We estimated the multivariable adjusted HR of prostate cancer ( 574 cases in 62,192 person-years ) for statin drug use and duration of use during the trial using Cox proportional hazards regression .


During 7 years of followup statin drug use during the trial was not associated with the risk of total prostate cancer ( HR 1.03 , 95 % CI 0.82-1 .30 ) , or lower grade ( HR 0.96 , 95 % CI 0.71-1 .29 ) or higher grade ( HR 1.27 , 95 % CI 0.85-1 .90 ) prostate cancer .


Duration of use during followup was also not associated with the risk of total , or lower or higher grade disease ( p trend = 0.7 , 0.5 and 0.2 , respectively ) .


These prospective results do not support the hypothesis that statin drugs protect against prostate cancer in the setting of regular prostate cancer screening .


Use of sedative agents for difficult to manage children during dental procedures has been indicated for years , but neither the agent nor the route has been found to be ideal .


The aim of the study was to evaluate and compare the efficacy and safety of oral dexmedetomidine ( D ) and ketamine ( K ) in producing moderate sedation among uncooperative pediatric dental patients .


This prospective , triple-blind , randomized comparative study included 112 ASA grade I children of both sexes aged 3-10years , who satisfied all the inclusion criteria .


They were randomly divided into four groups and ketamine 8mgkg ( -1 ) ( K ) or dexmedetomidine 3gkg ( -1 ) ( D1 ) , 4gkg ( -1 ) ( D2 ) and 5gkg ( -1 ) ( D3 ) were given orally .


Similar dental procedures were performed in these patients , and effects of these drugs were assessed in terms of changes in vital signs , onset and duration of sedation , analgesia , and amnesia .


Secondary outcomes such as level of sedation , behavior , adverse effects , and overall success were also measured .


The onset of sedation was significantly rapid with K and D3 as compared to D1 and D2 .


Recovery from sedation was fastest in group D1 .


Intra - and postoperative analgesia and anterograde amnesia were highest with K and least with D1 , while D3 produced analgesia comparable to K.


In K treated group , vomiting was observed in five patients and two patients exhibited emergence phenomenon .


Overall , highest success rate was observed in D3 group .


Given by oral route , the novel sedative dexmedetomidine provides dose-dependent effective analgo-sedation , comparable to ketamine , with less adverse effects .


This study compared effectiveness of an enhanced versus standard implementation strategy ( Replicating Effective Programs [ REP ] ) on site-level uptake of Re-Engage , a national program for veterans with serious mental illness .


Mental health providers at 158 Veterans Affairs ( VA ) facilities were given REP-based manuals and training in Re-Engage , which involved identifying veterans who had not been seen in VA care for at least one year , documenting their clinical status , and coordinating further health care .


After six months , facilities not responding to REP ( N = 88 ) were randomized to receive six months of facilitation ( enhanced REP ) or continued standard REP. Site-level uptake was defined as percentage of patients ( N = 1,531 ) with updated documentation or with whom contact was attempted .


Rate of Re-Engage uptake was greater for enhanced REP sites compared with standard REP sites ( 41 % versus 31 % , p = .01 ) .


Total REP facilitation time was 7.3 hours per site for six months .


Added facilitation improved short-term uptake of a national mental health program .


Despite evidence that outcomes are highly valued when they are expected sooner rather than further into the future ( Ainslie , 1975 ) , limited research effort has been devoted to understanding the role of exercise outcome proximity .


The purpose of this study was to examine how temporal proximity to positive outcomes influences exercisers ' intrinsic motivation .


We expected that focusing people on temporally proximal exercise outcomes would increase intrinsic motivation , especially among low-frequency exercisers .


This online experimental study was completed by 135 community exercisers ( Mage = 31.11 , SD = 10.29 ; 62 % female ) who reported an average of 4.86 exercise bouts per week ( SD = 2.12 ) .


Participants were randomly assigned to a condition that primed temporally proximal positive exercise outcomes ( i.e. experienced during or directly following an exercise bout ) or temporally distal outcomes ( i.e. experienced after days , months , or years of regular exercise ) .


Participants then reported perceptions of behavioral regulation in exercise .


As expected , the proximal exercise outcome condition elicited increased intrinsic regulation among those participants who exercised less frequently ( i.e. 1 SD below the mean ) .


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 , 175 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 = 20 % , plus cognitive remediation = 49 % , p < .005 ) , whereas participants with higher functioning showed equivalent rates of employment ( 62 % versus 54 % , 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 15 centres in India .


Subjects , aged 18 to 70 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 > 3 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 ( < 8 mild , > or = 8 severe ) .


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


Eligible subjects were randomized to receive intravenous infusion of 200,000 IU ulinastatin or placebo in 100 mL of 0.9 % saline given over one hour every 12 hours for 5 days .


Of 135 randomized subjects , 129 completed the study ( mild 62 , severe 67 ) .


Pancreatitis was due to alcohol intake in a majority ( 81 % ) of subjects .


Baseline characteristics were similar between the ulinastatin and placebo groups .


Efficacy was evaluated in subjects who had received at least 3 days ( 6 doses ) of ulinastatin/placebo .


One subject with severe pancreatitis in the ulinastatin group versus six in the placebo group died ( p = 0.048 ) .


New organ dysfunction developed in 5 ulinastatin vs 4 placebo group subjects ( p = 0.744 ) with mild pancreatitis and 12 ulinastatin vs 29 placebo group subjects ( p = 0.0026 ) with severe pancreatitis .


Adverse events were significantly lower in subjects with severe pancreatitis in the ulinastatin group as compared to the placebo group ( p = 0.00001 ) .


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 5 patients were measured as 0.23 , 1.18 , 0.91 , 0.95 , 0.97 , 0.24 , and 0.20 Gy for the thyroid , lung , stomach , liver , small intestine , prostate ( or ovary ) , and rectum , respectively .


From the OED measurements , LAR incidence were calculated as 83 , 46 , 22 , 30 , 2 and 6 per 10 ( 4 ) 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 > 0.05 ) was found among the treatment groups on overall feed intake , egg weight , egg mass and feed conversion efficiency .


COM456 had a significant reduction ( P < 0.05 ) in faecal pH compared to the other groups at 28 weeks of age onwards .


COM456 had significant higher ( P < 0.05 ) level of lactic acid bacteria counts from 30 weeks of age onwards , followed by COM246 and COM345 at 32 and 34 weeks of age , respectively .


Significant reduction of faecal Enterobacteriaceae ( P < 0.05 ) were observed in COM246 and COM456 from 30 weeks of age onwards .


The lowest levels ( P < 0.05 ) of plasma and egg yolk cholesterol were observed in COM456 , followed by COM345 and COM246 .


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


Significant higher ( P < 0.05 ) content of C18 :3 , C20 :2 and C22 :6 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 , COM456 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 , 818 children aged 8 to 12 years were randomly selected from population-based registers ; 594 ( 73 % ) were followed up at the age of 13 to 17 years ( 344 males , 250 females ; median age 10 y 4 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 63 % for fine motor function to 98 % for hearing .


For gross motor function , communication , and cognitive level , the kappa and the lower bound of its 95 % confidence interval ( CI ) were above 0.75 , indicating stability between childhood and adolescence ; for fine motor function and feeding , the kappa was above 0.75 but the lower bound of the 95 % CI was below 0.75 , indicating probable stability ; for seizures and vision , the kappa was below 0.75 , although the upper bound of the 95 % CI was above 0.75 , indicating possible change ; for hearing the kappa and its entire CI were below 0.75 , indicating change .


Overall , 81 % of participants had no seizures in childhood , of whom 93 % 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 44 patients were achieved : 21 of PVP , 23 of PRP .


There were significant differences between two groups in operative bleeding , bladder irrigation time , indwelling catheter time and hospital stay ( P < 0.002 ) .


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 = 0.12 ) .


No significant differences were found 3 months postoperatively between two groups in all the data associated with urination ( IPSS , Qmax , PVR , QOL ) , P > 0.05 .


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 136 older adults completed two consecutive trials each of 3-m and 6-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 6-m course and the second trial of each course .


There was high concordance between the first and second trials for both the 3-m and 6-m courses .


The 3 - and 6-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 5 mm of residual crestal bone height and/or less than 3 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 ( 20 patients ; AB group ) from the mandibular ramus or the iliac crest , or with onlays blocks of spongious bone of equine origin ( 20 patients ; XB group ) .


Two centres treated 20 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 4 months and the xenografts for 7 months before placing implants , which were submerged .


After 4 months , either bar-retained overdentures or provisional reinforced acrylic prostheses were delivered .


Provisional prostheses were replaced , after 4 months , by definitive fixed prostheses .


Outcome measures were : prosthesis and implant failures ; complications ; patient satisfaction ; pain recorded 3 and 10 days post-augmentation ; number of days of hospitalisation , total and partial infirmity days .


All patients were followed for 4 months after loading .


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


Twenty-eight patients were augmented in the maxilla ( 15 with AB and 13 with XB ) and 12 in the mandible ( 5 with AB and 7 with XB ) .


No AB graft failed totally versus 10 XB grafts ( difference = 0.5 ; 95 % CI 0.23 to 0.68 ; P = 0.0004 ) .


In particular , all 7 XB mandibular grafts and 5 out of 6 XB blocks ( 3 in mandibles and 2 in maxillas ) , which were previously modelled on lithographic models of the jaws failed .


One implant failed in one AB patient versus 11 implants in 4 XB patients ( P = 0.3416 ) .


All but 1 prostheses were loaded in time in the AB patients , versus 4 prostheses which were loaded with delays in XB patients because of graft and implant failures ( P = 0.3416 ) .


Four complications occurred in 4 AB patients versus 15 complications in 12 XB patients ( difference = 0.4 ; 95 % CI 0.09 to 0.63 ; P = 0.0225 ) .


Fourteen AB patients reported moderate pain 3 days postoperatively versus 6 XB patients ( P = 0.0562 ) ; at 10 days , 10 AB patients reported moderate pain versus 1 XB patient ( difference = -0.45 ; 95 % CI -0.65 to -0.17 ; P = 0.0033 ) .


The 14 patients harvested from the iliac crest were hospitalised for an average of 3.1 nights , whereas 7 patients treated with XB were hospitalised on average for 1.4 nights ( P < 0.0001 ) .


The number of total and partial infirmity days was 126 for theAB group and 43 for the XB group , and 220 for the AB group and 93 for the XB group , respectively ( mean day difference = -4.15 ; 95 % CI -7.35 to -0.95 ; P = 0.0134 and mean day difference = -5.7 ; 95 % CI -10.01 to -1.39 ; P = 0.0116 , respectively ) .


Seventeen AB patients versus 19 XB patients were fully satisfied with function of their prostheses ( P = 0.6050 ) , 18 AB patients versus 12 XB patients were fully satisfied with aesthetics of their prostheses ( P = 0.0648 ) , and 5 and 3 patients , respectively would not undergo the same procedure again ( P = 0.6948 ) .


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 .


102 unresectable or metastatic BTC patients with histologically proven adenocarcinoma of gallbladder or intrahepatic bile ducts , Eastern Cooperative Oncology Group ( ECOG ) 0-2 were randomised to gemcitabine ( 1000 mg/m2 once weekly , first 7-weeks +1 - week rest followed by once 3-weeks +1 - week rest ) plus sorafenib ( 400 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 2 ( VEGFR-2 ) and stromal cell-derived factor 1 ( SDF1 ) 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 ( 3.0 versus 4.9 months , P = 0.859 ) , and no difference for median overall survival ( OS ) ( 8.4 versus 11.2 months , P = 0.775 ) .


Patients with liver metastasis after resection of primary BTC survived longer with sorafenib ( P = 0.019 ) compared to placebo .


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


Two sorafenib targets , VEGFR-2 and c-kit , were not expressed in BTC samples .


VEGFR-3 and Hif1 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 ( 45 male and 15 female ) were included in the study .


The mean age was 42 years for men and 40 years for women .


They were placed in group A and B ( 30 cases each ) .


Group A received local steroid injection ( triamcinolone 20 mg mixed with lignocaine 2 % 1 cc ) and topical NSAID cream application ( diclofenac diethylammonium ) twice a day , tab .


diclofenac sodium 50 mg twice a day for 3 weeks .


Group B received tab diclofenac 50 mg twice a day and , topical NSAID cream application twice a day for 3 weeks .


Assessment of patients was made 3 times ; first at the start of the study , 2nd time after 6 weeks , and 3rd time after 12 weeks .


A blinded assessor rated the elbow complaints of the patients at resisted dorsiflexion of wrist using VAS ( 0 = no severity , 1-3 mild , 4-6 moderate , 7-9 sever , 10 = maximum severity ) .


At six weeks , 22 ( 73.33 % ) patient in group A had no pain as compared to 7 ( 23.33 % ) patients in group B who were pain free ( p < 0.0001 , chi2 = 38.75 ) .


At 12 weeks 27 ( 90 % ) patients in group A were pain free compared to group B in which 7 ( 23.33 % ) patients were pain free ( p < 0.0001 , chi2 = 27.56 ) .


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 .


52 cancer patients were randomized to a control group ( n = 26 ) , an experimental group ( n = 26 ) whose members received 30 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 ( 0.003 ) and mood level ( 0.001 ) .


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 5 days before surgery or 2 applications of povidone-iodine solution into each nostril within 2 hours of surgical incision .


The primary study end point was deep SSI within the 3 months after surgery .


In the modified intent-to-treat analysis , a deep SSI developed after 14 of 855 surgical procedures in the mupirocin group and 6 of 842 surgical procedures in the povidone-iodine group ( P = .1 ) ; S. aureus deep SSI developed after 5 surgical procedures in the mupirocin group and 1 surgical procedure in the povidone-iodine group ( P = .2 ) .


In the per protocol analysis , S. aureus deep SSI developed in 5 of 763 surgical procedures in the mupirocin group and 0 of 776 surgical procedures in the povidone-iodine group ( P = .03 ) .


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


ClinicalTrials.gov identifier : NCT01313182 .


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 6 months , multiple outcome measures were examined .


The purpose of the current study is to examine the major efficacy parameters at 5 years .


Twenty of the original 30 patients were available for follow-up 5 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 6 months and 5 years were compared with original baseline values .


At 5 years , all quantitative parameters for both treatment protocols showed statistically significant improvements over baseline .


The primary outcome parameter , change in recession depth at 5 years , demonstrated statistically significant improvements in recession over baseline , although intergroup comparisons favored the control group at both 6 months and 5 years .


At 5 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 100 % root coverage and changes to CAL .


In the present 5-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 2 diabetic ( T2D ) subjects and whether vitamin D receptor ( VDR ) - FokI polymorphisms could modulate the response to vitamin D3 intake .


Subjects with T2D were allocated to one of the two groups to receive either plain doogh ( PD ; containing 150mg calcium and no vitamin D/250ml , n1 = 50 ) or vitamin D3-fortified doogh ( FD ; containing 500IU/250ml , n1 = 50 ) twice a day for 12 weeks .


Outcomes were changes in serum 25-hydroxyvitamin D ( 25 ( OH ) D ) , superoxide dismutase , glutathione ( GSH ) , total antioxidant capacity ( TAC ) and malondialdehyde ( MDA ) .


VDR genotypes in 140 T2D subjects in FD were determined by FokI restriction enzyme .


After 12 weeks , serum 25 ( OH ) D increased significantly in FD ( from 38.5202.2 to 72.023.5 , P < 0.001 ) as compared with PD ( from 38.822.8 to 33.422.8 , P = 0.28 ) .


Comparisons between FD and PD revealed significant differences in changes of serum MDA ( -0.540.82 mol/l vs. +0.171 mol/l , P < 0.001 ) , GSH ( +8.440.1 ng/l vs -13.129.4 ng/l , P = 0.002 ) and TAC ( +0.140.43 mmol/l vs. +0.020.45 mmol/l bovine serum albumin equivalent , P = 0.03 ) .


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 T2D 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 4 to 6 years were randomized to a multimodal distraction method during administration of routine vaccines with PP and 1 medical assistant ( experimental group ) or 2 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 , 76 children participated .


Despite group randomization , more children in the medical assistant-only group received a 3-injection series ( 25 ; 68 % ) than in the PP group ( 6 [ 15 % ] , P = .001 ) .


After adjustment for this imbalance , child-reported pain was higher in the PP group compared with the medical assistant-only group ( 2.95 vs 1.75 ; F = 5.87 ; df = 1.66 ; d = 0.64 ; P < .02 ) .


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-0332991 ) is an oral , small-molecule inhibitor of cyclin-dependent kinases ( CDKs ) 4 and 6 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 , HER2-negative breast cancer .


In this open-label , randomised phase 2 study , postmenopausal women with advanced oestrogen receptor-positive and HER2-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 1 , patients were enrolled on the basis of their oestrogen receptor-positive and HER2-negative biomarker status alone , whereas in cohort 2 they were also required to have cancers with amplification of cyclin D1 ( CCND1 ) , loss of p16 ( INK4A or CDKN2A ) , or both .


In both cohorts , patients were randomly assigned 1:1 via an interactive web-based randomisation system , stratified by disease site and disease-free interval , to receive continuous oral letrozole 2.5 mg daily or continuous oral letrozole 2.5 mg daily plus oral palbociclib 125 mg , given once daily for 3 weeks followed by 1 week off over 28-day cycles .


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


Accrual to cohort 2 was stopped after an unplanned interim analysis of cohort 1 and the statistical analysis plan for the primary endpoint was amended to a combined analysis of cohorts 1 and 2 ( instead of cohort 2 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 NCT00721409 .


Between Dec 22 , 2009 , and May 12 , 2012 , we randomly assigned 165 patients , 84 to palbociclib plus letrozole and 81 to letrozole alone .


At the time of the final analysis for progression-free survival ( median follow-up 29.6 months [ 95 % CI 27.9-36 .0 ] for the palbociclib plus letrozole group and 27.9 months [ 25.5-31 .1 ] for the letrozole group ) , 41 progression-free survival events had occurred in the palbociclib plus letrozole group and 59 in the letrozole group .


Median progression-free survival was 10.2 months ( 95 % CI 5.7-12 .6 ) for the letrozole group and 20.2 months ( 13.8-27 .5 ) for the palbociclib plus letrozole group ( HR 0.488 , 95 % CI 0.319-0 .748 ; one-sided p = 0.0004 ) .


In cohort 1 ( n = 66 ) , median progression-free survival was 5.7 months ( 2.6-10 .5 ) for the letrozole group and 26.1 months ( 11.2-not estimable ) for the palbociclib plus letrozole group ( HR 0.299 , 0.156-0 .572 ; one-sided p < 0.0001 ) ; in cohort 2 ( n = 99 ) , median progression-free survival was 11.1 months ( 7.1-16 .4 ) for the letrozole group and 18.1 months ( 13.1-27 .5 ) for the palbociclib plus letrozole group ( HR 0.508 , 0.303-0 .853 ; one-sided p = 0.0046 ) .


Grade 3-4 neutropenia was reported in 45 ( 54 % ) of 83 patients in the palbociclib plus letrozole group versus one ( 1 % ) of 77 patients in the letrozole group , leucopenia in 16 ( 19 % ) versus none , and fatigue in four ( 4 % ) versus one ( 1 % ) .


Serious adverse events that occurred in more than one patient in the palbociclib plus letrozole group were pulmonary embolism ( three [ 4 % ] patients ) , back pain ( two [ 2 % ] ) , and diarrhoea ( two [ 2 % ] ) .


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


11 ( 13 % ) patients in the palbociclib plus letrozole group and two ( 2 % ) in the letrozole group discontinued the study because of adverse events .


The addition of palbociclib to letrozole in this phase 2 study significantly improved progression-free survival in women with advanced oestrogen receptor-positive and HER2-negative breast cancer .


A phase 3 trial is currently underway .


Pfizer .


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 , 176 patients with rectal cancer after preoperative , short-term radiotherapy ( 5 5 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 171 patients were analyzed ; 86 were in the study group and 85 in the control group .


There were no statistically significant differences in the overall rate of early postoperative complications between the study and control group : 25.6 and 34.1 % respectively ; p = 0.245 , relative risk ( RR ) 0.750 [ 95 % confidence interval ( CI ) 0.471-1 .195 ] .


The reoperation rate was similar in both groups : 12.8 versus 9.4 % ; p = 0.628 ; RR 1.359 ; ( 95 % CI 0.575-3 .212 ) .


The total rate of SSI and organ space SSI were 22.2 and 15.8 % 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 : 2.6 versus 13.0 % ; p = 0.018 .


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 2 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 6 months to 9 months .


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


A total of 686 patients ( polymer-free sirolimus-eluting stents , n = 345 vs polymer-based paclitaxel-eluting stents , n = 341 ) and 751 lesions ( polymer-free sirolimus-eluting stents , n = 383 vs polymer-based paclitaxel-eluting stents , n = 368 ) were included in the study .


Control angiography ( 606lesions , 80.6 % ) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents ( 0.53 [ 0.59 ] mm vs 0.46 [ 0.57 ] mm ; P = .15 ) .


Median follow-up was 34.8 months .


Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction ( relative risk = 1.17 ; 95 % confidence interval , 0.49-2 .80 ; P = .71 ) , cardiac death or myocardial infarction ( relative risk = 1.17 ; 95 % confidence interval , 0.72-1 .89 ; P = .50 ) , target lesion revascularization ( relative risk = 0.98 ; 95 % confidence interval , 0.65-1 .47 ; P = .93 ) , and myocardial infarction ( relative risk = 1.79 ; 95 % confidence interval , 0.85-3 .76 ; P = .12 ) .


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 10-cm visual analog scale .


The pain scores among the 2 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 ( 3.1 and 2.9 , respectively ) , which was not significantly different between groups ( p = .80 ) .


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 ( 1 ) self-assessment without tailored feedback , ( 2 ) self-assessment with tailored feedback , and ( 3 ) generic information only .


A qualitative study explored participants ' engagement with each version of the intervention ( N = 24 ) .


A larger quantitative study systematically compared participants ' use of the intervention and self-reported engagement using a partial factorial design ( n = 178 ) .


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 12-week exercise intervention ( n = 84 ) or a comparison health and wellness intervention ( n = 87 ) .


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 ( -0.09 mg/dL , 95 % CI : -0.25 , 0.07 ) from pre - to post-intervention in the exercise arm ( p = 0.14 ) and increased ( 0.08 mg/dL , 95 % CI : -0.07 , 0.24 ) ( p = 0.64 ) in the health and wellness arm ; however the between group difference was not statistically significant ( p = 0.14 ) .


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 ( 0.09 mg/dL , 95 % CI : -0.14 , 0.33 ) , whereas women who maintained or increased their sports / exercise experienced a mean decrease in CRP ( -0.08 mg/dL , 95 % CI : -0.23 , 0.08 ) ( p = 0.046 ) .


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 .


ClinicalTrials.gov : NCT00728377 .


Registered 2 August 2008 .


Mixed venous and arterial ulcers account for approximately 15 % -30 % 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 20 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 18 females and ten males ( median age : 68.7 years ) treated with standard treatment ( compression therapy and surgery ) + SDX ( 600 lipoprotein lipase-releasing units/day intramuscularly ) for 15 days followed by SDX 250 lipase-releasing units every 12 hours day orally for 6 months as adjunctive treatment .


Group B ( control group ) comprised 17 females and eight males ( median age : 64.2 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 ( As2 O3 ) 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 = 61 ) and group B ( n = 64 ) .


All patients received transarterial chemoembolization .


Group A patients were given As2 O3 at 10 mg/d for 4 courses ( 21 days per course ) with a 2-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 , 81.96 % [ 95 % confidence interval ( CI ) , 72.32 % -91.62 % ] vs 59.37 % [ 95 % CI , 47.34 % -71.41 % ] , ( 2 ) = 7.650 , P < .05 ; CBR , 95.08 % [ 95 % CI , 89.66 % -100.00 % ] vs 81.25 % [ 95 % CI , 71.69 % -90.81 % ] , ( 2 ) = 5.659 , P < .05 ) .


There were fewer patients with extrahepatic metastases in group A versus group B ( group A , 6 cases or 9.84 % [ 95 % CI , 2.36 % -17.31 % ] ; group B , 12 cases or 18.75 % [ 95 % CI , 9.19 % -28.31 % ] ) .


The survival rate for group A patients was significantly higher than that for group B patients ( P < .05 ) .


No significant differences were found between the 2 groups in terms of hematology or digestive system , liver , or kidney dysfunction except for facial and limb edema .


LRT combined with As2 O3 treatment prevents extrahepatic metastasis and prolongs the survival time for primary HCC patients .


St John 's wort ( SJW ; Hypericum perforatum ) induces CYP3A4 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 1-14 , SJW plus boceprevir ( SJW on days 22-35 and together on days 31-35 ) and boceprevir on days 52-56 , separated by 7 day washout periods , or the same treatment in the opposite order .


Pharmacokinetic sampling was performed at the end of each phase .


Seventeen ( 11 female ) subjects completed the study and no serious adverse events were reported .


Geometric mean ratios ( GMRs ) and 90 % CIs for boceprevir ( with SJW versus alone ) AUC ( 0-8 ) , C ( max ) and C8 were 0.91 ( 0.87-0 .96 ) , 0.94 ( 0.82-1 .07 ) and 1.00 ( 0.79-1 .27 ) , respectively .


GMRs and 90 % CIs for hypericin , the active component of SJW , ( with boceprevir versus alone ) AUC ( 0-8 ) , C ( max ) and C ( 8 ) were 1.23 ( 1.10-1 .38 ) , 1.32 ( 1.16-1 .52 ) and 1.37 ( 1.19-1 .58 ) , 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 : ( 1 ) success rate of recruitment and quality of the study population ; ( 2 ) the quality of execution of the complex intervention ; and ( 3 ) 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 .


The study has been registered at the Netherlands National Trial Register : NTR1802 , registration date 6 May 2009 .


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 30 days .


Then , ten patients ( aged 75 years ) had to be consecutively enrolled collecting clinical data at hospital admission , discharge , and 3 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 ( 90 % ) 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 > 3 points on a scale of 5 points : 0 = useless ; 5 = 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 2015 .


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 8-week randomised , double-blind , parallel-group trial , patients were randomized to receive either extrafine BDP/FF NEXThaler ( ) 100/6g bid , extrafine BDP/FF 100/6g pMDI bid or non-extrafine BDP DPI 100g bid .


The primary efficacy variable was change from baseline to the entire 8-week randomised treatment period in average pre-dose morning PEF .


The ITT population comprised 754 patients .


Extrafine BDP/FF NEXThaler ( ) was non-inferior ( pre-defined margin : -15 L/min ) relative to extrafine BDP/FF pMDI ( mean difference : -1.84 ; 95 % CI : -6.73 , 3.05 ) 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 1 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 30-day mortality , 30-day mortality or HF hospitalization , and 180-day mortality .


We also assessed whether there was a differential association between early ( days 1-3 ) vs late ( day 4 ) WHF and outcomes .


Of 7,141 patients with acute HF , 354 ( 5 % ) 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 30-day mortality ( odds ratio 13.37 , 95 % CI 9.85-18 .14 ) , 30-day mortality or HF rehospitalization ( odds ratio 6.78 , 95 % CI 5.25-8 .76 ) , and 180-day mortality ( hazard ratio 3.90 , 95 % CI 3.14-4 .86 ) ( all P values < .0001 ) .


There was no evidence of a difference in outcomes between early and late WHF ( all P values for comparison .2 ) .


Worsening HF during index hospitalization was associated with worse 30 - and 180-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 10 % 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 = 18 ) who completed an 8-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 = 9 ) 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 2 equal parallel groups-alternate day therapy group ( group 1 ) and daily therapy group ( group 2 ) .


Patients in groups 1 and 2 received fixed dose combination of atorvastatin 10 mg and fenofibrate 160 mg on alternate days and daily , respectively , for 12 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 110 patients randomized , 99 completed the study till 12 weeks treatment duration .


The TGLs , non-HDL-C , TC , and LDL-C decreased by 56.4 % , 49.7 % , 36.5 % , and 39.2 % , respectively , in alternate day therapy group and by 57.5 % , 51.2 % , 37.5 % , and 39.4 % , respectively , in daily therapy group .


The HDL-C levels increased by 20.1 % in alternate day therapy group compared to 21.8 % 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 12 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 60 years ( 61-79years ) .


Twelve weeks of intervention with chair stand exercise , 3 sessions/week versus the control exercise ( stretch , 1 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 , 6-minute walking distance , maximum duration of chair stand exercise , health-related quality of life , cognitive function serum albumin , and hemoglobin .


Among the 27 patients who were randomized , 17 completed the study .


The change in FIM from baseline was greater in the intervention group ( 1 [ 1-3 ] vs. 0 [ 0-0 ] , median ( minimum to maximum ) , P < .001 ) 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 36-Item Short-Form Health Survey ( SF-36v2 ) .


Chair stand exercise improved ADL in the hemodialysis patients aged older than 60years .


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


A healthy sample of volunteers ( N = 48 ) 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 , 200 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 = 100 ) , or in the PACU ( n = 100 ) .


Patients who , at the time of surgery , were in cardiogenic shock , required renal dialysis , or had an additive EuroSCORE of more than 10 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 90 [ 50 ; 140 ] min in the PACU vs. 478 [ 305 ; 643 ] min in the ICU group ( P < 0.001 ) .


Median length of stay in PACU was 3.3 [ 2.7 ; 4.0 ] hours vs. 17.9 [ 10.3 ; 24.9 ] hours in the ICU ( P < 0.001 ) .


Of the adverse events examined , only the incidence of new onset cardiac arrhythmia ( 25 in PACU vs. 41 in ICU , P = 0.02 ) 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 .


ISRCTN71768341 .


Registered 11 March 2014 .


We describe neuropsychological test performance ( NP ) in antiretroviral treatment ( ART ) - nave HIV-positive individuals with CD4 cell counts above 500 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-8 ) , the average of the z-scores for the eight tests .


Associations of baseline factors with QNPZ-8 scores were assessed by multiple regression .


Mild neurocognitive impairment ( NCI ) was defined as z-scores < -1 in at least two of six cognitive domains .


A total of 608 participants had a median age of 34 years ; 11 % were women and 15 % were black ; the median time since HIV diagnosis was 0.9 years ; the median CD4 cell count was 633 cells/L ; 19.9 % had mild NCI .


Better NP was independently associated with younger age , being white , higher body mass index ( 0.10 per 10kg/m ( 2 ) higher ) , and higher haematocrit percentage ( 0.19 per 10 % higher ) .


Worse NP was associated with longer time since HIV diagnosis ( -0.17 per 10 years ) , diabetes ( -0.29 ) and higher Framingham risk score ( -0.15 per 10 points higher ) .


QNPZ-8 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 CD4 counts > 500 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 , 24 men ( 22.90.4 years ; 22.50.3 kg/m ( 2 ) ) were provided with isovolumetric ( 325ml ) treatments of CM , 1.25 % alginate CM , 2.5 % alginate CM or 2.5 % alginate solution .


Sodium alginate had a ratio of 0.78:1 of mannuronic acid ( M ) to guluronic acid ( G ) residues , and was block distributed .


Treatments were standardized for lactose , sucrose and calcium content , and provided 120min 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 2.5 % alginate to CM reduced peak glucose concentrations , at 30min , by an average of 6 % and 13 % compared with 1.25 % alginate CM ( 95 % confidence intervals ( CIs ) : 0.02-1 .08 ; P = 0.037 ) and CM alone ( 95 % CIs : 0.49-1 .55 ; P = 0.000 ) respectively .


Insulin peaks at 30min were lower by 46 % after 2.5 % alginate CM relative to CM ( 95 % CIs : 3.49-31 .78 ; P = 0.009 ) .


Pre-meal appetite was attenuated dose dependently by alginate addition to CM ; CM with 2.5 % alginate reduced mean appetite by an average of 134 % compared with CM alone ( 95 % CIs : 8.87-18 .98 ; P = 0.000 ) .


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 2h 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 ( 15-50 ng/ml ) were compared .


Thirty RLS patients who took either oral iron or pramipexole for 12 weeks and were followed at 2 , 4 , 8 and 12 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 50 % from baseline .


The 30 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 12 weeks , IRLS scores were lower than those at baseline in both groups ( iron -9.1 7.07 , P < 0.001 ; pramipexole -8.7 8.31 , P = 0.001 ) 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 46.7 % .


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 , 60 eyes of 60 patients affected with idiopathic macular pucker were enrolled .


Thirty eyes underwent 23-gauge pars plana vitrectomy associated with ILM peeling ( `` ILM peeling group '' ) , whereas 30 eyes did not undergo ILM peeling ( `` ILM not peeling group '' ) .


Retinal sensitivity , frequency of microscotomas , and all the other microperimetric parameters were tested by MP1 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 12-month follow-up , the mean retinal sensitivity in the 4 central area showed a greater and faster recovery in the ILM not peeling group than in the ILM peeling group ( P = 0.041 ) .


The number of absolute microscotomas ( 0 dB ) within the 12 central retinal area was significantly higher in the ILM peeling group than in the ILM not peeling group ( P = 0.044 ) .


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 12-month follow-up .


To observe the clinical efficacy of BO 's abdominal acupuncture for obese type-2 diabetes mellitus ( T2DM ) .


Sixty patients of obese T2DM were randomly divided into an acupuncture group and a medication group , 30 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 [ Zhongwan ( CV 12 ) , Xiawan ( CV 10 ) , Qihai ( CV 6 ) , Guanguan ( CV 4 ) ] , Fusiguan [ Huaroumen ( ST 24 ) , Wailing ( TE 5 ) ] , Tianshu ( ST 25 ) , Daheng ( SP 15 ) , Qixue ( KI 13 ) , etc. ; the treatment was given three times per week , 3 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 ) , 2-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-TT2hBG , FINS , GTT2h insulin , HOMA-IR , TC and LDL-C in the acupuncture group were all significantly reduced ( all P < 0.05 ) , while FPG , OGTT2H insulin and TG were increased in the medication group ( all P < 0.05 ) ' .


The differences of reducing SBP , WC , FPG , OGTT2H insulin , HOMA-IR , TC , TG and LDL-C were statistically significant between the two groups ( all P < 0.05 ) .


The total effective rate was 93.3 % ( 28/30 ) in the acupuncture group , which was significantly superior to 23.3 % ( 7/30 ) in the medication group ( P < 0.01 ) .


BO 's abdominal acupuncture has obvious clinical efficacy for obese type-2 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 > 50 % 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 EF45 % , a mitral E-wave velocity/mitral annular velocity ratio ( E/E ' ) > 15 or N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) concentration > 220 pg/ml , a left ventricular end-diastolic pressure ( LVEDP ) 18 mm Hg , and time-constant of relaxation ( tau ) 50 ms. Patients were randomized to ranolazine ( n = 12 ) or placebo ( n = 8 ) .


Treatment consisted of intravenous infusion for 24 h , followed by oral treatment for 13 days .


After 30 min of infusion , LVEDP ( p = 0.04 ) and pulmonary capillary wedge pressure ( p = 0.04 ) 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 120 beats/min ( p = 0.02 ) , 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 = 0.04 ) .


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


Echocardiographically , the E/E ' ratio did not significantly change after 22 h.


After 14 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 [ RALI-DHF ] ; NCT01163734 ) .


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 177 buprenorphine-treated opioid dependent participants with cocaine dependence or abuse to 12 weeks of double-blind treatment with disulfiram 250mg daily ( n = 91 ) or placebo ( n = 86 ) .


Of 155 participants genotyped , 84 were CC-homozygous , and 71 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 92 parotids ( 46 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 ( CTCAEv3 .0 ) collected weekly during treatment for 24/46 patients .


A higher r was observed during the first compared to last week of treatment ( -0,50 vs -0,05 HU , p-value = 0.0001 ) .


Based on early variations , a good estimation of the final changes may be obtained ( : AUC = 0.82 , p = 0.0001 ; vol : AUC = 0.77 , p = 0.0001 ) .


Both early r and rvol predict a higher `` mean '' acute xerostomia score ( median value , 1.57 ; p-value = 0.01 ) .


Median early density rate changes for patients with mean xerostomia score / < 1.57 were -0.98 vs -0.22 HU/day respectively ( p = 0.05 ) .


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 -0.50 HU/day and -380 mm ( 3 ) / 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 18 to 30 ( n = 3094 ) 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 1 of 3 cessation services .


Trial delivering counseling services by self-help booklet , telephone quit lines , or online expert system in the 48 continental United States .


Smokers could request a free 2-week course of nicotine replacement therapy ( NRT ) patches from the project .


Follow-up surveys at 12 and 26 weeks assessed smoking abstinence , use of NRT , counseling , and other cessation medications , and smoking-related variables .


Overall , 69.0 % of smokers reported using NRT ( M = 3.2 weeks ) at 12 weeks and 74.8 % ( M = 3.3 weeks ) at 26 weeks .


More smokers who were sent the free nicotine patches ( n = 1695 ; 54.8 % ) reported using NRT than those who did not receive them ( 12 weeks : 84.3 % vs 41.9 % , P < .001 ; 26 weeks : 87.6 % vs 51.1 % , P < .001 ) .


The use of NRT was associated with greater smoking abstinence at 12 weeks ( P < .001 ) and 26 weeks ( P < .05 ) , especially if used for more than 2 weeks ( P < .001 ) .


Smokers assigned to a self-help booklet or cessation Web site and heavier smokers were most likely to use NRT ( P < .05 ) , whereas those reporting marijuana use and binge drinking used NRT less ( P < .05 ) .


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 100 consecutive hand infections .


Forty-nine patients received povidone-iodine soaks 3 times daily , and 51patients 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 1.6 operations , and patients treated with daily dressing changes averaged 1.4 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 6-hour porcine endotoxemia model .


We aimed to further explore these effects in a 30-hour model with attention to clinically important variables .


Randomized controlled trial .


University animal laboratory .


Domestic piglets ( n = 30 ) .


Animals were randomized into 5 groups ( n = 6 each ) : 1 ) Controls , 2 ) LPS-only ( endotoxin/lipopolysaccharide ( LPS ) infusion ) , 3 ) LPS + iNO , 4 ) LPS + IV steroid , 5 ) 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 30-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 = 0.045 ) .


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 30 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 ( 44 cases ) and an acupuncture group ( 41 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 3 times .


In the acupuncture group , Fengchi ( GB 20 ) , Wangu ( TE 5 ) , Tianzhu ( BL 10 ) , Neck-Jiaji ( EX-B 2 ) , etc. were selected , once daily , for 15 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 < 0.01 ) , but there was no significant difference in the acupuncture group compared with those before treatment ( P > 0.05 ) ; the score of VAS in the scaping group after the first treatment was lower than that in the acupuncture group ( 3.66 + / - 0.74 vs 5.43 + / - 0.35 , P < 0.01 ) .


Compared with before treatment , the scores of VAS were decreased significantly after treatment in two groups ( both P < 0.01 ) , but without significant difference between two groups ( P > 0.05 ) ; the effective rate was 95.5 % ( 42/44 ) in the scaping group and 87.8 % ( 36/41 ) in the acupuncture group , the curative effects were similar ( P > 0.05 ) .


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 24-month standardized , telephone-based LI that included diet ( 500 to 1,000 kcal per day deficit ) and physical activity ( 150 to 200 minutes of moderate-intensity physical activity per week ) goals to achieve weight loss ( up to 10 % ) .


Women receiving adjuvant letrozole for T1-3N0-3M0 breast cancer with a body mass index ( BMI ) 24 kg/m ( 2 ) 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 338 of 2,150 planned patients because of loss of funding .


Mean weight loss was significantly ( P < .001 ) greater in the LI arm versus the comparison arm ( 4.3 v 0.6 kg or 5.3 % v 0.7 % at 6 months and 3.1 v 0.3 kg or 3.6 % v 0.4 % at 24 months ) and occurred consistently across strata ( BMI 24 to < 30 v 30 kg/m ( 2 ) ; 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 24 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 QAX576 , an mAb against IL-13 , in the treatment of patients with EoE .


Patients ( 18-50 years ) with proton pump inhibitor-resistant esophageal eosinophilia received intravenous QAX576 ( 6 mg/kg ) or placebo ( 2:1 ) at weeks 0 , 4 , and 8 and were followed for 6 months .


The primary end point was the responder rate for a greater than 75 % decrease in peak eosinophil counts at week 12 .


Efficacy was to be declared if the lower 90 % confidence limit for the proportion of responders on QAX576 was 35 % 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 12 , and 18 continued to the end of the study .


For the proximal and distal esophageal biopsies combined , the responder rate was 12.5 % ( 90 % confidence limit , 1 % to 43 % ) with placebo , compared to 40.0 % ( 90 % confidence limit , 22 % to 61 % ) with QAX576 .


Although the primary end point was not met , the mean esophageal eosinophil count decreased by 60 % with QAX576 versus an increase of 23 % with placebo ( P = .004 ) , and the decrease was sustained up to 6 months .


There was a trend for improved symptoms , particularly dysphagia .


QAX576 improved expression of EoE-relevant esophageal transcripts , including eotaxin-3 , periostin , and markers of mast cells and barrier function , for up to 6 months after treatment .


QAX576 was well tolerated .


QAX576 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 50 % 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 40 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 .


17 patients without symptoms of GER were randomized and 15 completed the study .


13 subjects underwent 24 hour ambulatory pH probe monitoring ; 62 % 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 = 0.3169 ) .


Five of nine subjects in the esomeprazole group compared with 2 of eight subjects in the placebo group experienced exacerbations ( esomeprazole vs. placebo : odds ratio = 3.455 , 95 % CI = ( 0.337 , 54.294 ) , Fisher 's exact test : p = 0.334 ) .


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 .


Clinicaltrials.gov , NCT01983774 .


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 : 21.20.6 years ; body mass index : 22.6 0.6 kg/m ( 2 ) ) participated in a randomized , cross-over design study in which they ingested an additional 75 g of fructose for 14 days while either maintaining low PA ( FR + inactive ) ( < 4500 steps/day ) or high PA ( FR + active ) ( > 12,000 steps/day ) .


Before and following the 2-week loading period , a fructose-rich meal challenge was administered and blood was sampled at baseline and for 6 h after the meal and analyzed for glucagon-like peptide-1 ( GLP-1 ) , glucose-dependent insulinotropic peptide ( GIP ) , c-peptide , glucose and insulin concentrations .


Plasma insulin , glucose , c-peptide , GIP and GLP-1 concentrations significantly increased in response to the test meal on all test visits ( P < 0.05 ) .


C-peptide incremental area under the curve ( AUC ) decreased by 10,208 120 pmol/l min for 6 h from pre to post Fr + active intervention ( P = 0.02 ) leading to a decrease in plasma insulin total AUC ( pre : 58,470.26261.0 pmol/l ; post : 49,444.33883.0 pmol/l ; P = 0.04 ) resulting in a decrease peak [ Insulin ] ( P = 0.009 ) .


Following the FR + active intervention , GIP total AUC significantly decreased ( P = 0.005 ) yet only males had a lower total GLP-1 AUC after both interventions ( P = 0.049 ) .


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 , 5 min of structured brief advice and 20 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 6 months ( negative status was a score of < 8 ) .


Secondary outcomes were AUDIT status at 12 months , experience of alcohol-related problems , health utility , service utilization , readiness to change and reduction in conviction rates .


Follow-up rates were 68 % at 6 months and 60 % at 12 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 ( 36 and 38 % , respectively ) than those in the client information leaflet group ( 50 % ) 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 161 volunteers randomly allocated to consume either 500 mL/d of skimmed ( S ) or semi-skimmed ( SS ) milk for 1 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 rs135549 SNP ) was significantly associated with a reduction in the TC/HDL and LDL/HDL ratios after 12 mo of S milk intake ( mean reduction -0.29 , 95 % confidence interval [ CI ] , -0.63 to 0.05 ; P = 0.0015 and -0.31 , 95 % CI , -0.58 to -0.03 ; P = 0.0005 , respectively ) .


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