This study reveals the importance of considering proximity as an important dimension of exercise outcomes-particularly when promoting intrinsic motivation among relatively infrequent exercisers .


This study was conducted to determine whether augmenting supported employment with cognitive remediation can improve vocational outcomes and whether augmentation is more important for participants with lower community functioning .


In this secondary analysis of data from two related , single-blind , randomized controlled trials , @ participants with schizophrenia or schizoaffective disorder received supported employment or supported employment plus cognitive remediation and were classified into higher or lower community functioning according to a median split of their quality-of-life scores at baseline .


Participants received one year of active intervention and follow-up a year later .


Primary outcome measures were competitive employment rates and total hours of work .


Employment rates over two years for participants with lower community functioning were significantly different for the two conditions ( supported employment = @ % , plus cognitive remediation = @ % , p < @ ) , whereas participants with higher functioning showed equivalent rates of employment ( @ % versus @ % , ns ) .


Among lower-functioning participants , those who received cognitive remediation also worked significantly more hours over two years than those who received supported employment only , but higher-functioning participants worked similar amounts of hours in both conditions .


Improvements in cognitive functioning and intrinsic motivation were related to employment outcomes but only for the lower-functioning group in the supported employment plus cognitive remediation condition , suggesting possible mechanisms for the observed effects .


Augmenting supported employment with cognitive remediation may boost vocational outcomes for participants with lower community functioning but may not be necessary for those functioning better in their communities .


Ulinastatin is reported to inhibit pro-inflammatory markers and also inhibits coagulation and fibrinolysis .


The drug is available in East Asia for the treatment of acute pancreatitis .


To study the effect of addition of ulinastatin to standard care on mortality and morbidity in Indian subjects with acute pancreatitis .


Randomized , double-blind , placebo-controlled , multi-centre trial across @ centres in India .


Subjects , aged @ to @ years , with acute pancreatitis and elevated serum C-reactive protein ( CRP ) levels , were eligible for enrolment .


Acute pancreatitis was diagnosed if the patient had at least two of the following criteria : suggestive abdominal pain , serum amylase and/or lipase > @ times upper limit of normal , and imaging findings of acute pancreatitis .


Subjects were classified as having mild or severe acute pancreatitis on the basis of the APACHE II score ( < @ mild , > or = @ severe ) .


Standard care was given to all subjects as per the treating physician 's protocol .


Eligible subjects were randomized to receive intravenous infusion of @,@ IU ulinastatin or placebo in @ mL of @ % saline given over one hour every @ hours for @ days .


Of @ randomized subjects , @ completed the study ( mild @ , severe @ ) .


Pancreatitis was due to alcohol intake in a majority ( @ % ) of subjects .


Baseline characteristics were similar between the ulinastatin and placebo groups .


Efficacy was evaluated in subjects who had received at least @ days ( @ doses ) of ulinastatin/placebo .


One subject with severe pancreatitis in the ulinastatin group versus six in the placebo group died ( p = @ ) .


New organ dysfunction developed in @ ulinastatin vs @ placebo group subjects ( p = @ ) with mild pancreatitis and @ ulinastatin vs @ placebo group subjects ( p = @ ) with severe pancreatitis .


Adverse events were significantly lower in subjects with severe pancreatitis in the ulinastatin group as compared to the placebo group ( p = @ ) .


Reduction in serum CRP was not different between the groups .


Median hospitalization was shorter by one day in the ulinastatin group ; the difference was not significant .


There was no infusion-related adverse event .


Ulinastatin prevents new organ dysfunction and reduces mortality in subjects with severe pancreatitis .


To evaluate and compare the risks of secondary cancers from therapeutic doses received by patients with hepatocellular carcinoma ( HCC ) during intensity-modulated radiotherapy ( IMRT ) , volumetric arc therapy ( VMAT ) , and tomotherapy ( TOMO ) .


Treatments for five patients with hepatocellular carcinoma ( HCC ) were planned using IMRT , VMAT , and TOMO .


Based on the Biological Effects of Ionizing Radiation VII method , the excess relative risk ( ERR ) , excess absolute risk ( EAR ) , and lifetime attributable risk ( LAR ) were evaluated from therapeutic doses , which were measured using radiophotoluminescence glass dosimeters ( RPLGDs ) for each organ inside a humanoid phantom .


The average organ equivalent doses ( OEDs ) of @ patients were measured as @ , @ , @ , @ , @ , @ , and @ Gy for the thyroid , lung , stomach , liver , small intestine , prostate ( or ovary ) , and rectum , respectively .


From the OED measurements , LAR incidence were calculated as @ , @ , @ , @ , @ and @ per @ ( @ ) person for the lung , stomach , normal liver , small intestine , prostate ( or ovary ) , and rectum .


We estimated the secondary cancer risks at various organs for patients with HCC who received different treatment modalities .


We found that HCC treatment is associated with a high secondary cancer risk in the lung and stomach .


Probiotics are beneficial bacteria that are able to colonize the host digestive system , increasing the natural flora and preventing colonization of pathogenic organisms and thus , securing optimal utility of the feed .


However , commercial probiotic often do not meet the expected standards and the viability of the efficacy of these strains remains questionable .


Another major issue has been highlighted in relation to the application of antibiotic resistant probiotics , the antibiotic resistant gene can be transferred between organisms .


Recently , postbiotic metabolites produced from microbes have been extensively studied as feed additive in order to substitute in-feed antibiotics .


No significant difference ( P > @ ) was found among the treatment groups on overall feed intake , egg weight , egg mass and feed conversion efficiency .


COM@ had a significant reduction ( P < @ ) in faecal pH compared to the other groups at @ weeks of age onwards .


COM@ had significant higher ( P < @ ) level of lactic acid bacteria counts from @ weeks of age onwards , followed by COM@ and COM@ at @ and @ weeks of age , respectively .


Significant reduction of faecal Enterobacteriaceae ( P < @ ) were observed in COM@ and COM@ from @ weeks of age onwards .


The lowest levels ( P < @ ) of plasma and egg yolk cholesterol were observed in COM@ , followed by COM@ and COM@ .


There was no significant difference in terms of yolk weight between the treatment groups .


Significant higher ( P < @ ) content of C@ :@ , C@ :@ and C@ :@ were found in treatments supplemented with metabolite combinations as compared with the control group .


The present study demonstrated the positive effects of metabolite combinations supplementation in laying hens .


Increase in hen-day egg production was observed in all treatments supplemented with metabolite combinations .


In addition , the metabolite combinations , COM@ had reduced the faecal pH and faecal Enterobacteriaceae population , improved the faecal lactic acid bacteria , reduced the plasma and yolk cholesterol and improved the faecal volatile fatty acids content .


Postbiotic metabolite combinations can be used as an alternative feed additive to achieve high productivity and better animal health while reducing the use of conventional chemotherapeutic agents such as in-feed antimicrobials .


The aim of the study was to investigate whether impairments associated with cerebral palsy were stable between childhood and adolescence .


The Study of Participation of Children with Cerebral Palsy Living in Europe ( SPARCLE ) longitudinal study was conducted in nine European regions .


In total , @ children aged @ to @ years were randomly selected from population-based registers ; @ ( @ % ) were followed up at the age of @ to @ years ( @ males , @ females ; median age @ y @ mo ) Research associates visited them in their homes and recorded their motor function and additional impairments .


Stability of impairment was assessed using the weighted kappa coefficient .


The proportion of participants whose level of impairment remained unchanged varied from @ % for fine motor function to @ % for hearing .


For gross motor function , communication , and cognitive level , the kappa and the lower bound of its @ % confidence interval ( CI ) were above @ , indicating stability between childhood and adolescence ; for fine motor function and feeding , the kappa was above @ but the lower bound of the @ % CI was below @ , indicating probable stability ; for seizures and vision , the kappa was below @ , although the upper bound of the @ % CI was above @ , indicating possible change ; for hearing the kappa and its entire CI were below @ , indicating change .


Overall , @ % of participants had no seizures in childhood , of whom @ % were seizure-free in adolescence .


Motor function and additional impairments were generally stable between childhood and adolescence .


To compare the clinical effects and safety between greenlight photoselective vaporization of prostate ( PVP ) and plasmakinetic resection of prostate ( PRP ) in eldly benign prostatic hyperplasia ( BPH ) men with high surgical risk .


METHODS ; Fifty three eldly BPH patients , who had the indication of surgical treatment but complicated with at least one internal disease , were randomly divided into PVP group and PRP group .


The clinical data of all the patients were collected and compared between the two groups , including pre-operative and post-operative international prostate symptom score ( IPSS ) , postvoid residual urine ( PVR ) , urine flow rate ( Qmax ) , quality of life ( QOL ) as well as prostate volume ( PV ) , operational time , operative bleeding volume , postoperative recovery , peri-operative complications .


The complete follow-up data of @ patients were achieved : @ of PVP , @ of PRP .


There were significant differences between two groups in operative bleeding , bladder irrigation time , indwelling catheter time and hospital stay ( P < @ ) .


The peri-operative bleeding was lower in PVP group , while the bladder irrigation time , indwelling catheter time and hospital stay were shorter in PVP group .


The operation time showed no difference ( P = @ ) .


No significant differences were found @ months postoperatively between two groups in all the data associated with urination ( IPSS , Qmax , PVR , QOL ) , P > @ .


Complications ( urethrostenosis , retrograde ejaculationwere acceptable in both groups .


For surgical treatment of eldly men with high surgical risk , both PVP and PRP are safe and effective with the internal disease being sufficient control .


Walking speed is an important marker of functionality that is measured over courses of varying lengths , but it is unclear if course length affects measured pace .


A total of @ older adults completed two consecutive trials each of @-m and @-m walking courses , the order of which was randomly assigned .


We calculated concordance correlation coefficients ( CCC ) and created Bland-Altman plots to evaluate the relationship between the two course distances .


Average walking speed was faster for the @-m course and the second trial of each course .


There was high concordance between the first and second trials for both the @-m and @-m courses .


The @ - and @-m courses had excellent test-retest reliability and faster walking speed in later than earlier trials .


Higher concordance between courses for later trials suggests the utility of practice trials and adjusting for course length when combining walking speed measurements between different course lengths .


To compare the effectiveness of onlay bone blocks of equine origin ( test or XB group ) with autogenous bone blocks ( control or AB group ) harvested from the ramus or the iliac crest for the rehabilitation of partially or fully edentulous atrophic jaws with implant supported prostheses .


Forty patients with partially or fully edentulous atrophic jaws having less than @ mm of residual crestal bone height and/or less than @ mm of bone thickness , as measured on computerised tomography ( CT ) scans , were randomised into two groups according to a parallel group design , either to be augmented with autogenous onlay bone blocks ( @ patients ; AB group ) from the mandibular ramus or the iliac crest , or with onlays blocks of spongious bone of equine origin ( @ patients ; XB group ) .


Two centres treated @ patients each .


Six XB blocks were modelled on lithographic models of the jaws before grafting .


The blocks were fixed with screws and osteosynthesis plates and were covered with resorbable barriers made of equine cortical bone and fixed with tacks .


The autogenous bone grafts were left to heal for @ months and the xenografts for @ months before placing implants , which were submerged .


After @ months , either bar-retained overdentures or provisional reinforced acrylic prostheses were delivered .


Provisional prostheses were replaced , after @ months , by definitive fixed prostheses .


Outcome measures were : prosthesis and implant failures ; complications ; patient satisfaction ; pain recorded @ and @ days post-augmentation ; number of days of hospitalisation , total and partial infirmity days .


All patients were followed for @ months after loading .


All patients could be rehabilitated with implant-supported prostheses and none dropped out .


Twenty-eight patients were augmented in the maxilla ( @ with AB and @ with XB ) and @ in the mandible ( @ with AB and @ with XB ) .


No AB graft failed totally versus @ XB grafts ( difference = @ ; @ % CI @ to @ ; P = @ ) .


In particular , all @ XB mandibular grafts and @ out of @ XB blocks ( @ in mandibles and @ in maxillas ) , which were previously modelled on lithographic models of the jaws failed .


One implant failed in one AB patient versus @ implants in @ XB patients ( P = @ ) .


All but @ prostheses were loaded in time in the AB patients , versus @ prostheses which were loaded with delays in XB patients because of graft and implant failures ( P = @ ) .


Four complications occurred in @ AB patients versus @ complications in @ XB patients ( difference = @ ; @ % CI @ to @ ; P = @ ) .


Fourteen AB patients reported moderate pain @ days postoperatively versus @ XB patients ( P = @ ) ; at @ days , @ AB patients reported moderate pain versus @ XB patient ( difference = -@ ; @ % CI -@ to -@ ; P = @ ) .


The @ patients harvested from the iliac crest were hospitalised for an average of @ nights , whereas @ patients treated with XB were hospitalised on average for @ nights ( P < @ ) .


The number of total and partial infirmity days was @ for theAB group and @ for the XB group , and @ for the AB group and @ for the XB group , respectively ( mean day difference = -@ ; @ % CI -@ to -@ ; P = @ and mean day difference = -@ ; @ % CI -@ to -@ ; P = @ , respectively ) .


Seventeen AB patients versus @ XB patients were fully satisfied with function of their prostheses ( P = @ ) , @ AB patients versus @ XB patients were fully satisfied with aesthetics of their prostheses ( P = @ ) , and @ and @ patients , respectively would not undergo the same procedure again ( P = @ ) .


There were no differences between the outcomes of the two centres with exception of prosthesis failures and complications in the maxilla .


Autogenous onlay bone blocks are superior to equine onlay bone blocks , especially in mandibles , where all equine blocks failed , therefore we strongly discourage the use of onlay bone blocks of equine origin in mandibles .


Since sorafenib has shown activity in different tumour types and gemcitabine regimens improved the outcome for biliary tract cancer ( BTC ) patients , we evaluated first-line gemcitabine plus sorafenib in a double-blind phase II study .


@ unresectable or metastatic BTC patients with histologically proven adenocarcinoma of gallbladder or intrahepatic bile ducts , Eastern Cooperative Oncology Group ( ECOG ) @-@ were randomised to gemcitabine ( @ mg/m@ once weekly , first @-weeks +@ - week rest followed by once @-weeks +@ - week rest ) plus sorafenib ( @ mg twice daily ) or placebo .


Treatment continued until progression or unacceptable toxicity .


Tumour samples were prospectively stained for sorafenib targets and potential biomarkers .


Serum samples ( first two cycles ) were measured for vascular endothelial growth factors ( VEGFs ) , vascular endothelial growth factor receptor @ ( VEGFR-@ ) and stromal cell-derived factor @ ( SDF@ ) by enzyme-linked immunosorbent assay ( ELISA ) .


Gemcitabine plus sorafenib was generally well tolerated .


Four and three patients achieved partial responses in the sorafenib and placebo groups , respectively .


There was no difference in the primary end-point , median progression-free survival ( PFS ) for gemcitabine plus sorafenib versus gemcitabine plus placebo ( @ versus @ months , P = @ ) , and no difference for median overall survival ( OS ) ( @ versus @ months , P = @ ) .


Patients with liver metastasis after resection of primary BTC survived longer with sorafenib ( P = @ ) compared to placebo .


Patients who developed hand-foot syndrome ( HFS ) showed longer PFS and OS than patients without HFS .


Two sorafenib targets , VEGFR-@ and c-kit , were not expressed in BTC samples .


VEGFR-@ and Hif@ were associated with lymph node metastases and T stage .


Absence of PDGFR expression correlated with longer PFS .


The addition of sorafenib to gemcitabine did not demonstrate improved efficacy in advanced BTC patients .


Biomarker subgroup analysis suggested that some patients might benefit from combined treatment .


Tennis elbow is a condition , characterised by pain and tenderness over the lateral epicondyle of the humerus , and pain on resisted dorsiflexion of the wrist , middle finger , or both .


The aim of this randomised controlled trial was to investigate the short term efficacy of local steroid injection compared with oral and topical NSAIDs .


Sixty patients ( @ male and @ female ) were included in the study .


The mean age was @ years for men and @ years for women .


They were placed in group A and B ( @ cases each ) .


Group A received local steroid injection ( triamcinolone @ mg mixed with lignocaine @ % @ cc ) and topical NSAID cream application ( diclofenac diethylammonium ) twice a day , tab .


diclofenac sodium @ mg twice a day for @ weeks .


Group B received tab diclofenac @ mg twice a day and , topical NSAID cream application twice a day for @ weeks .


Assessment of patients was made @ times ; first at the start of the study , @nd time after @ weeks , and @rd time after @ weeks .


A blinded assessor rated the elbow complaints of the patients at resisted dorsiflexion of wrist using VAS ( @ = no severity , @-@ mild , @-@ moderate , @-@ sever , @ = maximum severity ) .


At six weeks , @ ( @ % ) patient in group A had no pain as compared to @ ( @ % ) patients in group B who were pain free ( p < @ , chi@ = @ ) .


At @ weeks @ ( @ % ) patients in group A were pain free compared to group B in which @ ( @ % ) patients were pain free ( p < @ , chi@ = @ ) .


In patients with tennis elbow , the use of local steroid injection in combination with topical and oral NSAIDs is superior to the use of combination of topical and oral NSAIDs .


Better results with combination therapy using local steroid injection may be limited to the short term .


Few randomized controlled trial studies have focused on the effect of music in cancer patients , and there are no randomized controlled trials on the effects of live music with saxophone in cancer patients .


To determine the effects of live saxophone music on various physiological parameters , pain level , and mood level .


A randomized controlled trial study .


@ cancer patients were randomized to a control group ( n = @ ) , an experimental group ( n = @ ) whose members received @ minutes of live music therapy with saxophone .


Systolic and diastolic blood pressure , pulse rate , glycemia , oxygen saturation , pain level , and mood level were measured before and after the live music performance .


There was a statistical difference between the groups for oxygen saturation ( @ ) and mood level ( @ ) .


Live music performed with a saxophone could be introduced in oncology care to improve the oxygen saturation and mood in cancer patients .


Treatment of Staphylococcus aureus colonization before surgery reduces risk of surgical site infection ( SSI ) .


The regimen of nasal mupirocin ointment and topical chlorhexidine gluconate is effective , but cost and patient compliance may be a barrier .


Nasal povidone-iodine solution may provide an alternative to mupirocin .


We conducted an investigator-initiated , open-label , randomized trial comparing SSI after arthroplasty or spine fusion in patients receiving topical chlorhexidine wipes in combination with either twice daily application of nasal mupirocin ointment during the @ days before surgery or @ applications of povidone-iodine solution into each nostril within @ hours of surgical incision .


The primary study end point was deep SSI within the @ months after surgery .


In the modified intent-to-treat analysis , a deep SSI developed after @ of @ surgical procedures in the mupirocin group and @ of @ surgical procedures in the povidone-iodine group ( P = @ ) ; S. aureus deep SSI developed after @ surgical procedures in the mupirocin group and @ surgical procedure in the povidone-iodine group ( P = @ ) .


In the per protocol analysis , S. aureus deep SSI developed in @ of @ surgical procedures in the mupirocin group and @ of @ surgical procedures in the povidone-iodine group ( P = @ ) .


Nasal povidone-iodine may be considered as an alternative to mupirocin in a multifaceted approach to reduce SSI .


In a previously reported split-mouth , randomized controlled trial , Miller Class II gingival recession defects were treated with either a connective tissue graft ( CTG ) ( control ) or recombinant human platelet-derived growth factor-BB + - tricalcium phosphate ( test ) , both in combination with a coronally advanced flap ( CAF ) .


At @ months , multiple outcome measures were examined .


The purpose of the current study is to examine the major efficacy parameters at @ years .


Twenty of the original @ patients were available for follow-up @ years after the original surgery .


Outcomes examined were recession depth , probing depth , clinical attachment level ( CAL ) , height of keratinized tissue ( wKT ) , and percentage of root coverage .


Within - and across-treatment group results at @ months and @ years were compared with original baseline values .


At @ years , all quantitative parameters for both treatment protocols showed statistically significant improvements over baseline .


The primary outcome parameter , change in recession depth at @ years , demonstrated statistically significant improvements in recession over baseline , although intergroup comparisons favored the control group at both @ months and @ years .


At @ years , intergroup comparisons also favored the test group for percentage root coverage and change in wKT , whereas no statistically significant intergroup differences were seen for @ % root coverage and changes to CAL .


In the present @-year investigation , treatment with either test or control treatments for Miller Class II recession defects appear to lead to stable , clinically effective results , although CTG + CAF resulted in greater reductions in recession , greater percentage of root coverage , and increased wKT .


The objectives were to evaluate the effects of improvement of vitamin D status on biomarkers of oxidative stress ( OS ) in type @ diabetic ( T@D ) subjects and whether vitamin D receptor ( VDR ) - FokI polymorphisms could modulate the response to vitamin D@ intake .


Subjects with T@D were allocated to one of the two groups to receive either plain doogh ( PD ; containing @mg calcium and no vitamin D/@ml , n@ = @ ) or vitamin D@-fortified doogh ( FD ; containing @IU/@ml , n@ = @ ) twice a day for @ weeks .


Outcomes were changes in serum @-hydroxyvitamin D ( @ ( OH ) D ) , superoxide dismutase , glutathione ( GSH ) , total antioxidant capacity ( TAC ) and malondialdehyde ( MDA ) .


VDR genotypes in @ T@D subjects in FD were determined by FokI restriction enzyme .


After @ weeks , serum @ ( OH ) D increased significantly in FD ( from @ to @ , P < @ ) as compared with PD ( from @ to @ , P = @ ) .


Comparisons between FD and PD revealed significant differences in changes of serum MDA ( -@ mol/l vs. +@ mol/l , P < @ ) , GSH ( +@ ng/l vs -@ ng/l , P = @ ) and TAC ( +@ mmol/l vs. +@ mmol/l bovine serum albumin equivalent , P = @ ) .


Although there was no significant association between FokI genotypes and OS biomarkers , ff variant subgroup showed the weakest response to vitamin D.


Improvement of vitamin D status via daily intake of FD ameliorates OS biomarkers in T@D subjects and the interactive effect of FokI genotypes can not be ruled out .


This randomized controlled trial evaluated the effectiveness , feasibility , and acceptability of parent participation ( PP ) in an evidence-based method to reduce the pain of prekindergarten immunizations .


Healthy children aged @ to @ years were randomized to a multimodal distraction method during administration of routine vaccines with PP and @ medical assistant ( experimental group ) or @ medical assistants ( standard-of-care comparison group ) .


Children and parents rated the pain after injections , and a blinded observer coded children 's pain from videotapes .


In all , @ children participated .


Despite group randomization , more children in the medical assistant-only group received a @-injection series ( @ ; @ % ) than in the PP group ( @ -LSB- @ % -RSB- , P = @ ) .


After adjustment for this imbalance , child-reported pain was higher in the PP group compared with the medical assistant-only group ( @ vs @ ; F = @ ; df = @ ; d = @ ; P < @ ) .


There were no differences between groups for parent-reported and observer-rated measures of pain or in intervention fidelity , duration of procedure , or child or parent satisfaction .


Although child-reported pain was higher for the PP group , the magnitude of the difference may not be clinically significant .


PP was feasible and acceptable to both parents and children , did not take any longer , and reduced the need for additional medical personnel .


Together , these data provide preliminary support for PP for prekindergarten immunization pain management .


Palbociclib ( PD-@ ) is an oral , small-molecule inhibitor of cyclin-dependent kinases ( CDKs ) @ and @ with preclinical evidence of growth-inhibitory activity in oestrogen receptor-positive breast cancer cells and synergy with anti-oestrogens .


We aimed to assess the safety and efficacy of palbociclib in combination with letrozole as first-line treatment of patients with advanced , oestrogen receptor-positive , HER@-negative breast cancer .


In this open-label , randomised phase @ study , postmenopausal women with advanced oestrogen receptor-positive and HER@-negative breast cancer who had not received any systemic treatment for their advanced disease were eligible to participate .


Patients were enrolled in two separate cohorts that accrued sequentially : in cohort @ , patients were enrolled on the basis of their oestrogen receptor-positive and HER@-negative biomarker status alone , whereas in cohort @ they were also required to have cancers with amplification of cyclin D@ ( CCND@ ) , loss of p@ ( INK@A or CDKN@A ) , or both .


In both cohorts , patients were randomly assigned @:@ via an interactive web-based randomisation system , stratified by disease site and disease-free interval , to receive continuous oral letrozole @ mg daily or continuous oral letrozole @ mg daily plus oral palbociclib @ mg , given once daily for @ weeks followed by @ week off over @-day cycles .


The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population .


Accrual to cohort @ was stopped after an unplanned interim analysis of cohort @ and the statistical analysis plan for the primary endpoint was amended to a combined analysis of cohorts @ and @ ( instead of cohort @ alone ) .


The study is ongoing but closed to accrual ; these are the results of the final analysis of progression-free survival .


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


Between Dec @ , @ , and May @ , @ , we randomly assigned @ patients , @ to palbociclib plus letrozole and @ to letrozole alone .


At the time of the final analysis for progression-free survival ( median follow-up @ months -LSB- @ % CI @-@ @ -RSB- for the palbociclib plus letrozole group and @ months -LSB- @-@ @ -RSB- for the letrozole group ) , @ progression-free survival events had occurred in the palbociclib plus letrozole group and @ in the letrozole group .


Median progression-free survival was @ months ( @ % CI @-@ @ ) for the letrozole group and @ months ( @-@ @ ) for the palbociclib plus letrozole group ( HR @ , @ % CI @-@ @ ; one-sided p = @ ) .


In cohort @ ( n = @ ) , median progression-free survival was @ months ( @-@ @ ) for the letrozole group and @ months ( @-not estimable ) for the palbociclib plus letrozole group ( HR @ , @-@ @ ; one-sided p < @ ) ; in cohort @ ( n = @ ) , median progression-free survival was @ months ( @-@ @ ) for the letrozole group and @ months ( @-@ @ ) for the palbociclib plus letrozole group ( HR @ , @-@ @ ; one-sided p = @ ) .


Grade @-@ neutropenia was reported in @ ( @ % ) of @ patients in the palbociclib plus letrozole group versus one ( @ % ) of @ patients in the letrozole group , leucopenia in @ ( @ % ) versus none , and fatigue in four ( @ % ) versus one ( @ % ) .


Serious adverse events that occurred in more than one patient in the palbociclib plus letrozole group were pulmonary embolism ( three -LSB- @ % -RSB- patients ) , back pain ( two -LSB- @ % -RSB- ) , and diarrhoea ( two -LSB- @ % -RSB- ) .


No cases of febrile neutropenia or neutropenia-related infections were reported during the study .


@ ( @ % ) patients in the palbociclib plus letrozole group and two ( @ % ) in the letrozole group discontinued the study because of adverse events .


The addition of palbociclib to letrozole in this phase @ study significantly improved progression-free survival in women with advanced oestrogen receptor-positive and HER@-negative breast cancer .


A phase @ trial is currently underway .


Despite the findings of several randomized clinical studies , the role of gentamicin collagen implant ( GCI ) in rectal cancer surgery is unclear .


Local pelvic application of GCI following preoperative radiotherapy and total mesorectal excision ( TME ) was evaluated to determine the risk of surgical site infections ( SSI ) .


In this single-center trial , @ patients with rectal cancer after preoperative , short-term radiotherapy ( @ @ Gy ) were randomized either to the study group in which GCI was used or in the control group without GCI .


Prior to surgery and intraoperatively five patients were excluded from the study .


The remaining @ patients were analyzed ; @ were in the study group and @ in the control group .


There were no statistically significant differences in the overall rate of early postoperative complications between the study and control group : @ and @ % respectively ; p = @ , relative risk ( RR ) @ -LSB- @ % confidence interval ( CI ) @-@ @ -RSB- .


The reoperation rate was similar in both groups : @ versus @ % ; p = @ ; RR @ ; ( @ % CI @-@ @ ) .


The total rate of SSI and organ space SSI were @ and @ % without differences between the study and control group .


In patients without anastomotic leakage , the risk of organ space SSI was significantly reduced in patients who received GCI : @ versus @ % ; p = @ .


Application of GCI in the pelvic cavity after short-term preoperative radiotherapy and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage .


The angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate .


We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents .


Patient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the @ drug-eluting stents ( ISAR-TEST ) clinical trial and the LIPSIA Yukon clinical trial ( randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus ) were pooled .


The angiographic ( primary ) endpoint was in-stent late lumen loss at @ months to @ months .


The clinical ( secondary ) endpoints were death or myocardial infarction , cardiac death or myocardial infarction , target lesion revascularization , and myocardial infarction .


A total of @ patients ( polymer-free sirolimus-eluting stents , n = @ vs polymer-based paclitaxel-eluting stents , n = @ ) and @ lesions ( polymer-free sirolimus-eluting stents , n = @ vs polymer-based paclitaxel-eluting stents , n = @ ) were included in the study .


Control angiography ( @lesions , @ % ) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents ( @ -LSB- @ -RSB- mm vs @ -LSB- @ -RSB- mm ; P = @ ) .


Median follow-up was @ months .


Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction ( relative risk = @ ; @ % confidence interval , @-@ @ ; P = @ ) , cardiac death or myocardial infarction ( relative risk = @ ; @ % confidence interval , @-@ @ ; P = @ ) , target lesion revascularization ( relative risk = @ ; @ % confidence interval , @-@ @ ; P = @ ) , and myocardial infarction ( relative risk = @ ; @ % confidence interval , @-@ @ ; P = @ ) .


In this pooled analysis , polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy .


To determine whether language and word choice can reduce patients ' perception of pain experienced during colposcopy with biopsies .


Women reporting for colposcopy at an academic medical center were randomized to hear standard language or gentle , non-pain-based language during colposcopy with biopsy and/or endocervical curettage .


Participants then rated their pain during the procedure on a @-cm visual analog scale .


The pain scores among the @ groups were compared using a Student t test .


Both women hearing standard language and those hearing gentle language during colposcopy reported low pain during the procedure ( @ and @ , respectively ) , which was not significantly different between groups ( p = @ ) .


Although gentle language has been shown to effectively reduce pain associated with other procedures , it did not reduce the pain associated with colposcopy and biopsies in this study .


Internet-based health behaviour interventions have variable effects on health-related outcomes .


Effectiveness may be improved by optimizing the design of interventions .


This study examined the specific effect on engagement of providing two different design features - tailoring and self-assessment .


Three versions of an Internet-delivered intervention to support the self-care of mild bowel problems were developed that provided ( @ ) self-assessment without tailored feedback , ( @ ) self-assessment with tailored feedback , and ( @ ) generic information only .


A qualitative study explored participants ' engagement with each version of the intervention ( N = @ ) .


A larger quantitative study systematically compared participants ' use of the intervention and self-reported engagement using a partial factorial design ( n = @ ) .


Findings from the qualitative study suggested that self-assessment without tailored feedback appeared to be less acceptable to participants because it was viewed as offering no personal benefit in the absence of personalized advice .


In the quantitative study , self-assessment without tailored feedback was associated with greater dropout than when provided in conjunction with tailored feedback .


There were significant group differences in participants ' engagement with the intervention and perceptions of the intervention .


Self-assessment without tailored feedback was rated as marginally less engaging and was associated with fewer positive perceptions than the generic information condition .


The acceptability of self-assessment or monitoring components may be optimized by also providing tailored feedback .


Without tailored feedback , these components do not appear to be any more engaging than generic information provision .


Statement of contribution What is already known on this subject ?


Digital interventions can be effective for improving a range of health outcomes and behaviours .


There is huge variation in the success of different interventions using different combinations of design features .


What does this study add ?


This study used a systematic experimental design to identify the effect on engagement of providing interactive intervention design features alone and in combination .


Intervention engagement was better when self-assessment was provided in conjunction with tailored feedback .


C-reactive protein ( CRP ) during pregnancy has been associated with adverse maternal outcomes such as preeclampsia and gestational diabetes mellitus .


Randomized trials suggest that exercise programs may be associated with reductions in CRP in non-pregnant populations ; however , such studies have not been conducted among pregnant women .


The purpose of this study was to evaluate the impact of an individually-tailored motivationally-matched exercise intervention on CRP in pregnant women .


The Behaviors Affecting Baby and You study was a randomized controlled trial of prenatal physical activity to prevent the development of gestational diabetes mellitus in women at increased risk .


Women were randomized to either a @-week exercise intervention ( n = @ ) or a comparison health and wellness intervention ( n = @ ) .


High sensitivity CRP ( mg/dL ) was measured using a commercial immunoassay kit .


Physical activity was measured using the Pregnancy Physical Activity Questionnaire .


Mixed model analyses were used to evaluate the impact of the intervention on change in CRP using an intent-to-treat approach .


CRP decreased ( -@ mg/dL , @ % CI : -@ , @ ) from pre - to post-intervention in the exercise arm ( p = @ ) and increased ( @ mg/dL , @ % CI : -@ , @ ) ( p = @ ) in the health and wellness arm ; however the between group difference was not statistically significant ( p = @ ) .


Findings did not differ according to ethnic group or pre-pregnancy body mass index .


In a secondary analysis based on self-reported physical activity , women who decreased their time spent in sports/exercise experienced a mean increase in CRP ( @ mg/dL , @ % CI : -@ , @ ) , whereas women who maintained or increased their sports / exercise experienced a mean decrease in CRP ( -@ mg/dL , @ % CI : -@ , @ ) ( p = @ ) .


Findings from this randomized trial in an ethnically and socio-economically diverse population of pregnant women were consistent with a positive impact of the exercise intervention on CRP levels , but not of statistical significance .


Mixed venous and arterial ulcers account for approximately @ % -@ % of all venous leg ulcerations .


Several studies have shown that matrix metalloproteinases ( MMPs ) and neutrophil gelatinase-associated lipocalin ( NGAL ) play a central role in the pathophysiology of venous and arterial diseases .


Some studies have shown the efficacy of glycosaminoglycans , such as sulodexide ( SDX ) , in treating patients with leg ulcers .


The aim of this study was to evaluate clinical effects of SDX and its correlation with MMPs and NGAL expression in patients with mixed arterial and venous leg ulcers .


Patients eligible for this study were of both sexes , older than @ years , and with a clinical and instrumental diagnosis of mixed ulcer .


Fifty-three patients of both sexes were enrolled and divided into two groups by means of randomization tables .


Group A ( treated group ) comprised @ females and ten males ( median age : @ years ) treated with standard treatment ( compression therapy and surgery ) + SDX ( @ lipoprotein lipase-releasing units/day intramuscularly ) for @ days followed by SDX @ lipase-releasing units every @ hours day orally for @ months as adjunctive treatment .


Group B ( control group ) comprised @ females and eight males ( median age : @ years ) treated with standard treatment only ( compression therapy and surgery ) .


The type of surgery was chosen according to anatomical level of vein incompetence : superficial venous open surgery and/or subfascial endoscopic perforating surgery .


In all enrolled patients , blood samples were collected in order to evaluate the plasma levels of MMPs and NGAL through enzyme-linked immunosorbent assay .


These results were compared to another control group ( Group C ) of healthy individuals .


Moreover , biopsies of ulcers were taken to evaluate the tissue expression of MMPs and NGAL through Western blot analysis .


Our results revealed that SDX treatment is able to reduce both plasma levels and tissue expression of MMPs improving the clinical conditions in patients with mixed ulcers .


Inhibition of MMPs could represent a possible therapeutic intervention to limit the progression of leg ulceration .


In particular , our findings demonstrate the efficacy of SDX in patients with mixed arterial and venous chronic ulcers of the lower limbs .


The objective of this study was to determine the efficacy and safety of locoregional therapy ( LRT ) combined with arsenic trioxide ( As@ O@ ) treatment in primary hepatocellular carcinoma ( HCC ) patients .


One hundred twenty-five primary HCC patients were recruited for a randomized controlled study .


Patients were randomly divided into group A ( n = @ ) and group B ( n = @ ) .


All patients received transarterial chemoembolization .


Group A patients were given As@ O@ at @ mg/d for @ courses ( @ days per course ) with a @-week interval between courses .


Survival times , therapeutic responses , extrahepatic metastases , and adverse events were recorded .


A better therapeutic response was found in group A patients , as shown by higher objective response rate ( ORR ) and clinical benefit rate ( CBR ) values in group A versus group B ( ORR , @ % -LSB- @ % confidence interval ( CI ) , @ % -@ % -RSB- vs @ % -LSB- @ % CI , @ % -@ % -RSB- , ( @ ) = @ , P < @ ; CBR , @ % -LSB- @ % CI , @ % -@ % -RSB- vs @ % -LSB- @ % CI , @ % -@ % -RSB- , ( @ ) = @ , P < @ ) .


There were fewer patients with extrahepatic metastases in group A versus group B ( group A , @ cases or @ % -LSB- @ % CI , @ % -@ % -RSB- ; group B , @ cases or @ % -LSB- @ % CI , @ % -@ % -RSB- ) .


The survival rate for group A patients was significantly higher than that for group B patients ( P < @ ) .


No significant differences were found between the @ groups in terms of hematology or digestive system , liver , or kidney dysfunction except for facial and limb edema .


LRT combined with As@ O@ treatment prevents extrahepatic metastasis and prolongs the survival time for primary HCC patients .


St John 's wort ( SJW ; Hypericum perforatum ) induces CYP@A@ that is involved in the metabolism of the hepatitis C virus ( HCV ) protease inhibitor boceprevir .


Reduced boceprevir exposure and efficacy would contribute to therapeutic failure and increase the risk for resistance development .


Boceprevir is co-administered with interferon/ribavirin , and depression has been described frequently in patients undergoing HCV treatment .


Patients may purchase over-the-counter herbals to manage depression , and knowing the interaction between SJW and boceprevir is desirable .


This Phase I , open-label , three-period , cross-over pharmacokinetic study enrolled healthy males and females who , following consent and screening procedures , were randomized to receive SJW on days @-@ , SJW plus boceprevir ( SJW on days @-@ and together on days @-@ ) and boceprevir on days @-@ , separated by @ day washout periods , or the same treatment in the opposite order .


Pharmacokinetic sampling was performed at the end of each phase .


Seventeen ( @ female ) subjects completed the study and no serious adverse events were reported .


Geometric mean ratios ( GMRs ) and @ % CIs for boceprevir ( with SJW versus alone ) AUC ( @-@ ) , C ( max ) and C@ were @ ( @-@ @ ) , @ ( @-@ @ ) and @ ( @-@ @ ) , respectively .


GMRs and @ % CIs for hypericin , the active component of SJW , ( with boceprevir versus alone ) AUC ( @-@ ) , C ( max ) and C ( @ ) were @ ( @-@ @ ) , @ ( @-@ @ ) and @ ( @-@ @ ) , respectively .


SJW did not have a clinically significant effect on boceprevir plasma concentrations ( or those of its metabolite ) , suggesting that SJW and boceprevir can be safely co-administered .


A randomized controlled trial of a multicomponent dyadic intervention ( a translated and adapted version of an intervention that has been shown to be effective for people with dementia in the USA ) was performed .


The exercise and support intervention was intended to reduce depressive symptoms of people with dementia and their caregivers .


The purpose of this process evaluation is to create in-depth insight into the delivery of the intervention and the effect analysis , to prevent drawing inappropriate conclusions on the efficacy or effectiveness of the intervention , and to formulate recommendations for future studies on complex geriatric interventions .


Qualitative and quantitative data were collected .


The process evaluation was performed according to the model presented by Reelick and colleagues , which encompasses the following three process components : ( @ ) success rate of recruitment and quality of the study population ; ( @ ) the quality of execution of the complex intervention ; and ( @ ) the process of acquisition of the data .


The study design met high research standards and the intervention was carefully delivered .


Evaluation of the study population quality revealed a profound recruitment process resulting in a reasonable sample size .


Attrition rate during follow-up was acceptable .


With regard to the evaluation of the intervention quality , most interviewed participants experienced benefits of the intervention .


Attendance at the home visits was high and attrition to homework was moderate .


Evaluation of the data acquisition showed the positive value of the use of a mixed design ; qualitative analysis of the intervention revealed outcomes not measured in the quantitative analysis .


The process evaluation revealed a carefully and soundly performed study .


The mixed design contributed to valuable insights .


However , there were some restrictions worth considering .


The intervention components may have a different feasibility by moderate attrition to homework and some negative experiences of participants , which may be an indication of too intensive an intervention for this frail population in this specific country .


As a result , the results of the statistical effect analysis should be interpreted with caution .


E-learning is an efficient and cost-effective educational method .


This study aimed at evaluating the feasibility of an educational e-learning intervention , focused on teaching geriatric pharmacology and notions of comprehensive geriatric assessment , to improve drug prescribing to hospitalized elderly patients .


Eight geriatric and internal medicine wards were randomized to intervention ( e-learning educational program ) or control .


Clinicians of the two groups had to complete a specific per group e-learning program in @ days .


Then , ten patients ( aged @ years ) had to be consecutively enrolled collecting clinical data at hospital admission , discharge , and @ months later .


The quality of prescription was evaluated comparing the prevalence of potentially inappropriate medications through Beer 's criteria and of potential drug-drug interactions through a specific computerized database .


The study feasibility was confirmed by the high percentage ( @ % ) of clinicians who completed the e-learning program , the recruitment , and follow-up of all planned patients .


The intervention was well accepted by all participating clinicians who judged positively ( a mean score of > @ points on a scale of @ points : @ = useless ; @ = most useful ) the specific contents , the methodology applied , the clinical relevance and utility of e-learning contents and tools for the evaluation of the appropriateness of drug prescribing .


The pilot study met all the requested goals .


The main study is currently ongoing and is planned to finish on July @ .


The fixed combination of extrafine beclomethasone dipropionate and formoterol fumarate ( BDP/FF ) pMDI ( Foster ( ) ) is approved for treatment of adult asthmatic patients .


In order to provide an alternative drug delivery system for BDP/FF to physicians and patients , a dry powder inhaler ( NEXThaler ( ) ) has been developed , capable to deliver extrafine particles to the lungs and therefore improve the dosing of the drugs , especially in patients with poor hand-breath coordination .


This trial was performed to compare efficacy and safety of extrafine BDP/FF NEXThaler ( ) with extrafine BDP/FF pMDI or non-extrafine BDP DPI alone in adult patients with controlled asthma .


In this @-week randomised , double-blind , parallel-group trial , patients were randomized to receive either extrafine BDP/FF NEXThaler ( ) @/@g bid , extrafine BDP/FF @/@g pMDI bid or non-extrafine BDP DPI @g bid .


The primary efficacy variable was change from baseline to the entire @-week randomised treatment period in average pre-dose morning PEF .


The ITT population comprised @ patients .


Extrafine BDP/FF NEXThaler ( ) was non-inferior ( pre-defined margin : -@ L/min ) relative to extrafine BDP/FF pMDI ( mean difference : -@ ; @ % CI : -@ , @ ) in terms of the primary efficacy variable , change from baseline in average pre-dose morning PEF .


Statistical superiority of both extrafine BDP/FF formulations over non-extrafine BDP DPI was demonstrated for the primary efficacy variable ( providing evidence of assays sensitivity of the trial ) , ACQ score and percentage of rescue medication use-free days .


No significant safety signals were observed .


NEXThaler ( ) is an effective and well-tolerated delivery device for treatment of patients with asthma who need a regular treatment .


Despite initial in-hospital treatment of acute heart failure ( HF ) , some patients experience worsening HF ( WHF ) .


There are limited data about the outcomes and characteristics of patients who experience in-hospital WHF .


We assessed the characteristics and outcomes of patients with and without WHF in the ASCEND-HF trial .


Worsening HF was defined as at least @ symptom or sign of new , persistent , or WHF requiring additional intravenous inotropic/vasodilator or mechanical therapy during index hospitalization .


We assessed the relationship between WHF and @-day mortality , @-day mortality or HF hospitalization , and @-day mortality .


We also assessed whether there was a differential association between early ( days @-@ ) vs late ( day @ ) WHF and outcomes .


Of @,@ patients with acute HF , @ ( @ % ) experienced WHF .


Patients with WHF were more often male and had a history of atrial fibrillation or diabetes , lower blood pressure , and higher creatinine .


After risk adjustment , WHF was associated with increased @-day mortality ( odds ratio @ , @ % CI @-@ @ ) , @-day mortality or HF rehospitalization ( odds ratio @ , @ % CI @-@ @ ) , and @-day mortality ( hazard ratio @ , @ % CI @-@ @ ) ( all P values < @ ) .


There was no evidence of a difference in outcomes between early and late WHF ( all P values for comparison @ ) .


Worsening HF during index hospitalization was associated with worse @ - and @-day outcomes .


Worsening HF may represent an important patient-centered outcome in acute HF and a focus of future treatments .


Chronic insomnia is a major public health problem affecting approximately @ % of adults .


Use of meditation and yoga to develop mindful awareness ( ` mindfulness training ' ) may be an effective approach to treat chronic insomnia , with sleep outcomes comparable to nightly use of prescription sedatives , but more durable and with minimal or no side effects .


The purpose of this study was to understand mindfulness training as experienced by patients with chronic insomnia , and suggest procedures that may be useful in optimizing sleep benefits .


Adults ( N = @ ) who completed an @-week mindfulness-based stress reduction ( MBSR ) program as part of a randomized , controlled clinical trial to evaluate MBSR as a treatment for chronic insomnia were invited to participate in post-trial focus groups .


Two groups were held .


Participants ( n = @ ) described how their sleep routine , thoughts and emotions were affected by MBSR and about utility ( or not ) of various mindfulness techniques .


Groups were audio-recorded , transcribed and analyzed using content analysis .


Four themes were identified : the impact of mindfulness on sleep and motivation to adopt a healthy sleep lifestyle ; benefits of mindfulness on aspects of life beyond sleep ; challenges and successes in adopting mindfulness-based practices ; and the importance of group sharing and support .


Participants said they were not sleeping more , but sleeping better , waking more refreshed , feeling less distressed about insomnia , and better able to cope when it occurred .


Some participants experienced the course as a call to action , and for them , practicing meditation and following sleep hygiene guidelines became priorities .


Motivation to sustain behavioral changes was reinforced by feeling physically better and more emotionally stable , and seeing others in the MBSR class improve .


The body scan was identified as an effective tool to enable falling asleep faster .


Participants described needing to continue practicing mindfulness to maintain benefits .


First-person accounts are consistent with published trial results of positive impacts of MBSR on sleep measured by sleep diary , actigraphy , and self-report sleep scales .


Findings indicate that mindfulness training in a group format , combined with sleep hygiene education , is important for effective application of MBSR as a treatment for chronic insomnia .


The long half-life of atorvastatin and fenofibrate makes them suitable for alternate day therapy .


Hence , we aimed to study the efficacy , safety , and cost-effectiveness of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia .


Eligible patients with mixed dyslipidemia were randomly allotted into @ equal parallel groups-alternate day therapy group ( group @ ) and daily therapy group ( group @ ) .


Patients in groups @ and @ received fixed dose combination of atorvastatin @ mg and fenofibrate @ mg on alternate days and daily , respectively , for @ weeks .


Mean percentage change from baseline in triglycerides ( TGLs ) , non-high-density lipoprotein cholesterol ( non-HDL-C ) , HDL-C , low-density lipoprotein cholesterol ( LDL-C ) , total cholesterol ( TC ) , and TC-HDL ratio , incidence of adverse effects , and cost-effectiveness were compared in both the groups .


Among @ patients randomized , @ completed the study till @ weeks treatment duration .


The TGLs , non-HDL-C , TC , and LDL-C decreased by @ % , @ % , @ % , and @ % , respectively , in alternate day therapy group and by @ % , @ % , @ % , and @ % , respectively , in daily therapy group .


The HDL-C levels increased by @ % in alternate day therapy group compared to @ % in daily therapy group .


No statistically significant difference was seen between both the groups in mean percentage change in lipid parameters from baseline to end of @ weeks .


Incidence of adverse events was reasonably less in alternate day therapy group .


Alternate day therapy with atorvastatin-fenofibrate combination is an effective and safe alternative to daily therapy in mixed dyslipidemia .


Apart from significant cost savings , reasonable reduction in the incidence of adverse events is seen with alternate day regimen .


However , larger studies are needed to more reliably confirm our interesting but preliminary results .


Muscle atrophy and weakness impair activity of daily living ( ADL ) .


We examined whether chair stand exercise can improve ADL of hemodialysis patients .


A randomized controlled trial .


A single center study .


Outpatients on hemodialysis older than @ years ( @-@years ) .


Twelve weeks of intervention with chair stand exercise , @ sessions/week versus the control exercise ( stretch , @ session/week ) .


The primary outcome was the change in functional independence measure ( FIM ) score from baseline .


The secondary outcomes were changes in thigh circumference , muscle strength of quadriceps , @-minute walking distance , maximum duration of chair stand exercise , health-related quality of life , cognitive function serum albumin , and hemoglobin .


Among the @ patients who were randomized , @ completed the study .


The change in FIM from baseline was greater in the intervention group ( @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- , median ( minimum to maximum ) , P < @ ) due to the significant improvement in the FIM subscales related to mobility ( bed/chair/wheel chair ) and locomotion ( stair ) .


Among the secondary outcomes , significant difference was noticed in the changes in thigh circumference and the physical component summary score of health-related quality of life by Medical Outcome Study @-Item Short-Form Health Survey ( SF-@v@ ) .


Chair stand exercise improved ADL in the hemodialysis patients aged older than @years .


To investigate suggestion-induced placebo effects in inflammatory skin reactions .


A healthy sample of volunteers ( N = @ ) attended two laboratory sessions .


In each , a local short term inflammatory skin reaction was induced with histamine .


Participants were told that one session was a control session and the other was a treatment session in which an antihistamine cream would be applied to the arm to reduce the size of the weal and the experience of itch .


Inert aqueous cream was applied in both sessions .


Participants were randomly allocated to undergo either the control or the treatment session first .


The placebo manipulation successfully reduced self-reported itch from the control to the placebo treatment session , but no placebo effect was demonstrated in weal size .


Order effects were observed such that only those who underwent control procedures first had a smaller weal in the placebo treatment session as compared to the control session .


The same order effect was seen for reported itch at one minute post histamine administration , but this disappeared at the three and five minute measures .


Findings suggest that explicit verbal suggestion can reduce the experience of itch .


In addition to conscious awareness , a concrete representation of the suggested changes gained from prior experience to the stimulus may be an important component of placebo effects on inflammatory skin reactions .


Fast-track treatment in cardiac surgery has become the global standard of care .


We compared the efficacy and safety of a specialised post-anaesthetic care unit ( PACU ) to a conventional intensive care unit ( ICU ) in achieving defined fast-track end-points in adult patients after elective cardiac surgery .


In a prospective , single blinded , randomized study , @ adult patients undergoing elective cardiac surgery ( coronary artery bypass graft ( CABG ) , valve surgery or combined CABG and valve surgery ) , were selected to receive their postoperative treatment either in the ICU ( n = @ ) , or in the PACU ( n = @ ) .


Patients who , at the time of surgery , were in cardiogenic shock , required renal dialysis , or had an additive EuroSCORE of more than @ were excluded from the study .


The primary end points were : time to extubation ( ET ) , and length of stay in the PACU or ICU ( PACU/ICU LOS respectively ) .


Secondary end points analysed were the incidences of : surgical re-exploration , development of haemothorax , new onset cardiac arrhythmia , low cardiac output syndrome , need for cardio-pulmonary resuscitation , stroke , acute renal failure , and death .


Median time to extubation was @ -LSB- @ ; @ -RSB- min in the PACU vs. @ -LSB- @ ; @ -RSB- min in the ICU group ( P < @ ) .


Median length of stay in PACU was @ -LSB- @ ; @ -RSB- hours vs. @ -LSB- @ ; @ -RSB- hours in the ICU ( P < @ ) .


Of the adverse events examined , only the incidence of new onset cardiac arrhythmia ( @ in PACU vs. @ in ICU , P = @ ) was statistically different between groups .


Treatment in a specialised PACU rather than an ICU , after elective cardiac surgery leads to earlier extubation and quicker discharge to a step down unit , without compromising patient safety .


We describe neuropsychological test performance ( NP ) in antiretroviral treatment ( ART ) - nave HIV-positive individuals with CD@ cell counts above @ cells/L .


In a neurology substudy of the International Network for Strategic Initiatives in Global HIV Trials ( INSIGHT ) Strategic Timing of AntiRetroviral Treatment ( START ) study , eight neurocognitive tests were administered .


The primary measure of NP was the quantitative NPz-score ( QNPZ-@ ) , the average of the z-scores for the eight tests .


Associations of baseline factors with QNPZ-@ scores were assessed by multiple regression .


Mild neurocognitive impairment ( NCI ) was defined as z-scores < -@ in at least two of six cognitive domains .


A total of @ participants had a median age of @ years ; @ % were women and @ % were black ; the median time since HIV diagnosis was @ years ; the median CD@ cell count was @ cells/L ; @ % had mild NCI .


Better NP was independently associated with younger age , being white , higher body mass index ( @ per @kg/m ( @ ) higher ) , and higher haematocrit percentage ( @ per @ % higher ) .


Worse NP was associated with longer time since HIV diagnosis ( -@ per @ years ) , diabetes ( -@ ) and higher Framingham risk score ( -@ per @ points higher ) .


QNPZ-@ scores differed significantly between geographical locations , with the lowest scores in Brazil and Argentina/Chile .


This is the largest study of NP in ART-nave HIV-positive adults with CD@ counts > @ cells/L .


Demographic factors and diabetes were most strongly associated with NP .


Unmeasured educational/sociocultural factors may explain geographical differences .


Poorer NP was independently associated with longer time since HIV diagnosis , suggesting that untreated HIV infection might deleteriously affect NP , but the effect was small .


Sodium alginate reduces appetite and glycemia , when consumed in water - and sugar-based drinks .


But , its effects when added to other commonly consumed beverages have not been reported .


Because chocolate milk ( CM ) is criticized for raising blood glucose more than unflavored milk , the aim of our study was to investigate the effect of adding a strong-gelling sodium alginate to CM on glycemia , insulinemia , appetite and food intake .


In a randomized crossover design , @ men ( @ years ; @ kg/m ( @ ) ) were provided with isovolumetric ( @ml ) treatments of CM , @ % alginate CM , @ % alginate CM or @ % alginate solution .


Sodium alginate had a ratio of @:@ of mannuronic acid ( M ) to guluronic acid ( G ) residues , and was block distributed .


Treatments were standardized for lactose , sucrose and calcium content , and provided @min before an ad libitum pizza meal during which food intake was measured .


Appetite and blood glucose and insulin were measured at baseline and at intervals pre - and post-meal .


Addition of @ % alginate to CM reduced peak glucose concentrations , at @min , by an average of @ % and @ % compared with @ % alginate CM ( @ % confidence intervals ( CIs ) : @-@ @ ; P = @ ) and CM alone ( @ % CIs : @-@ @ ; P = @ ) respectively .


Insulin peaks at @min were lower by @ % after @ % alginate CM relative to CM ( @ % CIs : @-@ @ ; P = @ ) .


Pre-meal appetite was attenuated dose dependently by alginate addition to CM ; CM with @ % alginate reduced mean appetite by an average of @ % compared with CM alone ( @ % CIs : @-@ @ ; P = @ ) .


However , total caloric intake at the pizza meal did not differ among treatments .


The addition of a strong-gelling sodium alginate to CM decreases pre-meal glycemia , insulinemia and appetite , but not caloric intake at a meal @h later , in healthy adult men .


It is not clear which is preferred between iron supplement and a dopamine agonist in the treatment of restless legs syndrome ( RLS ) with iron deficiency .


The efficacies of oral iron supplementation and pramipexole for treatment of RLS with low-normal serum ferritin ( @-@ ng/ml ) were compared .


Thirty RLS patients who took either oral iron or pramipexole for @ weeks and were followed at @ , @ , @ and @ weeks after treatment commencement were enrolled .


Severities of RLS symptoms were assessed using the international RLS study group rating scale for severity ( IRLS ) at every visit .


Treatment response was defined as a decrease in IRLS score of at least @ % from baseline .


The @ subjects were assigned equally to an iron or pramipexole group .


At baseline , IRLS scores and serum ferritin levels were similar between these two groups .


After @ weeks , IRLS scores were lower than those at baseline in both groups ( iron -@ @ , P < @ ; pramipexole -@ @ , P = @ ) and similar between the two groups .


Changes in IRLS scores from baseline were similar between the two groups at each visit .


The response rates of the groups were identical at @ % .


Pramipexole was not different from oral iron in terms of efficacy and improvement speed in RLS patients with a low-normal serum ferritin , but response rate of either oral iron or pramipexole alone was moderate .


Some proportion of RLS patients with iron deficiency might benefit from combined use of oral iron and dopamine agonists .


To compare functional and anatomical outcomes after idiopathic macular pucker removal between eyes that underwent internal limiting membrane ( ILM ) peeling and eyes that did not .


In this multicentric , randomized clinical trial , @ eyes of @ patients affected with idiopathic macular pucker were enrolled .


Thirty eyes underwent @-gauge pars plana vitrectomy associated with ILM peeling ( `` ILM peeling group '' ) , whereas @ eyes did not undergo ILM peeling ( `` ILM not peeling group '' ) .


Retinal sensitivity , frequency of microscotomas , and all the other microperimetric parameters were tested by MP@ microperimetry .


Best-corrected visual acuity was investigated with the Early Treatment Diabetic Retinopathy Study chart .


Anatomical outcomes were analyzed with spectral domain optical coherence tomography .


After a @-month follow-up , the mean retinal sensitivity in the @ central area showed a greater and faster recovery in the ILM not peeling group than in the ILM peeling group ( P = @ ) .


The number of absolute microscotomas ( @ dB ) within the @ central retinal area was significantly higher in the ILM peeling group than in the ILM not peeling group ( P = @ ) .


The ILM not peeling group seems to show better outcomes than the ILM peeling group as measured by mean retinal sensitivity and number of microscotomas after a @-month follow-up .


To observe the clinical efficacy of BO 's abdominal acupuncture for obese type-@ diabetes mellitus ( T@DM ) .


Sixty patients of obese T@DM were randomly divided into an acupuncture group and a medication group , @ cases in each one .


Patients in the medication group were treated with basic treatment combined with oral administration of regular antidiabetics , three weeks as one session .


Patients in the acupuncture group , based on the medication group , were treated with abdominal acupuncture at Yinqiguiyuan -LSB- Zhongwan ( CV @ ) , Xiawan ( CV @ ) , Qihai ( CV @ ) , Guanguan ( CV @ ) -RSB- , Fusiguan -LSB- Huaroumen ( ST @ ) , Wailing ( TE @ ) -RSB- , Tianshu ( ST @ ) , Daheng ( SP @ ) , Qixue ( KI @ ) , etc. ; the treatment was given three times per week , @ weeks as one session .


The systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , body weight , waist circumference ( WC ) , hip circumference , body mass index ( BI ) were observed before and after treatment in the two groups , and fasting plasma glucose ( FPG ) , fasting insulin ( FINS ) , @-hours postprandial blood glucose by oral glucose tolerance test ( OGTT ) and insulin , total cholesterol ( TC ) , triglyceride ( TG ) , high-density lipoprotein cholesterol ( HDL-C ) and low-density lipoprotein cholesterol ( LDL-C ) , HOMA-IR of insulin resistance index were calculated and adverge events were recorded .


Compared before the treatment , SBP , WC , body weight , BMI , FPG , OG-TT@hBG , FINS , GTT@h insulin , HOMA-IR , TC and LDL-C in the acupuncture group were all significantly reduced ( all P < @ ) , while FPG , OGTT@H insulin and TG were increased in the medication group ( all P < @ ) ' .


The differences of reducing SBP , WC , FPG , OGTT@H insulin , HOMA-IR , TC , TG and LDL-C were statistically significant between the two groups ( all P < @ ) .


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


BO 's abdominal acupuncture has obvious clinical efficacy for obese type-@ diabetes mellitus , featuring in lowering blood pressure , reducing weight , decreasing blood glucose , im - proving insulin resistance and lowering lipid , which has no adverse effects and is worthy of clinical popularization and application .


This study investigated whether inhibiting late Na ( + ) current by using ranolazine improved diastolic function in patients with heart failure with preserved ejection fraction ( HFpEF ) .


HFpEF accounts for > @ % of all HF patients , but no specific treatment exists .


The RALI-DHF ( RAnoLazIne for the Treatment of Diastolic Heart Failure ) study was a prospective , randomized , double-blind , placebo-controlled small proof-of-concept study .


Inclusion criteria were EF@ % , a mitral E-wave velocity/mitral annular velocity ratio ( E/E ' ) > @ or N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) concentration > @ pg/ml , a left ventricular end-diastolic pressure ( LVEDP ) @ mm Hg , and time-constant of relaxation ( tau ) @ ms. Patients were randomized to ranolazine ( n = @ ) or placebo ( n = @ ) .


Treatment consisted of intravenous infusion for @ h , followed by oral treatment for @ days .


After @ min of infusion , LVEDP ( p = @ ) and pulmonary capillary wedge pressure ( p = @ ) decreased in the ranolazine group but not in the placebo group .


Mean pulmonary artery pressure showed a trend toward a decrease in the ranolazine group that was significant under pacing conditions at @ beats/min ( p = @ ) , but not for the placebo group .


These changes occurred without changes in left ventricular end-systolic pressure or systemic or pulmonary resistance but in the presence of a small but significant decrease in cardiac output ( p = @ ) .


Relaxation parameters ( e.g. , tau , rate of decline of left ventricular pressure per minute -LSB- dP/dtmin -RSB- ) were unaltered .


Echocardiographically , the E/E ' ratio did not significantly change after @ h.


After @ days of treatment , no significant changes were observed in echocardiographic or cardiopulmonary exercise test parameters .


There were no significant effects on NT-pro-BNP levels .


Results of this proof-of-concept study revealed that ranolazine improved measures of hemodynamics but that there was no improvement in relaxation parameters .


( Ranolazine in Diastolic Heart Failure -LSB- RALI-DHF -RSB- ; NCT@ ) .


Disulfiram may be efficacious for treating cocaine dependence or abuse , possibly through inhibiting dopamine - hydroxylase ( DH ) .


Consequently , this randomized , placebo-controlled clinical trial of disulfiram during buprenorphine maintenance treatment evaluated the study hypothesis that disulfiram is superior to placebo and explored whether disulfiram response is greatest for participants with a single nucleotide polymorphism coding for genetically low DH ( T-allele carriers ) .


We randomized @ buprenorphine-treated opioid dependent participants with cocaine dependence or abuse to @ weeks of double-blind treatment with disulfiram @mg daily ( n = @ ) or placebo ( n = @ ) .


Of @ participants genotyped , @ were CC-homozygous , and @ CT or TT genotypes .


Primary outcomes included days per week cocaine use , number of cocaine-negative urine tests , and maximum consecutive weeks of cocaine abstinence .


We analyzed an intention-to-treat comparison between disulfiram and placebo .


We also explored potential pharmacogenetic interactions and examined treatment responses of four participant groups based on medication ( disulfiram or placebo ) by genotype ( CC-homozygous or T-allele carrier ) classification .


Disulfiram participants reported significantly less frequent cocaine use ; the differences in cocaine-negative urine tests or consecutive weeks abstinence were not significant .


Frequency of cocaine use was lowest in disulfiram-treated T-allele carriers ; differences in cocaine-negative urine tests or consecutive weeks abstinence were not significant among the four medication-genotype groups .


The findings provide limited support for the efficacy of disulfiram for reducing cocaine use and suggest that its mechanism of action may involve inhibition of DH .


Further studies of its efficacy , mechanism of action , and pharmacogenetics of response are warranted .


To quantitatively assess the predictive power of early variations of parotid gland volume and density on final changes at the end of therapy and , possibly , on acute xerostomia during IMRT for head-neck cancer .


Data of @ parotids ( @ patients ) were available .


Kinetics of the changes during treatment were described by the daily rate of density ( r ) and volume ( rvol ) variation based on weekly diagnostic kVCT images .


Correlation between early and final changes was investigated as well as the correlation with prospective toxicity data ( CTCAEv@ @ ) collected weekly during treatment for @/@ patients .


A higher r was observed during the first compared to last week of treatment ( -@,@ vs -@,@ HU , p-value = @ ) .


Based on early variations , a good estimation of the final changes may be obtained ( : AUC = @ , p = @ ; vol : AUC = @ , p = @ ) .


Both early r and rvol predict a higher `` mean '' acute xerostomia score ( median value , @ ; p-value = @ ) .


Median early density rate changes for patients with mean xerostomia score / < @ were -@ vs -@ HU/day respectively ( p = @ ) .


Early density and volume variations accurately predict final changes of parotid glands .


A higher longitudinally assessed score of acute xerostomia is well predicted by higher r and rvol in the first two weeks of treatment : best cut-off values were -@ HU/day and -@ mm ( @ ) / day for r and rvol respectively .


Further studies are necessary to definitively assess the potential of early density/volume changes in identifying more sensitive patients at higher risk of experiencing xerostomia .


Young adult smokers have the highest smoking prevalence among all US age groups but are least likely to use evidence-based cessation counseling or medication to quit .


Use and effectiveness of nicotine patch were explored in a randomized trial evaluating smoking cessation interventions with this population .


Smokers aged @ to @ ( n = @ ) were recruited through online and off-line methods and from telephone quit lines and analyzed .


Smokers were enrolled in a pretest-posttest trial , and randomized to @ of @ cessation services .


Trial delivering counseling services by self-help booklet , telephone quit lines , or online expert system in the @ continental United States .


Smokers could request a free @-week course of nicotine replacement therapy ( NRT ) patches from the project .


Follow-up surveys at @ and @ weeks assessed smoking abstinence , use of NRT , counseling , and other cessation medications , and smoking-related variables .


Overall , @ % of smokers reported using NRT ( M = @ weeks ) at @ weeks and @ % ( M = @ weeks ) at @ weeks .


More smokers who were sent the free nicotine patches ( n = @ ; @ % ) reported using NRT than those who did not receive them ( @ weeks : @ % vs @ % , P < @ ; @ weeks : @ % vs @ % , P < @ ) .


The use of NRT was associated with greater smoking abstinence at @ weeks ( P < @ ) and @ weeks ( P < @ ) , especially if used for more than @ weeks ( P < @ ) .


Smokers assigned to a self-help booklet or cessation Web site and heavier smokers were most likely to use NRT ( P < @ ) , whereas those reporting marijuana use and binge drinking used NRT less ( P < @ ) .


Many young adults were willing to try NRT , and it appeared to help them quit in the context of community-based cessation services .


Strategies should be developed to make NRT available to this age group and support them in using it to prevent lifelong smoking .


To determine the effect of povidone-iodine soaks on outcomes of hand infections after operative drainage .


We performed a single-center , prospective , randomized trial to evaluate @ consecutive hand infections .


Forty-nine patients received povidone-iodine soaks @ times daily , and @patients received only daily dressing changes .


Outcome measures were the number of operations , readmissions , reoperations for wound complications , and days spent in the hospital .


Patients treated with povidone soaks averaged @ operations , and patients treated with daily dressing changes averaged @ operations , a statistically insignificant difference .


The mean number of operations was also not different between groups for the dorsal hand or dorsal finger abscess subcategories .


No significant differences were found in length of stay , number of readmissions , or number of reoperations for wound complications .


Povidone-iodine soaks are not helpful in the postoperative management of hand infections


Therapeutic II .


It has previously been shown that a combination of inhaled nitric oxide ( iNO ) and intravenous ( IV ) steroid attenuates endotoxin-induced organ damage in a @-hour porcine endotoxemia model .


We aimed to further explore these effects in a @-hour model with attention to clinically important variables .


Randomized controlled trial .


University animal laboratory .


Domestic piglets ( n = @ ) .


Animals were randomized into @ groups ( n = @ each ) : @ ) Controls , @ ) LPS-only ( endotoxin/lipopolysaccharide ( LPS ) infusion ) , @ ) LPS + iNO , @ ) LPS + IV steroid , @ ) LPS + iNO + IV steroid .


Exposure to LPS temporarily increased pulmonary artery mean pressure and impeded renal function with elevated serum creatinine and acidosis compared to a control group over the @-hour study period .


Double treatment with both iNO and IV steroid tended to blunt the deterioration in renal function , although the only significant effect was on Base Excess ( p = @ ) .


None of the LPS + iNO + IV steroid treated animals died during the study period , whereas one animal died in each of the other LPS-infused groups .


This study suggests that combined early therapy with iNO and IV steroid is associated with partial protection of kidney function after @ hours of experimental LPS infusion .


To observe the clinical efficacy difference between segmentation scraping and conventional acupuncture for cervical spondylosis ( CS ) so as to provide effective treatment method .


Eighty-five cases of cervical type of CS were randomly divided into a scraping group ( @ cases ) and an acupuncture group ( @ cases ) .


The segmentation scraping therapy was used in the scraping group .


The scraping group was treated with focusing on scraping the head and joint part of neck and occiput in the upper cervical spine injury , and focusing on scraping the lower section of cervical and shoulder in the lower cervical spine injury , once every seven days , totally for @ times .


In the acupuncture group , Fengchi ( GB @ ) , Wangu ( TE @ ) , Tianzhu ( BL @ ) , Neck-Jiaji ( EX-B @ ) , etc. were selected , once daily , for @ days .


The visual analogue scale ( VAS ) was used to evaluate the immediate analgesic effect after the first treatment and the clinical efficacy was observed after the end of treatment .


After the first treatment , the score of VAS was decreased significantly in the scaping group ( P < @ ) , but there was no significant difference in the acupuncture group compared with those before treatment ( P > @ ) ; the score of VAS in the scaping group after the first treatment was lower than that in the acupuncture group ( @ + / - @ vs @ + / - @ , P < @ ) .


Compared with before treatment , the scores of VAS were decreased significantly after treatment in two groups ( both P < @ ) , but without significant difference between two groups ( P > @ ) ; the effective rate was @ % ( @/@ ) in the scaping group and @ % ( @/@ ) in the acupuncture group , the curative effects were similar ( P > @ ) .


Both of scraping and acupuncture therapies have good analgesic effect for cervical spondylosis , and overall effects are similar , but the immediate analgesic effect of scraping thrapy is better than that of conventional acupuncture .


Obesity is associated with poor outcomes in women with operable breast cancer .


Lifestyle interventions ( LIs ) that help women reduce their weight may improve outcomes .


We conducted a multicenter randomized trial comparing mail-based delivery of general health information alone or combined with a @-month standardized , telephone-based LI that included diet ( @ to @,@ kcal per day deficit ) and physical activity ( @ to @ minutes of moderate-intensity physical activity per week ) goals to achieve weight loss ( up to @ % ) .


Women receiving adjuvant letrozole for T@-@N@-@M@ breast cancer with a body mass index ( BMI ) @ kg/m ( @ ) were eligible .


Weight was measured in the clinic , and self-report physical activity , quality-of-life ( QOL ) , and diet questionnaires were completed .


The primary outcome was disease-free survival .


Accrual was terminated at @ of @,@ planned patients because of loss of funding .


Mean weight loss was significantly ( P < @ ) greater in the LI arm versus the comparison arm ( @ v @ kg or @ % v @ % at @ months and @ v @ kg or @ % v @ % at @ months ) and occurred consistently across strata ( BMI @ to < @ v @ kg/m ( @ ) ; prior v no prior adjuvant chemotherapy ) .


Weight loss was greatest in those with higher baseline levels of moderate-intensity physical activity or improvement in QOL .


Hospitalization rates and medical events were similar .


A telephone-based LI led to significant weight loss that was still evident at @ months , without adverse effects on QOL , hospitalizations , or medical events .


Adequately powered randomized trials with cancer end points are needed .


Eosinophilic esophagitis ( EoE ) is a chronic allergic disease with limited treatment options .


We evaluated QAX@ , an mAb against IL-@ , in the treatment of patients with EoE .


Patients ( @-@ years ) with proton pump inhibitor-resistant esophageal eosinophilia received intravenous QAX@ ( @ mg/kg ) or placebo ( @:@ ) at weeks @ , @ , and @ and were followed for @ months .


The primary end point was the responder rate for a greater than @ % decrease in peak eosinophil counts at week @ .


Efficacy was to be declared if the lower @ % confidence limit for the proportion of responders on QAX@ was @ % or greater .


Secondary end points included changes in esophageal eosinophil counts , symptoms assessed by questionnaire scores , and quantification of a series of biomarkers .


Twenty-three patients completed the study up to week @ , and @ continued to the end of the study .


For the proximal and distal esophageal biopsies combined , the responder rate was @ % ( @ % confidence limit , @ % to @ % ) with placebo , compared to @ % ( @ % confidence limit , @ % to @ % ) with QAX@ .


Although the primary end point was not met , the mean esophageal eosinophil count decreased by @ % with QAX@ versus an increase of @ % with placebo ( P = @ ) , and the decrease was sustained up to @ months .


There was a trend for improved symptoms , particularly dysphagia .


QAX@ improved expression of EoE-relevant esophageal transcripts , including eotaxin-@ , periostin , and markers of mast cells and barrier function , for up to @ months after treatment .


QAX@ was well tolerated .


QAX@ significantly improved intraepithelial esophageal eosinophil counts and dysregulated esophageal disease-related transcripts in adults with EoE in a sustained manner .


Gastro esophageal reflux ( GER ) is common in cystic fibrosis ( CF ) and may contribute to lung disease .


Approximately @ % of patients with cystic fibrosis are being treated with proton pump inhibitors ( PPIs ) .


In a randomized controlled study in adults , we compared treatment with esomeprazole @ mg twice daily versus placebo in patients with CF and frequent respiratory exacerbations over a thirty-six week treatment period to determine effect on time to first exacerbation and other health related outcomes .


@ patients without symptoms of GER were randomized and @ completed the study .


@ subjects underwent @ hour ambulatory pH probe monitoring ; @ % had pH probe evidence of GER .


Forty one percent of subjects had a pulmonary exacerbation during the study .


There was no significant difference in time to first pulmonary exacerbation ( log rank test p = @ ) .


Five of nine subjects in the esomeprazole group compared with @ of eight subjects in the placebo group experienced exacerbations ( esomeprazole vs. placebo : odds ratio = @ , @ % CI = ( @ , @ ) , Fisher 's exact test : p = @ ) .


There was no change in Forced Expiratory Volume in one second , Gastroesophageal Symptom Assessment Score or CF Quality of Life score between the two treatment groups .


There was a trend to earlier exacerbation and more frequent exacerbations in subjects randomized to esomeprazole compared with placebo .


The effect of proton pump inhibitors on pulmonary exacerbations in CF warrants further investigation .


The purpose of the current study was to determine whether increased physical activity ( PA ) altered glycemic control while ingesting an energy-balanced high-fructose diet .


Twenty-two normal-weight men and women ( age : @ years ; body mass index : @ @ kg/m ( @ ) ) participated in a randomized , cross-over design study in which they ingested an additional @ g of fructose for @ days while either maintaining low PA ( FR + inactive ) ( < @ steps/day ) or high PA ( FR + active ) ( > @,@ steps/day ) .


Before and following the @-week loading period , a fructose-rich meal challenge was administered and blood was sampled at baseline and for @ h after the meal and analyzed for glucagon-like peptide-@ ( GLP-@ ) , glucose-dependent insulinotropic peptide ( GIP ) , c-peptide , glucose and insulin concentrations .


Plasma insulin , glucose , c-peptide , GIP and GLP-@ concentrations significantly increased in response to the test meal on all test visits ( P < @ ) .


C-peptide incremental area under the curve ( AUC ) decreased by @,@ @ pmol/l min for @ h from pre to post Fr + active intervention ( P = @ ) leading to a decrease in plasma insulin total AUC ( pre : @,@ pmol/l ; post : @,@ pmol/l ; P = @ ) resulting in a decrease peak -LSB- Insulin -RSB- ( P = @ ) .


Following the FR + active intervention , GIP total AUC significantly decreased ( P = @ ) yet only males had a lower total GLP-@ AUC after both interventions ( P = @ ) .


There were no sex differences in GIP levels .


Increased PA attenuates the deleterious effects on glycemic control caused by a high-fructose diet .


These changes in glycemic control with PA are associated with decreases in insulin and GIP concentrations .


To evaluate the effectiveness of different brief intervention strategies at reducing hazardous or harmful drinking in the probation setting .


Offender managers were randomized to three interventions , each of which built on the previous one : feedback on screening outcome and a client information leaflet control group , @ min of structured brief advice and @ min of brief lifestyle counselling .


A pragmatic multicentre factorial cluster randomized controlled trial .


The primary outcome was self-reported hazardous or harmful drinking status measured by Alcohol Use Disorders Identification Test ( AUDIT ) at @ months ( negative status was a score of < @ ) .


Secondary outcomes were AUDIT status at @ months , experience of alcohol-related problems , health utility , service utilization , readiness to change and reduction in conviction rates .


Follow-up rates were @ % at @ months and @ % at @ months .


At both time points , there was no significant advantage of more intensive interventions compared with the control group in terms of AUDIT status .


Those in the brief advice and brief lifestyle counselling intervention groups were statistically significantly less likely to reoffend ( @ and @ % , respectively ) than those in the client information leaflet group ( @ % ) in the year following intervention .


Brief advice or brief lifestyle counselling provided no additional benefit in reducing hazardous or harmful drinking compared with feedback on screening outcome and a client information leaflet .


The impact of more intensive brief intervention on reoffending warrants further research .


The association of dairy food consumption with the risk for developing cardiovascular disease ( CVD ) has been investigated in many studies , but results often have been contradictory .


The aim of the present study was to determine whether genetic polymorphisms are associated with interindividual variation in the response of CVD risk biomarker values after milk consumption .


Fourteen single nucleotide polymorphisms ( SNPs ) in nine genes related to lipid metabolism were examined in @ volunteers randomly allocated to consume either @ mL/d of skimmed ( S ) or semi-skimmed ( SS ) milk for @ year in addition to their usual diets .


Total cholesterol/high-density lipoprotein cholesterol ( TC/HDL-C ) and low-density lipoprotein/HDL-C ratios were used as biomarkers of CVD risk .


Three-way repeated-measures analysis of variance was used to examine the effect of time , treatment ( S or SS ) , and genotype on these biomarkers .


A TT genotype for the proliferator-activated receptor alpha polymorphism ( PPARA rs@ SNP ) was significantly associated with a reduction in the TC/HDL and LDL/HDL ratios after @ mo of S milk intake ( mean reduction -@ , @ % confidence interval -LSB- CI -RSB- , -@ to @ ; P = @ and -@ , @ % CI , -@ to -@ ; P = @ , respectively ) .


However , no differences were observed after consuming either S or SS milk in the C allele carriers .


Saturated fatty acid consumption has long been linked to an increased risk for CVD ; indeed , the consumption of saturated fat-free products is recommended as a means of reducing this risk .


However , the present results suggest that many individuals might not benefit from such general recommendations .


Genetic analysis of PPARA rs@ might help identify those individuals who are more likely to benefit from reducing the saturated fatty acid content of their diet .


A significant waning of enterovirus @ ( EV@ ) antibody titer after priming immunization with an inactivated EV@ vaccine implied the potential need for a booster dose .


In this randomized , double-blind , placebo-controlled clinical trial , we recruited participants who had received at least @ dose of priming EV@ vaccine in an early phase @ clinical trial that was conducted in healthy infants and children aged @-@ months .


All participants were grouped according to the priming EV@ vaccine formulations ( @U , @U , and @U with adjuvant and @ U without adjuvant ) and then randomly assigned ( ratio , @:@ ) to receive a booster dose of vaccine or placebo within each formulation group .


The primary end point was the geometric mean titer @ days after the booster dose .


A total of @ participants were enrolled .


Significantly greater immunological responses were induced by the booster shot of all @ formulations of EV@ vaccine , compared with that induced by placebo ( P < @ ) .


The frequencies of adverse reactions were similar between vaccine and placebo groups within each formulation group .


A booster dose of EV@ vaccine @ year after the priming EV@ immunization shows excellent immunogenicity and good safety profile .


Clinical Trials Registration : NCT@ .


The aim of the study was to estimate the cost-effectiveness of a weight management programme including elements of physical exercise and dietary restriction which are designed to help women lose excess weight gained during pregnancy in the vulnerable postnatal period and inhibit the development of behaviours which could lead to future excess weight gain and obesity .


A mathematical model based on a regression equation predicting change in weight over a fifteen year postnatal period was developed .


The model included programme effectiveness and resource data based on a randomized controlled trial of a weight management programme implemented in a postnatal population in the United States .


Utility and mortality data based on body mass index categories were also included .


The model adopted a National Health Service ( NHS ) and personal social services ( PSS ) perspective , a lifetime time horizon and estimated the cost effectiveness of a weight management programme against a no change comparator in terms of an incremental cost-effectiveness ratio ( ICER ) .


The baseline results show that the difference in weight between women who received the weight management programme and women who received the control intervention was @ kg at six months and @ kg at fifteen years following childbirth .


This results in an ICER of @ per quality adjusted life year ( QALY ) for women who were married at childbirth .


The estimated ICER would suggest that such a weight management programme is cost-effective at a NICE threshold of @,@ per QALY .


However significant structural and evidence based uncertainty is present in the analysis .


Postnatal mental health problems , which are an international public health priority , are a suitable target for preventive approaches .


The financial burden of these disorders is borne across sectors in society , including health , early childhood , education , justice and the workforce .


This paper describes the planned economic evaluation of What Were We Thinking , a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers .


The evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness .


Cost-effectiveness and costs-utility analyses will be conducted , resulting in estimates of cost per percentage point reduction in combined @-day prevalence of depression , anxiety and adjustment disorders and cost per quality-adjusted life year gained .


Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves .


Additional cost analyses relevant for implementation will also be conducted .


Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial .


To examine the effects of `` Rusie Dutton '' on health and quality of life in menopausal women .


Menopausal women ( aged @-@ ) were recruited and randomly allocated to @ groups .


Rusie Dutton group ( n = @ ) practiced Rusie Dutton conducted by Wat Pho Thai Traditional Massage School for @ weeks .


The control group ( n = @ ) was assigned to a waiting list and received no intervention .


BW , BMI , restingHR , BP , flexibility , VO@max , and MENQOL including vasomotor , physical , psychosocial and sexual domains were measured at the beginning and the end .


A paired-sample t-test and independent sample t-test were used for statistical analysis .


Significant improvement was found in all variables within group ( p < @ ) in Rusie Dutton group , and a significant difference between groups was found ( p < @ ) in all variables except BW and BMI .


Therefore , it is concluded that the traditional Thai exercise Rusie Dutton can promote health related physical fitness and QOL in menopausal women .


To compare cefazolin concentrations in biopsied tissue samples collected from surgically created wounds treated with negative pressure wound therapy to those collected from surgically created wounds treated with nonadherent dressings .


Prospective , controlled , experimental study .


Adult female spayed Beagles ( n = @ ) .


Full thickness cutaneous wounds were created on each antebrachium ( n = @ ) .


Immediately after surgery , cefazolin ( @mg/kg intravenously -LSB- IV -RSB- ) was administered to each dog and continued every @hours during the study .


The right wound was randomly assigned to group I or group II whereas the wound on the contralateral antebrachium was assigned to the other group .


Group I wounds were treated with negative pressure wound therapy ( NPWT ) and group II wounds were treated with nonadherent dressings for @ days .


Dressings were changed and tissue biopsies obtained from wound beds at @hours intervals for both groups .


Cefazolin wound tissue and plasma concentrations were measured by liquid chromatography mass spectrometry ( LC-MS/MS ) .


Blood samples for measuring plasma cefazolin concentrations were collected before biopsy sampling .