-IFN/RBV ) in patients with chronic HCV infection .


Treatment-naive patients with HCV genotype @ infection were assigned randomly to @ of thefollowing groups : PEG-IFN/RBV for @ weeks ( group A , n = @ ) , PEG-IFN/RBV for @ weeks followed by PEG-IFN/RBV for @ weeks with @ injections of TG@ ( group B , n = @ ) , or TG@ for @ weeks ( @ injections ) followed by PEG-IFN/RBV for @ weeks with @ injections of TG@ ( group C , n = @ ) .


The primary end point was complete early virologic response ( cEVR ) , defined as HCV-RNA level less than@ IU/mL after @ weeks of PEG-IFN/RBV treatment .


In group C , @ % of evaluable patients achieved cEVR , compared with @ % in group A and @ % in group B ( P = @ for group C vs A ) .


A higher percentage of patients achieved a sustained virologic response @ weeks after therapy ended in group C ( @ % ) than in groups A ( @ % ) or B ( @ % ) .


HCV - and MVA-specific T-cell responses were observed predominantly in group C.


As expected , most patients given injections of TG@ developed anti-MVA antibodies .


The combination of TG@ and PEG-IFN/RBV was reasonably well tolerated .


However , PEG-IFN-associated thrombocytopenia developed in @ patients who carried the class II HLA allele DRB@ * @ .


A higher percentage of patients with chronic HCV infection who received immunotherapy with TG@ followed by TG@ and PEG-IFN/RBV achieved a cEVR compared with patients who received only PEG-IFN/RBV therapy .


These findings show that immunotherapies that activate T cells are effective in patients with chronic HCV infection .


ClinicalTrials.gov number , NCT@ .


We aimed to identify doses of mirogabalin ( DS-@ ) providing clinically meaningful efficacy with manageable side effects for treatment of diabetic peripheral neuropathic pain ( DPNP ) .


Adults ( @ years ) with type @ or @ diabetes , HbAc @ % at screening , and DPNP for @ months were eligible for study participation .


Subjects ( n = @ ) were randomized ( @:@:@:@:@:@:@ ratio ) to placebo , dose-ranging mirogabalin ( @ , @ , @ , @ , and @ mg/day ) , or pregabalin ( @ mg/day ) for @ weeks .


The primary end point was weekly change in average daily pain score ( ADPS ; @ to @ numeric rating scale ) from baseline to week @ ( minimally meaningful effect , @-point decrease versus placebo ) .


ANCOVA was conducted using last observation carried forward , and treatment effect least squares ( LS ) means were provided for each contrast .


Safety assessments included adverse events ( AEs ) , clinical laboratory tests , and electrocardiograms .


LS mean differences in change in ADPS from baseline to week @ versus placebo were -@ , -@ , -@ , -@ , and -@ for the mirogabalin @ - , @ - , @ - , @ - , and @-mg/day treatment groups , respectively , and -@ in the pregabalin group ( P < @ versus placebo for mirogabalin @ , @ , and @ mg/day ) .


Most frequent AEs ( n = @ ) were primarily mild to moderate dizziness ( @ % ) , somnolence ( @ % ) , and headache ( @ % ) ; otherwise , mirogabalin was well tolerated .


Mirogabalin @ , @ , and @ mg/day had statistically significant reductions in ADPS versus placebo , and mirogabalin @ mg/day also met the criteria of minimally meaningful effect .


Mirogabalin may be a promising new treatment option for patients with DPNP .


Flexible fiber-optic bronchoscope-guided orotracheal intubation is a valuable technique with demonstrated benefits in the management of difficult airways .


Despite its popularity with anesthesia providers , the technique is not fail-safe and airway-related complications secondary to failed intubation attempts remain an important problem .


We sought to determine the effect of incorporating lingual traction on the success rate of fiber-optic bronchoscope-guided intubation in patients with anticipated difficult airways .


In this prospective , randomized , cohort study , we enrolled @ adult patients with anticipated difficult airways scheduled for elective surgery to undergo fiber-optic bronchoscope-guided orotracheal intubation alone or with lingual traction by an individual anesthesiologist after induction of general anesthesia and neuromuscular blockade .


A total of @ patients were randomized : @ patients to the fiber-optic bronchoscope-guided intubation with lingual traction group and @ patients to the fiber-optic bronchoscope-guided intubation alone group .


The primary endpoint was the rate of successful first attempt intubations .


The secondary outcome was sore throat grade on post-operative day @ .


Fiber-optic intubation with lingual traction compared to fiber-optic intubation alone resulted in a higher success rate ( @ vs. @ % , ( @ ) = @ , p = @ ) and greater odds for successful first attempt intubation ( OR @ , @ % CI @-@ @ , p = @ ) .


Sore throat severity on post-operative day @ was not significantly different but trended towards worsening grades with lingual traction .


In this study , lingual traction was shown to be a valuable maneuver for facilitating fiber-optic bronchoscope-guided intubation in the management of patients with anticipated difficult airways .


Levels of physical activity ( PA ) in UK children are much lower than recommended and novel approaches to its promotion are needed .


The Children , Parents and Pets Exercising Together ( CPET ) study is the first exploratory randomised controlled trial ( RCT ) to develop and evaluate an intervention aimed at dog-based PA promotion in families .


CPET aimed to assess the feasibility , acceptability and potential efficacy of a theory-driven , family-based , dog walking intervention for @-@ year olds .


Twenty-eight families were allocated randomly to either receive a @-week dog based PA intervention or to a control group .


Families in the intervention group were motivated and supported to increase the frequency , intensity and duration of dog walking using a number of behaviour change techniques .


Parents in the intervention group were asked to complete a short study exit questionnaire .


In addition , focus groups with parents and children in the intervention group , and with key stakeholders were undertaken .


The primary outcome measure was @ week change in total volume of PA using the mean accelerometer count per minute ( cpm ) .


Intervention and control groups were compared using analysis of covariance .


Analysis was performed on an intention to treat basis .


Twenty five families were retained at follow up ( @ % ) and @ % of all outcome data were collected at baseline and follow up .


Thirteen of @ ( @ % ) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable .


There was a mean difference in child total volume of PA of @ cpm ( @ % CI -@ , @ ) and -@ cpm ( @ % CI -@ , @ ) for intervention and control group children , respectively .


This was not statistically significant .


Approximately @ % of dog walking time for parents and @ % of dog walking time for children was moderate-vigorous PA. .


The acceptability of the CPET intervention and outcome measures was high .


Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable , but did not result in a significant increase in child PA in this exploratory trial .


The aim of this study was to assess the prognostic performance of C-terminal provasopressin ( copeptin ) , midregional pro-adrenomedullin ( MR-proADM ) , and midregional pro-atrial natriuretic peptide ( MR-proANP ) in a large prospective cohort of patients with non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) .


Copeptin , MR-proADM , and MR-proANP are emerging biomarkers of hemodynamic stress that have been associated with adverse cardiovascular ( CV ) outcomes in heart failure ( HF ) and stable ischemic disease .


We measured copeptin , MR-proADM , and MR-proANP concentrations in @,@ patients with NSTE-ACS who were randomized to treatment with ranolazine or placebo in the MERLIN-TIMI @ ( Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes-Thrombolysis In Myocardial Infarction @ ) trial and followed up for @ year .


A high concentration ( quartile @ vs. quartiles @ to @ ) of each biomarker identified an increased risk of CV death or HF ( copeptin : @ % vs. @ % , p < @ ; MR-proADM : @ % vs. @ % , p < @ ; MR-proANP : @ % vs. @ % , p < @ ) as well as CV death , HF , and myocardial infarction individually ( all p @ ) .


After adjustment for important covariates , each biomarker remained associated with CV death or HF at @ year ( adjusted hazard ratio : copeptin , @ ; MR-proADM , @ ; MR-proANP , @ ; all p @ ) .


These biomarkers improved prognostic discrimination and patient re-classification for CV death or HF at @ year ( all categorical NRI > @ % , p < @ ) , and maintained independent association with composite CV death or HF when concurrently assessed in a model with clinical indicators plus BNP , cTnI , ST@ , PAPP-A , and MPO ( each p@ @ ) -LSB- corrected -RSB- .


Copeptin , MR-proADM , and MR-proANP are complementary prognostic markers for CV death and HF in patients with NSTE-ACS that perform as well as or better than established and other emerging biomarkers and warrant further investigation of application for therapeutic decision making .


( Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes ; NCT@ ) .


Glutamine rate of appearance ( Ra ) may be used as an estimate of endogenous glutamine production .


Recently a technique employing a bolus injection of isotopically labeled glutamine was introduced , with the potential to allow for multiple assessments of the glutamine Ra over time in critically ill patients , who may not be as metabolically stable as healthy individuals .


Here the technique was used to evaluate the endogenous glutamine production in critically ill patients in the fed state with and without exogenous glutamine supplementation intravenously .


Mechanically ventilated patients ( n = @ ) in the intensive care unit ( ICU ) were studied on two consecutive days during continuous parenteral feeding .


To allow the patients to be used as their own controls , they were randomized for the reference measurement during basal feeding without supplementation , before or after the supplementation period .


Glutamine Ra was determined by a bolus injection of @C-glutamine followed by a period of frequent sampling to establish the decay-curve for the glutamine tracer .


Exogenous glutamine supplementation was given by intravenous infusion of a glutamine containing dipeptide , L-alanyl-L-glutamine , @ g/kg during @ hours .


A @ % increase of endogenous glutamine Ra was seen at the end of the intravenous supplementation period as compared to the basal measurements ( P = @ ) .


The bolus injection technique to measure glutamine Ra to estimate the endogenous production of glutamine in critically ill patients was demonstrated to be useful for repetitive measurements .


The hypothesized attenuation of endogenous glutamine production during L-alanyl-L-glutamine infusion given as a part of full nutrition was not seen .


The purpose of this study was to evaluate the effect of the use of preoperative breast MRI on surgical and long-term outcomes among women with early-stage breast cancer undergoing breast conservation therapy .


A retrospective review yielded the cases of @ women with stage @ , I , or II breast cancer who underwent preoperative MRI between @ and @ .


A control group of @ patients who did not undergo preoperative MRI before breast conservation therapy was matched by age , histopathologic finding , stage , and surgeon .


Features compared included breast density , presence of mammographically occult disease , margin status , lymph node involvement , lymphovascular invasion , extensive intraductal component , hormone receptor status , and use of adjuvant therapy .


Outcomes , including rates of reexcision , ipsilateral recurrence , and disease-free survival , were compared by Kaplan-Meier methods and the log-rank test .


Patients referred for preoperative breast MRI were more likely to have extremely dense breasts ( @ % vs @ % , p < @ ) and mammographically occult cancer ( @ % vs @ % , p = @ ) .


The two groups had identical rates of final negative margins , lymph node involvement , lymphovascular invasion , extensive intraductal component status , positive hormone receptor results , and systemic adjuvant therapy .


Fewer patients in the preoperative MRI group needed reexcision ( @ % vs @ % , p = @ ) .


The median follow-up period after treatment was @ years .


There was no significant difference in locoregional recurrence ( p = @ ) or disease-free survival ( p = @ ) rates between the two groups .


Reexcision rates among patients with early breast cancer undergoing conservation therapy were lower among women who underwent preoperative breast MRI .


There was no statistically significant effect of the use of preoperative MRI on rates of locoregional recurrence or disease-free survival .


Pulmonary rehabilitation ( PR ) is an evidence-based intervention in patients with chronic obstructive pulmonary disease ( COPD ) which improves the exercise capacity and quality of life ( QoL ) .


We studied @ patients after an episode of acute exacerbation of COPD ( AECOPD ) .


They were randomised to receive conventional treatment without pulmonary rehabilitation ( CTWPR ) ( n = @ ) or , standard treatment plus a @-week post-exacerbation pulmonary rehabilitation ( PEPR ) programme in addition .


Assessment of exercise capacity by six minute walk test ( @MWT ) and QoL measured by St George 's Respiratory Questionnaire ( SGRQ ) were carried out initially and at the end of three months .


The baseline characteristics of both the groups were found to be similar .


There was a statistically significant increase in the six minute walk distance ( @MWD ) ( increase by @ meters , p < @ ) and a significant decline in the total SGRQ score ( by @ units p < @ ) in the PEPR group compared to CTWPR group .


Early pulmonary rehabilitation in patients with an AECOPD has significant benefits on the QoL and exercise capacity .


A phase IIa study investigated efficacy and safety/tolerability of ascending doses of mavrilimumab ( anti-granulocyte-macrophage colony-stimulating factor receptor -LSB- GM-CSFR -RSB- monoclonal antibody ) in adult subjects with moderate to severe rheumatoid arthritis from Japan and Europe .


Findings from the Japanese population are presented .