The present study tests this reinforcement-reduction hypothesis among smokers preparing to quit .


After a one-week baseline , treatment-seeking smokers were randomized to receive three weeks of varenicline or placebo ( Weeks @-@ ) .


During each of the four weeks of the study , smokers completed a hypothetical cigarette purchase task ( CPT ) via handheld devices in their natural environment .


Behavioral economic measures of simulated smoking if cigarettes were free ( demand intensity ) , sensitivity of consumption to increasing price ( elasticity ) , and price at which purchases would drop to @ ( breakpoint ) were estimated .


The exponential demand equation fit the purchase task data well across subjects and time .


As predicted , demand intensity decreased and sensitivity to price ( elasticity ) increased over time .


However , changes in demand intensity did not differ by treatment group .


Contrary to our hypothesis that varenicline would increase sensitivity to price , the placebo group tended to become more elastic in their purchases during Weeks @ and @ ; the groups did not differ in elasticity at Week @ .


Breakpoint did not vary by group , time , or their interaction .


Simulated smoking demand can be validly assessed in the natural environment of treatment-seeking smokers .


Simulated demand indices of smoking reinforcement diminished as smokers approached their target quit date .


However , there was no evidence that varenicline facilitated these changes over a three-week period , leaving open the mechanisms by which varenicline reduces smoking rate prior to cessation and improves long-term abstinence .


In @ , we reported that selenium ( Se ) supplementation during radiation therapy ( RT ) is effective for increasing blood Se levels in Se-deficient cervical and uterine cancer patients , and reduced the number of episodes and severity of RT-induced diarrhea .


In the current study , we examine whether of Se supplementation during adjuvant RT affects long-term survival of these patients .


Former patients were identified and questioned with respect to their health and well-being .


A total of @ patients were randomized in the initial supplementation study , @ of whom received Se ( selenium group , SeG ) and @ of whom served as controls ( control group , CG ) .


When former patients were reidentified after a median follow-up of @ months ( range = @-@ ) , the actuarial @-year disease-free survival rate in the SeG was @ % compared to @ % in the CG ( P = @ ) , and the actuarial @-year overall survival rate of patients in the SeG was @ % compared to @ % in the CG ( P = @ ) .


Our extended follow-up analysis demonstrates that Se supplementation had no influence on the effectiveness of the anticancer irradiation therapy and did not negatively affect patients ' long-term survival .


In view of its positive effects on RT-induced diarrhea , we consider Se supplementation to be a meaningful and beneficial adjuvant treatment in Se-deficient cervical and uterine cancer patients while undergoing pelvic radiation therapy .


A long oral exposure to food and a high-energy density of food have been shown to increase satiety feelings .


The effect of energy density is predominantly caused by an inhibition of gastric emptying .


It is hypothesized that prolonging oral exposure may have an additional effect on this inhibition of gastric emptying .


However , little human data are available to support this hypothesis .


The objective was to assess the effect of the duration of oral exposure to food on gastric emptying rate of gastric loads ( GLs ) low and high in energy density and on satiety feelings .


Twenty-six healthy men -LSB- mean SD age : @ @ y ; BMI ( in kg/m ( @ ) ) : @ @ -RSB- participated in a randomized crossover trial with @ treatments and a control .


Treatments consisted of either @ - or @-min modified sham feeding ( MSF ) of cake , and a GL of either @ or @ kcal infused in the stomach via a nasogastric tube ( @ mL , @ mL/min ) .


The control consisted of no MSF and a GL of @ mL of water .


Gastric emptying rate was assessed with a ( @ ) C breath test .


Breath samples and satiety feelings were collected at fixed time points until @ min after start of the treatment .


Gastric emptying rate and satiety feelings were not affected by duration of MSF ( P @ ) .


However , the @-kcal GL treatments slowed gastric emptying -LSB- @ % lower area under the curve ( AUC ) -RSB- and increased satiety feelings ( @-@ % higher AUC ) compared with the @-kcal GL treatments ( P < @ ) .


No interaction between MSF duration and energy density of GL was found ( P @ ) .


Higher gastric energy density inhibited gastric emptying and increased satiety feelings in healthy young men .


However , prolonging oral exposure to food did not have an additional effect .


This study provides more insight in satiety regulation .


This trial was registered at trialregister.nl as NTR@ .


Many recent studies suggest that the kallikrein-kinin system play a protective role in the impairment of vascular smooth muscle cells and vascular endothelial cell .


The study aims to determine whether tissue kallikrein is efficacy for preventing the long-term in-stent restenosis after stenting of symptomatic atherosclerotic stenosis of the middle cerebral artery M@ segment .


This is a Phase II , randomized , single-blinded , controlled trial .


In line with SAMMPRIS stenting indications , patients ( n = @ ) with the symptomatic the middle cerebral artery M@ segment stenosis @ % and successfully treated with stent will be enrolled .


Eligible patients will be randomized using computer generated numbers , and allocated to receive tissue kallikrein treatment or not .


Patients in tissue kallikrein treatment group will be prescribed with intravenous infusion of tissue kallikrein ( @ PNAU/d , dissolved in @ ml saline ) for @ days after stenting and then oral administration of pancreatic kallikrein enteric-coated tablet ( @ U , @/d ) to the end of study .


As the foundation treatment , all the enrolled patients will receive aspirin ( @ mg/d ) , clopidogrel ( @ mg/d ) , and atorvastatin ( @ mg/d ) for the first @ months and continue with the combination of aspirin and atorvastatin at the previous dosage .


Patients will be evaluated at @ , @ and @ months after stenting .


The primary outcomes are the in-stent restenosis rate , new stroke or aggravation of the previous ischemic stroke ipsilateral to the severe stenotic artery .


Secondary outcomes include stroke of other artery territories , myocardial infarction and vascular death .


Modification of stroke knowledge , exercise and diet habit , smoking cessation and available laboratory data will also be recorded .


As our pilot study , tissue kallikrein would be expected to prevent the long-term in-stent restenosis after stenting of the symptomatic middle cerebral artery dramatically .


Advanced glycation end product ( AGE ) accumulation is thought to be a measure of cumulative metabolic stress that has been reported to independently predict cardiovascular disease in diabetes and renal failure .


The aim of this study was to evaluate the association between AGE accumulation , measured as skin autofluorescence , and the progression of renal disease in pre-dialysis patients with chronic kidney disease ( CKD ) .


Skin autofluorescence was measured noninvasively with an autofluorescence reader at baseline in @ pre-dialysis patients with CKD .


The primary end point was defined as a doubling of serum creatinine and/or need for dialysis .


Thirty-three patients were lost to follow-up .


Forty six patients reached the primary end point during the follow-up period ( Median @ months ) .


Kaplan-Meier analysis showed a significantly higher risk of development of the primary end points in patients with skin autofluorescence levels above the optimal cut-off level of @ arbitrary units , derived by receiver operator curve analysis .


Cox regression analysis revealed that skin autofluorescence was an independent predictor of the primary end point , even after adjustment for age , gender , smoking history , diabetes , estimated glomerular filtration rate and proteinuria ( adjusted hazard ratio @ , P = @ ) .


Tissue accumulation of AGEs , measured as skin autofluorescence , is a strong and independent predictor of progression of CKD .


Skin autofluorescence may be useful for risk stratification in this group of patients ; further studies should clarify whether AGE accumulation could be one of the therapeutic targets to improve the prognosis of CKD .


There is no consensus on the optimal perioperative antibiotic prophylaxis regimen for renal transplant recipients .


Some studies have reported that irrigation of the wound at the time of closure without systemic antibiotics may suffice to minimize the risk for surgical site infection ( SSI ) , but many centers still use long-term , multidose regimens in which antibiotics are administered until removal of foreign bodies occur , such as the urethral catheter , drain and central line .


We designed a prospective , randomized , multicenter , controlled trial to compare a single dose versus a multidose regimen of systemic antibiotic prophylaxis in adult , nondiabetic , non-morbidly obese patients undergoing renal transplantation .


The primary endpoint was the incidence of SSI ; the assessment of other infection in the first postoperative month was the secondary endpoint .


Two hundred five patients were enrolled and randomized to receive either a single ( n = @ ) or multidose antibiotic regimen ( n = @ ) for prophylaxis .


The incidences of SSI and urinary tract infection were similar in both groups .


As the dramatic increase in antibiotic resistance has mandated the implementation of global programs to optimize the use of antibiotic agents in humans , we believe that the single dose regimen is preferred , at least in nondiabetic , non-morbidly obese , adult renal transplant recipients .


To investigate the relationship between binge eating behavior and weight loss maintenance over a two-year period in adults .


Secondary data analysis using the Keep It Off study , a randomized trial evaluating an intervention to promote weight loss maintenance .


@ men and women ( ages : @ to @y ; BMI : @-@kg / m@ ) who had intentionally lost @ % of their weight during the previous year .


Body weight was measured and binge eating behavior over the past @ months was reported at baseline , @ months and @ months .


Height was measured at baseline .


Prevalence of binge eating at baseline was @ % ( n = @ ) .


Prevalence of binge eating at any time point was @ % ( n = @ ) .


Although rate of weight regain did not differ significantly between those who did or did not report binge eating at baseline , binge eating behavior across the study period ( additive value of presence or absence at each time point ) was significantly associated with different rates of weight regain .


Tailoring weight loss maintenance interventions to address binge eating behavior is warranted given the prevalence and the different rates of weight regain experienced by those reporting this behavior .


To assess whether the increased sensitivity of screening for human papillomavirus ( HPV ) may represent overdiagnosis and to compare the long term duration of protective effect against cervical intraepithelial neoplasia grade @ or worse ( CIN@ + ) in HPV based and cytology based screening .


@ year follow-up of the Swedescreen randomised controlled trial of primary HPV screening .


Organised cervical screening programme in Sweden .


@,@ women aged @-@ attending organised screening were enrolled and randomised to HPV and cytology double testing ( intervention arm , n = @ ) or to cytology only , with samples frozen for future HPV testing ( control arm , n = @ ) .


Cumulative incidence of CIN@ + and CIN@ + ( Kaplan Meier curves ) .


Longitudinal test characteristics were calculated for cytology only , HPV testing only , and cytology and HPV testing combined , adjusting for censoring .


The increased detection of CIN@ + in the intervention arm decreased over time .


After six years , the cumulative incidence of CIN@ + was similar in both trial arms , and after @ years the cumulative incidence of CIN@ + became similar in both arms .


The longitudinal sensitivity of cytology for CIN@ + in the control arm at three years was similar to the sensitivity of HPV testing in the intervention arm at five years of follow-up : @ % ( @ % confidence interval @ % to @ % ) v @ % ( @ % to @ % ) .


The sensitivity of HPV screening for CIN@ + after five years was @ % ( @ % to @ % ) and for cytology after three years was @ % ( @ % to @ % ) .


Over long term follow-up , the cumulative incidence of CIN@ + was the same for HPV screening and for cytology , implying that the increased sensitivity of HPV screening for CIN@ + reflects earlier detection rather than overdiagnosis .


The low long term risks of CIN@ + among women who tested negative in HPV screening , support screening intervals of five years for such women .


In the US , past month tobacco use is higher among young adults aged @-@ years than among any other age group .


Neighborhood disorder may be a malleable environmental determinant of tobacco use among young adults ; its correlation with tobacco use is understudied .


The purpose of this study is to examine whether perceived and objectively measured neighborhood factors are associated with tobacco use among young adults in Baltimore City .


This cross-sectional study of predominately African American young adults ( n = @ ) used logistic regression models via generalized estimating equations ( GEE ) to estimate the association of perceived and objective neighborhood disorder with past month tobacco use , adjusting for race , age , sex , income , and other substance use .


Two measures of perceived neighborhood environment - neighborhood drug involvement , and neighborhood social cohesion - were derived from the Neighborhood Environment Scale ( NES ) .


Objective neighborhood disorder was measured via trained field raters using the Neighborhood Inventory for Environmental Typology ( NIfETy ) instrument .


Sex modified the relationship between perceived neighborhood drug involvement and past month tobacco use , and the association was significant among women only ( aOR = @ ; @ % CI = @-@ @ ) .


Perceptions of neighborhood social cohesion ( aOR = @ ; @ % CI = @-@ @ ) , and objective neighborhood disorder ( aOR = @ ; @ % CI = @-@ @ ) were not significantly associated with past month tobacco use .


Understanding the correlation between perceived and objective neighborhood disorder , and their independent association with tobacco use can potentially lead to environmentally based interventions aimed at reducing tobacco use among young adults who live in urban environments .


Severe perineal tears sustained during childbirth cause significant distress and morbidity amongst women .


The objective of this study was to compare the use of straight scissors for cutting an episiotomy with the use of curved scissors , which are designed to curve away from the anal sphincter .


We used a single-centre , randomised feasibility trial .


The intervention was the use of curved scissors .


Women were recruited during a prenatal visit and randomised in the delivery suite , when it became clear that an episiotomy was required .


The feasibility outcomes were the proportion of women able to be recruited , randomised and followed up .


We also calculated the incidence of obstetric anal sphincter injury when either straight or curved scissors were used to cut an episiotomy .


Other outcomes assessed were pain , length of hospital stay , perineal infection and perineal dehiscence .


Of the @ patients recruited in the prenatal period , only @ ( @ % ) were eventually randomised at birth .


The main reasons for the high loss were that women either did not have a vaginal delivery ( @ , @ % ) , or they did not need an episiotomy ( @ , @ % ) .


Rates of obstetric anal sphincter injury and other outcomes were similar between groups .


Anal sphincter injury during childbirth remains an important problem .


Although the use of curved scissors provides a theoretical solution , we found that the high attrition rate made feasibility of conducting a suitably powered , randomised trial using the current design untenable .


Alternative strategies have been suggested to make any future study more viable .


To assess the antiviral efficacy of lamivudine ( LAM ) , entecavir ( ETV ) , telbivudine ( LDT ) , and lamivudine and adefovir dipivoxil ( CLA ) combination in previously untreated hepatitis B patients at different time points during a @-week treatment period .


A total of @ patients were included in this prospective , open-label , head-to-head study .


Serum levels of alanine transaminase ( ALT ) , hepatitis B virus ( HBV ) DNA , and hepatitis B e antigen ( HBeAg ) were measured at baseline , and at @ , @ , and @ weeks of treatment .


Median reductions in serum HBV DNA levels at @ weeks ( log @ copies/mL ) were as follows : LAM , @ ; ETV , @ ; LDT , @ ; and CLA , @ .


The corresponding HBV DNA undetectability rates were @ % , @ % , @ % , and @ % , respectively .


These two measures showed no significant intergroup differences .


Clinical efficacy appeared related to HBV DNA level reduction after @ weeks of therapy .


Patients were divided into three groups based on HBV DNA levels at week @ : Undetectable ( < @ ( @ ) copies/mL ) , detectable but < @ ( @ ) copies/mL , and > @ ( @ ) copies/mL .


Patients with levels below quantitation limit ( QL ) were analyzed at @ weeks for HBV DNA undetectability rate ( @ % ) , ALT normalization rate ( @ % ) , and viral breakthrough rate ( @ % ) .


The corresponding values in the QL-@ ( @ ) copies/mL group were @ % , @ % , and @ % , whereas those in the above @ ( @ ) copies/mL group were @ % , @ % , and @ % .


There were significant differences at week @ for HBV DNA levels and viral breakthrough rate between the three groups .


Different nucleos ( t ) ide ( NUC ) analogues tested exhibited no significant differences in effectiveness for Chinese NUC-naive HBV patients during @-year treatment period .


Chronic renal failure is a progressive and irreversible loss of kidney function , and the hemodialysis ( HD ) is one of the most common modalities in this regard .


Oxidative stresses -LSB- like interleukin-@ ( IL-@ ) and tumor necrosis factor-alpha ( TNF - ) -RSB- and inflammation are the main risk factors associated with cardiovascular diseases and other complications in many organs in hemodialysis patients ; meanwhile , antioxidants like alpha lipoic acid ( ALA ) may reduce the oxidative stress markers and the levels of inflammatory cytokines , so can improve of the patient 's quality of life .


In this randomized clinical trial study , @ HD patients were randomly categorized in two case and control groups .


Case group received a daily capsule of @ mg of ALA supplementation for @ weeks , and the control group received placebo capsules daily .


The serum level of IL-@ and TNF - was measured in both groups before and after the intervention .


There were no significant differences in age , gender , duration of dialysis , and causative factor for dialysis between both groups ( P > @ ) .


The mean of IL-@ and TNF - after the intervention in case group was @ @ and @ @ , respectively ; the difference between both groups was not statistically significant ( P > @ ) .


Based on the better feeling and other beneficial effects of ALA were found in our study ; we can conclude that it is a beneficial and recommended supplement , especially , for diabetic and dialysis patients .


To compare the efficacy and safety of antithrombotic prophylaxis given for @ week or @ weeks in patients undergoing laparoscopic surgery for colorectal cancer .


Extending antithrombotic prophylaxis beyond @ week reduces the incidence of venous thromboembolism ( VTE ) after open abdominal surgery for cancer .


In consecutive patients who underwent laparoscopic surgery for colorectal cancer , complete compression ultrasonography of the lower limbs was performed after @ @ days of antithrombotic prophylaxis .


Patients with no evidence of VTE were randomized to short ( heparin withdrawal ) or to extended ( heparin continued for @ additional weeks ) prophylaxis .


Complete compression ultrasonography was repeated at day @ @ after surgery by investigators blinded to treatment allocation .


The primary outcome of the study was the composite of symptomatic and ultrasonography-detected VTE at day @ @ after surgery .


Overall , @ patients were evaluated for inclusion in the study and @ were randomized .


VTE occurred in @ of @ patients randomized to short ( @ % ) and in none of the @ patients randomized to extended heparin prophylaxis ( P = @ ) .


The incidence of VTE at @ months was @ % and @ % in patients randomized to short or to extended heparin prophylaxis , respectively ( relative risk reduction : @ % , @ % confidence interval : @ % -@ % ; P = @ ) .


The rate of bleeding was similar in the @ treatment groups .


Two patients died during the study period , @ in each treatment group .


After laparoscopic surgery for colorectal cancer , extended antithrombotic prophylaxis is safe and reduces the risk for VTE as compared with @-week prophylaxis ( NCT@ ) .


We examined the effect of a single apple juice intake on the pharmacokinetics of fexofenadine enantiomers in healthy Japanese subjects .


In a randomized two phase , open-label crossover study , @ subjects received @mg of racemic fexofenadine simultaneously with water or apple juice .


For the uptake studies , oocytes expressing organic anion-transporting polypeptide @B@ ( OATP@B@ ) were incubated with @M ( R ) - and ( S ) - fexofenadine in the presence or absence of @ % apple juice .


One-time ingestion of apple juice significantly decreased the area under the plasma concentration-time curve ( AUC@-@ ) for ( R ) - and ( S ) - fexofenadine by @ and @ % , respectively , and prolonged the time to reach the maximum plasma concentration ( t max ) of both enantiomers ( P < @ ) .


Although apple juice greatly reduced the amount of ( R ) - and ( S ) - fexofenadine excretion into urine ( Ae@-@ ) by @ and @ % , respectively , the renal clearances of both enantiomers were unchanged between the control and apple juice phases .


For in vitro uptake studies , the uptake of both fexofenadine enantiomers into OATP@B@ complementary RNA ( cRNA ) - injected oocytes was significantly higher than that into water-injected oocytes , and this effect was greater for ( R ) - fexofenadine .


In addition , apple juice significantly decreased the uptake of both enantiomers into OATP@B@ cRNA-injected oocytes .


These results suggest that OATP@B@ plays an important role in the stereoselective pharmacokinetics of fexofenadine and that one-time apple juice ingestion probably inhibits intestinal OATP@B@-mediated transport of both enantiomers .


In addition , this study demonstrates that the OATP@B@ inhibition effect does not require repeated ingestion or a large volume of apple juice .


The introduction of all-trans-retinoic acid ( ATRA ) has significantly improved outcomes for acute promyelocytic leukemia ( APL ) , although a subset of patients still suffer relapse .


The purpose of this study was to evaluate the role of maintenance therapy with the synthetic retinoid tamibarotene in APL .


Patients with newly diagnosed APL in molecular remission at the end of consolidation therapy were randomly assigned to receive ATRA or tamibarotene , both orally , for @ days every @ months for up to @ years .


A total of @ patients were enrolled .


Of the @ eligible patients , @ ( @ % ) achieved complete remission .


After completing three courses of consolidation therapy , @ patients underwent maintenance random assignment .


The relapse-free survival ( RFS ) rate at @ years was @ % for the ATRA arm and @ % for the tamibarotene arm ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ) .


When the analysis was restricted to @ high-risk patients with an initial WBC count @ @ ( @ ) / L , the intergroup difference was statistically significant , with @-year RFS rates of @ % for the ATRA arm and @ % for the tamibarotene arm ( HR , @ ; @ % CI , @ to @ ) .


For patients with non-high-risk disease , the HR was @ ( @ % CI , @ to @ ) .


The test for interaction between treatment effects and these subgroups resulted in P = @ .


Both treatments were generally well tolerated .


In this trial , no difference was detected between ATRA and tamibarotene for maintenance therapy .


In an exploratory analysis , there was a suggestion of improved efficacy of tamibarotene in high-risk patients , but this requires further study .


Medical students often lack training in complex geriatric medical decision making .


We therefore developed the serious game , GeriatriX , for training medical decision making with weighing patient preferences , and appropriateness and costs of medical care .


We hypothesized that education with GeriatriX would improve the ability to deal with geriatric decision making and also increase cost consciousness .


A randomized , controlled pre-post measurement design .


Fifth-year medical students .


Playing the serious game GeriatriX as an additive to usual geriatric education .


We evaluated the effects of playing GeriatriX on self-perceived knowledge of geriatric themes and the self-perceived competence of weighing patient preferences , appropriateness , and costs of medical care in geriatric decision making .


Cost consciousness was evaluated with a postmeasurement to estimate costs of different diagnostic tests .


There was a large positive increase in the self-perceived competence of weighing patient preferences , appropriateness , and costs of medical care in the intervention group ( n = @ ) ( effect sizes of @ , @ , and @ , respectively ) , which was significantly better for the last @ aspects than in the control group ( n = @ ) .


The intervention group performed better on cost consciousness .


Although the self-perceived knowledge increased substantially on some geriatric topics , this improvement was not different between the intervention and control groups .


After playing the serious game , GeriatriX , medical students have a higher self-perceived competence in weighing patient preferences , appropriateness , and costs of medical care in complex geriatric medical decision making .


Playing GeriatriX also resulted in better cost consciousness .


We therefore encourage wider use of GeriatriX to teach geriatrics in medical curricula and its further research on educational and health care outcomes .


To evaluate the mid-to long-term results of a randomized controlled trial of single-bundle ( SB ) versus double-bundle ( DB ) anterior cruciate ligament ( ACL ) reconstruction using a semitendinosus tendon .


Seventy-eight patients who underwent primary ACL reconstruction with an autologous semitendinosus tendon were prospectively randomized into @ groups : SB reconstruction ( n = @ ) and DB reconstruction ( n = @ ) .


In both groups , grafts were fixed at @ of flexion with a total tension of @ N.


The following evaluation methods were used : clinical examination , KT-@ arthrometer ( MEDmetric , San Diego , CA ) measurement , muscle strength , Tegner activity score , Lysholm score , subjective rating scale regarding patient satisfaction and sports performance level , graft retear , contralateral ACL tear , and additional meniscus surgery .


Fifty-three patients ( @ in SB group and @ in DB group ) who were followed up for a minimum of @ years ( mean , @ months ; range , @ to @ months ) were evaluated .


Preoperatively , there were no differences between the groups .


Postoperatively , the Lachman and pivot-shift test results were better in the DB group ( P = @ and P < @ , respectively ) .


KT measurements were better in the DB group ( mean , @ mm v @ mm ; P = @ ) .


The Tegner score was also better in the DB group ( P = @ ) .


There were no significant differences in range of motion , muscle strength , Lysholm score , subjective rating scale , graft retear , and secondary meniscal tear .


In ACL reconstruction using the transtibial approach , DB reconstruction was significantly better than SB reconstruction regarding anterior and rotational stability during the @ - to @-year follow-up .


The results of KT measurements and the Lachman and pivot-shift tests were significantly better in the DB group , whereas there was no difference in the anterior drawer test results .


The Tegner score was also better in the DB group ; however , there were no differences in the other subjective findings .


Level II , lesser-quality prospective randomized trial .


The study aim is to investigate synergistic effects of cilostazol and probucol combination therapy on coronary plaque volume and composition .


A total of @ patients undergoing coronary stenting were treated with probucol and cilostazol combination therapy ( group ) or with cilostazol monotherapy ( group ) in a double-blind , randomized multicenter trial , and evaluated by virtual histology intravascular ultrasound ( VH-IVUS ) at baseline and @-month follow-up for changes in coronary plaque volume and composition at an index intermediate lesion with luminal narrowing @ % and @ % and for neointimal hyperplasia at the stented segment .


In all patients simvastatin @ mg was started with enrollment .


Qualifying VH-IVUS data from @ patients were included in the final analysis .


There were no significant differences between group and with respect to the primary endpoint , nominal change in normalized total atheroma volume ( TAV ) of the index intermediate coronary lesion ( -@ vs. -@ mm ( @ ) , p = @ ) , or plaque composition .


Plaque regression was observed in more than @ % of patients in both groups .


Diabetes was the only significant independent determinant of changes in TAV ( = @ , p = @ ) .


There were greater decreases in total cholesterol ( -@ vs. -@ mg/dL , p@ @ ) and LDL ( -@ vs. -@ mg/dL , p = @ ) levels in group than in group .


However , HDL cholesterol ( -@ vs. @ mg/dL , p@ @ ) and apoA@ ( -@ vs. @ mg/dL , p@ @ ) levels were also significantly decreased in group compared with group .


There were no significant differences in changes in plaque volume or composition between the cilostazol and probucol combination therapy and cilostazol monotherapy group despite different impacts of the treatments on lipid biomarkers .


Aspiration pneumonia is a leading cause of death in people with Parkinson disease ( PD ) .


The pathogenesis of these infections is largely attributed to the presence of dysphagia with silent aspiration or aspiration without an appropriate cough response .


The goal of this study was to test reflex cough thresholds and associated urge-to-cough ( UTC ) ratings in participants with PD with and without dysphagia .


Twenty participants with PD were recruited for this study .


They completed a capsaicin challenge with three randomized blocks of @ , @ , @ , and @ M capsaicin and rated their UTC by modified Borg scale .


The concentration of capsaicin that elicited a two-cough response , total number of coughs , and sensitivity of the participant to the cough stimulus ( UTC ) were measured .


The dysphagia severity of participants with PD was identified with the penetration-aspiration scale .


Most participants with PD did not have a consistent two-cough response to @ M capsaicin .


UTC ratings and total number of coughs produced at @ M capsaicin were significantly influenced by dysphagia severity but not by general PD severity , age , or disease duration .


Increasing levels of dysphagia severity resulted in significantly blunted cough sensitivity ( UTC ) .


UTC ratings may be important in understanding the mechanism underlying morbidity related to aspiration pneumonia in people with PD and dysphagia .


Further understanding of decreased UTC in people with PD and dysphagia will be essential for the development of strategies and treatments to address airway protection deficits in this population .


Fluoroquinolones are the most commonly used group of antimicrobials for the treatment of enteric fever , but no direct comparison between two fluoroquinolones has been performed in a large randomised trial .


An open-label randomized trial was conducted to investigate whether gatifloxacin is more effective than ofloxacin in the treatment of uncomplicated enteric fever caused by nalidixic acid-resistant Salmonella enterica serovars Typhi and Paratyphi A.


Adults and children clinically diagnosed with uncomplicated enteric fever were enrolled in the study to receive gatifloxacin ( @ mg/kg/day ) in a single dose or ofloxacin ( @ mg/kg/day ) in two divided doses for @ days .


Patients were followed for six months .


The primary outcome was treatment failure in patients infected with nalidixic acid resistant isolates .


@ patients with a median age of @ ( IQR @-@ ) years were randomised .


Of the @ patients with culture confirmed enteric fever , @ patients were infected with nalidixic acid-resistant isolates .


In the ofloxacin group , @ out of @ patients had treatment failure compared to @ out of @ in the gatifloxacin group ( hazard ratio -LSB- HR -RSB- of time to failure @ , @ % CI @ to @ , p = @ ) .


The median time to fever clearance was @ days ( IQR @-@ @ ) in the ofloxacin group versus @ days ( IQR @-@ @ ) in the gatifloxacin group ( HR = @ , @ % CI @ to @ , p = @ ) .


The results in all blood culture-confirmed patients and all randomized patients were comparable .


Gatifloxacin was not superior to ofloxacin in preventing failure , but use of gatifloxacin did result in more prompt fever clearance time compared to ofloxacin .


Intimate partner violence ( IPV ) and its associated negative mental health consequences are significant for women in New Zealand and internationally .


One of the most widely recommended interventions is safety planning .


However , few women experiencing violence access specialist services for safety planning .


A safety decision aid , weighing the dangers of leaving or staying in an abusive relationship , gives women the opportunity to prioritise , plan and take action to increase safety for themselves and their children .


This randomised controlled trial is testing the effectiveness of an innovative , interactive web-based safety decision aid .


The trial is an international collaborative concurrent replication of a USA trial ( IRIS study NCT@ ) , regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment , eligibility screening and consent .


In a fully automated web-based trial ( isafe ) @ abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website .


Intervention components include : ( a ) safety priority setting , ( b ) danger assessment and ( c ) an individually tailored safety action plan .


Self-reported outcome measures are collected at baseline and @ , @ , and @-months post-baseline .


Primary outcomes are depression ( measured by Center for Epidemiologic Studies Depression Scale , Revised ) and IPV exposure ( measured by Severity Violence Against Women Scale ) at @ months post-baseline .


Secondary outcomes include PTSD , psychological abuse , decisional conflict , safety behaviors and danger in the relationship .


This trial will provide much-needed information on the potential relationships among safety planning , improved mental health , reduced violence as well as decreased decisional conflict related to safety in the abusive relationship .


The novel web-based safety decision aid intervention may provide a cost-effective , easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates .


The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet .


Finally , the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment , eligibility screening , consent and retention procedures .


Cell-based strategies that combine in vitro - expanded autologous chondrocytes with matrix scaffolds are currently preferred for full-thickness cartilage lesions of the knee @cm ( @ ) .


Although this approach is reasonable , continuing advances in the field of cartilage repair will further expand the options available to improve outcomes .


In the present clinical study , we compared the outcomes of matrix-induced autologous mesenchymal stem cell implantation ( m-AMI ) with matrix-induced autologous chondrocyte implantation ( m-ACI ) for the treatment of isolated chondral defects of the knee .


Prospective , single-site , randomized , single-blind pilot study .


Fourteen patients with isolated full-thickness chondral lesions of the knee > @cm ( @ ) were randomized into two treatment groups : m-AMI and m-ACI .


Outcomes were assessed pre-operatively and @ , @ , @ and @months post-operatively .


Clinical evaluations revealed that improvement from pre-operation to @months post-operation occurred in both groups ( p < @ ) .


At all follow-up intervals , m-AMI demonstrated significantly better functional outcomes ( motion deficit and straight leg raise strength ) than did m-ACI ( p < @ ) .


At all follow-up intervals , m-AMI demonstrated significantly better subjective sub-scale scores for pain , symptoms , activities of daily living and sport and recreation of the knee injury and osteoarthritis outcome score ( KOOS ) than did m-ACI ( p < @ ) .


Additionally , m-AMI demonstrated significantly better ( p < @ ) scores than m-ACI for the quality of life sub-scale of the KOOS and visual analog scale ( VAS ) severity at the @-month follow-up .


The Tegner activity score and VAS frequency were not significantly different between the two groups .


Graft failure was not observed on magnetic resonance imaging at the @-month follow-up .


m-AMI and m-ACI demonstrated very good-to-excellent and good-to-very good infill , respectively , with no adverse effects from the implant , regardless of the treatment .


For the treatment of isolated full-thickness chondral lesion of the knee , m-AMI can be used effectively and may potentially accelerate recovery .


A larger patient cohort and follow-up supported by histological analyses are necessary to determine long-term outcomes .


To evaluate the change in drusen volume following treatment with eculizumab , a systemic inhibitor of complement component @ .


Single-center , prospective , randomized , double-masked clinical trial .


Patients were randomized @:@ to receive intravenous eculizumab or placebo over @ weeks .


decrease in drusen volume of at least @ % at @-week follow-up .


Mean drusen cube root volumes were @ mm and @ mm ( P = @ ) at baseline and @ mm and @ mm ( P = @ ) at @ weeks in the eculizumab and placebo groups , respectively .


In the placebo group , one eye had a decrease in drusen volume of at least @ % and two eyes developed neovascularization through @ weeks .


Systemic complement inhibition with eculizumab did not significantly reduce drusen volume .


Drusen growth was dependent on the number of complement at-risk alleles .


Future trials should consider the use of a composite clinical trial endpoint in which efficacy is defined by the treatments ability to prevent drusen growth , neovascularization , and the formation of geographic atrophy over @ year .


Left atrial ( LA ) strain is a sensitive measure of LA mechanics .


However , its relationship with rhythm outcomes after catheter ablation in patients with atrial fibrillation ( AF ) is not well established .


The aim of this study was to evaluate whether baseline LA global longitudinal strain ( LA ) predicts rhythm outcomes in patients who undergo catheter ablation for AF .


In @ patients with AF ( paroxysmal , @ ; persistent , @ ) , comprehensive echocardiography was performed with assessment of LA by using Velocity Vector Imaging to calculate average strain values from apical four - and two-chamber views before ablation ( median , @ days ; interquartile range , @-@ days ) .


After a median of @ months ( interquartile range , @-@ @ months ) of follow-up , @ patients ( @ % ) had maintained sinus rhythm and @ patients ( @ % ) had recurrence of AF .


In our study cohort ( mean age @years ; mean left ventricular ejection fraction , @ % ) , impaired total LA ( LAtotal ) was associated with greater left ventricular mass index ( r = -@ , P < @ ) and worsening left ventricular diastolic function ( ratio of transmitral flow peak early diastolic velocity to peak early diastolic velocity of the mitral annulus : r = -@ , P < @ ; maximal LA volume index : r = -@ , P < @ ) .


Patients with LAtotal < @ % showed a higher incidence of AF recurrence compared with patients with LAtotal @ % ( log-rank P < @ ) .


In multivariate Cox proportional-hazards analysis , LAtotal was independently related to rhythm outcomes ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) after AF ablation .


Moreover , LAtotal provided incremental predictive value for rhythm outcomes over clinical features ( increment in global ( @ ) = @ , P < @ ) .


In patients with AF , baseline LAtotal was associated with rhythm outcome after catheter ablation .


Antimicrobial drugs are frequently prescribed to children for respiratory tract infections such as otitis , tonsillitis , sinusitis , and pneumonia .


We assessed the effect of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV@ ; GlaxoSmithKline ) on antimicrobial purchases .


In this nationwide phase @-@ cluster-randomised , double-blind trial , children younger than @ months were randomly assigned to receive PHiD-CV@ in @ of @ clusters or hepatitis B or A vaccine as control in @ clusters according to three plus one or two plus one schedules ( infants younger than @ months ) or catch-up schedules ( children aged @-@ months ) .


The main objective for the antimicrobial treatment outcome was to assess vaccine effectiveness against outpatient prescriptions of antimicrobial drugs recommended by national treatment guidelines for acute otitis media in Finland in children who received at least one dose of study vaccine before @ months of age .


Masked follow-up lasted from the date of first vaccination ( from Feb @ , @ , through Oct @ , @ ) to Dec @ , @ .


We obtained data on all purchased antimicrobial prescriptions through the benefits register of the Social Insurance Institution of Finland .


This and the nested acute otitis media trial are registered at ClinicalTrials.gov , numbers NCT@ and NCT@ .


More than @,@ children were enrolled .


In @,@ infants younger than @ months at enrollment , @,@ outpatient antimicrobial purchases were reported with incidence of @ per person-year in the control clusters .


Analysis of the main objective included @ % of all antimicrobial purchases : @,@ in the control and @,@ in the PHiD-CV@ clusters .


Vaccine effectiveness was @ % ( @ % CI @-@ ) and the incidence rate difference @ per person-year corresponding to the number needed to vaccinate of five ( @ % CI @-@ ) to prevent one purchase during the @ year follow-up for combined PHiD-CV@ three plus one and two plus one infant schedules .


The vaccine effectiveness was identical for the two infant schedules .


In the catch-up schedules , the vaccine effectiveness was @ % ( @ % CI -@ to @ ) .


Despite low relative rate reductions the absolute rate reductions were substantial because of the high incidence of the outcome .


This reduction would lead to over @,@ fewer antimicrobial purchases per year in children younger than @ months in Finland ( birth cohort of @,@ children ) .


To investigate the clinical efficacy of Shuganyiyang Capsule combined with conventional Western medicine ( tamsulosin hydrochloride sustained release tablets + prostat tablets ) for the treatment of type III prostatitis complicated by erectile dysfunction ( ED ) .


Eighty patients with type III prostatitis complicated by ED were equally randomized to an experimental and a control group , the former treated with Shuganyiyang Capsule combined with tamsulosin hydrochloride sustained release tablets and prostat tablets , while the latter with tamsulosin hydrochloride and prostat only , both for @ weeks .


Then the prostatitis symptoms , erectile function and psychological conditions of the patients were evaluated using NIH-CPSI , IIEF-@ , and hospital anxiety and depression scale ( HADA and HADD ) respectively .


The rates of recovery , excellence , effectiveness and ineffectiveness were calculated .


The scores on NIH-CPSI , IIEF-@ , HADA and HADD obtained at @ and @ weeks after treatment showed statistically significant differences between the two time points as well as from the baseline ( P < @ ) .


At @ weeks , the scores on NIH-CPSI , IIEF-@ , HADA and HADD were @ + / - @ , @ + / - @ , @ + / - @ , and @ + / - @ in the experimental group , as compared with @ + / - @ , @ + / - @ , @ + / - @ , and @ + / - @ in the control ( P < @ ) .


The rate of effectiveness was significantly higher in the experimental than in the control group ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- , P < @ ) .


Shuganyiyang Capsule combined with conventional Western medicine , such as alpha blockers and galenica , produces definite effect on chronic prostatitis complicated by ED , improves the psychological conditions of the patient , and enhances the therapeutic efficiency of chronic prostatits .


The purpose was to evaluate the effectiveness of Staying Healthy-Asthma Responsible & Prepared , an academic asthma health education and counseling program , on fostering the use of effective asthma self-care behaviors .


This was a phase III , two-group , cluster randomized , single-blinded , longitudinal design-guided study .


Caregivers of @ fourth - and fifth-grade students completed the asthma health behaviors survey at preintervention , and @ , @ , and @ months postintervention .


Analysis involved multilevel modeling .


All students demonstrated improvement in episode management , risk reduction/prevention , and health promotion behaviors ; Staying Healthy-Asthma Responsible & Prepared students demonstrated increased improvement in episode management and risk reduction/prevention behaviors .


Working with schoolteachers , nurses can improve the use of effective asthma self-care behaviors .


Macrolide resistance is an increasing problem ; there is therefore debate about when to implement maintenance treatment with macrolides in patients with chronic obstructive pulmonary disease ( COPD ) .


We aimed to investigate whether patients with COPD who had received treatment for three or more exacerbations in the previous year would have a decrease in exacerbation rate when maintenance treatment with azithromycin was added to standard care .


We did a randomised , double-blind , placebo-controlled , single-centre trial in The Netherlands between May @ , @ , and June @ , @ .


Patients ( @ years ) with a diagnosis of COPD who had received treatment for three or more exacerbations in the previous year were randomly assigned , via a computer-generated randomisation sequence with permuted block sizes of ten , to receive @ mg azithromycin or placebo three times a week for @ months .


Randomisation was stratified by use of long-term , low-dose prednisolone ( @ mg daily ) .


Patients and investigators were masked to group allocation .


The primary endpoint was rate of exacerbations of COPD in the year of treatment .


Analysis was by intention to treat .


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


We randomly assigned @ patients to the azithromycin group ( n = @ ) or the placebo group ( n = @ ) , of whom @ ( @ % ) versus @ ( @ % ) completed the study .


We recorded @ exacerbations in patients in the azithromycin group compared with @ in those in the placebo group .


The unadjusted exacerbation rate per patient per year was @ ( @ % CI @-@ ) for the azithromycin group and @ ( @-@ ) for the placebo group .


After adjustment , azithromycin resulted in a significant reduction in the exacerbation rate versus placebo ( @ , @ % CI @-@ ; p = @ ) .


Three ( @ % ) patients in the azithromycin group reported serious adverse events compared with five ( @ % ) in the placebo group .


During follow-up , the most common adverse event was diarrhoea in the azithromycin group ( nine -LSB- @ % -RSB- patients vs one -LSB- @ % -RSB- in the placebo group ; p = @ ) .


Maintenance treatment with azithromycin significantly decreased the exacerbation rate compared with placebo and should therefore be considered for use in patients with COPD who have the frequent exacerbator phenotype and are refractory to standard care .


To investigate the effect of ulinastatin , a urinary trypsin inhibitor , on the postoperative liver function in patients who have received bilateral total knee arthroplasty ( TKA ) under pneumatic tourniquet .


Totally @ patients who were scheduled to receive bilateral TKA under thigh tourniquet were randomly assigned into trial group ( U group , receiving intravenous ulinastatin ) and control group ( C group , receiving natural saline ) .


All patients received the same general anesthesia and postoperative analgesia .


The plasma concentrations of alanine transaminase ( ALT ) , total bilirubin ( TBil ) , and direct bilirubin ( DBil ) were recorded and compared preoperatively and @ , @ , @ , and @ hours after the surgery .


The demographic data were not significantly different between these two groups ( P > @ ) .


The ALT was not significantly changed after the surgery in the C group ( P > @ ) but was significantly decreased @ hours ( P = @ ) and @ hours ( P = @ ) after the surgery in the U group .


TBil and DBil were significantly increased @ hours ( P = @ , P = @ ) and @ hours ( P = @ , P = @ ) after the surgery in C group , while only that at @ hours ( P = @ , P = @ ) was significantly increased in the U group .


ALT @ hours ( P = @ ) , @ hours ( P = @ ) , @ hours ( P = @ ) after the surgery were significantly lower in the U group than those in C group .


TBil at the @ hours postoperatively in U group was significantly lower than that in C group ( P = @ ) .


DBil was not significantly different between C group and U group at all time points ( all P > @ ) .


The application of ulinastatin in bilateral TKA can protect postoperative liver function .


Chinese monogamous women may contract sexually transmitted diseases ( STD ) from their sole male sex partner , but these women do not have high self-efficacy in negotiating about condom use with their regular sex partners .


We aim to investigate the relative efficacy of a theory-based and clinic-based cognitive behavioral intervention versus a control intervention in increasing prevalence of condom use with their male sex partner among Chinese monogamous female sexually transmitted disease patients .


A randomized controlled trial ( RCT ) was conducted .


Participants were randomly allocated into the intervention group ( n = @ ) or the control group ( n = @ ) .


All participants were phone interviewed at baseline and at @ and @ months after completion of the baseline survey .


The three-session group intervention was based on the information-motivation-behavioral skills ( IMB ) model .


Participants of the control group were provided with educational pamphlets .


The primary outcome was consistent condom use in the last month .


Relative risks were calculated , and multiple logistic regression models were fit .


As compared to the control group , the intervention group reported higher prevalence of consistent condom use with the sole male sex partner in the last month at month @ ( @ versus @ % , RR = @ , @ % CI = @ , @ ) and month @ ( @ versus @ % , RR = @ , @ % CI = @ , @ ) , whilst the baseline between-group difference was statistically non-significant .


Some other secondary outcomes such as `` intention to request condom use in the next month even if the sexual partner dislikes using condoms '' were also statistically significant .


Furthermore , the majority ( @ % ) of the intervention group members were satisfied with the intervention .


The theory-based intervention is potentially efficacious , but the follow-up period was relatively short .


Large-scale randomized clinical trials and subsequent translational research are greatly warranted in the future .


This study aimed to examine the acute effect of caffeine on exercise capacity , exercise-related fatigue , and functional performance in prostate cancer survivors .


In this randomized , placebo-controlled , double-blind crossover study , @ prostate cancer survivors ( age , @ @ yr ; body mass , @ @ kg ; mean SD ) consumed @ @ mgkg ( -@ ) of anhydrous caffeine or a placebo @ h before completing a battery of exercise capacity and functional performance tests .


Testing sessions were separated by @-@ wk .


Immediate fatigue and perceived exertion were measured directly pre - and postexercise at both testing sessions .


Caffeine increased exercise capacity by @ s ( +@ % ; P = @ ) ; however , postexercise fatigue and perception of exertion were comparable with the placebo session ( P = @ and P = @ , respectively ) .


Increases in isometric grip strength trended toward significance in both dominant ( +@ % ; P = @ ) and nondominant ( +@ % ; P = @ ) hands in the caffeine trial compared with placebo .


Caffeine ingestion did not result in improvements in performance for any of the remaining functional measures , including the timed up-and-go test , repeated chair stands , @-m fast walk , and @-m backward tandem walk .


Systolic blood pressure and HR were significantly increased ( P = @ and P = @ , respectively ) upon completion of the testing battery when compared with placebo .


Consumption of caffeine @ h before exercise induced improvements in exercise capacity and muscular strength in prostate cancer survivors .


However , there was no change in exercise-related fatigue when compared with placebo despite reduction in timed performance of the @-m walk .


Caffeine seems to enhance exercise tolerance through improved performance with no subsequent increase in fatigue or perception of exertion and may be an appropriate strategy to promote exercise participation in prostate cancer survivors .


To determine whether initiation of cholinesterase inhibitors is associated with significant weight loss in a real-word clinical setting .


Retrospective cohort study from @ to @ comparing weight loss in individuals with dementia newly prescribed cholinesterase inhibitors and those newly prescribed other chronic medications .


National Veterans Affairs data .


Individuals aged @ and older with a diagnosis of dementia who received a new prescription for a cholinesterase inhibitor or other new chronic medication .


The primary outcome was time to @-pound weight loss over @ months .


Propensity score matching was used to control for the likelihood of receiving a cholinesterase inhibitor based on baseline characteristics .


Data were analyzed in a priori defined subgroups according to age , comorbid burden , and initial weight .


Of @,@ individuals that met study criteria , @,@ started on cholinesterase inhibitors were matched to @,@ started on other medications .


The propensity-matched cohorts were well balanced on baseline covariates .


Participants initiated on cholinesterase inhibitors had a higher risk of weight loss than matched controls at @ months ( hazard ratio = @ , @ % confidence interval ( CI ) = @-@ @ ) .


At @ months , @ % of participants taking cholinesterase inhibitors had experienced weight loss , compared with @ % of nonusers , corresponding to a number needed to harm of @ ( @ % CI = @-@ @ ) over @ year .


There were no significant differences in the risk of weight loss within subgroups .


These results are consistent with the available data from randomized controlled trials .


Clinicians should consider the risk of weight loss when prescribing cholinesterase inhibitors .


To evaluate whether the calcitonin gene-related peptide ( CGRP ) receptor antagonist telcagepant might be effective for migraine prevention .


In this randomized , double-blind , placebo-controlled , multicenter trial ( ClinicalTrials.gov NCT@ ) , patients experiencing @-@ migraine days during a @-week baseline were randomized to telcagepant @ mg , telcagepant @ mg , or placebo twice daily for @ weeks .


Efficacy was assessed by mean monthly headache days and migraine/probable migraine days ( headache plus @ associated symptom ) .


The trial was terminated following a recommendation from the Safety Monitoring Board due to hepatotoxicity concerns .


At termination , the planned @ patients had been randomized , @ had been treated with @ dose of study medication , and @ had completed the trial .


The mean treatment duration was @-@ days .


Thirteen patients , all in the telcagepant groups , had an alanine aminotransferase ( ALT ) elevation @ the upper limit of normal and @ of these also had an aspartate aminotransferase elevation @ the upper limit of normal .


Two patients had very high symptomatic transaminase elevations that occurred within @-@ weeks of treatment initiation and resolved after treatment discontinuation .


The originally planned efficacy analysis over @ weeks was not performed due to limited data at later time points , but there was evidence that telcagepant resulted in a larger reduction from baseline than placebo for mean monthly headache days ( month @ : @ mg = -@ , @ mg = -@ , placebo = -@ ; p < @ ) and migraine/probable migraine days ( month @ : @ mg = -@ , @ mg = -@ , placebo = -@ ; p < @ ) .


These data suggest a potential role for CGRP receptor antagonism in migraine prophylaxis .


However , the observed aminotransferase elevations do not support the use of telcagepant for daily administration .


This study provides Class II evidence that in patients with migraine , telcagepant taken daily reduces headache days by @ days per month compared to placebo and causes @ % of patients to have elevations of serum ALT levels .


Healthcare professionals play a critical role in women 's choice of contraceptive methods .


However , national surveys on sexual and reproductive health ( SRH ) among physicians are rare and present low participation rates .


We conducted a randomized trial to test for the effectiveness of three interventions to improve survey participation of private physicians delivering reproductive health services in France .


The study comprised a national random sample of @ general practitioners and @ gynecologists working in private offices .


All received a postal invitation to participate either by completing a paper , phone or online questionnaire .


Physicians were randomly assigned to six groups to test for the effect of three interventions : a non-monetary incentive in the form of a scientific book , telephone contact , and the possibility of completing the questionnaire by phone .


Overall , @ questionnaires were collected ( @ online , @ by phone ) and @ physicians were ineligible .


The completion rate increased from @ % in physicians who received no intervention to @ % in those who received the book and a phone call .


The phone call increased the completion rate by @ % percentage points ( P = @ ) , while the book had no significant effect .


Results from multivariate logistic regressions also indicate that gynecologists ( OR = @ ) and female physicians ( OR = @ ) were more likely to participate than others .


The results suggest that phone calls substantially increase participation of physicians in sexual and reproductive health surveys but have little impact on sampling distortion .


Differentials in response rates by physicians ' characteristics should be considered in future SRH studies among physicians .


Allogeneic stem-cell transplantation has had limited success for patients with refractory and relapsed aggressive B-cell or T-cell lymphoma .


We investigated the effect of adding rituximab to standard prophylaxis for graft-versus-host disease after transplantation and estimated overall survival when using a lymphoma-directed myeloablative conditioning regimen .


We did this randomised , open-label , phase @ study at seven German transplantation centres .


We enrolled patients with aggressive B-cell or T-cell lymphoma and primary refractory disease , early relapse ( < @ months after first-line treatment ) , or relapse after autologous transplantation .


Conditioning with fludarabine ( @ mg/m ( @ ) ) , busulfan ( @ mg/kg oral or @ mg/kg intravenous ) , and cyclophosphamide ( @ mg/kg ) was followed by allogeneic stem-cell transplantation .


Patients were randomly assigned ( @:@ ) to receive rituximab ( @ mg/m ( @ ) on days @ , @ , @ , @ , @ , @ , @ , and @ ) or not .


Allocation was done with a centralised computer-generated procedure ; patients were stratified by histological subtype ( B-cell vs T-cell lymphoma ) and donor match ( HLA-identical vs non-identical ) .


Neither investigators nor patients were masked to allocation .


The primary endpoints were the incidence of acute graft-versus-host disease grade @-@ in each treatment group and overall survival at @ year in both groups combined .


All analyses were done for the intention-to-treat population .


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


Between June @ , @ , and March @ , @ , we screened @ patients and enrolled @ ; @ were randomly assigned to each group .


The cumulative incidence of grade @-@ acute graft-versus-host disease was @ % ( @ % CI @-@ ) in the rituximab group and @ % ( @ % CI @-@ ) in the no rituximab group ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ; p = @ ) .


Overall survival at @ year for the whole study population was @ % ( @ % CI @-@ ) .


Grade @ haematological toxic effects and grade @ alopecia occurred in all patients .


The most common non-haematological grade @ toxic effects were pneumonia ( nine in the no rituximab group vs ten in the rituximab group ) and other infections ( seven vs four ) .


The lymphoma-directed myeloablative conditioning regimen developed here is promising for patients with refractory and relapsed aggressive B-cell and T-cell lymphomas .


However , the addition of rituximab did not affect the incidence of graft-versus-host disease or overall survival .


This study , based on Oklahoma 's statewide Child Development Accounts ( CDAs ) program , presents findings from the first experimental test of the hypothesis that creating lifelong savings accounts for children at birth promotes their long-term well-being .


To examine the effects of CDAs , an innovative social policy to encourage lifelong saving and asset building for long-term development , on parent-reported social-emotional development in early childhood .


A statewide randomized experiment of CDAs was conducted in @ , drawing a probability sample of @ children from all infants born in two @-month periods in Oklahoma ( April @ through June @ and August @ through October @ , @ ) .


After agreeing to participate in the experiment , caregivers of @ infants completed a baseline survey and were randomly assigned to treatment ( n = @ ) and control groups ( n = @ ) .


Approximately @ % of participants completed a follow-up survey in the spring of @ .


The intervention offered CDAs , built on the existing Oklahoma @ college-savings plan , to treatment participants .


It also provided additional financial incentives and information .


The primary outcome-child social-emotional development-is measured by scores from a @-item version of the Ages and Stages Questionnaire : Social-Emotional .


Caregivers completed it in the @-year follow-up survey .


Lower scores indicate better functioning .


The CDAs have positive effects on social-emotional development for children at approximately age @ years .


The nonweighted treatment-control difference is -@ ( @ % CI , -@ to -@ ; P = @ ) , but the weighted difference is nonsignificant .


The effects appear to be greater for disadvantaged subsamples , such as low-income households ( weighted mean difference,-@ @ ; @ % CI , -@ to -@ ; P = @ ) .


As a complement to other early education and health interventions , CDAs may improve social-emotional development in early childhood .


Their effects may be explained as a mediating process that influences parents .


Child Development Accounts may influence parental attitudes , behaviors , expectations , and involvement ; in turn , these may affect child development .


Asthma with neutrophil predominance is challenging to treat with corticosteroids .


Novel treatment options for asthma include those that target innate immune activity .


Recent literature has indicated a significant role for IL-@ in both acute and chronic neutrophilic asthma .


This study used inhaled endotoxin ( LPS ) challenge as a model of innate immune activation to ( @ ) assess the safety of the IL-@ receptor antagonist anakinra in conjunction with inhaled LPS and ( @ ) to test the hypothesis that IL-@ blockade will suppress the acute neutrophil response to challenge with inhaled LPS .


In a phase I clinical study @ healthy volunteers completed a double-blind , placebo-controlled crossover study in which they received @ daily subcutaneous doses of @ mg/kg anakinra ( maximum dose , @ mg ) or saline ( placebo ) .


One hour after the second treatment dose , subjects underwent an inhaled LPS challenge .


Induced sputum was assessed for neutrophils @ hours after inhaled LPS .


The effect of anakinra compared with placebo on airway neutrophil counts and airway proinflammatory cytokine levels after LPS challenge was compared by using a linear mixed-model approach .


Anakinra pretreatment significantly diminished airway neutrophilia compared with placebo .


LPS-induced IL-@ , IL-@ , and IL-@ levels were significantly reduced during the anakinra treatment period compared with those seen after placebo .


Subjects tolerated the anakinra treatment well without an increased frequency of infections attributable to anakinra treatment .


Anakinra effectively reduced airway neutrophilic inflammation and resulted in no serious adverse events in a model of inhaled LPS challenge .


Anakinra is a potential therapeutic candidate for treatment of asthma with neutrophil predominance in diseased populations .


To validate a magnetic resonance imaging sequence suitable for quantitative assessment of acid suppression by a proton pump inhibitor ( PPI ) on gastric secretion and emptying in clinical practice .


A golden angle radial sequence ( GOLD ) was validated in a series of in vitro and in vivo experiments and clinical feasibility was shown in two studies .


The impact of free breathing and image plane orientation on T@ values was evaluated in a controlled in vivo experiment .


The free-breathing GOLD sequence was compared against a standard breath-hold gradient echo sequence for gastric half emptying time in @ subjects during a gastric emptying study .


Pilot data from five subjects assessed the sensitivity of the GOLD sequence to detect changes in acid secretion volume produced by PPI treatment .


The coronal free-breathing GOLD sequence and the axial breath-hold standard gradient echo sequence showed good agreement of the gastric half emptying time ( @ @ min , P = @ ) .


The GOLD sequence demonstrated sensitivity to reduction of gastric secretion volumes induced by PPI treatment ( @ @ mL , P < @ ) .


The GOLD sequence allowed for free breathing , multislice , combined imaging and T@ mapping of the stomach content .


GOLD presents a promising multipurpose , noninvasive imaging tool for monitoring gastric function in clinical studies .


In spite of several studies , the impact of homocysteine level and folic acid supplementation on bone metabolism is yet to be recognized .


In this registered clinical trial ( IRCT@N@ ) , we aimed to find out the power of @-month folic acid supplementation on homocysteine level and bone metabolism .


Forty postmenopausal osteoporotic women ( @ to @years ) were enrolled in the study .


All participants were randomized to receive folic acid @mg ( n = @ ) or placebo ( n = @ ) .


At baseline , @months , and finally @months post intervention , the level of homocysteine , vitamin B@ , and bone biomarkers were measured .


Both groups were similar at baseline .


The homocysteine decreased in both groups but statistically non-significant ( P > @ ) .


The changes of the serum level of vitamin B@ , osteocalcin , and cross laps were significant between groups after @months ( P@ @ ) .


The trend of changes of bone biomarkers after @months folic acid supplementation shows that homocysteine concentration and/or folic acid supplementation have impact on the rate of bone metabolism .


However , further investigations by larger sample size and differentiating age and gender are still needed to clarify the exact role of folate , homocysteine and vitamin B@ .


Theta-burst transcranial magnetic stimulation ( TBS ) has been shown to induce potent and long lasting effects on cortical excitability .


In a previous open study , we demonstrated safety , tolerability and antidepressant properties of continuous TBS ( cTBS ) in major depression ( MD ) .


The present study was aimed to evaluate the therapeutic efficacy of cTBS in depressed patients using a double-blind , sham-controlled design .


Twenty nine patients with MD were randomized to receive either active cTBS to the right dorsolateral prefrontal cortex ( n = @ ) or sham cTBS ( n = @ ) for @ consecutive work days .


After the @th session , patients who received sham TBS were crossed over to active cTBS which consisted of @ daily sessions .


Patients who received active cTBS continued with the same treatment protocol for additional @ treatments .


Each treatment session consisted of @ stimuli at an intensity of @ % of the active motor threshold .


Severity of depression was assessed weekly .


Overall , there was no significant difference in the degree of clinical improvement between active and sham cTBS groups .


However , in patients whose medication status remained unchanged before the trial ( n = @ ) and in those who were medication-free ( n = @ ) , active cTBS resulted in a significantly greater reduction of Hamilton depression scores as compared to sham cTBS .


A small sample size , confounding effect of medication and short treatment period .


Our results suggest that the antidepressant effect of cTBS is modest , yet it might be beneficial to patients nonresponsive to ongoing pharmacological treatment .


A direct comparison between cTBS and conventional rTMS protocols is warranted .


To study the effects of continuous ultrasonic phacoemulsification performed with and without an anterior chamber maintainer ( ACM ) on corneal endothelial damage in patients with hard nuclear cataract .


Sixty eyes in @ patients with hard nuclear cataract ( grade IV ) , one lesion per eye , were randomly allocated into @ groups : continuous ultrasonic phacoemulsification with ( group A ) or without ( group B ) ACM .


The intraoperative accumulated energy complex parameter ( AECP ) , frequency of shallow anterior chamber , and postoperative corneal incision edema , corneal endothelial cell counts , and visual recovery were compared between the groups .


The intraoperative AECP , postoperative corneal incision edema , and postoperative visual recovery showed no significant differences between the groups ( p > @ ) .


At @ month postoperatively , the corneal endothelial cell loss rate and hexagonal cell percentage ( postoperative compared to preoperative ) in groups A and B were @ @ and @ @ % and @ @ and @ @ % , respectively , with no significant difference noted ( p > @ ) .


The endothelial cell mutation rate was significantly lower in group A than in group B at @ @ % and @ @ % , respectively ( p < @ ) .


The frequency of intraoperative shallow anterior chamber was significantly lower in group A than in group B ( @ vs @ times , p < @ ) .


Continuous ultrasonic phacoemulsification with ACM is a safe , effective , simple , and easy method to treat hard nuclear cataract and causes minimal damage to corneal endothelial cells .


It is an ideal surgical option and is worth popularizing .


Shorter resident duty periods are increasingly mandated to improve patient safety and physician well-being .


However , increases in continuity-related errors may counteract the purported benefits of reducing fatigue .


We evaluated the effects of @ resident schedules in the intensive care unit ( ICU ) on patient safety , resident well-being and continuity of care .


Residents in @ university-affiliated ICUs were randomly assigned ( in @-month rotation-blocks from January to June @ ) to in-house overnight schedules of @ , @ or @ hours .


The primary patient outcome was adverse events .


The primary resident outcome was sleepiness , measured by the @-point Stanford Sleepiness Scale .


Secondary outcomes were patient deaths , preventable adverse events , and residents ' physical symptoms and burnout .


Continuity of care and perceptions of ICU staff were also assessed .


We evaluated @ ( @ % ) of @ residents , all @ admissions , @ patient-days and @ staff surveys .


We found no effect of schedule ( @ - , @ - or @-h shifts ) on adverse events ( @ , @ and @ events per @ patient-days , respectively ; p = @ ) or on residents ' sleepiness in the daytime ( mean rating @ , @ and @ , respectively ; p = @ ) or at night ( mean rating @ , @ and @ , respectively ; p = @ ) .


Seven of @ preventable adverse events occurred with the @-hour schedule ( p = @ ) .


Mortality rates were similar for the @ schedules .


Residents ' somatic symptoms were more severe and more frequent with the @-hour schedule ( p = @ ) ; however , burnout was similar across the groups .


ICU staff rated residents ' knowledge and decision-making worst with the @-hour schedule .


Our findings do not support the purported advantages of shorter duty schedules .


They also highlight the trade-offs between residents ' symptoms and multiple secondary measures of patient safety .


Further delineation of this emerging signal is required before widespread system change .


Postpericardiotomy syndrome , postoperative atrial fibrillation ( AF ) , and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery .


Postoperative use of colchicine prevented these complications in a single trial .


To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome , postoperative AF , and postoperative pericardial or pleural effusions .


Investigator-initiated , double-blind , placebo-controlled , randomized clinical trial among @ consecutive candidates for cardiac surgery enrolled in @ Italian centers between March @ and March @ .


At enrollment , mean age of the trial participants was @ years ( SD , @ years ) , @ % were men , and @ % had planned valvular surgery .


Main exclusion criteria were absence of sinus rhythm at enrollment , cardiac transplantation , and contraindications to colchicine .


Patients were randomized to receive placebo ( n = @ ) or colchicine ( @ mg twice daily in patients @ kg or @ mg once daily in patients < @ kg ; n = @ ) starting between @ and @ hours before surgery and continued for @ month after surgery .


Occurrence of postpericardiotomy syndrome within @ months ; main secondary study end points were postoperative AF and pericardial or pleural effusion .


The primary end point of postpericardiotomy syndrome occurred in @ patients ( @ % ) assigned to colchicine and in @ ( @ % ) assigned to placebo ( absolute difference , @ % ; @ % CI , @ % -@ % ; number needed to treat = @ ) .


There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF ( colchicine , @ patients -LSB- @ % -RSB- ; placebo , @ patients -LSB- @ % -RSB- ; absolute difference , @ % ; @ % CI , -@ % to @ % ) or postoperative pericardial/pleural effusion ( colchicine , @ patients -LSB- @ % -RSB- ; placebo , @ patients -LSB- @ % -RSB- ; absolute difference , @ % ; @ % CI , -@ % to @ % ) , although there was a reduction in postoperative AF in the prespecified on-treatment analysis ( placebo , @/@ patients -LSB- @ % -RSB- ; colchicine , @/@ patients -LSB- @ % -RSB- ; absolute difference , @ % ; @ % CI , @ % -@ % ) .


Adverse events occurred in @ patients ( @ % ) in the placebo group vs @ ( @ % ) in the colchicine group ( absolute difference , @ % ; @ % CI ; @ % -@ % ; number needed to harm = @ ) , but discontinuation rates were similar .


No serious adverse events were observed .


Among patients undergoing cardiac surgery , perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion .


The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting .


It is uncertain whether HIV-@ antiretroviral exposure and clinical response varies between males and females or different race/ethnic groups .


We describe ritonavir-enhanced atazanavir pharmacokinetics in relation to virological failure , safety and tolerability in treatment-naive individuals to investigate potential differences .


Plasma samples were collected from participants in AIDS Clinical Trials Group Study A@ for measurement of antiretroviral concentrations .


Individual estimates of apparent oral clearance of atazanavir ( L/h ) were calculated from a one-compartment model and divided into tertiles as slow ( < @ ) , middle ( @ to < @ ; reference group ) and fast ( @ ) .


Associations between atazanavir clearance and clinical outcomes were estimated with a hazard ratio ( HR ) from Cox proportional hazards models .


Interactions between atazanavir clearance and sex , race/ethnicity and NRTIs were investigated for each of the outcomes .


Among @ participants , average atazanavir clearance was slower in females ( n = @ ) than males ( n = @ ) .


Atazanavir clearance was associated with time to virological failure ( P = @ ) and this relationship differed significantly by sex ( P = @ ) .


Females in the fast atazanavir clearance group had shorter time to virological failure ( HR @ ; @ % CI @-@ @ ) compared with the middle ( reference ) atazanavir clearance group .


Among males , the slow atazanavir clearance group had a higher risk of virological failure ( HR @ ; @ % CI @-@ @ ) .


Atazanavir clearance differed by sex .


Females with fast clearance and males with slow clearance had increased risk of virological failure .


Transthoracic oesophagectomy requires prolonged one-lung ventilation causing systemic and local inflammatory responses .


Application of continuous positive airway pressure ( CPAP ) to the collapsed lung potentially reduces pulmonary damage , hypoxia , and consequent inflammation .


This randomized controlled trial studied the influence of CPAP applied to the collapsed right lung during thoracoscopic oesophagectomy on local and systemic inflammatory response .


Broncho-alveolar lavage fluid ( BALF ) from the right collapsed and left ventilated lung and serum samples were obtained during surgery from @ patients undergoing thoracolaparoscopic oesophagectomy for cancer who were randomized for one-lung ventilation with or without CPAP applied to the collapsed right lung .


Concentrations of cytokines and chemokines , in BALF and serum , were determined with Luminex .


Patients from the control ( no CPAP ) group had significantly increased concentrations of interleukin ( IL ) -@ , IL-@ , IL-@ , tumour necrosis factor-alpha , macrophage inflammatory protein ( MIP ) -@ , pulmonary and activation-regulated chemokine ( PARC ) , and IL-@ in the collapsed ( right ) lung when compared with patients from the CPAP group ( P < @ ) .


The ventilated ( left ) lung of the control group showed increased concentrations of monocyte chemoattractant protein ( MCP ) -@ and MIP-@ ( P < @ ) .


Serum concentrations of cytokines and chemokines increased during surgery , but did not differ between the control and CPAP groups .


A significantly lower local immune response was observed during one-lung ventilation when CPAP was applied to the collapsed lung .


The findings suggest a beneficial effect of CPAP on the collapsed lung during oesophagectomy with one-lung ventilation .


To identify the factors underlying prostate cancer ( PCa ) patients ' depression-anxiety , sexual problems , urinary dysfunction and androgen deprivation therapy ( ADT ) - linked breast changes and hot flushes , and test these as predictors of loss of masculinity ( LoM ) over @ months following diagnosis .


One thousand seventy patients from the TROG @ ( RADAR ) trial the EORTC QLQ C-@ and PR @ questionnaires , and the International Prostate Cancer Symptom Score of the American Urological Association at baseline , @ , @ , @ , @ , @ and @ months .


Selected items from these scales were factor-analysed to identify a four-component solution for responses at @ and @ months , and these components were regressed against a single-item measuring LoM .


Depression-anxiety factor was the most powerful predictor of LoM at both time points , followed by sexual problems of ADT side effects ( breast changes and hot flushes ) .


Urinary dysfunction was not a consistent predictor of LoM .


Depression-anxiety was also the most significant factor distinguishing between those men who reported LoM and those who did not .


Although LoM is often reported as arising from ADT , the relative power of depression-anxiety in predicting LoM , both at the selected time points and using a time-lagged analysis , plus the finding that depression-anxiety was the most consistent difference between men who reported LoM and those who did not , argues for the presence of adverse mood states as being the key ingredient in deciding if PCa patients experience loss of their feelings of masculinity .


The insulin-like growth factor @ receptor ( IGF@R ) has yet to be established as a biomarker in non-small cell lung cancer ( NSCLC ) but could prove useful in customized chemotherapy .


We explored its prognostic value using both quantitative real-time reverse transcriptase polymerase chain reaction ( qRT-PCR ) and immunohistochemistry ( IHC ) .


Analyses of IGF@R were performed on patients with advanced NSCLC , included in a randomized chemotherapy trial , having large , representative tissue samples .


IGF@R mRNA and protein expression were correlated to clinical end-points .


Surgical tissue samples were available from @ patients deemed inoperable .


IGF@R status varied according to histopathology .


Patients with tumors positive for IGF@R mRNA expression had a shorter progression-free and overall survival when compared to the negative sub-group ( @ vs. @ months , p = @ and @ vs. @ months , p = @ , respectively ) .


IGF@R protein expression showed a similar , although non-significant tendency .


IGF@R mRNA expression may be a prognostic biomarker in advanced NSCLC and should be investigated in a larger population .


The ideal spread of local anesthetic for effective , rapid , and safe sciatic nerve block is debated .


We hypothesized that subparaneural ultrasound-guided injection results in faster onset and has a better success rate than extraneural circumferential spread .


Patients undergoing elective tibial , foot , and ankle surgery with popliteal sciatic nerve blocks were prospectively enrolled .


After randomization , the needle tip position was adjusted to ensure circumferential extraneural or subparaneural spread ; @ mL/kg of mepivacaine @ mg/mL was injected .


Post hoc video analysis was used to group the patients according to extraneural , subparaneural , and unintentional intraepineural spread .


There were @ ( @ % ) patients in the subparaneural group and @ ( @ % ) in the extraneural group .


Block onset time was shorter in the subparaneural group than in the extraneural group ( @ -LSB- @-@ -RSB- minutes ; mean -LSB- @ % confidence interval -RSB- , @ -LSB- @-@ @ -RSB- minutes and @ -LSB- @-@ -RSB- minutes ; mean -LSB- @ % confidence interval -RSB- @ -LSB- @-@ @ -RSB- minutes , respectively ; P = @ ) .


The duration of sensory blockade increased ( @ -LSB- @-@ -RSB- minutes vs @ -LSB- @-@ -RSB- minutes ; P = @ ) .


The success rate of the block also increased .


Unintentional intraepineural injection occurred in @ % of patients ( @ patients in the subparaneural group and @ patient in the extraneural group ; NS ) .


Block onset time was shorter than for the subparaneural and extraneural groups ( @ -LSB- @-@ -RSB- minutes , @ -LSB- @-@ -RSB- minutes , and @ -LSB- @-@ -RSB- minutes ; P = @ ) .


A subparaneural injection accelerated the onset time and increased the duration of tibial nerve sensory blockade compared with circumferential extraneural injection .


With unintentional intraepineural spread , the onset time was significantly shorter than for the other groups .


The optimal agents and duration of primary antifungal prophylaxis in recipients of allogeneic hematopoietic stem cell transplantation ( allo-HSCT ) remain a matter of discussion .


Our objective was to compare the efficacy and safety of long-term and short-term administration of itraconazole ( ITCZ ) for primary antifungal prophylaxis in allo-HSCT recipients .


This multicenter , randomized , open-label pilot study was performed in @ transplant centers in China .


Recipients of allo-HSCT without a history of invasive fungal disease ( IFD ) were randomly assigned to the long-term or the short-term arm .


Randomization was carried out by a center computer system .


Intravenous ITCZ was given to the patients in both study arms with a loading dose of @ mg/day for @ days followed by @ mg/day until day +@ or when the white blood cell count was > @ @ ( @ ) / L , and then switched to oral ITCZ solution ; prophylaxis was continued until day +@ post transplantation in the short-term arm or until day +@ in the long-term arm .


The trough serum concentrations of ITCZ also were measured .


The primary study endpoint was the incidence of IFD ( proven , probable , and possible ) within day +@ post transplantation .


A total of @ recipients were enrolled in this study ; @ of them were randomized to the long-term arm and @ were randomized to the short-term arm , forming the modified intent-to-treat ( mITT ) set .


The incidence of IFD within day +@ , the primary endpoint , was not significantly different between the @ arms for the mITT set ( @ % in the long-term arm vs. @ % in the short-term arm , P = @ ) , or for the per-protocol set ( @ % in the long-term arm vs. @ % in the short-term arm , P = @ ) .


From day +@ to day +@ , the incidence of IFD was @ % and @ % , respectively , in the patients with long-term and short-term prophylaxis for the mITT set ( P = @ ) .


The mean trough serum concentrations of ITCZ was maintained at > @ ng/mL throughout administration .


The incidences of withdrawal because of drug-related adverse events in patients with long-term and short-term prophylaxis were @ % and @ % , respectively ( P = @ ) .


Long-term and short-term administration of ITCZ both seemed effective in preventing IFD in recipients of allo-HSCT .


Further study with large sample size should be performed to evaluate this result .


ITCZ shows the same pharmacokinetics in recipients of allo-HSCT as in non-recipients .


Fixed-dose rate gemcitabine plus docetaxel achieves objective response in @ % of patients with uterine leiomyosarcoma ( uLMS ) .


This study aimed to determine whether the addition of bevacizumab to gemcitabine-docetaxel increases progression-free survival ( PFS ) in uLMS .


In this phase III , double-blind , placebo-controlled trial , patients with chemotherapy-naive , metastatic , unresectable uLMS were randomly assigned to gemcitabine-docetaxel plus bevacizumab or gemcitabine-docetaxel plus placebo .


PFS , overall survival ( OS ) , and objective response rates ( ORRs ) were compared to determine superiority .


Target accrual was @ patients to detect an increase in median PFS from @ months ( gemcitabine-docetaxel plus placebo ) to @ months ( gemcitabine-docetaxel plus bevacizumab ) .


Treatment effects on PFS and OS were described by hazard ratios ( HRs ) , median times to event , and @ % CIs .


In all , @ patients were accrued : gemcitabine-docetaxel plus placebo ( n = @ ) and gemcitabine-docetaxel plus bevacizumab ( n = @ ) .


Accrual was stopped early for futility .


No statistically significant differences in grade @ to @ toxicities were observed .


Median PFS was @ months for gemcitabine-docetaxel plus placebo versus @ months for gemcitabine-docetaxel plus bevacizumab ( HR , @ ; P = @ ) .


Median OS was @ months for gemcitabine-docetaxel plus placebo and @ months for gemcitabine-docetaxel plus bevacizumab ( HR , @ ; P = @ ) .


Objective responses were observed in @ ( @ % ) of @ patients randomly assigned to gemcitabine-docetaxel plus placebo and @ ( @ % ) of @ patients randomly assigned to gemcitabine-docetaxel plus bevacizumab .


Mean duration of response was @ months for gemcitabine-docetaxel plus placebo versus @ months for gemcitabine-docetaxel plus bevacizumab .


The addition of bevacizumab to gemcitabine-docetaxel for first-line treatment of metastatic uLMS failed to improve PFS , OS , or ORR .


Gemcitabine-docetaxel remains a standard first-line treatment for uLMS .


This pilot study aimed to investigate the feasibility of two different training programs in patients with advanced gastrointestinal cancer undergoing palliative chemotherapy .


Potential effects of training programs on the patients ' quality of life , physical performance , physical activity in daily living , and biological parameters were exploratorily evaluated .


Patients were randomly assigned to a resistance ( RET ) and aerobic exercise training group ( AET ) .


Both underwent supervised training sessions twice a week for @ weeks .


RET was performed at @-@ % of the one-repetition maximum and consisted of @-@ sets of @-@ repetitions .


The AET group performed endurance training at @-@ % of their predetermined pulse rate ( for @ to @ min ) .


A total of @ gastrointestinal cancer patients could be randomized .


Twenty-one patients completed the @ weeks of intervention .


The median adherence rate to exercise training of all @ patients was @ % , while in patients who were able to complete @ weeks , adherence was @ % .


The fatigue score of all patients decreased from @ to @ post-intervention .


Sleeping duration increased in both groups and muscular strength increased in the RET group .


A higher number of steps in daily living was associated with higher levels of physical and social functioning as well as lower scores for pain and fatigue .


RET and AET are feasible in gastrointestinal cancer patients undergoing palliative chemotherapy .


Both training programs seem to improve cancer-related symptoms as well as the patient 's physical activities of daily living .


The aims of the study were to @ ) determine the effectiveness of QuikClot Combat Gauze ( QCG ) ; @ ) determine the arterial blood pressure at which rebleeding occurs ; @ ) determine how much intravenous fluid could be administered before hemorrhage reoccurred , and @ ) determine the number extremity movement on rebleeding when QCG was used .


This was a prospective , randomized , experimental study .


Adult Yorkshire pigs were randomly assigned to two groups QCG ( n = @ ) or control ( n = @ ) .


After the swine were anesthetized , the investigators transected the femoral artery and vein .


After @ minute of uncontrolled bleeding , QCG was placed in the wound followed by standard wound packing .


The control group underwent the same procedures without QCG .


After @ minutes of firm , manual pressure , a pressure dressing was applied .


Following @ minutes , the dressings were removed and blood loss was calculated .


If hemostasis occurred , phenylephrine was administered until there was rebleeding .


If no bleeding , up to @ L of IV crystalloid was administered until there was hemorrhage .


If no bleeding , the extremity on the side of the hemorrhage was moved through flexion , extension , abduction , and adduction @ times or until rebleeding occurred .


QCG compared to a control was more effective in controlling hemorrhage , withstanding increases in systolic blood pressure , more latitude in resuscitation fluid , and movement ( p < @ ) .


Benign prostatic hyperplasia ( BPH ) is the most common cause of lower urinary tract symptoms in elderly men .


Selective alfa@-adrenergic antagonists are now first-line drugs in the medical management of BPH .


We conducted a single-blind , parallel group , randomized , controlled trial to compare the effectiveness and safety of the new alfa@-blocker silodosin versus the established drug tamsulosin in symptomatic BPH .


Ambulatory male BPH patients , aged above @ years , were recruited on the basis of International Prostate Symptom Score ( IPSS ) .


Subjects were randomized in @:@ ratio to receive either tamsulosin @ mg controlled release or silodosin @ mg once daily after dinner for @ weeks .


Primary outcome measure was reduction in IPSS .


Proportion of subjects who achieved IPSS < @ , change in prostate size as assessed by ultrasonography and changes in peak urine flow rate and allied uroflowmetry parameters , were secondary effectiveness variables .


Treatment emergent adverse events were recorded .


Data of @ subjects - @ on silodosin and @ on tamsulosin were analyzed .


Final IPSS at @-week was significantly less than baseline for both groups .


However , groups remained comparable in terms of IPSS at all visits .


There was a significant impact on sexual function ( assessed by IPSS sexual function score ) in silodosin arm compared with tamsulosin .


Prostate size and uroflowmetry parameters did not change .


Both treatments were well-tolerated .


Retrograde ejaculation was encountered only with silodosin and postural hypotension only with tamsulosin .


Silodosin is comparable to tamsulosin in the treatment of BPH in Indian men .


However , retrograde ejaculation may be troublesome for sexually active patients .


Invastigation of macrolides in the treatment of drug effects in chronic rhinosinusit .


The @ patients with chronic rhinosinusit were randomly divided into @ cases of macrolides drug group and @ cases of cephalosporins group , and therapeutic effect was observed .


The therapeutic effect of macrolides was also observed in refractory chronic rhinosinusit .


Comparing macrolides group and cephalosporins group , there is not statistically significant ( P > @ ) .


Treatment with macrolides cefixime tablet ineffective treatment of patients for @ months , compared before and after treatment was statistically significant ( P < @ ) .


Treatment with cefixime tablet macrolides ineffective treatment of patients for @ months , compared before and after treatment was not statistically significant ( P > @ ) .


Long-term low-dose applications of macrolides have a good effect in patients with chronic rhinosinusit , particularly for refractory chronic rhinosinusit have a significant effect .


To assess sublingual asenapine for acute agitation .


Agitated adults @-@ years ( any diagnosis ) presenting for treatment in an emergency department and found to have a score of @ on the Positive and Negative Syndrome Scale-Excited Component ( PANSS-EC ) were randomized to receive either a single dose of a sublingual @ mg tablet of asenapine or placebo .


Primary outcome measure was change in the PANSS-EC score from baseline to @ h after medication or placebo administration .


Secondary outcomes included the percentage of responders with a @ % reduction from baseline on the PANSS-EC score at @ h.


A total of @ subjects were randomized , @ each to sublingual asenapine or placebo .


Mean ( SE ) baseline PANSS-EC scores for the asenapine-treated and placebo-treated subjects were @ @ and @ @ , respectively .


Mean PANSS-EC scores at endpoint ( LOCF ) was @ @ for the asenapine-treated subjects and @ @ for the placebo-treated subjects .


Change in PANSS-EC score at @ h was statistically significantly greater for the asenapine-treated subjects compared with the placebo-treated subjects .


NNT for response vs. placebo was @ ( @ % CI @-@ ) .


Sublingual asenapine was efficacious in the treatment of agitation with an effect size comparable to that observed in prior studies of intramuscular antipsychotics .


The aim of this study was to evaluate the effects of an mHealth intervention ( intervention using mobile technology ) consisting of tailored advice regarding exposure to daylight , sleep , physical activity , and nutrition , and aiming to improve health-related behavior , thereby reducing sleep problems and fatigue and improving health perception of airline pilots .


A randomized controlled trial was conducted among @ airline pilots .


The intervention group was given access to both the MORE Energy mobile application ( app ) with tailored advice and a website with background information .


The control group was directed to a website with standard information about fatigue .


Health-related behavior , fatigue , sleep , and health perception outcomes were measured through online questionnaires at baseline and at three and six months after baseline .


The effectiveness of the intervention was determined using linear and Poisson mixed model analyses .


After six months , compared to the control group , the intervention group showed a significant improvement on fatigue ( = -@ , P < @ ) , sleep quality ( = -@ , P = @ ) , strenuous physical activity ( = @ , P = @ ) , and snacking behavior ( = -@ , P < @ ) .


No significant effects were found for other outcome measures .


The MORE Energy mHealth intervention reduced self-reported fatigue compared to a minimal intervention .


Some aspects of health-related behavior ( physical activity and snacking behavior ) and sleep ( sleep quality ) improved as well , but most did not .


The results show offering tailored advice through an mHealth intervention is an effective means to support employees who have to cope with irregular flight schedules and circadian disruption .


This kind of intervention might therefore also be beneficial for other working populations with irregular working hours .


To explore the effect of prophylactic hepatic artery infusion chemotherapy ( HAIC ) on survival probability after curative resection in patients with hepatocellular carcinoma ( HCC ) .