This study proposes a randomized , double-blind , placebo-controlled crossover trial to assess the effects of a prophylactic combination of N-acetylcysteine ( @ mg ) and magnesium ( @ mg ) prior to leisure noise exposure in young adults .


The primary outcome measure is the tinnitus loudness scored by a visual analogue scale ( VAS ) .


Secondary outcome measures are the differences in audiological measurements for the antioxidant treatments compared to placebo intake .


Audiological testing comprising of pure tone audiometry including frequencies up to @ kHz , distortion product otoacoustic emissions , transient-evoked otoacoustic emissions and speech-in-noise testing will be performed prior to and within @ hours after noise exposure .


By use of a mixed effects statistical model , the effects of antioxidants compared to placebo intake will be assessed .


As adolescents and young adults often do not use hearing protection while being exposed to loud music , the use of preventive antioxidant intake may provide a useful and harmless way to prevent noise-induced hearing damage in this population .


Furthermore , when exposed to hazardous noise levels the protection provided by hearing protectors might not be sufficient to prevent hearing damage and antioxidants may provide additive otoprotective effects .


Previous research mainly focused on occupational noise exposure .


The present study provides a protocol to assess the usefulness of antioxidants during leisure noise activities .


The open abdominal ( OA ) approach is a management strategy used in the most severely injured trauma patients .


In addition to the morbidity and mortality , a major challenge is the gradual development of dense adhesions that make reoperations progressively more difficult .


This randomized , prospective , proof-of-concept study was conducted to determine the effect of carboxymethylcellulose sodium hyaluronate adhesion barrier ( CMHAB ; Seprafilm , Genzyme Biosurgery , Bridgewater , NJ ) on abdominal adhesions and wound characteristics in trauma open abdomens .


A prospective , randomized , controlled study of wound and adhesion characteristics with or without CMHAB was conducted at @ level I trauma centers .


Consenting patients were randomized to either CMHAB or no adhesion barrier ( NAB ) groups .


We evaluated patient demographics , injury characteristics/severity , reason for OA management , wound sizes ( transverse/longitudinal ) , Zuhlke adhesion score , abdominal contamination score , hospital/intensive care durations of stay , morbidity , and mortality .


Thirty patients were enrolled ( @ randomized to CMHAB ; @ randomized to NAB ) with mean age of @ , Injury Severity Score of @ , Abbreviated Injury Score ( AIS ) - abdomen of @ , APACHE II score of @ , and @ % blunt trauma mechanism .


The groups were well-matched with regard to age , sex , Injury Severity Score/abdominal AIS , penetrating/blunt injury rates , initial lactate/base deficit , mortality , OA indications , and contamination scores .


There were no differences in nonabdominal or abdominal complications ( ie , fistula , abscess , wound related ) between the groups .


Patients with CMHAB had shorter intensive care unit durations of stay ( @ vs @ days ; P < @ ) .


Intraoperative adhesion scores were not different during the first four operations but diverged significantly at the @th operative intervention or after about @ week of OA therapy .


After the @th operation , adhesion scores in the NAB group were @ % greater ( approximately @ Zuhlke point ) than the CMHAB group .


We did not note differences between wound sizes over time , closure types , or wound closure characteristics between CMHAB and NAB .


Although CMHAB did not eliminate adhesions in this proof-of-concept study , it limited their severity , particularly in abdomens left open > @ days or requiring @ operations .


There was no difference in wound sizes , overall or abdominal complications , or mortality between the groups .


Further research is warranted to better delineate potential benefits of CMHAB , especially in the setting of reoperations in post-OA patients .


The large contribution of inexperience to the high crash rate of newly licensed teens suggests that they enter licensure with insufficient skills .


In a prior analysis , we found moderate support for a direct effect of a web-based intervention , the TeenDrivingPlan ( TDP ) , on teens ' driving performance .


The purpose of the present study was to identify the mechanisms by which TDP may be effective and to extend our understanding of how teens learn to drive .


A randomized controlled trial conducted with teen permit holders and parent supervisors ( N = @ dyads ) was used to determine if the effect of TDP on driver performance operated through five hypothesized mediators : ( @ ) parent-perceived social support ; ( @ ) teen-perceived social support ; ( @ ) parent engagement ; ( @ ) practice quantity ; and ( @ ) practice diversity .


Certified driving evaluators , blinded to teens ' treatment allocation , assessed teens ' driving performance @weeks after enrollment .


Mediator variables were assessed on self-report surveys administered periodically over the study period .


Exposure to TDP increased teen-perceived social support , parent engagement , and practice diversity .


Both greater practice quantity and diversity were associated with better driving performance , but only practice diversity mediated the relationship between TDP and driver performance .


Practice diversity is feasible to change and increases teens ' likelihood of completing arigorous on-road driving assessment just before licensure .


Future research should continue to identify mechanisms that diversify practice driving , explore complementary ways to help families optimize the time they spend on practice driving , and evaluate the long-term effectiveness of TDP .


The role of low-dose dopamine infusion in patients with acute decompensated heart failure ( ADHF ) remains controversial .


We aim to evaluate the efficacy and safety of high - versus low-dose furosemide with or without low-dose dopamine infusion in this patient population .


@ ADHF patients ( @ years ; @ % female ; ejection fraction @ % ) were randomized to @-hour continuous infusions of : a ) high-dose furosemide ( HDF , n = @ , @mg/h ) , b ) low-dose furosemide and low-dose dopamine ( LDFD , n = @ , @mg/h and @ g kg ( -@ ) min ( -@ ) respectively ) , or c ) low-dose furosemide ( LDF , n = @ , furosemide @mg/h ) .


The main outcomes were @-day and one-year all-cause mortality ( ACM ) and hospitalization for HF ( HHF ) .


Dyspnea relief ( Borg index ) , worsening renal function ( WRF , rise in serum creatinine ( sCr ) @ mg/dL ) , and length of stay ( LOS ) were also assessed .


The urinary output at @ , @ , @ , @ , and @h was not significantly different in the three groups .


Neither the ACM at day @ ( @ % , @ % , and @ % ; P = @ ) or at one year ( @ % , @ % and @ % , P = @ ) nor the HHF at day @ ( @ % , @ % , and @ % , P = @ ) or one year ( @ % , @ % , and @ % , P = @ ) differed between HDF , LDFD , and LDF groups , respectively .


No differences in the Borg index or LOS were noted .


WRF was higher in the HDF than in LDFD and LDF groups at day @ ( @ % vs. @ % vs. @ % , P < @ ) but not at sCr peak ( @ % vs. @ % vs. @ % , P = @ ) .


No significant differences in adverse events were noted .


In ADHF patients , there were no significant differences in the in-hospital and post-discharge outcomes between high - vs. low-dose furosemide infusion ; the addition of low-dose dopamine infusion was not associated with any beneficial effects .


Adequate surgical field visualization is among the most important factors in preventing complications in functional endoscopic sinus surgery ( FESS ) .


The aim of this study was to assess the effect of topical cocaine vs adrenaline on surgical field visualization and intraoperative bleeding during FESS .


A randomized controlled trial was conducted .


A total of @ patients that underwent FESS for chronic rhinosinusitis were randomized to the side of the nose that received adrenaline or cocaine-soaked patties , and the side that was operated first .


The surgeon evaluating the bleeding was blinded to the vasoconstrictor allocation .


At the commencement of surgery and at regular @-minute intervals , the operating surgeon evaluated the extent of bleeding in the operative field according to a validated scale .


At each assessment , mean arterial pressure ( MAP ) , heart rate , and end tidal CO@ were also recorded .


At the end of each side , total blood loss was measured .


There was no difference in the mean surgical field scores between the adrenaline and cocaine sides ( @ @ vs @ @ , p = @ ) , nor the total blood loss ( p = @ ) .


On the cocaine side , there was a correlation between surgical field grade and duration of surgery ( p < @ ) as well as blood loss ( p < @ ) and MAP ( p < @ ) .


There is no difference in the quality of the surgical field achieved through the use of topical cocaine or adrenaline during FESS .


Either of these agents can be effectively used for topical decongestion at the onset of surgery .


Heart failure ( HF ) pathophysiology is believed to be mediated by autonomic dysfunction , including chronic sympathoexcitation and diminished baroreflex sensitivity , which correlate with mortality risk .


Baroreflex activation therapy ( BAT ) is a device-based treatment providing chronic baroreflex activation through electrical stimulation of the carotid sinus .


BAT chronically reduces sympathetic activity in resistant hypertension .


The purpose of this investigation is to determine BAT effects in clinical HF .


In a single-centre , open-label evaluation , patients with NYHA class III HF , EF < @ % , optimized medical therapy , and ineligible for cardiac resynchronization received BAT for @ months .


Efficacy was assessed with serial measurement of muscle sympathetic nerve activity ( MSNA ) and clinical measures of quality of life and functional capacity .


Eleven patients participated in the trial .


MSNA was reduced over @ months from @ @ to @ @ bursts/min and from @ @ to @ @ bursts/@ heartbeats , decreases of @ % and @ % , respectively ( P < @ ) .


Concomitant improvements occurred in baroreflex sensitivity , EF , NYHA class , quality of life and @ min hall walk ( @ MHW ) distance ( P @ each ) .


On an observational basis , hospitalization and emergency department visits for worsening HF were markedly reduced .


One complication , perioperative anaemia requiring transfusion , occurred during the study .


BAT was safe and provided chronic improvement in MSNA and clinical variables .


Based on present understanding of HF pathophysiology , these results suggest that BAT may improve outcome in HF by modulating autonomic balance .


Prospective , randomized trials to test the hypothesis are warranted .


We hypothesized that the psychosocial factors perceived stress and sense of personal control mediated the relationship between self-reported racism and experience of toothache .


We hypothesized that social support moderated this relationship .


Data from @ pregnant Aboriginal Australian women were used to evaluate experience of toothache , socio-demographic factors , psychosocial factors , general health , risk behaviors , and self-reported racism exposure .


Hierarchical logistic regression models estimated odds ratios ( ORs ) and @ percent confidence intervals ( CIs ) for experience of toothache .


Perceived stress and sense of personal control were examined as mediators of the association between self-reported racism and experience of toothache .


Social support was examined as a moderator .


Self-reported racism persisted as a risk indicator for experience of toothache ( OR @ , @ percent CI @-@ @ ) after controlling for age , level of education , and difficulty paying a $ @ dental bill .


The relationship between self-reported racism and experience of toothache was mediated by sense of control .


The direct effect of self-reported racism on experience of toothache became only marginally significant , and the indirect effect was significant ( coefficient = @ , bias-corrected @ percent CI @-@ @ , @ percent of effect mediated ) .


Stress was insignificant as a mediator .


Social support was insignificant as a moderator .


The findings indicate that high levels of self-reported racism were associated with experience of toothache and that sense of control , but not perceived stress , mediated the association between self-reported racism and experience of toothache among this sample of pregnant Aboriginal Australian women .


Social support did not moderate the association between self-reported racism and experience of toothache .


To investigate whether betamethasone decreases the incidence of postoperative nausea/vomiting ( PONV ) and reduces postoperative pain following partial mastectomy .


Prospective randomized , double-blinded study .


Operating room and Postanesthesia Care Unit of a university hospital .


@ ASA physical status @ and @ women scheduled for elective breast cancer surgery .


Patients were randomly allocated to two groups in double-blinded fashion : Group B ( betamethasone ; @ pts ) and Group C ( control ; @ pts ) .


Group B received @ mg of betamethasone intravenously before the start of surgery .


The rate of PONV and pain were recorded using a numeric rating scale ( NRS ; @-@ ) , as well as rescue doses of antiemetics ( ondansetron ) and analgesics ( ketobemidone ) .


There was a significant lower incidence of postoperative nausea ( PON ) scoring NRS @ in Group B in the @ to @-hour period compared with Group C ( P = @ ) .


The cumulative incidence of PON was @ % in Group B versus @ % in Group C ( P = @ ) .


The overall incidence of postoperative vomiting ( POV ) was @ % and @ % in Groups B and C , respectively .


Postoperative pain was reduced by @ % in Group B in the @ to @-hour period , but the mean dose of postoperative rescue analgesic did not differ between the groups .


Preoperative betamethasone reduces the severity of PONV and pain in patients undergoing elective breast surgery .


Luseogliflozin , a sodium glucose cotransporter @ inhibitor , inhibits reabsorption of glucose in the proximal renal tubule .


It was developed for the treatment of type @ diabetes mellitus .


For this first human study of luseogliflozin , randomized , single-blind , placebo-controlled , single ascending dose ( @-@mg ) and multiple ascending dose ( @ or @mg/day , @days ) trials were conducted in healthy male Japanese subjects to investigate safety , pharmacokinetics , and pharmacodynamics .


There were no serious adverse events , adverse events leading to discontinuation , or episodes of hypoglycemia .


After administration of a single oral dose of luseogliflozin , its maximum plasma level ( C max ) and area under the concentration-time curve increased in a dose-dependent manner , and no food effects were observed on pharmacokinetics .


The mean time taken to reach C max ( T max ) ranged from @ to @ h.


The mean plasma half-life of luseogliflozin ( T @/@ ) after multiple dosing for @days ranged from @ to @ h , and no detectable accumulation of luseogliflozin was observed .


Urinary glucose excretion increased in a dose-dependent manner , ranging from @ to @ g ( single-dose study ) .


Luseogliflozin was well tolerated and showed favorable pharmacokinetic and pharmacodynamic profiles in healthy male Japanese subjects .


For patients with relapsed or refractory aggressive lymphoma , we hypothesized that gemcitabine-based therapy before autologous stem-cell transplantation ( ASCT ) is as effective as and less toxic than standard treatment .


We randomly assigned @ patients with relapsed/refractory aggressive lymphoma to treatment with gemcitabine , dexamethasone , and cisplatin ( GDP ) or to dexamethasone , cytarabine , and cisplatin ( DHAP ) .


Patients with B-cell lymphoma also received rituximab .


Responding patients proceeded to stem-cell collection and ASCT .


Coprimary end points were response rate after two treatment cycles and transplantation rate .


The noninferiority margin for the response rate to GDP relative to DHAP was set at @ % .


Secondary end points included event-free and overall survival , treatment toxicity , and quality of life .


For the intention-to-treat population , the response rate with GDP was @ % ; with DHAP the response rate was @ % ( @ % CI for difference , -@ % to @ % ) , meeting protocol-defined criteria for noninferiority of GDP ( P = @ ) .


Similar results were obtained in a per-protocol analysis .


The transplantation rates were @ % with GDP and @ % with DHAP ( P = @ ) .


At a median follow-up of @ months , no differences were detected in event-free survival ( HR , @ ; stratified log-rank P = @ ) or overall survival ( HR , @ ; P = @ ) between GDP and DHAP .


Treatment with GDP was associated with less toxicity ( P < @ ) and need for hospitalization ( P < @ ) , and preserved quality of life ( P = @ ) .


For patients with relapsed or refractory aggressive lymphoma , in comparison with DHAP , treatment with GDP is associated with a noninferior response rate , similar transplantation rate , event-free survival , and overall survival , less toxicity and hospitalization , and superior quality of life .


To evaluate the efficacy of two maintenance strategies compared to usual care after discharge from a pharmacist-led cardiovascular risk reduction clinic ( CRRC ) .


Open-label , randomized-controlled trial of @ consecutive CRRC patients that met clinic discharge criteria ( HbA@c @ % ( @ mmol/mol ) ; blood pressure @/@ mmHg for those with diabetes and @/@ mmHg for those without diabetes ; and an LDL-cholesterol @ mmol/l ) .


Participants were randomized to either quarterly group medical visits or quarterly CRRC individual clinic visits , or a usual care control arm with the standard primary care alone first in a @:@:@ ratio , followed by a @:@:@ ratio after first @ patients .


Primary outcome measures were time to failure for guideline recommended goals of HbA@c and blood pressure over @-months .


Of the @ participants randomized , @ % had diabetes and were similar in other cardiovascular risk factors .


After @-year , the HbA@c failure rate was @ -LSB- @ % CI , @-@ @ -RSB- per quarter for the group medical visit arm , @ -LSB- @ % CI , @-@ @ -RSB- per quarter for the quarterly CRRC individual arm and , @ -LSB- @ % CI , @-@ @ -RSB- per quarter for the usual care control arm , p < @ .


The rate of failure for blood pressure was @ -LSB- @ % CI , @-@ @ -RSB- per quarter for the group medical visit arm , @ -LSB- @ % CI , @-@ @ -RSB- per quarter for the CRRC individual arm and , @ -LSB- @ % CI , @-@ @ -RSB- per quarter the control arm , p < @ .


After discharge from a CRRC program , both individual and group interventions are more effective in maintaining glycemia and blood pressure control for patients with diabetes than usual care after @-year of follow-up .


While studies of HIV-infected adults on antiretroviral treatment ( ART ) report no sex differences in immune recovery and virologic response but more ART-associated complications in women , sex differences in disease progression and response to ART among children have not been well assessed .


The objective of this study was to evaluate for sex differences in response to ART in South African HIV-infected children who were randomized to continue ritonavir-boosted lopinavir ( LPV/r ) - based ART or switch to nevirapine-based ART .


ART outcomes in HIV-infected boys and girls in Johannesburg , South Africa from @-@ were compared .


Children initiated ritonavir-boosted lopinavir ( LPV/r ) - based ART before @ months of age and were randomized to remain on LPV/r or switch to nevirapine-based ART after achieving viral suppression .


Children were followed for @ weeks post-randomization and then long-term follow up continued for a minimum of @ weeks and maximum of @ weeks after randomization .


Viral load , CD@ count , lipids , anthropometrics , drug concentrations , and adherence were measured at regular intervals .


Outcomes were compared between sexes within treatment strata .


A total of @ children ( median age @ months , IQR @-@ @ ) , including @ boys and @ girls , initiated LPV/r-based ART and @ children were randomized .


No sex differences in risk of virological failure ( confirmed viral load > @ copies/mL ) by @ weeks post-randomization were observed within either treatment group .


Girls switched to nevirapine had more robust CD@ count improvement relative to boys in this group through @ weeks post-randomization .


In addition , girls remaining on LPV/r had higher plasma concentrations of ritonavir than boys during post-randomization visits .


After a mean of @ years post-randomization , girls remaining on LPV/r also had a higher total cholesterol : HDL ratio and lower mean HDL than boys on LPV/r .


Sex differences are noted in treated HIV-infected children even at a young age , and appear to depend on treatment regimen .


Future studies are warranted to determine biological mechanisms and clinical significance of these differences .


Chloroquine-azithromycin is being evaluated as combination therapy for malaria .


It may provide added benefit in treating or preventing bacterial infections that occur in children with malaria .


We aim to evaluate the effect of treating clinical malaria with chloroquine-azithromycin on the incidence of respiratory-tract and gastrointestinal-tract infections compared to treatment with chloroquine monotherapy .


We compared the incidence density and time to first events of respiratory-tract and gastrointestinal-tract infections among children assigned to receive chloroquine-azithromycin or chloroquine for all symptomatic malaria episodes over the course of @ year in a randomized longitudinal trial in Blantyre , Malawi .


The incidence density ratios of total respiratory-tract infections and gastrointestinal-tract infections comparing chloroquine-azithromycin to chloroquine monotherapy were @ ( @ % confidence interval -LSB- CI -RSB- , @ , @ ) and @ ( @ % CI , @ , @ ) , respectively .


The time to first lower-respiratory-tract and gastrointestinal-tract infections were significantly longer in the chloroquine-azithromycin arm compared to the chloroquine arm ( P = @ and P = @ , respectively ) .


Children treated routinely with chloroquine-azithromycin had fewer respiratory and gastrointestinal-tract infections than those treated with chloroquine alone .


This antimalarial combination has the potential to reduce the burden of bacterial infections among children in malaria-endemic countries .


Childhood eczema , or childhood atopic dermatitis , causes significant distress to children and their families through sleep disturbance and itch .


The main cause of treatment failure is nonuse of prescribed treatments .


The objective of this study was to develop and test a Web-based intervention to support families of children with eczema , and to explore whether support from a health care professional ( HCP ) is necessary to engage participants with the intervention .


We followed the PRECEDE-PROCEED model : regular emollient use was the target behavior we were seeking to promote and we identified potential techniques to influence this .


LifeGuide software was used to write the intervention website .


Carers of children with eczema were invited through primary care mail-out and randomized to @ groups : ( @ ) website only , ( @ ) website plus HCP support , or ( @ ) usual care .


Patient-Oriented Eczema Measure ( POEM ) scores were measured online by carer report at baseline and at @ weeks .


Qualitative interviews were carried out with @ HCPs ( primarily practice nurses ) and @ participants to explore their experiences of taking part in the study .


A total of @ carers were recruited through @ practices .


We found a decrease of @ in follow-up compared with baseline POEM score in @ of @ ( @ % ) participants in the website only group , @ of @ ( @ % ) in the usual care group , and @ of @ ( @ % ) in the website plus HCP group .


Website use data showed that @ of @ ( @ % ) participants allocated to the website groups completed the core modules , but less than half used other key components ( videos : @ % ; regular text reminders : @ % ) .


There were no consistent differences in website use between the website only or the website plus HCP groups .


Qualitative feedback showed that most HCPs had initial concerns about providing support for eczema self-care because this was not a condition that they felt expert in .


However , HCPs reported productive consultations and that they found it helpful to use the website in consultations , while observing that some participants seemed to need more support than others .


Qualitative interviews with participants suggested that HCP support was valued highly only by a minority , generally those who were less confident in their management of eczema or less confident using the Internet .


Our pilot trial demonstrated the potential for greater improvements in POEM scores in both website intervention groups and that a full-scale trial is feasible .


Such a trial would quantify the effectiveness and cost-effectiveness of this intervention to determine whether it should be widely promoted to families of children with newly diagnosed eczema .


In this study population , HCP support was not strongly valued by participants and did not lead to better outcomes or website use than use of the Web-based intervention alone .


Exposure-based cognitive-behavioural therapy ( CBT ) delivered via the internet has been shown to be effective for severe health anxiety ( hypochondriasis ) but has not been compared with an active , effective and credible psychological treatment , such as behavioural stress management ( BSM ) .


To investigate two internet-delivered treatments - exposure-based CBT v. BSM - for severe health anxiety in a randomised controlled trial ( trial registration : NCT@ ) .


Participants ( n = @ ) with a principal diagnosis of severe health anxiety were allocated to @ weeks of exposure-based CBT ( n = @ ) or BSM ( n = @ ) delivered via the internet .


The Health Anxiety Inventory ( HAI ) was the primary outcome .


Internet-delivered exposure-based CBT led to a significantly greater improvement on the HAI compared with BSM .


However , both treatment groups made large improvements on the HAI ( pre-to-post-treatment Cohen 's d : exposure-based CBT , @ ; BSM , @ ) .


Exposure-based CBT delivered via the internet is an efficacious treatment for severe health anxiety .


The efficacy of the ALK inhibitor crizotinib as compared with standard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer ( NSCLC ) is unknown .


We conducted an open-label , phase @ trial comparing crizotinib with chemotherapy in @ patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease .


Patients were randomly assigned to receive oral crizotinib at a dose of @ mg twice daily or to receive intravenous chemotherapy ( pemetrexed , @ mg per square meter of body-surface area , plus either cisplatin , @ mg per square meter , or carboplatin , target area under the curve of @ to @ mg per milliliter per minute ) every @ weeks for up to six cycles .


Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy .


The primary end point was progression-free survival as assessed by independent radiologic review .


Progression-free survival was significantly longer with crizotinib than with chemotherapy ( median , @ months vs. @ months ; hazard ratio for progression or death with crizotinib , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) .


Objective response rates were @ % and @ % , respectively ( P < @ ) .


Median overall survival was not reached in either group ( hazard ratio for death with crizotinib , @ ; @ % CI , @ to @ ; P = @ ) ; the probability of @-year survival was @ % with crizotinib and @ % with chemotherapy .


The most common adverse events with crizotinib were vision disorders , diarrhea , nausea , and edema , and the most common events with chemotherapy were nausea , fatigue , vomiting , and decreased appetite .


As compared with chemotherapy , crizotinib was associated with greater reduction in lung cancer symptoms and greater improvement in quality of life .


Crizotinib was superior to standard first-line pemetrexed-plus-platinum chemotherapy in patients with previously untreated advanced ALK-positive NSCLC .


( Funded by Pfizer ; PROFILE @ ClinicalTrials.gov number , NCT@ . )


Following maternal administration , local anesthetics pass into breast milk .


In the present study , we aimed to compare the passage of levobupivacaine and bupivacaine into breast milk following epidural anesthesia for cesarean delivery .


A total of @ women undergoing elective cesarean delivery under epidural anesthesia were randomized to receive either @ % levobupivacaine or @ % racemic bupivacaine via an epidural catheter .


Immediately before and @min , @h , @h , @h , @h and @h after administration of epidural local anesthetic , maternal blood and breast milk samples were taken simultaneously .


Drug concentrations in plasma and milk were determined via high-performance liquid chromatography .


The infant 's drug exposure was determined by calculating milk/plasma ratios of levobupivacaine and bupivacaine .


Both levobupivacaine and bupivacaine were detected in breast milk @min after epidural administration .


Concentrations of both agents showed constant and similar decreases in milk and plasma and were nearly undetectable at @h .


The milk/plasma ratios were @ for levobupivacaine and @ for bupivacaine .


Both levobupivacaine and bupivacaine pass into breast milk following epidural administration .


The concentration of both drugs was approximately three times lower in breast milk than in maternal plasma .


Knowledge of the skin cancer examination ( SCE ) and its practice remain relevant competency gaps among medical students .


We elaborate on a method of SCE known as the Integrated Skin Exam and discuss the development of an instructional film that illustrates its principles .


We assess the tool 's effect on knowledge , attitudes , and perceptions related to the SCE .


Second-year students among @ randomized schools viewed the film and completed pre-post questionnaires .


After viewing The Integrated Skin Exam film , students demonstrated improved melanoma knowledge , including identification of high-risk demographic groups ( @ % vs @ % , P < @ ) , high-risk anatomic sites in women ( @ % vs @ % , P < @ ) and men ( @ % vs @ % , P < @ ) , and the ABCDEs of melanoma ( @ % vs @ % , P < @ ) .


Students demonstrated increased confidence in the SCE ( @ % vs @ % , P < @ ) and augmented intentions to practice it ( @ % vs @ % , P < @ ) .


A greater proportion ( @ % vs @ % , P < @ ) of students thought less than @ minutes were required to integrate SCE into the routine examination .


Longitudinal impact of the film was not assessed .


The Integrated Skin Exam film introduces an integrated approach to the SCE that addresses knowledge gaps , mitigates perceived barriers , and augments intention related to practice of the SCE .


Physical activity is associated with better physical and mental health in older adults .


Pole walking is a form of walking which may have additional health benefits in older adults , because of the addition of hand held poles , and consequent upper limb involvement .


However , few studies have examined the potential additional effects of pole walking on physical and psychosocial health in older adults compared with walking .


The aim of this study is to compare the effect of a pole walking program with the effects of a walking program , on physical and psychosocial wellbeing , in older adults in assisted living facilities .


Sixty men and women from assisted living communities over @ years will be recruited from senior retirement facilities and randomized into a group based , pole walking program , or walking program .


The pole walking group will use the Exerstrider method of pole walking .


Total duration of the programs is @ weeks , with three sessions per week , building from @ minute to @ minute sessions.The primary outcome is physical function , as measured by items from the Seniors Fitness Test and hand grip strength .


Secondary outcomes include , physical activity levels , sedentary behaviour , joint pain , and quality of life .


All outcomes will be assessed before and after the programs , using valid and reliable measures .


The study will add to the evidence base for the effects of pole walking , compared with walking , on physical and psychosocial health and physical function , in healthy older adults .


This will improve understanding about the feasibility of pole walking programs and its specific benefits in this population .


To investigate the acute cellular rejection rate of liver transplant recipients taking or not taking calcitriol in a prospective , randomized , controlled clinical study .


Primary liver transplant patients were randomized to receive the placebo ( arm A ) , calcium gluconate ( arm B ) or calcium gluconate plus calcitriol ( arm C ) .


The composition of circulating T cell subpopulations was determined by flow cytometry at baseline and one week post transplant .


The primary endpoint was acute cellular rejection rate at one month post transplant .


Seventy-five liver transplant recipients were eligible , including @ patients each in arm A , B and arm C.


The mean baseline serum @ - ( OH ) vitamin D content was @ + / - @ ( range , @ to @ ) ng/mL , with no statistical difference among the three arms .


Among @ ( @ % ) patients who developed definite acute cellular rejection ( Banff score > or = @ ) , only @ ( @ % , @/@ ) were from arm C while @ ( @ % , @/@ ) of them were from either arm A or B.


The acute cellular rejection rate was @ % ( @/@ ) for arm C , @ % ( @/@ ) for arm A and @ % ( @/@ ) for arm B ( arm C vs. arm A or B , P < @ ) .


Flow cytometric analysis showed that the proportion of circulating CD@ + CD@ ( high ) CD ( @ - ) ( Treg ) cells in arm C increased by @ % at one week post transplant ( @ + / - @ % ) compared to baseline ( @ + / - @ % ) ( P < @ ) .


No significant difference was observed in arm A or B ( P > @ in both vs. baseline ) .


Furthermore , no significant difference was noted among the three arms in the proportion of CD@ ( + ) CD@RA ( - ) CD@RO ( + ) , CD@ ( + ) CD@ ( low ) CD@RA ( + ) and CD@ ( + ) CD@ ( low ) CD@RA ( - ) T cells at one week post transplant compared to baseline .


Calcitriol has apparent beneficial effect on acute cellular rejection of liver transplants , which may be associated with increases in the proportion of circulating Treg cells .


Whether culture-expanded mesenchymal stem cells or whole bone marrow mononuclear cells are safe and effective in chronic ischemic cardiomyopathy is controversial .


To demonstrate the safety of transendocardial stem cell injection with autologous mesenchymal stem cells ( MSCs ) and bone marrow mononuclear cells ( BMCs ) in patients with ischemic cardiomyopathy .


A phase @ and @ randomized , blinded , placebo-controlled study involving @ patients with ischemic cardiomyopathy and left ventricular ( LV ) ejection fraction less than @ % ( September @ , @-July @ , @ ) .


The study compared injection of MSCs ( n = @ ) with placebo ( n = @ ) and BMCs ( n = @ ) with placebo ( n = @ ) , with @ year of follow-up .


Injections in @ LV sites with an infusion catheter .


Treatment-emergent @-day serious adverse event rate defined as a composite of death , myocardial infarction , stroke , hospitalization for worsening heart failure , perforation , tamponade , or sustained ventricular arrhythmias .


No patient had a treatment-emergent serious adverse events at day @ .


The @-year incidence of serious adverse events was @ % ( @ % CI , @ % to @ % ) for MSCs , @ % ( @ % CI , @ % -@ % ) for BMCs , and @ % ( @ % CI , @ % -@ % ) for placebo .


Over @ year , the Minnesota Living With Heart Failure score improved with MSCs ( -@ ; @ % CI , -@ to @ ; repeated measures of variance , P = @ ) and with BMCs ( -@ ; @ % CI , -@ to @ ; P = @ ) but not with placebo ( @ ; @ % CI , -@ to @ ; P = @ ) .


The @-minute walk distance increased with MSCs only ( repeated measures model , P = @ ) .


Infarct size as a percentage of LV mass was reduced by MSCs ( -@ % ; @ % CI , -@ to -@ ; within-group , P = @ ) but not by BMCs ( -@ % ; @ % CI , -@ % to @ % ; within-group , P = @ ) or placebo ( -@ % ; @ % CI , -@ % to @ % ; within-group , P = @ ) .


Regional myocardial function as peak Eulerian circumferential strain at the site of injection improved with MSCs ( -@ ; @ % CI , -@ to @ ; within-group repeated measures , P = @ ) but not BMCs ( -@ ; @ % CI , -@ to @ ; P = @ ) or placebo ( -@ ; @ % CI , -@ to @ ; P = @ ) .


Left ventricular chamber volume and ejection fraction did not change .


Transendocardial stem cell injection with MSCs or BMCs appeared to be safe for patients with chronic ischemic cardiomyopathy and LV dysfunction .


Although the sample size and multiple comparisons preclude a definitive statement about safety and clinical effect , these results provide the basis for larger studies to provide definitive evidence about safety and to assess efficacy of this new therapeutic approach .


A combination of psychosocial interventions and medications has been highly recommended as a successful treatment package for schizophrenia .


Its cost-effectiveness has not been fully explored yet .


The aim of the present analysis was to evaluate the cost-effectiveness of antipsychotics combined with psychosocial treatment and treatment as usual for patients with early-stage schizophrenia .


Patients with schizophrenia ( N = @ , @ ) were assigned to the combination of medication and psychosocial intervention or treatment as usual for up to @ months .


Cost analysis included direct medical costs , direct nonmedical costs and indirect costs .


Quality-adjusted life year ( QALY ) ratings were assessed with Short - Form @D .


Average monthly psychosocial intervention costs for combined treatment were higher than treatment as usual ( p = @ ) , but no significant differences were found in direct costs , indirect costs , and total costs between two groups ( all p-values @ ) .


Combined treatment was associated with significant higher QALY ratings than treatment as usual ( p = @ ) .


Compared with treatment as usual , combined treatment resulted in a gain of @ QALY ratings at an additional cost of US$ @ , yielding an incremental cost-effectiveness ratio of US$ @ per QALY gained .


Despite some limitations , our results supported that medication combined with psychosocial treatment was more cost-effective than treatment as usual for patients with early-stage schizophrenia .


To evaluate T@-relaxation times of chronic myocardial infarction ( CMI ) using gadobutrol and gadopentetate dimeglumine ( Gd-DTPA ) over time and to determine the optimal imaging window for late enhancement imaging with both contrast agents .


Twelve patients with CMI were prospectively included and examined on a @ T magnetic resonance ( MR ) system using relaxivity-adjusted doses of gadobutrol ( @ mmol/kg ) and Gd-DTPA ( @ mmol/kg ) in random order .


T@-relaxation times of remote myocardium ( RM ) , infarcted myocardium ( IM ) , and left ventricular cavity ( LVC ) were assessed from short-axis TI scout imaging using the Look-Locker approach and compared intraindividually using a Wilcoxon paired signed-rank test ( < @ ) .


Within @ min of contrast agent administration ( CA ) , IM showed significantly lower T@-relaxation times than RM with both contrast agents , indicating beginning cardiac late enhancement .


Differences between gadobutrol and Gd-DTPA in T@-relaxation times of IM and RM were statistically not significant through all time points .


However , gadobutrol led to significantly higher T@-relaxation times of LVC than Gd-DTPA from @ to @ min ( @ @ ms vs. @ @ ms p < @ ) onwards , resulting in a significantly greater T@ of IM to LVC at @-@ min ( -@ @ ms vs. @ @ ms , p < @ ) and @-@ min ( -@ @ ms vs. -@ @ ms , p < @ ) .


Using Gd-DTPA , comparable T@ values were reached only after @-@ min .


This study indicates good delineation of IM to RM with both contrast agents as early as @ min after administration .


However , we found significant differences in T@ relaxation times with greater T@ IM-LVC using @ mmol/kg gadobutrol compared to @ mmol/kg Gd-DTPA after @-@ min post-CA suggesting earlier differentiability of IM and LVC using gadobutrol .


Negative symptoms are known to undermine functional outcomes in people with schizophrenia ; however , most studies have not accounted for whether these symptoms were primary or secondary to other psychopathological factors .


The present study examined the impact of primary negative symptoms on functional outcomes in patients with schizophrenia .


The sample included @ patients with schizophrenia who completed the baseline visit in the CATIE study .


Symptoms were assessed with the Positive and Negative Syndrome Scale and Calgary Depression Scale , extrapyramidal side effects with the Simpson-Angus scale , and functional status with the Heinrichs-Carpenter Quality of Life Scale .


Negative symptoms were significantly and inversely related to each domain of functioning examined .


These relationships remained after statistically controlling for the influence of potential sources of secondary negative symptoms .


In addition , the relationships between negative symptoms and specific domains of functioning remained in patients who had mild/absent positive , depressive , anxiety and extrapyramidal symptoms .


Negative symptoms were associated with functional outcomes even in antipsychotic-free patients .


Primary negative symptoms significantly contribute to the functional impairment seen in people with schizophrenia .


A better understanding of the etiology and pathobiology of these symptoms is required to guide the search for effective therapeutics that promote functional recovery .


Although ultrasound-guided supraclavicular block has a good success rate , it remains unclear whether multiple injections are superior to single injection ( SI ) .


We compared the sensory block success rate of SI versus triple injection ( TI ) .


In this randomized double-blind study , @ end-stage renal disease patients undergoing arteriovenous fistula creation or superficialization were randomly allocated to receive either SI or TI .


The primary outcome was the combined score of sensory blockade of the @ nerves ( median , ulnar , radial , medial cutaneous nerve of the forearm , and musculocutaneous ) measured at @ , @ , @ , and @ minutes after injection .


Secondary outcome variables were the time to onset of the blockade , performance time ( time to do the block ) , separate success rate for each of the above nerves , success rate of surgical anesthesia , and the complication rate .


The combined success of the sensory block was @ % to @ % higher in the TI group than in the SI group at @ , @ , and @ minutes after injection ( all P < @ ) .


The block of the musculocutaneous nerve in the TI group was faster and more successful than in the SI group , at all time points ( all P < @ ) .


The average time needed to perform the block was significantly longer in the TI than the SI group ( @ @ vs @ @ minutes , P = @ ) .


The overall success of surgical anesthesia measured at @ minutes did not differ significantly between the @ groups ( @ % in TI vs @ % in SI , P = @ ) .


Although the performance time of the SI technique was shorter , TI had a faster onset and resulted in a more successful block of all nerves in the first @ minutes .


Pancreatic ductal adenocarcinoma ( PDA ) is one of the most aggressive malignancies with marked resistance to chemo - and radiotherapy .


PDA-cancer stem cells ( CSCs ) are not targeted by current therapies and may be a reason for poor prognosis .


Studies indicate that diets rich in cabbage , broccoli , and cauliflower offer cancer preventative and therapeutic benefits .


Recent experimental studies have confirmed these findings and demonstrated that isothiocyanate , sulforaphane , and the polyphenol , quercetin , effectively reduced tumor growth and enhanced the sensitivity of the cancer cells to current chemotherapeutics .


The aim of the present study is to test the feasibility of a randomized controlled trial on the application of freeze-dried broccoli sprouts in patients with advanced PDA .


The study is designed as a prospective randomized , double-blinded pilot trial with a treatment and a placebo-controlled arm in a single center setting .


A total number of forty patients ( @ years or older ) in two parallel groups with advanced , surgically non-resectable PDA under palliative chemotherapy are planned for recruitment .


Patients in the treatment group will receive fifteen capsules of the study substance per day ( @ mg of active sulforaphane ) during the chemotherapy treatment course .


Patients in the placebo group will receive the same capsule size and portion distribution with inactive substances ( mainly methylcellulose ) .


The follow-up duration is one year .


Feasibility of the study substance , adverse effects , and patient compliance , as well as levels of serum tumor markers ( CEA , CA @-@ ) , quality of life , and patient overall survival rates will be assessed at defined points of time .


The POUDER trial is expected to transfer promising experimental and epidemiological data into a clinical pilot study to assess the effectiveness of broccoli sprout extracts in the treatment of advanced PDA .


The study objectives will provide data on the clinical feasibility and acceptability of a supportive treatment option accompanying palliative chemotherapy .


Based on these results , future clinical studies to create further evidence in this field are possible .


This study aimed to test the hypothesis that high-dose prednisolone ( @ mg/kg/day ) may be more efficacious than usual-dose ( @ mg/kg/day ) prednisolone for spasm resolution at @-days in children with infantile spasms .


This was a randomized , open-label-trial conducted at a tertiary-level-hospital from February-@ to March-@ .


Children aged @-months to @-years presenting with infantile spasms in clusters ( at least @ cluster/day ) with hypsarrhythmia or its variants on EEG were enrolled .


The study participants were randomized to receive either high-dose prednisolone ( @ mg/kg/day ) or the usual-dose ( @ mg/kg/day ) prednisolone .


The primary outcome measure was the proportion of children who achieved spasm freedom for @-h at day-@ after treatment initiation as per parental reports in both the groups .


The adverse effects were also monitored .


The study was registered with the clinicaltrials.gov ( ClinicalTrials.gov Identifier : NCT@ ) .


Sixty-three children were randomized into the two groups with comparable baseline characteristics .


The proportion of children with spasm cessation on day-@ was significantly higher in the high-dose group as compared to the usual-dose group ( @ % vs. @ % , p = @ ) .


The absolute risk reduction was @ % ( @ % confidence interval @-@ @ % ) with number needed to treat being @ .


The adverse effects were comparable in both the groups .


High-dose prednisolone ( @ mg/kg/d ) was more effective than low-dose prednisolone ( @mg/kg/d ) in achieving spasm cessation at @-days ( as per parental reports ) in children with infantile spasms .


Erectile dysfunction ( ED ) is an independent risk factor for cardiovascular events sharing mutual risk factors with coronary artery disease .


Several guidelines for the management of ED in cardiovascular disease have been proposed , recommending cardiologists to routinely inquire about erectile function .


However , males ' specific needs and wishes regarding sexual health care in cardiology are unknown .


We sought to identify male patients ' view concerning possible improvements in sexual health care and preferred forms of sexual counseling in the cardiology practice .


This is a cross-sectional multicentered survey study among randomly selected males visiting a cardiologist .


Of @ respondents , @ questionnaires were eligible for analysis .


Mean age of respondents was @ years .


Overall , @ % ( n = @ ) had ED , with up to @ % in patients with heart failure .


Mean bother experienced due to ED was @ ( @ ) on a @ to @ scale .


Most respondents indicated to feel comfortable discussing sexual health with the cardiologists ( @ % ) .


Of men with ED ( n = @ ) , @ % would like to have a conversation with the cardiologist about possibilities to improve sexual function , @ % would be helped if questions could be asked during consultation with a specialized nurse , and @ % would appreciate written information .


Of all respondents ( n = @ ) , @ % ever tried a phosphodiesterase inhibitor ; @ % received the prescription of the cardiologists .


Erectile dysfunction is highly prevalent in patients with a variety of cardiovascular diagnosis and care for sexual function is mandatory .


Patients indicated that above consultation with the cardiologist , both consultation with a specialized nurse and written information would be helpful .


For visually impaired individuals , motivation to be mobile and the individual 's emotional states are predetermining factors of functioning .


In addition , loss of confidence at the time of diagnosis could inhibit the ability to make progress .


The aim of this study is to evaluate whether Problem-Solving Treatment , a brief , structured psychological intervention , leads to better psychological well-being in people who have been recently diagnosed as blind or partially sighted .


A pilot randomised controlled trial : the trial aims to recruit @ individuals who have either : ( @ ) been diagnosed with severe , irreversible sight loss , or ( @ ) registered as blind or partially sighted within the last @months .


Individuals will be randomly allocated to either the intervention or control group with randomisation stratified by severity of vision loss .


Those in the intervention arm will receive Problem-Solving Treatment , an established intervention that addresses individual 's confidence , motivation and psychological well-being by undertaking specific tasks to help individuals work through their problems , and recognising steps to problem resolution .


Both groups will continue to receive routine care , such as mobility training .


The primary outcome is psychological well-being measured at @ , @ , and @months after recruitment and assignment to intervention or control group .


Secondary outcomes include symptoms of distress , mobility and quality of life .


@-Reductase ( @R ) types @ and @ catalyze the A-ring reduction of steroids , including androgens and glucocorticoids .


@-R inhibitors lower dihydrotestosterone in benign prostatic hyperplasia ; finasteride inhibits @R@ , and dutasteride inhibits both @R@ and @R@ .


In rodents , loss of @R@ promotes fatty liver .


Our objective was to test the hypothesis that inhibition of @R@ causes metabolic dysfunction in humans .


This double-blind randomized controlled parallel group study at a clinical research facility included @ men ( @-@ years ) studied before and after intervention .


Oral dutasteride ( @ mg daily ; n = @ ) , finasteride ( @ mg daily ; n = @ ) , or control ( tamsulosin ; @ mg daily ; n = @ ) was administered for @ months .


Glucose disposal was measured during a stepwise hyperinsulinemic-euglycemic clamp .


Data are mean ( SEM ) .


Dutasteride and finasteride had similar effects on steroid profiles , with reduced urinary androgen and glucocorticoid metabolites and reduced circulating DHT but no change in plasma or salivary cortisol .


Dutasteride , but not finasteride , reduced stimulation of glucose disposal by high-dose insulin ( dutasteride by -@ -LSB- @ -RSB- mol/kg fat-free mass/min , versus finasteride +@ -LSB- @ -RSB- , and tamsulosin +@ -LSB- @ -RSB- ) .


Dutasteride also reduced suppression of nonesterified fatty acids by insulin and increased body fat ( by @ % -LSB- @ % -RSB- ) .


Glucose production and glycerol turnover were unchanged .


Consistent with metabolic effects of dutasteride being mediated in peripheral tissues , mRNA for @R@ but not @R@ was detected in human adipose tissue .


Dual inhibition of @Rs , but not inhibition of @R@ alone , modulates insulin sensitivity in human peripheral tissues rather than liver .


This may have important implications for patients prescribed dutasteride for prostatic disease .


Feed intake affects the GH-IGF system and may be a key factor in determining the ovarian follicular growth rate .


In fat mares , the plasma IGF-@ concentration is high with low GH and a quick follicular growth rate , in contrast to values observed in thin mares .


Nothing is known regarding the long-term effects of differential feed intake on the IGF system .


The objective of this experiment was to quantify IGFs , IGFBPs , GH , glucose , insulin , gonadotropin and progesterone ( P@ ) in blood and in preovulatory follicular fluid ( FF ) in relation to feeding levels in mares .


Three years prior to the experiment , Welsh Pony mares were assigned to a restricted diet group ( R , n = @ ) or a well-fed group ( WF , n = @ ) .


All mares were in good health and exhibited differences in body weight and subcutaneous fat thickness .


Follicular development was scanned daily and plasma was also collected daily .


Preovulatory FF was collected by ultrasound-guided follicular aspiration .


Hormone levels were assayed in FF and plasma with a validated RIA .


According to scans , the total number of follicles in group R was @ % lower than group WF .


Insulin and IGF-@ concentrations were higher in WF than in R mares .


GH and IGF-@ concentrations were lower in plasma from WF mares than from R mares , but the difference was not significant in FF .


The IGFBP-@ / IGFBP-@ ratio in FF was not affected by feeding but was dramatically increased in R mare plasma .


No difference in gonadotropin concentration was found with the exception of FSH , which was higher in the plasma of R mares .


On the day of puncture , P@ concentrations were not affected by feeding but were higher in preovulatory FF than in plasma .


The bioavailability of IGF-@ or IGF-@ , represented by the IGFBP@/IGFBP@ ratio , is modified by feed intake in plasma but not in FF .


These differences partially explain the variability in follicular growth observed between well-fed mares and mares on restricted diets .


Obesity and its associated cardiometabolic co-morbidities are increasing worldwide .


Since thyroid hormone mimetics are capable of uncoupling the beneficial metabolic effects of thyroid hormones from their deleterious effects on heart , bone and muscle , this class of drug is considered as adjacent therapeutics to weight-lowering strategies .


This study investigated the safety and efficacy of TRC@ , a thyroid hormone mimetic .


This @-week , randomized , placebo-controlled , double-blind trial was conducted in India and The Netherlands .


Forty subjects were randomized at a @:@ ratio to receive either TRC@ dosed at @ mg or placebo once daily for @ weeks .


Hyperinsulinemic euglycemic clamp and ( @ ) H-Magnetic Resonance Spectroscopy ( MRS ) were performed before and after treatment .


At baseline , subjects were characterized by markedly impaired hepatic and peripheral insulin sensitivity .


TRC@ dosed @ mg once daily was safe and well tolerated .


Hepatic nor peripheral insulin sensitivity improved after TRC@ treatment , expressed as the suppression of Endogenous Glucose Production from @ to @ % ; p = @ , and the rate of glucose disappearance from @ to @ mol kg ( -@ ) min ( -@ ) , p = @ .


TRC@ administration did not result in differences in fasting plasma free fatty acids from @ to @ mmol/L , p = @ or in insulin-mediated suppression of lipolysis from @ to @ % , p = @ .


Also , intrahepatic triglyceride content was unaltered .


Collectively , these data show that , in contrast to the potent metabolic effects in experimental models , TRC@ at a dose of @ mg daily does not improve the metabolic homeostasis in subjects at an increased cardiometabolic risk .


Further studies are needed to evaluate whether TRC@ has beneficial effects in patients with more severe metabolic derangement , such as overt diabetes mellitus and hypertriglyceridemia .


We previously observed that @ months of inhaled corticosteroid ( ICS ) treatment can attenuate FEV@ decline in COPD , but it is unclear whether withdrawal induces a relapse .


We hypothesized that FEV@ decline , airway hyperresponsiveness ( AHR ) , and quality of life ( QOL ) deteriorate after ICS cessation even after prolonged use .


One hundred fourteen patients with moderate to severe COPD finished randomized @-month or @-month treatment with fluticasone ( @ g bid ) , @-month treatment with fluticasone and salmeterol ( @/@ g bid ) , or placebo ( first part of the Groningen and Leiden Universities Corticosteroids in Obstructive Lung Disease -LSB- GLUCOLD -RSB- study -LSB- GL@ -RSB- ) .


The subsequent @ years , patients were prospectively followed annually , treated by their physician ( GLUCOLD follow-up study -LSB- GL@ -RSB- ) .


Postbronchodilator FEV@ , AHR , and QOL were initially recorded at baseline , at @ months ( GL@ ) , and annually during GL@ .


Analysis was performed by linear mixed-effects models .


Among @ adherent patients during GL@ , @ patients started and @ completed GL@ .


Patients using ICSs during GL@ , but only using ICSs @ % to @ % of the time during GL@ ( n = @ of @ ) , had significantly accelerated annual FEV@ decline compared with GL@ ( difference GL@-GL@ -LSB- @ % CI -RSB- : @-month treatment with fluticasone and salmeterol , -@ mL/y -LSB- -@ to -@ -RSB- , P = @ ; @-month treatment with fluticasone , -@ mL/y -LSB- -@ to -@ -RSB- , P = @ ) , accompanied by deterioration in AHR and QOL .


ICS discontinuation after @ months in COPD can worsen lung function decline , AHR , and QOL during @-year follow-up .


This suggests that ICS treatment lacks sustained disease-modifying effect after treatment cessation .


To investigate the effect of a fluoride-containing aluminocalciumsilicate nanoparticle glass dispersed aqueous solution ( Nanoseal ) on enamel and dentin , under the hypothesis that this material can form insoluble mineral deposits that confer acid resistance to the tooth structure and occlude open dentin tubules .


Labial enamel and dentin of human extracted incisors were used .


Morphology of the enamel and dentin artificially demineralized with a lactic acid solution that before and/or after coated with the test material were analyzed with a wavelength-dispersive X-ray spectroscopy electron probe microanalyzer with an image observation function ( SEM-EPMA ) .


Moreover , incorporation of the calcium and silicon by enamel and dentin were also detected with SEM-EPMA .


Application of the fluoroaluminocalciumsilicate-based tooth coating material resulted in the deposition of substances ( nanoparticles ) onto the enamel surface porosities and open dentin tubules on the artificial lesions .


Prior coating with the test material reduced the demineralization-induced loss of enamel and dentin .


Moreover , Ca and Si incorporation into superficial enamel and dentin was detected .


Neonatal hepatitis B vaccination has been implemented worldwide to prevent hepatitis B virus ( HBV ) infections .


Its long-term protective efficacy on primary liver cancer ( PLC ) and other liver diseases has not been fully examined .


The Qidong Hepatitis B Intervention Study , a population-based , cluster randomized , controlled trial between @ and @ in Qidong , China , included @,@ newborns who were randomly assigned to the vaccination group in which @,@ participants completed the HBV vaccination series and @,@ newborns who were randomly assigned to the control group in which the participants received neither a vaccine nor a placebo .


However , @,@ ( @ % ) participants in the control group received catch-up vaccination at age @-@ years .


By December @ , a total of @,@ ( @ % ) in the vaccination group and @,@ ( @ % ) in the control group were lost to follow-up .


Information on PLC incidence and liver disease mortality were collected through linkage of all remaining cohort members to a well-established population-based tumor registry until December @ , @ .


Two cross-sectional surveys on HBV surface antigen ( HBsAg ) seroprevalence were conducted in @-@ and @-@ .


The participation rates of the two surveys were @ % ( @,@ ) and @ % ( @,@ ) in the vaccination group and @ % ( @,@ ) and @ % ( @,@ ) in the control group , respectively .


Using intention-to-treat analysis , we found that the incidence rate of PLC and the mortality rates of severe end-stage liver diseases and infant fulminant hepatitis were significantly lower in the vaccination group than the control group with efficacies of @ % ( @ % CI @ % -@ % ) , @ % ( @ % CI @ % -@ % ) , and @ % ( @ % CI @ % -@ % ) , respectively .


The estimated efficacy of catch-up vaccination on HBsAg seroprevalence in early adulthood was @ % ( @ % CI @ % -@ % ) , substantially weaker than that of the neonatal vaccination ( @ % , @ % CI @ % -@ % ) .


Receiving a booster at age @-@ years decreased HBsAg seroprevalence if participants were born to HBsAg-positive mothers ( hazard ratio -LSB- HR -RSB- = @ , @ % CI @-@ @ ) .


Limitations to consider in interpreting the study results include the small number of individuals with PLC , participants lost to follow-up , and the large proportion of participants who did not provide serum samples at follow-up .


Neonatal HBV vaccination was found to significantly decrease HBsAg seroprevalence in childhood through young adulthood and subsequently reduce the risk of PLC and other liver diseases in young adults in rural China .


The findings underscore the importance of neonatal HBV vaccination .


Our results also suggest that an adolescence booster should be considered in individuals born to HBsAg-positive mothers and who have completed the HBV neonatal vaccination series .


Please see later in the article for the Editors ' Summary .


Gabapentinoids are currently being used anecdotally for postoperative pain following photorefractive keratectomy ( PRK ) despite the lack of evidence .


The purpose of this study is to evaluate the effectiveness of pregabalin in mitigating pain after PRK compared to the standard of care .


One hundred thirty-five patients scheduled for PRK at the Joint Warfighter Refractive Surgery Center in San Antonio , Texas were randomized to receive either oral pregabalin @mg twice daily for @ days or placebo , in addition to the standard pain care regimen .


There was no statistically significant difference in the primary outcome of @ % improvement in subjective pain scores between the treatment and placebo groups at any point during the postoperative period , but there was a trend for lower subjective pain scores in the pregabalin group .


There was a statistically significant difference in the frequency of rescue pain medications used on postoperative days @ and @ .


The pregabalin group required an average of @ doses of rescue medications on postoperative day @ versus @ doses in the placebo group , and @ doses versus @ doses on postoperative day @ ( P < @ ) .


This study demonstrates that pregabalin may provide an alternative or add-on option to standard narcotics for pain relief after PRK .


Although livestock vaccination is effective in preventing Rift Valley fever ( RVF ) epidemics , there are concerns about safety and effectiveness of the only commercially available RVF Smithburn vaccine .


We conducted a randomized controlled field trial to evaluate the immunogenicity and safety of the new RVF Clone @ vaccine , recently registered in South Africa .


In a blinded randomized controlled field trial , @ animals ( @ cattle , @ sheep , and @ goats ) in three farms in Kenya were divided into three groups .


Group A included males and non-pregnant females that were randomized and assigned to two groups ; one vaccinated with RVF Clone @ and the other given placebo .


Groups B included animals in @st half of pregnancy , and group C animals in @nd half of pregnancy , which were also randomized and either vaccinated and given placebo .


Animals were monitored for one year and virus antibodies titers assessed on days @ , @ , @ , @ and @ .


In vaccinated goats ( N = @ ) , @ % developed anti-RVF virus IgM antibodies and @ % neutralizing IgG antibodies .


In vaccinated sheep ( N = @ ) , @ % developed IgM and @ % neutralizing IgG antibodies .


Vaccinated cattle ( N = @ ) did not develop IgM antibodies but @ % developed neutralizing IgG antibodies .


At day @ post-vaccination , the odds of being seropositive for IgG in the vaccine group was @ ( @ % CI , @ - @ ) in cattle , @ ( @ % CI , @ - @ ) in goats , and @ ( @ % CI , @ - @ ) in sheep .


Abortion was observed in one vaccinated goat but histopathologic analysis did not indicate RVF virus infection .


There was no evidence of teratogenicity in vaccinated or placebo animals .


The results suggest RVF Clone @ vaccine is safe to use and has high ( > @ % ) immunogenicity in sheep and goats but moderate ( > @ % ) immunogenicity in cattle .


Polyunsaturated fatty acid ( PUFA ) metabolism abnormalities have been long implicated in the etiology of schizophrenia .


Although several randomized clinical trials have been carried out to assess the efficacy of omega-@ PUFA as add-on therapy in reducing psychopathology in populations of chronic patients with schizophrenia , only a few concern first-episode schizophrenia .


The majority of these studies used a @-week intervention based on ethyl-eicosapentaenoic acid ( ethyl-EPA ) , however , with conflicting results .


An intervention based on docosahexaenoic acid plus EPA has not been used in first-episode schizophrenia studies so far .


No add-on supplementation studies have been carried out in medicated first-episode schizophrenia patients to assess the efficacy of omega-@ PUFA in preventing relapses .


A randomized placebo-controlled one-center trial will be used to compare the efficacy of @-week intervention , composed of either @mg/day of EPA and @mg/day of DHA , or olive oil placebo with regard to symptom severity and relapse rate in first-episode schizophrenia patients .


Eighty-two patients ( aged @-@ ) will be recruited for the study .


Eligible patients will be randomly allocated to one of two intervention arms : an active arm or a placebo arm ( olive oil ) .


The primary outcome measure of the clinical evaluation is schizophrenia symptom severity measured by the Positive and Negative Syndrome Scale ( PANSS ) .


Other outcomes include depressive symptoms , patient functioning and the level of insight .


Correlates of change measured during the study will include structural brain changes , oxidative stress and defense , as well as neuroplasticity indicators .


Metabolic syndrome components will also be assessed throughout the study .


By comparing @-week administration of EPA+DHA or ( placebo ) olive oil as add-on therapy in reducing symptom severity and one-year relapse rate in patients with first episode schizophrenia , it is intended to provide new insights into the efficacy of omega-@ PUFA and correlates of change , and contribute to the improvement of mental health care for individuals suffering from schizophrenia .


To investigate the effects and mechanism of postoperative insulin resistance in gastrectomy patients with preoperative oral carbohydrate .


From April to October @ , @ consecutive gastric cancer patients met inclusion criteria were divided into oral carbohydrate group and placebo group by randomized double-blind principles .


Resting energy expenditure ( REE ) , fasting blood glucose , insulin and triglyceride level were detected in @ hours preoperatively .


The @ ml carbohydrate or placebo were administrated orally @-@ hours before anaesthesia .


Two group patients underwent radical distal subtotal gastrectomy under epidural compounded intravenous anesthesia .


After laparotomy and before the abdomen was closed , a piece of rectus abdominis was taken and fixed in @ % glutaraldehyde .


REE , fasting blood glucose , insulin and triglyceride level were detected immediately after surgery .


The changes of insulin resistance index , blood triglycerides level , REE and respiratory quotient were compared pre - and post-operatively .


The changes of rectus abdominis mitochondrial ultrastructure were observed by transmission electron microscopy respectively .


There were @ patients ( @ males and @ females ) completed the trial .


The @ and @ patients in oral placebo and carbohydrate groups respectively .


In oral placebo group , post-operative insulin resistance index , REE , respiratory quotient , serum triglyceride level and the rectus abdominis mitochondrial damage index were @ @ , ( @ @ ) kcal/d , @ @ , ( @ @ ) g/L and @ @ , respectively .


And the above items were @ @ , ( @ @ ) kcal/d , @ @ , ( @ @ ) g/L and @ @ in oral carbohydrate groups respectively .


All difference was statistically significant ( t = @ , @ , @ , @ and @ , all P < @ ) .


Oral placebo group showed a markedly swollen mitochondria , steep membrane was not clear , mitochondria appeared vacuolated changes .


Preoperative oral carbohydrate could reduce the insulin resistance and REE , improve the material metabolism status in radical gastrectomy patients .


The possible mechanisms should be related to promotion of insulin release and protection of mitochondrial function .


Colorectal cancer ( CRC ) screening is effective but underutilized .


Although physician recommendation is an important predictor of screening , considerable variation in CRC screening completion remains .


To characterize the influence of patient trust in care providers on CRC screening behavior .


Data were collected as part of a cluster-randomized CRC screening intervention trial performed in the San Francisco Community Health Network from March @ to January @ ( analysis , Spring @ ) .


All study participants received a recommendation to complete CRC screening from their primary care provider ( PCP ) .


Included participants were aged @-@ years , not current with screening , and completed the Wake Forest Trust Scale ( WFTS ) measuring trust in PCPs and doctors in general .


Primary outcome was CRC screening completion ( colonoscopy or fecal occult blood testing ) within @ months following enrollment .


Multivariable association adjusted for race/ethnicity , language , and other sociodemographics was estimated using generalized estimating equations with logit link and binomial distribution .


WFTS response was @ % ( @ ) .


Most participants ( @ % ) were Latino , Asian , or black .


Most had income < $ @,@ ( @ % ) and public health insurance ( @ % ) .


Higher trust in PCP was associated with screening completion ( OR = @ , @ % CI = @ , @ ) , but trust in doctors was not ( OR = @ , @ % CI = @ , @ ) .


Race , language , and other sociodemographic factors were not significant in multivariable analysis .


After controlling for traditional factors , trust in PCP remained the only significant driver of CRC screening completion in low-income patients .


Interventions to promote CRC screening may be improved by including efforts to enhance patient trust in PCP .


Prematurity and the associated risk for bronchopulmonary dysplasia ( BPD ) remain a significant threat to extremely low birth weight ( ELBW ) infants .


Vitamin A has been considered a therapeutic alternative in reducing the rate of BPD and mortality .


To investigate whether early postnatal , additional high-dose oral vitamin A supplementation for @ days is more efficient in reducing BPD or death in ELBW infants than placebo treatment .


This is a multicenter , double-blind RCT comparing postnatal high-dose oral vitamin A supplementation ( @,@ IU vitamin A/kg/day vs. placebo ) for @ days in ELBW neonates requiring mechanical ventilation , noninvasive ventilatory support or supplemental oxygen at @ h of age .


The primary end point is the proportion of children who died before @ weeks ' gestational age or developed moderate or severe BPD .


BPD is defined as the need for supplemental oxygen to maintain SaO@ of @ % at rest at @ weeks ' postmenstrual age ( PMA ) .


Clinical secondary end points include the following : BPD ( including mild form ) , intraventricular hemorrhage , periventricular leukomalacia , retinopathy of prematurity , necrotizing enterocolitis , total number of days of mechanical ventilation and oxygen supplementation , and safety and tolerability of high-dose vitamin A supplementation .


The results of the NeoVitaA trial will provide robust data with regard to the efficacy of high-dose oral vitamin A supplementation in reducing the incidence of BPD or death at @ weeks ' PMA in ELBW infants .


Research on the role of nutrition in type @ diabetes has largely focused on macro/micronutrient composition and dietary fiber intake , while fewer studies have tested the effects of differing food choice .


Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems .


Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products .


The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control , while keeping participants ' weight stable and other food parameters , such as macro/micronutrient composition , dietary fiber and glycemic load , the same in both diets .


We intend to include @ adult patients with a medical diagnosis of type @ diabetes mellitus with or without medication and with an increased waist circumference ( @cm for women and@cm for men ) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period .


Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content , but differing in the type of food included , with one diet being without cereal grains and dairy products .


Lunch will be served in a hospital kitchen for control of nutrient intake , while the rest of the meals will be eaten at home according to specific directions .


The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods .


Primary outcomes will be change in fasting plasma glucagon and fructosamine , while secondary outcomes include change in fasting glucose and glycated hemoglobin , glucose and glucagon response during oral glucose tolerance test , blood lipids , blood pressure , C-reactive protein , body composition , quality of life , subjective experience with the two diets , satiety scores and changes in medication .


Using these results , we will assess the need to conduct larger and longer studies with similar design .


Curcumin , the principal curcuminoid derived from the spice turmeric , influences several biological mechanisms associated with major depression , namely those associated with monoaminergic activity , immune-inflammatory and oxidative and nitrosative stress pathways , hypothalamus-pituitary-adrenal ( HPA ) axis activity and neuroprogression .


We hypothesised that curcumin would be effective for the treatment of depressive symptoms in individuals with major depressive disorder .


In a randomised , double-blind , placebo-controlled study , @ individuals with major depressive disorder were treated with curcumin ( @ mg twice daily ) or placebo for @ weeks .


The primary measure was the Inventory of Depressive Symptomatology self-rated version ( IDS-SR@ ) .


Secondary outcomes included IDS-SR@ factor scores and the Spielberger State-Trait Anxiety Inventory ( STAI ) .


From baseline to week @ , both curcumin and placebo were associated with improvements in IDS-SR@ total score and most secondary outcome measures .


From weeks @ to @ , curcumin was significantly more effective than placebo in improving several mood-related symptoms , demonstrated by a significant group x time interaction for IDS-SR@ total score ( F@ , @ = @ , p = @ ) and IDS-SR@ mood score ( F@ , @ = @ , p = @ ) , and a non-significant trend for STAI trait score ( F@ , @ = @ , p = @ ) .


Greater efficacy from curcumin treatment was identified in a subgroup of individuals with atypical depression .


Partial support is provided for the antidepressant effects of curcumin in people with major depressive disorder , evidenced by benefits occurring @ to @ weeks after treatment .


Investigations with larger sample sizes , over extended treatment periods , and with varying curcumin dosages are required .


Malaria continues to be a prominent global public health challenge .


This study tested the effectiveness of two service delivery models for reducing the malaria burden , e.g. supportive supervision of community health workers ( CHW ) and community mobilization in promoting appropriate health-seeking behaviour for febrile illnesses in Odisha , India .


The study population comprised @ villages from two purposively chosen malaria-endemic districts , with @ villages randomly assigned to each of the two treatment arms , one with both supportive supervision and community mobilization and one with community mobilization alone , as well as an observational control arm .


Outcome measures included changes in the utilization of bed nets and timely care-seeking for fever from a trained provider compared to the control group .


Analysis was by intention-to-treat .


Significant improvements were observed in the reported utilization of bed nets in both intervention arms ( @ % in arm A and @ % in arm B versus @ % in the control arm ; p < @ ) .


While overall rates of treatment-seeking were equal across study arms , treatment-seeking from a CHW was higher in both intervention arms ( @ % ; p = @ and @ % ; p = @ ) than in the control arm ( @ % ) .


Fever cases were significantly more likely to visit a CHW and receive a timely diagnosis of fever in the combined interventions arm than in the control arm ( @ % vs. @ % ; p = @ ) .


Care-seeking from trained providers also increased with a substitution away from untrained providers .


Further , fever cases from the combined interventions arm ( @ % ; p = @ ) and the community mobilization arm ( @ % ; p = @ ) were more likely to have received treatment from a skilled provider within @ hours than fever cases from the control arm ( @ % ) .


In particular , women from the combined interventions arm were more likely to have received timely treatment from a skilled provider ( @ % vs. @ % ; p = @ ) .


A community-based intervention combining the supportive supervision of community health workers with intensive community mobilization and can be effective in improving care-seeking and preventive behaviour and may be used to strengthen the national malaria control programme .


To compare immediate and @h postoperative removal of urinary catheter after elective cesarean section .


In a prospective clinical trial at a university teaching hospital , @ eligible women admitted for primary or repeat elective cesarean section were randomized into two equal groups .


In group A , the catheter was removed immediately after the procedure ; whereas in group B , the catheter was removed @h postoperatively .


The incidence of postoperative significant bacteruria ( p = @ ) , dysuria ( p = @ ) , burning on micturition ( p = @ ) , urinary frequency ( p = @ ) , and urgency ( p = @ ) were significantly lower in group A compared with group B.


The mean postoperative ambulation time ( p < @ ) , time till the first voiding ( p < @ ) , and length of hospital stay ( p < @ ) were also significantly shorter in group A.


There were no significant differences between the two groups in the incidence of urinary retention necessitating recatheterization ( p = @ ) .


Immediate removal of urinary catheter after elective cesarean section is associated with lower risk of urinary infection and earlier postoperative ambulation .


Scoliosis repair is a major orthopaedic surgery associated with severe post-operative pain .


Ketamine and magnesium have an established efficacy as morphine-sparing agents .


Our purpose was to evaluate the morphine-sparing effect of both magnesium and ketamine given simultaneously compared with ketamine alone during scoliosis surgery .


Fifty patients scheduled for posterior instrumentation were randomised in a prospective double-blind study .


The Gr ( K + Mg ) received , after induction , an intravenous ( IV ) bolus of ketamine @ mg/kg and magnesium @ mg/kg , followed by continuous infusion of ketamine ( @ mg/kg/h ) and magnesium ( @ mg/kg/h ) until extubation .


The Gr ( K ) received the same dose of ketamine associated with bolus and continuous infusion of normal saline .


All patients received multimodal analgesia associated with IV morphine administered via patient-controlled analgesia pump .


Morphine consumption , visual analogue scale ( VAS ) pain scores and occurrence of side effects were followed until @ h post-operatively .


Sleep quality and patient satisfaction were also followed .


P < @ was considered statistically significant .


The average cumulative morphine consumption was significantly lower in the Gr ( K + Mg ) compared with the Gr ( K ) at post-operative hours @ , @ , @ , @ , @ , @ and @ .


The relative difference in the post-operative morphine consumption was @ % : Gr ( K + Mg ) @ mg vs. Gr ( K ) @ mg .


VAS scores were not statistically different between the two groups .


However , qualities of sleep and satisfaction scores on the first night were significantly better in the Gr ( K + Mg ) ( P = @ and P = @ , respectively ) .


Ketamine and magnesium association reduces the post-operative morphine consumption after scoliosis surgery .


It seems to provide a better sleep quality and improves patient satisfaction .


Prolonged sitting time has been identified as a health risk factor .


Sit-stand workstations allow desk workers to alternate between sitting and standing throughout the working day , but not much is known about their acceptability and feasibility .


Hence , the aim of this study was to qualitatively evaluate the acceptability , feasibility and perceptions of using sit-stand workstations in a group of desk-based office workers .


This article describes the qualitative evaluation of the randomized controlled cross-over Stand@Work pilot trial .


Participants were adult employees recruited from a non-government health agency in Sydney , Australia .


The intervention involved using an Ergotron Workfit S sit-stand workstation for four weeks .


After the four week intervention , participants shared their perceptions and experiences of using the sit-stand workstation in focus group interviews with @-@ participants .


Topics covered in the focus groups included patterns of workstation use , barriers and facilitators to standing while working , effects on work performance , physical impacts , and feasibility in the office .


Focus group field notes and transcripts were analysed in an iterative process during and after the data collection period to identify the main concepts and themes .


During nine @-min focus groups , a total of @ participants were interviewed .


Participants were largely intrinsically motivated to try the sit-stand workstation , mostly because of curiosity to try something new , interest in potential health benefits , and the relevance to the participant 's own and organisation 's work .


Most participants used the sit-stand workstation and three common usage patterns were identified : task-based routine , time-based routine , and no particular routine .


Common barriers to sit-stand workstation use were working in an open plan office , and issues with sit-stand workstation design .


Common facilitators of sit-stand workstation use were a supportive work environment conducive to standing , perceived physical health benefits , and perceived work benefits .


When prompted , most participants indicated they were interested in using a sit-stand workstation in the future .


The use of a sit-stand workstation in this group of desk-based office workers was generally perceived as acceptable and feasible .


Future studies are needed to explore this in different desk-based work populations and settings .


The aim was to investigate whether a strategy of direct drug-eluting stent ( DES ) implantation without pre-dilation is associated with a reduced incidence of restenosis compared with CS with pre-dilation or provisional stenting ( PS ) .


Previous studies were performed comparing direct stenting ( DS ) with conventional stenting ( CS ) after pre-dilation ; however , none of these in the DES era .


Therefore , the STRESSED ( direct Stenting To reduce REStenosis in Stent Era with Drug elution ) study was designed and carried out .


A total of @ patients with angina pectoris or recent myocardial infarction were randomized to a DS , CS , or PS strategy .


The primary endpoint was the mean minimal lumen diameter at @-month follow-up angiography .


Secondary endpoints were clinical procedural success defined as angiographic success without in-hospital major adverse cardiac events ( MACE ) , and MACE at @-month and @-year follow-up .


Stent implantation in the DS group was @ % , @ % in the CS group , and @ % in the PS group .


Percutaneous coronary intervention success was @ % in all groups .


The minimal lumen diameter at @-month follow-up was @ @ mm ( DS ) , @ @ mm ( CS ) , and @ @ mm ( PS ) , p = @ for comparison of DS with CS , p = @ for comparison of DS with PS .


The absolute difference was-@ @ ( DS to CS ) , @ % confidence interval : -@ to-@ @ , p = @ and @ ( DS to PS ) , confidence interval : -@ to-@ @ , p = @ .


Restenosis was found in @ % ( DS ) , @ % ( CS ) , and @ % ( PS ) , p = @ .


At @-month and @-year follow-up , MACE occurred in @ % and @ % ( DS ) , @ % and @ % ( CS ) , and @ % and @ % ( PS ) ( p = @ and @ ) , respectively .


Direct DES implantation compared with conventional DES implantation did not reduce restenosis .


Provisional stenting , however , was associated with a higher rate of restenosis .


This did not translate into a difference in the rate of MACE .


( STRESSED study : direct Stenting To reduce REStenosis in Stent Era with Drug elution ; ISRCTN@ ) .


The vaginal microbiota may play a role in mediating susceptibility to sexually transmitted infections , including Trichomonas vaginalis ( TV ) .


Data were analyzed from HIV-@-seronegative women participating in HIV Prevention Trials Network Protocol @ .


At quarterly visits for up to @ months , participants completed structured interviews and specimens were collected for genital tract infection testing .


T. vaginalis was detected by saline microscopy .


Bacterial vaginosis ( BV ) was characterized by Gram stain using the Nugent score ( BV = @-@ ; intermediate = @-@ ; normal = @-@ -LSB- reference group -RSB- ) .


Cox proportional hazards models stratified by study site were used to assess the association between Nugent score category at the prior quarterly visit and TV acquisition .


In this secondary analysis , @ participants from Malawi , South Africa , United States , Zambia , and Zimbabwe contributed @,@ follow-up visits .


Bacterial vaginosis was detected at @ ( @ % ) visits , and TV was detected at @ ( @ % ) visits .


Adjusting for age , marital status , hormonal contraceptive use , unprotected sex in the last week and TV at baseline , intermediate Nugent score , and BV at the prior visit were associated with an increased risk of TV ( intermediate score : adjusted hazard ratio -LSB- aHR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; BV : aHR , @ ; @ % CI , @-@ @ ) .


Sensitivity analyses excluding @ participants with TV at baseline were similar to those from the full study population ( intermediate score : aHR , @ ; @ % CI , @-@ @ ; BV : aHR , @ ; @ % CI , @-@ @ ) .


Women with a Nugent score higher than @ were at an increased risk for acquiring TV .


If this relationship is causal , interventions that improve the vaginal microbiota could contribute to reductions in TV incidence .


Habitual exposure to carbon dioxide ( CO@ ) is expected , but it is not proven , to dull ventilatory sensitivity to co@ by reducing hypercapnic ventilatory response ( HCVR ) as it is expressed by the slope of the derived response curve ( CO@ sensitivity : VE/PetCO@ ) .


It was hypothesized that HCVR is decreased by repeated breath hold maximal efforts ( RBHE ) before and after apnea training in comparison with no training and the control condition .


Two groups of breath holders , a control ( CBH ) group and novices to breath hold activities ( NBH ) , visited the laboratory on four different occasions .


In the first visit , subjects performed a HCVR test , whereas in the second visit they completed five successive RBHE separated by @-min intervals .


Another HCVR test was performed @ min after cessation of the last apnea .


For the next @ d , only the NBH group trained by performing daily five RBHE separated by @-min intervals .


Subsequently , in a third and a fourth condition , subjects repeated the experimental protocol of the second and first visit .


Although breath hold time ( BHT ) increased after apnea training in the NBH group by ~ @ % , CO@ sensitivity slopes were not different among experimental conditions and groups ( @ @ , @ @ L min ( @ ) mmHg ( @ ) in the CBH and @ @ , @ @ L min ( @ ) mmHg ( @ ) in the NBH during the second and third visit , respectively ) .


HCVR after five RBHE or @ d of apnea training was not decreased despite the achieved BHT enhancement .


Hypercapnic dullness of ventilation is a complex biological process which takes more than @ d of training to develop .


Bourdas DI , Tsakiris TS , Pavlakis KI , Triantafillou DV , Geladas ND .


Repeated apneas and hypercapnic ventilatory response before and after apnea training .


Olive oil-based lipid emulsion ( LE ) and medium chain triglyceride/long chain triglyceride ( MCT/LCT ) emulsion are both LEs with low -@ polyunsaturated fat acids ( PUFAs ) content .


However , which one of these LEs is associated with a lower infection risk in patients receiving parenteral nutrition ( PN ) remains unclear .


The aim of the study was to compare the effects of the two LEs in PN in esophageal cancer patients undergoing surgery .


Patients with resectable esophageal carcinoma were recruited and allocated randomly to two groups .


The test group was given enteral nutrition ( EN ) with PN containing olive oil-based LE after tumor resection for @ days , and the patients in the control group were supported by EN with MCT/LCT emulsion-based PN after surgery for the same time period .


Immunological markers and inflammatory indicators were tested and perioperative clinical outcomes were determined .


The trial was registered in the Chinese Clinical Trial Register , number ChiCTR-TRC-@ @ Patients were recruited , and grouped ( olive oil-based LE , n = @ and MCT/LCT , n = @ ) , matched for sex , age , body mass index , histological type , TNM stage , and nutrition risk screening ( NRS ) @ score .


There were no differences in perioperative fever ( > @ C ) , infectious complications , length of hospital stay ( > @ days ) , length of critical care stay ( > @ days ) , time for oral food intake , and in-hospital mortality between the two groups .


The test group showed a higher increase in IgG level compared with the MCT/LCT group ( p = @ ) .


There was no difference in other immunological markers and inflammatory indicators between the two groups .


PN containing olive oil-based or MCT/LCT LEs had similar effects on perioperative outcome , cell-mediated immune function and inflammatory response in esophageal cancer patients who had undergone surgery and were receiving EN .


Cardiac surgery is accompanied by an increase of oxidative stress , a significantly reduced antioxidant ( AOX ) capacity , postoperative inflammation , all of which may promote the development of organ dysfunction and an increase in mortality .


Selenium is an essential co-factor of various antioxidant enzymes .


We hypothesized a less pronounced decrease of circulating selenium levels in patients undergoing off-pump coronary artery bypass ( OPCAB ) surgery due to less intraoperative oxidative stress .


In this prospective randomised , interventional trial , @ patients scheduled for elective coronary artery bypass grafting were randomly assigned to undergo either on-pump or OPCAB-surgery , if both techniques were feasible for the single patient .


Clinical data , myocardial damage assessed by myocard specific creatine kinase isoenzyme ( CK-MB ) , circulating whole blood levels of selenium , oxidative stress assessed by asymmetric dimethylarginine ( ADMA ) levels , antioxidant capacity determined by glutathionperoxidase ( GPx ) levels and perioperative inflammation represented by interleukin-@ ( IL-@ ) levels were measured at predefined perioperative time points .


At end of surgery , both groups showed a comparable decrease of circulating selenium concentrations .


Likewise , levels of oxidative stress and IL-@ were comparable in both groups .


Selenium levels correlated with antioxidant capacity ( GPx : r = @ ; p < @ ) and showed a negative correlation to myocardial damage ( CK-MB : r = -@ , p < @ ) .


Low postoperative selenium levels had a high predictive value for the occurrence of any postoperative complication .


OPCAB surgery is not associated with less oxidative stress and a better preservation of the circulating selenium pool than on-pump surgery .


Low postoperative selenium levels are predictive for the development of complications .


Post-operative nausea and vomiting is one of the most frequently occurring side effects affecting one third of the cases .


Objective of the study was to compare the efficacy of ondansetron alone and ondansetron plus dexamethasone in preventing postoperative nausea and vomiting after middle ear surgery .


This randomized controlled trial was conducted at the Anaesthesia and ENT departments of Ayub Medical College , Abbottabad from January-June @ .


Forty American Society of Anaesthesiologists ( ASA ) I and @ physical status patients undergoing middle ear surgery were divided into two groups by blocked randomization .


Patients in group-@ ( n = @ ) received ondansetron @ mg while group-II ( n = @ ) received ondansetron @ mg with dexamethasone @ mg just before start of operation .


The whole postoperative period of @ hours was divided into two phases , early @-@ hours and late phase @-@ hour .


Nausea score and its frequency was significantly higher in Group-I ( p < @ ) .


Vomiting and its frequency were found more in group-I patients .


In Group-II , the nausea score was significantly less ( p < @ ) at @ and @ hours after surgery .


The total incidence of vomiting was reduced from @ % in group-@ to @ % in group-II .


Rescue antiemetic requirement was significantly less ( p < @ ) in group-II .


Prophylaxis with a combination of ondansetron and dexamethasone decreased the incidence of nausea and vomiting after middle ear surgery .


Ulcerative colitis ( UC ) is a chronic , relapsing and remitting intestinal inflammatory disorder .


Zinc is known to be efficacious for the repair of damaged tissue and has been shown to protect against gastric ulceration .


This study focused on Polaprezinc ( PZ ) , N - ( @-aminopropionyl ) - L-histidinato zinc , which accelerates ulcer healing through actions such as prostaglandin-independent cytoprotection and antioxidative activity .


In this randomized , placebo-controlled , investigator-blinded trial , @ patients with active UC at The Jikei University Hospital were randomly divided into two groups : one treated with a @ mg PZ enema ( n = @ ) and the other not treated with a PZ enema ( n = @ ) .


All patients received usual induction therapy .


Clinical symptoms , endoscopic findings and histological findings were evaluated at entry and one week later .


In the PZ group , modified Matts ' endoscopic scores were significantly improved after treatment compared to baseline in the rectum ( p = @ ) , sigmoid colon ( p = @ ) and descending colon ( p = @ ) .


In the non-PZ group , scores were not significantly improved in the rectum ( p = @ ) and descending colon ( p = @ ) , but were improved in the sigmoid colon ( p = @ ) .


In the PZ group , the Mayo scores at baseline and at Day @ were @ @ and @ @ ( p = @ ) , respectively , and in the placebo group , the scores were @ @ and @ @ ( p = @ ) , respectively .


Clinical response or remission was significantly better in the PZ group ( @ % ) than in the placebo group ( @ % ) .


A zinc-carnosine chelate compound , PZ , enema may become a useful new add-on treatment to accelerate mucosal healing in UC .


Quantification of disease severity supports the development of evidence-based treatments .


Assessments to capture clinical improvement in hidradenitis suppurativa ( HS ) can be improved .


This study aimed to validate the Hidradenitis Suppurativa Clinical Response ( HiSCR ) , which is defined as a @ % reduction in inflammatory lesion count ( sum of abscesses and inflammatory nodules , AN ) , and no increase in abscesses or draining fistulas in HS when compared with baseline as a meaningful clinical endpoint for HS treatment .


Patients with @ ANs at baseline in a Phase II adalimumab trial for HS were included for analysis .


HiSCR achievers vs. nonachievers were assessed at week @ and week @ .


Criteria measures included physician-rated assessments -LSB- Hurley stage , modified Sartorius score ( MSS ) , and HS Physician 's Global Assessment -RSB- and patient-reported outcomes ( PROs : visual analogue pain scale , Dermatology Life Quality Index , and Work Productivity and Activity Impairment questionnaire ) .


Test-retest reliability , convergent validity , responsiveness and predictive validity of HiSCR , and its meaningfulness to patients were assessed .


Among @ eligible study participants , the majority were female ( @ % ) with a mean age of @ years .


The mean ( median ) MSS was @ ( @ ) at baseline .


Test-retest reliability of the AN count was @ .