In PACTG @ , infants received @ doses of ALVAC-HIV-@ / AIDSVAX B/B with alum ( n = @ ) or placebo ( n = @ ) between @ and @ weeks of age .


By @ weeks of age , the majority of maternally acquired antibodies had waned and vaccine Env-specific immunoglobulin G ( IgG ) responses in vaccinees were higher than in placebo recipients .


Chiron vaccine recipients had higher and more-durable IgG responses than VaxGen vaccine recipients or ALVAC/AIDSVAX vaccinees , with vaccine-elicited IgG responses still detectable in @ % of recipients at @ years of age .


Remarkably , at peak immunogenicity , the concentration of anti-V@V@ IgG , a response associated with a reduced risk of HIV-@ acquisition in the RV@ adult vaccine trial , was @-fold higher in Chiron vaccine recipients , compared with RV@ vaccinees .


As exemplified by the Chiron vaccine regimen , vaccination of infants against HIV-@ can induce robust , durable Env-specific IgG responses , including anti-V@V@ IgG .


Adverse events during colonoscopy are more likely to occur in elderly .


To avoid the adverse events without decreasing the bowel cleanliness is still an unsolved problem .


The aim of this study was to determine the effect of enteral nutrition before colonoscopy in a randomized controlled trail .


A total of @ patients over sixty-five years of age and indicated for colonoscopy were randomized into four groups .


Group @ received a solution of two packages of polyethylene glycol electrolyte powder dissolved in @ mL water .


Group @ received @ mL of enteral nutrition plus polyethylene glycol of the same dosage as in group @ .


Group @ received @ mL of @ % magnesium sulfate solution .


Group @ received @ mL of enteral nutrition plus @ % magnesium sulfate solution of the same dosage as in group @ .


The intestinal cleaning and various physiological indications were measured before , after bowel preparation , and during colonoscopy .


No significant difference in the quality of colon cleansing was found among the four groups .


The incidence of adverse effects in groups @ and @ was less than in groups @ and @ .


Additional enteral nutrition in elderly patients before bowel preparation did not affect the quality of colon cleansing .


However , the process can significantly reduce the incidence of adverse effects .


Endoscopic variceal ligation ( EVL ) is effective in preventing esophageal variceal rebleeding .


However , the optimal EVL interval remains unclear .


To investigate the effectiveness and safety of EVL using two intersession intervals .


methods : From January @ to October @ , @ patients with acute esophageal variceal bleeding were screened .


Emergency ligation was performed for patients with acute variceal bleeding .


After achieving hemodynamic stability , eligible patients ( n = @ ) were randomized to either the monthly group or the biweekly group .


Median time from randomization to variceal obliteration was @ months in the monthly group and @ months in the biweekly group , at a mean of @ @ and @ @ sessions , respectively .


After a median follow up of @ months , six patients ( @ % ) in the monthly group and nine patients ( @ % ) in the biweekly group developed upper gastrointestinal rebleeding ( P = @ ) .


Esophageal variceal rebleeding occurred in six patients ( @ % ) in the monthly group and in seven patients ( @ % ) in the biweekly group ( P = @ ) .


No rebleeding from EVL ulcers occurred in the monthly group and was @ % ( n = @ ) for the biweekly group .


Both treatment groups had similar rates of esophageal variceal recurrence and mortality .


Notably , the incidence of post-EVL ulcers in the monthly group was lower than that in the biweekly group ( @ % vs @ % , P < @ ) .


Patients receiving EVL monthly had similar rebleeding rate , variceal recurrence , and mortality to those receiving EVL biweekly for secondary prophylaxis of variceal bleeding ; however , the monthly interval was associated with fewer post-EVL ulcers found at follow-up endoscopies .


The aim of this pilot study was to evaluate the effect of low-level laser therapy on pain , mandibular movements , and occlusal contacts in adolescents and young adults with temporomandibular disorder .


Individuals aged @ to @ years were evaluated .


The Research Diagnostic Criteria for Temporomandibular Disorders were used for the diagnosis of temporomandibular disorders .


Pain was assessed with a visual analog scale .


Occlusal contacts were recorded using the T-Scan III program ( Tekscan , Boston , MA ) .


The participants were randomly allocated to @ groups : active or placebo laser treatment .


The laser parameters were as follows : wavelength of @ nm , energy density of @ J/cm ( @ ) , power of @ mW , power density of @ W/cm ( @ ) , and @-second exposure time .


The Kolmogorov-Smirnov test was used to determine the normality of the data distribution .


The paired t test was used for the comparisons of the pretreatment and post-treatment results .


The SPSS program for Windows ( version @ ; SPSS , Chicago , IL ) was used for all analyses , with the level of significance set at @ % ( P < @ ) .


No statistically significant differences between groups were found for the right and left anterior temporal muscles ( P = @ and P = @ , respectively ) , superior masseter muscles ( P = @ and P = @ , respectively ) , medial masseter muscles ( P = @ and P = @ , respectively ) , or inferior masseter muscles ( P = @ and P = @ , respectively ) after treatment .


No statistically significant differences were found regarding pain , mandibular range of motion , or the distribution of occlusal contacts after treatment with low-level laser therapy .


These preliminary results need to be verified in a larger sample of patients to confirm the lack of response to low-level laser therapy .


External stents inhibit saphenous vein graft ( SVG ) intimal hyperplasia in animal studies .


We investigated whether external stenting inhibits SVG diffuse intimal hyperplasia @ year after coronary artery bypass graft surgery .


Thirty patients with multivessel disease undergoing coronary artery bypass graft surgery were enrolled .


In addition to an internal mammary artery graft , each patient received one external stent to a single SVG randomly allocated to either the right or left coronary territories ; and one or more nonstented SVG served as the control .


Graft patency was confirmed at the end of surgery in all patients .


The primary endpoint was SVG intimal hyperplasia ( mean area ) assessed by intravascular ultrasonography at @ year .


Secondary endpoints were SVG failure , ectasia ( > @ % initial diameter ) , and overall uniformity as judged by Fitzgibbon classification .


One-year follow-up angiography was completed in @ patients ( @ % ) .


All internal mammary artery grafts were patent .


Overall SVG failure rates did not differ significantly between the two groups ( @ % stented versus @ % nonstented SVG , p = @ ) .


The SVG mean intimal hyperplasia area , assessed in @ SVGs , was significantly reduced in the stented group ( @ @ mm ( @ ) ) versus nonstented group ( @ @ mm ( @ ) , p = @ ) .


In addition , stented SVGs demonstrated marginally significant improvement in lumen uniformity ( p = @ ) and less ectasia ( @ % versus @ % , p = @ ) .


There was some evidence that ligation of side branches with metallic clips increased SVG failure in the stented group .


External stenting has the potential to improve SVG lumen uniformity and reduce diffuse intimal hyperplasia @ year after coronary artery bypass graft surgery .


This study aims at investigating the effect of a single pre-operative oral administration of morphine sulphate ( Oramorph ) on pain after laparoscopic cholecystectomy ( LC ) .


Forty-one ASA I-III patients , aged @-@ years , undergoing LC were randomly , double-blindly allocated to treatment ( N. = @ , @mg Oramorph , group M ) or placebo ( N. = @ , group P ) .


General anesthesia was maintained with propofol and remifentanil .


All patients received ketamine @ mg/kg iv at induction , intraoperative ketorolac @mg iv and tramadol postoperatively ( iv PCA : bolus @ mg , lock-out @ min , max @ mg/@ hours ) .


Numerical rating scale for pain ( NRS ) , White 's fast track and PADSS scores , tramadol consumption and adverse events were recorded for the first @h .


All patients underwent State Trait Anxiety Inventory ( STAI ) and Mini Mental State Examination ( MMSE ) .


Anthropometric characteristics , MMSE , STAI , ASA status , NRS rest , White 's and PADDS scores , PONV incidence were similar .


Group M showed significantly lower NRS on movement during the first @ hours after awakening .


Cumulative tramadol consumption was lower in group M than in group P ( @ mg versus @ mg , P = @ ) .


Within a multimodal approach , a single preoperative oral administration of @ mg of morphine sulphate in patients undergoing LC did not improve pain at rest , but improved NRS on movement during the first @ hours after awakening .


Group P required a higher mean dose of tramadol compared to Group M , although not significantly .


The safety profile of Oramorph allowed fast extubation and awakening times as well as prompt home discharge within @ hours from surgery .


Further survival benefits may be gained from low-dose chest computed tomography ( CT ) by assessing vertebral fractures and bone density .


We sought to assess the association between CT-measured vertebral fractures and bone density with all-cause mortality in lung cancer screening participants .


Following a case-cohort design , lung cancer screening trial participants ( N = @,@ ) who died ( N = @ ) during a median follow-up of @ years ( inter-quartile range : @-@ @ ) were identified and added to a random sample of N = @ from the trial .


We assessed vertebral fractures using Genant 's semiquantative method on sagittal reconstructions and measured bone density ( Hounsfield Units ( HU ) ) in vertebrae .


Cox proportional hazards modelling was used to determine if vertebral fractures or bone density were independently predictive of mortality .


The prevalence of vertebral fractures was @ % ( @ % confidence interval @-@ % ) among survivors and @ % ( @-@ % ) amongst cases .


After adjusting for age , gender , smoking status , pack years smoked , coronary and aortic calcium volume and pulmonary emphysema , the adjusted hazard ratio ( HR ) for vertebral fracture was @ ( @-@ @ ) .


For each @ HU decline in trabecular bone density , the adjusted HR was @ ( @-@ @ ) .


Vertebral fractures and bone density are independently associated with all-cause mortality .


Lung cancer screening chest computed tomography contains additional , potentially useful information .


Vertebral fractures and bone density are independently predictive of mortality .


This finding has implications for screening and management decisions .


Irritable bowel syndrome ( IBS ) is a common gastrointestinal functional disorder with no effective therapy .


Traditional Chinese medicine ( TCM ) is one of the most common complementary therapies in China .


We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule ( SQTX Granule ) , a TCM treatment , in patients with IBS with diarrhea ( IBS-D ) .


A randomised , double-blinded , placebo-controlled , multi-centre , superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed .


Eligible patients ( Rome III ) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group .


Patients will receive a @-day treatment and a @-month follow-up .


The primary outcome measures include the scores of IBS-quality of life ( IBS-QOL ) rating scale and IBS-symptom severity scale ( IBS-SSS ) rating scale .


The secondary outcome measures include the improvement of symptom scores , and the duration of abdominal pain and diarrhea .


According to TCM theory , SQTX Granule has a regulating effect on abdominal pain , diarrhea and the syndrome of liver-spleen disharmony , which is similar to the symptoms of IBS-D .


This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment .


To explore changes of B and T lymphocyte attenuator ( BTLA ) , superoxide dismutase ( SOD ) , catalase ( CAT ) , total antioxidant capacity ( TAOC ) , reactive oxygen species ( ROS ) , reactive nitrogen species ( RNS ) , malondialdehyde ( MDA ) in ankylosing spondylitis ( AS ) patients , and the effect of Xinfeng Capsule ( XFC ) on them .


Totally @ AS patients were assigned to two groups according to random digit table method , the XFC group ( @ XFC pills each time , @ times a day ) and the SASP group ( @ SASP tablets each time , twice a day ) , @ in each group .


All patients were treated for @ months .


Another @ healthy subjects were recruited as a healthy control group .


The expression frequency and activation levels of BTLA were detected using flow cytometry .


Serum oxidative stress indices ( such as SOD and CAT , TAOC , ROS , RNS , MDA ) and contents of cytokines -LSB- tumor necrosis factor ( TNF - ) , IL-@ , IL-@ , and IL-@ -RSB- were detected using enzyme-linked immunoassay ( ELISA ) .


Erythrocyte sedimentation rate ( ESR ) was detected using Westergren method .


High-sensitivity C-reactive protein ( Hs-CRP ) was detected using HITACHI @ type automatic biochemical analyzer .


Clinical efficacies of ASAS @ and BASDAI@ were assessed using VAS .


Correlation analysis between scoring for quality of life and BTLA expression frequency was performed .


( @ ) Clinical efficacies of ASAS @ and BASDAI@ were significantly better in the XFC group than in the SASP group ( P < @ ) .


( @ ) Compared with the healthy control group , BTLA expressions in the peripheral blood of AS patients decreased significantly ( P < @ ) ; SOD , CAT , and TAOC values significantly decreased ( P < @ , P < @ ) ; ROS , RNS , and MDA values significantly increased ( P < @ , P < @ ) ; TNF - , IL-@ , ESR , and Hs-CRP values significantly increased ( P < @ ) ; IL-@ and IL-@ values decreased significantly ( P < @ , P < @ ) .


( @ ) Compared with pre-treatment in the same group , BTLA/CD@ + B , BTLA/CD@ + B , SOD , TAOC , IL-@ , SF-@ -LSB- physical functioning ( PF ) , social functioning ( SF ) , role limitation due to physical problems ( RP ) , role limitation due to emotional problems ( RE ) , body pain ( BP ) , mental health ( MH ) , vitality ( VT ) , general health ( GH ) -RSB- were significantly elevated ; ROS , MDA , TNF - , ESR , Hs - CRP , VAS , BASDAI and BASFI , BAS-G were significantly lower in the peripheral blood of the two groups after treatment ( P < @ , P < @ ) .


Better effect was shown in the XFC group in elevating BTLA/CD@ + B , BTLA/CD@ + B , SOD , TAOC , IL-@ , BP , MH , VT , and SF ; and lowering ROS , IL-@ , MDA , TNF - , ESR , Hs-CRP , VAS , BASDAI , BASFI , and BAS-G ( P < @ , P < @ ) .


( @ ) Pearson correlation analysis showed , BTLA/CD@ + B expression of the peripheral blood was positively correlated with SOD , CAT , TAOC , IL-@ , IL-@ , GH , RP , BP , and SF ( r = @ , @ , @ , @ , @ , @ , @ , @ , @ , respectively , P < @ , P < @ ) , while it was negative correlated with ROS , MDA , TNF - , IL-@ , ESR , VAS , and BASDAI ( r = -@ , -@ , -@ , -@ , -@ , -@ , -@ , respectively , P < @ , P < @ ) .


BTLA/CD@ B expression of the peripheral blood was positively correlated with SOD , TAOC , IL-@ , IL-@ , GH , RP , BP , SF , RE , MH , VT ( r = @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , respectively , P < @ , P < @ ) , while it was negative correlated with ROS , RNS , MDA , ESR , Hs-CRP , VAS , BASDAI , and BASFI ( r = -@ , -@ , -@ , -@ , -@ , -@ , -@ , -@ , respectively , P < @ , P < @ ) .


XFC could improve BTLA expression in the peripheral blood of AS patients , negatively regulate activation and proliferation of B cells , and reduce abnormal immune responses and oxidative stress injury , thereby effectively alleviating joint stiffness and pain .


To evaluate the impacts on the short-term efficacy and the long-term prevention of recurrence of allergic rhinitis treated with the triple-strong stimulation at Dazhui ( GV @ ) so as to provide the convenient and long-term effective therapy of acupuncture and moxibustion for allergic rhinitis .


One hundred and twenty cases of allergic rhinitis were randomized into an acupuncture group , an acupuncture + medication group and a triple-strong stimulation group , @ cases in each one .


In the acupuncture group , acupuncture was applied at Dazhui ( GV @ ) , Fengchi ( GB @ ) , Baihui ( GV @ ) , Yintang ( GV @ ) and the others , stimulating with reinforcing manipulation for the deficiency and reducing manipulation for the excess , once every day .


In the acupuncture + medication group , on the basis of acupuncture therapy , claritin ( loratadine tablets ) was supplemented for oral administration , @ mg , once every two days , continuously for @ days .


In the triple-strong stimulation group , on the basis of acupuncture therapy , the strong needling , strong cupping and strong moxibustion were applied at Dazhui ( GV @ ) .


This combined therapy was given once every day in the first @ days and once every two days afterwards .


The @ day treatment made one session , at the interval of @ days between the sessions and totally @ sessions were required in the three groups .


Separately , before treatment , after treatment and in @ months after treatment , the changes of symptom and physical sign score and value of single item symptom including nasal itching , nasal blockage , sneezing and rhinorrhea were observed in the patients of the three groups .


And the long-term clinical efficacy was compared among the three groups .


The symptom and physical sign score and the value of single item symptom were all reduced in the three groups after treatment and in @ months after treatment ( P < @ , P < @ , P < @ ) .


The results in the triple-strong stimulation group were superior to the other two groups ( all P < @ ) .


In the triple-strong stimulation group , the total effective rate was @ % ( @/@ ) in the follow-up of @ months after treatment , which was better than @ % ( @/@ ) in the acupuncture group and @ % ( @/@ ) in the acupuncture + medication group ( both P < @ ) .


The combined therapy of acupuncture and the triple-strong stimulation at Dazhui ( GV @ ) achieves the reliable and effective result in the clinical treatment of allergic rhinitis and displays the good role on the prevention from long-term recurrence .


To analyse change in selected bone markers in peri-implant sulcus fluid ( PISF ) sampled before treatment and after @ months and test correlation with change in disease progression .


Peri-implant sulcus fluid was sampled from @ patients in a randomized , clinical study comparing peri-implant defect re-construction with or without porous titanium granules .


Matrix metalloproteinase @ levels were measured using the Quantikine Human Total MMP-@ ( DMP@ ) ELISA .


Multianalyte profiling of the level of bone markers -LSB- interleukin-@ , osteprotegerin ( OPG ) , osteocalcin , leptin , osteopontin , parathyroid hormone , tumour necrosis factor - , adiponectin and insulin -RSB- was performed by Luminex using Human Bone Panel IB .


Changes in bone marker levels were compared and correlation with clinical findings was tested .


No differences in clinical parameter or bone marker levels between test and control group were found .


When comparing bone marker levels irrespective of treatment allocation between baseline and @ months , a significant reduction in total protein , matrix metalloproteinase -@ , interleukin-@ , OPG , leptin and adiponectin were demonstrated .


Positive correlations were found between the reduction in interleukin-@ ( r = @ ) , insulin ( r = @ ) and matrix metalloproteinase-@ ( r = @ ) concentration , and probing pocket depth reduction .


Peri-implantitis surgical treatment induced some reduction of the studied bone markers .


Conclusive evidence for correlation between change in bone marker concentrations with disease resolution was not found .


Screening of natural compounds for the development of anti-acne therapeutic agents has been steadily required considering various side effects of acne medications .


However , previous studies have mainly focused on experimental tests without clinical trials and histopathological analysis .


To compare the clinical efficacy , safety and histopathological changes between Lactobacillus-fermented Chamaecyparis obtusa ( LFCO ) and existing tea tree oil ( TTO ) .


A total of @ patients were instructed to apply @ % LFCO to the involved areas of a randomly allocated side and @ % TTO extract to the other side for @ weeks in a double-blind split-face clinical trial .


After @ weeks , inflammatory acne lesions were reduced by @ % on the LFCO side and by @ % on the TTO side .


LFCO was also superior to TTO in the onset time of efficacy ( p < @ ) .


The LFCO side further demonstrated improvement for non-inflammatory lesions ( @ % , p < @ ) , decreased size of sebaceous glands and sebum output reductions .


Patients ' subjective satisfaction was also higher without severe adverse reactions .


Protein expressions of nuclear factor B decreased earlier on the LFCO side , and those of interleukin-@ ( IL-@ ) , IL-@ , insulin-like growth factor @ receptor and sterol regulatory element-binding protein @ decreased subsequently .


Ultra-performance liquid chromatography/high-resolution mass spectrometry further demonstrated that the contents of dihydroxybenzoic acid , taxifolin and quercetin were increased in LFCO after fermentation .


LFCO treatment was rapid and effective for treating acne lesions compared to TTO .


Histopathological findings correlated well with the clinical acne grade and treatment response .


This novel natural compound appears to be effective and safe for acne treatment .


This study aims to investigate the possible differences in skin temperature and blood perfusion changes between single and triple moxibustion .


Thirty healthy volunteers were randomly divided into two groups : a triple moxibustion group ( n = @ ) received indirect moxibustion on CV@ for @min and a single moxibustion group ( n = @ ) for @min .


After @min of bed rest , skin temperature and blood perfusion were measured by digital infrared thermal imaging and laser Doppler perfusion imaging eight times in total , pre-moxibustion and @ , @ , @ , @ , @ , @ and @min post moxibustion .


The changes in the skin temperature and blood perfusion in an area @cm in diameter around CV@ at @min post treatment compared to baseline was the main outcome measurement .


The difference of changes in skin temperature and blood perfusion on CV@ between the two groups remained statistically significant for @min in an area @cm in diameter around CV@ and for @min in a @-cm-diameter area .


No adverse events were reported .


Triple moxibustion with large , indirect moxa appeared to induce greater increases in skin temperature and blood perfusion than single moxibustion .


Published correlations between histological abnormalities and right ventricular ( RV ) function , as evaluated by speckle tracking echocardiography ( STE ) , are scarce in patients with tetralogy of Fallot ( TOF ) .


The purpose of the study is to assess age-associated differences in the effect of RV myocardial remodeling on ventricular function in patients with TOF .


Operatively resected crista supraventricularis muscle from @ patients ( median age @months ) undergoing intracardiac repair of TOF were studied by light microscopy .


The patients were divided into younger ( age at surgery @months ) and older ( age at surgery > @months ) subgroups .


The RV global longitudinal peak systolic strain ( GLS ) , strain rate ( GLSRs ) and early diastolic strain rate ( GLSRe ) were measured by two-dimensional STE before and @months after repair .


The histopathological data revealed hypertrophy of the cardiomyocytes , a thickened endocardium , and increased interstitial and perivascular collagen in RV , which were associated with older age at the time of repair .


The RV global systolic and diastolic functions in patients with repaired TOF were increased compared with the preoperative values .


The RV cardiomyocyte diameter and collagen volume fraction ( CVF ) correlated with the preoperative GLS , GLSRs and GLSRe , respectively , in the younger patients ( r@ = -@ , P@ = @ ; r@ = -@ , P@ = @ ; r@ = -@ , P@ = @ ) .


The RV cardiomyocyte diameter and CVF correlated with preoperative GLS , GLSRs and GLSRe , respectively , in the older patients ( r@ = -@ , P@ = @ ; r@ = -@ , P@ = @ ; r@ = -@ , P@ = @ ) .


The correlation of the RV cardiomyocyte diameter with the postoperative GLS and GLSRe ( r@ = -@ , P@ = @ ; r@ = -@ , P@ = @ ) and the CVF with the postoperative GLSRs and GLSRe ( r@ = -@ , P@ = @ ; r@ = -@ , P@ = @ ) were identified only in the older patients .


Multivariate analysis indicated that the age at repair was an independent predictor of postoperative GLSRs and GLSRe in all of the patients ( = -@ , P = @ ; = -@ , P = @ ) .


The effect of RV myocardial remodeling on preoperative RV function was more pronounced in the older patients with TOF than in the younger ones .


Preoperative myocardial remodeling affected the postoperative RV function in the older but not in the younger patients .


The age at the time of surgical repair was the independent determinant of the postoperative RV myocardial function .


While meta-analyses and clinical trials show improved survival in advanced NSCLC treated with platinum-containing chemotherapy , there are few data concerning front-line platinum-free ifosfamide-based regimens .


We aimed to compare cisplatin-based chemotherapy to ifosfamide-gemcitabine ( IG ) with pre-defined second-line docetaxel .


@ Untreated advanced inoperable NSCLC cases were randomised to either GIP ( gemcitabine , ifosfamide , cisplatin ) , DP ( docetaxel , cisplatin ) or IG .


Primary outcome was overall survival .


Median age of the patients was @ years with a predominance of males ( @ % ) , adenocarcinoma ( @ % ) , Karnofsky PS @-@ ( @ % ) and stage-IV disease ( @ % ) .


Median survival times were @ , @ and @ months for IG , GIP and DP ( p = @ ) .


GIP presented with ( p < @ ) greater neutropenia , thrombopenia , vomiting , while greater cardiotoxicity , diarrhea , peripheral neuropathy were observed for DP and encephalopathy for IG .


In advanced NSCLC , cisplatin-based CT is not superior to a platinum-free regimen ( ifosfamide-gemcitabine ) with a favourable toxicity profile .


The aim of this study was to compare the antiinflammatory effect and ocular surface toxicity of topical nonpreserved methylprednisolone sodium succinate @ % and preserved prednisolone acetate suspension @ % for the management of acute anterior uveitis ( AAU ) .


In this prospective , randomized , investigator-masked , comparative clinical trial , patients with mild-to-moderate noninfectious AAU were assigned randomly to receive either hourly nonpreserved methylprednisolone @ % ( group A ) or preserved prednisolone @ % ( group B ) eye drops followed by a @-week tapering regimen .


Anterior chamber cells and flare were clinically evaluated for the objective comparison of the antiinflammatory effect .


The main outcome measure was the percentage of patients with a resolution of inflammation ( anterior chamber cells < @ + ) on day @ .


Ocular surface toxicity was assessed by means of the corneal fluorescein staining score , tear breakup time , Schirmer I test , and questionnaire-based grading of ocular discomfort parameters .


Seventy-two eyes of @ patients were studied , of which @ eyes were enrolled in group A and @ eyes were enrolled in group B. On day @ , @ % of the patients in group A had resolution of inflammation compared with @ % of the patients in group B , proving noninferiority ( = @ , P = @ ) .


The mean anterior chamber cell grade reduction for patients in group A was similar to that in group B ( @ vs. @ , respectively ; P = @ ) .


Group A patients showed significantly lower corneal fluorescein staining scores ( P < @ ) and reported milder subjective ocular discomfort ( @ vs. @ , P = @ ) as compared with group B.


Both preparations demonstrated equal antiinflammatory effects for the treatment of AAU .


Nonpreserved methylprednisolone eye drops exhibited a significantly lower ocular surface toxicity profile and milder subjective discomfort when compared with that exhibited by preserved prednisolone .


To determine whether @ head-down tilt ( HDT ) used for secretion clearance is safe for acute trauma patients .


There are concerns that HDT may lead to cardiac irregularities in intubated patients in the ICU .


Eleven mechanically ventilated trauma patients ( @-@ yrs ) without cardiovascular problems received two interventions , one supine HDT for @ min and a control in the horizontal supine position ( HS ) , in a crossover design .


Compared to baseline there were statistically significant ( p < @ ) increases in SBP ( @ mm Hg ; @ % CI @ , @ ) and CVP ( @ cm H@O ; @ , @ ) during @ min HDT although these were not of clinical concern .


Heart rate and oxygen saturation were unchanged .


No episodes of arrhythmia or hypoxemia were observed .


All values returned close to baseline during @ min horizontal recovery .


There were no significant changes during the control HS intervention .


@ HDT entails minimal risk for trauma patients who have no underlying cardiovascular disease .


To examine whether or not the combination of diclofenac suppository with peri-prostatic nerve block ( PPNB ) was effective in reducing the degree of pain experienced during transrectal ultrasound ( TRUS ) - guided prostate biopsy in a randomised single-blind placebo-controlled trial .


In all , @ patients having a planned TRUS-guided prostate biopsy were randomised into one of the following arms on a @:@ basis : @mL @ % lignocaine PPNB and placebo suppository ( control ) or @mL @ % lignocaine PPNB and @mg diclofenac suppository ( treatment ) .


Pain scores were recorded using the Numerical Rating Scale for pain ( @-@ ) at the following time-points : ( i ) introduction of probe , ( ii ) during biopsy , ( iii ) @h after biopsy , ( iv ) later that evening ( @h after biopsy ) and ( v ) @ day after biopsy .


Patients were asked about their preferred method for pain control if a repeat TRUS-guided prostate biopsy was required : local anaesthetic ( LA ) again or intravenous sedation .


There were no significant differences in age ( P = @ ) or PSA level ( P = @ ) between either study arm .


The differences in pain scores between the control and treatment groups were not significant at Time @ ( probe insertion ; P = @ ) , Time @ ( biopsy ; P = @ ) , Time @ ( evening after ; P = @ ) and Time @ ( @ day after biopsy ; P = @ ) .


At Time @ ( @h after biopsy ) , the control pain scale scores were statistically significantly higher than the treatment pain scale scores ( P = @ ) .


There was no difference between treatment ( @ % ) and control ( @ % ) groups as to whether they would prefer to repeat the biopsy under LA ( P = @ ) .


The use of a diclofenac suppository with PPNB did not show any clinically meaningful effect in decreasing pain or improving tolerability of TRUS-guided prostate biopsy and is not recommended .


PPNB TRUS-guided biopsy is extremely well tolerated , with > @ % of patients electing for subsequent LA biopsy if required .


In the Determining the Efficacy and Tolerability of cholesteryl ester transfer protein ( CETP ) INhibition with AnacEtrapib ( DEFINE ) trial , anacetrapib added to statin produced robust low-density lipoprotein cholesterol ( LDL-C ) - lowering and high-density lipoprotein cholesterol ( HDL-C ) - raising vs placebo in patients with coronary heart disease ( CHD ) .


Predictors of the degree of LDL-C and HDL-C responses to anacetrapib , however , are poorly understood .


Lipid effects of anacetrapib in patient subgroups within the DEFINE trial ( clinicaltrials.gov : NCT@ ) are reported .


The percent of placebo-corrected changes from baseline for LDL-C ( estimated by Friedewald calculation -LSB- Fc-LDL-C -RSB- ) and HDL-C after @weeks of anacetrapib @mg/day were compared among patients by age , gender , race , diabetes status , type of concomitant statin with or without other lipid therapies , and baseline HDL-C , Fc-LDL-C , and triglyceride ( TG ) levels .


Percent decreases in Fc-LDL-C and increases in HDL-C with anacetrapib were similar ( magnitude of difference generally < @/@ of the overall treatment effect ) across subgroups by age , gender , diabetes status , lipid-modifying regimen , and baseline Fc-LDL-C , HDL-C , or TG .


On the other hand , anacetrapib effects on Fc-LDL-C ( -@ % vs -@ % ) and HDL-C ( +@ % vs +@ % ) appeared to be less in black vs white patients , respectively .


Effects of anacetrapib on Fc-LDL-C and HDL-C were generally comparable across subgroups , including being relatively independent of baseline Fc-LDL-C , HDL-C , or TG levels .


The clinical impact of the lipid-modifying effects of anacetrapib is being evaluated in the cardiovascular disease outcomes trial , Randomized EValuation of the Effects of Anacetrapib though Lipid-modification ( REVEAL ) .


Three months of a once-weekly combination of rifapentine and isoniazid for treatment of latent tuberculosis infection is safe and effective for persons @ years or older .


Published data for children are limited .


To compare treatment safety and assess noninferiority treatment effectiveness of combination therapy with rifapentine and isoniazid vs @ months of isoniazid treatment for latent tuberculosis infection in children .


A pediatric cohort nested within a randomized , open-label clinical trial conducted from June @ , @ , through December @ , @ , with follow-up through September @ , @ , in @ study sites in the United States , Canada , Brazil , Hong Kong ( China ) , and Spain .


Participants were children ( aged @-@ years ) who were eligible for treatment of latent tuberculosis infection .


Twelve once-weekly doses of the combination drugs , given with supervision by a health care professional , for @ months vs @ daily doses of isoniazid , without supervision by a health care professional , for @ months .


We compared rates of treatment discontinuation because of adverse events ( AEs ) , toxicity grades @ to @ , and deaths from any cause .


The equivalence margin for the comparison of AE-related discontinuation rates was @ % .


Tuberculosis disease diagnosed within @ months of enrollment was the main end point for testing effectiveness .


The noninferiority margin was @ % .


Of @ children enrolled , @ were eligible for evaluation of effectiveness .


Of @ in the combination-therapy group , @ ( @ % ) completed treatment vs @ of @ ( @ % ) in the isoniazid-only group ( P = @ ) .


The @ % CI for the difference in rates of discontinuation attributed to an AE was -@ to @ , which was within the equivalence range .


In the safety population , @ of @ participants ( @ % ) who took the combination drugs had a grade @ AE vs @ of @ ( @ % ) who received isoniazid only .


Neither arm had any hepatotoxicity , grade @ AEs , or treatment-attributed death .


None of the @ in the combination-therapy group developed tuberculosis vs @ of @ ( cumulative rate , @ % ) in the isoniazid-only group , for a difference of -@ % and an upper bound of the @ % CI of the difference of +@ % , which met the noninferiority criterion .


Treatment with the combination of rifapentine and isoniazid was as effective as isoniazid-only treatment for the prevention of tuberculosis in children aged @ to @ years .


The combination-therapy group had a higher treatment completion rate than did the isoniazid-only group and was safe .


To evaluate the safety and efficacy of daclatasvir , an HCV NS@A inhibitor with pangenotypic activity , administered with peginterferon-alfa-@a / ribavirin .


In this Phase @b double-blind , placebo-controlled study , treatment-naive adults with HCV genotype @ ( N = @ ) or @ ( N = @ ) infection were randomly assigned ( @:@:@ ) to daclatasvir @mg or @mg , or placebo once daily plus weekly peginterferon-alfa-@a and twice-daily ribavirin .


Daclatasvir recipients achieving protocol-defined response ( PDR ; HCV-RNA < lower limit of quantitation at Week @ and undetectable at Week @ ) were rerandomised at Week @ to continue daclatasvir/peginterferon-alfa -@ a/ribavirin for @weeks total duration or to placebo/peginterferon-alfa -@ a/ribavirin for another @weeks .


Patients without PDR and placebo patients continued peginterferon-alfa/ribavirin through Week @ .


Primary efficacy endpoints were undetectable HCV-RNA at Weeks @ and @ ( extended rapid virologic response , eRVR ) and at @weeks post-treatment ( sustained virologic response , SVR@ ) among genotype @-infected patients .


Overall , eRVR was achieved by @ % ( @/@ ) of genotype @-infected patients receiving daclatasvir @mg , @ % ( @/@ ) receiving @mg versus @ % ( @/@ ) receiving placebo .


SVR@ was achieved among @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) patients in these groups , respectively .


Higher proportions of genotype @-infected patients receiving daclatasvir @mg ( @ % ; @/@ ) or @mg ( @ % ; @/@ ) achieved SVR@ versus placebo ( @ % ; @/@ ) .


A majority of daclatasvir-treated patients achieved PDR and experienced less virologic failure and higher SVR@ rates with a shortened @-week treatment duration .


Adverse events occurred with similar frequency across all treatment groups .


The combination of daclatasvir/peginterferon-alfa/ribavirin was generally well tolerated and achieved higher SVR@ rates compared with placebo/peginterferon-alfa/ribavirin among patients infected with HCV genotype @ or @ .


Examine whether cognitive behavioral therapy for insomnia ( CBT-I ) improves sleep in posttraumatic stress disorder ( PTSD ) as well as nightmares , nonsleep PTSD symptoms , depression symptoms , and psychosocial functioning .


RANDOMIZED CONTROLLED TRIAL WITH TWO ARMS : CBT-I and monitor-only waitlist control .


Department of Veterans Affairs ( VA ) Medical Center .


Forty-five adults ( @ females : -LSB- mean age @ y ( @-@ y ) -RSB- with PTSD meeting research diagnostic criteria for insomnia , randomly assigned to CBT-I ( n = @ ; @ females ) or monitor-only waitlist control ( n = @ ; nine females ) .


Eight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist .


Measures included continuous monitoring of sleep with diary and actigraphy ; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale ( CAPS ) ; and pre , mid , and post self-report questionnaires , with follow-up of CBT-I participants @ mo later .


CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time .


Compared to waitlist participants , CBT-I participants reported improved subjective sleep ( @ % full remission versus @ % ) , disruptive nocturnal behaviors ( based on the Pittsburgh Sleep Quality Index-Addendum ) , and overall work and interpersonal functioning .


These effects were maintained at @-mo follow-up .


Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares .


Cognitive behavioral therapy for insomnia ( CBT-I ) improved sleep in individuals with posttraumatic stress disorder , with durable gains at @ mo. .


Overall psychosocial functioning improved following CBT-I .


The initial evidence regarding CBT-I and nightmares is promising but further research is needed .


Results suggest that a comprehensive approach to treatment of posttraumatic stress disorder should include behavioral sleep medicine .


Irritable bowel syndrome ( IBS ) is a common disorder in Iran with challenging treatment .


Although trials have suggested that probiotics alleviate the complaints of patients with minimal side effects , they have not been investigated in Iranian adults .


In a randomized double-blind study , @ eligible IBS patients ( Rome III Criteria ) aged @ - @ years who referred consecutively to a clinical center in Tehran with abdominal bloating from @ to @ received a combination probiotics or placebo twice daily for @ weeks .


The objective was to evaluate the efficacy and safety of a multi-strain probiotics combination .


One week prior to and throughout the treatment , the participants recorded their abdominal symptoms on a daily basis , using visual analogue scale and reported satisfactory relief of general symptoms at the end of each week .


Adverse events were evaluated by self-reporting and physical examination .


Continuous variables were analyzed by independent t-test and chi-square was used for binomials .


The baseline characteristics were balanced ( @ % female , mean age @ @ ) .


A total of @ ( @ intervention , @ control ) completed the treatment .


Intention to treat analysis was done on @ allocated subjects .


@ % of the probiotic group reported satisfactory relief of general symptoms compared with @ % in the control group ( P < @ ) .


A reduction in abdominal bloating and pain with probiotic was superior to placebo -LSB- -@ vs. -@ ( P < @ ) , -@ vs. -@ ( P = @ ) , respectively -RSB- .


No severe adverse drug reaction was seen in either group .


A @-week period of treatment with the combination probiotics twice daily was safe , well tolerated , and effective in our patients .


Further investigation is recommended for other subgroups of IBS .


Trial Registration : IRCT.ir IRCT@N@ .


Laparoscopic resection and a multimodal approach known as an enhanced recovery program ( ERP ) have been major changes in colorectal perioperative care that have improved clinical outcomes for colorectal cancer resection .


EnROL ( Enhanced Recovery Open Versus Laparoscopic ) is a multicenter randomized controlled trial examining whether the benefits of laparoscopy still exist when open surgery is optimized within an ERP .


Adults with colorectal cancer suitable for elective resection were randomly assigned at a ratio of @:@ to laparoscopic or open surgery within an ERP , stratified by center , cancer site ( colon v rectum ) , and age group ( < @ v @-@ v > @ years ) using minimization .


The primary outcome was physical fatigue at @ month postsurgery .


Secondary outcomes included hospital stay , complications , other patient-reported outcomes ( PROs ) , and physical function .


Patients and outcome assessors were blinded until @ days postsurgery or discharge if earlier .


Central independent and blinded pathologic assessment of surgical quality was undertaken .


A total of @ patients ( laparoscopy , n = @ ; open surgery , n = @ ) were recruited from @ UK centers from July @ to April @ .


One-month physical fatigue scores were similar in both groups ( mean : laparoscopy , @ ; @ % CI , @ to @ v open surgery , @ ; @ % CI , @ to @ ; adjusted mean difference , -@ ; @ % CI , -@ to @ ) .


Median total hospital stay was significantly shorter after laparoscopic surgery ( median : laparoscopy , @ ; interquartile range -LSB- IQR -RSB- , @ to @ v open surgery , @ ; IQR , @ to @ days ; P = @ ) .


There were no differences in other secondary outcomes or in specimen quality after central pathologic review .


In patients treated by experienced surgeons within an ERP , physical fatigue and other PROs were similar in both groups , but laparoscopic surgery significantly reduced length of hospital stay .


This @-week study assessed the efficacy and tolerability of imeglimin as add-on therapy to the dipeptidyl peptidase-@ inhibitor sitagliptin in patients with type @ diabetes inadequately controlled with sitagliptin monotherapy .


In a multicenter , randomized , double-blind , placebo-controlled , parallel-group study , imeglimin ( @,@ mg b.i.d. ) or placebo was added to sitagliptin ( @ mg q.d. ) over @ weeks in @ patients with type @ diabetes ( mean age @ years ; BMI @ kg/m ( @ ) ) that was inadequately controlled with sitagliptin alone ( A@C @ % ) during a @-week run-in period .


The primary efficacy end point was the change in A@C from baseline versus placebo ; secondary end points included corresponding changes in fasting plasma glucose ( FPG ) levels , stratification by baseline A@C , and percentage of A@C responders .


Imeglimin reduced A@C levels ( least-squares mean difference ) from baseline ( @ % ) by @ % compared with an increase of @ % with placebo ( between-group difference @ % , P < @ ) .


The corresponding changes in FPG were -@ mmol/L with imeglimin vs. -@ mmol/L with placebo ( P = @ ) .


With imeglimin , the A@C level decreased by @ % in @ % of subjects vs. @ % with placebo ( P < @ ) , and @ % of subjects receiving imeglimin achieved a decrease in A@C level of @ % compared with subjects receiving placebo ( @ % ) ( P = @ ) .


Imeglimin was generally well tolerated , with a safety profile comparable to placebo and no related treatment-emergent adverse events .


Imeglimin demonstrated incremental efficacy benefits as add-on therapy to sitagliptin , with comparable tolerability to placebo , highlighting the potential for imeglimin to complement other oral antihyperglycemic therapies .


There is a need for effective population-based physical activity interventions .


The internet provides a good platform to deliver physical activity interventions and reach large numbers of people at low cost .


Personalised advice in web-based physical activity interventions has shown to improve engagement and behavioural outcomes , though it is unclear if the effectiveness of such interventions may further be improved when providing brief video-based coaching sessions with participants .


The purpose of this study is to determine the effectiveness , in terms of engagement , retention , satisfaction and physical activity changes , of a web-based and computer-tailored physical activity intervention with and without the addition of a brief video-based coaching session in comparison to a control group .


Participants will be randomly assigned to one of three groups ( tailoring + online video-coaching , tailoring-only and wait-list control ) .


The tailoring + video-coaching participants will receive a computer-tailored web-based physical activity intervention ( ` My Activity Coach ' ) with brief coaching sessions with a physical activity expert over an online video calling program ( e.g. Skype ) .


The tailoring-only participants will receive the intervention but not the counselling sessions .


The primary time point 's for outcome assessment will be immediately post intervention ( week @ ) .


The secondary time points will be at @ and @months post-baseline .


The primary outcome , physical activity change , will be assessed via the Active Australia Questionnaire ( AAQ ) .


Secondary outcome measures include correlates of physical activity ( mediators and moderators ) , quality of life ( measured via the SF-@v@ ) , participant satisfaction , engagement ( using web-site user statistics ) and study retention .


Study findings will inform researchers and practitioners about the feasibility and effectiveness of brief online video-coaching sessions in combination with computer-tailored physical activity advice .


This may increase intervention effectiveness at an acceptable cost and will inform the development of future web-based physical activity interventions .


Asthma exacerbations lead to frequent emergency visits and hospitalizations , and are associated with high morbidity and occasionally mortality .


New therapeutic strategies are needed .


We sought to investigate whether the addition of high-dose inhaled budesonide to standard therapy would shorten the length of stay ( LOS ) in hospital of children admitted for asthma exacerbations .


The study was designed as a single-center , double-blind , placebo-controlled and parallel-group trial .


Children aged @-@ months and admitted with an asthma exacerbation clinical asthma score ( CAS ) of between @ and @ were allocated to either the budesonide ( n = @ ) or the placebo ( n = @ ) group .


Hospital LOS was compared between children who received @ mg/day of budesonide versus placebo in addition to standard management of asthma exacerbation involving oxygen inhalation and @-agonist , anticholinergic and oral corticosteroid therapy .


All patients were assessed every @ h. Children with a CAS < @ , a peripheral oxygen saturation > @ % and normal pulmonary function , and those with a symptom-free period of at least @ h after salbutamol treatment were discharged .


Total hospital LOS was significantly shorter in the budesonide group than in the placebo group ( median : @ vs. @ h , respectively ; p = @ ) .


When compared with placebo , the number of inpatients was significantly less in the budesonide group at all the assessed end points ( Kaplan-Meier ; p = @ ) .


Additionally , nebulized budesonide was found to reduce the overall cost of treatment .


We demonstrated that , for children hospitalized for asthma exacerbations , an additional @ mg/day of nebulized budesonide significantly reduced hospital LOS as well as the overall cost of treatment .


Barrett esophagus containing low-grade dysplasia is associated with an increased risk of developing esophageal adenocarcinoma , a cancer with a rapidly increasing incidence in the western world .


To investigate whether endoscopic radiofrequency ablation could decrease the rate of neoplastic progression .


Multicenter randomized clinical trial that enrolled @ patients with a confirmed diagnosis of Barrett esophagus containing low-grade dysplasia at @ European sites between June @ and June @ .


Patient follow-up ended May @ .


Eligible patients were randomly assigned in a @:@ ratio to either endoscopic treatment with radiofrequency ablation ( ablation ) or endoscopic surveillance ( control ) .


Ablation was performed with the balloon device for circumferential ablation of the esophagus or the focal device for targeted ablation , with a maximum of @ sessions allowed .


The primary outcome was neoplastic progression to high-grade dysplasia or adenocarcinoma during a @-year follow-up since randomization .


Secondary outcomes were complete eradication of dysplasia and intestinal metaplasia and adverse events .


Sixty-eight patients were randomized to receive ablation and @ to receive control .


Ablation reduced the risk of progression to high-grade dysplasia or adenocarcinoma by @ % ( @ % for ablation vs @ % for control ; @ % CI , @ % -@ % ; P < @ ) and the risk of progression to adenocarcinoma by @ % ( @ % for ablation vs @ % for control ; @ % CI , @ % -@ % ; P = @ ) .


Among patients in the ablation group , complete eradication occurred in @ % for dysplasia and @ % for intestinal metaplasia compared with @ % for dysplasia and @ % for intestinal metaplasia among patients in the control group ( P < @ ) .


Treatment-related adverse events occurred in @ % of patients receiving ablation ( P < @ ) .


The most common adverse event was stricture , occurring in @ patients receiving ablation ( @ % ) , all resolved by endoscopic dilation ( median , @ session ) .


The data and safety monitoring board recommended early termination of the trial due to superiority of ablation for the primary outcome and the potential for patient safety issues if the trial continued .


In this randomized trial of patients with Barrett esophagus and a confirmed diagnosis of low-grade dysplasia , radiofrequency ablation resulted in a reduced risk of neoplastic progression over @ years of follow-up .


The aim of this study was to compare the efficiency of dopamine agonist , Cabergoline , in decreasing the size of endometrioma , with that of luteinizing hormone releasing hormone ( LHRH ) agonist , triptorelin acetate .


This was a prospective , randomized study .


The setting was in two private medical centers in the UAE , from January @ to February @ .


One hundred and forty patients complaining of endometrioma , and fulfilling the eligibility criteria , were chosen and divided into two groups as follows : Group I comprised @ patients ; all of them received Cabergoline tablets , @ mg tablets , twice per week for @weeks .


Group II comprised @ patients ; all of them received LHRH agonist , decapeptyl , @ mg subcutaneous , single injection , once a month for @months .


All patients underwent vaginal ultrasound before and after the treatment period to compare the change in the size of endometrioma by the same sonography team in each hospital that was blind to the treatment groups .


The outcome was measured by the changes in the endometrioma size by vaginal ultrasound after completion of the @months ' treatment period .


The management line was considered to be significantly effective if the endometrioma size was reduced by more than @ % of its original pretreatment size .


Group I : @ out of the @ patients ( @ % ) had significant decrease in endometrioma size .


Group II : @ out of @ patients ( @ % ) had significant decrease in endometrioma size .


Paired t test to compare the means of the two groups was highly significant ( p < @ ) CONCLUSION : Cabergoline ( dostinex ) yields better results in decreasing the size of endometrioma , compared to LHRH-agonist by exerting antiangiogenic effects through vascular endothelial growth factor receptor-@ ( VEGFR-@ ) inactivation .


It has no major side effects , easier to administer , and cheaper than LHRH agonists .


Among laboratory technicians , the prevalence of neck and shoulder pain is widespread possibly due to typical daily work tasks such as pipetting , preparing vial samples for analysis , and data processing on a computer including mouse work - all tasks that require precision in motor control and may result in extended periods of time spent in static positions.In populations characterized by intense chronic musculoskeletal pain and diagnosed conditions in conjunction with psycho-physiological symptoms such as stress-related pain and soreness and other disabling conditions , multifactorial approaches applying a combination of individually tailored physical and cognitive strategies targeting the areas most needed , may be an effective solution to the physical and mental health challenges.The aim of this study is therefore to investigate the effect of an individually tailored biopsychosocial intervention strategy on musculoskeletal pain , stress and work disability in lab technicians with a history of musculoskeletal pain at a single worksite in Denmark .


In this single-blind two-armed parallel-group randomized controlled trial with allocation concealment , participants receive either an individualized multifactorial intervention or `` usual care '' for @ weeks at the worksite .


@ ) female laboratory technician ( @-@ years of age ) and @ ) Pain intensity@ ( @-@ Visual Analogue Scale ) lasting @ months with a frequency of@ days per week in one or more of the following regions : i ) upper back i ) low back iii ) neck , iv ) shoulder , v ) elbow and/or vi ) hand .


@ ) life-threatening disease and @ ) pregnancy .


Stress , as measured by Cohens perceived stress questionnaire is not an inclusion criteria , thus participants can participate regardless of their stress level.We will implement an individualized intervention addressing biopsychosocial elements of musculoskeletal pain with the following components ; i ) increasing physical capacity through strength - and motor control training ; ii ) lowering or preventing development of stress through mindfulness practice and learning de-catastrophizing pain management strategies through cognitive training.The primary outcome at @-week follow-up is the between-group difference in intensity of perceived musculoskeletal pain during the last week ( average value of back , neck , shoulder , elbow and hand ) assessed by questionnaire ( modified visual analogue scale @-@ ) .


This study will provide experimental evidence to guide workplace initiatives designed towards reducing chronic musculoskeletal pain and stress .


Because of the increasing number of interventional endovascular procedures with fluoroscopy and the corresponding high annual dose for interventionalists , additional dose-protecting measures are desirable .


The purpose of this study was to evaluate the effect of disposable radiation-absorbing surgical drapes in reducing scatter radiation exposure for interventionalists and supporting staff during an endovascular aneurysm repair ( EVAR ) procedure .


This was a randomized control trial in which @ EVAR procedures were randomized between execution with and without disposable radiation-absorbing surgical drapes ( Radpad : Worldwide Innovations & Technologies , Inc. , Kansas City , US , type @A ) .


Dosimetric measurements were performed on the interventionalist ( hand and chest ) and theatre nurse ( chest ) with and without the use of the drapes to obtain the dose reduction and effect on the annual dose caused by the drapes .


Use of disposable radiation-absorbing surgical drapes resulted in dose reductions of @ % , @ % , and @ % , respectively , measured on the hand and chest of the interventionalist and the chest of the theatre nurse .


The use of disposable radiation-absorbing surgical drapes significantly reduces scatter radiation exposure for both the interventionalist and the supporting staff during EVAR procedures .


Clonidine may help prevent cardiac complications in patients undergoing non-cardiac surgery and receiving chronic beta-blocker therapy .


We conducted a multicentre pilot randomized trial to estimate recruitment rates for a full-scale trial and to assess the safety and tolerability of combining clonidine with chronic beta-blockade .


Patients who were at elevated perioperative cardiac risk , receiving chronic beta-blockade , and scheduled for major non-cardiac surgery were recruited in a blinded ( participants , clinicians , outcome assessors ) placebo-controlled randomized trial at three Canadian hospitals .


Participants were randomized to clonidine ( @ mg oral tablet one hour before surgery , plus @ mgday ( -@ ) transdermal patch placed one hour before surgery and removed four days after surgery or hospital discharge , whichever came first ) or matching placebo .


Feasibility was evaluated based on recruitment rates , with each centre being required to recruit @ participants within @-@ months .


Additionally , we reviewed study drug withdrawals and safety outcomes , including clinically significant hypotension or bradycardia .


Eighty-two of the @ participants were randomized to receive clonidine and @ to receive placebo .


The average time to recruit @ participants at each centre was @ months .


Six patients ( @ % ) withdrew from clonidine , while four ( @ % ) withdrew from placebo .


Based on qualitative review , there were no major safety concerns related to clonidine .


There was a moderate overall rate of cardiac morbidity , with @ participants ( @ % ) suffering postoperative myocardial infarction .


This pilot randomized trial confirmed the feasibility , safety , and tolerability of a full-scale trial of oral and transdermal clonidine for reducing the risk of cardiac complications during non-cardiac surgery .


This trial was registered at www.clinicaltrials.gov : NCT@ .


To explore the effect and feasibility of acupuncture in uterine involution after cesarean section .


Seventy cases of cesarean section in primipara were randomized into an observation group ( @ cases ) and a control group ( @ cases ) .


In the control group , the conventional treatment was adopted after cesarean section .


In the observation group , on the basic treatment as the control group , acupuncture was applied at Sanyinjiao ( SP @ ) , Hegu ( LI @ ) , Qihai ( CV @ ) and Guanyuan ( CV @ ) .


In @ h after operation , acupuncture started , once a day , continuously for five times .


The daily height of uterine fundus , daily uterine fundus decreasing degree , postpartum blood loss , lochia duration and ultrasonic B test in @ days of postpartum were compared between the two groups .


The therapeutic methods of the two groups all promoted uterine contraction .


The postpartum height of uterine fundus in the observation group was lower than that in the control group ( all P < @ ) and the uterine fundus decreasing degree was higher than that in the control group ( all P < @ ) .


The blood loss in @ h , @ to @ h and @ to @ h of postpartum was less than that in the control group ( all P < @ ) .


The lochia duration in the observation group was shorter than that in the control group ( P < @ ) .


Acupuncture promotes uterine contraction , reduces postpartum blood loss and lochia duration and benefits uterine involution after cesarean section .


We compared the efficacy and safety of indacaterol and tiotropium in patients with severe chronic obstructive pulmonary disease ( COPD ) and a history of at least one moderate to severe exacerbation in the previous @ months .


In this multicentre , randomised , blinded , double-dummy , parallel group study , we enrolled patients aged @ years or older with severe COPD and at least one exacerbation within the previous year .


We used a computer-generated sequence to randomly allocate patients ( @:@ ; stratified by baseline inhaled corticosteroid use , with the balance of treatments maintained at country level ) to receive either indacaterol ( @ g ) or tiotropium ( @ g ) once-daily for @ weeks .


Our primary and key secondary objectives were to investigate whether indacaterol was non-inferior to tiotropium for trough forced expiratory volume in @ s ( FEV@ ) at week @ ( primary endpoint ) , and for rate of exacerbations at week @ ( secondary endpoint ) .


Analysis populations for the primary and key secondary endpoints were per-protocol sets .


The safety set included all patients who received at least one dose of study drug .


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


Between March @ , @ , and July @ , @ , we enrolled and randomly allocated @ patients : @ to indacaterol and @ to tiotropium .


At week @ , the estimated least squares mean trough FEV@ difference between the groups was -@ L ( least squares mean with indacaterol -LSB- n = @ -RSB- @ L -LSB- SE @ -RSB- vs tiotropium -LSB- n = @ -RSB- @ L -LSB- @ -RSB- ; one-sided @ % CI lower limit -@ L ; p < @ ) .


The lower limit of the @ % CI was above the prespecified non-inferiority margin of -@ L , suggesting that indacaterol was non-inferior to tiotropium .


Indacaterol did not show non-inferiority in terms of annualised exacerbation rates : @ ( indacaterol , n = @ ) versus @ ( tiotropium , n = @ ) ; ratio @ ( one-sided @ % CI upper limit @ ) .


In the safety set , we recorded no between-group difference in the number of patients who had adverse events ( indacaterol @ -LSB- @ % -RSB- of @ patients vs tiotropium @ -LSB- @ % -RSB- of @ patients ) or serious adverse events ( indacaterol , @ -LSB- @ % -RSB- of @ patients vs tiotropium , @ -LSB- @ % -RSB- of @ patients ) .


Respiratory disorders , particularly worsening of COPD , were the most common adverse events ( COPD : indacaterol , @ -LSB- @ % -RSB- of @ patients and tiotropium , @ -LSB- @ % -RSB- of @ patients ) and serious adverse events ( COPD : indacaterol , @ -LSB- @ % -RSB- of @ patients and tiotropium , @ -LSB- @ % -RSB- of @ patients ) .


Indacaterol and tiotropium provided clinically relevant improvements in lung function with comparable safety profiles .


Tiotropium afforded greater protection from exacerbations , although the absolute number of events was small and the difference between treatments is of uncertain clinical importance .


The present data offer evidence consistent with current guidelines .


To estimate and compare the cost-effectiveness and safety of nebivolol with sustained-release metoprolol in reducing blood pressure by @ mm of Hg per day in hypertensive patients .


This was a prospective , randomized , open label , observational analysis of cost-effectiveness , in a questionnaire-based fashion to compare the cost of nebivolol ( @ mg , @ mg , @ mg ) and sustained released metoprolol succinate ( @ mg , @ mg , @ mg ) in hypertensive patients using either of the two drugs .


A total of @ newly detected drug nave hypertensive patients were considered for the comparison , of which @ patients were prescribed nebivolol and the other @ were prescribed metoprolol succinate as per the recommended dosage .


Based on the data , statistical analysis was carried out using GraphPad Prism @ and MS Excel Spreadsheet @ .


The cost of reducing @ mm of Hg blood pressure per day with nebivolol was @ , @ , and @ INR , whereas that of metoprolol succinate was @ , @ , and @ INR at their respective equivalent doses , hence significantly lower with the nebivolol group as compared to the metoprolol group ( P < @ ) .


This pharmacoeconomic analysis shows that nebivolol is more cost-effective as compared to metoprolol when the cost per reduction in blood pressure per day is considered .


This may affect the patients economically during their long-term use of these molecules for the treatment of hypertension .


Female breast cancer patients with a BRCA@/@ mutation have an increased risk of contralateral breast cancer .


We investigated the effect of rapid genetic counselling and testing ( RGCT ) on choice of surgery .


Newly diagnosed breast cancer patients with at least a @ % risk of a BRCA@/@ mutation were randomised to an intervention group ( offer of RGCT ) or a control group ( usual care ; ratio @:@ ) .


Primary study outcomes were uptake of direct bilateral mastectomy ( BLM ) and delayed contralateral prophylactic mastectomy ( CPM ) .


Between @ and @ , we recruited @ women .


On the basis of intention-to-treat analyses , no significant group differences were observed in percentage of patients opting for a direct BLM ( @ % for the RGCT group vs @ % for the control group ; odds ratio ( OR ) @ ; confidence interval ( CI ) @-@ @ ; P = @ ) or for a delayed CPM ( @ % for the RGCT group vs @ % for the control group ; OR @ ; CI @-@ @ ; P = @ ) .


Per-protocol analysis indicated that patients who received DNA test results before surgery ( @ out of @ women in the RGCT group ) opted for direct BLM significantly more often than patients who received usual care ( @ % vs @ % ; OR @ , CI @-@ @ , P = @ ) .


Although the large majority of patients in the intervention group underwent rapid genetic counselling , only a minority received DNA test results before surgery .


This may explain why offering RGCT yielded only marginally significant differences in uptake of BLM .


As patients who received DNA test results before surgery were more likely to undergo BLM , we hypothesise that when DNA test results are made routinely available pre-surgery , they will have a more significant role in surgical treatment decisions .


To assess links between comorbid health status , severe excess weight , and weight-related quality of life ( WRQOL ) in adolescents with severe obesity and undergoing weight-loss surgery ( WLS ) to inform clinical care .


Baseline ( preoperative ) data from Teen Longitudinal Assessment of Bariatric Surgery , a prospective multicenter observational study of @ adolescents with severe obesity ( MedianBMI = @ kg/m ( @ ) ; Meanage = @ ; @ % female ; @ % white ) undergoing WLS , were used to examine the impact of demographics , body mass index ( BMI ) , presence/absence of @ comorbid conditions , and a cumulative comorbidity load ( CLoad ) index on WRQOL scores ( Impact of Weight on Quality of Life-Kids ) .


WRQOL was significantly lower than reference samples of healthy weight , overweight , and obese samples .


Of @ comorbid conditions , the most prevalent were dyslipidemia ( @ % ) , chronic pain ( @ % ) , and obstructive sleep apnea ( @ % ) .


Male subjects had a greater CLoad ( P = @ ) and BMI ( P = @ ) , yet less impairment in total WRQOL ( P < @ ) than females .


CLoad was a significant predictor of male WRQOL .


For females , psychosocial ( vs physical ) comorbidities , BMI , and white race were significant predictors of WRQOL impairment .


Less prevalent conditions ( eg , stress urinary incontinence ) also emerged as contributors to lower WRQOL .


WRQOL impairment is substantial for adolescents with severe obesity undergoing WLS , with predictors varying by sex .


These patient-data highlight targets for education , support , and adjunctive care referrals before WLS .


Furthermore , they provide a comprehensive empirical base for understanding heterogeneity in adolescent WRQOL outcomes after WLS , as weight and comorbidity profiles change over time .


To evaluate the effects and safety of penetrating needling on head acupoints for perennial allergic rhinitis ( PAR ) .


Eighty-one cases of PAR were randomly divided into an acupuncture group ( @ cases ) and a medication group ( @ cases ) .


Penetrating needling at head acupoints was adopted from Baihui ( GV @ ) to Qianding ( GV @ ) and from Shangxing ( GV @ ) to Shenting ( GV @ ) in the acupuncture group .


A to tal @-week treatment was given to the patients with @ treatments a week .


Loratadine tablet and azelastine hydrochloride nasal spray were given to the medication group continuously for @ days .


A follow-up was carried out @ months after the treatment .


The efficacy , symptom score and physical sign score , and side accidents were observed in both groups .


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


The total scores of clinical symptoms and each partial scores after the treatment , and total scores of clinical symptoms in follow-up were obviously decreased in both groups ( all P < @ ) , the nasal obstruction score and the total scores of clinical symptoms in the acupuncture group were better than those in the medication group ( P < @ , P < @ ) .


Obvious side-effect had not been found during the treatment .


Penetrating needling at head acupoints is a safe therapy for patients with PAR , and favorable effects can be found in both short term and long term .


Skin fragments during lumbar punctures may develop intraspinal epidermoid tumors .


The aim of this study was to determine the incidence of epithelial cells that reflow along with the fi rst and third drops of CSF of patients undergoing spinal anesthesia .


Samples of the fi rst and third drops of cerebrospinal fluid were collected from @ adult patients undergoing spinal anesthesia with a @G Quincke needle .


Four microscope slides were prepared : one for the fi rst drop , one for third drop , one for the needle , and one with a drop of saline for control .


A pathologist examined the slides randomly .


Squamous epithelial cells were identified in @ ( @ % ) samples from the fi rst drop , @ ( @ % ) from the third drop , and @ ( @ % ) from spinal needle .


The third drop showed a mean number of cells larger than the fi rst drop ( p = @ ) .


Nucleated epithelial cells were found in a sample of the fi rst drop ( @ % ) , in four samples of third drop ( @ % ) , and in one spinal needle ( @ % ) .


Third drop showed a mean number of nucleated cells higher than fi rst drop with no statistical difference ( p = @ ) .


High percentage of epithelial cells was found in the fi rst ( @ % ) and third ( @ % ) drops of CSF reflow and in used needles ( @ % ) .


Skin cells were found even using small gauge disposable needles with well-adapted mandrel .


Omega-@ fatty acids ( n-@ FAs ) may have beneficial clinical effects , and n-@ FA supplements may improve outcome after surgery .


In a randomized double-blind placebo-controlled trial in single centre , patients referred for elective colorectal cancer surgery received either an n-@ FA-enriched oral nutritional supplement ( ONS ) ( Supportan , @ ml twice daily ) providing @ g eicosapentaenoic acid ( EPA ) and @ g docosahexaenoic acid ( DHA ) per day , or a standard isocaloric and isonitrogenous ONS , for @ days before and @ days after surgery .


The primary endpoint was infectious and non-infectious complications within @ days of surgery .


Secondary endpoints were length of hospital stay , intensive care unit admission , readmissions , and concentrations of marine n-@ FAs and arachidonic acid in granulocyte membranes .


Some @ consecutive patients ( @ women , @ men ; mean age @ ( range @-@ ) years ) were randomized .


There was no significant difference between groups in infectious or non-infectious postoperative complications ( P = @ ) .


Granulocyte levels of EPA , DHA and docosapentaenoic acid ( DPA ) were significantly higher in the n-@ FA-enriched supplement group compared with the control group ( P < @ ) .


The arachidonic acid level in granulocytes was significantly lower in the enriched group than in the control group ( P < @ ) .


EPA , DHA and DPA were incorporated into granulocytes in patients receiving n-@ FAs , but this was not associated with improved postoperative outcomes .


The aim of this study was to investigate and evaluate the efficacy of Rheum emodi in the management of primary dysmenorrhoea .


A randomized , single-blind , standard controlled trial compared efficacy of R. emodi against mefenamic acid on diagnosed subjects of primary dysmenorrhoea for three consecutive cycles .


Experimental group ( n = @ ) received capsules of R. emodi powder two times a day , two days before the expected date of menstruation , and continued first three days of menstruation , while control group ( n = @ ) participants received mefenamic acid capsules three times a day on the same protocol .


The primary outcome measures were reduced in severity and duration of pain , assessed by visual analogue scale ( VAS ) and verbal multidimensional scoring system ( VMSS ) , and secondary outcome measures were overall improvement of dysmenorrhoea and improved in quality of life ( QOL ) .


Statistical analysis was done by repeated measures analysis of variance and Chi-square/Fisher Exact test .


The menstrual pain was significantly decreased in both groups after three-cycle intervention .


Significant changes were observed in VAS ( p < @ ) and VMSS ( p < @ ) in the experimental group .


There is a significant ( p < @ ) reduction in duration of pain in both the groups .


Associated symptoms and QOL were markedly improved after treatment ( p < @ ) .


It has been clear from the above result that R. emodi is an effective herb in alleviating symptoms of primary dysmenorrhoea .


It can serve as an alternative treatment without any apparent side effects .


These results deserve further investigations .


To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks ( IANB ) .


A randomized , triple-blind clinical trial comprising @ patients who required lower third molar removal was performed .


In the control group , all patients received an IANB using the conventional Halsted technique , whereas in the experimental group , a modified technique using a more inferior injection point was performed .


A total of @ patients were randomized .


The modified technique group showed a significantly higher onset time in the lower lip and chin area , and was frequently associated to a lingual electric discharge sensation .


Three failures were recorded , @ of them in the experimental group .


No relevant local or systemic complications were registered .


Both IANB techniques used in this trial are suitable for lower third molar removal .


However , performing an inferior alveolar nerve block in a more inferior position ( modified technique ) extends the onset time , does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries .


In a randomized trial comparing nevirapine ( NVP ) - based versus lopinavir/ritonavir ( LPV/r ) - based antiretroviral therapy ( ART ) in HIV-infected children -LSB- primary endpoint discontinuation of study treatment for any reason or virologic failure by week @ -RSB- aged @ months to @ years , we assessed whether clinical , virologic , immunologic and safety outcomes varied by prior single-dose NVP exposure ( PrNVP ) for prevention of mother-to-child HIV transmission and other covariates .


Efficacy was assessed by time to ART discontinuation or virologic failure , virologic failure/death and death ; safety by time to ART discontinuation because of a protocol-defined toxicity and first grade @ adverse event ; immunology and growth by changes in CD@ % , weight/height World Health Organization z-scores from entry to week @ .


Cox proportional hazards and linear regression models were used to test whether treatment differences depended on PrNVP exposure and other covariates .


Over a median follow up of @ ( PrNVP ) and @ ( no PrNVP ) weeks , there was no evidence of differential treatment effects by PrNVP exposure or any other covariates .


LPV/r-based ART was superior to NVP-based ART for efficacy and safety outcomes ; however , those on NVP had larger improvements in CD@ % , weight and height z-scores .


Lower pretreatment CD@ % and higher HIV-@ RNA levels were associated with reduced efficacy , lower pretreatment CD@ % with shorter time to ART discontinuation because of a protocol-defined toxicity , and no PrNVP with shorter time to first grade @ adverse event .


Differences between LPV/r and NVP ART in efficacy , safety , immunologic and growth outcomes did not depend on PrNVP exposure , prior breast-feeding , sex , HIV-@ subtype , age , pretreatment CD@ % , HIV-@ RNA or World Health Organization disease stage .


This finding should be considered when selecting an ART regimen for young children .


To describe characteristics associated with neurotoxicity ( NT ) in advanced ovarian cancer patients treated on Gynecologic Oncology Group @ and examine effect of substituting docetaxel for paclitaxel in these patients .


The development of NT was defined as Common Toxicity Criteria grade ( G ) @ .


The association between substitution with docetaxel and NT improvement was explored with generalized estimating equations adjusting for treatment cycle and NT grading at previous cycle .


Of @ evaluable patients , @ ( @ % ) developed G@ NT during the study .


Nearly half appeared within the first two cycles of chemotherapy , with @ % experiencing G@ .


Older patients or those with worse quality of life ( QoL ) scores at baseline ( p < @ ) were more likely to experience NT .


One-hundred-six patients received docetaxel as substitute for paclitaxel .


Of them , @ patients started with docetaxel at cycle one due to reaction to paclitaxel ( n = @ ) , fear of NT ( n = @ ) , and other reasons ( n = @ ) , whereas @ patients switched to docetaxel during cycle @-@ due to NT ( n = @ ) , reaction to paclitaxel ( n = @ ) , and other reasons ( n = @ ) .


Although the protocol instructed otherwise , the majority continued paclitaxel despite G@ NT symptoms .


There was no evidence that substitution with docetaxel improved NT ( Odds Ratio : @ ; @ % CI @-@ @ ; p > @ ) .


Of @ patients who switched to docetaxel , only seven ( @ % ) discontinued taxane prior to chemotherapy completion .


A roughly equal chance of worsening NT was reported on paclitaxel ( @ % ) as on docetaxel ( @ % ) .


Age and worse QoL at baseline are associated with NT .


Substitution of docetaxel did not improve NT symptoms .


In a randomized phase III study , trametinib prolonged progression-free survival and improved overall survival versus chemotherapy in patients with BRAF V@ mutation-positive melanoma .


Patients ' quality of life ( QOL ) was assessed at baseline and follow-up visits using the European Organisation for Research and Treatment of Cancer Core QOL questionnaire .


In the primary efficacy population ( BRAF V@E + , no brain metastases ) from baseline to weeks @ and @ , patients ' global health status scores worsened by @-@ points with chemotherapy but improved by @-@ points with trametinib .


Rapid and substantive reductions in QOL functionality ( e.g. role functioning , @-@ points at weeks @ and @ ) and symptom exacerbation ( e.g. fatigue , @-@ points ; nausea and vomiting , @ points , both at weeks @ and @ ) were observed in chemotherapy-treated patients .


In contrast , trametinib-treated patients reported small improvements or slight worsening from baseline at week @ , depending on the functional dimension and symptom .


The mean symptom-scale scores for chemotherapy-treated patients increased from baseline ( symptoms worsened ) for seven of eight symptoms at week @ ( except insomnia ) and six of eight symptoms at week @ ( except dyspnea and insomnia ) .


In contrast , at weeks @ and @ , the mean symptom-scale scores for trametinib decreased from baseline ( symptoms improved ) for pain ( @-@ points ) , insomnia ( @-@ points ) , and appetite loss ( @-@ points ) , whereas those for diarrhea worsened ( @-@ points ) .


Mixed-model repeated-measures analyses showed significant ( P < @ ) and/or clinically meaningful improvements ( small to moderate ) from baseline in favor of trametinib for global health ; physical , role , and social functioning ; fatigue ; pain ; insomnia ; nausea and vomiting ; constipation ; dyspnea ; and appetite at weeks @ and/or @ .


QOL results for the intent-to-treat population were consistent .


This first QOL assessment for a MEK inhibitor in metastatic melanoma demonstrated that trametinib was associated with less functional impairment , smaller declines in health status , and less exacerbation of symptoms versus chemotherapy .


Daily azithromycin decreases acute exacerbations of chronic obstructive pulmonary disease ( AECOPD ) , but long-term side effects are unknown .


To identify the types of exacerbations most likely to be reduced and clinical subgroups most likely to benefit from azithromycin , @ mg daily , added to usual care .


Enrollment criteria included irreversible airflow limitation and AECOPD requiring corticosteroids , emergency department visit , or hospitalization in the prior year or use of supplemental oxygen .


Recurrent events and cumulative incidence analyses compared treatment received for AECOPD by randomization group , stratified by subgroups of interest .


Cox proportional hazards models estimated treatment effects in subgroups adjusted for age , sex , smoking status , FEV@ % predicted , concomitant COPD medications , and oxygen use .


Azithromycin was most effective in reducing AECOPD requiring both antibiotic and steroid treatment ( n = @,@ ; cumulative incidence analysis , P = @ ; recurrent events analysis , P = @ ) .


No difference in treatment response by sex ( P = @ ) , presence of chronic bronchitis ( P = @ ) , concomitant inhaled therapy ( P = @ ) , or supplemental oxygen use ( P = @ ) was observed .


Older age and milder Global Initiative for Chronic Obstructive Lung Disease stage were associated with better treatment response ( P = @ and @ , respectively ) .


A significant interaction between treatment and current smoking was seen ( P = @ ) and azithromycin did not reduce exacerbations in current smokers ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Azithromycin is most effective in preventing AECOPD requiring both antibiotic and steroid treatment .


Adjusting for confounders , we saw no difference in efficacy by sex , history of chronic bronchitis , oxygen use , or concomitant COPD therapy .


Greater efficacy was seen in older patients and milder Global Initiative for Chronic Obstructive Lung Disease stages .


We found little evidence of treatment effect among current smokers .


Clinical trial registered with www.clinicaltrials.gov ( NCT@ and NCT@ ) .


Current osteoporosis medications increase bone mineral density ( BMD ) modestly and reduce , but do not eliminate , fracture risk .


Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful .


Conversely , @ months of concomitant denosumab and teriparatide therapy increases BMD more than either drug alone .


The purpose of this study was to determine whether @ months of combined denosumab and teriparatide will increase hip and spine BMD more than either individual agent .


Preplanned continuation of the Denosumab and Teriparatide Administration ( DATA ) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide ( @ g daily ) , denosumab ( @ mg every @ months ) , or both medications for @ months .


Participants were @ postmenopausal women with osteoporosis .


Lumbar spine , femoral neck , total hip , and distal radius BMD and serum markers of bone turnover were measured .


At @ months , lumbar spine BMD increased more in the combination group ( @ @ % ) than in either the teriparatide ( @ @ % , P = @ ) or denosumab ( @ @ % , P = @ ) groups .


Femoral neck BMD also increased more in the combination group ( @ @ % ) than in either the teriparatide ( @ @ % , P = @ ) or denosumab ( @ @ % , P = @ ) groups .


Similarly , total hip BMD increased more in the combination group ( @ @ % ) than in the teriparatide ( @ @ % ) or denosumab ( @ @ % ) groups ( P < @ for both ) .


Although spine and hip BMD continued to increase in the second year in all groups , these year @ increases did not differ among groups .


Serum C-telopeptide and N-terminal propeptide of type @ procollagen were equally suppressed in the denosumab and combination groups , whereas osteocalcin decreased more in the denosumab group than in the combination group , a difference that persisted , but lessened , in the second year of therapy .


Two years of concomitant teriparatide and denosumab therapy increases BMD more than therapy with either medication alone and more than has been reported with any current therapy .


The combination of these agents may prove to be an important treatment option in patients at high risk of fracture .


Biocompatible solutions may lower peritonitis rates , but are more costly than conventional solutions .


The aim of the present study was to assess the additional costs and health outcomes of biocompatible over conventional solutions in incident peritoneal dialysis patients to guide practice decisions .


Secondary economic evaluation of a randomized controlled trial .


@ participants in the balANZ trial .


Cost-effectiveness of biocompatible compared to standard solution over the @ years using an Australian health care funder perspective .


Intervention group received biocompatible solutions and control group received standard solutions over @ years .


Costs included dialysis charges , costs of treating peritonitis , non-peritonitis-related hospital stays , and medication .


Peritonitis was the health outcome of interest ; incremental cost-effectiveness ratios were reported in terms of the additional cost per additional patient avoiding peritonitis at @ years .


Mean total per-patient costs were A$ @,@ and A$ @,@ for the biocompatible and standard-solution groups , respectively .


The base-case analysis indicated an incremental cost of A$ @,@ per additional patient avoiding peritonitis at @ years for biocompatible compared to standard solution .


In a sensitivity analysis excluding extreme outliers for non-peritonitis-related hospitalizations , mean per-patient costs were A$ @,@ and A$ @,@ for the biocompatible and standard-solution groups , respectively .


Consequently , the incremental cost-effectiveness ratio also was reduced significantly : biocompatible solution became both less costly and more effective than standard solution and , in economic terms , was dominant over standard solution .


Peritonitis was a secondary outcome of the balANZ trial .


Health outcomes measured only in terms of patients avoiding peritonitis over @ years may underestimate the longer term benefits ( eg , prolonged technique survival ) .


Biocompatible dialysis solutions may offer a cost-effective alternative to standard solutions for peritoneal dialysis patients .


Reductions in peritonitis-related hospital costs may offset the higher costs of biocompatible solution .


Nasal polyposis ( NP ) is defined as a specific form of chronic rhinosinusitis ( CRS ) , characterized by bilateral and multifocal polyps .


Functional endoscopic sinus surgery represents the gold standard therapy when medical treatment fails .


The availability of different tools raises the question of which one provides significant advances in technique and surgical outcome .


This study considered the outcome of the surgical treatment of NP in relation to several comorbidities and the surgical device used : the microdebrider versus the Blakesley traditional forceps .


Other studies compared the two instruments but did not evaluate the clinical relevance of history of comorbidities such as asthma , allergy , and eosinophilia .


A prospective randomized single-blind study was designed to analyze @ cases of bilateral CRS with NP .


Each patient served as his/her own control , meaning that one side was operated on using the Blakesley forceps and the opposite side using the microdebrider .


The follow-up period was @ @ months .


The Blakesley forceps caused a significantly lower NP recurrence rate than the microdebrider ( p < @ ) , which was more effective in preventing synechia formation ( p < @ ) .


Only asthma was significantly associated with a higher recurrence rate , without being influenced by the instrument used ( p < @ ) .


The manual instrument allowed for a significantly lower recurrence incidence but yielded a higher rate of synechia formation compared with the microdebrider .


Only asthma was significantly associated with a poorer clinical outcome , and gender , age , allergy , and eosinophilia did not affect the surgical prognosis .


We assessed the effectiveness of a worksite management intervention ( the @W program ) for overweight and obese hotel employees .


The program was tested in a @-year cluster-randomized trial involving @ hotels that employed nearly @,@ individuals .


All participating hotels were on Oahu , Hawaii .


The intervention was implemented within hotel worksites .


Participants were included in the analysis if they had an initial body mass index ( BMI ) @ , were assessed at least twice , were not missing other data needed for the analysis , and did not switch to employment at a hotel in a different experimental condition .


Of the @ employees we assessed , data from @ individuals ( intervention : @ ; control : @ ) met these criteria and contributed to the analysis .


The intervention had two components : ( @ ) group meetings and ( @ ) a workplace environment intervention .


Weight and waist to height ratio ( WHtR ) were measured at three annual assessments .


The effect of the intervention on change in BMI and WHtR was estimated in hierarchical mixed regression models using full maximum likelihood to estimate model parameters .


The effects on change in BMI and WHtR were in the expected direction but were not statistically significant .


The @W program was not effective .


The low intensity of the intervention may have contributed to its ineffectiveness .


To determine whether kangaroo holding of healthy preterm infants over the first eight weeks of an infant 's life facilitates co-regulation of salivary cortisol between mother and infant .


Randomized control trial .


Infants were assigned to receive @h of daily kangaroo ( skin-to-skin contact on the chest of mother ) or blanket holding ( dressed and held in mother 's arms ) .


A registered nurse visited mothers weekly for eight weeks to encourage holding and provide information about infant development .


A control group had no holding restrictions and received weekly brief social visits .


The study included @ preterm infants , born between @ and @weeks gestational age and were a mean of @days ( @ ) at enrollment .


Co-regulation was conceptualized as progressive reduction in the absolute difference between mother and infant cortisol levels across @min of holding at each holding session .


Mother and infant cortisol levels were measured before holding and at @ and @min after holding began during three holding sessions ( baseline and at two and eight weeks after study initiation ) .


Primary analyses were conducted using hierarchical linear models .


There was much variability in cortisol levels .


Levels of mother and infant cortisol decreased during holding .


No significant co-regulation occurred in any group at any holding session or over time .


Decreasing level of cortisol in both mothers and infants suggests that holding promoted the expected decline in stress hormone levels .


However , supported holding methods did not differentially affect co-regulation compared to controls .


Holding is pleasurable and stress may need to be present in order for mothers and infants to demonstrate co-regulation in cortisol levels .


The drug treatments of choice for obsessive-compulsive disorder ( OCD ) are serotonin reuptake inhibitors ( SRIs ) .


However , a correlation between the neuropeptide oxytocin in cerebrospinal fluid and the severity of OCD has previously been shown , and oxytocin and serotonin are interconnected within the brain .


Few studies have investigated whether SRIs have any effect on oxytocin ; thus , our aim was to explore the possibility that oxytocinergic mechanisms contribute to the anti-obsessive effect of SRIs .


In a randomized , double-blind trial , comparing SRIs ( clomipramine and paroxetine ) with placebo in @ adults with OCD ( characterized for subtypes ) , plasma oxytocin was measured with radioimmunoassay after plasma extraction , at baseline , after @ week , and after @ weeks of treatment , and related to baseline severity and clinical response after @ weeks , as measured by the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) .


Baseline oxytocin levels correlated positively with baseline Y-BOCS ratings , but only among the future SRI responders .


Patients with early onset of OCD had higher baseline oxytocin .


During treatment , plasma oxytocin did not differ between SRI and placebo treatment .


In SRI responders , plasma oxytocin first decreased and then increased ; in non-responders ( to SRI as well as to placebo ) , the reverse was the case .


After @ weeks , treatment responders had attained higher oxytocin levels compared to non-responders .


The intra-individual range ( i.e. , the variability ) of plasma oxytocin between measurements was the measure that best differentiated responders from non-responders .


This range was higher in responders than non-responders , and lower in patients with autistic traits .


SRIs have highly variable effects on plasma oxytocin between individuals .


The associations between baseline oxytocin and OCD severity and between oxytocin changes and treatment response support the notions that oxytocin is involved in OCD pathophysiology , and that the anti-obsessive effects of SRIs are partly exerted through oxytocinergic mechanisms .


To investigate the intra-ocular pressure ( IOP ) - lowering effects of a selective Rho kinase inhibitor , ripasudil ( K-@ ) , over @ hr in patients with primary open-angle glaucoma ( POAG ) or ocular hypertension ( OHT ) .


In this multicenter , prospective , randomized , open-label , @-period , Latin-square crossover clinical study , @ patients with POAG or OHT whose IOP level was @ mmHg or higher were subdivided into three groups .


Each patient was treated with placebo and ripasudil in concentrations of @ and @ % , at @:@ and @:@ on day @ through a total of @ periods separated by washout periods .


IOP was measured at @:@ , @:@ , @:@ , @:@ , @:@ , @:@ , @:@ , @:@ and @:@ on day @ , and @:@ , @:@ , @:@ and @:@ on day @ in sitting position using Goldmann applanation tonometer .


Main outcome measure was the IOP reduction of placebo and ripasudil from baseline .


The mean IOP reduction was -@ mmHg for @ % , -@ mmHg for @ % and -@ mmHg for placebo at @ hr after the first instillation .


Also , the corresponding values were -@ mmHg for @ % , -@ mmHg for @ % and -@ mmHg for placebo at @ hr after the second instillation .


Statistically significant IOP reduction , compared with placebo , was found for both @ and @ % from @ through @ hr after each instillation .


In safety , conjunctival hyperaemia was observed in @ patients ( @ % ) for @ % , @ patients ( @ % ) for @ % and three patients ( @ % ) for placebo .


Ripasudil is a promising new topical medication to lower IOP for at least @ hr after instillations in patients with POAG or OHT .


Extremely preterm babies ( delivered at < @ completed weeks of gestation ) are frequently diagnosed with hypotension and treated with inotropic and pressor drugs in the immediate postnatal period .


Dopamine is the most commonly used first-line drug .


Babies who are treated for hypotension more frequently sustain brain injury , have long-term disability or die compared to those who are not .


Despite the widespread use of drugs to treat hypotension in such infants , evidence for efficacy is lacking , and the effect of these agents on long-term outcomes is unknown .


In extremely preterm babies , restricting the use of dopamine when mean blood pressure ( BP ) values fall below a nominal threshold and using clinical criteria to determine escalation of support ( ` restricted ' approach ) will result in improved neonatal and longer-term developmental outcomes .


RESEARCH PLAN : In an international multi-centre randomised trial , @ infants born at < @ weeks of gestation , and within @ h of birth , will be allocated to @ of @ alternative treatment options ( dopamine vs. restricted approach ) to determine the better strategy for the management of BP , using a conventional threshold to commence treatment .


The first co-primary outcome of survival without brain injury will be determined at @ weeks ' postmenstrual age and the second co-primary outcome ( survival without neurodevelopmental disability ) will be assessed at @ years of age , corrected for prematurity .


It is essential that appropriately designed trials be performed to define the most appropriate management strategies for managing low BP in extremely preterm babies .


Cytotoxic T-lymphocyte-associated antigen @ ( CTLA-@ ) blockade with ipilimumab prolongs survival in patients with metastatic melanoma .


CTLA-@ blockade and granulocyte-macrophage colony-stimulating factor ( GM-CSF ) - secreting tumor vaccine combinations demonstrate therapeutic synergy in preclinical models .


A key unanswered question is whether systemic GM-CSF ( sargramostim ) enhances CTLA-@ blockade .


To compare the effect of ipilimumab plus sargramostim vs ipilimumab alone on overall survival ( OS ) in patients with metastatic melanoma .


The Eastern Cooperative Oncology Group ( ECOG ) conducted a US-based phase @ randomized clinical trial from December @ , @ , until July @ , @ , of patients ( N = @ ) with unresectable stage III or IV melanoma , at least @ prior therapy , no central nervous system metastases , and ECOG performance status of @ or @ .